pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Investigation of Filaggrin Gene Mutations Among Latinx Patients With Atopic Dermatitis
NCT Number: NCT06464133
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Atopic Dermatitis|Eczema
Sponsor: University of Pennsylvania
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-15
Completion Date: 2027-12-31

Summary:
The study, Investigation of Filaggrin Gene Mutations among Latinx patients with Atopic Dermatitis, will examine the association between pathogenic FLG LOF variants and AD in a new population of Latinx patients for which clinical and disease characteristics will be well-described.

Primary Outcome Measures: To identify and describe Filaggrin (FLG) loss of function (LOF) variants in the GAD-L cohort using a high-throughput PCR approach that incorporates Fluidigm microfluidics technology and next-generation sequencing (NGS) to sequence the entire FLG gene., 2 year data/sample collection period - cross-sectional cohort study of patients with a diagnosis of atopic dermatitis
Other Outcome Measures: To examine the association between loss of function (LOF) Filaggrin (FLG) mutations and disease onset and severity among Latinx patients with atopic dermatitis (AD)., 2 year data/sample collection period - cross-sectional cohort study of patients with a diagnosis of atopic dermatitis
Endometrial Cell Collection With the PadKit
NCT Number: NCT06464107
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Neoplasms
Interventions: DEVICE: PadKit™ from Preprogen
Sponsor: Hackensack Meridian Health
Collaborators: Preprogen
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SCREENING
Start Date: 2024-05-31
Completion Date: 2026-05-30
Locations: Jersey Shore University Medical Center, Neptune, New Jersey, 07753, United States|Riverview Medical Center, Red Bank, New Jersey, 07701, United States

Summary:
All patients will be provided with a Preprogen Pad to be worn for 4-6 hours to collect cells shed by the endometrium. After the kit is returned to the Preprogen laboratory, a brief survey will be completed. Analysis will be conducted to determine if the PadKit™ can collect a sample of endometrial cells sufficient to differentiate between normal and atypical hyperplasia/malignant cells in blinded samples provided to the laboratory for analysis.

Primary Outcome Measures: Observation of the presence of endometrial cells captured by the pad., Direct observation of the absence or presence of endometrial cells on the pad by the pathologist, Within 7 days after receipt of the pad from patients|Association of the presence/absence of cells and morphology, Analysis for the presence of abnormal histology and morphological classification as normal, hyperplastic, or malignant., Within 7 days after receipt of the pad from patients
Secondary Outcome Measures: Patient preferences - Comfort, To determine patient preferences for using the interlabial PadKit™ vs current standard of care diagnostic tools including transvaginal ultrasound, endometrial biopsy, CT scan, and/or Dilation \& Curettage (D\&C).

Patient preferences regarding comfort of wearing the pad are captured using a 1-3 Likert scale with 1 being not comfortable and 3 being comfortable., Within the same day and after wearing the pad for 4-6 hours|Patient preferences - Simplicity of using the pad, To determine patient preferences for using the interlabial PadKit™ vs current standard of care diagnostic tools including transvaginal ultrasound, endometrial biopsy, CT scan, and/or Dilation \& Curettage (D\&C).

Patient preferences regarding simplicity of using the pad are captured using a 4 Likert scale with 1 being not easy and 4 being very easy., Within the same day and after wearing the pad for 4-6 hours
Tongue Muscular Assessment in Children (TMAC) - Reproducibility Testing
NCT Number: NCT06464081
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Healthy
Interventions: OTHER: Sleep quality assessment|OTHER: Anthropometry|OTHER: Tongue strength assessment|OTHER: Tongue endurance assessment|OTHER: Orofacial praxis assessment
Sponsor: Université Catholique de Louvain
Sex: ALL
Age: CHILD
Enrollment: 56
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2026-02-01
Locations: Cliniques universitaires Saint-Luc, Woluwe-Saint-Lambert, Brussels, 1200, Belgium

Summary:
This study aims to assess intra-rater and inter-rater reliability in measuring tongue motor skills in children.

