pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Reaching a Caloric Goal Using a Gastric Sonar Versus Aspiration of Gastric Contents in Critically Ill Patients Receiving Nasogastric Enteral Nutrition
NCT Number: NCT06557629
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Enteral Nutrition Intolerance in Critically Ill Patients
Interventions: DIAGNOSTIC_TEST: Ultrasound assessment
Sponsor: Meir Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-10-01
Completion Date: 2027-10-01
Locations: Meir Medical Center, Kfar Saba, Israel

Summary:
Enteral nutrition intolerance, manifested in delayed gastric emptying and high gastric residual, is a common problem in critically ill patients in intensive care, with adverse consequences on patients' outcomes. A decrease in the levels of the ghrelin hormone in these patients may contribute to this problem. The gastric residual test (GRV) is used to assess enteral absorption and gastric motility, but the traditional methods can lead to inaccuracy and waste of resources. In recent years, the use of ultrasound (PoCUS) to assess GRV has developed, but its effect on the rate of reaching the caloric goal has not yet been evaluated.

Primary Outcome Measures: Reaching the daily caloric goal, To compare the daily caloric goal via gastric residual volume assessment with ultrasound vs. gastric aspiration, 3 days
Safety and Efficacy of the CoolCryo System for Cardiac Cryoablation in the Treatment of Atrial Fibrillation
NCT Number: NCT06557616
Acronym: CoolCryo
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Atrial Fibrillation, Paroxysmal or Persistent|Mitral Valve Disease
Sponsor: Medinice S.A.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-03
Completion Date: 2025-12-31
Locations: Silesian Centre for Heart Diseases, Zabrze, 41-800, Poland

Summary:
The study involves endocardial cryoablation of the left and/or right atrium of the heart using the CoolCryo system as an adjunct to mitral valve surgery, with the aim of eliminating atrial fibrillation (AF), which is a common sequelae of mitral valve defects and is associated with an increased risk of ischaemic stroke, heart failure and death.

Primary Outcome Measures: Percentage of patients with no documented recurrence of atrial fibrillation on continuous 48h Holter ECG recording during 6-month follow-up., To verify whether atrial fibrillation is present in the recordings obtained during 48h Holter. ECG monitorin, 12 weeks (+/- 7 days) and 25 weeks (+/- 7 days) after the procedure|Incidence of adverse events and serious adverse events related to the use of the, Recording of adverse events/serious life-threatening events., 6 day (+/- 1 day), 12 weeks (+/- 7 days) and 25 weeks (+/- 7 days) after the procedure
Secondary Outcome Measures: The occurrence of serious adverse events during surgery (intraoperatively) or after the procedure until the patient is discharged from the unit (postoperatively)., Recording of all adverse events/serious life-threatening events., During the procedure, 6 day (+/- 1 day) after the procedure|Incidence of all adverse events and serious adverse events at 6-month follow-up after surgery., Recording of all adverse events/serious life-threatening events., 6 day (+/- 1 day), 12 weeks (+/- 7 days) and 25 weeks (+/- 7 days) after the procedure|The proportion of patients who had a return to sinus rhythm at 3 and 6 months postoperatively., To verify whether sinus rhythm is present in the recordings obtained during 48h Holter ECG monitoring., 12 weeks (+/- 7 days) and 25 weeks (+/- 7 days) after the procedure
Bioequivalence Study of Ivermectin 1% Cream and Soolantra (Ivermectin) 10 mg/g Cream
NCT Number: NCT06557603
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Rosacea
Interventions: DRUG: Ivermectin cream|DRUG: Soolantra ® (Ivermectin) cream
Sponsor: Humanis Saglık Anonim Sirketi
Sex: ALL
Age: ADULT
Enrollment: 44
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-03-06
Completion Date: 2024-07-22
Locations: Cliantha Research Limited, Vadodara, Gujarat, 390012, India

Summary:
Single dose bioequivalence study of Ivermectin 1% cream and Soolantra (Ivermectin) 10 mg/g cream in healthy adult human subjects.

Primary Outcome Measures: Maximum measured plasma concentration (Cmax), If the reference product intra-subject CV is less than or equal to 30% for Cmax, then the 90% confidence interval of the relative mean Cmax of the test to reference formulation for Ln-transformed data was to be within 80.00% to 125.00%., 21 hours|Area under the plasma concentration versus time curve from the time zero time point to the last quantifiable concentration (AUCt), The 90% confidence interval of the relative mean (Geometric mean) of the Test to reference formulation for Ln-transformed AUCt was to be within 80.00% to 125.00%, 21 hours
Secondary Outcome Measures: Area under the plasma concentration versus time curve from time zero to infinity (AUCi), Descriptive statistic, 21 hours|Time of the maximum measured plasma concentration (Tmax), Descriptive statistic, 21 hours
18F-FAPI-04 PET/CT and PET/MR in Patients With Various Types of Malignant Tumors
NCT Number: NCT06557590
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cancer|FAP
Interventions: DIAGNOSTIC_TEST: 18F-FAPI-04
Sponsor: Hunan Cancer Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-01
Completion Date: 2028-12-31
Locations: Hunan Cancer hospital, Changsha, Hunan, 410000, China

Summary:
To evaluate the potential usefulness of 18F-FAPI-04 positron emission tomography/computed tomography (PET/CT) and positron emission tomography/magnetic resonance imaging （PET/MR）for the diagnosis of primary and metastatic lesions, detection of recurrence or assessment of pathologic response in various types of cancer.

