pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Community Clinic Model to Improve Early Detection of Breast and Cervical Cancers in Kenya
NCT Number: NCT06572774
Acronym: C3Link
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breast Cancer|Cervical Cancer
Interventions: BEHAVIORAL: C3Link Strategies
Sponsor: Implenomics
Collaborators: Kenya Medical Research Institute|RTI International
Sex: FEMALE
Age: ADULT
Enrollment: 5400
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SCREENING
Start Date: 2024-09-03
Completion Date: 2028-01-31
Locations: Public Health Facilities in Machakos, Nyeri and Nakuru, Machakos, Kenya

Summary:
Kenya has a high incidence of breast and cervical cancers, and most women are diagnosed with late-stage disease. We will conduct a study to assess the effectiveness and cost-effectiveness of strategies to increase the uptake of cancer screening and completion of recommended diagnostic and treatment services. The findings can be used to design optimal approaches and plan investments in infrastructure to scale up implementation of breast and cervical cancer screening.

Primary Outcome Measures: Breast and cervical cancer screening, The primary endpoint is the proportion who complete both recommended breast and cervical cancer screenings at 24 months, 24 months
Secondary Outcome Measures: Follow-up diagnostic procedure, Proportion who complete recommended follow-up supplemental or diagnostic procedures (within 3 months of receiving follow-up referral), 24 months|Initiation of cancer treatment, Proportion who initiative cancer treatment (within 3 months of diagnosis), 24 months
A Combination of Antibiotics to Decrease Neonatal Morbidity and Mortality for Previable Threatened Labor
NCT Number: NCT06572761
Acronym: ECHEC-MAT
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Previable Labour With Intact Membranes
Interventions: DRUG: Combination of antibiotics|DEVICE: Emergency cerclage|DRUG: Vaginal progesterone
Sponsor: Assistance Publique - Hôpitaux de Paris
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 350
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2028-05
Locations: Centre Hospitalier Poissy-Saint Germain, Poissy, 78300, France

Summary:
The purpose of this study is to determine whether a combination of antibiotics (cephalosporin 3rd generation, clarithromycin, metronidazole) are effective to prolong pregnancies complicated with previable threatened labour with intact membranes.

Primary Outcome Measures: A perinatal composite outcome, * Late miscarriage
* Perinatal mortality
* Bronchodysplasia,
* Sepsis proven by blood culture,
* Intraventricular hemorrhage ≥3,
* Periventricular leukomalacia ≥2,
* Ulcero-necrotizing enterocolitis at stage ≥2 according to the Bell classification., Up to 24 weeks
Secondary Outcome Measures: Gestationnal age at delivery, * Gestationnal age at delivery ≥ 24 weeks of gestation (wg) 0/7, 28 wg0/7, 32 wg0/7, 34 wg0/7 et 37 wg0/7
* Latency period between randomisation and delivery (≥2 days, ≥7 days, ≥14 days et ≥28 days), 6 months|Maternal Morbidty, Chorioamniotitis, postpartum endometritis , sepsis proven par positive hemocultures, 6 months|Bacteriological, Acquisition of multi-resistant germs during childbirth, 6 months
Perioperative Immunotherapy for NSCLC (ECTOP-1030)
NCT Number: NCT06572722
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Lung Cancer
Interventions: DRUG: Atezolizumab|DRUG: Nivolumab|DRUG: Pembrolizumab
Sponsor: Fudan University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2029-09-01

Summary:
This trial is a randomized, multicenter, open label phase II clinical study. The main objective is to evaluate the efficacy of three perioperative immunotherapy modalities (atezolizumab adjuvant therapy, nivolumab neoadjuvant therapy, pembrolizumab neoadjuvant+adjuvant therapy) in early-stage resectable NSCLC patients. The enrolled patients are randomly assigned in a 1:1:1 ratio to receive relevant treatment in the three perioperative immunotherapy groups mentioned above, and undergoing short-term pathological efficacy evaluation and long-term prognosis follow-up after surgery.

Primary Outcome Measures: Disease-free survival, the time from randomisation to the date of first recurrence, occurrence of new primary lung cancer, or death from any cause, 2 years
Secondary Outcome Measures: Overall survival, the time from randomisation to the date of death from any cause, 2 years|Major pathological response, ≤10% residual viable tumor cells in the primary tumor and sampled lymph nodes, 2 years
Ultrasonographic Evaluation of Parasternal Intercostal Muscles in Stroke Patients
NCT Number: NCT06572709
Acronym: UEPIMSP
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Stroke|Respiratory Muscle
Interventions: DIAGNOSTIC_TEST: Parasternal intercostal muscle thickness with ultrasonography
Sponsor: Fatih Sultan Mehmet Training and Research Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-07
Completion Date: 2024-09-04
Locations: Istanbul Physıcal Therapy And Rehabılıtatıon Traınıng And Research Hospıtal, Istanbul, Turkey

Summary:
Ultrasonographic evaluation of parasternal intercostal muscles and to determine whether there is a correlation with PFT parameters in stroke patients

