pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
TIL Therapy in Non-small-cell Lung Cancer (NSCLC) Patients
NCT Number: NCT06455917
Acronym: BaseTIL-02
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Non-Small Cell Lung Cancer
Interventions: DRUG: Combination of TIL Transfer and low dose IL-2
Sponsor: University Hospital, Basel, Switzerland
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2029-12
Locations: University Hospital Basel, Basel, Basel-Stadt, 4031, Switzerland

Summary:
Aim of the study is to investigate the efficacy and safety of Adoptive cell therapy (ACT) with tumor-infiltrating lymphocytes (TILs) in NSCLC patients in a phase II clinical trial.

Primary Outcome Measures: Progression-free rate at 6 months after Tumor-infiltrating lymphocytes transfer., Progression-free rate (PFR) (RECIST v1.1 / iRECIST) at 6 months after TIL transfer, defined by the Kaplan-Meier estimator for progression-free survival (RECIST v1.1 / iRECIST) at 6 months (+/- 4 weeks as we allow this interval in the tumor assessment at 6 months)., 5-7 months after TIL transfer
Secondary Outcome Measures: Progression-free survival (PFS), The progression-free survival (PFS) is defined as the time from registration to objective tumor progression (determined by local investigators), or death due to any cause, whichever occurred first. PFS time for patients who have not progressed or died will be censored at the time of the last tumor assessment, up to one year after TIL transfer|Overall survival (OS), OS is defined as the time from registration to the date of death due to any cause, up to one year after TIL transfer|Severity of adverse events (CTCAE v5.0 criteria), Severity of adverse events (CTCAE v5.0 criteria) will be recorded to assess safety of combination of Tumor-infiltrating lymphocytes with IL-2

CTCAE (Common Terminology Criteria for Adverse Events): Grade 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = fatal., up to one year after TIL transfer|Objective response rate (ORR), ORR is defined as the proportion of patients with a best overall response of partial response or better (assessed by the local investigators, up to one year after TIL transfer|Duration of response (DOR), DOR is defined as the time from the first documented response and the date of the first documented tumor progression, death, or the last tumor assessment that occurred before subsequent therapy. DOR time for responders who have not progressed or died will be censored at the time of last tumor assessment, up to one year after TIL transfer|Frequency of adverse events (number), Frequency of adverse events (number) will be recorded to assess safety of combination of Tumor-infiltrating lymphocytes with IL-2, up to one year after TIL transfer|Incidence of adverse events (%), Incidence of adverse events (%) will be recorded to assess safety of combination of Tumor-infiltrating lymphocytes with IL-2, up to one year after TIL transfer
MYCobiome Analysis in Atopic Dermatitis With Head and Neck Involvement
NCT Number: NCT06455891
Acronym: MYCAH
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Atopic Dermatitis
Sponsor: Assistance Publique - Hôpitaux de Paris
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 45
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06
Completion Date: 2025-06
Locations: Tenon Hospital APHP dermatology and allergology department, Paris, 75020, France

Summary:
It is an open study, explorative, proof of concept study concerning mycobiota dysbiosis implication in AD patients with head and neck involvement.

Primary Outcome Measures: Description and comparison of head and neck mycobiome in AD patients, with generalized AD and HNAD, compared to head and neck mycobiome in controls., To conduct a mycobiome analysis in the Head and Neck areas in adults with AD compared to healthy control using matrix-assisted laser desorption ionization time of ﬂight mass spectrometry (MALDI-TOF) after culture. An additional analysis of the mycobiome by next generation sequencing (NGS) will also be carried out., 18 months
Secondary Outcome Measures: Lectins and gene polymorphism implicated in innate response to mycobiome in AD patients with head and neck involvement. 15 mL of blood will be collected., Study the interaction between mycobiome dysbiosis and immune responses in AD patients with head and neck involvement 1., 18 months|Antifungal systemic immune response., 20 mL of blood will be collected for specific Ig A, G, M and E detection and analysis of adaptive immune response against the predominant fungi identified in mycobiome of AD patients with head and neck involvement in order to study the interaction between mycobiome dysbiosis and immune responses in AD patients with head and neck involvement 2, 18 months
Correlates of Protection for Cholera
NCT Number: NCT06455852
Acronym: CoP
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cholera
Interventions: BIOLOGICAL: oral cholera vaccine or typhoid conjugate vaccine
Sponsor: Massachusetts General Hospital
Collaborators: International Centre for Diarrhoeal Disease Research, Bangladesh
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 1219
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-10-01
Completion Date: 2029-09-30

