pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Vorasidenib in Combination With Temozolomide (TMZ) in IDH-mutant Glioma
NCT Number: NCT06478212
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: IDH1-mutant Glioma|IDH2-mutant Glioma
Interventions: DRUG: Vorasidenib|DRUG: Temozolomide (TMZ)
Sponsor: Institut de Recherches Internationales Servier
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 45
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-12-02
Completion Date: 2028-01

Summary:
The objective of this study is to determine the safety and tolerability of vorasidenib in combination with temozolomide (TMZ) and to establish the recommended combination dose (RCD) of vorasidenib. The study will begin as a Phase Ib study to determine the RCD and then will transition to a Phase II study to assess the clinical efficacy of vorasidenib at the RCD in combination with TMZ. During the treatment period participants will have study visits on day 1 and 22 of each cycle, with additional visits occurring during the first cycle of the Phase 1b study. Approximately 30 days after treatment has ended, a safety follow-up visit will occur and then participants will be followed for survival every 3 months. Study visits may include questionnaires, blood tests, ECG, vital signs, and a physical examination.

Primary Outcome Measures: Phase 1b ONLY: Dose-limiting toxicities (DLTs), Through cycle 1 (each cycle is 28 days)|Number and severity of adverse events (AEs), serious adverse events (SAEs), and AEs of special interest (AESIs), Through 30 days after the end of treatment (Approximately 3 years)|Progression-free Survival (PFS) status at 12 months, 12 months after treatment initiation
Secondary Outcome Measures: PFS, Through study completion (Approximately 3 years)|Overall survival (OS), Through study completion (Approximately 3 years)|Objective response rate (ORR), Through study completion (Approximately 3 years)|Clinical benefit rate (CBR) (CR+partial response [PR]+stable disease [SD]), Through study completion (Approximately 3 years)|Plasma concentration of vorasidenib and its metabolite AGI-69460, Through cycle 13 (each cycle is 28 days)|Phase 1b ONLY: Plasma concentration of TMZ, Through cycle 2 (each cycle is 28 days)|Area under the curve (AUC) of vorasidenib and its metabolite AGI-69460, Through cycle 13 (each cycle is 28 days)|Time to maximum concentration (Tmax) of vorasidenib and its metabolite AGI-69460, Through cycle 13 (each cycle is 28 days)|Maximum concentration (Cmax) of vorasidenib and its metabolite AGI-69460, Through cycle 13 (each cycle is 28 days)|Trough concentration (Ctrough) of vorasidenib and its metabolite AGI-69460, Through cycle 13 (each cycle is 28 days)|Phase 1b ONLY: Area under the curve (AUC) of TMZ, Through cycle 2 (each cycle is 28 days)|Phase 1b ONLY: Time to maximum concentration (Tmax) of TMZ, Through cycle 2 (each cycle is 28 days)|Phase 1b ONLY: Maximum concentration (Cmax) of TMZ, Through cycle 2 (each cycle is 28 days)|Phase 1b ONLY: Trough concentration (Ctrough) of TMZ, Through cycle 2 (each cycle is 28 days)
PLR and NLR as Predictor Factors for Semen Abnormality
NCT Number: NCT06478199
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Abnormal Semen
Interventions: DIAGNOSTIC_TEST: semen analysis
Sponsor: Kafrelsheikh University
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2025-07-01
Locations: Kafrelsheikh University hospital, Kafr Ash Shaykh, Egypt

Summary:
The aim of this study was to evaluate the relationship of seminal parameters with the neutrophil-to-lymphocyte ratio (NLR) and the platelet-to-lymphocyte ratio (PLR), which are inflammatory markers, in men with an abnormal semen analysis and men with normozoospermia.

Primary Outcome Measures: result of labs, cbc and semen analysis, 1 day
Closed-blood Sampling Devices in the Adult Critically Ill Patient
NCT Number: NCT06478160
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Acceptability of Health Care
Interventions: DEVICE: Closed-Blood Sampling Devices|OTHER: Waste discard volume
Sponsor: University of Barcelona
Collaborators: Hospital Universitario 12 de Octubre|Hospital Universitario Rey Juan Carlos|Hospital General Universitario Gregorio Marañon|Hospital Universitario Virgen Macarena
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 216
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-11-04
Completion Date: 2026-04-07

Summary:
Based on the hypothesis that the strategy of using Closed-Blood Sampling Devices (CSBD, experimental group) compared to the usual practice (waste discard volume, control group), in critically ill adult patients, will decrease the amount of blood withdrawn for laboratory tests, we want to analyze the number of red blood cells (RBC) administered and arterial catheter-related adverse events (catheter-related bacteremia, catheter obstruction, CBSD malfunction, loss of arterial pressure waveform on the patient's bedside monitor) in both study groups, during ICU stay and up to a maximum of 21 days.