Primary Outcome Measures: Parasternal intercostal muscle thickness and thickening ratio, Parasternal intercostal muscle ultrasonographic millimetric measurement, 15 minute
Secondary Outcome Measures: Correlation between parasternal intercostal muscle thicknesses and spirometry parameters, Vital capacity\[VC\], forced vital capacity \[FVC\], forced expiratory volume 1 second \[FEV1\] , FEV1/FVC, maximal expiratory flow rate \[PEF\], maximum inspiratory pressure \[MIP\] maximum expiratory pressure \[MEP\] in patients' PFT \], 15 minute
Ultrasonographic Evaluation of Asymptomatic Shoulder Joint Pathologies in Rheumatoid Arthritis Patients
NCT Number: NCT06572696
Acronym: UEASJPRAP
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Rheumatoid Arthritis|Shoulder Injuries and Disorders
Interventions: DIAGNOSTIC_TEST: Shulder Ultrasound
Sponsor: Fatih Sultan Mehmet Training and Research Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-12
Completion Date: 2024-09-02
Locations: Istanbul Physıcal Therapy And Rehabılıtatıon Traınıng And Research Hospıtal, Istanbul, Turkey

Summary:
Ultrasonographic determination of changes and degree of damage in asymptomatic shoulder joint periarticular structures in RA patients and comparison with healthy controls.

Primary Outcome Measures: Ultrasound Shoulder Pathology Rating Scale, Ultrasound Shoulder Pathology Rating Scale point, 20 minute
Secondary Outcome Measures: Acromiohumeral Distance, Acromiohumeral Distance millimetric measurement, 5 minute
The Effect of Progressive Relaxation Exercise Performed Before Coronary Angiography
NCT Number: NCT06572670
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Coronary Angiography|Progressive Relaxation Exercise|Nursing
Interventions: OTHER: Progressive relaxation exercise before coronary angiography
Sponsor: TC Erciyes University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 70
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09-15
Completion Date: 2025-02-15

Summary:
This study was planned to examine the effects of progressive relaxation exercise on anxiety, comfort, pain and physiological parameters in patients undergoing coronary angiography. The data of the study will be collected using the Descriptive Characteristics Questionnaire Form, State and Trait Anxiety Inventory, Perianesthesia Comfort Questionnaire, Visual Analog Scale (VAS), Vital Signs Follow-up Form, Complication Follow-up Form and Progressive Relaxation Exercise Application Guidelines.

Primary Outcome Measures: Anxiety level, This inventory, which consists of a total of 40 items, is analyzed in two separate sections: The first part is the State Anxiety Inventory, which consists of 20 items, and the individual answers this section with his/her current feelings. The second part is the Trait Anxiety Inventory, which also consists of 20 items, and the individual answers this section with the feelings they have felt in the last 7 days., 30 minutes after angiography|Comfort level, The scale, which is based on the concept of comfort, consists of a total of 24 items, 12 of which question the comfort status of the individual before and after the surgical intervention, 12 of which question positive and 12 of which question negative experiences., 30 minutes after angiography|Pain level, Pain will be assessed with the Visual Analog Scale. This scale consists of a 10 cm line with values between 0 and 10. The beginning of the line (number 0) indicates "no pain", while the end of the line (number 10) indicates the most severe pain., 30 minutes after angiography
Secondary Outcome Measures: Blood pressure to be assessed with monitor, The patient's blood pressure will be measured from the brachial artery with a bedside monitor and the result will be recorded in mmHg., 30 minutes after angiography|Pulse to be assessed with monitor, Heart rate will be measured with a bedside monitor that can be measured from a finger and recorded as beats/min., 30 minutes after angiography|Respiratory rate, Respiratory rate will be measured by counting the number of inspirations and expiration from the patient's chest movements., 30 minutes after angiography
Comparison of the Effects of Aerobic Exercise and Computerized Cognitive Stimulation in Patients With Schizophrenia - A Randomized Controlled Trial
NCT Number: NCT06572657
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Schizophrenia|Exercise|Computerized Cognitive Stimulation
Interventions: OTHER: cognitive stimulation|OTHER: physical exercise
Sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital
Sex: ALL
Age: ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-02-02
Completion Date: 2024-09-06
Locations: Kartal Dr Lütfi Kırdar Şehir Hastanesi, İstanbul, Turkey

Summary:
Schizophrenia is a chronic mental disorder characterized by the occurrence of both positive symptoms, such as hallucinations and delusions, and negative symptoms, such as apathy and withdrawal, repetition of cognitive skills and disorganization. There are approximately 20 million people with schizophrenia worldwide and this number will continue to increase every year.