Primary Outcome Measures: Test-retest reproducibility of tongue peak pressure, Tongue peak pressure during elevation and protrusion movements will be measured. The inter-rater and intra-rater reliability of these measures will be computed., Measured at baseline, and then at two other time points. These three time points will each be interspersed by a one-week to one-month interval
Secondary Outcome Measures: Test-retest reproducibility of tongue endurance, Tongue endurance during elevation and protrusion movements will be measured. The inter-rater and intra-rater reliability of these measures will be computed., Measured at baseline, and then at two other time points. These three time points will each be interspersed by a one-week to one-month interval|Test-retest reproducibility of tongue pressure during swallowing, Tongue pressure during swallowing will be measured. The inter-rater and intra-rater reliability of these measures will be computed., Measured at baseline, and then at two other time points. These three time points will each be interspersed by a one-week to one-month interval|Test-retest reproducibility of tongue mobility restriction, Assessed through the ratio between maximal mouth opening and maximal mouth opening with tongue to palate. The inter-rater and intra-rater reliability of these measures will be computed., Measured at baseline, and then at two other time points. These three time points will each be interspersed by a one-week to one-month interval|Test-retest reproducibility of orofacial praxis, Orofacial praxis will be assessed. The inter-rater and intra-rater reliability of this measure will be computed., Measured at baseline, and then at two other time points. These three time points will each be interspersed by a one-week to one-month interval
Complications in Pediatric Mechanical Circulatory Assistance: Evaluation of Infection Management.
NCT Number: NCT06464016
Acronym: VADINFECT
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Heart-Assist Devices|Infections|Heart Transplant Infection
Interventions: DEVICE: Ventricular Assist Device with Berlin Heart EXCOR
Sponsor: Claude Bernard University
Collaborators: Hospices Civils de Lyon
Sex: ALL
Age: CHILD, ADULT
Enrollment: 47
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-07-04
Completion Date: 2025-11-01
Locations: Hospices Civils de Lyon, Lyon, 69677, France

Summary:
Heart failure is a major cause of mortality and morbidity in children. Heart transplantation can significantly improve the prognosis of patients with severe heart failure, but access is limited by a shortage of transplants.

Long-term mechanical circulatory support is a major advance in the management of heart failure and can provide haemodynamic support while awaiting myocardial recovery or heart transplantation. The Berlin Heart (BH) EXCOR is the only long-term support system available for children.

Despite technical and medical advances in circulatory support, infection is a common complication and a major cause of morbidity and mortality in patients on BH.

There are few studies on the management of infection with mechanical support. Current ISHLT (International Society for Heart and Lung Transplantation) recommendations are based on expert opinion and observational studies. Some experts recommend anti-infective therapy until transplantation for specific support infections or for support-associated infections with persistent bacteraemia.

Primary Outcome Measures: Relapse of VAD-infection after discontinuation of anti-infective therapy, Clinical and microbiological diagnosis of recurrence of infection with the same pathogen within 3 months of cessation of anti-infective therapy for a VAD-specific or VAD-related infection., 3 months
Orthodontic Screening in Public Healthcare
NCT Number: NCT06464003
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Malocclusion|Compliance, Patient
Interventions: OTHER: Questionnaire
Sponsor: University of Helsinki
Sex: ALL
Age: CHILD
Enrollment: 350
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-06
Completion Date: 2026-06-06
Locations: University of Helsinki, Helsinki, FI-00014, Finland|Vantaa and Kerava wellbeing services county, Vantaa, 01030, Finland

Summary:
The aim of the study is to examine orthodontic screening practises in public health care.

Primary Outcome Measures: Treatment need, Orthodontic treatment need, Baseline
Secondary Outcome Measures: Subjective evaluation, A questionnaire enquiring subjective evaluation of the treatment need and impact of malocclusion on oral heath related quality of life, Baseline
Influence of TyG Index and TG/HDL-C Ratio on Fetal Macrosomia
NCT Number: NCT06463990
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Fetal Macrosomatia|Lipid Metabolism Disorders|Hyperlipidemias
Interventions: OTHER: TyG index
Sponsor: Ankara Etlik City Hospital
Sex: FEMALE
Age: ADULT
Enrollment: 302
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-01-01
Completion Date: 2024-08-25
Locations: Ankara Etlik City Hospital, Ankara, Yenimahalle, Turkey

Summary:
Metabolic disorders that can occur during pregnancy, in particular disorders of lipid metabolism and insulin resistance, can have a detrimental effect on pregnancy and the fetus.

