pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Deep Learning With MRI-based Multimodal-data Fusion Enhanced Postoperative Risk Stratification of Breast Cancer
NCT Number: NCT06546072
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Breast Cancer
Interventions: OTHER: MRI
Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 1199
Study Design: Observational Model: |Time Perspective: p
Start Date: 2011-03-23
Completion Date: 2021-12-06

Summary:
Breast cancer poses a significant global health challenge, especially among women, with high rates of recurrence and distant spread despite early interventions. The timely identification of metastasis risk and accurate prediction of treatment strategies are critical for improving prognosis. However, the complex heterogeneity of breast tumors presents challenges in precise prognosis prediction. Therefore, the development of innovative methods for tumor segmentation and prognosis assessment is essential.

The research conducted is a multicenter study that enrolled 1,199 non-metastatic breast cancer patients from four independent centers. Our study leverages the advancements in artificial intelligence (AI) to address this challenge. This study is the first successful application of MRI-based multimodal prediction system to precisely identify the risk of postoperative recurrence in breast cancer patients.

Primary Outcome Measures: DFS, Disease-free survival, The time from surgery to tumor recurrence, including local and/or distant recurrence, disease progression, or death, assessed up to 100 months.
Gasdermin D Expression in Generalized Vitiligo Patients After Narrow-band Ultraviolet B Therapy
NCT Number: NCT06546059
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Vitiligo, Generalized
Interventions: DEVICE: narrow band ultraviolet-B
Sponsor: South Valley University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2024-11

Summary:
The aim of this study is to:

1. Evaluate the role of tissue Gasdermin D expression using immunehistochemstry techniques in patients with generalized vitiligo and compare it with healthy controls.
2. Evaluation expression of tissue Gasdermin D using immunehistochemstry techniques in patients with generalized vitiligo after narrow band ultraviolet B therapy.
3. Determine whether there is a relationship between Gasdermin D levels and disease duration and involved body surface area (VISA) in vitiligo patients.

Primary Outcome Measures: Evaluate the role of tissue Gasdermin D expression using immunehistochemstry techniques in patients with generalized vitiligo and compare it with healthy controls., 1- Evaluate the role of tissue Gasdermin D expression using immunehistochemstry techniques in patients with generalized vitiligo and compare it with healthy controls.techniques in patients with generalized vitiligo and compare it with healthy controls., three months
Secondary Outcome Measures: 2- Evaluation expression of tissue Gasdermin D using immunehistochemstry techniques in patients with generalized vitiligo after narrow band ultraviolet B therapy., 2- Evaluation expression of tissue Gasdermin D using immunehistochemstry techniques in patients with generalized vitiligo after narrow band ultraviolet B therapy., three months|3- Determine whether there is a correlation between tissue immunehistochemstry Gasdermin D levels and disease duration and involved body surface area (VISA) in vitiligo patients., 3- Determine whether there is a correlation between tissue immunehistochemstry D levels and disease duration and involved body surface area (VISA) in vitiligo patients., three months
Analysis of the Efficacy and Stability of a Wearable ECG Monitor
NCT Number: NCT06546046
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Arrhythmias, Cardiac|Bradycardia|Tachycardia|Atrial Fibrillation|Atrial Flutter|Ventricular Premature Complexes
Interventions: DEVICE: ECG monitoring by telemetry device and patch-type ECG monitor at the same time
Sponsor: Mezoo Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SCREENING
Start Date: 2024-09-09
Completion Date: 2025-03-30

Summary:
This study aims to analyze the efficacy and safety of wearable electrocardiogram (ECG) monitoring by simultaneously attaching a single-channel patch-type wearable ECG monitoring device (HiCardi+ by Mezoo Co., Ltd.) and a telemetry device (IntelliVue MX40 by Philips) used in actual wards to patients prescribed with ECG monitoring

Primary Outcome Measures: The number of total QRS complex, Number of total QRS complex is compared based on the data obtained simultaneously from two devices., Within 3 months after electrocardiogram monitoring procedure|The rate of signal loss, Rate of signal loss is compared based on the data obtained simultaneously from two devices., Within 3 months after electrocardiogram monitoring procedure
Secondary Outcome Measures: Average heart rate, Average heart rate is compared based on the data obtained simultaneously from two devices., Within 3 months after electrocardiogram monitoring procedure|The number of arrhythmia and technical alarm, Number of arrhythmia and technical alarm is compared based on the data obtained simultaneously from two devices., Within 3 months after electrocardiogram monitoring procedure|Results of satisfaction survey, Satisfaction survey responses from the medical staff, Within 3 months after electrocardiogram monitoring procedure
Intermittent Fasting and Mediterranean Diet in Patient With Multiple Sclerosis
NCT Number: NCT06546033
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Multiple Sclerosis|Intermittent Fasting
Interventions: OTHER: application of different types of diet
Sponsor: Nigde Omer Halisdemir University
Collaborators: Acibadem University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 34
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-02
Completion Date: 2026-12-02
Locations: Nigde Omer Halisdemir University, Nigde, Bor, 51200, Turkey

Summary:
When the literature was reviewed, there is no study in which the effects of intermittent fasting and Mediterranean diet on quality of life, sleep, circadian rhythm and appetite hormones leptin and ghrelin levels in MS patients were evaluated and the two diet types were comparatively examined in terms of all these parameters.

