pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Contemporary Restorative Materials in Primary Molars
NCT Number: NCT06544486
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dental Caries
Interventions: PROCEDURE: Caries Removal|PROCEDURE: Filling
Sponsor: Akdeniz University
Sex: ALL
Age: CHILD
Enrollment: 86
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2021-03-01
Completion Date: 2024-07-19
Locations: Akdeniz University, Antalya, Turkey

Summary:
This randomized controlled trial aims to compare the clinical effectiveness of four ion-releasing restorative materials in the proximal cavities of primary molars that underwent selective caries removal. The main questions to answer are:

* Will there be any difference among the restorative materials clinical succes in the means of modified United States Public Health Services (USPHS) criteria for dental restorations?
* Will there be any difference among the restorative materials in the means of preservation of pulpal vitality? Eighty six children (262 teeth), between 5 and 9 years old (7.15±1.14) enrolled for the study. Researchers will compare the clinical performance of restorative materials, (1:Equia Forte HT; 2: Fuji II LC; 3: Cention N; 4: ChemFil Rock), applied to the proximal cavities of primary molars following selective caries removal, according to the modified USPHS criteria.

Participants will:

- visit the clinic 1st,3rd,6th,12th,18th,24th,30th and 36th months after the restoration.

Primary Outcome Measures: Clinical evaluation of the filling materials according to the modified USPHS criteria, Restorations were evaluated for retention, marginal discoloration, marginal adaptation, color stability, secondary caries, and postoperative sensitivity according to the modified USPHS with scores assigned as follows: the best being Alpha and the worst being Charlie. Each restoration received a score of Alpha, Bravo, or Charlie at each time interval., Evaluations were conducted at the 1st, 3rd, 6th, 12th, 18th, 24th, 30th and 36th months.
Secondary Outcome Measures: Preservation of pulpal vitality, The modified USPHS criteria do not include the measure of pulpal vitality when evaluating the success of restorations. However, maintaining pulpal vitality is also a criterion for the success of a restoration and is assessed not by a graded score but by the presence or absence of symptoms and findings. In this study, pulpal vitality was clinically evaluated based on the presence or absence of percussion sensitivity, palpation sensitivity, gingival redness, fistula or abscess. If percussion sensitivity, palpation sensitivity, or the formation of a fistula or abscess were present, the restoration was classified as unsuccessful regarding pulpal vitality. In cases of gingival redness or unclear clinical symptoms, a periapical radiograph was taken. If presence or absence of radiolucency in the periapical or furcal area was detected in the radiograph, the restoration was classified as unsuccessful regarding pulpal vitality., Evaluations were conducted at the 1st, 3rd, 6th, 12th, 18th, 24th, 30th and 36th months.
Determining Dose Equivalence Between Oral and Transdermal Estrogen Treatment in Women With Turner Syndrome
NCT Number: NCT06544473
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Turner Syndrome|Hypogonadism; Ovarian|Hormone Replacement Therapy|Estrogen Replacement Therapy|Estrogen Deficiency
Interventions: DRUG: 17-beta estradiol|DRUG: 17-beta estradiol
Sponsor: Aarhus University Hospital
Collaborators: University of Aarhus
Sex: FEMALE
Age: ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-11-29
Completion Date: 2026-12-31
Locations: Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Aarhus N, 8200, Denmark

Summary:
This 5-week, phase IV randomized crossover trial aims to compare the effects of oral versus transdermal estrogen replacement therapy (ERT) in women with Turner syndrome (TS). The objective is to establish the equipotency between the two estradiol regimens by evaluating various estradiol-dependent surrogate markers. The study involves 50 women with TS, aged 18-50 years, who are randomized to receive either oral or transdermal ERT for 14 days, followed by a crossover to the alternate treatment for another 14 days, with a one-week washout period in between. Blood tests are conducted at baseline, after the first 14 days of treatment, after the washout period, and after the final 14 days of treatment. The investigators anticipate that this study will provide clinicians with a better understanding of ERT in treating women with TS.

Primary Outcome Measures: Equipotency, Levels of luthenizing hormone and follicle stimulating hormone are measured at different doses, After 14 days
Secondary Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy for PARP Inhibitors Resistance Patients
NCT Number: NCT06544460
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Ovarian Cancer
Interventions: PROCEDURE: Secondary cytoreduction|DRUG: Hyperthermic intraperitoneal chemotherapy
Sponsor: Fudan University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 94
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-31
Completion Date: 2026-12-31
Locations: Fudan university shanghai cancer center, Deparment of gynecologic oncology, Shanghai, Shanghai, 200032, China

Summary:
At present, the treatment of recurrent ovarian cancer after PARP inhibitor therapy is quite challenging, and there is no research on the application of hyperthermic intraperitoneal chemotherapy(HIPEC) for the above-mentioned patients. Therefore, this study aims to explore the safety and efficacy of secondary cytoreduction combined with hyperthermic intraperitoneal chemotherapy for recurrent ovarian cancer after maintenance therapy with PARP inhibitors through a single-center, prospective, single-arm, phase II clinical trial. The goal is to explore the treatment options for ovarian cancer patients in the era of PARP inhibitors, thereby improving the overall treatment level and prognosis of ovarian cancer.