Summary:
Background: Vibrio cholerae causes millions of cholera cases and thousands of deaths annually. Vaccines are in short supply. There is no agreement on how to introduce new vaccines or evaluate their effectiveness, and the lack of 'correlates of protection' (CoPs) against cholera is a major obstacle to vaccine development. CoPs are markers of effective immune response to vaccination. While other infectious diseases have well established CoPs, none are widely accepted for cholera.

Relevance: Lack of accepted CoPs impedes development of cholera vaccines, limiting progress toward improved vaccines, slowing the licensure of new vaccines, and contributing to the current vaccine shortage; an immediate obstacle to achieving reductions in cholera-related illness and deaths. The identification of new CoPs will speed the development of improved cholera vaccines and provide a pathway to their licensure and use.

Hypothesis: We hypothesize that some individuals who receive inactivated oral cholera vaccine (OCV) will develop antibody responses which predict protection against V. cholerae infection and that specific immune responses distinguish individuals who are protected against cholera by prior natural infection from those who are protected from OCVs.

Objectives: We will administer an OCV or typhoid vaccine (TCV) control and monitor antibody responses to identify better CoPs for cholera following both vaccination and natural infection.

Methods: We will randomize 1219 individuals; 554 will receive an inactivated bivalent OCV, 665 will receive a TCV control. We will collect 12 blood samples over two-years following vaccination to measure antibodies against V. cholerae and to monitor for re-infection.

Outcome measures/variables: The endpoint of interest is V. cholerae infection after vaccination. We define infection as positive culture or PCR for V. cholerae or seroconversion events observed over the 2-year follow up period.

Primary Outcome Measures: Vibrio cholerae infection, Serologic, PCR or culture evidence of infection, 2 years
MAD of IVT VP-001 in PRPF31 Mutation-Associated Retinal Dystrophy Subjects (Wallaby)
NCT Number: NCT06455826
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Retinitis Pigmentosa 11|Retinal Degeneration|Eye Diseases|Retinal Disease|Retinal Dystrophies
Interventions: DRUG: VP-001
Sponsor: PYC Therapeutics
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 12
Study Design: Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06
Completion Date: 2025-11
Locations: University of Florida Health, Jacksonville, Florida, 32209, United States|University of Michigan Kellogg Eye Center, Ann Arbor, Michigan, 48105, United States|Oregon Health and Science University - Casey Eye Institute, Portland, Oregon, 97239, United States|Retina Foundation of the Southwest, Dallas, Texas, 75321, United States|Baylor College of Medicine- Alkek Eye Center, Houston, Texas, 77030, United States

Summary:
A Phase 1 Open-Label, Multiple Ascending Dose Study to Evaluate the Safety and Tolerability of Intravitreally Administered VP-001 in Participants with Confirmed PRPF31 Mutation-Associated Retinal Dystrophy