Primary Outcome Measures: Diagnostic Performance, Diagnostic accuracy, The sensitivity, specificity and accuracy of 18F-FAPI-04 PET/CT and PET/MR were calculated., 1 year
Diagnosis of Graft Pathology by TruGraf
NCT Number: NCT06557564
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Acute Graft Rejection
Interventions: GENETIC: TruGraf liver gene expression
Sponsor: University Health Network, Toronto
Collaborators: Transplant Genomics, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 471
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-20
Completion Date: 2027-12-30
Locations: Toronto General Hospital -UHN, Toronto, Ontario, M5G 2N2, Canada

Summary:
The goal of this observational study is to to identify different causes of liver diseases or damage in liver transplant patients and develop a machine learning algorithm as a non-invasive tool leveraging gene expression and patient clinical information to classify transplant liver diseases We will collect blood samples of the participants who had undergone or will undergo the liver biopsy as part of standard of care, and use this blood in TruGarf. TruGraf is a non-invasive test that measures differentially expressed genes in the blood of transplant recipients to rule out liver damage. Researcher will collect the biopsy result from the medical record and this will be compared with the TruGarf results.

Primary Outcome Measures: Develop and validate a ML-based algorithm, Develop and validate a ML-based algorithm that identifies major graft pathologies using liver biopsy as the reference method., 36 months
Secondary Outcome Measures: Identify specific etiologies of ongoing graft damage, Identify specific etiologies of ongoing graft damage by examining TruGraf gene expression array., 36 months
A Comparison of Automatic ABPI vs Manual ABPI Device Scores
NCT Number: NCT06557538
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Lower Limb Ulcers
Interventions: DEVICE: Automatic Ankle Brachial Pressure Index device assessment|DEVICE: Manual Ankle Brachial Pressure Index assessment
Sponsor: University of Southampton
Collaborators: Berkshire Healthcare NHS Foundation Trust
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 54
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-19
Completion Date: 2025-03
Locations: Berkshire Healthcare NHS Foundation Trust, Bracknell, Berkshire, rg12 2ut, United Kingdom

Summary:
The aim of the study is to compare the Ankle Brachial Pressure Index (ABPI) scores of two devices. The two devices that will be compared are the MESI MD ABPI automatic device and the Huntleigh Dopplex manual device.

The Huntleigh Dopplex manual device is widely used, though the MESI MD ABPI automatic devices can reduce waiting times, reduce discomfort for patients and save nursing time. ABPI devices provide a score that supports nurses to provide suitable treatment for patients with a lower limb ulcer.

In the community, patients with lower limb ulcers are offered an ABPI assessment and then treatment is decided based on the score. Participants will be patients with lower limb ulcers referred to community nursing for a lower limb and ABPI assessment. At their routine appointment patients will have a manual assessment and an automatic assessment, and the results will be compared. The study will take place in the county of Berkshire either in patients' homes or in the lower limb clinic. Registered nurses will undertake all assessments. The direct care part of the study will run from July 2024 - December 2024. The data will be pseudonymised, and the findings written as a report that may be sent for publishing.

Primary Outcome Measures: Ankle Brachial Pressure score, Difference between ABPI scores from automatic and manual ABPI device., Through study completion of average of 7 months
Secondary Outcome Measures: Difference in lower limb ulcer classification, Difference in lower limb ulcer classification between automatic and manual ABPI device., Through study completion of average of 7 months
Lidocaine Versus Fentanyl for Hemodynamic Stability
NCT Number: NCT06557473
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Hypertension|Fentanyl|Lidocaine
Interventions: DRUG: Lidocaine IV|DRUG: Fentanyl
Sponsor: Theodor Bilharz Research Institute
Sex: ALL
Age: ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-04-01
Completion Date: 2024-07-01
Locations: Theodor Bilharz Research Institute, Giza, Egypt

Summary:
Hypertension is an important health challenge that affects millions of people across the world today and is a major risk factor for multiple system comorbidities. Intraoperative hypotension may lead to negative outcomes. 'Post-induction hypotension' (PIH; i.e. arterial hypotension defined as hypotension during the first 20 min after anesthesia induction, or from anesthesia induction until the beginning of surgery) and 'early intraoperative hypotension' (eIOH; i.e. arterial hypotension occurring during the first 30 min of surgery). Lidocaine is a local anesthetic drug with multiple systemic uses. Systemic lidocaine used as at the perioperative period has analgesic, and anti-inflammatory properties which make it capable of reducing intra- and postoperative drug consumptions and patients' hospital stay. Therefore, we hypothesize that the use of lidocaine as an adjuvant to propofol might reduce the risk of post induction hypotension and hence having more stable hemodynamic profile during induction of anesthesia.