Primary Outcome Measures: PFS, Progression free survival, Two years
Secondary Outcome Measures: OS, Overall Survival, Two years
Transcutaneous Auricular Vagus Nerve Stimulation in Dry Eye Disease With Meibomian Gland Dysfunction
NCT Number: NCT06544447
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Dry Eye
Interventions: DEVICE: taVNS|DRUG: Hyaluronic acid eye drops
Sponsor: Beijing Tongren Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 135
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2021-06-01
Completion Date: 2024-10-01
Locations: China Beijing TongRen Hospital, Capital Medical University Beijing, China, Beijing, Beijing, 100730, China

Summary:
Objective: To evaluate the effect of transcutaneous auricular vagus nerve stimulation (taVNS) for the patients with dry eye disease with meibomian gland dysfunction.

Methods: We enrolled 270 patients at Beijing Tongren Hospital. All treatments were self-administered by the patients at home after training at the hospital. Patients completed questionnaires at baseline, 1 month, 3 months, and 6 months.

OSDI score, TBUT, OPAS, NPSI-eye, and Schirmer I expressibility and secretion score to evaluate the therapeutic effects. A difference of P \< 0.05 was considered statistically significant.

Primary Outcome Measures: OSDI, Ocular Surface Disease Index (OSDI) questionnaire: The OSDI questionnaire is designed to assess the severity of symptoms and the impact of ocular surface diseases, such as dry eye disease, on a patient's quality of life., Baseline, month 1, 3, and 6
Secondary Outcome Measures: OPAS, Ocular Surface Disease Index-Personalized Assessment Score (OPAS): The OPAS is a tailored version of the traditional Ocular Surface Disease Index (OSDI). It is designed to offer a more personalized assessment of ocular surface diseases by adapting the standard questionnaire to reflect individual patient experiences and symptoms more accurately. The personalized nature of OPAS aims to offer a more precise measure of how the disease impacts the patient's quality of life and daily functioning., Baseline, month 1, 3, and 6|NPSI-eye, Neuropathic Pain Symptom Inventory - Eye (NPSI-eye): The NPSI-eye is a specialized tool designed to assess neuropathic pain symptoms specifically in the context of eye conditions. It helps in identifying and quantifying symptoms associated with neuropathic pain in the ocular region. Higher scores indicate more severe or frequent neuropathic pain symptoms., Baseline, month 1, 3, and 6|TBUT, Tear Breakup Time (TBUT): TBUT is a diagnostic test used to evaluate the stability of the tear film and diagnose dry eye disease. It measures the time it takes for dry spots to appear on the corneal surface after blinking while using a fluorescent dye. A shorter TBUT indicates less stable tear film, which is often associated with dry eye disease., Baseline, month 1, 3, and 6|SchirmerI, The Schirmer I test assesses tear production to diagnose dry eye syndrome. The length of the wetting is measured in millimeters. A lower measurement indicates reduced tear production, suggesting dry eye disease., Baseline, month 1, 3, and 6
Prospective Study on COVID -19 Reinfection on Vaccinated and Non-vaccinated Outpatients
NCT Number: NCT06544369
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: COVID-19 Pandemic
Interventions: BIOLOGICAL: COVID-19 vaccin
Sponsor: Soad Ali
Sex: ALL
Age: ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-11-20
Completion Date: 2022-01-18
Locations: Deraya university, Minya, 05673, Egypt

Summary:
the aim of the study is to compare the severity of symptoms in case of reinfection with COVID-19. the study will compare between two groups; vaccinated and non vaccinated. the side effects from vaccination and symptoms of infection and reinfection will be reprted.

Primary Outcome Measures: percent of reinfection with COVID-19 in vaccinated and non vaccinated, one year
Secondary Outcome Measures: scoring of symptoms in case of reinfection in vaccinated and non vaccinated, one year
Health Literacy and Newborn Screenings
NCT Number: NCT06544356
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Health Literacy and Newborn Screening
Interventions: OTHER: No intervention, questionnaire filled out
Sponsor: Yuzuncu Yıl University
Sex: FEMALE
Age: ADULT
Enrollment: 425
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-02-01
Completion Date: 2023-08-30
Locations: Van Yuzuncu Yıl University, Van, Turkey

Summary:
Health literacy, the ability to understand and use health information, is crucial in all health processes such as healthy living, disease prevention, diagnosis, treatment, and personal care. The newborn screening program (NSP) helps reduce morbidity and mortality by early diagnosing rare diseases in infants. Health literacy impacts parents' vaccination choices and attitudes, and higher health literacy is sometimes associated with lower adherence to vaccination protocols. Various studies highlight the significance of health literacy in childhood vaccinations, breastfeeding effectiveness, and attitudes toward YTP, emphasizing parents' lack of knowledge about NSP and the need for education. Notably, parents who give birth outside of hospitals have significant knowledge gaps regarding NSP.

