pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
A Study of Vemurafenib and Obinutuzumab Compared to Cladribine and Rituximab in People With Hairy Cell Leukemia (HCL)
NCT Number: NCT06561360
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Hairy Cell Leukemia
Interventions: DRUG: Vemurafenib|DRUG: Obinutuzumab|DRUG: Cladribine|DRUG: Rituximab
Sponsor: Memorial Sloan Kettering Cancer Center
Collaborators: Genentech, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 86
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-31
Completion Date: 2027-08-31
Locations: Dana Farber Cancer Institute, Boston, Massachusetts, 02115, United States|Mayo Clinic Cancer Center, Rochester, Minnesota, 55905, United States|Memorial Sloan Kettering at Basking Ridge (All Protocol Activities), Basking Ridge, New Jersey, 07920, United States|Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown, New Jersey, 07748, United States|Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale, New Jersey, 07645, United States|Memorial Sloan Kettering Cancer Commack - Suffolk (Limited Protocol Activities), Commack, New York, 11725, United States|Memorial Sloan Kettering Westchester (All Protocol Activities), Harrison, New York, 10604, United States|Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York, New York, 10065, United States|Memorial Sloan Kettering Nassau (Limited Protocol Activities), Uniondale, New York, 11553, United States|Ohio State University, Columbus, Ohio, 43210, United States

Summary:
The researchers are doing this study to compare the safety of vemurafenib in combination with obinutuzumab to the standard of approach of cladribine in combination with rituximab. The researchers will look at which treatment causes fewer or milder side effects. Researchers think vemurafenib and obinutuzumab (non-chemotherapy drugs) may cause fewer side effects compared with the usual approach of chemotherapy drugs. They will also compare the two approaches to see which approach is more effective at eliminating cancer cells.

Primary Outcome Measures: incidences of ≥ grade 3 treatment-related toxicities, per CTCAE v5.0 within first 6 months from the start of the treatment to account delayed toxicities of the treatments, within 6 months of treatment
Secondary Outcome Measures: complete remission, Response will be determined by the Consensus Resolution response criteria.

Complete response (CR)

* A morphological absence of hairy cells in the blood and bone marrow
* A normalization of any organomegaly and cytopenias, 2 years|partial response, Partial response (PR)

°A normalization of cytopenias

°≥50% reduction in organomegaly and bone marrow hairy cells., 2 years
Spasmodic Dysphonia Interviews
NCT Number: NCT06561334
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Spasmodic Dysphonia|Quality of Life
Interventions: PROCEDURE: Botulinum toxin injections
Sponsor: Manchester University NHS Foundation Trust
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08
Completion Date: 2025-07

Summary:
Previous research has shown that patients with voice disorders often have a lower quality of life and struggle with employment. Spasmodic Dysphonia (SD) is a voice disorder that causes abrupt and uncontrollable spasms of the voice box, often resulting in the person having lifelong changes in their voice and speech pattern. The current mainstay of treatment is injecting botulinum toxin (BT) injections into the vocal cord to ease the spasms. The same research team conducted a pilot study in April 2021 on patients with SD. The pilot study used questionnaires and short interviews to understand the livelihood of 10 SD patients. It displayed that SD may impact patients' quality of life. The investigators now aim to run an official research project, ethically approved, to explore the following questions further:

1. Does SD impact the socio-economic lives of its patients? If so, how?
2. What role does BT play in the socio-economic livelihood of SD patients?

To answer these questions, the investigators aim to interview 20 patients with Spasmodic Dysphonia.

Primary Outcome Measures: Does Spasmodic Dysphonia impact the socio-economic lives of its patients? If so, how?, Outcome will be measured through qualitative analysis of participant answers regarding how the target condition, spasmodic dysphonia, affects the social and economic aspects of their livelihood., Through study completion, which is expected to be a year
Secondary Outcome Measures: What role do botulinum toxin injections play in the socio-economic livelihood of Spasmodic Dysphonia patients?, Outcome will be measured through qualitative analysis of participant answers regarding how receiving Botulinum toxin injections may improve their livelihood., Through study completion, which is expected to be a year
Optimal Timing for Spontaneous Breathing Trials
NCT Number: NCT06561295
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Respiration, Artificial|Weaning
Interventions: OTHER: Later Morning Timing of Spontaneous Breathing Trials
Sponsor: Rush University Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 348
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-09-30
Completion Date: 2026-06-30
Locations: Rush University Medical Center, Chicago, Illinois, 60612, United States

Summary:
This study aims to explore how the timing of Spontaneous Breathing Trials (SBTs) affects recovery in adult patients who are on mechanical ventilation in the ICU. SBTs are tests used to determine if a patient is ready to breathe on their own without the help of a ventilator. The study will compare two different timing strategies for these trials: one group of patients will have the test early in the morning, while the other group will have it later in the morning. By observing the outcomes, such as how long patients need to stay on the ventilator, the study hopes to find the best time to perform these trials to help patients recover more quickly and safely.