Primary Outcome Measures: MAP, Mean Arterial blood pressure 1 minute after induction of anesthesia., 1 minute after GA induction
Secondary Outcome Measures: Number of hypotensive episodes, MAP less than 65 mmHg., 20 minutes
A PHASE IIB, RANDOMIZED, ASSESSOR-MASKED, MULTICENTER CLINICAL TRIAL TO ASSESS THE SAFETY AND EFFICACY OF SUBRETINAL IMPLANTATION OF THE CPCB-RPE1 IMPLANT IN SUBJECTS WITH ADVANCED, DRY AMD (GEOGRAPHIC ATROPHY)
NCT Number: NCT06557460
Acronym: PATCH-AMD
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Dry Age-related Macular Degeneration|Geographic Atrophy
Interventions: DEVICE: Surgical implantation of the CPCB-RPE1 implant
Sponsor: Regenerative Patch Technologies, LLC
Collaborators: California Institute for Regenerative Medicine (CIRM)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 24
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2040-12

Summary:
This is a Phase IIb randomized, clinical trial designed to assess the safety and efficacy of unilateral implantation of the CPCB-RPE1 implant in subjects with geographic atrophy involving the fovea.

Up to 6 surgical implantation sites will deliver the CPCB-RPE1 in this Phase IIb clinical trial. Additional study sites may serve as referral or follow-up sites. Twenty-four (24) subjects will participate in the trial and will be randomized 3:1 to one of 2 groups:

* The treatment group receiving the CPCB-RPE1 implant (up to 18 subjects).
* The control group receiving a simulated "sham" implantation procedure (up to 6 subjects)

Primary Outcome Measures: Change in retinal sensitivity, Change in retinal sensitivity by microperimetry, 1 year post implantation
Secondary Outcome Measures: Change in best corrected visual acuity, Change in best corrected visual acuity, 1 year post implantation
An Exploratory Clinical Investigation Evaluating Two Abutment Surfaces
NCT Number: NCT06557447
Acronym: Exploratory
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Peri-implant Crevicular Fluid
Interventions: DIAGNOSTIC_TEST: Immunological and microbiological sample of peri-implant crevicular fluid; clinical evaluation
Sponsor: Studio Ban Mancini Fabbri
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 22
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-12
Completion Date: 2025-04

Summary:
A total of 22 subjects will be included in the study. The subjects who were treated with NobelActive TiUnite and On1 machined abutment will be enrolled in the control group and subjects who were treated with NobelActive TiUltra and On1 Base Xeal abutments will be enrolled in the test group. Two peri-implant crevicular fluid (PICF) samples will be collected for immunological testing and two plaques samples will be collected for microbiological testing from all the enrolled subjects one from the control/test implant site and one from the contralateral tooth/implant site. 3 weeks after the first sampling PICF and plaques sampling will be repeated the same way.

Primary Outcome Measures: Evaluate immunological markers in peri-implant crevicular fluid, Immunological sample collection of subgingival area (per-implant crevicular fluid) on implant and contralateral tooth/implant for test and control group, 2 samples collections with 3 weeks of interval|Evaluate microbiological response in peri-implant crevicular fluid, Microbiological sample collection of subgingival area (per-implant crevicular fluid) on implant and contralateral tooth/implant for test and control group, 2 samples collections with 3 weeks of interval|Bleeding Index, Bleeding on probing will be assessed on implant and contralateral tooth/implant for test and control group, Pre-treatment/initial visit|Gingival Index, Gingival status will be assessed on implant and contralateral tooth/implant for test and control group, Pre-treatment/initial visit|Plaque Index, Dental plaque will be assessed on implant and contralateral tooth/implant for test and control group, Pre-treatment/initial visit
AV-23-001 AVAVA MIRIA Pilot Study
NCT Number: NCT06557434
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Wrinkle|Acne Scars - Mixed Atrophic and Hypertrophic|Pigmented Lesions|Skin Laxity|Scars
Interventions: DEVICE: MIRIA
Sponsor: AVAVA, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-11-06
Completion Date: 2025-01-01
Locations: Skinfluence Long Island, Dix Hills, New York, 11746, United States|Laser and Skin Surgery Center of New York, New York, New York, 10010, United States

Summary:
This non-significant risk study is intended to demonstrate the use of the MIRIA Skin Treatment System can show improvement in dermatologic conditions currently indicated for treatment with a laser (such as, but not limited to, benign pigmented lesions, benign cutaneous lesions, wrinkles, textural irregularities, or scars). The study is also intended to assist in determination of the optimal laser configuration and treatment parameters that most consistently yield results.