Primary Outcome Measures: Health Literacy Scale, The Health Literacy Scale (HLS-14) was used. The scale consists of three sub-dimensions: Functional Health Literacy (5 items), Interactive Health Literacy (5 items), and Critical Health Literacy (4 items). The scale has a maximum score of 70 and a minimum score of 15. The higher the score, the higher the level of health literacy., 6 monts
Secondary Outcome Measures: Knowledge and Attitude Scale about Newborn Screening, The Knowledge and Attitude Scale Regarding Newborn Screenings, adapted into was used. The scale has a maximum score of 52 and a minimum score of 0. The higher the score, the lower the level of knowledge and attitudes about newborn screening., 6 monts
Other Outcome Measures: Maternal Introductory Information Form, For the determination of socio-demographic characteristics, the 24-question Maternal Introductory Information Form, which was prepared by using the literature, was used., 6 monts
Autologous CD19 CAR-T Cell Therapy (SYNCAR-001) + Orthogonal IL-2 (STK-009) in Subjects With Severe, Refractory Systemic Lupus Erythematosus
NCT Number: NCT06544330
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Systemic Lupus Erythematosus|Lupus Nephritis
Interventions: DRUG: SYNCAR-001|DRUG: STK-009
Sponsor: Synthekine
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 42
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2041-04

Summary:
This is a phase 1 study of SYNCAR-001 + STK-009 in patients with severe, refractory systemic lupus erythematosus.

Primary Outcome Measures: Dose-Limiting Toxicities (DLTs), Incidence of adverse events (AEs) meeting protocol defined DLT criteria in the dose escalation phase of the study., Up to 28 days after SYNCAR-001 infusion|Adverse Events, Incidence and severity of AEs including treatment-emergent AEs and serious AEs., Up to 96 weeks after SYNCAR-001 infusion
Secondary Outcome Measures: Remission rate per Definition of Remission in SLE (DORIS), Up to 96 weeks after SYNCAR-001 infusion|Lupus Low Disease Activity State (LLDAS) attainment rate, Up to 96 weeks after SYNCAR-001infusion|Change over time in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K), The SLEDAI-2K assessment consists of 24 items with a total score of 0 (no symptoms) to 105 (presence of all defined symptoms) with higher scores indicating increased disease activity., Up to 96 weeks after SYNCAR-001 infusion|Change over time in British Isles Lupus Activity Group (BILAG) score, The BILAG instrument assesses 97 clinical signs, symptoms, and laboratory parameters across 9 organ system domains related to SLE. BILAG scoring represents: A=severe disease, B=moderate disease, C=stable mild disease, D=inactive but previously active disease, E=never involved., Up to 96 weeks after SYNCAR-001 infusion|To evaluate disease related to biomarkers., Levels of anti-double stranded DNA (anti-dsDNA) in serum., Up to 96 weeks after SYNCAR-001 infusion|To evaluate disease related to biomarkers., Levels of complement C3, C4 in serum., Up to 96 weeks after SYNCAR-001 infusion|Complete renal response rate (CRR), Lupus Nephritis only. CRR will be defined as a UPCR \< 0.5 and no eGFR decrease \> 15% from baseline., Up to 96 weeks after SYNCAR-001 infusion
Buttock Augmentation With Polymethylmethacrylate
NCT Number: NCT06544304
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Aesthetics|Augmentation
Interventions: DEVICE: PMMA
Sponsor: MTC MEDICAL COMERCIO INDUSTRIA IMPORTACAO E EXPORTACAO DE PRODUTOS BIOMEDICOS LTDA
Sex: ALL
Age: ADULT
Enrollment: 133
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2025-01
Completion Date: 2026-08

Summary:
Single-arm multicenter interventional clinical trial of buttock augmentation with polymethyl methacrylate.

The objective is to evaluate the safety and effectiveness of using 30% Biosimetric PMMA gel for buttock augmentation.

Primary Outcome Measures: Number of participants with treatment-related adverse events as assessed by clinical evaluation, Occurrence of adverse events in patients who underwent gluteal augmentation with 30% Biosymmetric PMMA. Expected events will be classified as adverse events when they persist for more than two weeks, and should be reported throughout the study. Adverse events not previously identified will also be monitored at all visits., Before application of PMMA and 6 and 9 months after the procedure
Secondary Outcome Measures: Changes in normal values of laboratory biochemical tests, laboratory biochemical exams, Before application of PMMA and 6 and 9 months after the procedure|Volumetric capacity of filled muscle assessed by ultrasound imaging, Using an ultrasound device, images of the gluteus will be obtained to analyze the thickness of the muscle, and thus estimate its volumetric capacity., Before application of PMMA and 6 and 9 months after the procedure|Physician satisfaction assessed by GAIS scale, Physician satisfaction will be assessed using the Portuguese version of the Global Aesthetic Improvement Scale, assigning values according to the following parameters:

Much improved (5): excellent cosmetic result after the procedure. Much improved (4): marked improvement in appearance from the initial condition, but not completely optimal for the patient.

Better (3): obvious improvement in appearance from the initial condition. Unchanged (2): appearance is essentially the same as the original condition. Worse (1): appearance is worse than the original condition., Before application of PMMA and 4, 6 and 9 months after the procedure|Patient satisfaction assessed by GAIS scale, Patient satisfaction will be assessed using the Portuguese version of the Global Aesthetic Improvement Scale, assigning values according to the following parameters:

Much improved (5): excellent cosmetic result after the procedure. Much improved (4): marked improvement in appearance from the initial condition, but not completely optimal for the patient.

