pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Efficacy and Safety of DKF-MA102 in Patients With Prostate Cancer
NCT Number: NCT06490328
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Advanced Prostate Cancer
Interventions: DRUG: DKF-MA102
Sponsor: Dongkook Pharmaceutical Co., Ltd.
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 154
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-30
Completion Date: 2025-05-20
Locations: Ewha Womans University mokdong Hospital, Seoul, Korea, Republic of

Summary:
A phase 3, multi-center, single-group, open-label study to evaluate the efficacy and safety of DKF-MA102 in patients with prostate cancer.

Primary Outcome Measures: Percentage of participants, Percentage of participants with testosterone suppression(≤ 50ng/dL) at Week 4, Week 4|Percentage of participants, Percentage of participants with testosterone suppression(≤ 50ng/dL) from Week 4 to Week 24, Week 24
Secondary Outcome Measures: Serum luteinizing hormone(LH) levels, Changes in serum luteinizing hormone(LH) levels from baseline to Weeks 4, 12 and 24, Week 24|Serum prostate specific antigens(PSA), Changes in serum prostate specific antigens(PSA) from baseline to Weeks 4, 12 and 24, Week 24|Percentage of participants, Percentage of participants with testosterone suppression(≤ 20ng/dL) from Week 4 to Week 24, Week 24|Quality of life(FACT-P), Comparative evaluation of quality of life(FACT-P) of subjects from baseline to Weeks 4, 12 and 24, Week 24
Clinical Evaluation of Two Toric Soft Contact Lenses
NCT Number: NCT06490302
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Astigmatism
Interventions: DEVICE: Lens A (ocufilcon D)|DEVICE: Lens B (fanfilcon A)
Sponsor: Coopervision, Inc.
Sex: ALL
Age: ADULT
Enrollment: 40
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-05-25
Completion Date: 2024-06-28
Locations: Consultorio Optométrico Queretaro, Mexico City, 06760, Mexico

Summary:
The aim of this study is to compare the short-term clinical performance of two toric contact lenses.

Primary Outcome Measures: Lens Fit Acceptance Ratings, Overall lens fit acceptance will be measured on a scale from 0-4 (0= Should not be worn, 4= Perfect), At the end of 15 minutes of daily wear
Clinical Efficiency of Natural Herbal Based Gel.
NCT Number: NCT06490289
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Oral Ulcer
Interventions: OTHER: Denpro oral gel
Sponsor: Pakistan Institute of Medical Sciences
Sex: ALL
Age: ADULT
Enrollment: 202
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-06-15
Completion Date: 2024-01-16
Locations: Afsheen Mansoor, Islamabad, 44080, Pakistan

Summary:
This clinical trial was conducted in School of Dentistry, Islamabad from 15th June 2023 to 16th January 2024. A total 202 participants took part in study and were divided equally into two groups i.e Control group and Experimental group where Control group was not given any treatment for oral ulcer whereas Experimental group was given herbal based Denpro oral gel 2-4 times a day for at least 4 weeks topically on ulcer area. Mouth ulcer size in patients was measured on first day " Visit=0", second day " Visit=1", third day " Visit=2", fourth day " Visit=3", seventh day " Visit=4" and fourteenth day " Visit=5" for reduction and complete recovery. Data was analyzed by One way ANOVA and POST HOC Tukey test.

Primary Outcome Measures: Reduction in size of Oral Ulcer and recovery of oral mucosa, Mouth ulcer size in both the control group and Experimental group was measured on the first day " Visit=0" which was taken as the baseline, again measured on second day " Visit=1" , third day " Visit=2" , fourth day " Visit=3" , seventh day " Visit=4" and finally, fourteenth day " Visit=5", treatment of the ulcer 2-4 times a day for at least 2 weeks.
Biofeedback Gait Training on Gait Quality in Stroke
NCT Number: NCT06490276
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stroke
Interventions: OTHER: Gait training with biofeedback|OTHER: Gait training without biofeedback
Sponsor: National Yang Ming Chiao Tung University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2027-12-31

Summary:
Post-stroke gait dysfunction is characterized by reduced gait velocity and stride length, along with gait asymmetry and instability. Gait asymmetry and instability are considered as indicators for gait quality, which affect independence and quality of life in individual with stroke. Previous studies have suggested that gait biofeedback is a promising strategy for enhancing the efficacy of post-stroke gait training. However, there is insufficient evidence on the effects of kinematic biofeedback gait training on gait asymmetry and instability in individuals with stroke. Therefore, the purpose of this study is to investigate the effects of real-time kinematic gait biofeedback training on gait quality in individuals with stroke.

