pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Efficacy and Safety of Chemotherapy Combined With CAR-T Cells in Newly Diagnosed Adult Patients With Ph- B-ALL
NCT Number: NCT06481241
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Philadelphia Chromosome Negative ALL|Acute Lymphoblastic Leukemia, Adult
Interventions: COMBINATION_PRODUCT: CAR-T cells|DRUG: Venetoclax
Sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 77
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06
Completion Date: 2028-06
Locations: Institute of Hematology & Blood Diseases Hospital, Tianjin, 300020, China

Summary:
In recent years, immunotherapy (eg. blinatumomab, inotuzumab ozogamicin, CAR-T cells) has demonstrated a high safety and efficacy profile in relapsed/refractory (R/R）B-ALL. The available data suggest that the advancement of immunotherapy from relapsed/refractory (R/R) field to the frontline setting may be an important approach to increase the depth of remission, which ultimately translates into a survival benefit. In this study, the investigators propose a treatment regimen using CAR-T cell therapy as a consolidation method for Ph- B-ALL patients achieving complete remission (CR) with chemotherapy, aiming to reduce the total cycles of chemotherapy and related toxicities, shorten length of hospitalization, and ultimately improve patients' survival and quality of life.

Primary Outcome Measures: Disease-free Survival (DFS), From CR1 to relapse, death from any cause or last follow-up, Up to 2 years post-registration
Secondary Outcome Measures: MRD-negative complete remission rate measured by flow cytometry., No blasts were detected by flow cytometry when CR criteria were met after induction therapy., After induction (4 week)]|Overall survival (OS), From the date of registration to the date of death resulting from any cause., Up to 5 years post-registration|Event-free survival (EFS), From the date of registration to the date of induction failure, relapse, death from any cause, or last follow-up, Up to 5 years post-registration|MRD-negative complete remission rate measured by NGS tracking clonal IG/TR rearrangements, No clonal IG/TR rearrangements were detected by NGS, Up to 1 year post-registration|Cumulative incidence of relapse (CIR), Calculated with the cumulative incidence method, with death in patients who had a complete hematologic response as a competing risk., Up to 2 years post-registration]|The rate of adverse events, adverse events during the treatment, Up to 5 years post-registration
Efficacy and Safety of TKI Combined With Chemotherapy and Sequential CAR-T Cells in ND Adult Patients With Ph+ ALL
NCT Number: NCT06481228
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Philadelphia Positive Acute Lymphoblastic Leukemia|Acute Lymphoblastic Leukemia, Adult
Interventions: COMBINATION_PRODUCT: CAR-T cells|DRUG: Venetoclax|DRUG: Olverembatinib
Sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 82
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06
Completion Date: 2028-06
Locations: Institute of Hematology & Blood Diseases Hospital, Tianjin, 300020, China

Summary:
In recent years, immunotherapy (eg. blinatumomab, inotuzumab ozogamicin, CAR-T cells) has demonstrated a high safety and efficacy profile in relapsed/refractory (R/R）B-ALL. The available data suggest that the advancement of immunotherapy from R/R field to the frontline setting may be an important approach to increase the depth of remission, which ultimately translates into a survival benefit. In this study, the investigators propose a treatment regimen using CAR-T cell therapy as a consolidation method for Ph+ ALL patients achieving complete remission (CR) with overembatinib, venetoclax and reduced-intensity chemotherapy, aiming to reduce the total cycles of chemotherapy and related toxicities, shorten length of hospitalization, and ultimately improve patients' survival and quality of life.

Primary Outcome Measures: Disease-free Survival (DFS), From CR1 to relapse, death from any cause or last follow-up, Up to 2 years post-registration
Secondary Outcome Measures: Overall survival (OS), From the date of registration to the date of death resulting from any cause., Up to 5 years post-registration|Event-free survival (EFS), From the date of registration to the date of induction failure, relapse, death from any cause, or last follow-up, Up to 5 years post-registration|Cumulative rate of complete molecular response, The cumulative rate of patients achieving complete molecular remission, Up to 1 year post-registration|MRD-negative complete remission rate measured by NGS tracking clonal IG/TR rearrangements, No clonal IG/TR rearrangements were detected by NGS, Up to 1 year post-registration|Cumulative incidence of relapse (CIR), Calculated with the cumulative incidence method, with death in patients who had a complete hematologic response as a competing risk., Up to 2 years post-registration|The rate of adverse, adverse events during the treatment, Up to 5 years post-registration
A Safety and Pharmacokinetics Study of Ustekinumab Biosimilar GNR-068 and Stelara® in Healthy Volunteers
NCT Number: NCT06481215
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy Volunteers
Interventions: BIOLOGICAL: GNR-068|BIOLOGICAL: Stelara®
Sponsor: AO GENERIUM
Sex: MALE
Age: ADULT
Enrollment: 122
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2022-03-11
Completion Date: 2022-12-20
Locations: State budgetary healthcare institution of the city of Moscow "City Clinic No. 2 of the Moscow Health Department", Moscow, 117556, Russian Federation|Federal State Budgetary Educational Institution of Higher Education "Moscow State Medical and Dental University named after A.I. Evdokimov" of the Ministry of Health of the Russian Federation, Moscow, 127473, Russian Federation

Summary:
This is a randomized open comparative parallel group study of the safety and pharmacokinetics of GNR-068 and Stelara® in healthy volunteers. Participants received a single subcutaneous dose of ustekinumab 45 mg. The follow up period was 84 days.