Primary Outcome Measures: Biochemical parameter, Hemogram values of the group 1 and group 2 patients with multiple sclerosis participating in the study will be compare., baseline- 3 months
Secondary Outcome Measures: The Morning and Evening Questionnaire, The Morning and Evening Questionnaire was developed by Horne and Ostberg in 1975. The Turkish validity and reliability scale has 19 questions and is unidimensional. It is a 5-point Likert type (1=absolutely morning person-5=absolutely evening person) and the score that can be obtained from the scale varies between 0 and 86. Each score to be taken from the scale remains in different score ranges. This represents a different personality trait., baseline- 3 months|Pittsburgh Sleep Quality Index, Pittsburgh Sleep Quality Index (PSQI) was developed by Buysse et al. The scale, which was developed by Buysse et al. and its Turkish validity and reliability was performed, consists of 18 self-report questions and measures the sleep quality of the individual in the last 4 weeks. PDQI has 7 components. Each of these components is scored between 0-3. A minimum score of 0 and a maximum score of 21 is obtained from the scale. A total score of 5 and above indicates poor sleep quality., baseline- 3 months|Multiple Sclerosis Quality of Life-MuSiQoL, Multiple Sclerosis Quality of Life-MuSiQoL scale was developed by Vickrey et al. in 1995 to evaluate the quality of life of MS patients. The original version consists of 74 questions and there is also a short form consisting of 31 questions. MuSiQoL consists of a total of 9 subgroups including activities of daily living, psychological status, findings, friendships, family relationships, emotional and sexual life, acceptance, coping with the disease and satisfaction with health services. During the assessments, individuals are asked to answer by taking into account their situation in the last 4 weeks. They are asked to tick the option that best expresses themselves from the options of never (0: Never), rarely (1: Occasionally), sometimes (2: Some), frequently (3: Very) and always (4: Very much). Turkish validity and reliability studies were conducted., baseline- 3 months
Rarecells Molecular Biomarkers for Early Detection of Lung Cancer
NCT Number: NCT06546007
Acronym: BioMolCTC
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Lung Cancer|Pulmonary Neoplasm
Interventions: DIAGNOSTIC_TEST: CTC-DNA
Sponsor: Rarecells Diagnostics SAS
Collaborators: Meditrial USA Inc.|Meditrial Europe Ltd.|Meditrial SrL
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-11-01
Completion Date: 2025-10-01
Locations: Università Cattolica del Sacro Cuore Gemelli Hospital, Roma, Italy

Summary:
Early diagnosis of these cancers is a public health priority. Additionally, early detection of recurrences after treatment is crucial for optimizing disease management.

This study seeks to demonstrate the accuracy of the Rarecells ISET® circulating tumor cells DNA (CTC-DNA), combined with circulating tumor DNA (ctDNA), for the early diagnosis of lung cancer.

Primary Outcome Measures: Sensitivity of CTC-DNA, Comparatively evaluate the sensitivity of CTC-DNA with the ISET® method and ctDNA for the analysis of lung cancer mutations in patients with operable tumors., 30 days post procedure
Secondary Outcome Measures: Performance of CTC-DNA, To evaluate the performance of CTC-DNA obtained with the ISET® method in different histological subtypes of operable lung cancer., 30 days post procedure
A Prospective Cohort Study on the Serum Kisspeptin Levels Throughout Pregnancy in PCOS
NCT Number: NCT06545994
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Polycystic Ovary Syndrome|Pregnancy Complications
Interventions: OTHER: Observation
Sponsor: Fudan University
Sex: FEMALE
Age: ADULT
Enrollment: 180
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-28
Completion Date: 2026-06-30
Locations: OB & GYN Hospital of Fudan University, Shanghai, Shanghai, 200011, China

Summary:
The current study aims to investigate the dynamic serum kisspeptin levels throughout pregnancy and to explore its predictive value for GDM in PCOS.

Primary Outcome Measures: Dynamic changes of serum kisspeptin levels throughout pregnancy in PCOS patients, Serum kisspeptin levels in the first, second trimester and late pregnancy of PCOS patients and control group., 40 weeks
Secondary Outcome Measures: The association between serum Kisspeptin levels and the prevalence of GDM in PCOS patients, The predictive value of serum Kisspeptin levels in the first trimester for GDM in PCOS patients, 40 weeks|The association between serum Kisspeptin levels and the prevalence of insulin resistance in PCOS patients, The predictive value of serum Kisspeptin levels in the first trimester for insulin resistance in PCOS patients, 40 weeks
A Social Media Intervention to Improve Retention in Care for Adolescents and Young Adults With HIV in Uganda
NCT Number: NCT06545968
Acronym: REMAIN
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Adolescent Behavior
Interventions: BEHAVIORAL: A social media based intervention
Sponsor: Mbarara University of Science and Technology
Collaborators: Fogarty International Center of the National Institute of Health
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 105
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08-30
Completion Date: 2028-01-30
Locations: Mbarara University of Science and Technology, Mbarara, Uganda

Summary:
Adolescents and young adults with HIV (AYWH) aged 15- 24 years are the fastest-growing population of people living with HIV worldwide. AYWH have worse outcomes along the HIV continuum of care than adults with HIV; HIV/AIDS is the second leading cause of mortality and the fourth leading cause of disability among AYWH worldwide. This study will develop a youth-friendly, mobile health (mHealth) intervention to improve retention in care that has the potential to improve AIDS-related mortality and morbidity among AYWH and decrease onward new transmission, thus contributing towards ending the HIV/AIDS pandemic.