Primary Outcome Measures: Gait symmetry, Using GAITRite system to measure the symmetry of saptiotemporal parameters, Change from baseline at 4 weeks after training and 4 weeks follow-up|Gait variability, Using GAITRite system to measure the coefficient of variation of saptiotemporal parameters, Change from baseline at 4 weeks after training and 4 weeks follow-up
Secondary Outcome Measures: Propulsive force, Using Force plate to measure the ground reaction force, Change from baseline at 4 weeks after training and 4 weeks follow-up|Gait performance, Using the GAITRite system to evaluate saptiotemporal parameters, Change from baseline at 4 weeks after training and 4 weeks follow-up|Berg Balance Scale, Using Berg Balance Scale to evaluate balance ability, Change from baseline at 4 weeks after training and 4 weeks follow-up|Activities-specific Balance Confidence Scale, Using Activities-specific Balance Confidence Scale to evaluate individual's balance confidence in performing daily activities, Change from baseline at 4 weeks after training and 4 weeks follow-up|Taiwan Chinese version Falls Efficacy Scale, Using Taiwan Chinese version Falls Efficacy Scale to evaluate concerns about falling, Change from baseline at 4 weeks after training and 4 weeks follow-up|Frenchay Activities Index, Using Frenchay Activities Index to measure individual's capacity to perform instrumental activities of daily living, Change from baseline at 4 weeks after training and 4 weeks follow-up|Stroke Impact Scale, Using Stroke Impact Scale to evaluate disability and quality of life after stroke, Change from baseline at 4 weeks after training and 4 weeks follow-up
Coding of Speech Signals in the Human Auditory Nerve
NCT Number: NCT06490237
Acronym: NeuroSpeech
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hearing Loss
Interventions: PROCEDURE: near field recording of human auditory nerve activity during retro sigmoid approach with contact electrode
Sponsor: CHU de Reims
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2021-12-07
Completion Date: 2027-06-07
Locations: Damien JOLLY, Reims, France

Summary:
The fine evaluation of the function of auditory neurons in silence and in noise in humans is difficult, if not impossible, to date with the conventional methods available. That is why in certain situations, the hearing aids of patient with hearing loss fail, especially in the presence of noise.

In this study the investigators aim at investigating the global spontaneous and sound evoked human auditory nerve activity from electrophysiological acquisitions performed directly on the cochlear nerve in patients requiring posterior fossa surgery.

Primary Outcome Measures: Compare the amplitude of global evoked auditory nerve activity, Compare the amplitude and spectrum of global evoked auditory nerve activity in silence and in noise with basic and speech stimuli between patients defined as normo and hearing loss based on preoperative audiometric tests., 66 months|Compare the spectrum of global evoked auditory nerve activity, Compare the spectrum of global evoked auditory nerve activity in silence and in noise with basic and speech stimuli between patients defined as normo and hearing loss based on preoperative audiometric tests, 66 months
Secondary Outcome Measures: Compare the difference of coding of the temporal envelope, Compare the difference of coding of the temporal envelope of the collected signal in the normo and hearing impaired groups., 66 months|Compare the difference of coding of the fine structure, Compare the difference of coding of the fine structure of the collected signal in the normo and hearing impaired groups., 66 months|Compare the two groups of investigation, To investigate within the group of normo hearing patients whether the amplitude of global evoked auditory nerve activity is different between those with the best and worst results in the pre-operative vocal speech in noise test., 66 months|Compare the two groups of investigation, To investigate within the group of normo hearing patients whether the spectrum of global evoked auditory nerve activity is different between those with the best and worst results in the pre-operative vocal speech in noise test., 66 months
Measuring and Displaying the Subjective
NCT Number: NCT06490224
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Physician-Patient Relations|Communication Research
Interventions: BEHAVIORAL: Relevant Patient Reported Outcome Measures (PROMs)|OTHER: My Whole Health Map
Sponsor: University of Texas at Austin
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: OTHER
Start Date: 2023-11-19
Completion Date: 2024-04-06
Locations: University of Texas at Austin, Austin, Texas, 78701, United States

Summary:
The investigators developed a brief set of subjective health measures designed to feel more relevant to patients seeking musculoskeletal specialty care, presented the scores to patients and clinicians using an easy-to-understand visual display, and measured whether or not this process harmed patient experience.

Primary Outcome Measures: CollaboRATE survey, Quality of shared decision-making (Numerical scale from 1-27; Higher scores equal better outcome), Immediately after the intervention|Jefferson Scale Patient Perceptions of Physician Empathy (JSPPPE), Patient perceived clinician empathy (Numerical scale from 1-35; Higher scores equal better outcome), Immediately after the intervention
The Research Value of Multi-omics and Multi-modal Information in the Diagnosis and Treatment of Urinary System Tumors
NCT Number: NCT06490211
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Urinary System Carcinoma
Sponsor: Wuhan Union Hospital, China
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-11-20
Completion Date: 2026-11-20
Locations: Union Hospital，Tongji Medical College，Huazhong University of Science and Technology, Wuhan, Hubei, 430000, China

Summary:
Obtain puncture or surgically removed tumor tissue samples from patients with urinary tract tumors and perform RNA-sequencing, Single-cell RNA-sequence, Spatial Transcriptomics, Proteomics, and Intratumoral Microbiome.