Primary Outcome Measures: Pharmacokinetics: Area under the plasma concentration versus time curve (AUC), Analysis of equivalence of AUC from time 0 (predose) to the last quantifiable data point and extrapolated to infinity of GNR-068 and Stelara®, Day 84|Pharmacokinetics: Peak Plasma Concentration (Cmax), Analysis of equivalence of maximum concentration (Cmax) of GNR-068 and Stelara®, Day 84
Secondary Outcome Measures: Proportion of volunteers with adverse events (AE), The Investigator will carefully monitor each subject throughout the study for any AEs (coded to preferred term and system organ class using the Medical Dictionary for Regulatory Activities \[MedDRA\]), Day 84|Proportion of patients with Antidrug antibodies (ADA), Binding and neutralizing ADA will be identified, Day 84
A Safety and Pharmacokinetic Study of Complarate (Tocilizumab Biosimilar) and Actemra® in Healthy Volunteers
NCT Number: NCT06481202
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy Volunteers
Interventions: BIOLOGICAL: Complarate®|BIOLOGICAL: Actemra®
Sponsor: AO GENERIUM
Sex: MALE
Age: ADULT
Enrollment: 43
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: OTHER
Start Date: 2022-04-11
Completion Date: 2022-08-19
Locations: Department of Clinical Research, Center for Clinical Drug Research, Moscow, 119435, Russian Federation|Federal State Autonomous Educational Institution of Higher Education "First Moscow State Medical University named after I.M. Sechenov" of the Ministry of Health of Russia, Moscow, 119991, Russian Federation

Summary:
This is a randomized double-blind comparative parallel group study of the safety, pharmacokinetics and pharmacodynamics of Complarate and Actemra® in healthy volunteers. Participants received a single intravenous dose of tocilizumab 8 mg/kg. The follow up period was 43 days

Primary Outcome Measures: Pharmacokinetics: Area under the plasma concentration versus time curve (AUC), Analysis of equivalence of area under concentration-time curve from time 0 (predose) to the last quantifiable data point and to infinity of Complarate and Actemra®, day 43|Pharmacokinetics: Peak Plasma Concentration (Cmax), Analysis of equivalence of Cmax of Complarate and Actemra®, day 43
Secondary Outcome Measures: Pharmacodynamics: Concentration of interleukine-6 (IL-6), IL-6 concentration, day 43|Pharmacodynamics: Concentration of soluble interleukine-6 receptor (sIL-6R), sIL-6R concentration, day 43|Pharmacodynamics: Concentration of high-sensitivity C-reactive protein (hsCRP), hsCRP concentration, day 43|Adverse events, The Investigator will carefully monitor each subject throughout the study for any adverse events (coded to preferred term and system organ class using the Medical Dictionary for Regulatory Activities \[MedDRA\]), day 43|Immunogenicity, antidrug antibodies (ADA) level, day 43
A Safety, Pharmacokinetics and Pharmacodynamics Study of GNR-086 and Ilaris® in Healthy Volunteers
NCT Number: NCT06481189
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy Volunteers
Interventions: BIOLOGICAL: GNR-086|BIOLOGICAL: Ilaris®
Sponsor: AO GENERIUM
Sex: ALL
Age: ADULT
Enrollment: 105
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: OTHER
Start Date: 2022-09-06
Completion Date: 2023-05-26
Locations: State budgetary healthcare institution of the city of Moscow "City Clinic No. 2 of the Moscow Health Department", Moscow, 117556, Russian Federation|Federal State Budgetary Educational Institution of Higher Education "Moscow State Medical and Dental University named after A.I. Evdokimov" of the Ministry of Health of the Russian Federation, Moscow, 127473, Russian Federation

Summary:
This is a randomized single-blind comparative parallel group study of the safety, pharmacokinetics and pharmacodynamics of GNR-086 and Ilaris® in healthy volunteers. Participants received a single subcutaneous dose of canakinumab 150 mg. The follow up period was 120 days.

Primary Outcome Measures: Pharmacokinetics: Area under the plasma concentration versus time curve (AUC), Analysis of equivalence of area under concentration-time curve from time 0 (predose) extrapolated to infinity (AUC(0-∞) of GNR-086 and Ilaris®, Day 120|Pharmacokinetics: Peak Plasma Concentration (Cmax), Analysis of equivalence of Cmax of GNR-086 and Ilaris®, Day 120
Secondary Outcome Measures: Pharmacodynamics: interleukin-1β (IL-1β), IL-1β concentration, Day 120|Pharmacodynamics: Area Under IL-1β Curve (AUC), Area under the curve "Relative difference in total IL-1β concentration compared to baseline - time", Day 120|Proportion of volunteers with adverse events (AE), The Investigator will carefully monitor each subject throughout the study for any AEs (coded to preferred term and system organ class using the Medical Dictionary for Regulatory Activities \[MedDRA\]), Day 120|Immunogenicity, Antidrug antibodies (ADA) level, Day 120
Telacebec (T) Treatment in Adults With Buruli Ulcer (BU).
NCT Number: NCT06481163
Acronym: TREAT-BU
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Buruli Ulcer
Interventions: DRUG: Telacebec
Sponsor: Barwon Health
Collaborators: Global Alliance for TB Drug Development
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-09
Completion Date: 2025-12
Locations: Barwon Health, Geelong, Victoria, 3220, Australia|Royal Melbourne Hospital, Melbourne, Australia

Summary:
The goal of this interventional clinical trial is to determine if treatment with 4 weeks of telacebac (T) will completely heal lesions in participants with Buruli ulcer (BU) by 52 weeks after treatment initiation, without relapse and/or surgery. Males and females age 18 and older will be included.