Primary Outcome Measures: mechanical ventilation duration, The primary outcome of this study is the duration of mechanical ventilation, which refers to the total number of days a patient remains on a mechanical ventilator in the ICU. This measure begins from the moment a patient is initially placed on the ventilator and continues until the patient is successfully extubated (the breathing tube is removed) and can breathe independently without the need for ventilatory support., From enrollment to the end of study at 28 days
Secondary Outcome Measures: Duration Between SBT Success and Extubation, This outcome measures the time interval (in hours) between when a patient successfully passes a Spontaneous Breathing Trial (SBT) and when they are extubated. A successful SBT indicates that the patient is likely ready to breathe independently without mechanical support., From enrollment to the end of study at 28 days|ICU and Hospital Mortality, This outcome records the percentage of patients who die while in the ICU or during their overall hospital stay., From enrollment to the end of study at 28 days|ICU and Hospital Lengths of Stay, This outcome measures the total number of days a patient remains in the ICU and the hospital from admission to discharge., From enrollment to the end of study at 28 days|Reintubation Rates, This outcome measures the percentage of patients who require reintubation within 48 hours of being extubated., From enrollment to the end of study at 28 days|Tracheostomy Rates, This outcome records how often tracheostomy procedures are performed on patients who are unable to be weaned from mechanical ventilation via SBTs. A tracheostomy is a surgical procedure to create an opening through the neck into the trachea for long-term ventilatory support., From enrollment to the end of study at 28 days
Predictive Role of Glucose/Potassium Ratio on Mortality in Major Burns.
NCT Number: NCT06561282
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Burns|Burn Injury|Inhalation Injury
Sponsor: Konya Meram State Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-05-01
Completion Date: 2024-07-01
Locations: Konya Training and Research Hospital, Konya, 42090, Turkey

Summary:
The aim of this observational study is to investigate the role of the glucose-potassium ratio in predicting mortality in patients with major burn trauma.

The main question it aims to answer is: Can the glucose-potassium ratio predict mortality in major burn patients? The glucose-to-potassium ratios of major burn patients at the time of initial hospitalization will be determined, and their relationship with mortality will be analyzed.

Primary Outcome Measures: Glucose-to-potassium ratio, The glucose-to-potassium ratio is calculated by dividing the participants' glucose values when they first apply to the hospital by their potassium values., 2 days
Secondary Outcome Measures: Female/Male ratio, It is calculated by dividing the number of females by the number of males in the study population., 2 days|Mean percent of total body surface area burned, It is calculated by adding the total burn surface area percentage values of all patients and dividing by the number of participants., 2 days|Burn infection rate, The number of patients developing burn infection is calculated by dividing by the number of all participants., 2 days|Mortality rate, The mortality rate is calculated by dividing the number of patients who developed mortality by the number of all participants., 2 days
Multifidus Plane Block Versus Caudal Block for Hypospadias
NCT Number: NCT06561269
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hypospadias|Caudal Block
Interventions: PROCEDURE: Multifidus plane block|PROCEDURE: caudal block
Sponsor: Ain Shams University
Sex: MALE
Age: CHILD
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2024-08
Completion Date: 2025-06

Summary:
This study aims to evaluate the safety and efficacy of ultrasound-guided sacral multifidus plane block and compare its analgesic effect to ultrasound-guided caudal block in pediatric patients undergoing hypospadias surgery under general anesthesia

Primary Outcome Measures: is to measure the first time to rescue analgesia postoperative (24 hours)., Measure the first time to rescue analgesia post operative, 24 hours postoperative
Secondary Outcome Measures: Heart rate, measuring HR changes, start to end of surgery|Blood pressure, measuring BP changes, start to end of the surgery.
Leveraging EA8191 to Assess AI-Augmented EHR Abstraction
NCT Number: NCT06561230
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Prostate Cancer
Interventions: OTHER: Chart review
Sponsor: University of Pennsylvania
Collaborators: Mendel AI
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-31
Completion Date: 2025-07
Locations: University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States

Summary:
The goal of this prospective study is to assess the performance of AI (artificial intelligence) augmentation (compared against historical controls) to identify oncology patients who meet inclusion criteria for a clinical trial. The study staff will leverage a natural language processing (NLP)-based AI algorithm that rank-orders patients most likely to meet inclusion criteria for a trial. We hypothesize that this collaborative Human+AI workflow can improve the efficiency, accuracy, and diversity of trial prescreening.

Primary Outcome Measures: Efficiency, The number of eligible patients per 10 charts prescreened, 1 year
Secondary Outcome Measures: Accuracy, The proportion of total charts identified correctly as eligible, 6 months|Diversity, The proportion of eligible individuals who identified from groups historically underrepresented in clinical trials, 6 months
Assessing the Performance of Artificial Intelligence (AI)-Augmented Electronic Health Record (EHR) Data Abstraction for Clinical Trial Patient Screening
NCT Number: NCT06561217
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Cancer
Sponsor: University of Pennsylvania
Collaborators: Mendel AI
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 357
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-08-18
Completion Date: 2024-07-12
Locations: University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States

Summary:
Identifying eligible patients is a key process in the clinical trial enterprise. Currently, this process relies on time-intensive manual chart review, creating a rate-limiting step for trial participation.