Primary Outcome Measures: Montreal Cognitive Assessment Scale, MOCA is a short cognitive assessment method developed to detect particularly mild stages of cognitive impairment., 12 weeks|International Physical Activity Questionnaire-Short Form, The International Physical Activity Questionnaire was developed by an international consensus group in 1998., 12 weeks
Performance of an Ultrasensible Malaria Rapid Diagnostic Test Among Pregnant Women in Burkina Faso
NCT Number: NCT06572644
Acronym: HS-RDT-MiP
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Malaria,Falciparum
Sponsor: Centre MURAZ/Institut National de Santé Publique
Collaborators: University of Ghana
Sex: FEMALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 288
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-10-11
Completion Date: 2023-12-31
Locations: Centre Médical Urbain de Lafiabougou, Bobo-Dioulasso, Houet, 390, Burkina Faso

Summary:
The goal of this observational study is to learn about the diagnostic performance of the highly sensitive rapid diagnostic test (HS-RDT) compared to an ultrasensitive qPCR for detection of falciparum malaria in pregnant women attending antenal care (ANC) in Burkina Faso. The main question it aims to answer is:

• What are the sensitivity and specificity of the HS-RDT compared to ultrasensitive quantitative polymerase chain reaction (qPCR) considered as gold standard for dection of falciparum malaria in pregnant women attending ANC in Burkina Faso ? Participants will be included during their ANC visits and screened for malaria using the HS_RDT, the conventional RDT (Co_RDT), microscopy, and qPCR.

Primary Outcome Measures: Sensitivity of HS_RDT, It is defined as the proportion of positives that are correctly identified when compared with the gold standard (qPCR)., At baseline|Specificity of HS_RDT, It is defined as proportion of negatives that are correctly identified when compared with the gold standard (qPCR)., At baseline
Secondary Outcome Measures: Positive predictive value, Probability that P. falciparum infection is present when HS_RDT, Co_RDT, and microscopy are positive, At baseline|Negative predictive value, Probability that P. falciparum infection is not present when HS_RDT, Co_RDT, and microscopy are negative, At baseline|The prevalence of Pfhrp2 and Pfhrp3 genes deletions among the study participants, Proportion of pregnant women with malaria parasites carrying Pfhrp2/Pfhrp3 deletions, At baseline|Impact of intermittent preventive treatment in pregnancy with sulfadoxine-pyrimethamine (IPTp- SP) on falciparum parasitaemia, Proportion of pregnant women with falciparum parasitaemia 30 days after uptake of IPTp-SP, 30 days after uptake of IPTp-SP
Other Outcome Measures: Prevalence of anaemia, Proportion of pregnant women with haemoglobin concentration \<11 g/dL, At baseline|Prevalence of Pfdhfr & Pfhdps mutations, Proportion of pregnant women with Pfdhfr (N51I, C59R, S108N, I164L) and Pfdhps (A437G, K540E) mutations, At baseline
The Predictive Value of MRI for Adult-type Diffuse Gliomas
NCT Number: NCT06572592
Acronym: MRI; glioma;
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Glioma
Sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-22
Completion Date: 2030-05

Summary:
The goal of this observational study is to learn about the diagnostic value of preoperative MRI examination for adult-type diffuse gliomas. The main question it aims to answer is:

* Can preoperative MRI examination noninvasively predict genotype of gliomas?
* Can preoperative MRI examination noninvasively predict the overall survival of gliomas?
* Can preoperative MRI examination noninvasively predict Ki-67 proliferation status?

Primary Outcome Measures: A model for predicting glioma grade and the status of prognosis-related molecular mutations, constructed using multiparametric MRI, The prognosis-related molecular mutation status, such as IDH mutation, is classified as dichotomous data. Mutations, deletions, or amplifications are categorized into the positive group and are denoted as 1; the absence of mutation, deletion, or amplification is categorized into the negative group and is denoted as 0., Through study completion, an average of 7 years
A Pilot Registry for Ultrasound-guided Pharmacopuncture
NCT Number: NCT06572579
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Neck Pain|Back Pain
Interventions: PROCEDURE: Ultrasound-guided pharmacopuncture treatment
Sponsor: Jaseng Medical Foundation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-26
Completion Date: 2025-12-31

Summary:
A pilot study of prospective resigstry to evaluate the safety and efficacy of ultrasound-guided pharmacopuncture for spinal disorders

Primary Outcome Measures: Adverse Event, Adverse events assessment, Treatment visits up to 12 weeks, and Week 2, 4, 8, 12 follow-ups
Secondary Outcome Measures: Spinal pain numeric rating scale, Spinal pain numeric rating scale, Week 0, Treatment visits up to 12 weeks, and Week 2, 4, 8, 12 follow-ups|Disability index, Neck disability index or Oswestry Disability Index, Week 0, 2, 4, 8, 12|EQ-5D-5L, Quality of life using EQ-5D-5L, Week 0, 2, 4, 8, 12|Patient satisfaction, Patient satisfaction survey, Week 4
Study on Neuropsychiatric Behavior in Cadmium-exposed People
NCT Number: NCT06572566
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cadmium Exceeds the Standard
Interventions: OTHER: Non-invasive examination and assessment.
Sponsor: Jianersheng (Zhuhai) Pharmaceutical Technology Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 84
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-08
Completion Date: 2024-12-30
Locations: Hunan Occupational Disease Prevention and Control Institute, Changsha, Hunan, 410000, China

Summary:
This study hypothesized that excessive cadmium is related to clinical pain, depression, and cognitive impairment, and that related indicators will improve after cadmium is eliminated.