Primary Outcome Measures: Units of red blood cells transfusion, Number of red blood cells (RBC) units administered in both study groups, Every day during the ICU stay and up to a maximum of 21 days after randomization (day 0)
Secondary Outcome Measures: Volume of blood drawn, Volume of blood drawn in mL for laboratory testing in both study groups, Every day during ICU stay and up to a maximum of 21 days after randomization (day 0).|Levels of hemoglobine and hematocrit, Hemoglobin (Hb) in g/dL and hematocrit (%) in both study groups, Every day during ICU stay and up to a maximum of 21 days after randomization (day 0).|Number and type of adverse events, Arterial catheter-related adverse events in both groups (infection and/or catheter obstruction; lose of arterial pressure monitoring), Every day during the stay and up to a maximum of 21 days after randomization (day 0):
Efficacy and Safety of a Multiple-Action Tear Substitute (TriMix) in Dry Eye Disease
NCT Number: NCT06478134
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE2|PHASE3
Conditions: Dry Eye
Interventions: DRUG: Trimix tear substitutes|DRUG: Hyaluronic acid tear substitute
Sponsor: University of Seville
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 124
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-07-01
Completion Date: 2024-05-01
Locations: Novovision ophthalmologic clinic, Murcia, 30009, Spain

Summary:
The objective of the study is to assess the efficacy and safety of TriMix tear substitute in patients with dry eye disease. For this purpose, a randomized, double-blind clinical trial has been designed, using an Hyaluronic acid-based tear substitute as a control.

Primary Outcome Measures: Ocular surface disease index questionnaire, The OSDI questionnaire were employed to assess the severity of DED symptoms, with scores ranging from 0 (indicating no ocular surface disease) to 100 (indicating severe ocular surface disease) points. This questionnaire was provided during consultations at each follow-up visit., This outcome measure was analyzed at baseline, 3 months and 6 months.|Non-invasive tear film break-up time, Tear film stability was automatically assessed using NIBUT by projecting Placido rings from the Sirius device (CSO, Florence, Italy) onto the corneal surface. The time interval between the last blink and the initial distortion of the ring pattern was defined as first NIBUT. This variable was always measured at least 12 hours after administration of the study medication and the average of 3 consecutive measurements was calculated for statistical analysis., This outcome measure was analyzed at baseline, 3 months and 6 months.|Schirmer I test without anesthesia, During the test, the patient is instructed to look upward while the test strip is carefully positioned between the palpebral conjunctiva of the lower eyelid and the bulbar conjunctiva. Subsequently, the patient is asked to keep their eyes gently closed for five minutes. After this period, the test strip is removed, and the Schirmer test score is determined by measuring the length of the moistened area on the strip., This outcome measure was analyzed at baseline, 3 months and 6 months.
Understanding Beta Cell Disorders Through the Study of Rare Genotypes (ENDURE)
NCT Number: NCT06478121
Acronym: ENDURE
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Diabetes Mellitus|Monogenic Diabetes|Hyperinsulinism
Interventions: OTHER: Data and Blood collection|OTHER: MRI
Sponsor: University of Exeter
Collaborators: Royal Devon University Healthcare NHS Foundation Trust
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-20
Completion Date: 2029-02-28
Locations: Royal Devon University Healthcare NHS Foundation Trust, Exeter, Devon, EX2 5DW, United Kingdom

Summary:
This observational 'recruit by genotype' study aims to provide insights into the cellular and molecular pathways underlying beta cell disorders and their physiological consequences. Eligible individuals are those with and without a pathogenic genetic variant, acting as case and control, respectively. Using a "recruit by genotype" approach, the researchers will perform detailed and specific analysis according to the individual's genetic variant.

The study's main aims are to : 1) identify and describe biomarkers and cellular features in blood samples that occur because of the rare causal genetic variant; 2) study the altered physiology or cellular function that are due to the rare causal genetic variant.

Participants will attend a study visit that will entail:

* Consent
* Data collection
* Height and weight measures
* Blood samples
* MRI (optional), dependent on genotype and sub-study objectives.

There is no treatment and the participants' normal clinical care will be unaffected and will continue uninterrupted.

A small subset of participants may be invited for further sub-studies in the future. Researchers may recruit sex-matched healthy controls (without the variant of interest) with similar age and BMI (age: +/-15%, BMI: +/- 3 kg/m2) for specified case-control studies.

Primary Outcome Measures: Identification and description of biomarkers or cellular features associated with specific rare causal genetic variants., Study of cellular features (assessing gene and protein expression by relevant methodologies, including RNA sequencing and Flow Cytometry) in blood samples that occur because of the rare causal genetic variant., 5 years|Identification of alterations in physiological function with specific rare genetic variants., Study of the altered physiology (assessed by magnetic resonance imaging) or cellular function (biochemical assessment of pancreatic hormones/enzymes) that are due to the rare causal genetic variant., 5 years
Interventional Software for Multi-immunotherapy of Solid Tumors
NCT Number: NCT06478108
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2|PHASE3
Conditions: Lung Cancer|Liver Cancer|Solid Tumor, Adult
Interventions: DEVICE: IRSW-MIM
Sponsor: Second Affiliated Hospital of Guangzhou Medical University
Collaborators: Immuno (Guangzhou) Biomedicine S&T Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-04-01
Completion Date: 2033-12-30
Locations: Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China

Summary:
This trial is designed to investigate the safety, response rates and survival outcomes of patients with advanced solid tumors by intra-tumor (IT) injection of multiple drugs including CTLA4, PD1, and/or PDL1 antibodies combined with drugs-eluting beads loaded with IL2, chemodrug, anti-angiogenesis drug, et. al that will be recommended by an AI-based medical software named IRSW-MIM developed by a cooperating company.