Primary Outcome Measures: The primary intervention outcome will be the acceptability, feasibility of the intervention., Acceptability will be measured using the Acceptability of Intervention Measure (AIM) and will be considered acceptable if ≥70% (35/50) of intervention participants rate all 4 items on the AIM (a 5-point Likert scale) as "agree" or higher.

The intervention will be considered feasible if ≥70% (35/50) of intervention participants rate all 4 items on the Feasibility of Intervention Measure (FIM), (a 5-point Likert scale) as "agree" or higher., 12 months
Secondary Outcome Measures: Retention, The secondary outcome of the intervention will be retention in care, which will be assessed at the end of 12 months. This will be defined as the proportion of participants active in care (i.e have not missed a scheduled appointment in the last 12 months) The investigators will compare the proportion of participants actively engaged in care in the immediate intervention and the deferred intervention arm., 12 months
A Trial to Evaluate Intravesical Nadofaragene Firadenovec Alone or in Combination With Chemotherapy or Immunotherapy in Participants With High-grade BCG Unresponsive Non-muscle Invasive Bladder Cancer
NCT Number: NCT06545955
Acronym: ABLE-22
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Non-muscle Invasive Bladder Cancer With Carcinoma in Situ
Interventions: DRUG: Nadofaragene Firadenovec|DRUG: Gemcitabine|DRUG: Docetaxel|DRUG: Pembrolizumab
Sponsor: Ferring Pharmaceuticals
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-31
Completion Date: 2028-07-30

Summary:
The pivotal phase 3 trial (rAd-IFN-CS 003) evaluating the efficacy of nadofaragene firadenovec showed that 55 (53.4%) of 103 subjects with CIS ± high-grade Ta/T1 achieved a complete response (CR) at 3 months. In this trial, the safety and efficacy of intravesical instillation of nadofaragene firadenovec alone or in combination with chemotherapy or immunotherapy will be evaluated in participants with NMIBC CIS (± high-grade Ta/T1).

Primary Outcome Measures: Complete response, Complete response (defined as absence of low- and high-grade disease) achieved at month 3 and that is followed by absence of high-grade disease recurrence up to and including month 12, up to 12 months
Secondary Outcome Measures: Durability of complete response, Durability of complete response (defined as time from achieved CR to high-grade disease recurrence, progression or death) and assessed after first achieved CR, Up to 21 months|Muscle-invasive progression of disease, Muscle-invasive progression of disease (defined as time from first treatment to first evidence of muscle-invasive disease or death), up to 36 months|Cystectomy-free survival, Cystectomy-free survival (defined as time from first treatment to either cystectomy or death due to any cause), up to 36 months|Pathological staging, Pathological staging (tumor, node, metastasis staging system) in subjects at time of cystectomy, up to 36 months|Overall survival, Overall survival (defined as time from first treatment to death), up to 36 months|Adverse events, Adverse events collected for nadofaragene firadenovec in combination with chemotherapy (gemcitabine and docetaxel) or immunotherapy (pembrolizumab), up to 36 months
Study of Sunobinop on Craving in Alcohol Use Disorder
NCT Number: NCT06545929
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Alcohol Use Disorder
Interventions: DRUG: Sunobinop|DRUG: Placebo to match sunobinop
Sponsor: Imbrium Therapeutics
Collaborators: Purdue Pharma LP
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2025-07

Summary:
The purpose of this study is to evaluate the efficacy of sunobinop compared to placebo on alcohol craving in subjects with moderate to severe alcohol use disorder and these subjects are seeking treatment.

Primary Outcome Measures: Alcohol Urge Questionnaire (AUQ), The questionnaire consists of 8 items; each with 7-item scale in which 1= "strongly disagree" and 7 = "strongly agree"., Day 14
Secondary Outcome Measures: Desire for Alcohol Visual Analog Scale (DFA-VAS), The scale consists of 1 item with 10-point scale in which 0 = "not at all" and 10 = "extremely high", Day 14
Study of Sunobinop on Alcohol Consumption in Alcohol Use Disorder
NCT Number: NCT06545916
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Alcohol Use Disorder
Interventions: DRUG: Sunobinop|DRUG: Placebo to match sunobinop
Sponsor: Imbrium Therapeutics
Collaborators: Purdue Pharma LP
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2025-07

Summary:
The purpose of this study is to evaluate the efficacy of sunobinop compared to placebo on alcohol consumption in subjects with alcohol use disorder.