Primary Outcome Measures: progression-free survival, 2 years
Phase 2 Study: OBI-833/OBI-821 Maintenance for Globo H+ Advanced Biliary Tract Cancer After Gemcitabine/Cisplatin
NCT Number: NCT06490198
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Cholangiocarcinoma|Chemotherapy Effect|Immunotherapy
Interventions: DRUG: OBI-833/OBI-821
Sponsor: Chang Gung Memorial Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-31
Completion Date: 2027-07-31
Locations: Chang Gung Memorial Hospital Linkou Branch, Taoyuan, 333, Taiwan|Chang-Gung Memorial Hospital, Linkou Branch, Taoyuan, Taiwan

Summary:
A Phase 2 clinical trial protocol for evaluating the efficacy and safety of OBI-833/OBI-821, a carbohydrate-conjugate vaccine combined with an immune adjuvant, as maintenance therapy in combination with first-line gemcitabine and cisplatin chemotherapy for patients with Globo H-positive advanced biliary tract cancer. The study is designed as a single-arm trial with 30 patients who have achieved stable disease, partial response, or complete response after 3±1 months of initial chemotherapy. The primary endpoint is progression-free survival, with secondary endpoints including overall survival, tumor response, and safety profile. The treatment regimen involves subcutaneous injections of OBI-833/OBI-821 on a gradually decreasing frequency schedule for up to 80 weeks. The trial also includes exploratory objectives to assess immune responses and biomarkers. This study aims to address the unmet need for improved treatment options in advanced biliary tract cancer by leveraging the potential of immunotherapy targeting the Globo H antigen.

Primary Outcome Measures: Progression-free survival, The time from start of treatment until disease progression or death from any cause, 12 to 18 months of subject recruitment, 80 weeks of OBI-833/OBI-821 treatment, and another 1 year for overall survival follow-up.
Secondary Outcome Measures: Overall survival, The time from start of treatment until death from any cause, 12 to 18 months of subject recruitment, 80 weeks of OBI-833/OBI-821 treatment, and another 1 year for overall survival follow-up.|Best overall tumor response, by RECIST 1.1 criteria, 12 to 18 months of subject recruitment, 80 weeks of OBI-833/OBI-821 treatment, and another 1 year for overall survival follow-up.|Adverse events, Incidences of adverse events and serious adverse events, Local injection site reaction, Changes in laboratory tests, including hematology and serum chemistry, Changes in vital signs, Changes in physical examination, 12 to 18 months of subject recruitment, 80 weeks of OBI-833/OBI-821 treatment, and another 1 year for overall survival follow-up.|Correlation between anti-Globo H IgM and IgG concentrations and survival, biomarker response and survival correlation analysis, 12 to 18 months of subject recruitment, 80 weeks of OBI-833/OBI-821 treatment, and another 1 year for overall survival follow-up.
Peri-appendiceal Abscess and Phlegmon in Acute Complicated Appendicitis Patients
NCT Number: NCT06490185
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Acute Complicated Appendicitis With Peri-appendiceal Abscess or Phlegmon
Interventions: OTHER: Clinical data collection
Sponsor: Shanghai Zhongshan Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2025-01-01
Completion Date: 2026-12-31

Summary:
This study aim to analyze the clinical data of patients who underwent emergency appendectomy for acute complicated appendicitis with peri-appendiceal abscess or phlegmon, identify factors influencing the post-operative length of hospital stay (LOS), and improve treatment strategies.

Primary Outcome Measures: The post-operative length of hospital stay (LOS), January 01, 2025 to December 31, 2025.
Predicting Peripheral Neuropathy of Paclitaxel for Gastric Cancer
NCT Number: NCT06490159
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Gastric Cancer|Chemotherapy-induced Peripheral Neuropathy|Paclitaxel|Ramucirumab
Interventions: DRUG: Paclitaxel
Sponsor: City of Hope Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2018-10-01
Completion Date: 2025-12-31
Locations: Kawasaki Medical University, Kurashiki, Okayama, 7010192, Japan

Summary:
Although advances in chemotherapy have improved the prognosis of gastric cancer patients, many patients still suffer from adverse events. Therefore, it is necessary to establish personalized treatment by identifying patients at high risk for side effects. Although paclitaxel-based therapy is the standard second-line treatment, peripheral neuropathy is a troublesome adverse event. The purpose of this study is to establish a liquid biopsy assay to predict paclitaxel-induced peripheral neuropathy in gastric cancer patients.

Primary Outcome Measures: Incidence of peripheral neuropathy, The standard approach to treatment-related adverse events that occur during anticancer treatment is the Common Terminology Criteria for Adverse Events (CTCAE), which is maintained by the US National Cancer Institute., 1 year
Evaluation of Consuming Olive Extract on Total Cholesterol Levels
NCT Number: NCT06490133
Acronym: OLICOL
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Metabolic Syndrome &#X7C; Serum or Plasma &#X7C; Chemistry - Non-Challenge|Overweight
Interventions: DIETARY_SUPPLEMENT: Polyhpenol extract|DIETARY_SUPPLEMENT: Placebo
Sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-04-03
Completion Date: 2024-09-15
Locations: Centro de Investigacion en Nutricion. Universidad de Navarra, Pamplona, Navarra, 31008, Spain

Summary:
The main objective of this nutritional intervention is to assess the efficacy of polyphenol-rich capsules on reducing metabolic syndrome traits, mainly cholesterol levels. For this purpose, a double blind, placebo controlled study of 12 weeks will be carried out.