Better (3): obvious improvement in appearance from the initial condition. Unchanged (2): appearance is essentially the same as the original condition. Worse (1): appearance is worse than the original condition., Up to 4, 6 and 9 months after the procedure
The Impact of Probiotics on Sperm Quality in Middle-aged Men
NCT Number: NCT06544278
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Sperm Quality
Interventions: DIETARY_SUPPLEMENT: probiotic product|DIETARY_SUPPLEMENT: Maltodextrin
Sponsor: Wecare Probiotics Co., Ltd.
Sex: MALE
Age: ADULT
Enrollment: 46
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-30
Completion Date: 2025-06-01
Locations: Qilu Hospital of Shangdong University, Jinan, Shangdong, 250012, China

Summary:
The clinical trial aims to investigate the impact of probiotic strain BL21 on sperm quality among 46 middle-aged male participants. The primary objective is to validate whether probiotic strain BL21 can effectively improve sperm quality among middle-aged male participants. Initially, participants were instructed to consume the recommended amount of probiotic powder for approximately 8 weeks. At baseline, week 4, and week 8 endpoints, semen analysis, hormone level testing, serum cytokine testing were conducted on the participants, and stool samples were collected from them.

Primary Outcome Measures: Change in Sperm Motility Percentage Assessed by Computer-Assisted Sperm Analysis System (CASA) After 8 Weeks, The percentage change in sperm motility will be measured using a Computer-Assisted Sperm Analysis System (CASA). Sperm samples will be collected at baseline and after the 8-week intervention. Results will be presented as mean ± standard deviation. The data will be used to assess the effect of Bifidobacterium longum subsp. longum BL21 on sperm motility in middle-aged men., 8 weeks
SynKIR-310 for Relapsed/Refractory B-NHL
NCT Number: NCT06544265
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: B Cell Lymphoma|NHL, Adult|Mantle Cell Lymphoma|Relapsed Non-Hodgkin Lymphoma|Refractory Non-Hodgkin Lymphoma|Aggressive B-Cell Non-Hodgkin Lymphoma|Indolent B-Cell Non-Hodgkin Lymphoma|Follicular Lymphoma|Marginal Zone Lymphoma|DLBCL - Diffuse Large B Cell Lymphoma|HGBL With MYC and BCL2 and/or BCL6 Rearrangements|High-grade B-cell Lymphoma|Diffuse Large B Cell Lymphoma|Large B-cell Lymphoma|T-Cell/Histiocyte Rich Lymphoma|Non-hodgkin Lymphoma,B Cell|Primary Mediastinal Large B-cell Lymphoma (PMBCL)|Epstein-Barr Virus Positive DLBCL, Nos|Follicular Lymphoma Grade 3B|DLBCL (Diffuse Large B-Cell Lymphoma) Associated With Chronic Inflammation|High Grade B-Cell Lymphoma, Not Otherwise Specified|Follicular Lymphoma Grade 3|Marginal Zone Splenic Lymphoma|DLBCL
Interventions: BIOLOGICAL: SynKIR-310
Sponsor: Verismo Therapeutics
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 18
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2028-12

Summary:
This first-in-human (FIH) trial is designed to assess the safety, feasibility and preliminary efficacy of a single intravenous (IV) dose of SynKIR-310 administered to participants with relapsed/refractory B-NHL.

Primary Outcome Measures: Evaluate the safety of SynKIR310, The incidence, frequency, and severity of adverse events (AEs), including serious adverse events (SAEs), treatment-emergent adverse events (TEAEs), and dose-limiting toxicities (DLTs)., Up to 24 months|Recommended Phase 2 Dose (RP2D), All available data from dose escalation cohorts will be evaluated to determine RP2D, Up to 24 months
Secondary Outcome Measures: Feasibility of SynKIR-310, Number of enrolled patients who receive SynKIR-310., Up to 24 months|Preliminary efficacy : Objective response rate (ORR), Percentage of patients with a complete or partial response determined by Investigator, Up to 24 months|Preliminary efficacy: Complete response rate (CR), Percentage of patients with a Complete Response determined by Investigator, Up to 24 months|Preliminary efficacy: Duration of response (DOR), Time from the date of the first occurrence of complete response or partial response to the date of progression, relapse, or death from any cause, determined by Investigator, Up to 24 months|PD profile of SynKIR-310, To evaluate concentration of cytokines in serum over time following SynKIR-310 infusion, Up to 24 months|PK profile of SynKIR-310, To evaluate the patients who show CAR T persistence in blood (measured in the blood by quantitative polymerase chain reaction (PCR)) at multiple study time points following SynKIR-310 infusion, Up to 24 months
Intra-operative Air Leak Management After Minimally Invasive Lung Segmental Resection
NCT Number: NCT06544200
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Lung Cancer Stage I|Lung; Node|Air Leak From Lung
Interventions: DEVICE: Polymeric Hydrogel Matrix
Sponsor: University Hospital Padova
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-07-15
Completion Date: 2025-07-01
Locations: Thoracic Surgery Unit, Padua, 35128, Italy

Summary:
In patients undergoing minimally invasive thoracoscopic surgery (video-assisted thoracoscopic surgery, or VATS), a still unsolved issue is represented by intraoperative alveolar air leaks (IOAALs), which if prolonged beyond the fifth postoperative day can lead to higher risk of complications and higher medical costs. The polymeric hydrogel matrix (PHM) is a novel tool to manage intraoperative IOAALs. The primary end-point of our study was to verify whether PHM would be able to reduce postoperative air leaks; secondary end-points were the possible reduction of the permanence time of the chest drain (CD) and the hospital length (HL) in the PHM group compared with no treatment.