The triglyceride level and other lipids increase slightly during pregnancy. This increase has a positive effect on the development of the fetus. However, an excessive increase in lipid levels can cause some metabolic disorders such as gestational diabetes and increase feto-maternal morbidity/mortality.

While some existing studies have shown that elevated triglyceride levels can cause fetal macrosomia, others have found no correlation between these two variables. The ratio of triglycerides to HDL is a widely used marker for lipid disorders. In addition, the triglyceride-glucose index is also an index used to detect insulin resistance.

Primary Outcome Measures: The TyG index, The triglyceride-glucose index was determined using the formula Ln \[fasting triglycerides (mg/dL) × fasting plasma glucose (mg (dL)/2\], with blood samples taken from pregnant women in the third trimester., between 28 and 40 weeks of pregnancy|The triglyceride to high density lipoprotein cholesterol ratio, The triglyceride to high density lipoprotein cholesterol ratio was calculated from the blood samples taken from pregnant women in the third trimester., between 28 and 40 weeks of pregnancy
Secondary Outcome Measures: HOMA-IR, HOMA-IR was calculated according to the formula: fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5 with blood samples taken from pregnant women in the third trimester., between 28 and 40 weeks of pregnancy
Predictors of Acute Kidney Injury in Patients With Acute Decompensated Heart Failure in Emergency
NCT Number: NCT06463964
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Acute Kidney Injury|Acute Heart Failure
Interventions: DIAGNOSTIC_TEST: Serum Creatinine
Sponsor: Sohag University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-01
Completion Date: 2024-12-01
Locations: Sohag university Hospital, Sohag, Egypt

Summary:
Acute Decompensated Heart Failure ADHF is one of the leading causes of hospitalization. ADHF is a growing global health problem affecting more than 26 million individuals worldwide Acute Kidney Injury AKI is a common event in the natural disease history of patients with Heart Failure HF, The clinical importance of the co-existence of acute cardiac and renal dysfunction, known as acute cardiorenal syndrome CRS, and its management have recieved great attention recently Various studies have employed different criteria to define and calssify AKI. According to Risk, Injury, and Failure; and Loss, and End-stage kidney disease RIFLE criteria formulated by the Acute Dialyisis Quality Initiative ADQI AKI can be divided into five stages; renal injury risk, renal impairment, renal failure, renal function loss, and end stage kidney disease

Primary Outcome Measures: Change in serum creatinine in mg/dL in patients with acute decompensated heart failure in ER, Change in serum creatinine in patients with acute decompensated heart failure in ER, 6 months
A Clinical Trial to Compare Lasotronix Alone or in Combination With CPP-ACP to Treat DH
NCT Number: NCT06463938
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dentin Sensitivity|Hypersensitivity|Cervical Lesion
Interventions: OTHER: Active comparator|DEVICE: Experimental group|COMBINATION_PRODUCT: Combination of laser and paste|BEHAVIORAL: Control group
Sponsor: Dow University of Health Sciences
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-05-12
Completion Date: 2024-10-10
Locations: Dr Sanam Faheem, Karachi, Sindh, 75330, Pakistan

Summary:
Dentin hypersensitivity (DH) is defined as sharp pain of a shorter duration arise from exposed dentin in response to several chemicals and thermal or tactile stimuli that cannot be ascribed to other dental defects". DH has a prevalence rate ranging from 1.3% to 92.1%, commonly affecting old ages. The use of laser has opened new dimensions in the treatment of DH. To the author's knowledge, not much research work has been conducted using LASOTRONIX as a treatment modality with CPP-ACP. Therefore, this research aims to determine the effectiveness of Casein phospho peptide paste (CPP-ACP) used alone or combined with a diode laser (LASOTRONIX).

Primary Outcome Measures: treatment of dentin hypersensitivity, VAS Visual analogue scale will be used to determine the efficacy of different treatment methods., 0-3 moths
Evaluation of Effaclar Duo+M on Acne Lesions in Subjects With Mild to Moderate Acne on Face and Trunk
NCT Number: NCT06463925
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Acne
Interventions: OTHER: acneic participants group
Sponsor: Cosmetique Active International
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 65
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2023-12-07
Completion Date: 2024-09
Locations: CIDP Brasil, Rio De Janeiro, Brazil

Summary:
This single-center, open, non-randomized study aims the efficacy evaluation of Effaclar Duo+M and Effaclar+M Purifying foaming gel on total acne lesion count, pigmented lesions and scars for 6 months in subjects with mild to moderate facial and truncal acne.