The integration of AI technology into the trial screening process has potential to improve participation rates. This study aims to assess the performance (accuracy, speed) of AI-augmented patient identification and inform optimal integration into clinical research screening processes.

Primary Outcome Measures: Mean proportion of criterion correctly abstracted by human-augmented reviewers, Mean proportion of criterion correctly abstracted by human-augmented reviewers, 1 year|Mean proportion of criterion correctly abstracted by human-alone reviewers, Mean proportion of criterion correctly abstracted by human-alone reviewers, 1 year|Non-inferiority margin, Non-inferiority margin, set as 0.05 for conservative sample size estimates, 1 year
Full-mouth Electronic Toothbrush vs. Conventional Electronic Toothbrush
NCT Number: NCT06561204
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Toothbrush|Gingivitis|Plaque
Interventions: DEVICE: FMET
Sponsor: University of Minnesota
Collaborators: FENO.Co
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 105
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2025-10-01

Summary:
The goal of this randomized, masked-examiner clinical trial is to investigate a full-mouth electronic toothbrush (FMET). The three arms are: 1) FMET + American Dental Association (ADA) approved dentifrice, 2) conventional electronic toothbrush (ETB) + ADA dentifrice and 3) FMET + foam system.

Primary Outcome Measures: Löe & Silness gingival index (GI), Scale 0-3, Baseline and 30-days|Turesky modification of the Quigley-Hein index, Scale 0-5, Baseline and 30-days
Functionality of Albumin in the Context of Hemodialysis
NCT Number: NCT06561191
Acronym: FACED
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Albumin|Dialysis|Redox State|Uremic; Toxemia
Interventions: OTHER: Hemodialysis mode, dialyzer type
Sponsor: Universität Duisburg-Essen
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2025-12
Locations: University Hospital Essen, Essen, 45147, Germany

Summary:
Hemodialysis treatment enables patients with end-stage chronic kidney disease to survive. At the same time, however, this treatment also increases cardiovascular mortality, in particular due to a chronically increased level of inflammation and usually incomplete removal of uraemic toxins. Both of these are closely linked with the functional properties of albumin.

The aim of this study is to investigate the effects of various parameters of dialysis, in particular dialyzer properties and dialysis mode on the functional properties of albumin and to what extent these parameters can be used therapeutically, to improve the treatment quality of hemodialysis treatment in the long term by modifying albumin functional properties.

Our own preliminary work in this field and the current state of research indicate that, for example, the use of high-flux dialyzers can contribute to a reduction of the oxidative stress level. It also appears possible that treatment mode (haemodiafiltration instead of haemodialysis) may also have an effect on the binding and detoxification efficiency of albumin and thus on the removal of uraemic toxins.

Previous results have mostly been collected in observational studies. As a proof-of-concept study, this study will further investigate the concrete therapeutic applicability in an interventional study design.

Primary Outcome Measures: Level of irreversibly oxidized albumin HNA-2, change of human mercaptalbumin-2 HNA-2, after 9 month|Level of albumin binding and detoxification efficiency, Change of albumin binding and detoxification efficiency, meausurement according to PMID: 37558390, after 9 month
Individualized Tumor-Informed CtDNA Analysis for Monitoring Postoperative Recurrence in ESCC (NEOCRTEC2401)
NCT Number: NCT06561178
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Esophageal Squamous Cell Carcinoma
Sponsor: Sun Yat-sen University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-26
Completion Date: 2028-06-01

Summary:
The goal of this observational study or is to explore the correlation between dynamic changes in postoperative circulating tumor DNA (ctDNA) and recurrence risk using a novel, tumor-informed ctDNA detection technique, thus laying the foundation for further promoting ctDNA detection to guide postoperative adjuvant therapy decisions. This study focuses on patients with esophageal squamous cell carcinoma who did not achieve pCR following neoadjuvant therapy combined with surgical resection. The main question it aims to answer is:

Is there a correlation between postoperative ctDNA changes and tumor recurrence?

Participants will be asked to undergo postoperative ctDNA detection.

