pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Gene Therapy(FT-003) for Wet AMD
NCT Number: NCT06492863
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Neovascular Age-related Macular Degeneration
Interventions: GENETIC: FT-003
Sponsor: Frontera Therapeutics
Collaborators: Tianjin Medical University Eye Hospital|The First Affiliated Hospital of Soochow University|Peking Union Medical College Hospital|Beijing Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 78
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-08-15
Completion Date: 2028-10-15
Locations: Tianjin Medical University Eye Hospital, Tianjin, Tianjin,China, 300392, China

Summary:
The goal of this clinical trial is to evaluate the safety, tolerability and efficacy of disposable vitreous injection of FT-003 in subjects with neovascular age-related Macular Degeneration (nAMD). The study was divided into two phases, Phase 1 dose escalation and Phase II dose expansion.

Primary Outcome Measures: Safety and tolerability after FT-003 injection, Incidence and severity of AE (Common Terminology Criteria for Adverse Events 5.0), At Week 12
Secondary Outcome Measures: To evaluate the efficacy after FT-003 injection, the BCVA and OCT change from baseline, At Week 24
Gene Therapy for RPGR Gene Mutation-associated X-linked Retinitis Pigmentosa
NCT Number: NCT06492850
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: X-Linked Retinitis Pigmentosa (XLRP)
Interventions: GENETIC: FT-002
Sponsor: Frontera Therapeutics
Sex: MALE
Age: CHILD, ADULT
Enrollment: 32
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-04-01
Completion Date: 2026-02-01
Locations: Peking Union Medical College Hospital, Beijing, Beijing, 100142, China

Summary:
The aim of this study was to evaluate the safety, tolerability, and efficacy of one-time subretinal injection of FT-002 in male subjects (8-45 years of age) with RPGR (Retinitis Pigmentosa GTPase Regulator) gene mutation-associated X-linked retinitis pigmentosa, of XLRP. This study includes Phase I (dose escalation phase) and Phase II (dose expansion phase).

Primary Outcome Measures: To evaluate the safety and tolerance of FT-002, Incidence and severity of AEs, from FT-002 administration through up to 1 years
Secondary Outcome Measures: To evaluate the efficacy of FT-002, Changes in visual sensitivity /FST/BCVAfrom baseline, from FT-002 administration through up to 1 years
Text Based Digital Interventions Prompting Enjoyable and Healthy Behaviors
NCT Number: NCT06492824
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Depression|Anhedonia
Interventions: BEHAVIORAL: Enjoyable Activities Condition|BEHAVIORAL: Healthy Activities Condition
Sponsor: Florida State University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 156
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2022-11-01
Completion Date: 2023-02-01
Locations: Florida State University, Tallahassee, Florida, 32304, United States

Summary:
The proposed project aims to examine the effectiveness of an automated digital (i.e., text message based) intervention prompting adults with at least moderate depressive symptoms to complete enjoyable daily activities (i.e., Behavioral Activation \[BA\]) over the course of one month compared to adults with moderate or more depressive symptoms that complete an active and a passive control condition broadly prompting a healthier lifestyle or no prompts at all. More specifically, we aim to examine if the BA intervention will improve mental health and overall well-being among adults experiencing moderate or more symptoms of depression over and beyond the active and passive control conditions. We will measure symptoms such as current depression, anxiety, and stress pre- and post- interventions to determine their effectiveness.

Primary Outcome Measures: Change in depressive symptoms, Depression, Anxiety, and Stress Scale (DASS-21) creates a total score for depression based on 7 items. Scores range from 0-42, higher score indication more depression., Collected at baseline and one month|Change in anhedonia, Personality Inventory for DSM-5 (PID 5), anhedonia subscale, creates a score of current anhedonic symptoms consisting of 8 items. Scores range from 0-24, higher scores indicating more symptoms of anhedonia., Collected at baseline and one month
Hyaluronic Acid-enriched Transfer Medium in Single Blastocyst Transfer
NCT Number: NCT06492785
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Infertility
Interventions: BIOLOGICAL: High Hyaluronic Acid concentrations (0.5 mg/ml)|BIOLOGICAL: Low Hyaluronic Acid concentrations (0.125 mg/ml)
Sponsor: Northwest Women's and Children's Hospital, Xi'an, Shaanxi
Collaborators: Jiangxi Maternal and Child Health Hospital|Tongji Hospital|Gansu Provincial Maternal and Child Health Care Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 858
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2026-09-30

Summary:
The purpose of this study is to compare the live birth rates of high concentration of Hyaluronic Acid (0.5 mg/ml) transfer medium (EmbryoGlue®) to those containing low Hyaluronic Acid concentrations (0.125 mg/ml) (G2 medium) in women undergoing single fresh and frozen blastocyst transfer.