Primary Outcome Measures: Safety of the reccommended treatment generated by the medical device, Safety will be assessed by recording all types of advise effects upon and after the treatment., 5 years|Progression-free survival, Progression-free survival (PFS) will be defined as the elapsed time from the first date of study treatment until documented disease progression (as per RECIST 1.1) or death from any cause, whichever is earlier. For patients who remain alive without progression, follow-up time will be censored at the date of last disease assessment., 5 years|Disease control rate, Disease control rate will be defined as objective response rate + steady disease rate., 5 years|Duration of remission (DOR), DOR will be defined as the duration of the cancer remission, 5 years
Secondary Outcome Measures: Overall survival, Overall survival (OS) will be defined as the elapsed time from the enrollment to death from any cause. For surviving patients, follow-up will be censored at the date of last contact (or last date known to be alive). Follow-up for OS will occur every 12 weeks (±1 month) until death or withdrawal of consent from the study., 5 years
Preoperative Visual Aids on Glaucoma Surgical Patients
NCT Number: NCT06478095
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Anti-Glaucoma Medications
Interventions: BEHAVIORAL: Visual aids
Sponsor: Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong
Collaborators: Shantou University Medical College
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 133
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (CARE_PROVIDER)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2023-03-08
Completion Date: 2024-03-28
Locations: Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong, Shantou, Guangdong, 515041, China

Summary:
This study aims to evaluate the impact of preoperative visual aids on anxiety and pain management in patients with low educational backgrounds undergoing glaucoma filtration surgery.

Primary Outcome Measures: Anxiety levels, pain scores, blood pressure, and pulse rates, measured at multiple time points, 1 day prior to surgery; 30 minutes prior to surgery; 5 minutes after the onset of surgery; the conclusion of the surgical procedure
Postural Assessment of Stroke Patients by Pose Estimation and Effects of Dynamic Core Postural Chain Stabilization
NCT Number: NCT06478069
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stroke
Interventions: DIAGNOSTIC_TEST: Group A|BEHAVIORAL: Group B
Sponsor: Superior University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2023-10-01
Completion Date: 2024-09-30
Locations: Sevices Hospital Shadman 1, Lahore, Punjab, Pakistan

Summary:
This study focuses on a two-pronged strategy to enhance the rehabilitation of stroke patients. It first investigates the application of pose estimating technologies to objectively measure posture.

Primary Outcome Measures: Berg Balance Scale, For evaluating balance in a variety of functional tasks, the BBS is a commonly used and validated test. After the intervention period, the BBS scores of the control group and the intervention group (who received DCS techniques) can be compared. The efficacy of DCS in enhancing postural control would be strongly supported by a statistically significant increase in the intervention group's BBS score., 12 Months|Trunk Impairment Scale (TIS) Score, The total score for TIS ranges between 0 for a minimal performance to 23 for a perfect performance. In a recent version of the TIS (version 2.0) for adults, the static subscale was removed because of a ceiling effect, total score ranges between 0 and 16 points, 12 months
Correlation of Portal and Peripheral Venous ctDNA in Pancreatic Adenocarcinoma
NCT Number: NCT06478056
Acronym: VEINOPAN
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pancreatic Cancer
Interventions: PROCEDURE: pancreatectomy
Sponsor: University Hospital, Rouen
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-04-29
Completion Date: 2026-04-29
Locations: University Hospital, Rouen, Rouen, 76031, France

Summary:
This study aims to evaluate the prognostic impact of the detection of circulating tumor DNA in peripheral venous blood, portal venous blood, collected intraoperatively, as well as its detection in peritoneal fluid.

Primary Outcome Measures: level of ctDNA, the level of ctDNA measured in peripheral venous and portal blood before and after mobilization of the specimen during surgery, Surgery
Secondary Outcome Measures: level of ctDNA, ctDNA levels measured in peripheral venous and portal blood before and after mobilization of the specimen during surgery, surgery|peritoneal ctDNA level, ctDNA levels measured in peritoneal fluid during surgery., surgery
A Study to Investigate the Efficacy and Safety of Ivonescimab Combined With Irinotecan Liposome as Second-line Regimen for ES-SCLC
NCT Number: NCT06478043
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Extensive-stage Small-cell Lung Cancer
Interventions: DRUG: ivonescimab|DRUG: irinotecan liposome
Sponsor: Zhejiang Cancer Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 54
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2027-09-01
Locations: Zhejiang Cancer Hospital, Hangzhou, Zhejiang, 310022, China

Summary:
This is an open-label, single-arm, prospective phase 2 study, evaluating the efficacy and safety of ivonescimab combined with irinotecan liposome for relapsed extensive stage small cell lung cancer, who progressed on PD-(L)1 -based first-line therapy.