Primary Outcome Measures: efficacy on total acne lesion count on face and trunk, The counting is performed by region (back, chest, face, total) and type of lesion (post-inflammatory hyperpigmentation, post-inflammatory erythema, scars, pustules, nodules, papules, closed comedones, open comedones., from baseline to Day168
Secondary Outcome Measures: Evaluation of the degree of severity of acne on the face, Evaluation performed thanks to the Global Evaluation Acne (GEA) scale on a 6-point score: from 0 (Clean. No lesions) to 5 (Very severe)., from baseline to Day168|Evaluation of the degree of severity of acne on the trunk, Evaluation performed thanks to the Investigator Global Assessment (IGA) scale on a 6-point score: from 0 (Absent) to 5 (Very serious)., from baseline to Day168
Screening for Hepatitis c in People Who Inject Drugs in Armenia-Colombia
NCT Number: NCT06463912
Acronym: HCV-PIWD
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Hepatitis C Virus Infection
Interventions: OTHER: Does not apply
Sponsor: Asociación Colombiana de Hepatología
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 205
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-20
Completion Date: 2025-03-31
Locations: Colombian Association of Hepatology, Armenia, Quindio, 050001, Colombia

Summary:
Hepatitis C virus infection is a major cause of chronic hepatitis, cirrhosis, and liver cancer. The risk of developing cirrhosis for people with chronic infection with the virus ranges from 15% to 30% over 20 years. Despite undeniable advances in the treatment of hepatitis C infection and the WHO strategy to eliminate hepatitis C by 2030, this infection continues to be a major public health problem globally and many HCV-positive individuals are unaware of their HIV status. People who inject drugs (PWID) are at increased risk for HCV. Several studies have reported high HCV prevalence rates, especially among PWID. PWID are usually exposed to a higher risk of various infectious diseases, mainly due to their drug consumption behaviors and habits, in addition to the risks and harms associated with the respective routes of self-administration.

Worldwide, there are around 11 million PWIDs and there are approximately 2.3 million coinfections between HIV and HCV worldwide, of which more than half (1.3 million) occur in PWID. The coexistence of these two health conditions leads to accelerate the progression of liver disease. The global prevalence of HCV in 2019 among PWID was 50.2%, which is equivalent to 5.6 million people who inject drugs and live with hepatitis C. PWID had been considered a difficult group to reach, manage, and treat because HCV treatment management in these individuals is challenging and they have a higher risk of reinfection and some past HCV treatment guidelines excluded PWIDs from consideration, citing concerns about adherence, increased susceptibility to side effects, and reinfection. However, there is now compelling evidence that HCV treatment is safe and effective among PWID.

In Colombia, the prevalence of hepatitis C among PWID has been measured locally in some cities. In Bogotá, it went from 1.7% in 2002 to 6.7% in 2014. For 2021, the prevalence of hepatitis C was measured in Bogotá, Medellín, Santiago de Cali, the metropolitan area of Pereira, Dos Quebradas, Medellín, Cucuta, and Armenia. The results of prevalence of antibodies against hepatitis C were as follows: Cali with 80.2%, is the city with the highest reactivity, followed by Pereira and Dos Quebradas with 71.4%, Armenia with 69.6%, and Cucuta with 62.8%. We do not have recent data about the impact of intervention to reduce HVC transmission in those groups.

Primary Outcome Measures: HCV antibody prevalence rate, Hepatitis C virus prevalence, 10 months
Secondary Outcome Measures: Proportion of patients with access to HCV treatment, Access to treatment for hepatitis C virus infection, 10 months
Striving Towards EmPowerment and Medication Adherence R01
NCT Number: NCT06463886
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hiv|Mental Health Issue
Interventions: BEHAVIORAL: STEP-AD|BEHAVIORAL: Enhanced treatment as usual (E-TAU)
Sponsor: University of Miami
Collaborators: National Institute of Mental Health (NIMH)
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 250
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-19
Completion Date: 2029-06-01
Locations: University of Miami, Miami, Florida, 33136, United States