* Participants will attend visits every week during treatment (4 weeks)
* Thereafter they will be followed every 2 weeks until week 24 followed by visits as weeks 30, 40 and 52.
* Dependent on site requirements, there may be follow up visits on site or remotely.

Primary Outcome Measures: Rate of complete lesion healing by 52 weeks from treatment initiation., Ulcerated Lesions: Healing and re-epithelialisation of ulcerated area with stable scar formation. Non-ulcerated Lesions: resolution of induration of skin.

Complete healing rate will be summarized as percentage with corresponding Clopper-Pearson 95% confidence interval., 52 weeks from treatment initiation
Secondary Outcome Measures: Complete lesion healing rate at 52 weeks from treatment initiation., Complete healing rate will be summarized as percentage with corresponding Clopper-Pearson 95% confidence interval., 52 weeks from treatment initiation|Median time to healing, Kaplan-Meier methods will be applied to estimate median time to healing., 52 weeks from treatment initiation|Recurrence rate within 52 weeks from treatment initiation, Complete lesion healing followed by a recurrent lesion at the same site or a new lesion appearing at a separate site, detected within 52 weeks of treatment initiation, that is culture positive and not judged to be due to a paradoxical response to telacebec treatment on clinical and/or histological findings., 52 weeks from treatment initiation|Treatment failure rate within 52 weeks from treatment initiation, Lack of complete healing within the 52 weeks observation period; Recurrence, Use of alternative buruli ulcer (BU) treatment, BU curative intent surgery, 52 weeks from treatment initiation|Paradoxical response rate with 52 weeks from treatment initiation, An increase in lesion surface area by more than 20% compared with a previous measurement, after initial reduction in lesion size, or the development of a new lesion appearing at a separate site that does not show evidence of disease relapse on histopathology and/or mycobacterial culture examination., 52 weeks from treatment initiation
A Novel Approach for Reducing Hyperoxaluria and Kidney Stone Risk.
NCT Number: NCT06481150
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Hyperoxaluria
Interventions: DRUG: Tenapanor|OTHER: Placebo
Sponsor: University of Texas Southwestern Medical Center
Collaborators: National Center for Advancing Translational Sciences (NCATS)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-07-01
Completion Date: 2025-04-30
Locations: UT Southwestern Medical Center, Dallas, Texas, 75390, United States

Summary:
This pilot study is proposing a novel approach to directly target intestinal oxalate absorption with the drug Tenapanor, which was recently FDA-approved for treating hyperphosphatemia in patients with chronic kidney disease. Tenapanor works by blocking paracellular phosphate absorption by the intestine, but the underlying mechanisms have not been clearly defined. Since phosphate and oxalate ions are absorbed through the same paracellular pathway, and are of similar size and charge, Tenapanor is hypothesized to also reduce dietary oxalate absorption and consequently lower urinary oxalate excretion.

Primary Outcome Measures: 24-h urine oxalate, Study participants collect two 24-hour urine specimens for analysis of their stone-risk profile, including oxalate (mg/24 h), comparing placebo with drug treatment (Tenapanor)., Two 24-h urine on days 4 and 5 of each arm
Reversibility of Cardiac Conduction Disturbances Following TAVI
NCT Number: NCT06481137
Acronym: TAVI-REVERSE
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Aortic Stenosis|Transcatheter Aortic Valve Implantation|Conduction Disturbances
Interventions: DIAGNOSTIC_TEST: Electrophysiological study (EP study)|DIAGNOSTIC_TEST: ePatch (extended Holter Monitoring)
Sponsor: Institut d'Investigació Biomèdica de Bellvitge
Collaborators: Hospital Universitari de Bellvitge|Hospital Universitario La Paz|Hospital Vall d'Hebron|Hospital Universitario Ramon y Cajal|Hospital Universitario A Coruna Spain|Hospital Clinico Universitario de Santiago|Hospital Universitario Central de Asturias|Hospital Universitario Marqués de Valdecilla|Hospital Clínico Universitario de Valladolid
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 209
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-06-17
Completion Date: 2026-12-31
Locations: Hospital Universitari de Bellvitge, L' Hospitalet De Llobregat, Barcelona, 08097, Spain

Summary:
The management of patients with conduction disturbances (CDs) after transcatheter aortic valve implantation (TAVI) is unclear, especially in those with de novo electrocardiographic CDs (ECG-CDs) such as left bundle branch block.

In this study, the investigators will evaluate the incidence of retrogradation of infra-Hisian CDs in patients with de novo ECG-CDs and positive electrophysiological study (EPS) 3-7 days following TAVI. In addition, the investigators will evaluate the need for cardiac pacing and the incidence of clinical events in patients with negative EPS performed 3-7 days following TAVI.