Primary Outcome Measures: presence of postoperative air leaks, The presence of postoperative air leaks from pleural drainage, from the end of surgery to the last day the air leaks are detected., days from end of surgery up to 40 days of postoperative follow-up
Secondary Outcome Measures: Chest drain length of stay, The duration of pleural drainage placement from the first postoperative day until the day of its removal, days from the first postoperative day up to 40 days of postoperative follow-up|In-Hospital length of stay, The length of hospital stay, measured from the first postoperative day until the patient is discharged from the hospital ward, days from the first postoperative day up to 40 days of postoperative follow-up|Incidence of postoperative complications, Any complications arising in patients are recorded and assigned a severity grade according to the Clavien-Dindo classification., days from the first postoperative day up to 40 days of postoperative follow-up
Long-term Clinical Follow up After PCI for CTO
NCT Number: NCT06544174
Acronym: LT-CTO
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Coronary Total Occlusion
Interventions: OTHER: Percutaneous Coronary Intervention of CTO
Sponsor: University Hospital, Montpellier
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 463
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-11-01
Completion Date: 2024-05-01
Locations: CHU Montpellier, Montpellier, Herault, 34090, France

Summary:
The research aimed to evaluate the impact of a successful Percutaneous coronary intervention of chronic total occlusions (CTO-PCI) on long-term MACE (Major Cardiovascular Events), symptoms, survival, Left Ventricular Ejection Fraction (LVEF) and myocardial ischemia up-to-8-years follow-up.

Primary Outcome Measures: Major cardiovascular events (MACE), Incidence of composite of cardiac death, non-fatal myocardial infarction and new target vessel revascularization, Up to 8 years
Secondary Outcome Measures: Non combined MACE components, Incidence of Cardiac death, non-fatal myocardial infarction and new target vessel revascularization, Up to 8 years|In-hospital events, Incidence of Procedural complications including death, periprocedural MI, coronary perforation, pericardial tamponade requiring drainage, local vascular complications, major bleeding, contrast induced nephropathy, stroke, Up to one week|Restenosis, Incidence of Restenosis Defined as a greater than 50% diameter stenosis at follow-up angiogram of the first dilated total occlusion. Reocclusion was defined as recurrent total occlusion of the first dilated total occlusion., Up to 8 years|Ischemic burden, Comparison between pre and post-CTO ischemic tests, Up to 8 years|Stent thrombosis, Incidence of stent thrombosis defined as any myocardial infarction with angiographic confirmation of in-stent thrombus or unexplained death, Within 30 days after the procedure|LVEF, Percentage of Increase or decrease in LVEF after the CTO procedure compared with baseline LVEF, Up to 8 years
Use of Thermal Imaging Camera to Assess Perfusion Before and After Vascular Intervention
NCT Number: NCT06544135
Acronym: TIC
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Peripheral Arterial Disease|Critical Limb Ischemia|Critical Lower Limb Ischemia
Interventions: DEVICE: FLIR One Pro LT
Sponsor: Jun Li
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 25
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-01
Completion Date: 2027-10
Locations: University Hospitals Ahuja Medical Center, Beachwood, Ohio, 44122, United States|University Hospitals Cleveland Medical Center, Cleveland, Ohio, 44106, United States|University Hospitals Parma Medical Center, Parma, Ohio, 44129, United States

Summary:
This is a preliminary prospective observational study measuring change in lower extremity temperature in response to revascularization procedure.

The main question this study aims to answer is:

- Are temperature measurements from a forward looking infrared (FLIR) camera of the lower extremity useful in predicting outcome of revascularization procedures?

Primary Outcome Measures: Change in ABI, Ankle brachial index will be taken before and after intervention and correlated with thermal readings from FLIR., Up to 90 days before revascularization; Up to 1 year after revascularization
Secondary Outcome Measures: Major amputations, Any associated amputations the subject had after revascularization, Up to 1 year after revascularization|Major revascularizations post-initial intervention, Any revascularization procedures done after the initial revascularization, Up to 1 year after revascularization|Mortality, Subject deaths during the length of the study, Up to 1 year after revascularization
Effect of Transcranial Direct Current Stimulation on the Voice
NCT Number: NCT06544122
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Voice and Resonance Disorders|Transcranial Direct Current Stimulation|Voice Disturbance
Interventions: DEVICE: Transcranial direct current stimulation
Sponsor: Universidade Federal de Pernambuco
Sex: ALL
Age: ADULT
Enrollment: 16
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2023-03-30
Completion Date: 2024-04-20
Locations: Laboratório de Neurociência Aplicada, Recife, Pernambuco, 50740-560, Brazil

Summary:
The goal of this clinical trial is to verify the effect on the voice of transcranial direct current stimulation (tDCS) in vocally healthy non-singers. The main question it aims to answer is: What is the brain area in which tDCS promotes better vocal performance in vocally healthy individuals? Each participants received anodal tDCS applied at an intensity of 2 mA for a duration of 20 minutes for tDCS stimulations in different areas with a 7-day washout period between stimulations. Vocal assessments was conducted before and after the intervention. The targeted places were the primary motor cortex (M1), primary somatosensory cortex (S1), Cerebellum, and dorsolateral prefrontal cortex (DLPFC).