Primary Outcome Measures: Live birth rate, The primary outcome measure was Live birth rate per embryo transfer., Live birth is defined as the birth of at least one live baby after 24 weeks of gestation.
Personal BP - CAI Study
NCT Number: NCT06492746
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Blood Pressure
Interventions: DEVICE: HemoSphere Advanced Monitoring Platform with Acumen IQ sensor and Tissue Oximetry Monitoring
Sponsor: Edwards Lifesciences
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-06-03
Completion Date: 2025-05
Locations: Northwestern University Hospital, Evanston, Illinois, 60611, United States

Summary:
A single-center, prospective, observational pilot of the Cerebral Adaptive Index for assessing personalized blood pressure targets

Primary Outcome Measures: To determine the magnitude and duration of CAI, To determine the sum of the product of magnitude and duration that CAI during cardiopulmonary bypass (CPB) is at or above the threshold of 45 during current standard of care and assess the incidence of CAI ≥45 in the absence of decreased cerebral StO2 or MAP thresholds., Duration of the procedure through 30 days
A Pilot Study to Evaluate the Efficacy and Safety of NaviFUS™ System Neuromodulating Treatment for Patients With Drug Resistant Epilepsy
NCT Number: NCT06492720
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Drug Resistant Epilepsy|Epilepsy|Epilepsy, Temporal Lobe
Interventions: DEVICE: Focused ultrasound (FUS) treatment
Sponsor: NaviFUS Corporation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 16
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-07-11
Completion Date: 2026-08-10
Locations: Taipei Veterans General Hospital, Taipei, Taiwan

Summary:
This will be a prospective, pilot, open-label, two-arm, parallel-group, randomized study to evaluate the efficacy and safety of low-intensity focused ultrasound (LIFU) neuromodulation using NaviFUS System in patients with drug-resistant epilepsy (DRE).

Primary Outcome Measures: Changes of seizure frequency after treatment compared to baseline, The changes in patient's seizure frequency from baseline through the study completion will be assessed based on the seizure diaries., up to 33 weeks
Secondary Outcome Measures: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability], The incidence and severity of AEs associated with LIFU neuromodulation in patients with DRE., up to 33 weeks|Responder rate (≧50% seizure reduction), The changes in responder rate (≧50% seizure reduction) from baseline through the study completion will be assessed based on the seizure diaries., up to 33 weeks|Change from baseline in number of seizure-free days, The changes in number of seizure-free days from baseline through the study completion will be assessed based on the seizure diaries., up to 33 weeks|Change from baseline in subjective seizure strength, The changes in subjective seizure strength from baseline through the study completion will be assessed based on the seizure diaries., up to 33 weeks|Quality of Life in Epilepsy (QOLIE-31), The QOLIE-31 is a survey of health-related quality of life for adults with epilepsy. There are 31 questions about patient's health and daily activities. The total score is calculated as a weighted mean of the sub-scale scores and the scoring of the QOLIE-31 requires the conversion of raw data to a scale of 0 to 100 for each sub-scale, with higher scores reflecting higher quality of life., up to 33 weeks|Changes of Beck Anxiety Inventory (BAI) after treatment compared to baseline, BAI is a 21-question multiple-choice self-report inventory that is used to measure the severity of anxiety. Each answer is scored on a scale value of 0 (not at all) to 3 (severely). Higher total scores indicate more severe anxiety symptoms., up to 33 weeks|Changes of Beck Depression Inventory (BDI) after treatment compared to baseline, BDI-II, a 21-question multiple-choice self-report inventory, is a psychological test used to measure the severity of depression. Each answer is rated on a scale of 0 (none at all) to 3 (severe). Higher total scores indicate more severe depressive symptoms., up to 33 weeks
Correlation Between Optic Nerve Sheath Diameter and Neurological Deficit in Adult Patients With Suspected Ischemic Stroke
NCT Number: NCT06492681
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Ischemic Stroke|Optic Nerve Sheath
Sponsor: Clinica Mexico
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2025-09-01

Summary:
The ultrasound of the optic nerve sheath diameter (ONSD) is a non-invasive tool used in the detection of intracranial hypertension and other neurological conditions. The aim of this research is to evaluate the correlation between the ultrasound measurement of the optic nerve sheath diameter and the side of neurological focus in the physical examination of adult patients evaluated in emergency departments.

Primary Outcome Measures: Correlation between optic nerve sheath and side of clinical neurological focalization, Estimate the correlation between the ultrasound measurement of the optic nerve sheath diameter and the side of neurological focus in the physical examination of adult patients evaluated in emergency departments., In the first 4 hours of arrival to Emergency Department
Secondary Outcome Measures: sensitivity and specificity of the ultrasound measurement of the optic nerve sheath diameter for predicting the side of neurological focus., Determine the sensitivity and specificity of the ultrasound measurement of the optic nerve sheath diameter for predicting the side of neurological focus., In the first 4 hours of arrival to Emergency Department
Risk of Exposure and Prevention of Ticks and Tick-borne Diseases Among Foresters in Alsace
NCT Number: NCT06492668
Acronym: PREFORTIC
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Lyme Borreliosis
Sponsor: University Hospital, Strasbourg, France
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-01
Completion Date: 2025-07-08
Locations: Centre National de Référence Borrelia - CHU de Strasbourg - France, Strasbourg, Les Hôpitaux Universitaires De Strasbourg, 67091, France

Summary:
Ticks are blood-sucking arthropods that feed on vertebrate hosts. Although wild and domestic animals are the primary source of tick blood meals, humans can be an accidental host. During a blood meal, a microorganism can be transmitted to the host who can develop a disease. All infectious diseases transmitted by ticks are referred to as tick-borne diseases (TBDs). They are the most prevalent vector-borne diseases in the Northern Hemisphere. Among these diseases, Lyme borreliosis is the most common.