In this multicenter, longitudinal, prospective study, patients with clinical indication of EP study due to new-onset ECG-CDs after TAVI will be included. A permanent pacemaker will be implanted in patients with positive EPS and a second EPS will be performed in 30-45 days. Additionally, these patients will undergo 4-week continuous monitoring using the ePatch (Philips) long-term Holter recorder, to identify episodes of paroxysmal complete atrioventricular block. Patients with negative EP study will undergo clinical follow-up and continuous monitoring for 4 weeks.

Primary Outcome Measures: Incidence of retrogradation, 1. Patients with positive EP: Evaluate the incidence of retrogradation of infra-Hisian conduction disturbance at 30-45 days following TAVI., 30 days|Need for cardiac pacing (incidence of advanced atrioventricular block), 2. Patients with negative EP: Evaluate the rate of patients in need for cardiac pacing (incidence of clinical events related to advanced atrioventricular block)., 30 days
Prospective Monocentric Registry of Patients Undergoing Vitamin D Treatment at San Raffaele Hospital
NCT Number: NCT06481111
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Hypovitaminosis D
Interventions: DRUG: supplementary treatment with vitamin D
Sponsor: IRCCS San Raffaele
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06
Completion Date: 2034-12-01

Summary:
The Endocrinology Unit of the IRCCS San Raffaele Hospital is dedicated to establishing a prospective single-center registry with data from patients undergoing vitamin D supplementation, initiating their first visit to the outpatient unit until December 2029. 1000 patients will be enrolled, aligning with the unit's recent patient influx for hypovitaminosis D.

The registry's goal is to assess the epidemiological trend, identify risk factors, and evaluate the diagnostic and therapeutic clinical management strategies for hypovitaminosis D. It will involve collecting clinical, laboratory, and historical data during outpatient visits, adhering to the standard diagnostic and therapeutic protocols for endocrine-metabolic diseases. This data collection is expected to continue for a duration of ten years.

Primary Outcome Measures: Change from baseline of data in outpatient accessing Endocrinology Unit of the IRCCS San Raffaele Hospital for endocrine-metabolic diseases who are on supplementary treatment with vitamin D., The main outcome of the study is to assess the prevalence changes of major comorbidities and their complications including cardiovascular diseases, diabetes, cancer, and osteoporosis, during the study-period in relation to the use and characteristics of vitamin D supplementation, in order to evaluate the potential influence of vitamin D use on patient's outcomes. The pathological conditions will be diagnosed according to current major guidelines and clinical practice., 10 years
A Phase 1 Study to Assess HM15275 in Healthy and Obese Subjects.
NCT Number: NCT06481098
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Obesity
Interventions: DRUG: HM15275|DRUG: Placebo of HM15275
Sponsor: Hanmi Pharmaceutical Company Limited
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-05-28
Completion Date: 2025-09-17
Locations: ProSciento, Inc., Chula Vista, California, 91911, United States

Summary:
This Study is a Phase 1 Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15275 in Healthy and Obese Subjects.

Primary Outcome Measures: Part A: Safety and Tolerability, Number of participants with treatment-emergent adverse events (TEAEs) after a single subcutaneous dose, Up to Day 29|Part B: Safety and Tolerability, Number of participants with treatment-emergent adverse events (TEAEs) after multiple subcutaneous doses, Up to Day 57
Secondary Outcome Measures: Part A: Pharmacokinetics, Plasma concentration profile of HM15275 over time after a single subcutaneous dose, Up to Day 29|Part B: Pharmacokinetics, Plasma concentration profile of HM15275 over time after multiple subcutaneous doses, Up to Day 57
Other Outcome Measures: Part A: Pharmacodynamics, Change in body weight (kg) from baseline, Up to Day 29|Part B: Pharmacodynamics, Change in body weight (kg) from baseline, Up to Day 57
Digital Psychological Intervention for Pediatric Functional Abdominal Pain Disorders in Primary Care
NCT Number: NCT06481072
Acronym: FAPD
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Functional Abdominal Pain Syndrome
Interventions: OTHER: Digital patient education|OTHER: Digital patient education and iCBT
Sponsor: Göteborg University
Sex: ALL
Age: CHILD
Enrollment: 300
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-04-01
Completion Date: 2026-12-31
Locations: Gothenburg University, Gothenburg, Sweden

Summary:
The project involves researching two psychological treatments for functional abdominal pain in children. The treatments will be offered to children as an early intervention, at primary care level. The study will aim to find out if the treatments are effective and which children the different treatments are effective for.