Primary Outcome Measures: Objective response rate（ORR）, Objective response rate (ORR) is defined as the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1., Interval between the date of enrollment and the date of death from any cause, up to approximately 2 years
Secondary Outcome Measures: Incidence of Grade 3 or higher adverse events (AEs), Frequency and severity of adverse events measured according to NCI Common Toxicity Criteria Adverse Event (CTCAE), version 5.0., Interval between the date of enrollment and the date of death from any cause, up to a maximum of 2 years|Disease control rate (DCR), DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥8 weeks), based on RECIST v1.1., Interval between the date of enrollment and the date of death due to any cause , up to a maximum of approximately 2 years|Duration of Response (DOR), DOR is defined as the duration from the first documentation of objective response to the first documented disease progression (based on RECIST v1.1) or death due to any cause, whichever occurs first., Interval between the date of enrollment and the date of death from any cause, up to a maximum of 2 years|Progression free survival (PFS), PFS is defined as the time from the date of first dosing till the first documentation of disease progression (per RECIST v1.1) assessed by the investigator or death due to any cause (whichever occurs first)., Interval between the date of enrollment and the date of progressive disease, or death due to any cause (whichever occurs first), up to a maximum of 2 years|Overall survival (OS), OS is the time from the date of randomization or first dosing date to death due to any cause., Interval between the date of enrollment and the date of death from any cause, up to a maximum of 2 years
Combined Screening for Gastrointestinal Tumors
NCT Number: NCT06478030
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Gastrointestinal Tumors
Interventions: DIAGNOSTIC_TEST: questionnaire, Helicobacter pylori (H. pylori) test, fecal immunochemical test (FIT)
Sponsor: Zhejiang Cancer Hospital
Collaborators: Fenghua District People's Hospital, Ningbo City|Fenghua District Traditional Chinese Medicine Hospital, Ningbo City|Xikou Hospital in Fenghua District, Ningbo City
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-03-01
Completion Date: 2028-12-31
Locations: Fenghua District, Ningbo, Zhejiang, 315500, China

Summary:
All participants are required to complete a questionnaire, a Helicobacter pylori (H. pylori) test, and a fecal immunochemical test (FIT). The questionnaire covers nine aspects: basic information of the participants, symptoms and previous examinations, medical history and surgical history, medication history, smoking history, alcohol consumption history, dietary habits, physical exercise, and family history. After quality control, the data is entered by staff into the Zhejiang Province Cancer Screening Information Platform. Combining the results of the Helicobacter pylori test and the fecal immunochemical test, the system identifies high-risk individuals who need clinical screening. Additionally, stool, urine, blood, tongue coating, saliva, tongue appearance, gastric juice, and fresh tissue (gastric mucosa tissue and/or intestinal polyp tissue) samples are collected from all participants undergoing clinical screening.

Participants are required to complete at least one passive follow-up annually. Active follow-ups are conducted for those with positive screening results to ensure timely completion of endoscopic examinations. For those who have not undergone endoscopic examinations despite positive screening results, health education is provided, and they are mobilized to complete at least four endoscopic examinations within one month. For participants diagnosed and treated for precancerous lesions and tumors, diagnostic and treatment data must be collected, and they are encouraged to follow up as per medical advice. Both active and passive follow-up results must be recorded in the screening follow-up information record form and reported to the Zhejiang Province Cancer Screening Information Platform.

This is a government collaboration project. All subjects will also be followed by record linkage to Cancer Register and Population Register.

Primary Outcome Measures: Combined screening assessment results, Systematically assessed based on questionnaire information combined with Helicobacter pylori test and fecal immunochemical test results., 5 years
Secondary Outcome Measures: Early diagnosis rate of gastrointestinal tumors, To compare the early diagnosis rates of gastrointestinal tumors using different biomarkers., 5 years
The Efficacy of Watch and Wait Strategy or Surgery After Neoadjuvant Immunotherapy for Locally Advanced Colorectal Cancer With dMMR/MSI-H Guided by MRD Dynamic Monitoring: A Single-center, Open-label, Prospective, Phase II Clinical Trial.
NCT Number: NCT06477991
Acronym: WINDOW
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Clinical Complete Response Rate With Negative MRD
Interventions: DRUG: Tireilizumab（PD-1 inhibitor）
Sponsor: Yunnan Cancer Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 22
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-10-30
Completion Date: 2026-10-30
Locations: Yunnan Cancer Hospital, Kunming, Yunnan, 650118, China

Summary:
This study is a single arm, single center, phase II, prospective clinical study aimed at exploring the effectiveness and safety of watch and wait strategy guided by dynamic minimal disease residual (MRD) monitoring to achieve clinical complete response after neoadjuvant immunotherapy for locally advanced colorectal cancer with deficient mismatch repair/ microsatellite instability-high (dMMR/MSI-H).