In Europe, Lyme borreliosis does not cause high fevers (\> 38°C). Therefore, when a patient presents with a high fever with the notion of exposure to ticks, another etiology must be suspected. Anaplasma phagocytophilum and the tick-borne encephalitis virus are classically described as causing febrile syndromes.

In France, ticks and tick-borne diseases are increasing, particularly those associated with the Ixodes ricinus tick. This tick is mainly present in forest ecosystems with a peak of activity in May. Foresters represent a population with biting ticks and tick-borne diseases, notably Lyme borreliosis.

Primary Outcome Measures: Number of ticks found on clothing during activities in forest ecosystems, and if tick bites, their number., This study is carried out on foresters in the Alsacce region over a period of one year., 1 year
To Evaluate the Food Effect on Pharmacokinetic Profiles and Safety in Healthy Volunteers
NCT Number: NCT06492655
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: CKD-383(Fed)|DRUG: CKD-383(Fasted)
Sponsor: Chong Kun Dang Pharmaceutical
Sex: ALL
Age: ADULT
Enrollment: 28
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-04
Completion Date: 2024-08-08

Summary:
This is a randomized, open-label, single dose, crossover, phase 1 trial to evaluate the food effect on pharmacokinetic profiles and safety of CKD-383 in healthy volunteers

Primary Outcome Measures: AUCt of Empagliflozin, sitagliptin, metformin(Participants greater than or equal to 18.0 kg/m2 and less than 30 kg/m2), Pharmacokinetic characterization, 0 hour ~ 48 hour after drug administration|Cmax of Empagliflozin, sitagliptin, metformin(Participants greater than or equal to 18.0 kg/m2 and less than 30 kg/m2), Pharmacokinetic characterization, 0 hour ~ 48 hour after drug administration
Toripalimab Combined With Chidamide for the Treatment of Relapsed/Refractory Peripheral T-Cell Lymphoma
NCT Number: NCT06492629
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: PTCL
Interventions: DRUG: Toripalimab|DRUG: chidamide
Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 43
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-04-03
Completion Date: 2025-12-31
Locations: Department of Medical Oncology, Beijing, Beijing, 100021, China

Summary:
To evaluate the efficacy of Toripalimab combined with Chidamide in the treatment of relapsed/refractory peripheral T-cell lymphoma.

Primary Outcome Measures: Objective Response Rate (ORR), The primary efficacy endpoint will be assessed based on the Lugano 2014 criteria for Objective Response Rate (ORR), which includes both Complete Response (CR) and Partial Response (PR)., 24months
Secondary Outcome Measures: Overall Survival (OS), The time from the start of the trial to death from any cause, 24months
A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence
NCT Number: NCT06492616
Acronym: ELEGANT
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Breast Cancer
Interventions: DRUG: Elacestrant|DRUG: Anastrozole|DRUG: Letrozole|DRUG: Exemestane|DRUG: Tamoxifen
Sponsor: Stemline Therapeutics, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 4220
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2032-10

Summary:
The primary goal of this study is to evaluate the effectiveness of elacestrant versus standard endocrine therapy in participants with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer with high risk of recurrence.

Primary Outcome Measures: Invasive Breast Cancer-Free Survival (IBCFS), Assessed by the time from date of randomization to the date of first occurrence of:

* Ipsilateral invasive breast tumor recurrence
* Local/regional invasive breast cancer recurrence
* Distant recurrence
* Contralateral invasive breast cancer, or
* Death attributable to any cause, Up to 5 years
Secondary Outcome Measures: Distant Relapse-Free Survival (DRFS), Assessed by the time from date of randomization to the date of first occurrence of:

* Distant recurrence, or
* Death attributable to any cause, Up to 5 years|Overall Survival (OS), Up to 5 years|Invasive Disease-Free Survival (IDFS), Assessed by the time from date of randomization to the date of first occurrence of:

* Local/regional recurrence
* Contralateral recurrence
* Second primary non-breast invasive cancer
* Distant recurrence, or
* Death attributable to any cause, Up to 5 years|Number of Participants With Adverse Events (AEs), Up to 5 years plus 28 days|Change from Baseline in Global Health Status Quality of Life Scale score, as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5|Change from Baseline in the Physical Functioning Sub-Scale Score as Assessed by EORTC QLQ-C30, Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5|Change From Baseline in the Breast Cancer Endocrine Therapy Symptoms Sub-Scale Score, as Assessed by the EORTC Quality of Life Breast Cancer Questionnaire module (EORTC QLQ-BR42), Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5|Change From Baseline in Side Effects, as Assessed by the Question 168 of the European Organization for the Research and Treatment of Cancer Question Library (EORTC Q168), Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5|Area Under the Plasma Concentration Versus Time Curve at Steady State (AUCss) of Elacestrant, Predose up to 4 hours postdose|Maximum Plasma Concentration at Steady State (Cmaxss) of Elacestrant, Predose up to 4 hours postdose
Examination of Biomechanical Characteristics of Linea Alba in Diastasis Recti Patients
NCT Number: NCT06492603
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Separated Recti Abdominis
Interventions: DEVICE: Ultrasonography|DEVICE: The MyotonPRO Device
Sponsor: South Valley University
Sex: FEMALE
Age: ADULT
Enrollment: 40
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-20
Completion Date: 2024-12-30

Summary:
Diastasis recti is an increased distance between the rectus abdominis muscles at the midline caused by weakness in the anterior abdominal wall.

Primary Outcome Measures: Linea Alba Stiffness, It is a Biomechanical Characteristic of the Linea Alba, Assessment will be done at the 7th day postpartum and at the end of the 6th week postpartum|Linea Alba Elasticity, It is a Biomechanical Characteristic of the Linea Alba, Assessment will be done at the 7th day postpartum and at the end of the 6th week postpartum|Linea Alba Creep, It is a Viscoelastic Characteristic of the Linea Alba, Assessment will be done at the 7th day postpartum and at the end of the 6th week postpartum
Long COVID-19 Intervention (COVIDL/MIQoL)
NCT Number: NCT06492590
Acronym: COVIDL/MIQoL
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Long COVID-19
Interventions: BEHAVIORAL: Multicomponent intervention
Sponsor: Consorci Sanitari de Terrassa
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 108
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09
Completion Date: 2025-07

Summary:
The goal of this clinical trial is to assess the effectiveness of a multicomponent intervention in individuals with Long COVID. The main questions it aims to answer are:

* Does the intervention increase quality of life, mental well-being, resilience, and physical condition in individuals with Long COVID?
* Does the intervention decrease anxiety, depressed mood, and fatigue in individuals with Long COVID? The researchers will compare the multicomponent intervention with a control (non-intervention) group.

Participants will:

• Participate in a multicomponent intervention for 9 weeks (2 sessions each week, one of psycho-education and one of physical rehabilitation).

Primary Outcome Measures: Improved quality of life, Changes in level of quality of life using the EuroQol 5D-5L scale (EQ-5D-5L). Values range from 0 to 1 (full health). Higher scores, better outcome, Baseline (T0), post-intervention (9 weeks) (T1), and 24 weeks follow-up (T2)
Secondary Outcome Measures: Improve well-being, Changes in level of well-being using the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS). Values range from 14 to 70 . Higher scores, better outcome, Baseline (T0), post-intervention (9 weeks) (T1), and 24 weeks follow-up (T2)|Decreased anxiety and depression, Changes in level of anxiety and depression using the Hospital Anxiety and Depression Scale (HADS). Anxiety values range from 0 to 15 . Higher scores, worse outcome. Depression values range from 0 to 12. Higher scores, worse outcome, Baseline (T0), post-intervention (9 weeks) (T1), and 24 weeks follow-up (T2)|Increased resilience, Changes in level of resilience using the Connor-Davidson Resilience Scale (CD-RISC). Values range from 0 to 40 . Higher scores, better outcome, Baseline (T0), post-intervention (9 weeks) (T1), and 24 weeks follow-up (T2)|Improve physical activity, Changes in level of physical activity using the International Physical Activity Questionnaire (IPAQ). In each category a maximum of 21 hours of activity are permitted a week (3 hours X 7 days) To calculate MET minutes a week multiply the MET value given (r walking = 3.3, moderate activity = 4, vigorous activity = 8) by the minutes the activity was carried out and again by the number of days that that activity was undertaken. Higher scores, better outcome, Baseline (T0), post-intervention (9 weeks) (T1), and 24 weeks follow-up (T2)|Decreased fatigue, Changes in level of fatigue scale using the Chalder Fatigue Scale (CFS). Values range from 0 to 42 . Higher scores, worse outcome., Baseline (T0), post-intervention (9 weeks) (T1), and 24 weeks follow-up (T2)
Dose, Safety and Pathogenicity of SARS-CoV-2 Omicron Virus (BA.5)
NCT Number: NCT06492564
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: SARS-CoV-2 Infection
Interventions: BIOLOGICAL: SARS-CoV-2 omicron virus dose arm 1|BIOLOGICAL: SARS-CoV-2 omicron virus dose arm 2|BIOLOGICAL: SARS-CoV-2 omicron virus dose arm 3
Sponsor: Hvivo
Sex: ALL
Age: ADULT
Enrollment: 90
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-10
Completion Date: 2026-01
Locations: hVIVO Services Ltd, QMB Bioenterprise building, London, E1 2AX, United Kingdom