Primary Outcome Measures: Change from baseline in pain related functional disability., Functional disability is measured with the child report version of the Functional Disabilities Inventory (FDI). The FDI is a 15-item measure of difficulty in performing activities in the past several days, valid for youth with chronic pain, and is used in FAPD. Items are rated on a 5-point Likert scale, ranging from 0 to 4 ("No Trouble" to "Impossible") and summed to create a total score (range 0-60). Higher scores indicate greater disability., Within a week after intervention completion, 6 months after completion and 12 months after completion|Change from baseline in pain intensity., Level of pain intensity will be obtained using a Visual Analogue Scale (VAS) 0-10. Higher scores indicate greater pain intensity., Within a week after intervention completion, 6 months after completion and 12 months after completion.|Change from baseline in gastro symptom related worry., Child version of the Visceral Sensitivity Index (VSI-C) will be used to measure level of gastro-symptom related worry. The VSI-C is a 7-item rating scale, valid for children with functional abdominal pain disorders. Worry is rated 1-6 where higher scores indicate greater gastro-symptom related worry. Scores are summed to create a total score (range 0-42)., Within a week after intervention completion, 6 months after completion and 12 months after completion
suPAR is a Potential Biomarker of in Chronic Periodontitis Through the Impact of Post-radiotherapy on HNCs Patients
NCT Number: NCT06481059
Acronym: HNCs
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Head and Neck Cancer|Chronic Periodontitis|Radiotherapy; Complications
Interventions: RADIATION: Head and Neck cancer post-radiotherapy
Sponsor: Al-Maarif University College
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-09-01
Completion Date: 2023-06-23
Locations: Ahmed A. Al-Kubaisi, Ramadi, Anbar, 31001, Iraq

Summary:
This study aims to improve a soluble urokinase plasminogen activator receptor suPAR is a reliable biomarker of chronic periodontitis and may be replaced in patients with head and neck cancer post-radiotherapy (HNC post-RT).

Primary Outcome Measures: Measure of serum suPAR level, Measure of serum suPAR level in patients head and neck cancer who received radiotherapy, at 6 months
Secondary Outcome Measures: Periodontal parameters measured, All periodontal parameters (Clinical attachment level, Gingival bleeding Index, Plaque index, and Periodontal pocket depth measures were performed manually using a millimeter periodontal probe in patients who received radiotherapy., at 6 month
Treatment of Rotator Cuff Tears With Platelet Rich Plasma
NCT Number: NCT06481046
Status: WITHDRAWN
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Rotator Cuff Tears|Rotator Cuff Tendinitis
Interventions: BIOLOGICAL: Platelet Rich Plasma (PRP)
Sponsor: The Foundation for Orthopaedics and Regenerative Medicine
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 0
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2015-01-23
Completion Date: 2015-01-25
Locations: Illinois Sportsmedicine and Orthopaedic Centers, Glenview, Illinois, 60025, United States

Summary:
The purpose of this study is to evaluate the safety and effectiveness of dual platelet rich plasma (PRP) injections into the rotator cuff insertion and the area of the tendon proximal to the insertion.

Primary Outcome Measures: Quick Disabilities of the Arm, Shoulder and Hand Score (Quick-DASH), Quick-DASH questionnaire consists of 11 questions which are each scored 1-5. The scoring ranges from 0 for best to 100 for worst outcomes., change from baseline to 6 months|Quick Disabilities of the Arm, Shoulder and Hand Score (Quick-DASH), Quick-DASH questionnaire consists of 11 questions which are each scored 1-5. The scoring ranges from 0 for best to 100 for worst outcomes., change from baseline to 12 months|Quick Disabilities of the Arm, Shoulder and Hand Score (Quick-DASH), Quick-DASH questionnaire consists of 11 questions which are each scored 1-5. The scoring ranges from 0 for best to 100 for worst outcomes., change from baseline to 24 months
Secondary Outcome Measures: Visual Analog Scale (VAS) for pain, The Visual Analog Scale is a single question about current pain level. Scoring ranges from 0 which is no pain to 100 which is worst possible pain., change from baseline to 6 months|Visual Analog Scale (VAS) for pain, The Visual Analog Scale is a single question about current pain level. Scoring ranges from 0 which is no pain to 100 which is worst possible pain., change from baseline to 12 months|Visual Analog Scale (VAS) for pain, The Visual Analog Scale is a single question about current pain level. Scoring ranges from 0 which is no pain to 100 which is worst possible pain., change from baseline to 24 months|Global Improvement, Global improvement is a single question about percent improved compared to before treatment where 0 is not improved and 100 is completely improved., change from baseline to 6 months|Global Improvement, Global improvement is a single question about percent improved compared to before treatment where 0 is not improved and 100 is completely improved., change from baseline to 12 months|Global Improvement, Global improvement is a single question about percent improved compared to before treatment where 0 is not improved and 100 is completely improved., change from baseline to 24 months
Suicide Specific Rumination in Veterans
NCT Number: NCT06481033
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Depression|Suicide|Mood Disorders
Interventions: BEHAVIORAL: Real Time fMRI Neurofeedback
Sponsor: VA Office of Research and Development
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 15
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-08-01
Completion Date: 2026-12-31
Locations: James J. Peters VA Medical Center, Bronx, NY, Bronx, New York, 10468-3904, United States

Summary:
Few treatments target core features of suicidal thoughts and behaviors in Veterans. Real-time functional magnetic resonance imaging neurofeedback can provide information regarding brain activation associated with suicide-specific rumination, defined as a "repetitive mental fixation on one's suicidal thoughts and intentions." The goal of this feasibility study is for Veterans to learn strategies for modulating activity within brain regions that have been demonstrated to contribute to the maintenance of rumination, as they receive neurofeedback feedback signals from the brain.