Primary Outcome Measures: Cadmium load, To comprehensively assess the urinary cadmium levels in volunteers, blood cadmium and urinary cadmium levels were measured at different time points., Baseline, after 2 weeks, after 6 weeks|McGill Pain Questionnaire Short Form (MPQ), Pain was measured through the McGill Pain Questionnaire Short Form (MPQ)，The scale will include the unabbreviated scale title, the minimum and maximum values, and higher scores mean a worse outcome., Baseline, after 2 weeks, after 6 weeks|MATRICS Consensus Cognitive Battery (MCCB), The internationally recognized MATRICS Consensus Cognitive Battery (MCCB) for objective assessment of cognitive function.Cognitive scores for all individuals will be calculated using the MCCB software, yielding corrected scores for each test as well as an overall cognitive score., Baseline, after 2 weeks, after 6 weeks|The Hamilton Depression Rating Scale (HAMD), mental and psychological status was assessed with the Hamilton Depression Rating Scale (HAMD).The scale will include the unabbreviated scale title, the minimum and maximum values, and higher scores mean a worse outcome., Baseline, after 2 weeks, after 6 weeks
Secondary Outcome Measures: One of the early indicators of kidney injury--β2-MG, β2-microglobulin(β2-MG).Clinically, the measurement of β2-MG concentration in urine provides an early, reliable, and sensitive indicator for assessing renal function and diagnosing cadmium toxicity., Baseline, after 2 weeks, after 6 weeks|Hamilton Anxiety Scale（HAMA）, The HAMA scale will be used to assess the anxiety levels of volunteers, with higher scores indicating more severe anxiety., Baseline, after 2 weeks, after 6 weeks|One of the early indicators of kidney injury--NAG, N-acetyl-β-D-glucosaminidase,NAG. Urinary N-acetyl-beta-D-glucosaminidase (NAG) activity is one of the sensitive and specific indicators for renal tubular lesions and can serve as an early diagnostic marker for tubular damage, even providing earlier predictive value than urinary albumin., Baseline, after 2 weeks, after 6 weeks
Evaluation of Therapeutic Efficacy of Faricimab for Clinical AMD, DME, and RVO Patients
NCT Number: NCT06572553
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2|PHASE3
Conditions: Age-Related Macular Degeneration|Diabetic Macular Edema|Retinal Vein Occlusion
Interventions: DRUG: Faricimab
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-03-01
Completion Date: 2024-08-31
Locations: 2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China, Hanzhou, Zhejiang, 310000, China

Summary:
The goal of this clinical trial is to learn if drug Faricimab works to treat nAMD, DME or RVO in adults. It will also learn about the safety of drug Faricimab. The main questions it aims to answer are:

Does drug Faricimab can improve the best-corrected visual acuity of participants? What medical problems do participants have when inject drug Faricimab? Participants will inject drug Faricimab every month for 3 months. Visit the clinic once every 2 weeks for checkups.

Primary Outcome Measures: Best Corrected Visual Acuity (BCVA), BCVA will be measured at a standard distance of 4 metres under standardised lighting conditions (85-100 candela) by using an ETDRS optometer. Each eye will be tested separately with the participants who wear best corrected vision glasses. The smallest line of letters that the patient can correctly identify will be recorded as their BCVA.Measurements will be taken by trained ophthalmologists at baseline and at time points such as 2 weeks after the start of the trial and 1 month after the start of the trial to ensure consistency., through study completion, an average of 3 months.
Secondary Outcome Measures: central retinal thickness (CRT), Retinal thickness will be measured by using optical coherence tomography (OCT). Patients will undergo standardised retinal imaging, performed after pupil dilation. The average retinal thickness in and around the central sulcus will be measured using an automatically generated thickness map from the OCT device., through study completion, an average of 3 months.|Choroidal neovascularization (CNV), Choroidal neovascularisation was measured by OCT and OCTA. Standardised retinal imaging was performed after pupil dilation. Using the images provided by the OCT and OCTA devices, the presence or absence of accompanying choroidal neovascularisation was measured, and if present, the type was further determined, through study completion, an average of 3 months.
Transthoracic vs Transbronchial Cryoablation for Early-stage Peripheral Lung Cancer
NCT Number: NCT06572540
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Lung Cancer
Interventions: DEVICE: Transthoracic cryoablation|DEVICE: Transbronchial cryoablation
Sponsor: Jiayuan Sun
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 110
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2028-12-31
Locations: The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, 510120, China|Henan Provincial People's Hospital, Zhengzhou, Henan, 462000, China|Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, China|West China Hospital, Sichuan University, Chengdu, Sichuan, 610041, China|Sir Run Run Shaw Hospital , affiliated with the Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310009, China

Summary:
The study aims to compare the efficacy and safety of transthoracic cryoablation to transbronchial cryoablation in the treatment of early-stage peripheral lung cancer.