Primary Outcome Measures: Percent heavy drinking days (HDD), Day 57
Secondary Outcome Measures: Number of standard unit drinks, Day 57|Percent of drinking days (PDD), Day 57
Supraglottic Airways for Entrapped Trauma Patients
NCT Number: NCT06545903
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Airway Obstruction
Interventions: DEVICE: LMA Supreme|DEVICE: SLIPA|DEVICE: I-gel|DEVICE: AuraGain
Sponsor: Uniwersytet Radomski im. Kazimierza Pułaskiego
Sex: ALL
Age: ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2024-12-31
Locations: University of Radom, Radom, Mazowieckie, 26-600, Poland

Summary:
The aim of this clinical trial is to evaluate four supraglottic airway devices for ventilation in a simulated condition of an entrapped trauma patient with simultaneous cervical spine immobilisation. All the studied devices are evaluated by fully-qualified and experienced paramedics (both male and female). The main questions it aims to answer are:

1. Which device requires the shortest time required to achieve a successful ventilation?
2. What is the first attempt success rate of the studied devices?
3. Which device is the easiest to use and the most user-friendly? Study participants will evaluate four different supraglottic devices in a restricted access to the entrapped trauma patient's airway. The maximum number of insertion attempts is limited to three per device.

Primary Outcome Measures: Successful ventilation time, The time required to insert the device and achieve a successful ventilation, During procedure: 120 seconds
Secondary Outcome Measures: First attempt success rate of ventilation, The efficacy of an evaluated supraglottic airway device, During procedure: 120 seconds|The ease of use and user-friendliness, Device evaluation using the numerical rating scale (NRS). It is an 11-point scale where 0 corresponded to a very difficult to use device and 10 indicated an easy to use and user-friendly device., During procedure: 120 seconds
Ketofol Versus Dexmedetomidine for Prevention of Emergence Delirium in Pediatric Patients Undergoing Squint Surgeries
NCT Number: NCT06545890
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Emergence Delirium
Interventions: DRUG: Ketamine|DRUG: Dexmedetomidine
Sponsor: Cairo University
Sex: ALL
Age: CHILD
Enrollment: 46
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-08-10
Completion Date: 2024-11-10
Locations: Abu Elresh Hospitals ( Cairo university ), Cairo, Egypt|Abu ElResh hospital, Cairo, Egypt

Summary:
The aim of the study is to compare the effectiveness of ketofol for the prevention of emergence delirium in pediatric patients undergoing squint surgery, in comparison to dexmedetomidine.

Primary Outcome Measures: The incidence of postoperative ED using PAED scale at time of admission to PACU in both groups., During their stay at PACU, delirium will be assessed at 5, 10, 15, 20, 25, and 30 minutes following extubation via the Pediatric Anesthesia Emergence Delirium scale (PAED) . ED will be established when the child have a score of 10 or more. If the child has a score of 10 or more, rescue sedation will be done via propofol 1 mg/kg ., PAED score immediately after admission to PACU .
REKOVELLE PEN for S.C. Injection General Drug Use Survey (Controlled Ovarian Stimulation in Assisted Reproductive Technologies)
NCT Number: NCT06545877
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Infertility
Sponsor: Ferring Pharmaceuticals
Sex: FEMALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-09-16
Completion Date: 2029-06-22
Locations: Ferring Investigational Site, Omitama, Ibaraki, Japan

Summary:
This survey targets controlled ovarian stimulation with this drug for the development of multiple oocytes in women undergoing assisted reproduction (ART) such as in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI).

Primary Outcome Measures: Adverse Events, Frequency of Adverse Events, From initiation of the administration, in case of embryo transfer is not performed, until 1 week after oocyte collection, and in case embryo transfer is performed, 6 weeks after embryo transfer
Systemic Thrombolysis Versus Catheter Directed Management for Acute Intermediate-high Pulmonary Embolism
NCT Number: NCT06545864
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Acute Pulmonary Embolism
Interventions: DRUG: Streptokinase Injection|DEVICE: Penumbra System
Sponsor: Assiut University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-01
Completion Date: 2030-03-01
Locations: Hospital University, Assiut, Egypt

Summary:
To compare in hospital clinical outcomes and one month follow up of systemic thrombolysis versus catheter directed management for the treatment of acute intermediate- high risk pulmonary embolism (using streptokinase or tissue plasminogen activator (TPA) and catheter-based intervention group using Penumbra System).

Primary Outcome Measures: Change in blood pressure, during hospital stay (about 1 week) and one month after discharge|Change in heart rate, during hospital stay (about 1 week) and one month after discharge|Change in respiratory rate, during hospital stay (about 1 week) and one month after discharge|Change of O2 saturation., during hospital stay (about 1 week)|Change of RV signs of PE by Transthoracic echocardiography, during hospital stay (about 1 week) and one month after discharge|Need for mechanical ventilation., during hospital stay (about 1 week)|Need for surgical intervention., surgical embolectomy, during hospital stay (about 1 week)|Duration of hospital stay., during hospital stay (about 1 week)
Secondary Outcome Measures: incidence of Perforation of pulmonary artery, may occur during catheter directed interventions, during hospital stay (about 1 week)|incidence of pericardial effusion, due to: infection cardiac perforation during catheter directed interventions, during hospital stay (about 1 week) and one month after discharge|incidence of Major bleeding, that requires blood transfusions or urgent intervention, during hospital stay (about 1 week) and one month after discharge
Construction of a Cohort for Pan-Vascular Disease Among Employees of Taizhou People's Hospital
NCT Number: NCT06545799
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cardiovascular Death|Myocardial Infarction|Stroke
Sponsor: Jiangsu Taizhou People's Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2034-09-01