Primary Outcome Measures: Global Aesthetic Improvement Scale (GAIS), Scale used to compare before and after images of subjects treated. Scores include the following:

1. - Very Much Improved
2. - Much Improved
3. - Improved
4. - No Change
5. - Worse, 3 Months
Secondary Outcome Measures: Subject Questionnaire, Questionnaire that evaluates the subjects impression of the treatment (overall discomfort score, satisfaction with treatment results, notes on treatment sensation)., Immediate Post Treatment, 3 Months Post Treatment|Adverse Event Assessment, An assessment of side effects and adverse event profile to ensure safety of treatment. Data collected included the event, the duration, the severity, and any other interventions that may occur due to the adverse event., Immediate Post Treatment, 3 Months Post Treatment
De-Escalation Study Evaluating Venetoclax and Azacitidine Discontinuation in AML Responding Patients
NCT Number: NCT06557421
Acronym: STOP VEN
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Acute Myeloid Leukemia
Interventions: DRUG: Venetoclax|DRUG: Azacitidine
Sponsor: Institut Paoli-Calmettes
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-11-01
Completion Date: 2028-11-01

Summary:
The goal of this clinical trial is to test efficacy and safety of a VENETOCLAX-AZACITIDINE (VEN-AZA) de-escalation strategy in Acute Myeloid Leukemia responding patients. The main objectives of the study are:

* Evaluation of the efficacy of VEN-AZA de-escalation strategy by measuring the effect of VEN-AZA discontinuation in term of Disease-Free Survival.
* Evaluation of the other efficacy parameters and safety of VEN-AZA de-escalation strategy.

Patients from the prospective study will be compared to a retrospective cohort of patients who will be selected on the basis of identical eligibility criteria.

Participants will:

* Stop VEN-DASA treatment
* Be closely monitored by regular evaluation of the disease

Primary Outcome Measures: Disease-Free Survival, measured from inclusion (VEN-AZA de-escalation) to the date of morphologic or measurable residual disease relapse or death from any cause, whichever occurs first., 24 months
Secondary Outcome Measures: Absolute duration of hematologic response, defined as the time from inclusion to relapse or death., 24 months|Absolute duration of negative measurable residual disease response, defined as the time from inclusion to measurable residual disease relapse or death., 24 months|Cumulative incidence of relapse, defined as the probability of relapse over time., 24 months|Overall survival, defined as the time from inclusion (VEN-AZA de-escalation) to death., 24 months|Second complete remission occurence., 24 months|Time to second remission, defined as the time between date of treatment re initiation and complete remission., 24 months|Hospitalization rate associated with VEN-AZA de-escalation., 24 months|Transfusion occurrence associated with VEN-AZA de-escalation., 24 months|Grade 3-4 adverse events occurence associated with VEN-AZA de-escalation., 24 months|Correlation between age and duration of response and survival after VEN-AZA de-escalation., 24 months|Correlation between FAB classification and duration of response and survival after VEN-AZA de-escalation., 24 months|Correlation between cytogenetic and molecular alterations and duration of response and survival after VEN-AZA de-escalation., 24 months|Correlation between number of prior VEN-AZA cycles and duration of response and survival after VEN-AZA de-escalation., 24 months
Pancreatic Fistula After Minimally Invasive Enucleation
NCT Number: NCT06557408
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Pancreatic Tumor, Benign|Pancreatic Neuroendocrine Tumor|Solid Pseudopapillary Tumor of the Pancreas
Sponsor: Fudan University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 173
Study Design: Observational Model: |Time Perspective: p
Start Date: 2019-07-01
Completion Date: 2024-07-30
Locations: Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center Shanghai, Shanghai, China, Shanghai, Shanghai, China

Summary:
Patients suffering from postoperative pancreatic fistula (POPF) after minimally invasive enucleation (MEN) show a characteristic pattern of longer duration and milder symptoms, which is different from pancreatic fistula after standard pancreatectomy. This study aimed to analyze the factors influencing clinically-relevant POPF (CR-POPF) after minimally invasive enucleation, investigate and develop a personalized predictive model for accurate prediction of CR-POPF after minimally invasive enucleation.

Primary Outcome Measures: Incidence of Clinically Relevant Postoperative Pancreatic Fistula, Clinically Relevant Pancreatic Fistula including Grade B fistulas, which require treatment beyond simple drainage, as well as Grade C fistulas., Within 90 days after surgery.
Secondary Outcome Measures: Perioperative complication rate according to the Clavien-Dindo classification, Adverse events occurring during or after surgery reported according to the Clavien-Dindo classification., Within 90 days after surgery.
UNMET CARE PERCEPTIONS OF INTENSIVE CARE NURSES
NCT Number: NCT06557395
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Nurse's Role
Sponsor: Ondokuz Mayıs University
Sex: ALL
Age: ADULT
Enrollment: 1
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-04-01
Completion Date: 2023-09-30
Locations: Ondokuz Mayıs University, Samsun, Atakum, 55100, Turkey

Summary:
This study was conducted to determine the perceptions of intensive care nurses regarding unmet care. A qualitative descriptive approach. The study was completed between April and September 2023 by conducting semi-structured individual interviews with 20 intensive care nurses in a Training and Research Hospital in Turkey and analyzed using the inductive content analysis method.