Primary Outcome Measures: Vocal range profile, Min f0 (Hz) Max f0 (Hz) Ext f0 (Hz) Ext (ST) Mín int (dB) Max int (dB) Area (%)

Min f0 (Hz) Max f0 (Hz) Ext f0 (Hz) Ext (ST) Mín int (dB) Max int (dB) Area (%)

Minimum f0 (Hz); Maximum f0 (Hz); Extension f0; Extension in St; Minimum intensity (dB); Maximum intensity (dB); Area (%), through study completion, an average of 6 months
Secondary Outcome Measures: Voice, Jitter (%); Shimmer (%); Irregularity; GNE; DAI, through study completion, an average of 6 months|Laryngeal diadochokinesis, Change in the task of producing vowels separately, with rapid repetition of each vowel as quickly as possible for eight seconds, through study completion, an average of 6 months|Vocal effort, The Adapted Borg CR10 for Vocal Effort Ratings (BR) maintained a scale from 0 to 10, where 0 means "no vocal effort at all", and 10 "maximum vocal effort". First, the participants have to reproduce a note played on a virtual keyboard (3 tones below their maximum glissando frequency) and sustain the note while counting from 21 to 30, immediately afterwards, the participants answered the Adapted Borg CR10 for Vocal Effort Ratings (BR)., through study completion, an average of 6 months
Venetoclax for Prevention of Differentiation Syndrom in Acute Promyelocytic Leukemia Patients
NCT Number: NCT06544109
Acronym: Ven APL
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: PHASE2|PHASE3
Conditions: Acute Promyelocytic Leukemia
Interventions: DRUG: venetoclax
Sponsor: The First Affiliated Hospital of Soochow University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 98
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2023-08-01
Completion Date: 2028-08-01
Locations: Qiu huiying, Suzhou, Jiangsu, 215006, China

Summary:
This study is to assess the efficacy and safety of venetoclax for prevention of DS in APL patients undergoing ATRA/ATO induction regimen.

Primary Outcome Measures: the rate of differential symdrom, DS, known as retinoic acid syndrome, is a severe complication of ATRA or ATO during the differentiation of promyelocytes. Signs of DS are presented as fever, weight gain, hypertension, dyspnoea, radiographic opacities, peripheral edema and acute renal failure., the induction regimen (21 days to 28 days)
Application Evaluation of Newborn Home Skin Care Management System Under the Service of "WeChat Platform+Health Care"
NCT Number: NCT06544096
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Infants
Interventions: BEHAVIORAL: intervention group (WeChat platform + healthcare)|BEHAVIORAL: control group (routine health education)
Sponsor: Children's Hospital of Fudan University
Sex: ALL
Age: CHILD
Enrollment: 780
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-08-01
Completion Date: 2025-07-31
Locations: Children's Hospital of Fudan University, Shanghai, Shanghai, 201102, China

Summary:
Through the establishment of the newborn home skin care management system under the service of "WeChat platform+health care", the investigators focus on the common skin problems of newborns at home, push health education materials through the system, teach parents the methods and details of home skin care, and evaluate the effect of the system on reducing the incidence of newborn home skin problems and the prognosis of home skin problems through cluster randomized controlled research.

Primary Outcome Measures: Incidence of diaper dermatitis in newborns at home, The proportion of people with diaper dermatitis in the total number of people in the study.The diagnosis of diaper dermatitis is based on any rash in the diaper area reported by parents., Within six months after birth
Secondary Outcome Measures: Incidence rate of neonatal home facial eczema, The proportion of people with eczema in the total number of people in the study.The subjects reported by parents are itching, typical morphology and location (flexor dermatitis) or atypical morphology and location accompanied by xeroderma and chronic or recurrent course of disease; Have the above three items at the same time to diagnose., Within six months after birth
Early-stage Detection of Liver Cancer by Proteins in Peripheral Blood
NCT Number: NCT06544083
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Hepatocellular Carcinoma
Interventions: DIAGNOSTIC_TEST: Proteomics
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-02-05
Completion Date: 2026-02-28
Locations: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, 310009, China

Summary:
By collecting blood samples from liver cancer patients and healthy individuals, and comparing the blood protein profiles of the two, the biomarkers for early diagnosis and tissue traceability were identified to accurately establish an early diagnosis model for liver cancer and verify its efficacy.