Summary:
1. Participant Recruitment During the annual health check-ups for hospital staff, potential participants are recruited. Those who express interest are provided with a detailed explanation of the study's objectives, content, and procedures, and are required to sign an informed consent form.
2. Screening Phase Medical history is collected, including any previous occurrences of myocardial infarction, ischemic or hemorrhagic stroke, or history of coronary, carotid, or peripheral arterial revascularization.
3. Baseline Data Collection

1. Health Questionnaire Survey: Collect demographic information, medical history, and data on nutrition, physical activity, and smoking habits through a questionnaire.

2. Clinical Assessments: Conduct the following assessments for all enrolled participants:

* High-sensitivity cardiac troponin I and NT-proBNP testing
* Non-invasive arterial stiffness testing
* Measurement of visceral and subcutaneous fat content
* Fundus photography
* Body composition analysis

  4 Regular Follow-Up

Annual follow-up for a total of 10 years. The follow-up includes:

1. . Collection of updated demographic information and medical history, as well as repeated questionnaires on nutrition, physical activity, and smoking habits.
2. . Reassessment of the following items:

   * High-sensitivity cardiac troponin I and NT-proBNP testing
   * Non-invasive arterial stiffness testing
   * Measurement of visceral and subcutaneous fat content
   * Fundus photography
   * Body composition analysis

     5 Outcome Evaluation

1）. Primary Outcomes: Cardiovascular mortality, non-fatal myocardial infarction, or non-fatal stroke events.

2）. Secondary Outcomes: All vascular events, changes in cardiovascular biomarkers, and degree of arterial stiffness.

Primary Outcome Measures: Cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke events, Cardiovascular death: Death from heart or blood vessel diseases.

Non-fatal myocardial infarction: Heart attack that does not result in death.

Non-fatal stroke events: Stroke incidents that do not result in death., September 2024 to August 2034
Postoperative Pain After Conservative Root Canal Preparation
NCT Number: NCT06545773
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Periapical Diseases|Periapical Periodontitis|Postoperative Pain|Pulp Necroses|Flare Up, Symptom
Interventions: PROCEDURE: Root Canal Treatment with ProTaper Next Nickel-Titanium File (PTN)|PROCEDURE: Root Canal Treatment withTruNatomy Nickel-Titanium File (TN)
Sponsor: Istanbul University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-03-04
Completion Date: 2024-11-15
Locations: Istanbul University Faculty of Dentistry, Istanbul, Fatih, Turkey

Summary:
The goal of this clinical trial is to compare the pain experienced by healthy participants after root canal treatment with small versus large root canal sizes.

The main questions it aims to answer are:

1. Do small and large root canal sizes cause different pain levels?
2. What is the number of painkiller pills taken by each participant?
3. Does small root canal size cause severe pain and facial swelling?

The researcher will perform root canal treatment on lower molar teeth. The researcher will ask about the pain level, painkiller pill number, and swelling on the 6th,12th, 24th, 48th, 72nd hours, and 7th day after the treatment.

Primary Outcome Measures: Postoperative pain, Pain after root canal treatment will be assessed via the Numerical Rating System (NRS) at the 6th, 12th, 24th, 48th, and 72nd hours and on the 7th day. In the NRS, pain is evaluated by numbers from 0 to 10. A score of minimum means no pain, and a score of maximum 10 means the worst pain imaginable., 7 days
Secondary Outcome Measures: Analgesic intake, Number of painkiller pills will be asked at 6th, 12th, 24th, 48th and 72nd hours and 7th day., 7 days|Flare-up, Presence of Flare-ups will be determined according to swelling and severe pain., 7 days.
Adaptive Hypofractionated Radiotherapy for Locally Advanced NSCLC Based on Dynamic Enhanced MRI
NCT Number: NCT06545747
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Non-small Cell Lung Cancer
Interventions: RADIATION: DCE-MRI based split-course hypo-RT|RADIATION: CT based split-course hypo-RT|DRUG: Concurrent chemotherapy|DRUG: Consolidative immunotherapy
Sponsor: Sun Yat-sen University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 304
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-01-01
Completion Date: 2027-12-31
Locations: Sun Yat-sen University Cancer Center, Guangzhou, China

Summary:
This study is a randomized phase III trial that aiming to investigate the role of dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) guided hypofractionated radiotherapy (hypo-RT) in patients with locally advanced non-small cell lung cancer (LA-NSCLC) who are planned to receive hypo-RT combined with concurrent chemotherapy and consolidative immunotherapy. Patients will be randomized in a 1:1 ratio into two groups:

1. The study group will undergo adaptive dose-painting hypo-RT based on DCE-MRI.
2. The control group will undergo hypo-RT based on enhanced CT.

The treatment-related toxicity, local control and long-term survival will be evaluated compared between MRI-guided and CT-guided hypo-RT.