Summary:
An Exploratory Study to Establish the Dose, Safety and Pathogenicity of a SARS-CoV-2 Omicron Challenge Strain (BA.5) in Healthy Participants 18 to 30 Years of Age

Primary Outcome Measures: Occurrence of Adverse Events related to the viral challenge, Number of participants with challenge Agent-emergent adverse events (AEs) at least possibly related to the viral challenge from viral challenge (Day 0) up to the Day 28 follow-up, Day 0 to Day 28|Occurrence of Serious Adverse Events and Medically Attended Adverse Events, related to the viral challenge, Occurrence of serious AEs (SAEs) and Medically Attended Adverse Events (MAAEs) related to the viral challenge from viral challenge (Day 0) up to the Day 180 follow-up, Day 0 to Day 180|Induces laboratory-confirmed infection in ≥40% of inoculated participants, Quantitative reverse transcriptase-polymerase chain reaction (qRT-PCR)-confirmed SARS-CoV-2 omicron infection, defined as 2 quantifiable (≥ lower limit of quantification \[LLOQ\]) qRT-PCR measurements (reported on 2 or more independent nasal or throat samples over 2 days), starting from Day 1 pm up to discharge from quarantine (Day 14 am), Day 1 to Day 14
Post-COVID-19 Patients With Trak Tool
NCT Number: NCT06492551
Acronym: TRAK-COVID
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Post COVID-19 Condition
Interventions: OTHER: Trak exercise prescription protocol|OTHER: Conventional rehabilitation plan in the gym
Sponsor: Trak Health Solutions S.L.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2022-03-16
Completion Date: 2022-10-05
Locations: Asunción Klinika, Tolosa, Gipuzkoa, 20400, Spain

Summary:
The clinical trial aims to analyse the effectiveness of a physiotherapeutic exercise program delivered through the telerehabilitation tool (Trak) compared to a booklet-based rehabilitation format in post-COVID-19 patients.

This research seeks to provide insights into the acceptance of the TRAK tool in this specific population, contributing to the advancement of understanding in this field.

Participants will be assigned to either the control group, which will receive conventional rehabilitation, or the experimental group, which will undergo telerehabilitation. Both groups will undergo a 6-week physical intervention, with pre- and post-intervention evaluations.

Researchers will compare the control and experimental groups to determine if there are significant differences in the health conditions of each group.

Primary Outcome Measures: Barthel index, It assesses daily activities in patients with musculoskeletal or neuromuscular conditions., Baseline; up to 6 weeks
Secondary Outcome Measures: Resting heart rate, It is the number of times the heart beats per minute at rest, which can be an important sign of heart health., Baseline; up to 6 weeks|Lung capacity, It is measured by spirometry. It measures the volume of air exhaled at specific time points during complete exhalation by force, which is preceded by a maximal inhalation., Baseline; up to 6 weeks|Oxygen saturation, A measure of how much haemoglobin is currently bound to oxygen compared to how much is not. It is measured with a finger pulse oximeter., Baseline; up to 6 weeks|Borg scale, Numerical scale that ranges from 6 to 20, where 6 means "no exertion at all" and 20 means "maximal exertion"., Baseline; up to 6 weeks|Daniels scale, It measures the patient's strength in a specific movement and muscle from 0 to 5, with 0 indicating total paralysis and 5 indicating the entire joint movement with resistance., Baseline; up to 6 weeks|Trak satisfaction questionnaire, The Trak satisfaction questionnaire, which was provided to patients in Spanish, consists of 12 questions about usability, usefulness, and satisfaction, as well as a suggestions section at the end., Up to 6 weeks
Biometric Changes After Intervention of Anterior Chamber Angle : an Observational Study
NCT Number: NCT06492538
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Angle-closure Glaucoma|Minimally Invasive Glaucoma Surgery|Goniosynechialysis|Goniotomy|Glaucoma
Interventions: PROCEDURE: various types of angle interventions
Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-12-01
Completion Date: 2025-12-30
Locations: Zhongshan ophthalmic center, Guangzhou, Guangdong, 51006dddddd0, China

Summary:
The drainage angle in the anterior chamber of the eye mediates the outflow of aqueous humor, and pathological changes here can lead to high intraocular pressure and glaucoma. Minimally invasive glaucoma surgery, particularly angle surgery, has advanced recently, allowing clear visualization of angle structures like the trabecular meshwork and Schlemm's canal using surgical goniolens. Techniques for angle intervention include widening the angle, reopening closed angles, and rebuilding outflow pathways using methods such as laser peripheral iridotomy, Argon laser peripheral iridoplasty, and mechanical separation of adhered tissues. Our research team plans to conduct imaging studies to track the healing of angle tissues post-surgery, aiming to support innovation and standardization of minimally invasive angle surgery.