Primary Outcome Measures: What is the perception of care among intensive care nurses?, This study is a qualitative design study conducted with intensive care nurses. In the study, a purposeful sampling method was used in accordance with the qualitative research approach. The number of participants was determined according to data saturation and was based on the voluntary participation of a total of 20 intensive care nurses. During the interview, participants were asked to fill out a personal information form and expert opinions on the subject, as well as in-depth interview questions in a semi-structured information form consisting of eight questions. Data were collected through face-to-face individual interviews with nurses working in the intensive care unit of a Training and Research Hospital between April and September 2023. In-depth interview questions were prepared in line with literature knowledge and expert opinions were obtained., April-September 2023|What are the thoughts of intensive care nurses regarding the perception of unmet care?, After the interviews were completed, the raw data were manually transcribed by the researchers. The content analysis method was used in the evaluation of the data. The data were read several times by the researchers and codes were created from each word, sentence and paragraph. The analysis of the data was carried out manually using the level coding system and themes were created. Level coding was applied as open coding (first level), selective coding (second level), themes (third level) (Yıldırım \& Şimşek 2016). After this stage, the relevant codes were classified and themes and sub-themes were created (Elo \& Kyngäs, 2008; Vaismoradi et al., 2013)., April-September 2023
A Study of LY3532226 in Participants With Obesity
NCT Number: NCT06557356
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Obesity
Interventions: DRUG: LY3532226|DRUG: Placebo
Sponsor: Eli Lilly and Company
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 105
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-08
Completion Date: 2025-05
Locations: Fortrea CRU, Inc., Daytona Beach, Florida, 32117, United States

Summary:
The main purpose of this study is to evaluate the safety and tolerability of the study drug known as LY3532226 in participants with obesity. Blood tests will be performed to check how much LY3532226 gets into the bloodstream and how long it takes the body to eliminate it following weekly or monthly administration. Part A of the study will last approximately 16 weeks, excluding screening period. Part B of the study will last approximately 20 weeks, excluding the screening period.

Primary Outcome Measures: Part A: Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration, A summary of TEAEs and SAEs, regardless of causality, will be reported in the Reported Adverse Events module, Baseline to Study Completion (Up to 16 Weeks)|Part B: Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration, A summary of TEAEs and SAEs, regardless of causality, will be reported in the Reported Adverse Events module, Baseline to Study Completion (Up to 20 Weeks)
Secondary Outcome Measures: Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3532226, PK: Cmax of LY3532226, Predose on Day 1 through Week 16|Part A: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3532226, PK: AUC of LY3532226, Predose on Day 1 through Week 16|Part B: PK: Cmax of LY3532226, PK: Cmax of LY3532226, Predose on Day 1 through Week 20|Part B: PK: AUC of LY3532226, PK: AUC of LY3532226, Predose on Day 1 through Week 20
Single-Cell Sequencing Analysis of Radiation Pneumonitis Signals In Patients Treated For Cancer With Radiotherapy
NCT Number: NCT06557343
Acronym: SPITFIRE
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Radiation Pneumonitis
Interventions: DIAGNOSTIC_TEST: Single Cell Sequencing
Sponsor: NHS Lothian
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 5
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08
Completion Date: 2025-08
Locations: Centre for Information Research, University of Edinburgh, Edinburgh, EH16 4UU, United Kingdom|Henderson Lab, Edinburgh, EH16 4UU, United Kingdom|Edinburgh Cancer Centre, Edinburgh, EH4 2XU, United Kingdom

Summary:
Patients with signs of radiation induced lung inflammation, who are referred for a clinical bronchoscopy for investigation, will have a sample sent for single cell sequencing. This is a novel technique which allows for identification of which cells are present and what they are doing. This hopes to better understand radiation pneumonitis, a dose-limiting toxicity in cancer treatment which can be highly morbid and even fatal.

Primary Outcome Measures: Successful creation of dataset, If deep bronchial brushings generates sufficient viable cells for processing via single-cell sequencing this will generate a dataset of cellular activity for each of these five patients. The only way to know if this technique - ie. the use of deep bronchial brushings combined with single-cell sequencing, is to run the test on the samples and therefore successful generation of the dataset is proof of feasibility of the method. There may be further use for this dataset (ie. secondary outcome below) but primarily this process will prove feasibility simply by generating data. This is not a health outcome, simply demonstration of a viable sample using a novel combination of sampling and laboratory test., within a month of sample collection, a year to recruit five patients
Secondary Outcome Measures: Signals in pneumonitis, Comparison with normal lung dataset (publicly available) to potentially identify radiation pneumonitis signals that may be targetable via drug therapy or worth expanding to a larger trial to explore., 3-6 months
The Real World Study of BTK Inhibitor in the Treatment of Chronic Lymphocytic Leukemia in China
NCT Number: NCT06557304
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: CLL
Interventions: DRUG: BTK inhibitor
Sponsor: Peking University People's Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2027-12-30

Summary:
This is a Multicenter, Retrospective Real-world Study of Zanubrutinib in the Treatment of Chronic Lymphocytic Leukemia in China