Primary Outcome Measures: treatment-related G2+ respiratory toxicity, the percentage of patients who developed G2+ respiratory toxicity, including pneumonitis and proximal bronchial tree toxicity, Recorded from the enrollment to 1 year after the completion of hypo-RT or 3 months after the completion of consolidative immunotherapy
Secondary Outcome Measures: progression-free survival rate, 2-year|local control rate, 2-year|overall survival rate, 2-year|patient reported outcome assessed by QLQ-C30, assessed by QLQ-C30, 2 year|patient reported outcome, assessed by QLQ-LC13 questionnaires, 2 year
Music Perception in SeLECTs
NCT Number: NCT06545708
Acronym: EpiMUS
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Rolandic Epilepsy
Interventions: OTHER: Patients
Sponsor: Hospices Civils de Lyon
Sex: ALL
Age: CHILD
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08
Completion Date: 2026-08
Locations: Centre Hospitalier Le Vinatier (Bât. 452),, Bron, 69500, France|Hospices Civils de Lyon, Bron, 69500, France

Summary:
Self-limited epilepsy with centrotemporal spikes (SeLECTS) is the most frequent epilepsy syndrome in children between the ages of 4 and 13 years. SeLECTS is associated in 15 to 30% of patients with specific cognitive deficits, including in particular disorders in language, visuo-spatial memory, declarative memory, and attention. SeLECTS has the potential to evolve into Landau-Kleffner syndrome, the most extreme form of SeLECTS including symptoms of auditory agnosia and aphasia, with potential risks of persistent neuropsychological impairments. In a recent study in adults who had suffered Landau-Kleffner syndrome during childhood, the investigators have shown that these patients, in addition to their known deficit in verbal short-term memory, also exhibit persistent musical difficulties during adulthood, with in particular deficit in melody and rhythm short-term memory.

In the present project, the investigators intend to enlarge the understanding of cognitive deficits generated by SeLECTS in children by investigating the integrity of music perception, both for melody and rhythm. To date, data about music perception in children with epilepsy are scarce and we do not know how distinct components of melody and rhythm perception and memory may be altered.

Primary Outcome Measures: Performance obtained in melodic tasks, Comparison between controls and patients using Bayesian ANOVAs to the percentages of correct responses obtained with melodic tasks, 2 Years|Performance obtained in melodic tasks, Comparison between controls and patients using Bayesian ANOVAs to response times obtained with melodic tasks;, 2 Years|Performance obtained in rhythmic tasks, Comparison between controls and patients using Bayesian ANOVAs to the percentages of correct responses obtained with rhythmic tasks, 2 Years|Performance obtained in rhythmic tasks, Comparison between controls and patients using Bayesian ANOVAs to response times obtained with rhythmic tasks., 2 Years
Epidermal Growth Factor Receptor Inhibition for Keratinopathies
NCT Number: NCT06545695
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Epidermolytic Ichthyosis|Palmoplantar Keratoderma|Pachyonychia Congenita
Interventions: DRUG: Erlotinib
Sponsor: Northwestern University
Collaborators: Yale University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 44
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-12-01
Completion Date: 2029-06-30
Locations: Department of Dermatology, Northwestern University Feinberg School of Medicine, Chicago, Illinois, 60611, United States

Summary:
Epidermal growth factor receptor (EGFR) signaling plays a key role in regulating epidermal cell proliferation, survival, and differentiation. Keratins form a scaffold with epidermal desmosomes that involves ErbB/ EGFR signaling and keratin deficiency makes keratinocytes more sensitive to EGFR activation. Erlotinib, an EGFR inhibitor, was approved 20 years ago for cancer treatment and is generally used at 150 mg daily in adults \>50 kg. While gastrointestinal and cutaneous side effects commonly occur at doses of 150 mg, adverse events occur less often at lower doses. We first reported erlotinib as effective for Olmsted syndrome, a rare hereditary EDD with painful PPK that results from variants in TRPV3. Erlotinib is now the treatment of choice for children and adults with Olmsted syndrome. Erlotinib is thought to inhibit formation of a complex that includes TRPV3, EGFR, and its primary skin-based ligand, TGF-a, which in turn regulates keratinocyte proliferation and differentiation. High-throughput screening to identify compounds that stabilize keratin filaments have also pointed to the EGFR pathway for targeting. Reviews and recent case reports have suggested the benefit of erlotinib for PC,

Given these preliminary data, we hypothesize that EGFR activation is a characteristic feature of keratinopathies. Further, we expect that oral low-dose erlotinib will improve the scaling and skin thickening of the spectrum of keratinopathies and be tolerated by most patients. For those who experience pain, particularly from plantar involvement, we predict that erlotinib therapy will improve mobility and pain. Finally, we aim to find the mechanism by which erlotinib improves the phenotypes of the various keratinopathies to better understand these disorders and predict response. We will look specifically at the impact on differentiation vs. hyperproliferation and barrier function, as well as the immune modulatory effects of the erlotinib using a multi-omics approach.