Primary Outcome Measures: Clinical complete response rate with negative MRD, Clinical complete response rate with negative MRD, 2023/10/30-2026/10/30
The Prevalence of Sarcopenia in a Cohort of Haemodialysis Patients and Its Correlation With Mortality
NCT Number: NCT06477978
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: End-stage Kidney Disease|End-stage Renal Disease|Dialysis Dependent Chronic Kidney Disease|Sarcopenia
Interventions: DIAGNOSTIC_TEST: Hand grip function testing
Sponsor: Kasr El Aini Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 274
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2021-02-15
Completion Date: 2023-03-15
Locations: Kasr Alainy University Hospitals, Cairo, Egypt

Summary:
The study aims to explore the correlation between the prevalence of sarcopenia and one year mortality amongst patients on maintenance hemodialysis

Primary Outcome Measures: One year mortality, All cause mortality of patients with end stage kidney disease on hemodialysis, One year
Embo Registry; National Registry for Artery Embolization
NCT Number: NCT06477965
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Chronic Pain|Osteoarthritis, Knee|Osteoarthritis Thumb|Osteoarthritis Shoulder|Pain, Chronic|Tendonitis Elbow|Tendonitis Shoulder|Tendonitis;Achilles|Tenosynovitis
Interventions: PROCEDURE: Artery Embolization
Sponsor: Vascular Solutions of North Carolina
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-15
Completion Date: 2029-07-15
Locations: Vascular Solutions of North Carolina, Cary, North Carolina, 27518, United States

Summary:
Embo Registry is a retrospective and prospective observational study to evaluate real world effectiveness and the use of Artery Embolization as a treatment for chronic pain with patients that have osteoarthritis and localized pain to provide symptomatic relief. This study is to determine the efficacy and validity of procedure and that following procedure patients had decreased pain and improved quality of life.

Primary Outcome Measures: Primary Outcome, Clinical success at 3 months, defined as improvement in Western Ontario and McMaster University (WOMAC) Pain Subscale from pre-operative/baseline WOMAC scores., 3 months|Primary Outcome, Clinical success at 3 months, defined as improvement of Visual Analog Scale (VAS) Scores from pre-operative/baseline scores., 3 months|Primary Outcome, Comparative assessment at 3 months of decreased use of medication prescribed at baseline to 3 months post operatively., 3 months|Primary Outcome, Clinical success at 3 months, as defined by improvement in the quality of life using the EQ-5D-5L Quality of Life Questionnaire compared to baseline., 3 months
Secondary Outcome Measures: Secondary Outcome, Number of patients achieving clinical success at 1,3, 6, and 12-months post procedure., 12 months|Secondary Outcome, Decrease in Western Ontario and McMaster University (WOMAC) index compared to baseline, 1, 3, 6, and 12 months., 12 months|Secondary Outcome, Pain score assessed using Visual Analog Scale (VAS) Score from baseline, 1, 3, 6, and 12 months., 12 months|Secondary Outcome, Number of subjects who had pain reduction \>50% in the mean VAS pain scale at 1, 3, 6 and 12 months in comparison with baseline/preprocedural assessments., 12 months|Secondary Outcome, Change in the use of narcotics or non-steroidal anti-inflammatory drugs (NSAID's) compared to baseline through 1, 3, 6, and 12 months., 12 months|Secondary Outcome, Change in quality of life using the EQ-5D-5L Quality of Life Questionnaire compared to baseline through 1, 3, 6, and 12 months., 12 months|Secondary Outcome, Number of patients with confirmed cases of osteoarthritis with a Kellgren and Lawerence Grade Level 2-3 (confirmed by X-Ray) improved symptoms compared to baseline through to 1, 3, 6 and 12-months post procedure., 12 months
Study of Adding or Not Liposomal Transcrocetin (L-TC) With Concomitant HypoFractionated Radiation ThErapy and TEmozolomide in Newly Diagnosed GLioblastoma (GBM) Patients
NCT Number: NCT06477939
Acronym: THREE-GLEES
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Glioblastoma
Interventions: DRUG: Administration of L-TC|OTHER: Radiotherapy plus Temozolomide
Sponsor: Institut de cancérologie Strasbourg Europe
Collaborators: LEAF4Life, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 554
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-01-01
Completion Date: 2032-12-31
Locations: Institut de cancérologie Strasbourg Europe, Strasbourg, 67033, France

Summary:
This is phase III randomized, multicenter study adding or not intra-venous Liposomal Trasncrocetin (L-TC) to hypofractionated radiotherapy and concomitant Temozolomide followed by adjuvant Temozolomide in patients with histologically confirmed diagnosis of glioblastoma (GBM).