Summary:
This is a study for Black women living with HIV to test a counseling program for Black women living with HIV. This participant may be a good fit if the participant is a Black woman, living with HIV, has a history of trauma, and is currently taking Antiretroviral Therapy (ART) medicines

Primary Outcome Measures: Change in viral suppression, HIV viral load \<200 copies/ml time averaged. Measured by blood specimen., Baseline up to 1.5 years
Secondary Outcome Measures: Change in antiretroviral (ART) adherence, A 3-item self-report instrument that will measure reported adherence to ART. Responses range from 1 to 6. Responses will be averaged (min average of 1, max average of 6) across items with higher scores indicating higher adherence to ART medication., Baseline up to 1.5 years|Change in adherence to anti-retroviral medications questionnaire, A list of 12 reasons why individuals may miss taking their ART (e.g., forgot, change in routine) will be used from the AIDS Clinical Trials Group. The minimum score is 0 (no endorsed reasons for missing medication) and maximum score is 36 (endorsing more reasons for missing ART medication)., Baseline up to 1.5 years|Change in engagement in HIV care, Number of kept versus number of scheduled visits verified by self-report., Baseline up to 1.5 years|Change in PTSD as measured by PCL-5, Measured by the Posttraumatic Stress Disorder Checklist (PCL)-5, a 20-item self-report measure of PTSD symptoms. A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items. Higher scores indicate higher PTSD severity., Baseline up to 1.5 years|Change in Post-traumatic cognitions measured by PTCI, The Posttraumatic Cognitions Inventory (PTCI) is a 36-item, self-report questionnaire, and each item is rated on a 7-point Likert scale that ranges from 1 (totally agree) to 7 (totally disagree)., Baseline up to 1.5 years|Change in Post-traumatic Stress Disorder Diagnosis, A structured mental health diagnostic interview will be administered to evaluate participants' mental health symptoms and whether they meet criteria for mental health diagnoses (e.g. Post-traumatic Stress Disorder)., Baseline up to 1.5 years
Study of OmniGraft in Simultaneous Pancreas Kidney Recipients
NCT Number: NCT06463873
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Kidney Transplant; Complications|Pancreas Disease
Sponsor: University of Miami
Collaborators: Eurofins Lancaster Laboratories
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-01
Completion Date: 2027-07-17
Locations: University of Miami, Miami, Florida, 33136, United States

Summary:
The purpose of this research is learn about how OmniGraf works in kidney pancreas transplant patients. Also, to analyze the performance characteristics of OmniGrafTM (TruGraf Gene Expression Profiling (GEP) and T Cell Receptor Alpha Constant (TRAC) dd-cfDNA) in a population of simultaneous kidney pancreas transplants as a part of routine surveillance, as well as a part of the workup for patients clinically suspected to have rejection of the kidney and/or pancreas.

Primary Outcome Measures: Number of participants that underwent SPK transplant, Number of participants that underwent SPK transplant measured by Omnigraft testing. The Omnigraft test includes TruGraf GEP and TRAC dd-cfDNA., Up to 3 years
A Study of Sintilimab Combined With Chemotherapy for Neoadjuvant Treatment of Esophageal Squamous Cell Carcinoma
NCT Number: NCT06463834
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Esophageal Squamous Cell Carcinoma
Interventions: DRUG: Sintilimab
Sponsor: Fujian Cancer Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-03-20
Completion Date: 2028-03-19
Locations: Fujian Cancer Hospital, Fuzhou, Fujian, 350014, China

Summary:
This study is aimed to evaluate the efficacy and safety of sintilimab combined with chemotherapy (docetaxel+cisplatin+5-fluorouracil, DCF) in neoadjuvant treatment of locally advanced esophageal squamous cell carcinoma.