Primary Outcome Measures: Reduction in Investigator Global Assessment (IGA), Reduction in IGA score from baseline to week 24 of at least 50%. The Investigator Global Assessment/IGA will be the primary efficacy analysis, using the strata of clear 0, mild 1, moderate 2, severe 3, and very severe 4., 24 weeks|Percentage of Grade 3 and 4 Adverse Events, The percentage of participants with Grade 3 and 4 events, based on the current Common Toxicity Criteria for Adverse Events (CTCAE) listing, 24 weeks
Phase Ib Study of AlpeliSib With PEmbroLizumab in Patients With mEtastatic Breast caNcer or melanomA (SELENA)
NCT Number: NCT06545682
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Myelodysplastic Syndrome(MDS)|Acute Myelogenous Leukemia (AML)
Interventions: DRUG: Alpelisib + Pembrolizumab
Sponsor: M.D. Anderson Cancer Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-12-01
Completion Date: 2029-08-03
Locations: MD Anderson Cancer Center, Houston, Texas, 77030, United States

Summary:
To find a recommended dose of the combination of alpelisib and pembrolizumab that can be given to patients with metastatic breast cancer or melanoma.

Primary Outcome Measures: Adverse Events, Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0, Through study completion; an average of 1 year.
Daily Doxycycline to Inform Sexually Transmitted Infection Prophylaxis Regimens
NCT Number: NCT06545656
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Sexually Transmitted Infection
Interventions: DRUG: Doxycycline
Sponsor: Emory University
Collaborators: Centers for Disease Control and Prevention
Sex: ALL
Age: ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-09
Completion Date: 2025-09
Locations: Hope Clinic, Atlanta, Georgia, 30322, United States

Summary:
The goal of this project is to collect data regarding the concentrations of doxycycline in mucosal tissues after daily dosing for 7 days in people assigned male sex at birth (AMAB) and assigned female sex at birth (AFAB) to inform future studies of doxycycline to protect against bacterial sexually transmitted infections (STIs).

Primary Outcome Measures: Doxycycline Concentration in Rectal Tissue, Rectal tissue doxycycline concentrations collected 24 hours after 7 daily (T7) doses of 100 mg of doxycycline will be determined in AMAB participants., 24 hours after last dose (Hour 24/Day 1)|Doxycycline Concentration in Vaginal Tissue, Vaginal tissue doxycycline concentrations collected 24 hours after 7 daily (T7) doses of 100 mg of doxycycline will be determined in AFAB participants., 24 hours after last dose (Hour 24/Day 1)
Tumor Antigen-sensitized DC Vaccine for Colorectal Cancer Liver Metastases
NCT Number: NCT06545630
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Carcinoma|Colorectal Cancer
Interventions: BIOLOGICAL: Tumor antigen-sensitized DC vaccine
Sponsor: West China Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-11-01
Completion Date: 2026-05
Locations: Colorectal Cancer Center, West China Hospital, Chengdu, Chengdu/Sichuan, 610000, China

Summary:
The aim of this study is to explore the safety and efficacy of tumor antigen-sensitized DC vaccine in postoperative adjuvant treatment of R0 excision Colorectal Cancer Liver Metastases.

Primary Outcome Measures: Disease-free Survival, Time from assignment to treatment arm until a recurrence or progression of the disease, Up to 18 months
Secondary Outcome Measures: Adverse Events Related to Treatment, Rate of Adverse Events (AEs) related to the niraparib and dostarlimab combination per CTCAE v5.0, Up to 12 months|Overall Survival (OS), Time from assignment to treatment arm until death due to any cause, Up to 36 months|Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, Adverse events (AE) will be graded and documented according to NCI-CTC AE v4.0 from the beginning of treatment to 1 months after the last date of treatment. Documentary will include severity, lasting period and occurrence time. Main AEs include hypertension, albuminuria, skin reaction of hands and feet, hemorrhage, dysphonia, transaminase rise, abdominal pain / abdominal discomfort, blood bilirubin rise, thyroid dysfunction, infection, diarrhea, fatigue / fatigue, appetite decline, oral mucositis, weight loss, fecal occult blood and platelet count decline, 1 month after the last administration of Tumor Antigen-sensitized DC Vaccine
Comprehensive Yoga Therapy Based Lifestyle Prehabilitation Program for Women With Ovarian Cancer
NCT Number: NCT06545604
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Ovarian Cancer
Interventions: OTHER: Yoga Therapy for Nutritional, Physical, and Psychosocial Prehabilitation
Sponsor: M.D. Anderson Cancer Center
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 44
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2025-01-01
Completion Date: 2027-06-30
Locations: MD Anderson Cancer Center, Houston, Texas, 77030, United States

Summary:
To provide a comprehensive yoga therapy (CYT) program to patients with ovarian, fallopian tube, or primary peritoneal cancer who are scheduled to receive chemotherapy and then undergo surgery. Researchers want to learn about the effects of the program on patients' quality of life and other outcomes described below.

Primary Outcome Measures: 1. safety and adverse events (AEs). Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0, Through study completion; an average of 1 year
Predictive Role of sTREM in Endovascular Thrombectomy Outcomes
NCT Number: NCT06545591
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Acute Ischemic Stroke
Sponsor: The Affiliated Hospital of Xuzhou Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2027-12-31
Locations: Department of Neurology, Xuzhou, Jiangsu, China

Summary:
Soluble triggering receptor expressed on myeloid cells (sTREM), which reflects microglia activation, has been reported closely associated with neuronal injury and neuroinflammation. This study is to investigatethe prognostic roles of sTREM (sTREM1 and sTREM2) in patients with ischemic stroke who underwent endovascular thrombectomy (EVT).