Primary Outcome Measures: Correlation between the recurrence of patients and the quantitative measurement of circulating tumor DNA (ctDNA) concentration., Correlation were evaluated based on the sensitivity and specificity of ctDNA in predicting recurrence.The sensitivity and specificity were determined by evaluating the association between positive ctDNA and tumor recurrence., 3 years
Secondary Outcome Measures: Postoperative molecular residual disease (MRD) positive rate, 3 years|Correlation between ctDNA detection and postoperative adjuvant therapy., The ctDNA assay was employed to inform postoperative adjuvant therapy, with the objective of determining its potential to enhance patient prognosis., 3 years|correlation between patients' prognosis and landmark MRD status, The sensitivity and specificity were determined by evaluating the association between positive landmark MRD status and patients' prognosis., 3 years|2-year disease-free survival, 2 years|3-year disease-free survival, 3 years|5-year disease-free survival, 5 years|2-year overall survival, 2 years|3-year overall survival, 3 years|5-year overall survival, 5 years
Multifocal HD-tDCS and Motor Function
NCT Number: NCT06561165
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Healthy
Interventions: DEVICE: Standard HD-tDCS intervention|DEVICE: Multifocal network targeted HD-tDCS intervention|DEVICE: Functional Magnetic Resonance Imaging (fMRI)
Sponsor: University of Michigan
Collaborators: Medical University of South Carolina|Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sex: ALL
Age: OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-09
Completion Date: 2025-05
Locations: University of Michigan, Ann Arbor, Michigan, 48109, United States

Summary:
The purpose of this study is to understand how the brain controls movement and how Non-invasive Brain Stimulation (NIBS) with a technique called High-density transcranial direct current stimulation (HD-tDCS) can alter brain processes to improve behavior. Participants in this study will be randomized to either HD-tDCS with standard intervention or personalized dose-controlled multifocal network-targeted HD-tDCS.

The hypothesis is that dexterous hand function will improve after a standard HD-tDCS dose and increase even more after personalized dose-controlled multifocal network-targeted HD-tDCS.

Primary Outcome Measures: Percent change in precision force-tracking task, Squared distance (error) from the cursor to the target in precision force-tracking task, estimated as the root mean squared error (RMSE)., Baseline and 24 hours after the third sessions are completed|Percentage change in the time to complete the nine-hole peg test (9-HPT), 9-hole peg test is a manual dexterity measure, estimated as the time required to complete the task (seconds)., Baseline and 24 hours after the third sessions are completed
Secondary Outcome Measures: Percentage change in the mean choice reaction time, Mean reaction time for subjects responding in the 2-choice reaction time control task, for correct responses, Baseline and 24 hours after the third sessions are completed
Tagraxofusp and Low-Intensity Chemotherapy for CD123-Positive Relapsed or Refractory AML
NCT Number: NCT06561152
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Refractory Acute Myeloid Leukemia|Relapsed Acute Myeloid Leukemia
Interventions: DRUG: Tagraxofusp|DRUG: Cladribine (CLAD)|DRUG: Cytarabine
Sponsor: Stanford University
Collaborators: Stemline Therapeutics, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2028-10
Locations: Stanford University, Palo Alto, California, 94304, United States

Summary:
To determine the efficacy of the combination of tagraxofusp, cladribine, and cytarabine.

Primary Outcome Measures: Recommended Phase 2 dose, Determination of the recommended Phase 2 dose based on the safety of tagraxofusp in combination with cladribine and low-dose cyatarabine, as determined by DLT evaluation., up 2 years
Secondary Outcome Measures: Overall response rate (ORR), ORR will be determined by the proportion of study subjects achieving Complete Remission (CR), Complete remission with incomplete hematologic recovery (CRi), Complete remission with partial hematologic recovery (CRh), Morphological leukemia-free state (MLFS), or (Partial Response (PR), as defined by the ELN 2022 AML response criteria., up 2 years|Complete response, Complete Response will be determined by the proportion of study subjects achieving CR, as defined by the ELN 2022 AML Response Criteria., up 2 years|Composite complete response (CR+CRi +CRh), Composite complete response will be determined by the proportion of study subjects achieving CR, CRi, or CRh, as defined by the ELN 2022 AML Response Criteria., up 2 years|Rate of Minimal Residual Disease (MRD) negativity in responders, Rate of MRD negativity in responders, as measured by multi-parameter flow cytometry., up 2 years|Duration of overall survival, Overall survival (OS) will be measured as the date of enrollment in the study to the date of death from any cause., up 2 years|Incidence of drug-related adverse events, The Incidence of Drug-Related Adverse Events is a safety endpoint used to evaluate the frequency and severity of adverse events (AEs) that are attributed to the study drug All grades of adverse events determined to be treatment-related will be summarized descriptively., up 2 years
Mindfulness as an add-on Intervention in Treatment for Problem Gambling in Clinical Settings in Sweden
NCT Number: NCT06561139
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Problem Gambling
Interventions: BEHAVIORAL: Mindfulness
Sponsor: Region Skane
Collaborators: Lund University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-15
Completion Date: 2026-12-31
Locations: Malmö Addiction Center, Malmö, Sweden

Summary:
This study will test the effects of an add-on mindfulness intervention for patients with gambling problems, added to treatment as usual, compared to a waitlist control condition. The study will primarily aim to decrease gambling behaviour compared to the control condition which receives the intervention later, after two months, and secondarily to decrease symptoms of depressive and anxiety symptoms. In addition, patients who have undergone the mindfulness intervention will be offered participation in a qualitative interview study aiming to deepen the understanding of feasibility and challenges of a mindfulness add-on intervention against gambling problems.