Primary Outcome Measures: Peripheral blood protein concentrations, The blood of liver cancer patients before treatment and the blood of non-liver cancer subjects were collected, and the differences between the peripheral blood protein characteristics of the above groups and those of non-liver cancer subjects and the blood protein characteristics that can be used for tissue traceability were analyzed. Peripheral blood protein concentrations were quantitatively measured by proteomic methods. Univariate COX regression method will be used to analyze whether the differences between the two groups are related to the diagnosis of liver cancer., up to 2 years|An early diagnosis model of liver cancer, The sensitivity and specificity of an early diagnosis model for the diagnosis of liver cancer based on peripheral blood protein indexes and the accuracy of tissue traceability were established and verified., up to 2 years
Secondary Outcome Measures: Presence or absence of intrahepatic and extrahepatic metastases of liver cancer, The number and size of intrahepatic and extrahepatic metastases of liver cancer were measured by imaging methods to evaluate whether they were associated with the high risk predicted by the diagnostic model of liver cancer., up to 2 years
Capillary Blood Accuracy
NCT Number: NCT06544070
Acronym: CAPYBARA
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cancer
Interventions: DEVICE: Entia Liberty System
Sponsor: Entia Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 180
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-11-04
Completion Date: 2025-11-03

Summary:
Entia is a health technology company that has developed a blood testing device called Entia Liberty, which analyses blood collected by a finger prick. Entia is sponsoring this research study to compare the results from Entia Liberty finger prick tests to results from the gold-standard laboratory analyser that tests blood from the arm, port, or PICC line.

Primary Outcome Measures: Validity of of the Liberty System for haematological parameters of interest: Hb, WBC, PLT, ANC, The accuracy of the Liberty System will be measured by comparing the results of finger-prick blood samples that have been analysed using the Liberty System to the results of venous (blood from the arm, port or PICC line) blood samples that have been analysed by a standard laboratory haematology analyser., Through study completion, up to 8 days per participant.|Reliability of of the Liberty System for haematological parameters of interest: Hb, WBC, PLT, ANC, To measure the precision of the Liberty System by comparing the results of finger-prick blood samples that have been analysed by the Liberty System to each other, and to venous (blood from the arm, port or PICC line) blood samples that have been analysed by the Liberty System., Through study completion, up to 8 days per participant.
Efficacy of Brief Mindfulness Based Self- Compassion Intervention for Management of Anger Among Adolescents
NCT Number: NCT06544044
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Aggression
Interventions: BEHAVIORAL: Brief Mindfulness' Self compassion
Sponsor: Fatima Noor
Collaborators: Fatima Jinnah Women University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 25
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SCREENING
Start Date: 2024-02-10
Completion Date: 2024-06-10
Locations: Muhammad Rizwan, Multan, Punjab, Pakistan

Summary:
This study investigates the effectiveness of a short self-compassion mental intervention in reducing aggression among adolescents. Although they display potential, current solutions are arduous and time-consuming. The study provides preliminary results on the effectiveness of this method in addressing the lack of information. The intervention's simplicity and precision have the potential to greatly influence the treatment of teenage violence. This could lead to the general acceptance and implementation of mindfulness-based self-compassion, making it accessible at a reasonable cost. The study's brevity and specificity hold promise for broader implementation. A significant gap exists in the literature concerning brief mindfulness-based self-compassion interventions tailored specifically to address adolescent aggression. Most existing studies have explored more extended interventions or general mindfulness programs, leaving a dearth of research on the effectiveness of concise, targeted interventions for adolescents dealing with aggression.

Primary Outcome Measures: Psychological Wellbeing, after the intervention (mindfullness) students shows the significant improvement in their psychological wellbeing, 1 Month
Enhancing Knowledge and Attitudes Through the 'Healthy Nutrition' Education Program
NCT Number: NCT06544031
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Health Behavior|Nutrition, Healthy|Educational Activities
Interventions: BEHAVIORAL: Healthy Nutrition Education Program
Sponsor: Izmir Democracy University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 69
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2023-07-15
Completion Date: 2023-09-01
Locations: İzmir Democracy University, İ̇zmi̇r, Konak, 3505035, Turkey

Summary:
This study aims to assess the impact of a "Healthy Nutrition" education program on the knowledge and attitudes towards healthy eating among elderly individuals residing in a Social Life Campus. The study utilizes a Solomon four-group experimental design, involving participants divided into an experimental group and a control group. Participants were selected based on their ability to effectively participate in the education program, with no psychological or neurological illnesses

Primary Outcome Measures: Change in Nutrition Knowledge, The change in nutrition knowledge levels before and after the intervention will be assessed using the Nutrition Knowledge Scale (NKS). Developed by Yılmaz et al. in 2021, the NKS evaluates adult nutrition knowledge across food and nutrient knowledge, food preparation and cooking methods, and the relationship between nutrition and health. The scale includes both positive and reverse-scored items, rated on a 5-point Likert scale. The total score ranges from 0 to 126, with higher scores indicating greater nutrition knowledge. Specific cut-off points are as follows: \<79 for low knowledge, 79-89 for medium, 90-100 for high, and \>101 for very high knowledge levels.

Ref: Öngün Yılmaz, H., et al. (2021). Nutrition Knowledge Scale (NKS): Development, factor structure, and validation for healthy adults. Progress in Nutrition, 23(3). Available at: Mattioli 1885 Journals., Pre-test (baseline) and post-test (immediately after the intervention for experimental groups; same time points for control groups).
Secondary Outcome Measures: Change in Healthy Nutrition Attitudes, The change in attitudes towards healthy nutrition before and after the intervention will be evaluated using the Healthy Nutrition Attitude Scale (HNAS).