Primary Outcome Measures: Complete ablation rate at 12 months, Twelve months after the overall ablation procedure, the proportion that subjects whose lesion recevied ablation maintain completely ablated account for all evaluable subjects who receive cryoablation., Twelve months post-ablation
Secondary Outcome Measures: Technical success rate, It is defined as the number of lesions for which the ablation needle reached the location of the lesion and was successfully ablated as a proportion of the total number of lesions to be ablated, as assessed by immediate post-ablation imaging, Immediately after Each Operation|Complete ablation rate at 6 months, Six months after the overall ablation procedure, the proportion that subjects whose lesion recevied ablation maintain completely ablated account for all evaluable subjects who receive cryoablation., Six months post-ablation|Local control rates at 1, 2 and 3 years postoperatively, The number of lesions with complete and incomplete ablation at 1, 2, and 3 years after ablation treatment as a proportion of the number of all ablation-treated lesions., 12, 24, 36 monthspost-ablation|Progression-free survival (PFS), PFS was defined from the first day after ablation to progression of target lesions and/or appearance of new lesions or death., From the time of treatment to the time of disease progression or death (determined by the one which occurs first), up to 36 months|Overall survival（OS）, Overall survival（OS) is evaluated after the treatment of ablation until the patient death., From the time of treatment to the time of the patient death, up to 36 months|Adverse event, All adverse events will be recorded during operation and during the follow-up, and be evaluated according to the CTCAE v5.0. Related and possible related AEs and SAEs will be determined and evaluated., Twelve months psot-ablation
Child Health Coordinated Physical Activity Program
NCT Number: NCT06572527
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Physical Activity|Children, Only|Nurse's Role|Body Weight Changes
Interventions: BEHAVIORAL: Physical Activity Program
Sponsor: Selcuk University
Sex: ALL
Age: CHILD
Enrollment: 52
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-03-15
Completion Date: 2024-06-05
Locations: Emirdağ Fidan Ali Altıntaş Anaokulu, Afyonkarahisar, Turkey

Summary:
This study was conducted as a non-randomized study to evaluate the effects of physical activity interventions developed with the Nurse-led Child Health Coordinated Physical Activity Program on the physical activity levels of preschool children.

Research hypotheses; H1a: The anthropometric measurements of the group receiving the intervention are different from the control group.

H1b: The physical activity levels of the group receiving intervention according to family reports are different from the control group

Primary Outcome Measures: The parents' evaluation about their child's level of physical activity, This is a survey question. Parents rate their children's level of physical activity compared to their peers. (5-point scale from much more active to much less active), Pre-intervention (T0) Two weeks after the end of the intervention (T1)|The duration of watching TV or using a computer (in a day), Time spent watching TV or using a computer, Pre-intervention (T0) Two weeks after the end of the intervention (T1)|The status of organized planned physical activity, This question was developed based on the recommendation of at least 60 minutes of moderate-intensity physical activity per day. The status of moderate-intensity physical activity was explained with examples, and information about the child's activity status was obtained from the family for the past week . (Yes/no question) Expert opinion was obtained for the survey questions., Pre-intervention (T0) Two weeks after the end of the intervention (T1)|Time of playing outside, Time spent playing outside on weekdays and weekends,, Pre-intervention (T0) Two weeks after the end of the intervention (T1)|The frequency of some activities, Number of activities per week (ranging from never to more than 3 times per week). This survey question is in accordance with the Department of Health and Human Services recommendation., Pre-intervention (T0) Two weeks after the end of the intervention (T1)|Anthropometric measurements, Change in body mass index, height and weight, Pre-intervention (T0) Two weeks after the end of the intervention (T1)
De-escalation Radiation Strategy After NAC in Combination With ICI in LAHNSCC
NCT Number: NCT06572514
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Locally Advanced Head and Neck Squamous Cell Carcinoma
Interventions: DRUG: immunotherapy：pembrolizumab；chemo：albumin-bound paclitaxel and cisplatin
Sponsor: Ruijin Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-10-17
Completion Date: 2027-04
Locations: Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, Shanghai, 200025, China

Summary:
This study is a single-arm exploratory study conducted in LAHNSCC. Eligible patients received two cycles of pembrolizumab immunotherapy in combination with albumin-bound paclitaxel and cisplatin induction chemotherapy, followed by definitive concurrent radiochemotherapy. Three months after the completion of radiotherapy, a follow-up examination was conducted, and salvage surgery or systemic therapy was performed as necessary based on the follow-up results.

Primary Outcome Measures: Progression-free survival (PFS), Progression-free survival (PFS) (local-regional recurrence) is defined as the time from enrollment to the occurrence of local or regional lymph node recurrence or death for any reason., 1 year
Secondary Outcome Measures: Overall survival (OS), Overall survival is defined as the time from enrollment to death for any reason, 3-year|Clinical response rate, Clinical response is defined as the radiological evaluation of tumor regression as partial remission (PR) and complete remission (CR) on imaging assessment three months after the completion of treatment., 6 months|Safety(Grade 3-5 AE), Safety is primarily assessed based on the probability of occurrence of Grade 3-5 adverse effects in different organs according to CTCAE 4.0 (including radiation-related injuries and adverse reactions to immunotherapy)., 1-year|Quality of life, The assessment of quality of life is conducted using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Head and Neck Module (EORTC QLQ-H\&N 35), which includes eight domains: pain, swallowing, senses, speech, social eating, social contact, sexuality and single items. Each item is scored on a scale from 0 to 100. A high score for a functional scale or global QOL implies a high level of functioning or global QOL, whereas a high score for a symptom scale or single item implies a high level of symptoms., 6 month and 1 year after the treatment
Non-ablative Er:YAG for Recurrent Candidiasis
NCT Number: NCT06572488
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Candidiasis, Vulvovaginal|Candidiasis of Vagina|Candidiasis, Genital|Recurrent Candidiasis of Vagina|Infection, Candida|Vaginal Yeast Infections
Interventions: DEVICE: Non-ablative SMOOTH mode Er:YAG laser
Sponsor: Espacio Gaspar Clinic
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 167
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2019-01-03
Completion Date: 2022-09-26
Locations: Uroclinica, Mendoza, Argentina