Primary Outcome Measures: Acceptability and Feasibility, The Client Satisfaction Questionnaire will be used to assess acceptability and feasibility of implementing real-time fMRI neurofeedback in a Veteran population. The total score on the questionnaire ranges from from 8 to 32 with higher scores indicative of greater satisfaction., Total score obtained 2 weeks following first real-time fMRI neurofeedback session.
Secondary Outcome Measures: Suicide Rumination Scale, The Suicide Rumination Scale is a self-report inventory designed to quantify the extent to which an individual ruminates about suicide. The total score on the scale ranges from 0 to 32 with higher scores indicative of greater rumination., Change in total score from pre-treatment to post-treatment (2 weeks).
ALgerian Cholecystectomy Outcomes and Determinants Study (AL-CODS)
NCT Number: NCT06481007
Acronym: AL-CODS
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cholecystectomy|Adults|Gall Stone|Polyps|Pancreatitis Biliary|Gallbladder Dyskinesia|Cholecystitis
Sponsor: University of Oran 1
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2025-01-01
Completion Date: 2025-07-02

Summary:
Cholecystectomy, the surgical removal of the gallbladder, is a common procedure performed to treat benign gallbladder diseases such as cholelithiasis (gallstones), cholecystitis (inflammation of the gallbladder), and biliary dyskinesia. While generally considered safe, this surgery can be associated with significant morbidity and mortality, particularly in certain populations or healthcare settings. Understanding these outcomes and the factors influencing them is crucial for improving patient care and surgical practices.

In Algeria, the healthcare landscape presents unique challenges and opportunities for evaluating surgical outcomes. Limited studies have specifically focused on the morbidity and mortality associated with cholecystectomy in this context. This study aims to fill that gap by providing comprehensive data on 30-day postoperative outcomes following cholecystectomy for benign gallbladder diseases in Algeria. Such data is essential for benchmarking current practices, identifying areas for improvement, and ultimately enhancing patient safety and surgical efficacy.

Primary Outcome Measures: Evaluate the 30-day mortality and morbidity, Evaluation of rate of mortality and morbidity at 30 day, occuring in of before 30 day postopérative période.|factors associated with 30-day morbidity and mortality, determinants of the occurence of complications and mortality on or before 30 day in postopérative period, occuring in of before 30 day postopérative période.
Secondary Outcome Measures: estimate the incidence of incidental gallbladder cancer discovered during cholecystectomy in Algeria., postoperative periode ( during or after surgical procedure)|estimate the incidence of bile duct injuries following cholecystectomy for benign diseases, occuring in of before 30 day postopérative periode.|assess surgical practices related to cholecystectomy in Algeria., During surgical procedure ( Cholecystectomy)
Exclusion of Venous Thrombo-Embolism With a New Clinical Decision Support
NCT Number: NCT06480994
Acronym: EXTEND
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Venous Thromboembolism|Pulmonary Embolism|Deep Vein Thrombosis
Interventions: DIAGNOSTIC_TEST: Routine Assays on fresh plasma|DIAGNOSTIC_TEST: New Clinical Decision Support on fresh plasma|DIAGNOSTIC_TEST: New Clinical Decision Support on frozen plasma
Sponsor: Diagnostica Stago R&D
Collaborators: Centre Hospitalier de Niort|Centre Hospitalier le Mans
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1836
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-06-21
Completion Date: 2026-06
Locations: Centre Hospitalier de Niort, Niort, Sartres, 79021, France|Centre Hospitalier le Mans, Le Mans, Sartre, 72037, France

Summary:
The goal of this non interventional study is to demonstrate the diagnostic performances on fresh plasmas in comparison with the performances on frozen plasmas in any patients with VTE suspicion, whatever the pre-test probability. The main question it aims to answer is :

Are the performances equivalent on fresh plasmas in comparison with frozen plasmas or is it necessary to determine a new algorithm of the Clinical Decision Support with a new cut-off? Participants will be diagnosed and treated in accordance with routine standard of care.

Primary Outcome Measures: Reproducibility of the new clinical decision support with fresh plasma, Reproducibility (%) calculated with 70% of the study population with fresh plasma in comparison with frozen plasma., 37 months|Threshold of the new clinical decision support with fresh plasma, Threshold calculated with 70% of the study population with fresh plasma in comparison with frozen plasma., 37 months|PE / DVT sensitivity of the clinical decision support, Sensitivity of the clinical decision support with fresh plasma in comparison with reference diagnosis., 48 months|PE / DVT specificity of the clinical decision support, Specificity of the clinical decision support with fresh plasma in comparison with reference diagnosis., 48 months|PE / DVT likelihood ratio of the clinical decision support, Likelihood ratio of the clinical decision support with fresh plasma in comparison with reference diagnosis., 48 months|PE / DVT exclusion percentage of the clinical decision support, Exclusion percentage of the clinical decision support with fresh plasma in comparison with reference diagnosis., 48 months|PE / DVT negative predictive value of the clinical decision support, Negative Predictive Value of the clinical decision support with fresh plasma in comparison with reference diagnosis., 48 months
Multiple Ascending Dose Noribogaine PK/PD in Healthy Volunteers
NCT Number: NCT06480981
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Pharmacokinetics
Interventions: DRUG: Noribogaine
Sponsor: DemeRx NB
Sex: ALL
Age: ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-06-20
Completion Date: 2024-12-31
Locations: Richmond Pharmacology, London, United Kingdom

Summary:
This trial will be a randomised, double-blind, sequential-group, multiple-dose, placebo-controlled, dose escalation trial to characterise the pharmacokinetics (PK), pharmacodynamics (PD) and safety of noribogaine in healthy adult participants.