The target population is women and men with overweight or obesity. Researchers will compare the experimental capsules with placebo capsules, but will be blinded during the intervention and results analyses. Only after analysing the parameters, the groups will be revealed.

Primary Outcome Measures: Total cholesterol, Serum concentration of Total Cholesterol, Baseline|Total cholesterol, Serum concentration of Total Cholesterol, 12 weeks|HDL cholesterol, Serum concentration of HDL cholesterol, Baseline|HDL cholesterol, Serum concentration of HDL cholesterol, 12 weeks|LDL cholesterol, Serum Calculated LDL Cholesterol levels, Baseline|LDL cholesterol, Serum Calculated LDL Cholesterol levels, 12 weeks|Triglycerides, Serum Triglycerides levels, Baseline|Triglycerides, Serum Triglycerides levels, 12 weeks
Secondary Outcome Measures: Weight, Weight status, Baseline|Weight, Weight status, 12 weeks|Fat mass, Fat mass in kg, measured by Bioimpedance, Baseline|Fat mass, Fat mass in kg, measured by Bioimpedance, 12 weeks|Hemoglobin, Hemoglobin measured as mg/dL, Baseline|Hemoglobin, Hemoglobin measured as mg/dL, 12 weeks|Hematocrit, Hematocrit (%), Baseline|Hematocrit, Hematocrit (%), 12 weeks|Physical Activity, Measured through the IPAQ questionnaire, Baseline|Physical Activity, Measured through the IPAQ questionnaire, 12 weeks|Blood pressure, Measured in the dominant arm (mmHg), Baseline|Blood pressure, Measured in the dominant arm (mmHg), 12 weeks|Dietary intake, FFQ from the SUN Study, Baseline|Dietary intake, FFQ from the SUN Study, 12 weeks
Durvalumab Combined With S-1 as Adjuvant Therapy of Resectable BTC
NCT Number: NCT06490107
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Biliary Tract Cancer
Interventions: DRUG: Durvalumab combined with S-1
Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Collaborators: AstraZeneca
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-24
Completion Date: 2027-12-30
Locations: Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing, China

Summary:
The aim of this study is to assess the efficacy and safety of durvalumab combined with S-1 as adjuvant therapy of resectable Biliary Tract Cancer(BTC) with high risk of recurrence

Primary Outcome Measures: 2-year recurrence-free survival rate, The 2-year recurrence-free survival rate refers to the proportion of patients who did not experience disease recurrence within 2 years after surgery., 2 years
Secondary Outcome Measures: Overall survival（OS）, It is the time from the start of treatment to the death of the patient due to any cause., 3 years|Recurrence-free survival(RFS), It is the time from surgery to the earliest disease recurrence of the patient., 2 years|3-year overall survival rate(3-year OS rate), The proportion of patients who did not die with any cause within 3 years after receiving treatment., 3 years|Safety and tolerability by incidence, severity and outcome of adverse events, Safety and tolerance will be evaluated by incidence, severity and outcomes of adverse events (AEs) and categorized by severity in accordance with the NCI CTC AE Version 5.0, 3 years
Trilaciclib Prevents Myelosuppression With Chemoradiotherapy
NCT Number: NCT06490081
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Myelosuppression
Interventions: DRUG: Trilaciclib
Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-26
Completion Date: 2026-06-30
Locations: Cancer Hospital Chinese Academy of Medical Sciences, Beijing, Beijing, 100021, China

Summary:
To evaluate the protective effect of Trilaciclib on myelosuppression in patients with limited-stage small cell lung cancer associated with concurrent chemoradiotherapy and discuss the effect of gut microbiota changes on myelosuppression

Primary Outcome Measures: Occurrence of severe neutropenia, Grade 3/4 decline in neutropenia after the first cycle of chemotherapy during radiotherapy, 14 days|Duration of severe neutropenia, Duration of severe neutropenia after the first cycle of chemotherapy during radiotherapy (ANC\<1.0×10\^9/L for more than 5 days), 5 days|Occurrence of hematological toxicity, Grade 3/4 decline in neutrophils, platelets, and red blood cells, 5 days
Study of LTC004 Combine With Toripalimab in Patient With Solid Tumors Resistant to Immunotherapy
NCT Number: NCT06490068
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Advanced Solid Tumor
Interventions: DRUG: LTC004+Toripalimab
Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-04
Completion Date: 2026-03-31
Locations: Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing, China

Summary:
To evaluate the efficacy and safety of LTC004 in combination with Toripalimab in 10 patients with advanced solid tumors resistant to first-line immunotherapy, all eligible subjects will receive LTC004 on day 1 of Week 1 and day 1 of week 3. Beginning at week 5, all subjects will receive LTC004 in combination with Toripalimab regimen until disease progression, intolerance, informed withdrawal or up to 2 years of dosing, whichever occurred first.