Primary Outcome Measures: Change in past 30-day gambling (NODS 30 days), Change in the number of criteria met according to a diagnostic tool for gambling disorder, but measuring the past 30 days at baseline and at post-treatment, and 3 and 12 months post-treatment, Post-treatment (treatment completion) and 3 and 12 months after end of treatment
Secondary Outcome Measures: Change in past-2-week depressive symptoms, Change in scores on Patient Health Questionnaire-9, a well-recognised instrument measuring past-2-week depressive symptoms, Post-treatment (treatment completion) and 3 and 12 months after end of treatment|Change in past-2-week anxiety symptoms, Change in scores on Generalised Anxiety Disorder-7, a well-recognised instrument measuring past-2-week anxiety symptoms, Post-treatment (treatment completion) and 3 and 12 months after end of treatment
The Effect of Turkish Coffee on Postural Control and Hand-eye Coordination in Young Adults
NCT Number: NCT06561113
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Caffeine|Balance; Distorted|Coordination and Balance Disturbances
Interventions: OTHER: Caffeine intake
Sponsor: Bezmialem Vakif University
Sex: ALL
Age: ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-08-14
Completion Date: 2024-08-23
Locations: Bezmialem Vakif University, Istanbul, Turkey

Summary:
Although the effects of different doses of caffeine on balance have been evaluated in various studies, the effects of low doses of caffeine ingested with Turkish coffee on postural control and hand-eye coordination remain unclear. In this study, it will be investigated the acute effects of 60 mg caffeine intake via Turkish coffee on postural control and hand-eye coordination.

Primary Outcome Measures: Postural control assessment with Biodex Balance System, Postural control evaluation will be performed with "Biodex Balance System" (Shirley, NY). Three tests will be performed with the device: postural stability test, stability limits test, and the Modified Clinical Test for Sensory Interaction and Balance (mCTSIB). The test will then continue for 30 seconds, during which time the number of balls caught will be noted, Baseline and immediately after caffeine intake
Secondary Outcome Measures: Hand-eye coordination assessment with alternate hand-wall toss test, Alternate hand wall toss test will be used to measure hand-eye coordination. The Alternate-Hand Wall-Toss Test is a test of hand-eye coordination, where the participant throw a ball against a wall from one hand in an underarm action, and attempt to catch it with the opposite hand. The test will then continue for 30 seconds, during which time the number of balls caught will be noted., Baseline and immediately after caffeine intake
Phase II Randomized, Placebo- Controlled Study of Intralesional Nivolumab for High-risk Oral Premalignant Lesions
NCT Number: NCT06561087
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Premalignant Lesion
Interventions: DRUG: Nivolumab
Sponsor: M.D. Anderson Cancer Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 45
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-12-01
Completion Date: 2029-05-30
Locations: MD Anderson Cancer Center, Houston, Texas, 77090, United States

Summary:
To evaluate the antitumor efficacy of intralesional injections of nivolumab in patients with high-risk oral premalignant lesions

Primary Outcome Measures: Safety and AdverseEevents (AEs), Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0, Through study completion; an average of 1 year
A Phase 2 Study to Evaluate Efficacy of Calaspargase Pegol-mknl and Decitabine Combined With Venetoclax in Pediatric, Adolescent, and Young Adult Patients With Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia (T-ALL) and T- Cell Lymphoblastic Lymphoma (T-LLy)
NCT Number: NCT06561074
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: T-cell Acute Lymphoblastic Leukemia|T-Cell Lymphoblastic Lymphoma
Interventions: DRUG: Decitabine|DRUG: Venetoclax|DRUG: Calaspargase pegol-mknl
Sponsor: M.D. Anderson Cancer Center
Sex: ALL
Age: CHILD, ADULT
Enrollment: 22
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-02-28
Completion Date: 2031-12-31
Locations: MD Anderson Cancer Center, Houston, Texas, 77090, United States

Summary:
To learn if giving the study drugs calaspargase pegol-mknl and decitabine in combination with venetoclax can help to control relapsed/refractory T-ALL and T-LLy. The safety of this drug combination will also be studied.