Summary:
The objective of the study wa to assess the safety, acceptability and effectiveness of non-ablative Er:YAG laser therapy for treatment of symptoms and microbiological conditions of women with recurrent vulvovaginal candidiasis (RVVC). Eligible patients have received 4 laser therapies within four moths and will be assessed at baseline, 3 months and 9 months after last laser therapy.

The effects of laser therapy have been assessed by following the vaginal microbial status, by assessing the five bothersome symptoms related to vaginal infection (burning, itching, dyspareunia, dysuria, and abnormal discharge), by assessing the overall patient satisfaction, and throughout the study the safety of the laser therapy has been monitored.

Primary Outcome Measures: Improvement of bothersome symptoms (burning sensation,/irritation, itching or soreness, dyspareunia, dysuria, abnormal vaginal discharge, Patients were required to assess the symptom severity on a 0-10 VAS (Visual Analog Pain) scale, 0 referring to "absence of symptom" and 10 referring to "intolerable symptom", Change from Baseline at 3 and 9 months after last intervention
Secondary Outcome Measures: Change in lab cultures of vaginal swabs, Lab cultures of vaginal secretion on Sabouraud dextrose agar (SDA) were performed for diagnosis and determination of lead pathogen., Change from Baseline at 3 and 9 months after last intervention|Recording of frequency and severity of adverse effects related to laser treatment, Each visit included recording of any adverse effect. Patients were instructed to report and adverse effect that may have occured during the whole duration of the study., 9 months|Patient satisfaction with 5-point Likert scale, Patients were asked to assess their global satisfaction with the treatment on a 5-point Likert scale (1-Very unsatisfied, 2-Unsatisfied, 3-Neutral, 4-Satisfied, 5-Very satisfied)., Improvement from Baseline at 3 and 9 months after last intervention
ATG Individualized Dosing Model in URD-PBSCT.
NCT Number: NCT06572462
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Cytomegalovirus Infections|Infection Reactivation|Stem Cell Transplant Complications
Interventions: DRUG: individualized ATG dosing strategy
Sponsor: Chinese PLA General Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2019-12-31
Completion Date: 2025-06-30
Locations: Department of Hematology, First Medical Center of Chinese PLA General Hospital, Beijing, China

Summary:
Anti-thymocyte globulin (ATG) is widely used in allogeneic hematopoietic stem cell transplantation to prevent severe graft-versus-host disease (GVHD) and graft failure. However, overexposure to ATG may increase cytomegalovirus (CMV), Epstein-Barr virus (EBV) reactivation, non-relapse mortality, and disease recurrence. A targeted dosing strategy was established based on ATG concentration monitoring and conducted a phase 2 trial to evaluate the safety and efficacy of the dosing strategy in adult unmanipulated haplo-PBSCT, a encouraging result was attained. In this trial, The ATG-targeted dosing strategy was extended to adult unrelated donor allogeneic hematopoietic stem cell transplantation, ATG was administered for 4 days (-5 days to -2 days) during conditioning. The ATG doses on-3 days and- 2days were adjusted by our dosing strategy to achieve the optimal ATG exposure. The primary endpoint was CMV reactivation on +180 days.

Primary Outcome Measures: cumulative incidence of CMV reactivation, The primary endpoint was the cumulative incidence of CMV reactivation on +180 days after transplantation., 0Day-180Days
Prospective Analysis of EnVisio Spatial Intelligence for Soft Tissue Localization and Guided Surgical Excision
NCT Number: NCT06572410
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Tumors, Breast
Interventions: DEVICE: EnVisio Navigation System
Sponsor: Elucent Medical
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-07
Completion Date: 2026-02-15
Locations: Advent Winter Garden, Winter Garden, Florida, 34787, United States

Summary:
Observational study. The purpose of this study is to evaluate the use of real-time surgical navigation for the localization and surgical removal of soft tissue tumors. The goal is to collect information about the efficiency and effectiveness of the EnVisio Surgical Navigation for intraoperative guidance to obtain negative margin on initial specimen.

Prospective Patient Study: 200 consecutive patients

Primary Outcome Measures: Margin Positivity, Specimen surgical resection volume gross measurements in 3 dimensions (length, width, depth) day of surgery.

Definitive gross pathology results on final margin, Day of Surgery
Open-Label Study of Safety of H1337 in Healthy Volunteers
NCT Number: NCT06572397
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Glaucoma Open-Angle Primary|Ocular Hypertension
Interventions: DRUG: H-1337 1.0%
Sponsor: D. Western Therapeutics Institute, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 16
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-16
Completion Date: 2024-10-31

Summary:
The trial will evaluate the safety of one dose regimen of H-1337 \[1% twice daily (b.i.d.)\] in both eyes in healthy volunteers.