Primary Outcome Measures: Overall Survival, OS is defined as the time from the starting date of BTK inhibitor to the date of death due to any cause., up to five years
Secondary Outcome Measures: Time to Next Therapy (TTNT), The TTNT will be calculated as the difference between BTK inhibitor initiation date and initiation date of the first next therapy for CLL, up to two years|Adverse Events, Percentage of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and Special Situations, up to five years
Relapse-Free Survival With Adjuvant Dabrafenib/Trametinib Therapy in Patients With BRAF V600-mutated Stage III/IV Melanoma
NCT Number: NCT06557291
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: BRAF V600 Mutated-Stage III/IV Melanoma
Sponsor: Novartis
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 38
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-10-04
Completion Date: 2023-11-16
Locations: Novartis Pharmaceuticals, East Hanover, New Jersey, 07936, United States

Summary:
This was a retrospective chart review study of all proto-oncogene B-Raf (BRAF) V600-mutated patients who received adjuvant checkpoint inhibitor (CPI) therapy, relapsed locoregionally or distantly, and were again resected to no evidence of disease (NED) and treated with adjuvant dabrafenib and trametinib (dab/tram) combination therapy.

Primary Outcome Measures: Relapse-free Survival-2 (RFS-2), RFS-2 was defined as the time from the study index date until the date of the earliest clinician-documented disease progression, death, or start of a new line of anticancer treatment due to disease progression. Patients without a progression event as described above were censored at the last available follow-up, defined as last known clinic visit or last known contact with the patient (if occurred outside the clinic setting).

Index date was defined as the date that dab/tram combination therapy was initiated after being rendered disease-free for a second time following additional resection after prior relapse on initial CPI adjuvant therapy., Up to 63 months
Secondary Outcome Measures: Overall Survival (OS), OS was defined as the time from the study index date until death due to any cause. Patients without a death event were censored at last available follow-up, defined as last known clinic visit or last known contact with the patient (if occurred outside the clinic setting).

Index date was defined as the date that dab/tram combination therapy was initiated after being rendered disease-free for a second time following additional resection after prior relapse on initial CPI adjuvant therapy., Up to 63 months|Distant Metastases-free Survival (DMFS), DMFS was defined as the time from the study index date until the first observation of disease progression with distant metastasis. Patients without a DMFS event as described above were censored at last available follow-up, defined as last known clinic visit or last known contact with the patient (if occurred outside the clinic setting).

Index date was defined as the date that dab/tram combination therapy was initiated after being rendered disease-free for a second time following additional resection after prior relapse on initial CPI adjuvant therapy., Up to 63 months|Number of Patients with an Adverse Event (AE) Related to Dabrafenib and Trametinib Combination Therapy, Up to 63 months|Mean Number of Times an AE Related to Dabrafenib and Trametinib Combination Therapy was Experienced, Up to 63 months
Combined AlloStim+Anti-PD-L1 in MSS Metastatic Colorectal Cancer
NCT Number: NCT06557278
Acronym: COMUNITY
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Metastatic Colorectal Cancer
Interventions: BIOLOGICAL: AlloStim|DRUG: Bavencio
Sponsor: Mirror Biologics, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2026-03
Locations: Mt. Sinai Comprehensive Cancer Center, Miami Beach, Florida, 33140, United States|Hirschfield Oncology Center, Brooklyn, New York, 11206, United States

Summary:
Experimental immunotherapy in chemotherapy-refractory and immunotherapy-refractory metastatic colorectal cancer patients that have progressed, or are intolerant to, Longsurf (TAS-102) +/- Avastin (bevacizumab) or Stivarga (regorafenib) combining experimental AlloStim with an anti-programmed death ligand 1 (PD-L1) checkpoint inhibitor drug.

Primary Outcome Measures: Objective Tumor Response, CT scan RESIST 1.1, day 175|Overall Survival, survival from signing consent until death by any cause, 2 years
Secondary Outcome Measures: circulating tumor DNA, biological marker for tumor response, baseline to day 175
NKX019, Intravenous Allogeneic Chimeric Antigen Receptor Natural Killer Cells (CAR NK), in Adults With Autoimmune Disease (Ntrust-1)
NCT Number: NCT06557265
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Lupus Nephritis|Glomerulonephritis
Interventions: DRUG: NKX019|DRUG: Cyclophosphamide
Sponsor: Nkarta, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 21
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-13
Completion Date: 2027-04
Locations: Emory University, Atlanta, Georgia, 30322, United States

Summary:
This is an open-label, multi-center, non-randomized Phase 1 study to determine the safety and tolerability of NKX019 (allogeneic CAR NK cells targeting CD19) in participants with active lupus nephritis (LN).