Primary Outcome Measures: Safety and adverse events (AEs), Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0, Through study completion; an average of 1 year
Zinc for Infection Prevention in Sickle Cell Anemia-2 (ZIPS-2)
NCT Number: NCT06561061
Acronym: ZIPS-2
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2|PHASE3
Conditions: Sickle Cell Disease
Interventions: DRUG: zinc sulfate|DRUG: Placebo
Sponsor: Indiana University
Collaborators: Global Health Uganda LTD|Makerere University
Sex: ALL
Age: CHILD
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: PREVENTION
Start Date: 2024-09
Completion Date: 2025-09

Summary:
A randomized double-blinded placebo-controlled trial of zinc to reduce the incidence of severe or invasive infections in Ugandan children with sickle cell anemia (SCA)

Primary Outcome Measures: Incidence of all-cause infections in the zinc vs. placebo groups, Will assess the difference in the incidence of all cause infection between the Placebo arm and the experimental arm, 6 months
Secondary Outcome Measures: Incidence of infections requiring hospitalization, Incidence of Advance events greater or equal to grade 3, 6 months|Incidence of adverse events requiring discontinuation of study drug, Incidence of Zinc related Advance events, 6 months|Incidence of stroke or death, Incidence of death and stroke, 6 months
Other Outcome Measures: Change in Transcranial Doppler (TCD) velocity from enrollment to 6-month study endpoint, Change in TCD Velocity, 6 months
Soquelitinib vs Standard of Care in Participants With Relapsed/Refractory Peripheral T-cell Lymphoma Not Otherwise Specified, Follicular Helper T-cell Lymphomas, or Systemic Anaplastic Large-cell Lymphoma
NCT Number: NCT06561048
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Peripheral T-Cell Lymphoma, Not Otherwise Specified|Angioimmunoblastic T-cell Lymphoma|Follicular T-Cell Lymphoma|Nodal Peripheral T-Cell Lymphoma With TFH Phenotype|Systemic Anaplastic Large Cell Lymphoma|Lymphoma, T-Cell, Peripheral|Lymphoma, T-Cell
Interventions: DRUG: Soquelitinib|DRUG: Belinostat|DRUG: Pralatrexate
Sponsor: Corvus Pharmaceuticals, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2027-09

Summary:
A Phase 3, randomized, 2-arm, open-label, multicenter, stratified study of soquelitinib versus physician's choice standard of care (SOC) treatment (selected single agents) in participants with relapsed/refractory (R/R) peripheral T-cell lymphoma not otherwise specified (PTCL-NOS), follicular helper T-cell lymphomas (FHTCLs), or systemic anaplastic large-cell lymphoma (sALCL).

Primary Outcome Measures: Progression-free survival, Time from first study treatment to first occurrence of progression (as assessed by the Independent Review Committee) or death, whichever occurs first, Up to 4 years post study treatment initiation
Secondary Outcome Measures: Objective response rate, The rate of participants who achieve a partial response or complete response as assessed by the Independent Review Committee according to the Revised Criteria for Response Assessment of Malignant Lymphoma (Lugano Classification 2014), and modified Severity Weighted Assessment Tool (mSWAT) for participants with skin involvement, Up to 2 years post study treatment initiation|Overall survival, Time from first study treatment to death from any cause, Up to 4 years post study treatment initiation
ACL-R Opioid Sparing Study
NCT Number: NCT06561035
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Anterior Cruciate Ligament Injuries
Interventions: DRUG: Opiate Sparing|DRUG: Opiate Based
Sponsor: Campbell Clinic
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 56
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2026-06
Locations: Campbell Clinic, Memphis, Tennessee, 38138, United States

Summary:
This is a randomized control trial to investigate the effectiveness of a multimodal opiate sparing analgesic regimen in controlling post-operative pain and potentially reduce post-operative opioid consumption in patients undergoing Anterior Cruciate Ligament Reconstruction (ACL-R).

Primary Outcome Measures: Visual Analog Scale, Record pain score with 0 being no pain at all and 10 being worst pain possible., Once per day from postoperative day 1 to postoperative day 14; at two weeks follow up visit, 6 weeks follow up visit and 12 weeks follow up visit.|Oral morphine equivalent, Opiate pill count, daily pill count from postoperative day 1 to postoperative day 14; at 2-week follow up visit, 6-week follow up visit and 12-week follow up visit.
Secondary Outcome Measures: Incidence of treatment-emergent adverse event., From day of surgery to 12-week follow up visit.
Precision Treatment of HR+ HER2- Advanced Breast Cancer Based on SNF Molecular Subtyping
NCT Number: NCT06561022
Acronym: abemaSNF1/3
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Breast Cancer
Interventions: DRUG: Fluzoparib|DRUG: Everolimus|DRUG: Fulvestrant|DRUG: Abemaciclib
Sponsor: Fudan University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 260
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-21
Completion Date: 2026-06-30
Locations: 270 Dongan Road, Fudan University Shanghai Cancer Center, Shanghai, 200032, China

Summary:
To explore the efficacy and safety of Everolimus (SNF1 subtype) or Fluzoparib (SNF3 subtype) combined with Fulvestrant and Abemaciclib vs. Fulvestrant combined with Abemaciclib in patients with HR+/HER2- breast cancer of SNF1/SNF3 subtype who have progressed after CDK 4/6 inhibitor treatment.