Primary Outcome Measures: Overall Survival, Overall Survival (OS) is defined as the length of time from the date of tumor resection surgery or definitive biopsy to the date of death., Up to 24 months
Secondary Outcome Measures: Progression-Free Survival (PFS), RANO criteria will be used to evaluate response, Up to 24 months|Evaluation of hypoxia markers, Hypoxia imaging markers between two groups: comparison of volumetric metrics, Up to 24 months|Quality of life, European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Core Quality of Life Questionnaire (QLQ-C30), Up to 24 months|Quality of life (GBM module), EORTC 20-Item QOL-Brain Neoplasm (QLQ-BN20), Up to 24 months|Quality of life (specific for elderly population), Quality-of-Life Questionnaire EORTC Elderly Cancer Patients (EORTC QLQ-ELD14), Up to 24 months|Tolerance, EORTC Elderly Cancer Patients (EORTC QLQ-ELD14), Up to 24 months
A Study to Assess Relative Bioavailability and Food Effect of ABBV-668 Extended-Release Formulations in Adult Participants
NCT Number: NCT06477926
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy Volunteers
Interventions: DRUG: ABBV-668 IR|DRUG: ABBV-668 ER
Sponsor: AbbVie
Sex: ALL
Age: ADULT
Enrollment: 25
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-07-09
Completion Date: 2024-09-19
Locations: Acpru /Id# 266960, Grayslake, Illinois, 60030, United States

Summary:
The objectives of this study are to assess safety and tolerability of the new ABBV-668 ER tablets, to assess the oral bioavailability of the ABBV-668 ER tablets relative to the ABBV-668 IR capsules, and to assess the pharmacokinetics of the ER tablets under fasting and fed conditions in healthy adults.

Primary Outcome Measures: Maximum Plasma Concentration (Cmax) of ABBV-668, Cmax of ABBV-668, Up to approximately 47 days|Time to Cmax (Tmax) of ABBV-668, Tmax of ABBV-668, Up to approximately 47 days|Terminal Phase Elimination Rate Constant (Beta) of ABBV-668, Terminal phase elimination rate constant (beta) of ABBV-668, Up to approximately 47 days|Terminal Phase Elimination Half-Life (t1/2) of ABBV-668, Terminal phase elimination half-life of ABBV-668, Up to approximately 47 days|Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of ABBV-668, AUCt of ABBV-668, Up to approximately 47 days|Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-688, AUCinf of ABBV-688, Up to approximately 47 days|Number of Participants With Adverse Events (AEs), An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study, Up to Day 47
Impact of SMS Reminder on Weight Loss, as Part of a Health Pathway in Patients With Prediabetes (PREDIABCOACH)
NCT Number: NCT06477900
Acronym: PREDIABCOACH
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: PreDiabetes
Interventions: OTHER: SMS reception
Sponsor: Centre Hospitalier Universitaire de la Réunion
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-09
Completion Date: 2028-09
Locations: Territorial Health Professional Community (CPTS) Grand Sud, Saint-Philippe, 97442, Réunion

Summary:
The goal of this interventionnal study is to demonstrate that sending SMS messages with advice on physical activity or nutrition, in addition to a program of hygienic-dietary management, significantly increases weight loss in subjects with prediabetes in La Réunion.

Indeed, type 2 diabetes is a priority health problem on Reunion Island: 10% of the population are treated for type 2 diabetes, twice as many as in France.

International studies have demonstrated the value of modifying dietary and physical activity habits to reduce the risk of transition to diabetes in patients with prediabetes Against this backdrop, a Regional Nutrition Diabetes Program (PRND) 2020-2023 was launched by Réunion's Regional Health Agency (ARS) in 2020.

Studies have also demonstrated the effectiveness of using SMS to encourage and support weight loss interventions.

So, the main question it aims to answer are:

• Does the addition of 72 SMS of physical activity and nutriton advice, to the "FindRisc Péi-CPTS" program, significantly increase weight loss by 3% after 6 months of starting the program.

FindRiscPei-CPTS program includes sports sessions, dietary consultations and therapeutic education.

The 300 participants will be randomized into two arms

* 150 participants will take part in the FindRiscPei-CPTS program + receive SMS messages
* 150 participants will only take part in the FindRiscPei-CPTS program (no SMS)

All participants will follow procedures below:

* Inclusion: assessment of weight and waist circumference, Lifestyle Questionnaire and Socio-Efficacy Questionnaire.
* Participation in Findrisk program for 3 to 9 months (+ SMS for experimental group)
* 3 follow-up visits: 3 months, 6 months and 9 months after starting the program: weight and waist measurement, self-efficacy questionnaire.

Primary Outcome Measures: Weight loss > 3%, Proportion of patients with weight loss greater than or equal to 3% at T1+6 months (comparison between FindRisc Pei-CPTS program + SMS intervention versus FindRisc Pei-CPTS program alone)., 6 month
Assessment of Implants Placed in Consolidated Graft With Different Bone Drills.
NCT Number: NCT06477874
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Implant Complication|Bone Graft; Mechanical Complications
Interventions: PROCEDURE: Dental implants placement
Sponsor: Beni-Suef University
Sex: ALL
Age: ADULT
Enrollment: 12
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-09
Completion Date: 2025-04-01
Locations: Department of Oral and Maxillofacial Surgery, Faculty of Oral and Dental Medicine, Modern University for Technology & Information., Cairo, Egypt

Summary:
The anterior iliac crest is a popular source of bone harvest. However, when fused to the intramembranous jaw bones, it yields low-density bones that qualitatively and quantitatively endanger the fixture's stability.