Primary Outcome Measures: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability], Incidence and severity of treatment-emergent adverse events will be evaluated, 30 days after last dose of NKX019, up to a maximum of 44 days|Incidence of dose-limiting toxicities (DLTs) [Safety and Tolerability], Incidence of DLTs will be evaluated, The first 28 days after the first NKX019 dose
Secondary Outcome Measures: Number of participants who achieved renal response, Complete renal response and partial renal response to treatment will be assessed based on European Alliance of Associations for Rheumatology (EULAR)/European Renal Association-European Dialysis and Transplantation Association (ERA-EDTA) criteria, Up to 2 years after NKX019 infusion|Change from baseline in titer of anti-double-stranded DNA (anti-dsDNA) antibodies levels, Up to 2 years after NKX019 infusion|Change from baseline in complement levels, Up to 1 year after NKX019 infusion|Change from baseline in SLEDAI-2K (Systemic Lupus Erythematosus Disease Activity Index 2000) score, Up to 2 years from NKX019 infusion|Maximum Concentration (Cmax) of NKX019 in peripheral blood, Up to 2 years after NKX019 infusion|Time to Cmax (Tmax) of NKX019 in peripheral blood, Up to 2 years after NKX019 infusion|Area Under the Concentration-time Curve (AUC) of NKX019 in peripheral blood, Up to 2 years after NKX019 infusion|Half-life (t1/2) of NKX019 in peripheral blood, Up to 2 years after NKX019 infusion|Duration of Persistence of NKX019 in peripheral blood, Up to 2 years after NKX019 infusion|Incidence of positive anti-NKX019 antibodies to assess immunogenicity of NKX019 over time, Up to 2 years after NKX019 infusion
The Application of the PDCA Management Model in Improving the Diagnostic Accuracy of AIG
NCT Number: NCT06557252
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Autoimmune Gastritis
Interventions: BEHAVIORAL: PDCA training
Sponsor: Ningbo No. 1 Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 16
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-15
Completion Date: 2024-12-31
Locations: Ningbo first hospital, Ningbo, Zhejiang, 315000, China

Summary:
Autoimmune gastritis is currently relatively rare in China due to its insidious onset, diverse clinical manifestations involving multiple systems such as digestive, hematological, and nervous systems, and its association with other autoimmune diseases. It can also be complicated by hyperplastic gastric polyps, gastric neuroendocrine tumors, gastric adenocarcinoma, and other diseases, making it prone to clinical misdiagnosis. As a form of gastritis in the post-Helicobacter pylori era, its detection rate has been gradually increasing with the continuous improvement of endoscopic technology in China. Applying the PDCA cycle management in disease diagnosis can significantly improve the detection rate of the disease, benefiting patients. Through the PDCA management model, this study further enhanced gastroenterologists' understanding of this disease from various aspects, aiming to improve the clinical diagnosis of autoimmune gastritis.

Primary Outcome Measures: Diagnostic Accuracy of AIG, To diagnose Autoimmune Gastritis (AIG), the following two criteria must be simultaneously met:

Endoscopic or histopathological findings, or both, that are consistent with the characteristics of autoimmune gastritis.

Positive gastric autoantibody status, including the presence of anti-parietal cell antibodies (PCA) or anti-intrinsic factor antibodies (IFA), or both., 4months|The suspected diagnosis rate of AIG, If only the endoscopic or histopathological findings, or both, are consistent with the characteristics of autoimmune gastritis, but the gastric autoantibody status (anti-parietal cell antibodies or anti-intrinsic factor antibodies) is not confirmed to be positive, then the case should be considered as a suspected case of Autoimmune Gastritis (AIG)., 4months
Secondary Outcome Measures: Parietal Cell Antibody（PCA）, PCA is an important indicator in the diagnosis of AIG., 4months|IF-Ab, IFA is an important indicator in the diagnosis of AIG., 4months
Salivary Oxytocin as a Biomarker in Psychedelic Assisted Psychotherapy
NCT Number: NCT06557239
Acronym: PAP_OXT
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Depression, Anxiety
Interventions: DRUG: Lysergic Acid Diethylamide (LSD)
Sponsor: Tatiana Aboulafia Brakha
Sex: ALL
Age: ADULT
Enrollment: 10
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-05
Completion Date: 2024-12-31
Locations: Geneva University Hospitals, Geneva, Switzerland

Summary:
The main objective of this pilot study is to obtain preliminary data on the reactivity of salivary oxytocin during a single LSD intake as part of PAP treatment for anxiety disorders or depression (treatment authorisations granted in advance by the Federal Officie of Public Health for compassionate use of the substance).

There will be no interference with the usual clinical routine in our Service. The protocol is only for taking additional saliva measurements to measure oxytocin levels on the day of treatment.

Participants will be asked to give 4 saliva samples the day of their LSD treatment .In addition they will fill-in self-report questionnaires which are part of the clinical routine