Primary Outcome Measures: Pathological complete response, Total tumor regression rate under pathologyPrimary tumor or lymph node surgery specimen pathological examination without residual tumor cell, 4 weeks after surgery
Secondary Outcome Measures: Major pathological response, Total/moderate tumor regression rate under pathologyPrimary tumor or lymph node surgery specimen pathological examination without residual tumor cell, 4 weeks after surgery|Disease-free survival period, After surgery, there is no time for the disease to recur., 3-year|Incidence rate of adverse events, The ratio of the number of cases with adverse events to the total number of cases available for evaluation., 3-year
Symptom Spectrum and Risk Factors for Fever in Pediatric and Adult Patients With Omicron Infection
NCT Number: NCT06463821
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Symptom Spectrum and Risk Factors for Fever
Interventions: OTHER: observational questionnaires
Sponsor: Shanghai Children's Medical Center
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 2591
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-04-08
Completion Date: 2022-05-17
Locations: child-parent sections of the Fangcang shelter hospitals, Shanghai, China

Summary:
The omicron variant of coronavirus disease 2019 (COVID-19) has caused a global epidemic in 2022. The aim was to investigate the symptom spectrum and risk factors for fever in pediatric and adult patients with omicron infection. From April 8, 2022 to May 17, 2022, this prospective observational study included patients who attended the child-parent sections of the Fangcang shelter hospitals with laboratory-confirmed COVID-19. Patient data were collected from questionnaires. The risk factors for prolonged fever and high fever were identified by univariate and multivariate analyses.

Primary Outcome Measures: Number of Participants with prolonged fever or high fever, Fever's defined as temperature ≥ 38.0℃. Prolonged fever's defined as fever for more than 2 days. High fever's defined as temperature ≥ 39.1℃. Questionnaires for basic characteristic're finished as soon as they're admitted. Questionnaires for symptom and medication use tracking're filled out every day until discharge. The risk factors for prolonged fever and high fever're identified by univariate and multivariate analyses., From April 8, 2022 to May 17, 2022
Effect of Recombinant Human Brain Natriuretic Peptide on Ventricular Remodeling and Cardiac Function in Patients With Acute Anterior Myocardial Infraction Undergoing Percutaneous Coronary Intervention
NCT Number: NCT06463808
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Ventricular Remodeling|Myocardial Infarction, Anterior Wall
Interventions: DRUG: Recombinant Human Brain Natriuretic Peptide
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-05-03
Completion Date: 2025-02-28
Locations: the First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China

Summary:
This study is designed to evaluate the efficacy and safety of Recombinant Human Brain Natriuretic Peptide (rhBNP) in improving ventricular remodeling and cardiac function after acute anterior myocardial infarction undergoing percutaneous coronary intervention. 100 patients with acute anterior myocardial infarction after primary Percutaneous Coronary Intervention (pPCI) are randomly assigned 1:1 to rhBNP group(n=50) and control group(n=50) with follow-up of 24 weeks. Both groups are treated with standard therapy of AAMI, with the rhBNP group intravenous dripping rhBNP after pPCI for 3 days and the control group treated with placebo at the same time. The primary endpoint is the change in N terminal pro-B-type natriuretic peptide（NT-proBNP ）and cardiac troponin T(cTnT) level.The secondary endpoint is the change in 24-week echocardiographic including left ventricle ejection fraction (LVEF) , left ventricular end-diastolic volume index (LVEDVI) and left ventricular end-systolic volume index (LVESVI), arrhythmia and cardiovascular events (death, cardiac arrest or cardiopulmonary resuscitation, hospitalization due to heart failure or angina pectoris).

Primary Outcome Measures: ultrasonic cardiogram：left ventricle ejection fraction (LVEF), LVEF refers to the percentage of stroke output to left ventricular end-diastolic, from baseline to 6 months|ultrasonic cardiogram：left ventricular end-diastolic volume index (LVEDVI), LVEDVI（ml/m2）=left ventricular end-diastolic volume（ml）/body surface area, from baseline to 6 months|ultrasonic cardiogram：left ventricular end-systolic volume index (LVESVI), LVESVI（ml/m2）=left ventricular end-systolic volume（ml）/body surface area, from baseline to 6 months|N terminal pro-B-type natriuretic peptide（NT-proBNP ）decline level, NT-proBNP is a protein which is an "ingredient" for making the BNP hormone and a sign of heart failure can be obteined by blood, from baseline to 6 months|The level of Cardiac Troponin T(cTnT), The level of Cardiac Troponin T(cTnT) at 6 month, from baseline to 6 months
Secondary Outcome Measures: Adverse cardiovascular events, from baseline to 6 months
tDCS and Lower Limb Performance in Stroke
NCT Number: NCT06463795
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stroke
Interventions: DEVICE: tDCS|DEVICE: Sham tDCS
Sponsor: Riphah International University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2025-01-31
Locations: Pakistan Railway General Hospital, Rawalpindi, Punjab, Pakistan

Summary:
Lower limb rehabilitation is especially important, as the simple act of regaining the ability to walk has subsequent effects on the ability to engage in activities of daily living .So, this study will contribute in describing the management of lower limb motor recovery along with the therapeutic intervention (MRP) with tDCS (anodal stimulation). This study aims to address some of the drawbacks observed in previous studies like allocation concealment, small sample size due to drop outs, short term effects of tDCS and experimental designs as well.