Primary Outcome Measures: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0( Safety lead-in Phase), Number of participants with treatment-related adverse events as assessed by CTCAE v5.0, Baseline until disease progression or loss of clinical benefit, assessed up to 6 months|objective response rate (ORR)( Safety lead-in Phase), objective response rate (ORR), Baseline until disease progression or loss of clinical benefit, assessed up to 6 months|Progression-free survival (PFS)(Phase II), Progression-free survival (PFS), Baseline until disease progression or loss of clinical benefit, assessed up to 6 months
Secondary Outcome Measures: Overall survival (OS)(Phase II), Overall survival (OS), Baseline until disease progression or loss of clinical benefit, assessed up to 6 months|objective response rate (ORR)(Phase II), objective response rate (ORR), Baseline until disease progression or loss of clinical benefit, assessed up to 6 months|clinical benefit rate (CBR)(Phase II), clinical benefit rate (CBR), Baseline until disease progression or loss of clinical benefit, assessed up to 6 months|duration of response (DOR)(Phase II), duration of response (DOR), Baseline until disease progression or loss of clinical benefit, assessed up to 6 months|time to first response (TTR)(Phase II), time to first response (TTR), Baseline until disease progression or loss of clinical benefit, assessed up to 6 months|Number of participants with treatment-related adverse events as assessed by CTCAE v5.0(Phase II), Number of participants with treatment-related adverse events as assessed by CTCAE v5.0, Baseline until disease progression or loss of clinical benefit, assessed up to 6 months|Clinical benefit rate (CBR)( Safety lead-in Phase), Clinical benefit rate (CBR), Baseline until disease progression or loss of clinical benefit, assessed up to 6 months|Progression-free survival (PFS)( Safety lead-in Phase), Progression-free survival (PFS), Baseline until disease progression or loss of clinical benefit, assessed up to 6 months
Safety and Efficacy of BAFFR CART for Relapsed/ Refractory Neuromyelitis Optica Spectrum Disorder
NCT Number: NCT06561009
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Neuromyelitis Optica Spectrum Disorder
Interventions: DRUG: Anti-BAFFR CART
Sponsor: Tianjin Medical University General Hospital
Sex: ALL
Age: ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2027-10-01

Summary:
This is an open-label, single-arm, dose-escalation study in up to 20 participants with relapsed/refractory Neuromyelitis Optica Spectrum Disorders (NMOSD). The aim is to evaluate the safety and efficacy of the treatment with BAFFR CART.

Primary Outcome Measures: Incidence of dose-limiting toxicity (DLT), Incidence of dose-limiting toxicity (DLT) will be evaluated within the first 28 days following BAFFR CART cells infusion., Up to 28 days|Incidence and severity of adverse events, Adverse events will be evaluated following the chemotherapy preparative regimen and infusion of BAFFR CART cells within the first 28 days., Up to 28 days
Secondary Outcome Measures: Proportion of BAFFR CART cells in peripheral blood, The proportion of BAFFR CART cells in peripheral blood will be detected after infusion., Up to 1 years|Annualized relapse rate (ARR), ARR is defined as the number of attacks divided by the total participant-years after infusion., Up to 1 years|Changes of B cell levels in bone marrow and peripheral blood, The changes of B cell levels in bone marrow and peripheral blood after BAFFR CART infusion., Up to 1 years|Changes of AQP4 antibody titers, Changes of AQP4 antibody titers from baseline over 1 year after BAFFR CART infusion., Up to 1 years|Changes of cytokine in peripheral blood, Changes of cytokine(including IL-6, IFN-γ, TNF-α, and serum BAFF) in peripheral blood from baseline over 1 year after BAFFR CART infusion., Up to 1 years|Changes of Expanded Disability Status Scale (EDSS) score, Participant will be considered to have a worsening in overall EDSS score of at least 2 if baseline EDSS score was 0, or at least 1 point if baseline EDSS score is 1 to 5, or at least 0.5 point if baseline EDSS score is 5.5 or more., Up to 1 years|Changes of visual acuity, Corrected visual acuity is determine by Snellen E chart held at a distance of 5 meters., Up to 1 years|Accumulated total active MRI lesions, The changes of T2 lesions and/or enhancing T1 Lesions as detected by brain Magnetic Resonance Imaging (MRI)., Up to 1 years
Self-efficacy-based Auditory Rehabilitation with Over-the-Counter Hearing Aids
NCT Number: NCT06560918
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hearing Loss, Sensorineural
Sponsor: University of Arkansas
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 27
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-15
Completion Date: 2025-08-01

Summary:
This goal of this study is to learn if a new audiology treatment process called the self-efficacy-based auditory rehabilitation (SEBAR) can improve confidence and success with over-the-counter (OTC) hearing aids.

The main questions it aims to answer are:

* Can the SEBAR improve participants' confidence related to managing their over-the-counter hearing aids?
* Can the SEBAR improve participants' willingness to adopt over-the-counter hearing aids, their satisfaction, quality of life, and their emotional state? Researchers will compare these outcomes of the SEBAR with and without wearing OTC hearing aids.