Primary Outcome Measures: Changes in biological parameters of the anterior chamber angle, Biological parameter changes in the anterior chamber following angle intervention surgery will be measured using Casia2-OCT, 12 months
Secondary Outcome Measures: success rate of angle intervention surgeries, complete success was defined as postoperative IOP within the range of 6-18 mmHg, and a reduction of 20% from baseline without loss of light perception, additional ocular hypotensive medication, and reoperation. The definition of qualified success was similar to that of complete success, except for the need for ocular hypotensive medications. Postoperative ocular hypotensive medications were adjusted according to the IOP at each visit., 12 months
Other Outcome Measures: safety of angle intervention surgeries, The main observation includes recording intraoperative and postoperative complications, including hyphema, choroidal detachment, cyclodialysis, persistent hypotony, corneal decompensation, and intraocular inflammation., 1 months
Oral Iron Supplementation on Alternate vs. Consecutive Days for Iron Deficiency Anemia in Pregnancy
NCT Number: NCT06492512
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Iron-deficiency Anemia (IDA)|Pregnancy
Interventions: DRUG: daily ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill|DRUG: alternate day ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill
Sponsor: Southern Illinois University
Sex: FEMALE
Age: ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2028-06-30
Locations: Southern Illinois University School of Medicine, Springfield, Illinois, 62702, United States

Summary:
This will be a randomized clinical trial. Enrolled subjects will be randomized (1:1) into two study arms to receive either daily (Group 1) or alternate day (Group 2) supplementation with one oral pill containing ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill.

Primary Outcome Measures: reversal of iron deficient anemia, hemoglobin \> 10.5 g/dL, 8 weeks after the baseline visit ± 7 days|reversal of iron deficient anemia, ferritin \> 15 mcg/L, 8 weeks after the baseline visit ± 7 days
Secondary Outcome Measures: soluble transferrin receptor (sTfR) levels within normal range, 1.8-4.6 mg/L, 8 weeks after the baseline visit ± 7 days
Patient-Centric Innovation: Superior Vena Cava Approach in Zero-Fluoroscopy
NCT Number: NCT06492499
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Atrioventricular Nodal Reentrant Tachycardia
Interventions: PROCEDURE: Zero-Fluoroscopy Radiofrequency Catheter Ablation
Sponsor: Ning Zhou
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 31
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-10-01
Completion Date: 2024-06-20
Locations: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, 430030, China

Summary:
This study aims to evaluate the viability and therapeutic efficacy of zero-fluoroscopy radiofrequency catheter ablation (RFCA) using the superior vena cava (SVC) approach in patients with atrioventricular nodal reentrant tachycardia (AVNRT). The study compares outcomes between the SVC approach and the conventional inferior vena cava (IVC) approach. Patients diagnosed with AVNRT who underwent RFCA between June 2022 and October 2022 were retrospectively analyzed. The primary outcome measure is the non-inducibility of AVNRT, while secondary outcomes include postoperative recovery time and complication rates. The study seeks to provide a safer and more efficient RFCA method, enhancing patient recovery by minimizing radiation exposure and optimizing catheter access routes.

Primary Outcome Measures: Non-inducibility of Atrioventricular Nodal Reentrant Tachycardia (AVNRT), This is determined during the procedure by performing programmed stimulation to test for the presence of AVNRT. Non-inducibility is confirmed if AVNRT cannot be induced following the ablation, indicating a successful therapeutic intervention., During the procedure|Recurrence of supraventricular tachycardia, It is defined as any documented episode of supraventricular tachycardia, such as AVNRT, atrial fibrillation, or atrial flutter, confirmed by electrocardiographic evidence., Within 1 year post-procedure
Secondary Outcome Measures: Postoperative Recovery Time, It is defined as the duration from the completion of the RFCA procedure to the patient's ability to walk unassisted., Within 24 hours post-procedure|Complication Rate, It is defined as any documented episode of SVT, including AVNRT, confirmed by electrocardiographic evidence., Within 1 year post-procedure
Glioma Adaptive Radiotherapy With Development of an Artificial Intelligence Workflow
NCT Number: NCT06492486
Acronym: GLADIATOR
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Diffuse Glioma|Glioblastoma|Adaptive Radiotherapy|Artificial Intelligence
Interventions: RADIATION: Adaptive radiotherapy
Sponsor: Tata Memorial Centre
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2028-07-30

Summary:
Gliomas are common primary brain tumors in adults. Gliomas can be classified into different types based on tumor grade, histopathological features, and molecular characteristics. The common types of diffuse gliomas include glioblastoma, astrocytoma, and oligodendroglioma. The standard treatment for diffuse gliomas includes surgery followed by radiation and chemotherapy. As per standard institutional practice, a uniform dose of radiation is delivered to the disease area and MRI is done before and after the treatment. In this study, MRI and PET scan will be done before starting the treatment and standard dose of radiation will be delivered. The interval imaging will be done twice during the course of treatment with MRI and PET, followed by dose modifications. The CT, MRI, and PET will be combined. Based on PET imaging, specific dose will be altered and delivered to specific areas. Dose modification will be done with the help of artificial intelligence. Participant's assessment will be done at regular intervals.