In 1994, Summers first documented using the bone-condensing approach to improve the primary stability of dental implants.

This study aims to determine whether osseodensifying the consolidated mandibular bone grafts will improve implant stability and marginal bone loss

Primary Outcome Measures: Radiographic bone loss, Calibration of the amplitude of vertical bone loss, 6 months osseointegration period
Secondary Outcome Measures: Implant stability, Calibration of primary and secondary implant stability quotient, 6 months osseointegration period
The Role of Elastic Power in Predicting the Severity and Mortality in Adult Patients With ARDS Due to Pneumonia
NCT Number: NCT06477861
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Acute Respiratory Distress Syndrome
Interventions: OTHER: calculation of the elastic power of the lung in case of the ARDS and corolating with the severity index of Berline definition of ARDS in respect to mortality and severity
Sponsor: Benha University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 70
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-24
Completion Date: 2024-10-24
Locations: Banha University Hospital, Banhā, Al Qalubeyah, Egypt

Summary:
the role of elastic power in the prediction of severity and mortality in adults with ARDS secondary to pneumonia

Primary Outcome Measures: 28 day mortality, - survivors are defined as patients who are discharged from ICU or survive beyond 28 days, 28 days
Secondary Outcome Measures: elastic power normalized to compliance, investigators will compare the results of the elastic power and the elastic power normalized to compliance with the current criteria of Berlin definition of the severity of ARDS depending on the PO2/FiO2 ratio and the expected mortality to determine which is more accurate in prediction of severity and mortality. Investigators will compare the predicted values of Berline definition in regards to mortality with the values obtained from the elastic power and the elastic power corrected to compliance equations to investigate which was more reliable and accurate., 28 days
A Study to Evaluate the Efficacy and Safety of SIM0718 in Adult and Adolescent Patients With Moderate to Severe Atopic Dermatitis
NCT Number: NCT06477835
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Atopic Dermatitis
Interventions: BIOLOGICAL: SIM0718 Injection
Sponsor: Simcere Pharmaceutical Co., Ltd
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 250
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-10-15
Completion Date: 2026-07-31

Summary:
This study will evaluate the efficacy and safety of SIM0718 in adolescents (12- \< 18 years) and adults (18-75 years) with moderate to severe AD.

Primary Outcome Measures: EASI-75 at week 16, Proportion of subjects achieving EASI-75 at week 16., Day1-Week16|IGA score at week 16, Proportion of subjects with IGA score of 0 or 1 and a reduction of IGA score by ≥2 points from baseline at week 16., Day1-Week16
Secondary Outcome Measures: EASI-75 at each visit, Proportion of subjects achieving EASI-75 at each visit, Day1-Week52|EASI-50 at each visit, Proportion of subjects achieving EASI-50 at each visit, Day1-Week52|EASI-90 at each visit, Proportion of subjects achieving EASI-90 at each visit, Day1-Week52|NRS score, Percent change of NRS score from baseline, Day1-Week52|BSA, Body surface area (BSA) of involvement of atopic dermatitis, Day1-Week52|DLQI, Changes from baseline in Dermatology Life Quality Index (DLQI), Day1-Week52|Incidence of adverse events (AEs), Incidence of adverse events (AEs), abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing, Day1-Week60
Effect of a Sequence of Specific Manual Therapy Techniques Targeting the Autonomic Nervous System in Healthy Adults
NCT Number: NCT06477822
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Autonomic Imbalance
Interventions: PROCEDURE: Sequence of manual therapy techniques|PROCEDURE: Simulated manual therapy techniques
Sponsor: Universitat Internacional de Catalunya
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 96
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-05-23
Completion Date: 2024-12-28
Locations: Universitat Internacional de Catalunya, Sant Cugat Del Vallès, Barcelona, 08195, Spain

Summary:
The activity of the autonomic nervous system has been shown to influence the appearance of symptoms in some diseases such as rheumatoid arthritis, fibromyalgia, or migraine, among others. In the bibliography we find different authors who, through intervention using manual therapy, have demonstrated its effects on the autonomic nervous system, especially on the increase in parasympathetic activity and reduction in sympathetic activity. A clinical trial is proposed to verify these effects.