Primary Outcome Measures: Incidence of Treatment-Emergent Adverse Events Reporting [Safety and Tolerability], Incidence of ocular and systemic adverse events, Screening through Day 9
Open Versus Laparoscopic Dismembered Pyeloplasty Among Adult Patients With Primary Pelvi-Ureteric Junction Obstruction
NCT Number: NCT06572371
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Open|Laparoscopic|Dismembered Pyeloplasty|Primary Pelvi-Ureteric Junction|Obstruction
Interventions: PROCEDURE: Laparoscopic pyeloplasty|PROCEDURE: Open pyeloplasty
Sponsor: Tanta University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 34
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-10-01
Completion Date: 2023-10-01
Locations: Tanta University, Tanta, ElGharbia, 31527, Egypt

Summary:
To prospectively compare the perioperative, morphological and functional outcomes on short and medium term between laparoscopic (LP) and open pyeloplasty (OP) patients.

Primary Outcome Measures: Amount of blood loss, Amount of blood loss was recorded., Intraoperatively
Secondary Outcome Measures: Etiology of obstruction, Etiology of obstruction such as adynamic segment, crossing vessel, stenotic segment, adhesions, and abnormal gonadal vein were recorded., Intraoperatively|Complications, Complications was recorded such as wound complications, loin or abdominal pain, fever, chills and rigor, change of color of urine, dysuria., 24 hours postoperatively
Simulation-informed Modelling and Personalized Evaluation (SIMPLE) in Ageing Populations
NCT Number: NCT06572332
Acronym: SIMPLE
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Neurodegenerative Diseases|Aging|Brain|Cognitive Dysfunction
Sponsor: Chinese University of Hong Kong
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2026-12-31

Summary:
Multimodal magnetic resonance imaging (MRI), detecting brain structural and functional changes, has emerged as a powerful and promising technique to study individual's brain, as T1-weighted scans can detect morphometric features, diffusion tensor imaging (DTI) scans can quantify structural connectivity, and functional MRI can capture the features of functional connectivity. Notably, with the advances in quantitative methods, computational models of brain age and brain-predicted age difference (brain-PAD) detecting the ageing effects on individual's brain features are becoming increasingly popular in clinical studies, which might revolutionize the diagnostic and prognostic phonotypes of age-related brain diseases globally.

Primary Outcome Measures: Estimated brain age, Using the structural and functional connectivity, individual's brain age is calculated based on the connectivity features of core brain networks., Baseline|Cognitive maintenance, The dynamic change of cognitive status is used to evaluate cognitive maintenance. The performance of global cognition is used to determine the cognitive status, including mild NCD and major NCD. The global cognition is measured by MMSE., Baseline|Plasma β-amyloid, The levels of Aβ42 and Aβ40 in the plasma samples will be quantified by enzyme-linked immunosorbent assay., Baseline
Secondary Outcome Measures: Brain-predicted age difference (brain-PAD), The brain-PAD score is computed as the difference between estimated brain age and chronological age (brain age minus chronological age)., Baseline|Complex attention, Attention network test (ANT) is an individually administered computerized task designed to evaluate three attentional components., Baseline|Memory and learning, Word list learning test consisting of fifteen semantically non-associated words that is presented consecutively over three trials of immediate recall and a 20-min delayed recall., Baseline|Executive function, Executive function is measured by the category verbal fluency test (CVFT)., Baseline
Disitamab Vedotin Plus Trastuzumab in Patients With HER2 Positive GC/GEJ Patiens
NCT Number: NCT06572319
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: HER2-positive Gastric Cancer|HER2-positive Gastroesophageal Junction Adenocarcinoma
Interventions: DRUG: Disitamab Vedotin(RC48) Plus Tratuzumab
Sponsor: Zhejiang Cancer Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 35
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2026-12-31
Locations: Zhejiang Cancer Hospital, Hangzhou, Zhejiang, 310022, China

Summary:
This trial is a single center, single arm, open label clinical study aimed at evaluating the efficacy and safety of the combination therapy of Disitamab Vedotin and trastuzumab in the treatment of advanced HER-2 positive gastric/gastroesophageal junction tumors

Primary Outcome Measures: Objective response rate(ORR), he number of cases in which tumor size is reduced to PR or CR / the total number of evaluable cases (%), 12 months
Secondary Outcome Measures: Overall survival (OS), The time interval between the start date of study drug and the date of death (any cause), up to 36 months|Progression-free survival (PFS), Refers to the date from the date of admission to the date of the first progression of disease or death of any cause, using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)., up to 12 months|Disease control rate (DCR), Percentage of confirmed cases including complete remission (CR), partial remission (PR) and disease stability (SD) among patients with evaluable efficacy, up to 12 months|Incidence of Treatment-Emergent 3/4 Adverse Events, Number and percentage of participants with Adverse Events (any Grade and Grade 3/4), up to 12 months after enrollment or study close
Non-invasive Phrenic Nerve Stimulation in ARDS Patient
NCT Number: NCT06572280
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: ARDS, Human|Ventilator-Induced Lung Injury|Diaphragm Injury
Interventions: DEVICE: PNS group
Sponsor: Southeast University, China
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-08-01
Completion Date: 2025-01-30
Locations: Zhongda Hospital, School of Medicine, Southeast University, Nanjing, Jiangsu, 210009, China