Primary Outcome Measures: Pharmacokinetics Cmax, Determination of maximum plasma concentration of noribogaine, Day 1 to Day 8|Pharmacokinetics Tmax, Determination of the time to reach the maximum plasma concentration of noribogaine, Day 1 to Day 8|Pharmacokinetics AUC0-t, Determination of the area under the plasma concentration-time curve from time 0 to t of noribogaine, Day 1 to Day 8|Pharmacokinetics AUC0-infinity, Determination of the area under the plasma concentration-time curve from time 0 to infinity of noribogaine, Day 1 to Day 8|Pharmacokinetics t1/2, Determination of elimination half-life (t1/2) of noribogaine, Day 1 to Day 8
BOne Metastases REgistry for Patients Undergoing cryoAbLation With curatIve purpoSe
NCT Number: NCT06480955
Acronym: BOREALIS
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Bone Metastases
Interventions: DEVICE: Cryoablation system
Sponsor: Cardiovascular and Interventional Radiological Society of Europe
Collaborators: Boston Scientific Corporation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-11
Completion Date: 2027-11

Summary:
BOREALIS is a multicentre, prospective, observational cohort study designed to investigate the effectiveness, feasibility, safety and impact on pain and quality of life of curative-intent cryoablation for the treatment of bone metastases in patients with oligometastatic or bone oligo-progressive disease.

Primary Outcome Measures: Local progression-free survival rate, On a per lesion basis, proportion of target lesions free from local tumour progression using the Kaplan Meier estimate, 12 months
Secondary Outcome Measures: Technical feasibility, Adherence to a comprehensive SOC treatment protocol that includes i) peri-operative biopsy if indicated, ii) cryoablation, and iii) bone consolidation through osteoplasty or osteosynthesis if biomechanically indicated, Periprocedurally|Adverse events, Incidence and severity of adverse events graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, Through study completion|Complete local tumour response, On a per lesion basis, proportion of target lesions with complete response status, 12 months|Fracture-free survival, On a per lesion basis,time between cryoablation and fracture at treated site, End of study|Fracture-free survival rate, On a per lesion basis, proportion of target lesion(s) free from fracture, Until the end of the follow-up period (1 year)|Bone-disease progression-free survival, Time between cryoablation and progression in the bone (incl. new lesions), Until the end of the follow-up period (1 year)|Extraosseous disease progression-free survival, Time between cryoablation and extra-osseous progression (incl. new lesions), Until the end of the follow-up period (1 year)|Overall progression-free survival, Time between cryoablation and any progression (incl. new lesions) or death, Until the end of the follow-up period (1 year)|Overall survival, Time between cryoablation and death, Until the end of the follow-up period (1 year)|Systemic therapy-free survival, Time between cryoablation and the next systemic treatment (excluding any adjuvant treatment that was part of the patient's treatment plan), Until the end of the follow-up period (1 year)|Impact on patient pain, Patient-reported pain assessment using the Brief Pain Inventory - short form, 1, 3, 6, 12 months|Impact on patient quality of life, Patient-reported quality of life assessment using the EORTC QLQ-C30 questionnaire, 1, 3, 6, 12 months
Arterial Pressure Derived Dynamic Parameters to Detect Preload Responsiveness in Spontaneously Breathing Patients
NCT Number: NCT06480942
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Hypovolemia
Interventions: OTHER: Detection of preload responders by a PLR test
Sponsor: CHU de Reims
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-10-03
Completion Date: 2025-01
Locations: Chu Reims, Reims, 51092, France

Summary:
The management of septic shock patients includes the infusion of fluids, however fluids may be deleterious if the patient does not respond by increasing cardiac output. By consequence, it is now recommended to predict the fluid response (fluid or preload responsiveness) before infusing them. In this protocol, the investigators will include critically ill patients spontaneously breathing, for whom the physician in charge has decided to test preload responsiveness. The investigators will collect from the continuous monitoring of arterial pressure of the patient the pulse pressure(PP) which is the difference between systolic arterial pressure and diastolic arterial pressure and the pulse pressure variation (PPV) automatically displayed by the monitor in addition to other clinical (hemodynamic, respiratory) parameters. After one minute of passive leg raising manoeuvre (PLR) the investigators collect the same parameters and the investigators will compare the changes of these parameters in patients who are preload responsive to patients who are not. Preload responsiveness will de defined by echocardiographic parameters before and during PLR. More exactly, a surrogate of cardiac output measured by echocardiography wich is VTI of the sub-aorti flow; an increase of more than 12% defines apreload responsive patient.