Primary Outcome Measures: ORR, Antitumor efficacy of LTC004+Toripalimab treated patient with advanced solid tumors resistant to first-line immunotherapy, up to 12 months
Secondary Outcome Measures: DCR, Disease control rate of LTC004+Toripalimab treated patient with advanced solid tumors resistant to first-line immunotherapy, up to 12 months|DOR, Duration of Response of LTC004+Toripalimab treated patient with advanced solid tumors resistant to first-line immunotherapy, up to 12 months|PFS, Progression-Free Survival of LTC004+Toripalimab treated patient with advanced solid tumors resistant to first-line immunotherapy, up to 12 months|OS, Overall Survival of LTC004+Toripalimab treated patient with advanced solid tumors resistant to first-line immunotherapy, up to 12 months
Predicting the Efficacy in Advanced Gastric Cancer.
NCT Number: NCT06490055
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Gastric Cancer|Chemotherapy Effect|Paclitaxel|Ramucirumab
Interventions: DRUG: Paclitaxel
Sponsor: City of Hope Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2018-10-01
Completion Date: 2025-12-31
Locations: Kawasaki Medical University, Kurashiki, Okayama, 7010192, Japan

Summary:
With advances in chemotherapy for gastric cancer, it is important to identify patients who will respond effectively to specific therapies. This longitudinal study aimed to establish a liquid-biopsy assay that can predict response to ramucirumab plus paclitaxel therapy in patients with advanced gastric cancer.

Primary Outcome Measures: Chemotherapy response, Follows by response valuation criteria in solid tumors (RECIST) evaluation. Partial response (PR) and Stable disease (SD) are defined as treatment effective, while Progressive disease (PD) is defined as no treatment effective., 5 years
Diagnostic of Various Ototoxicity Induced by Cancer Treatment
NCT Number: NCT06490029
Acronym: BIO-OTOTOX
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Ototoxicity, Drug-Induced
Interventions: DIAGNOSTIC_TEST: Auditory, vestibular and electrophysiological investigations|DIAGNOSTIC_TEST: Biologic investigations; seric proteins
Sponsor: Direction Centrale du Service de Santé des Armées
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 540
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-19
Completion Date: 2027-09-19
Locations: HIA Bégin, Paris, France

Summary:
• Visit the clinic once every 2 weeks for checkups and tests The goal of this clinical trial is to learn if systematic hearing tests (eg fonctional assesment, electrophysiology and seric biomarkers) can diagnose hidden hearing loss or vestibular troubles in a population of patients treated for cancer; population study will include different population in terms of sex/gender, age, medical condition (cancer patients treated with surgery alone and/or radiotherapy and/or chemotherapy, and healthy volunteers).

The main question it aims to answer is:

• To assess the ototoxicity of anticancer drugs using a combination of auditory functional tests (including speech audiometry in noise), vestibular test , plasmatic samples and electrophysiological measures.

Participants will be studied:

Either only after exposition (single visit) Or before, during and after the exposition to potential otototoxic agents with a 4 times Visit the clinic checkups and tests (one before, two while ongoing potential ototoxic agents and 1 post exposition)

Participants will complete questionnaires, undergo audiometric and electrophysiological tests, and their routine biomedical data will be studied, without any modification of the routine care (planned cancer treatment)

Primary Outcome Measures: Descriptive statistics for audiometry of the various groups, Percentage of correct consonant identification as a function of signal-to-noise ratio for speech audiometry in noise, Day 0-Day1 (groups A, B, C) & Day 2, Day 0+7-14-21, Day 0+180-270 (for group C)|Descriptive statistics for electrophysiological tests of the various groups, amplitudes of the acoustic distortion products collected during the measurement of induced acoustic otoemissions, Day 0-Day1 (groups A, B, C) & Day 2, Day 0+7-14-21, Day 0+180-270 (for group C)|Descriptive statistics for protein analyses of the various groups, Concentration of selected proteins in plasma (/mL), Day 0-Day1 (groups A, B, C) & Day 2, Day 0+7-14-21, Day 0+180-270 (for group C)
Predicting Postoperative Chemotherapy Efficacy in Patients With Esophageal Squamous Cell Carcinoma
NCT Number: NCT06490003
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Esophageal Squamous Cell Carcinoma|Chemotherapy Effect|DNA Methylation
Interventions: DRUG: Fluoro Uracil
Sponsor: City of Hope Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2004-06-01
Completion Date: 2025-12-31
Locations: Yamanashi Universiy, Chuo, Yamanashi, 4093898, Japan

Summary:
Esophageal cancer remains a disease with a poor prognosis. Chemotherapy is an important part of its treatment, but there are cases in which chemotherapy is ineffective. The investigators aim to develop a model to predict the response to chemotherapy by DNA methylation of preoperative biopsy specimens to identify the chemotherapy ineffective group.