Primary Outcome Measures: The incidence, severity, and relatedness of treatment-emergent ocular adverse events and treatment-emergent serious adverse events, over a 4-week post-dose period|The incidence, severity, and relatedness of treatment-emergent ocular adverse events, over a 52-week period
Secondary Outcome Measures: Adverse Events and Treatment Emergent serious adverse events (TESAEs) in the fellow eye eye, over a 4-week post-dose time period|Adverse Events and Treatment Emergent serious adverse events (TESAEs) in the fellow eye eye, over a 52-week period|Incidence, severity, and relatedness of non-ocular Treatment Emergent adverse events (TEAEs), over a 4-week post-dose time period|Incidence, severity, and relatedness of non-ocular Treatment Emergent adverse events (TEAEs), over a 52-week period|BCVA letter score using ETDRS charts, over a 52-week period|Change in lowest passing light level using Ora- VNC™ mobility test, over a 52-week period|Low luminance visual acuity (LLVA) letter score, over a 52-week period|Visual field sensitivity as measured by static perimetry with topographic analysis (Hill of Vision), over a 52-week period|Mean retinal sensitivity as measured by fundusguided microperimetry, over a 52-week period|Visual fields as measured by kinetic perimetry utilizing I4e, II4e and V4e stimuli, over a 52-week period|Rod-and cone-mediated retinal function as measured by white, red and blue FST, over a 52-week period|Retinal thickness on SD-OCT, including retinal thickness in each ETDRS subfield and EZ area and volume, over a 52-week period|Retinal function using full-field electroretinography (ERG), over a 52-week period|Area of hypo-autofluorescence captured by FAF, over a 52-week period|Abnormalities captured by wide-field fundus photography, over a 52-week period
What Laxative Should Be Used After Hip Fracture Surgery?
NCT Number: NCT06455813
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Hip Fractures
Sponsor: Odense University Hospital
Sex: ALL
Age: OLDER_ADULT
Enrollment: 375
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-02
Completion Date: 2026-01-31

Summary:
To conduct a randomized clinical trial to determine how best to prevent constipation after hip fracture surgery using laxatives.

Primary Outcome Measures: The proportion of patients who will need rescue medication (Bisacodyl), Part of patients in each group who needs rescue medication after 72 hours or rescue medication before 72 hours on behalf of a medical assessment, 72 hours after surgery
Secondary Outcome Measures: Time to first bowel movements, Time to first bowel movements (in hours after finished surgery), hours up to 240 hours|Length of hospital stay, Length of hospital stay of the index admission from admission to discharge, days up to 10 days|Number of patients who are readmitted at hospital, The part of patients who are readmitted at hospital 30 days after discharge hospital, 30 days|Number of patients who have emergency room visits, The proportion of patients who have emergency room visits within 30 days of discharge hospital, 30 days|Constipation defined from the Bristol Stool Scale, constipation defined from the Bristol Stool Scale with type 1-7 where type 1 is constipation and type 7 is diarrhea and use/no use of rescue medication (bisacodyl), daily up to 10 days|Constipation score, Calculated score based of The Patient Assessment of Constipation symptoms Questionnaire from 0-48 where 48 is most severe constipation and use/no use of rescue medication (bisacodyl), daily up to 10 days
Severe Lung Disease in Childhood
NCT Number: NCT06455800
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Lung Disease Chronic
Interventions: DIAGNOSTIC_TEST: lung function measurements
Sponsor: Odense University Hospital
Sex: ALL
Age: CHILD, ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2040-12-31
Locations: Hans Christian Andersen Children's Hospital, Odense, 5000, Denmark

Summary:
Only little information exists about the long term consequences of having severe lung disease in childhood. The patient population is heterogenous and the prognostic markers are few.

This observational study will investigate which parameters that can be used to predict the outcome of having severe lung disease in childhood.

Primary Outcome Measures: FEV1, liter, 18 years|FVC, liter, 18 years|Lung Clearance Index (LCI), number, 18 years
Secondary Outcome Measures: height, meters, 18 years
J-Valve Transfemoral Pivotal Study
NCT Number: NCT06455787
Acronym: JOURNEY
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Aortic Valve Regurgitation|Aortic Valve Disease Mixed
Interventions: DEVICE: J-Valve Transfemoral (TF) System
Sponsor: JC Medical, Inc.
Collaborators: Bright Research Partners|Minneapolis Heart Institute Foundation|Cardiovascular Research Foundation, New York
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 171
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2030-07

Summary:
The primary objective of this study is to assess the safety and efficacy of the J-Valve Transfemoral (TF) System in patients with symptomatic, severe (grade 3 or 4), native aortic valve regurgitation (AR) and AR-dominant mixed aortic valve disease, who are judged by a multi-disciplinary heart team to be at high risk for open surgical aortic valve replacement (SAVR).