Primary Outcome Measures: Diagnostic performance of the decrease in Pulse Pressure Variation (PPV) during a Passive Leg Raising test (PLR) to predict preload responsiveness, To assess the diagnostic performance of the decrease in pulse pressure variation (PPV) during a passive leg raising test (PLR) to predict preload responsiveness in spontaneously breathing patients hospitalized in intensive care., Day 1
Secondary Outcome Measures: Evaluate the diagnostic performance of the increase in pulse pressure (PP) during a PLR test to predict preload responsiveness, Evaluate the diagnostic performance of the increase in pulse pressure (PP) during a PLR test to predict preload responsiveness in spontaneously breathing patients hospitalized in intensive care., Day 1|Compare PLR measurements other hemodynamic data, Compare before/after PLR measurements other hemodynamic data in spontaneously breathing patients hospitalized in intensive care., Day 1
LV Thrombus Screening in Anterior STEMI: Worth it?
NCT Number: NCT06480929
Acronym: LVT-CE-AMI
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Thrombus of Left Ventricle|Anterior Wall Myocardial Infarction|ST Elevation Myocardial Infarction|Echocardiography
Interventions: OTHER: Contrast TTE procedure, the SonoVue ultrasound agent
Sponsor: Centro Hospitalar Tondela-Viseu
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 68
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2021-02-01
Completion Date: 2023-02-28
Locations: Centro Hospitalar Tondela Viseu, Viseu, Visey, 3504-509, Portugal

Summary:
Left ventricular (LV) thrombus is more common in patients with anterior ST-elevation myocardial infarction (STEMI) compared to other types of acute myocardial infarction (AMI) and is linked to worse outcomes. Diagnosing LV thrombus remains challenging. Contrast echocardiography (TTE) has potential to improve diagnostic accuracy, affecting treatment strategies involving antithrombotic/anticoagulation therapy.

This study aimed to evaluate the effectiveness of contrast TTE as a routine screening method for detecting LV thrombus in the acute phase of anterior STEMI.

Primary Outcome Measures: left ventricular thrombus, Presence or absence of left ventricular thrombus detected via transthoracic echocardiography with or without contrast agent during hospital admission for acute anterior ST-elevation myocardial infarction (STEMI), 7 days (time of echoTT)
Secondary Outcome Measures: anterior/apical aneurysm, Presence or absence of anterior/apical aneurysm confirmed by echocardiography with or without contrast agent during hospital admission for acute anterior ST-elevation myocardial infarction (STEMI) and at follow-up visits post discharge, 7 days (time of echoTT)
Study of the Value of Maternal-fetal Transfers and Their Complexity of Their Implementation
NCT Number: NCT06480916
Acronym: TRANSFERT
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Maternal-Fetal Relations
Interventions: PROCEDURE: Maternal-fetal transfers
Sponsor: Centre Hospitalier Régional Metz-Thionville
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-04-01
Completion Date: 2025-04-01
Locations: Hopital Maillot, Briey, France|Maternité CH Léon Bourgeois, Châlons-en-Champagne, France|CHR Metz Thionville Hopital Femme Mère Enfant, Metz, 57085, France|Maternité - Hôpital Maurice Camuset, Romilly-sur-Seine, France|Clinique Saint Nabor, Saint-Avold, France|Matérnité Saint Dizier, Saint-Dizier, France|CHR Metz-Thionville Hopital Bel Air, Thionville, France|Hopital Saint Nicolas, Verdun, France

Summary:
It is an observational, descriptive, prospective, multicenter study of 8 maternity units in Lorraine and Champagne-Ardenne, aimed at comparing the percentage of "avoidable" maternal-fetal transfers (MFTs), defined as transfers in which the delivery finally meets the acceptance criteria of the sending maternity unit, according to the obstetrical indications for these MFTs.

Primary Outcome Measures: The percentage of "avoidable" maternal-foetal transfer (MFT), The main evaluation criterion is "avoidable" maternal-foetal transfer (MFT), i.e. resulting in a delivery that met the acceptance criteria of the original maternity hospital, after delivery, up to 6 weeks after the maternal-foetal transfer
Secondary Outcome Measures: Obstetrical indication for maternal-foetal transfer (MFT), as documented in the patient file, Up to 48 hours after the maternal-foetal transfer|Organizational arrangements for maternal-foetal transfer, Organizational arrangements for maternal-foetal transfer in the various centers, assessed by a specific questionnaire sent to maternity units., Up to 6 months after inclusion of a maternity unit in the study
Exploratory Study of EBV DNA Titre Clearance Whilst on Proton Beam Therapy
NCT Number: NCT06480903
Acronym: ClearED
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Nasopharyngeal Carcinoma|Head and Neck Cancer|Nasopharyngeal Cancer|Epstein-Barr Virus
Sponsor: The Christie NHS Foundation Trust
Sex: ALL
Age: CHILD, ADULT
Enrollment: 10
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-30
Completion Date: 2026-08-30

Summary:
How does plasma Epstein-Barr Virus (EBV) DNA level change during definitive radiation therapy for nasopharyngeal carcinoma (NPC) in the teenage and young adult cohort and does it correlate with outcomes?

Primary Outcome Measures: Plasma EBV during proton beam RT, Taken weekly, prior to each session of chemotherapy. Change in plasma EBV DNA levels (EBV VCA-IgM Ab) from each blood sample time point., 6 weeks
Secondary Outcome Measures: EBV and tumour correlates, Taken weekly, prior to each session of chemotherapy. Change in plasma EBV DNA levels (EBV VCA-IgM Ab) from each blood sample. Assessment whether EBV plasma clearance predicts tumour response., 2 years