Primary Outcome Measures: Overall response rate(Chemotherapy), The effect of initial chemotherapy is evaluated by imaging. Response evaluation criteria in solid tumors (RECIST) is used for treatment efficacy., 1year
Implementation Research on the Intervention Mode of " Comorbidity-Co-causes-Joint-prevention" Comprehensive Demonstration District of Depression and Obesity Among Children and Adolescents in Beijing
NCT Number: NCT06489990
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Depression|Obesity|High Risk of Depression|Overweight
Interventions: COMBINATION_PRODUCT: combination intervention strategy of [Comorbidity-Co-causes-Joint-prevention]|COMBINATION_PRODUCT: routine health education and mental health knowledge
Sponsor: Capital Medical University
Collaborators: Peking University|Center for Disease Control and Prevention of Bejing Economic-Technoloogical Develeopment Area
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 440
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-08-01
Completion Date: 2026-12-31
Locations: Beijing Anding Hospital, Capital Medical University, Beijing, Beijing, 100088, China

Summary:
Depression and obesity have become the most prominent health problems among adolescents and have caused a heavy burden on the health and social economy of the whole population. There are high incidence, comorbidity and co-pathogenic factors of depression and obesity in adolescents, but there is still a lack of research on joint prevention strategies and multi-sectoral collaborative prevention and control network. This project plans to screen and integrate effective intervention measures based on multi-stage optimization strategy, developing an intervention mode of \[Comorbidity-Co-causes-Joint-prevention\] for adolescents with depression or/and obesity, and then carry out with children or adolescents in Beijing based on digital platform. The investigators will be considering the accessibility, sustainability and replicability of the implement based on the RE-AIM framework including the coverage of population and organizations as well as the effect, implement and sustainability of the interventions. The research will be promoted with the help of the National Clinical Research Center for Mental Disorders and Monitoring of Student Common Diseases and Health Influencing Factors. The results of the research will establish an intervention mode of \[Comorbidity-Co-causes-Joint-prevention\] and a promotion model for adolescents' depression and obesity in Beijing, providing support for the realization of Healthy China 2030 and Healthy Beijing 2030 Plans.

Primary Outcome Measures: Patient Health Questionnaire-9(PHQ-9), The score ranges from 0 to 27, the higher scores mean more serious depression, From enrollment to the end of treatment at baseline、12weeks、6months
Secondary Outcome Measures: BMI, From enrollment to the end of treatment at baseline、12 weeks、6months
Rigid Corset Immobilisation of Patients Suffering From Spondylodiscitis: Practice Assessment
NCT Number: NCT06489977
Acronym: Cors'aime
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Management of Spondylodiscitis
Sponsor: University Hospital, Clermont-Ferrand
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2024-11-30
Locations: Chu Clermont Ferrand, Clermont-Ferrand, 63000, France

Summary:
Our study is a survey of the current management of patients suffering from spondylodiscitis.

Primary Outcome Measures: Physician survey to identify medical practices in the management of patients suffering from spondylodiscitis in hospital., Questionnaire to evaluate medical practices, 3 months
Secondary Outcome Measures: Practical application of rigid corset prescriptions by paramedical teams., Questionnaire to evaluate paramedical practices, 3 months|Patient compliance, feedback, understanding and satisfaction with wearing the corset, Questionnaire to assess patient compliance and feelings, 3 months
Efficacy and Safety of Vitamin D Supplementation Combined With Standard Behavioral Therapy in the Treatment of OAB-dry in Children
NCT Number: NCT06489951
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Overactive Bladder|Pediatric Disorder
Interventions: DRUG: Solifenacin|DIETARY_SUPPLEMENT: vitamin D|BEHAVIORAL: Standard behavioral therapy
Sponsor: Xing Liu
Collaborators: Beijing Children's Hospital|Shanghai Children's Hospital|Children's Hospital of Soochow University|Guizhou Provincial People's Hospital
Sex: ALL
Age: CHILD, ADULT
Enrollment: 180
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-12
Completion Date: 2026-01

Summary:
The aim of this study is to give children with dry OAB: (1) Standard behavioral therapy combined with classical anticholinergic drugs (Solinaxine), or (2) standard behavioral therapy combined with short-term high-dose exogenous vitamin D supplementation are used to compare the outcomes of lower urinary tract symptoms in children with dry OAB during follow-up. To provide more robust supporting evidence for the broader promotion of short-term high-dose exogenous vitamin D supplements in combination with standard behavioral therapy as an effective treatment for dry OAB treatment in children.

Primary Outcome Measures: Change in daily urination frequency, To explore whether standard behavioral therapy combined with short-term high dose vitamin D (2400IU daily) is superior to standard behavioral therapy combined with anticholinergic drugs (Solinaxine) in improving the daily frequency of urination in children with dry OAB., week 1, week6，week 12
Secondary Outcome Measures: Change in the mean urgency score, To explore whether standard behavioral therapy combined with short-term high dose exogenous vitamin D supplementation (2400IU daily) is superior to standard behavioral therapy combined with anticholinergic drugs (Solinaxine) in improving mean urinal urgency scores in children with dry OAB., week 1, week6，week 12|Change quality of life score, Quality of life scores are assessed on a scale of 0 to 3, where 0 indicates no impact on family, social or academic life; A score of 1 represents occasional effects; A score of 2 is a significant impact. A score of 3 indicates a serious impact on family, social or school life, week 1, week6，week 12
Overview of the Mental Health of Adolescents in Therapeutci, Educational and Pedagogical Facilities in France
NCT Number: NCT06489912
Acronym: PsyPreDi
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Mental Health Disorder
Interventions: DIAGNOSTIC_TEST: WAIS IV
Sponsor: University Hospital, Rouen
Sex: ALL
Age: CHILD
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-15
Completion Date: 2026-12-31

Summary:
Assess the prevalence of various psychiatric disorders in adolescents aged 12 to 16 receiving support from therapeutic, educational and pedagogical institutes.