Primary Outcome Measures: Rate of all-cause mortality at 1 year, 1-year post-procedure|The composite rate of early-safety outcomes at 30 days as defined by the Valve Academic Research Consortium 3 (VARC-3), Includes:

* All-cause death;
* All stroke;
* VARC-3 type 2-4 bleeding;
* Major vascular, access-related, or cardiac structural complication;
* Acute kidney injury (AKI) stage 3 or 4;
* New permanent pacemaker due to procedure-related conduction abnormalities;
* Surgery or intervention related to the device., 30-days post-procedure
Secondary Outcome Measures: Rate of improvement in cardiovascular-specific health status, As measured by the Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OS), Baseline to 1-year follow-up|Rate of the individual components of the composite early-safety endpoint at 30 days, Includes:

* All-cause death;
* All stroke;
* VARC-3 type 2-4 bleeding;
* Major vascular, access-related, or cardiac structuralcomplication
* Acute kidney injury (AKI) stage 3 or 4;
* New permanent pacemaker due to procedure-relatedconduction abnormalities;
* Surgery or intervention related to the device., 30-days post-procedure
68Ga-DOTA-NI-FAPI04 PET/CT in Patients With Various Types of Cancer
NCT Number: NCT06455761
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Tumor
Interventions: DRUG: 68Ga-DOTA-NI-FAPI04|DRUG: 68Ga-FAPI/18F-FDG
Sponsor: First Affiliated Hospital of Fujian Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-04-01
Completion Date: 2025-12-31
Locations: The First Affiliated Hospital of Fujian Medical University, Fuzhou, China

Summary:
As a novel radiotracer targeting fibroblast activation protein (FAP), 68Ga-DOTA-NI-FAPI04 is a novel agent incorporating a hypoxia sensitive nitroimidazole(NI)-moiety and a FAP-targeting. In this study, we observed the diagnostic performance of 68Ga-DOTA-NI-FAPI04 PET/CT in patients with different types of cancer, and compared its imaging results with those of 68Ga-FAPI or 18F-FDG PET/CT.

Primary Outcome Measures: Diagnostic value, Sensitivity and Specificity of 68Ga-DOTA-NI-FAPI04 in Patients With Various Types of Cancer and comrare it with 68Ga-FAPI/18F-FDG PET/CT., through study completion, an average of 3 months
Secondary Outcome Measures: SUV of tumors, Compare the SUV of tumors between 68Ga-DOTA-NI-FAPI04 PET/CT and 68Ga-FAPI/18F-FDG PET/CT., through study completion, an average of 3 months
68Ga-JH04 PET/CT in Patients With Various Types of Cancer
NCT Number: NCT06455735
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Tumor
Interventions: DRUG: 68Ga-JH04|DRUG: 68Ga-FAPI/18F-FDG
Sponsor: First Affiliated Hospital of Fujian Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-03-01
Completion Date: 2026-04-01
Locations: The First Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, 350000, China

Summary:
As a novel radiotracer targeting fibroblast activation protein (FAP), 68Ga-JH04 is promising as an excellent imaging agent for various cancers. In this study, we observed the diagnostic performance of 68Ga-JH04 PET/CT in patients with different types of cancer, and compared its imaging results with those of 68Ga-FAPI or 18F-FDG PET/CT.

Primary Outcome Measures: Diagnostic value, Sensitivity and Specificity of 68Ga-JH04 in Patients With Various Types of Cancer and comrared it with 68Ga-FAPI/18F-FDG PET/CT., through study completion, an average of 3 months
Secondary Outcome Measures: SUV of tumors, Compare the SUV of tumors between 68Ga-JH04 PET/CT and 68Ga-FAPI/18F-FDG PET/CT., through study completion, an average of 3 months