Participants will:

* Visit for one appointment to complete a few questionnaires without OTC hearing aids
* Wear a pair of ITC hearing aids for a week and use an app to answer questions about their experiences
* Visit for a second appointment to complete the same questionnaires with OTC hearing aids.

Primary Outcome Measures: Hearing Aid Self-Efficacy, Measured in unaided and aided condition, 1 week
Secondary Outcome Measures: Willingness to adopt hearing aids, Their readiness for adoption using the modified URICA, 1 week|hearing aid satisfaction, using the SADL, 1 week|emotional state, in the unaided and aided condition using the PANAS-SF, 1 week|Hearing-related Quality of Life, Using one-question reflecting degree of change in quality of life, 1 week
Preoperative Planning With PSMA-PET in Melanoma Surgery Trial
NCT Number: NCT06560905
Acronym: PPPIMS
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Malignant Melanoma
Interventions: DRUG: 68Ga-PSMA
Sponsor: Royal Marsden NHS Foundation Trust
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 16
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-09-01
Completion Date: 2025-12-15

Summary:
This is a non-randomised, single-centre Phase 2 study, investigating whether the diagnostic biomarker, prostate-specific membrane antigen (PSMA), can detect melanoma metastases using PSMA PET/ CT.

Primary Outcome Measures: PSMA PET-CT detection of melanoma metastases, The principal objective of the study is to investigate whether the diagnostic biomarker, prostate-specific membrane antigen (PSMA), can detect melanoma metastases using a PSMA PET/ CT., 1 Year
Secondary Outcome Measures: Compare FDG PET-CT & PSMA PET-CT, 1. To compare FDG PET-CT in identifying known metastasis with PSMA PET-CT
2. To compare the radiological information obtained by FDG PET-CT and PSMA PET-CT, 1 Year
Comparison of Intraperitoneal Bupivacaine Alone or With Dexmedetomidine
NCT Number: NCT06560892
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: LAPAROSCOPIC CHOLECYSTECTOMY
Interventions: DRUG: Bupivacaine injection|DRUG: Dexmedetomidine injection
Sponsor: RESnTEC, Institute of Research
Collaborators: Bahawal Victoria Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 68
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-01-01
Completion Date: 2024-06-30
Locations: Quaid-e-Azam Medical College, Bahawalpur, Punjab, 06318, Pakistan

Summary:
For patients with symptomatic cholelithiasis, laparoscopic cholecystectomy (LC) is a customary procedure for treatment these days. After LC, patients may experience considerable pain. This study was performed with the objective of comparing the mean duration of analgesia of intraperitoneal bupivacaine with dexmedetomidine to intraperitoneal bupivacaine alone in patients undergoing laparoscopic cholecystectomy.

Primary Outcome Measures: Duration of analgesia, The duration of postoperative analgesia was calculated as the time in minutes starting after the dressing of the patient in the operation room until the patient had a VAS≥3., 24 hours
Non-surgical Interventions for Infertility in Endometriosis
NCT Number: NCT06560814
Acronym: RCT
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Endometriosis|Infertility, Female
Interventions: DRUG: Cabergoline plus timed intercourse|DRUG: Dydrogesterone plus timed intercourse
Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Sex: FEMALE
Age: ADULT
Enrollment: 18
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2020-07-01
Completion Date: 2021-06-30
Locations: Bangabandhu Sheikh Mujib Medical University, Dhaka, 1200, Bangladesh

Summary:
A parallel design randomized clinical trial was carried out on 18 women with clinically diagnosed endometriosis who wish pregnancy in the Department of Reproductive Endocrinology and Infertility, Bangabandhu Sheikh Mujib Medical University, (BSMMU), Shahbag, Dhaka. Those who voluntarily provide consent to participate in this study will be randomly allocated to one of the two treatment arms. Allocation concealment will be done by sequentially numbered sealed envelopes. The arms and interventions are cabergoline (0.5 mg twice weekly for 6 months, plus timed intercourse) and dydrogesteron (20 mg daily from day 5 to day 25 of menstrual cycle for 6 months, plus timed intercourse).The women will be assessed by telephone interview at monthly intervals, TVS and serum Ca 125 at 3 months and 6 months.

Primary Outcome Measures: Pain reduction estimated by mean change on a Visual Analog Scale, Mean change in Visual Analogue Score (1-10), higher score means worse outcome, 24 weeks|Percentage change in size, Percentage change in size (maximum diameter) of chocolate cyst assessed by transvaginal ultrasound at week 24, 24 weeks|Pregnancy rate, Proportion in each group of participants of those who conceive , biochemical (serum beta hCG \> 40 IU/mL) or clinical (sonographic appearance of gestational sac), 24 weeks
Secondary Outcome Measures: Change in CA 125, Serum CA 125 level will be measured in blood, 24 weeks|Adverse effect, From patient drug history, 24 weeks