Primary Outcome Measures: Presence of psychiatric disorders, assessed according to DSM-5 by K- SADS-PL, Inclusion|nature of psychiatric disorders, assessed according to DSM-5 by K- SADS-PL, Inclusion
Secondary Outcome Measures: Describe the psychological characteristics of adolescents aged 12 to 16, Traumatisms, Inclusion|Describe the psychological characteristics of adolescents aged 12 to 16, Attachement, Inclusion|Describe the psychological characteristics of adolescents aged 12 to 16, Toronto Alexithymia Scale, Inclusion|Describe the psychological characteristics of adolescents aged 12 to 16, Empathy scale, Inclusion|Describe the psychological characteristics of adolescents aged 12 to 16, Impulsivity scale, Inclusion|Describe the psychological characteristics of adolescents aged 12 to 16, Reflective self esteem scale, Inclusion|Describe the psychological characteristics of adolescents aged 12 to 16, Abbreviated-diagnostic interview for borderlines, Inclusion|Describe the psychological characteristics of adolescents aged 12 to 16, Hostility, Inclusion|Describe the psychological characteristics of adolescents aged 12 to 16, Buss Durkee Hostility Inventory, Inclusion|Describe the psychological characteristics of adolescents aged 12 to 16, Mentoring assessed by Reflective Functioning Questionnaire, Inclusion|Describe the psychological characteristics of adolescents aged 12 to 16, Coping strategies assessed by Adolescent Coping Scale, Inclusion|Describe the psychological characteristics of adolescents aged 12 to 16, Risk behaviour assessed by COLUMBIA-SUICIDE SEVERITY RATING SCALE, Inclusion|cognitive abilities, Raven's Matrix, Inclusion|Adverse exepriences, Adverse Child Experiences, Inclusion
Lutein, Zeaxathin, and Fish Oil Supplementation
NCT Number: NCT06489873
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cognitive Performance|Age-Related Macular Degeneration|Bone Loss
Interventions: DIETARY_SUPPLEMENT: Active Comparator (Lutein, zeaxanthin, and fish oil supplement (LZF)|DIETARY_SUPPLEMENT: Placebo Comparator
Sponsor: Texas A&M University
Collaborators: Allen Foundation Inc.
Sex: ALL
Age: ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-02-07
Completion Date: 2025-05-01
Locations: Gilchrist Building, College Station, Texas, 77843, United States

Summary:
The goal of this clinical trial is to learn the impact of lutein, zeaxanthin, and fish oil (LZF) supplementation in healthy adults.

The main question it aims to answer is: Will supplementation with LZF improve macular pigment optical density (MPOD), cognitive performance and bone mass compared to controls after six months?

Subjects with an MPOD \<.43 will significantly improve MPOD after 6-months of LZF supplementation.

Consuming a LZFO supplement for 6-months will improve visual cognitive performance. Consuming a LZFO supplement for 6-months will improve bone density.

Participants will be asked to take either a LZF supplement or placebo daily for 6 months.

Primary Outcome Measures: Macular Pigment Optical Density (MPOD), The MPS II will be used to measure MPOD, MPOD will be measured at baseline, 3 months after the start of the study, and at the final 6 month visit, which will be the completion of the study.|Cognitive Performance, Neurotracker 3-dimensional software will be used to measure cognitive performance. Each cognitive performance session will include 15 6-second tests that will establish a speed threshold., Cognitive performance will be measured at the three baseline appointments, the three appointments at 3 months, and the 3 appointments at 6 months after the start of the study, which will be the completion of the study|Bone Density, The Horizon™ DXA System will be used for rapid, dual-energy bone density measurements in a single-sweep., Bone density will be measured at baseline and at the final 6 month visit, which will be the completion of the study.
Secondary Outcome Measures: Lutein and Zeaxanthin Serum Levels, Serum will be drawn and analyzed for lutein and zeaxanthin content, Serum lutein and zeaxanthin will be measured at baseline and at the final 6 month visit, which will be the completion of the study.
COVID-19 Rice Drug is Brand Name of Drug
NCT Number: NCT06489860
Acronym: Covid19R
Status: APPROVED_FOR_MARKETING
Study Type: EXPANDED_ACCESS
Conditions: COVID-19 Pneumonia
Interventions: DRUG: COVID-19 Rice Drug
Sponsor: DHA Coffee Co., Ltd
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Locations: Do Van Tin, Ho Chi Minh City, 84, Vietnam

Summary:
COVID-19 Rice Drug Serial Number: 12401 Code Name: Covid19R Covid 19 Drug Powder Packets Whole Natural Purity 20 -1 g Packets Net Weight 0.7 oz (20 g)
An Objective Assessment Tool for Evaluating Functioning in Older Adults
NCT Number: NCT06489847
Acronym: SPPB++ App
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Alzheimer Disease
Interventions: DIAGNOSTIC_TEST: SPPB++ Application
Sponsor: Stanford University
Collaborators: University of Massachusetts, Worcester
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2027-07-30

Summary:
The Investigators are seeking your consent to participate in research investigating the development of a mobile application that enhances physical and cognitive assessments.