Modifications in radiation plans are done based on the changes in disease seen in scans is likely to improve the accuracy of RT treatments. Dose modifications based on imaging to resistant areas will help achieve better tumor control, reduce treatment-related toxicities, precise delivery of the RT and adjusting doses to the organs at risk (OAR) and changes in disease leading to better treatment compliance. Creating an artificial intelligence framework in radiation oncology promises to improve quality of workflow, treatment planning and RT delivery.

The aim of the study is to develop an artificial intelligence workflow for treatment of glioma with adaptive radiotherapy. This study will be conducted in Tata Memorial Centre on a population of 60 patients for a duration of 2 years. The total study duration is 4 years.

Primary Outcome Measures: Proportion of patients undergoing volumetric and biological adaptation. Cumulative rate of symptomatic radionecrosis (RN) at 2 years., Proportion of patients where modification of radiation plan was done., 2 years|Cumulative rate of symptomatic radionecrosis at 2 years, Patients developing symptomatic radionecerosis will be analyzed using Kaplan-Meier survival method., 4 years
Secondary Outcome Measures: Progression free survival, Progression free survival will be analyzed using Kaplan Meier method., 4 years|Overall survival, Overall survival will be analyzed using Kaplan Meier method., 4 years
Clinical Evaluation Of Ventricular Septal Defect (VSD) In Children at Sohag Univesity Hospital
NCT Number: NCT06492473
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Ventricular Septal Defect
Interventions: DEVICE: ECHO
Sponsor: Sohag University
Sex: ALL
Age: CHILD
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-24
Completion Date: 2025-06-24
Locations: Sohag University hospitals, Sohag, Egypt

Summary:
ventricular septal defect(VSD) are one of the most common significant CHD and account for up to 40% of all cardiac abnormalities.VSD is commonly isolated defect as well as intrinsic component of several complex cardiac malformations including tetrology of fallot ,double- outlet right ventricle(RV),transposition of great vessles,aortic coartication or interruption ,and truncus arteriosus

Primary Outcome Measures: size of VSD, size of VSD in mm according echocardiology, 12 months
2 Courses of Concurrent Cisplatin Chemoradiotherapy After Surgery for High-risk Head and Neck Squamous Cell Carcinoma
NCT Number: NCT06492460
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Squamous Cell Carcinoma of Head and Neck
Interventions: DRUG: Drug：Cisplatin
Sponsor: Sun Yat-sen University
Collaborators: Hunan Cancer Hospital|Guilin Medical University, China|Jiangsu Cancer Institute & Hospital|Xiangya Hospital of Central South University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 422
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-17
Completion Date: 2033-07-17
Locations: Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510060, China|Affiliated Hospital of Guilin Medical College, Guilin, Guangxi, China|Hunan Cancer Hospital, Changsha, Hunan, China|Xiangya Hospital, Central South University, Changsha, Hunan, China|Jiangsu Cancer Hospital, Nanjing, Jiangsu, China

Summary:
The main objective of this trial was to determine the value of 2 courses of cisplatin concurrent chemotherapy in postoperative adjuvant radiotherapy for high-risk head and neck squamous cell carcinoma.

Primary Outcome Measures: Failure-free survival (FFS), calculated from enrolment to the date of locoregional recurrence,distant metastasis,or death from any cause, whichever occurred first., 3 years
Secondary Outcome Measures: Overall survival (OS), calculated from enrolment to the date of death from any cause., 3 years|Distant metastasis-free survival(DMFS), calculated from enrolment to the date of first distant metastasis., 3 years|locoregional recurrence-free survival (LRRFS), calculated from enrolment to the date of locoregional persistence or 1st locoregional recurrence., 3 years|Quality of life (QoL), The change of QoL from randomization to the start of radiotherapy,the end of radiotherapy,13-16 weeks after radiotherapy,2 years and 3 years after randomization. The EORTC QoL questionnaire-C30(EORTC quality of life questionnaire-C30#version 3.0 will be used. This questionnaire comprises 30 questions,24 of which are aggregated into nine multi- question scales,that is,five functioning scales (e.g.,physical),three symptom scales (e.g.,fatigue)and one global health status scale. The remaining six single-question (e.g.,dyspnoea)scales assess symptoms. These 15 scales will be scored according to the official Scoring Manual., 3 years
Correlation Study of Serum HER 2 Against HER 2-ADC Drug Efficacy in HER 2 Low-expressing Breast Cancer
NCT Number: NCT06492447
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: HER 2 Low-expressing Breast Cancer
Interventions: DRUG: Against HER 2-ADC Drug
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Collaborators: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-04
Completion Date: 2026-03-04

Summary:
Breast cancer is one of the most common malignancies in women worldwide, with HER2-positive breast cancer accounting for about 15-20% of all breast cancer cases. HER2 (Human epidermal growth factor receptor 2) is a tyrosine kinase receptor that, when overexpressed, promotes the growth and spread of tumor cells. The advent of anti-HER2 therapy, particularly antibody-coupled drugs (ADCs), has resulted in significant survival benefits for HER2-positive breast cancer subjects.