Measurement Tool: The Healthy Nutrition Attitude Scale (HNAS) was developed by Demir and Cicioğlu in 2019. It consists of 21 items categorized into four factors: Nutrition Knowledge (NK), Emotional Attitude towards Nutrition (EAN), Positive Nutrition (PN), and Poor Nutrition (PN). The scale is rated on a 5-point Likert scale, with higher scores indicating a more favorable attitude toward healthy nutrition.

Scoring: The possible score ranges are:

21 points: Very low attitude 23-42 points: Low attitude 43-63 points: Moderate attitude 64-84 points: High attitude 85-110 points: Ideal level of healthy nutrition attitude, Pre-test (baseline) and post-test (immediately after the intervention for experimental groups; same time points for control groups).
Implication of Long Non-coding RNA HOTTIP Haplotype on Liver Cancer Metastasis
NCT Number: NCT06544005
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Hepatocellular Carcinoma
Sponsor: Ain Shams University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 198
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-03-16
Completion Date: 2024-12
Locations: Faculty of Pharmacy, Ain Shams Univeristy, Advanced Biochemistry Research Lab., Cairo, Egypt

Summary:
Hepatocellular carcinoma (HCC) represents the fourth common cancer and the most common cause of mortality-caused and morbidity-related cancer. Different reports implied several lncRNAs role in the progression and metastasis of HCC such as Homeobox A (HOXA) transcript at the distal tip (HOTTIP). Dysregulation of HOTTIP is associated with various malignancies including HCC, affecting survival and prognosis of cancer patients. HOTTIP promoted HCC cell proliferation/metastasis and might act as an oncogenic-lncRNA in HCC.

Genetic variations such as single-nucleotide polymorphisms (SNPs), when inherited together, as a group, known as haplotypes. Haplotypes can alter the expression of coding genes and the protein non-coding genes like lncRNAs, therefore, affecting the disease course, including liver, a hypothesis to be addressed.

Only few studies have focused on the polymorphisms of the onco-lncRNA HOTTIP gene. A study found that specific HOTTIP SNPs have the potential to be biomarkers for HCC risk and prognosis, where one haplotype of HOTTIP "rs17501292-rs2067087-rs17427960" showed a 1.91-fold increased risk of HCC.

Primary Outcome Measures: Primary outcome, By the end of the current study, investigators will have elucidated the association of polymorphisms of SNPs (rs17501292\& rs2067087) in the lncRNA HOTTIP with HCC metastasis risk by comparing the two group of patients together using logistic regression. Additionally, investigators will assess prognosis in metastatic and non-metastatic primary HCC patients in liquid biopsy samples by using APRI score as an indicator of the prognosis.

Finally, by using Kaplan-Meier curve, the overall survival of each group will be compared and related with each SNP polymorph., 29 months
Anorectal Manometery in Pediatric Chronic Refractory Constipation
NCT Number: NCT06543979
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Chronic Constipation
Interventions: DRUG: lubiprostone , single arm|PROCEDURE: biofeed back sessions|PROCEDURE: botox injection
Sponsor: Ain Shams University
Sex: ALL
Age: CHILD
Enrollment: 60
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2025-10-01

Summary:
Anorectal manometry and high-resolution anorectal manometry (HRAM) are becoming the investigation of choice for understanding the pathophysiology of chronic constipation with or without fecal incontenance in children in many institutions. In high resolution anorectal manometery we are able to gain information whether the symptoms are related to sphincter dysfunction, impaired sensation, or pelvic floor dyssynergia

Primary Outcome Measures: To evaluate the manometric parameters in children with chronic refractory constipation, To measure the percent of the most common manometric parameters in children with chronic refractory constipation e.g dyssengeric defecation and reduced rectal sensetivity and anal sphincter dysfunction., 1 year|evaluate the efficacy of oral administration of lubiprostone 8 and 24 μg once daily for 4 weeks in participants with chronic refractory constipation, Spontaneous Bowel Movement (SBM) Frequency at Week 1,2,3 and 4 A SBM was defined as any bowel movement (BM) that does not occur within 24 hours after rescue medication use (laxative, suppository, or enema). Participants will be given a diary to complete at home where they will record all details of each SBM including the consistency of the stool and the difficulty they have in passing it., 1 month
Secondary Outcome Measures: To determine the effect of biofeed back sessions in children with dyssengeric defecation and in children with rectal hyposensetivity, Participants with chronic refractory constipation and manometry parameters showed dyssengeric defecation or hyposensitivity will receive biofeedback sessions and the investigators measure the difference in bowel management scoring tool before and after the biofeedback sessions the higher the score the worest the condition, 3 months|To determine the effect of cow milk protein free diet on chronic refractory constipation in children, Participants will receive cow milk free diet for 4 weeks and investigators measure the difference in bowel management scoring tool before and after cow milk free diet the higher the score the worest the condition, 1 month|To determine the effect of botulinum toxin injection in children with elevated anal canal resting pressure, Participants with chronic refractory and manometric parameters showed high anal canal resting pressure will have botulinum toxin injection and investigators measure the difference in bowel management scoring tool before and after the injection the higher the score the worest the condition, 3 month