This is in response to the growing significance of the Short Physical Performance Battery (SPPB) in Alzheimer's Disease and Related Dementias (AD/ADRD) research. The SPPB has proven its value in evaluating lower extremity function and mobility in older adults, providing predictive insights into declines in daily living activities, falls, hospitalization, disability, and mortality.

Recognizing the need for accessible and automated assessment tools, this project endeavors to design a mobile app with multi-fold functionality. The final version will guide users through SPPB tests, offer real-time performance scoring, and facilitate frequent, objective, and accurate physical and cognitive assessments. This is particularly critical for monitoring the progression of ADRD, identifying subtle physical changes indicative of cognitive decline, and enabling timely interventions tailored to patients' evolving needs.

Our goal is to collect video data from 20 to 30 participants 18+ years of age who are considered healthy with no severe mobility issues to perform the SPPB. The video data will be used to develop a prototype of the SPPB application and validate testing in the lab. The video recording will be automatically encrypted and securely uploaded to Stanford privacy protected computer servers to test and refine the application results.

Primary Outcome Measures: SPPB++ Application for mobile devices, To create an accessible \& automated assessment tool for SPPB test scores for users over time, 2 to 3 years
Group Drumming for Improving the Health of Community-Dwelling Elderly
NCT Number: NCT06489834
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Quality of Life|Depression|Sleep|Blood Pressure|Grip
Interventions: OTHER: Group Drumming
Sponsor: KK Women's and Children's Hospital
Collaborators: Lions Befriender|Toteboard|Institute of Mental Health, Singapore|National University of Singapore
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-07-01
Completion Date: 2026-06-30

Summary:
The study seeks to examine the effects that recreational group drumming has on the health of the community- dwelling elderly. It is hypothesized that it has positive and sustainable effects on various health outcome measures.

Primary Outcome Measures: Health related quality of life, European Quality of Life-5 Dimensions (EQ5D) Will be measured. The score ranges from 0 (death) to 1 (full health), with 5 dimensions comprising of mobility, self-care, usual activities, pain/discomfort and anxiety/ depression., 12 weeks|Depression, Geriatric Depression Scores will be measured. Scores will range from 0-15. Those will lower scores will have higher risk of depression, 12 weeks|Sleep Quality, Pittsburg Sleep quality index will be used to measure this outcome, 12 weeks
Secondary Outcome Measures: Psychological effects, Mini Mental State Examination (MMSE)will be measured. A score of less than 25 out of maximum of 30 is often suggestive of an underlying cognitive impairment., 12 weeks|Resting Blood Pressure, Resting Blood pressure will be measured at baseline and at 12 weeks. Both systolic and diastolic pressure would be captured in mmHg, 12 weeks|Heart Rate, Resting Heart Rate will be measured at baseline and at 12 weeks. This would be in beats/minute, 12 weeks
STereotactic Body Radiotherapy (SBRT) for Oligoprogressive Breast Cancer
NCT Number: NCT06489821
Acronym: STAR-B
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Metastatic Breast Cancer|Oligoprogression
Interventions: RADIATION: Stereotactic body radiotherapy
Sponsor: Juravinski Cancer Center
Collaborators: Juravinski Cancer Centre Foundation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 36
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2027-12-31

Summary:
Recent advances in systemic therapy have facilitated improved progression-free survival (PFS) and treatment tolerability in metastatic breast cancer patients (MBC). Oligoprogression (OP) refers to progression limited to five or fewer sites in otherwise controlled systemic disease on a drug therapy. Stereotactic body radiotherapy (SBRT) has the potential to locally ablate resistant OP lesions that develop on a systemic treatment, and may consequently delay the need for change in drug therapy, delay time to chemotherapy and prolong PFS. This is a phase II trial of SBRT plus continuation of current systemic therapy line for OP MBC patients, to determine rate of delay of change in systemic therapy of at six months. PFS, time to chemotherapy and quality of life will also be assessed.

Primary Outcome Measures: Percentage of patients with change in systemic therapy, Change in systemic therapy will occur with progression with the following criteria:

1. Progression not amenable to further SBRT, including multifocal (\>3) sites;
2. Progression in lesion not amenable to further SBRT;
3. Rapid progression such that treating medical oncologist believes change in therapy is warranted;
4. Progression in location including, including visceral metastasis, such that treating medical oncologist believes change in therapy is warranted, Six months
Secondary Outcome Measures: Progression-free survival, Progression outside radiotherapy field per RECIST 1.1, 3, 6, 12, 18, and 24 months|Local progression, Progression within a treated lesion per RECIST 1.1, 3, 6, 12, 18, and 24 months|Time to chemotherapy, Initiation of cytotoxic therapy, 3, 6, 12, 18, and 24 months|Overall Survival, Proportion of patients alive, 3, 6, 12, 18, and 24 months|CTCAE Toxicity, common terminology criteria for adverse events 5.0, 3, 6, 12, 18, and 24 months