Primary Outcome Measures: Dynamic changes in plasma levels of sTREM-1 and sTREM-2 following Endovascular Therapy, Plasma levels of sTREM-1 and sTREM-2 will be quantified using the ELISA method., From baseline to immediately, 24 hours, 3 days, and 7 days after Endovascular Therapy
Secondary Outcome Measures: favourable functional outcome, defined as modified Rankin Scale (mRS) 0-2, mRS ranges from 0-6, high score means poor outcome, 90 days|excellent functional outcome, defined as modified Rankin Scale (mRS) 0-1, mRS ranges from 0-6, high score means poor outcome, 30 days|early neurological improvement, defined as 4 or more decrease in National Institute of Health stroke scale (NIHSS), NIHSS ranges from 0-22, with high score meaning severe neurological deficit., 24 hours|Hemorrhagic transformation, Hemorrhagic transformation was diagnosed by Computed tomographic scans usually performed 24 to 72 hours after the procedure.Symptomatic intracranial hemorrhage was defined as neurologic deterioration (an increase of 4 or more points in the score on the NIHSS) and evidence of intracranial hemorrhage on imaging studies., 72 hours
Efficacy and Safety of a Dietary Supplement on Hair Growth and Hair Health in Female With Acute Telogen Effluvium
NCT Number: NCT06545552
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Telogen Effluvium|Healthy
Interventions: DIETARY_SUPPLEMENT: An oral formulation of green tea extract, bamboo shoot extract and selenium-enriched yeast|DIETARY_SUPPLEMENT: Placebo
Sponsor: Activ'inside
Collaborators: Complife Italia Srl
Sex: FEMALE
Age: ADULT
Enrollment: 66
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-30
Completion Date: 2025-01-24

Summary:
The study is aimed to assess the efficacy of a food supplement in reducing hair loss and accelerating the physiological growth in terms of elongation in female subjects showing acute telogen effluvium. Moreover, the efficacy of the product in increasing hair elasticity, thickness and brightness will be assess.

In order to reach this goal a randomized, double-blind, placebo controlled, parallel group (2 arms), clinical trial is carried out on 66 healthy female subjects aged between 18 and 52 years old, showing acute telogen effluvium will be enrolled.

Primary Outcome Measures: Change in Anagen hair density, Number of hairs in anagen phase per cm² and proportion (in %) using phototricogram (TrichoScan), after 84 days of supplementation
Secondary Outcome Measures: Change in hair brightness, 8° gloss value (average value of 5 measures) using spectrophotometer/colorimeter CM 700D (Konica-Minolta)., after 42 and 84 days of supplementation|Change in hair elasticity, using a dynamometer (Tensolab 2512A, Mesdan Lab), after 42 and 84 days of supplementation|Change in hair volume, Using a 7-point scale administred by a dermatologist, after 42 and 84 days of supplementation|Change in hair loss, Number of extracted hairs using a pull test, after 42 and 84 days of supplementation|Change in Total Hair Density, Number of total hairs per cm² using phototricogram (TrichoScan), after 42 and 84 days of supplementation|Change in Telogene Hair Density, Number of hairs in telogen phase per cm² and proportion (in %) using phototricogram (TrichoScan), after 42 and 84 days of supplementation|Change in Anagen hair density, Number of hairs in anagen phase per cm² and proportion (in %) using phototricogram (TrichoScan), after 42 days of supplementation
Does Participation in a Fall Preparedness Program Improve Fall Efficacy Among Older Adults
NCT Number: NCT06545539
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Fall Injury|Fall|Falls (Accidents) in Old Age
Interventions: OTHER: Fall Preparedness Exercise Class
Sponsor: Youngstown State University
Collaborators: YMCA
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-08-01
Completion Date: 2026-12-31
Locations: YMCA, Boardman, Ohio, 44512, United States|Youngstown State University, Youngstown, Ohio, 44555-0001, United States

Summary:
The purpose of this study is to determine if a fall preparedness program can reduce the fear of falling in older adults and subsequently improve their function and reduce falls with injury.

Participants will perform baseline measures 4 weeks before intervention and again at the start of intervention. They will perform a 12-week intervention and then complete outcome measures again at the conclusion of the program.

Primary Outcome Measures: Fall Efficacy Scale International (FES-I), Measure of self reported fall efficacy, 4 weeks before start of intervention through completion of intervention; approximately 15 weeks
Secondary Outcome Measures: short physical performance battery (SPPB), measure of physical performance, 4 weeks before start of intervention through completion of intervention; approximately 15 weeks|Physical Activity Scale for the Elderly (PASE), Measure of self reported activity level in older adults, 4 weeks before start of intervention through completion of intervention; approximately 15 weeks
Other Outcome Measures: Six-item cognitive impairment test (6CIT), cognitive impairment test used to rule out participants, 4 weeks before start of intervention