Primary Outcome Measures: Salivary oxytocin, oxytocin sampled in the saliva, the day of treatment administration (one day)
Secondary Outcome Measures: Self-reported symptoms of anxiety (STAI-T), State-Trait Anxiety Inventory (trait), total scores ranging from 20 to 80, higher scores indicating higher anxiety, over 6 months|Self-reported depressive symptoms (BDI-II), Beck Depresion Inventory-II, total scores ranging from 0 to 63, higher scores indicating higher depressive symptoms, over 6 months|Self-reported intensity of mystical experience, Assessed with the self-report Mystical experience Questionnaire (MEQ-30) with total man score ranging from 0 to 5, with higher scores indicating higher intensity of mystical experience, The 1 day of treatment administration|Self-reported intensity of Connectedness, Assessed with the self-report Watts Connectedness Scale,total mean score ranging from 0 to 100, with higher scores indicating higher connectedess, The 1 day of treatment administration
Oral (Hypo-)Function, General Function and Nutritional Status in Elderly Hospitalized Patients
NCT Number: NCT06557226
Acronym: Ohyp
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Oral Health|Oral Health Related Quality of Life|Nutrition Disorders in Old Age
Interventions: OTHER: oral and nutritional examination
Sponsor: University of Geneva, Switzerland
Sex: ALL
Age: OLDER_ADULT
Enrollment: 61
Study Design: Observational Model: |Time Perspective: p
Start Date: 2020-09-12
Completion Date: 2023-09-10
Locations: University clinics of dental medicine, Genève, Geneva 4, 1211, Switzerland|Geneva University Hospital, Geneva, 1233, Switzerland

Summary:
The goal of this observational study is to learn about the effects of a reduced oral function on the nutritional status of non-acute hospitalized elders and on their oral health quality of life.

Primary Outcome Measures: Malnutrition status as classified by the Global Leadership Initiative on Malnutrition (GLIM), The GLIM considers both (a) phenotypic (\>5% weight loss within the previous 6 months or \>10% weight loss in more than 6 months, BMI \< 22 kg/m2 if age \>70 years, FFMI \<17 kg/m2 in men and \<15 kg/m2 in women) and (b) aetiologic criteria (reduced food intake and level of inflammation with CRP \>10 mg/L). Participants were classified as malnourished when at least 1 phenotypic criterion and 1 aetiologic criterion were met. The severity of the malnutrition is based on the phenotypic criteria in a stage 1 "moderate malnutrition" and stage 2 "severe malnutrition." The participants were classified on a score scale from 0- 2 with o being normal, 1 for the moderate malnutrition and 2 for the severe malnutrition., baseline|Number of impaired oral functions, The Japanese society of gerodontology in 2016 published a position paper aiming to standardize the examination of oral disorders related to age and to suggest management strategies. They created a conceptual diagram divided into 4 stages: healthy state, oral frailty, oral hypofunction and oral dysfunction. The classification into the different stages result from an examination of 7 parameters: the oral hygiene, the oral dryness, the occlusal force, the tongue-lip motor function, the tongue pressure, the chewing function and the swallowing function. Oral hypofunction is defined as a state when 3 or more signs were present., baseline
Secondary Outcome Measures: Oral health related quality of life, General oral health assessment index (GOHAI) is a self-reported measure designed to assess the impact on daily life of oral health problems of older individuals. The 12 item GOHAI evaluates three dimensions of oral health related quality of life study (OHRQOL).

The GOHAI score is determined by summing the final score of each of the 12 items ranges from 0 to 60 with higher scores indicating better oral health., baseline
a Cohort Study (Gut Microbiota and HCC)
NCT Number: NCT06557213
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Liver Cancer
Sponsor: Xu Yong, MD
Collaborators: Nanjing Xiershou Biotechnology Co., Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-30
Completion Date: 2026-11-20

Summary:
To analyze the predictive role of intestinal microbiota in tyrosine kinase inhibitors (TKIs) combined with immunotherapy response in patients with intermediate and advanced liver cancer.

Primary Outcome Measures: Objective Progression-Free Survival (PFS), To analyse the Progression-Free Survival (PFS) of patients, Up to approximately 1 years|Objective Secondary Clinical Endpoints - Overall Growth Phase (OS), To analyse the Secondary Clinical Endpoints - Overall Growth Phase (OS) of patients, Up to approximately 1 years|Objective Objective Response Rate (ORR), To exprole the Objective Response Rate (ORR) of patients, Up to approximately 1 years|ObjectiveDuration of Response (DOR), To analyse the Duration of Response (DOR) of patients, Up to approximately 1 years|Diversity analysis, We will use 16S rRNA sequencing to measure fecal sample. The alpha and beta diversity of gut microbiota will be analyzed, including a series of statistical analysis indexes such as Chao, Shannon, Simpsonace, Simpson and Coverage, in order to reflect the microbial community diversity., 0 weeks, 12 weeks, 24 weeks and 48 weeks|Species differential analysis, We will use 16S rRNA sequencing to measure fecal sample. Based on the results of species annotation, the PCA、PCoA and NMDS analysis will be used to assess the similarities and differences in species composition., 0 weeks, 12 weeks, 24 weeks and 48 weeks|Feces Metabolomics, Changes of metabolites in feces measured by metabolomic mass spectrometry, unsupervised PCA (principal component analysis) was performed by statistics function prcomp, identified metabolites were annotated using KEGG Compound database., 0 weeks, 12 weeks, 24 weeks and 48 weeks|Serum Metabolomics, Changes of metabolites in serum measured by metabolomic mass spectrometry, unsupervised PCA (principal component analysis) was performed by statistics function prcomp, identified metabolites were annotated using KEGG Compound database., 0 weeks, 12 weeks, 24 weeks and 48 weeks