At present, the value of serum HER2 in the monitoring of anti-HER2-ADC drug therapy is insufficient. The purpose of this study was to investigate changes in serum HER2 expression levels in breast cancer subjects treated with anti-HER2-ADC drugs and the relationship between these changes and treatment effect. The therapeutic effect of HER2 was evaluated by continuous detection of HER2 serum, which provided a theoretical basis for the selection of clinical drug treatment.

Primary Outcome Measures: Objective Response Rate, Percentage of patient's measurable disease who have achieved either complete response (CR) or partial response (PR) according to RECIST 1.1., 1-2 years
Secondary Outcome Measures: PFS, 1-2 years
Enhancing Community Participation Through Peer-Delivered Decision Support
NCT Number: NCT06492434
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Severe Mental Disorder
Interventions: BEHAVIORAL: Peer decision coaching
Sponsor: Temple University
Collaborators: National Institute on Disability, Independent Living, and Rehabilitation Research
Sex: ALL
Age: ADULT
Enrollment: 40
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-07-01
Completion Date: 2025-08-31
Locations: Temple University, Philadelphia, Pennsylvania, 19122, United States|Copeland Center for Wellness and Recovery, Brattleboro, Vermont, 05302, United States

Summary:
The purpose of this study is to pilot test a peer-delivered decision support intervention ("peer decision coaching") designed to enhance decision-making about community participation among young adults with serious mental illness (SMI).

Primary Outcome Measures: Change in decisional conflict scale, The Factors Contributing to Uncertainty subscale of the Decisional Conflict Scale measures decision-making needs. Possible scores range from 0 to 36, with higher scores indicating a worse outcome., Baseline, through intervention completion (up to 3 months)|Change in decision self-efficacy scale, The Decision Self-Efficacy Scale assesses confidence in making an informed choice. Possible scores range from 0 to 44, with higher scores indicating a better outcome., Baseline, through intervention completion (up to 3 months)|Decision-making behaviors at post-intervention, Number of behaviors (range: 0-6) endorsed on Decision-Making Behaviors scale at post-intervention., Post-intervention (up to 3 months post-baseline)|Decision Satisfaction Scale Score at post-intervention, The Decision Satisfaction Scale assesses a person's satisfaction with a health decision. Possible scores range from 6-30, with higher scores indicating a better outcome., Post-intervention (up to 3 months post-baseline)|Change in Temple University Community Participation Measure (sufficiency), Sufficiency scores on the Temple University Community Participation Measure assess how satisfied individuals are with their amount of community participation in areas that are important to them. Possible scores range from 0-100, with higher scores indicating a better outcome., Baseline, through intervention completion (up to 3 months)|Change in Temple University Community Participation Measure (breadth ratio), Breadth ratio scores on the Temple University Participation Measure assess breadth of participation in areas considered important to a person. Possible scores range from 0-100, with higher scores indicating a better outcome., Baseline, through intervention completion (up to 3 months)
Neoadjuvant Intra-tumor Double Immunotherapy for Lung Cancer.
NCT Number: NCT06492421
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Lung Cancer|Surgery|Non-small Cell Lung Cancer
Interventions: DRUG: ipilimumab, pembrolizumab, durvalumab, idarubicin, bevacizumab
Sponsor: Second Affiliated Hospital of Guangzhou Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2035-12-30
Locations: The Second Affiliated Hospital of Guangzhou Medical University, Guanzhou, Guangdong, 51260, China

Summary:
This phase II trial studies how well intra-tumor injection of double checkpoint inhibitors work when given alone and in combination with chemotherapy or/and bevacizumab in treating patients with previously untreated stage I-IIIA non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as ipilimumab, pembrolizumab or durvalumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Drugs used in interventional radiological chemotherapy, such as idabubicin, can directly kill the cancer cell and release tumor antigens to activate DC function in situ. Giving intra-tumor injection of checkpoints inhibitors with or without chemotherapy and/or bevecizumab may work better than in vein infusion of the drugs in treating patients with non-small cell lung cancer.

Primary Outcome Measures: pCR rate for the study groups, Pathologic complete response (pCR) is defined as after neoadjuvant therapy, the surgical specimen can not find any residual cancer cells., Six months|mPR rate for the study groups, Major pathologic response (MPR) is defined as pathological less than 10% survival cancer cells after tumor resection., Six months
Secondary Outcome Measures: Toxicity of the study groups, Toxicity is assessed by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\] version 4., Six months|Response rates to neoadjuvant treatment, Recurrence-free survival is measured as routine., Six years|Overall survival, To correlate major pathologic response with recurrence-free and overall survival., Six years