Summary:
Reduced diaphragmatic activity during mechanical ventilation can lead to diaphragmatic disuse atrophy, atelectasis, increased lung stress and strain, and hemodynamic impairment. This, in turn, may prolong the duration of mechanical ventilation, make weaning more difficult, and even increase mortality. Synchronizing phrenic nerve stimulation to promote diaphragmatic activity may prevent ventilator-induced lung injury and ventilator-induced diaphragm dysfunction, thereby improving patient outcomes. Surgically implanted phrenic nerve stimulation has been used in certain neurological disorders, but the effects of percutaneous non-invasive synchronized phrenic nerve stimulation in patients with ARDS undergoing mechanical ventilation remain unclear and require further investigation.

Primary Outcome Measures: Frequency of enough Tidal volume, Percentage of stimulated breaths above the cut-off target tidal volume (3-6 ml/kg ideal body weigh) out of the total number of stimulated breaths, Procedure (from enrollment to extubation)|The speed of successful non-invasive electrical stimulation deployment, Time between first successful electrical phrenic stimulation and identification of the optimal stimulation locus in seconds, Procedure (from enrollment to extubation)
Secondary Outcome Measures: Driving pressure, driving pressure was measured in the volume-controlled mode and calculated as the difference between plateau pressure and positive end-expiratory pressure, Procedure (from enrollment to extubation)|Diaphragm thickening fraction, Diaphragm thickening fraction measured with ultrasound of the diaphragm., up to 28 days|Diaphragm excursion, Diaphragm excursion measured with ultrasound of the diaphragm., up to 28 days|Maximal inspiratory pressure (MIP), MIP is measured by the mechanical ventilator during electromagnetic phrenic nerve stimulation., Procedure (from enrollment to extubation)|ventilation distribution, ventilation distribution was measured by EIT, Procedure (from enrollment to extubation)|Respiratory system compliance, Respiratory system compliance is calculated as the ratio of tidal volume to the difference between plateau pressure and positive end-expiratory pressure., Procedure (from enrollment to extubation)
Safety and Efficacy of Meplazumab in Patients With Coronary Artery Disease
NCT Number: NCT06572267
Acronym: REC-SAFECAD
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Coronary Artery Disease
Interventions: DRUG: Mepolizumab low dose group|DRUG: Mepolizumab middle dose group|DRUG: Mepolizumab high dose group|DRUG: Saline
Sponsor: Xijing Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 18
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-26
Completion Date: 2026-03-01
Locations: Ling Tao, Xi'an, Shannxi, 710032, China

Summary:
The development of coronary atherosclerosis is closely related to inflammation, and CD147 may play an important role in its process. The present study was designed to evaluate the effects of long-term administration of mepolizumab (humanized anti-CD147 antibody) on lipid deposition and inflammation in coronary atherosclerotic plaques in patients with high-risk coronary artery disease, and to preliminarily explore the efficacy, safety, and dosage of long-term administration of mepolizumab in this population.

Primary Outcome Measures: Proportion of high PVAT attenuation coefficient among non-target lesion(s), Proportion of high PVAT attenuation coefficient (≥-70.1 HU) among non-target lesion(s) assessed by CCTA, 6 months
Secondary Outcome Measures: Change in PVAT attenuation coefficient of non-target lesion(s) from baseline to follow-up, 6 months|Change in non-target lesion plaque composition as assessed by CCTA from baseline to follow-up, 6 months|Changes in inflammatory biomarkers from baseline to follow-up, Biomarkers including hs-CRP, IL-1, IL-2, IL-4, IL-6, INF-α, IL-8, IL-10, IL-12p70, IL-17, IL-1β, TNF-α and IFN-γ, 6 months|Device-oriented clinical endpoint (DoCE), Device-oriented clinical endpoint is a composite endpoint including cardiac death, target vessel infarction, and clinically driven target lesion revascularization, 1 month and 6 months|Cardiac death, The individual component of the DoCE, 1 month and 6 months|Target vessel infarction, The individual component of the DoCE, 1 month and 6 months|Clinically driven target lesion revascularization, The individual component of the DoCE, 1 month and 6 months|Patient-oriented composite endpoint (PoCE), Patient-oriented composite endpoint is a composite endpoint including all-cause death, any stroke, any myocardial infarctions, and any revascularization, 1 month and 6 months|All-cause death, The individual component of the PoCE, 1 month and 6 months|Any stroke, The individual component of the PoCE, 1 month and 6 months|Any myocardial infarction, The individual component of the PoCE, 1 month and 6 months|Any revascularization, The individual component of the PoCE, 1 month and 6 months|Changes in gene expression of peripheral blood mononuclear cells, 6 months|Any adverse events, All adverse events (AE) will be recorded and categorized according to CTCAE Ver 5.0, 1, 2, 3, 4, 5, and 6 months