Primary Outcome Measures: Heart rate, The investigators will examine the difference between Time 1 and Time 2 and between groups in beats per minute., Day 1|Root mean square of the successive differences between adjacent RR intervals (RMSSD) in heart rate variability index, The investigators will examine the difference between Time 1 and Time 2 and between groups in HRV measured by Root mean square of the successive differences between adjacent RR intervals (RMSSD) in heart rate variability index, Day 1
Secondary Outcome Measures: High frequency (HF) band in heart rate variability index, The investigators will examine the difference between Time 1 and Time 2 and between groups in HRV measured by high frequency (HF) band in heart rate variability index ., Day 1|Respiratory rate, The investigators will examine the difference between Time 1 and Time 2 and between groups in breaths per minute., Day 1|Incidence of Treatment-Emergent Adverse Events, The investigators register if an adverse effect is present during the intervention or just after the intervention., Day 1
Improving Sleep in Veterans With the Polytrauma Clinical Triad
NCT Number: NCT06477796
Acronym: LIONv2
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Traumatic Brain Injury|Post-traumatic Stress Disorder|Chronic Pain
Interventions: DEVICE: Morning Bright Light Therapy|DEVICE: Negative Ion Generator
Sponsor: VA Office of Research and Development
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 138
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2025-05-01
Completion Date: 2028-09-29
Locations: VA Portland Health Care System, Portland, OR, Portland, Oregon, 97207-2964, United States

Summary:
The "polytrauma clinical triad" (PCT), a highly disabling constellation of factors, is defined by the coexistence of traumatic brain injury, post-traumatic stress disorder, and chronic pain. Veterans with the PCT are medically complex, often refractory to conventional therapies, and suffer from additional related chronic sequela. Notably, sleep disturbances and cognitive impairment, which the investigators hypothesize are significant contributing factors to these functional impairments and an impediment toward rehabilitation. Thus, the investigators' research aims to intervene "at the level of sleep", and by improving sleep, improve these interconnected, disabling, and difficult to treat enduring complexities associated with the PCT - ultimately to improve Veteran quality of life, functional independence, and restorative function. The investigators predict that the proposed intervention, morning bright light therapy, which is cost-effective, rapidly deployable and home-based, will be effective in improving sleep and overall PCT symptom management, thereby, resulting in a measurable and impactful improvement in quality of life.

Primary Outcome Measures: Sleep Efficiency via wrist based actigraphy, Sleep efficiency is defined by the total time asleep divided by total time spent in bed, Pre- and post-4 weeks of MBLT or sham treatment
Secondary Outcome Measures: Self-reported sleep quality via the Pittsburgh Sleep Quality Index, The Pittsburgh Sleep Quality Index is a validated questionnaire assessing metrics related to sleep quality., Pre- and post-4 weeks of MBLT or sham treatment
Study on the Clinical Efficacy of Teclistamab
NCT Number: NCT06477783
Acronym: TECTONIC
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Multiple Myeloma|Hematologic Diseases
Interventions: DRUG: Teclistamab
Sponsor: Universitaire Ziekenhuizen KU Leuven
Collaborators: Janssen Pharmaceutica
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2027-09
Locations: UZ Leuven Gasthuisberg, Leuven, 3000, Belgium

Summary:
The aim of this study is to assess the clinical efficacy and safety of the anti-BCMA/CD3 bispecific antibody teclistamab (Tecvayli®) in a prospective, real-life setting in Belgium.

Primary Outcome Measures: Overall response rate, The primary objective is the overall response rate (partial response (PR) or better) according to the 2016 IMWG response criteria of Multiple myeloma., At baseline, monthly until end of study (maximum 24 months)
Secondary Outcome Measures: Progression-free survival (PFS), The length of time during and after the treatment during which a patient lives with the disease but it does not get worse., At baseline, monthly until end of study (maximum 24 months)|Overall survival (OS), Duration of time between start of the treatment and up to the time of death., At baseline, monthly until end of study (maximum 24 months)|Incidence of (serious) adverse events, Incidence and severity of (serious) adverse events with with focus on hematological AE's (≥ grade 3), cytokine release syndrome (CRS) rate, Immune effector cell-associated neurotoxicity syndrome (ICANS) and infections (≥ grade 2) and serious adverse events related to teclistamab (Tecvayli®)., At baseline, monthly until end of study (maximum 24 months)|Depth of response, Evaluation of response in terms of depth. Assessment of response according to the 2016 IMWG response criteria of Multiple myeloma., At baseline, monthly until end of study (maximum 24 months)|Time to response (TTR), Assessment of the time it takes for a patient to achieve partial response (PR) or better., At baseline, monthly until end of study (maximum 24 months)|Duration of response, Assessment of the length of time during which a patient experiences a partial response (PR) or better. It is measure from the start of treatment until disease progression or death., At baseline, monthly until end of study (maximum 24 months)|Minimal Residual Disease (MRD) assessment, Evaluation of treatment efficacy by monitoring for the presence of a small number of cancer cells that are left in the body. MRD assessment will be done with Next Gen Flow (NGF) or Next Gen Sequencing (NGS)., At suspected CR, every 6 months thereafter until end of study (maximum 24 months)|Time to next treatment (TTNT), Assessment of the time interval between initiation of treatment with Tecvayli® and commencement of the next line of therapy., At baseline, monthly until end of study (maximum 24 months)