Primary Outcome Measures: FMA-lower extremity, FMA-LE is a method used to measure motor function, balance, and function of joints in post-stroke patients. Fugl Meyer Assessment of Lower Extremity (FMA-LE). FMA-LE is a method used to evaluate the performance of motor movement on the lower limbs (hips, knees, feet, and ankles) and predicts recovery function of motion in stroke patients. FMA-LE method consists of 17 items are organized into several sub-sections, namely reflection part, synergistic part, and coordination with Mild (˃45),Moderate (30-45),Severe (˂30) scores(12). It shows sensitivity of 0.87 and specificity of 0.81, 8 week|Six Minute walk Test, The Six-Minute Walk Test (6MWT) is a functional walking test in which the distance that a stroke patient can walk within six minutes is evaluated. This test has been used to assess individuals with stroke, head injury and Parkinson's disease. There are no actual items to the 6MWT.It is a simple test that requires a 100-ft, quiet, indoor, flat, straight rectangular hallway. The walking course must be 30m in length. The length of the 30m corridor must be marked by colored tape at every 3m. The turnaround must be marked with a cone. Some studies have used 20 and 50m corridors. It has excellent test-retest reliability (0.99 distance in meters) among stroke survivors, 8 week
Secondary Outcome Measures: Stroke Specific Quality of Life, The Stroke Specific Quality Of Life scale (SS-QOL) is a patient-centered outcome measure intended to provide an assessment of health-related quality of life specific to patients with stroke. It is a self-report scale containing 49 items in 12 domains including Energy, Mobility, Upper extremity function, Work/productivity, Mood, Self-care, Social roles, Family roles, Vision, Language, Thinking, and Personality. Score ranges from 49 to 245. Higher scores indicate better QOL(14).It has a sensitivity of 70.0% and a specificity of 75.8%, 8 week
AI Models to Predict Thyroid Cartilage Invasion in Laryngeal Carcinoma
NCT Number: NCT06463756
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Laryngeal Carcinoma|Thyroid Cartilage
Interventions: OTHER: AI
Sponsor: First Affiliated Hospital of Chongqing Medical University
Collaborators: Nankai University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 400
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-08-13
Completion Date: 2024-10-13
Locations: The First Affiliated Hospital of Chongqing Medical University, Chongqing, China

Summary:
This retrospective study was to develop and verify CT-based AI model to preoperatively predict the thyroid cartilage invasion of laryngeal cancer patients, so as to provide more accurate diagnosis and treatment basis for clinicians. In addition, the researchers investigated the prediction of survival outcomes of patients by the above optimal models.

Primary Outcome Measures: Area under the curve, AUC, Area under the curve(AUC) is a metric widely used in machine learning and medical research to evaluate the performance of models in binary classification problems. It reflects the ability of a model to identify true positives (True Positives) while avoiding falsely classifying negative examples as positive (False Positives)., Through study completion, an average of 6 months
Secondary Outcome Measures: Disease-Free-Survival, DFS, Disease-Free Survival (DFS) refers to the time from the start of randomization (usually the starting point of a clinical trial) to the recurrence of the disease or death of the patient due to disease progression. DFS is an important clinical and statistical indicator used to evaluate the long-term effects of cancer treatment., The date of surgery and the occurrence of events such as disease progression, the date of the last follow-up, or death from any cause, and the follow-up time was at least 3 years
Comparison Between Custom and Non-custom Serious Games Poststroke
NCT Number: NCT06463730
Acronym: SeriousGames
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stroke
Interventions: BEHAVIORAL: Serious games
Sponsor: University Rehabilitation Institute, Republic of Slovenia
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 28
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-04-19
Completion Date: 2024-06-30
Locations: University Rehabilitation Institute, Republic of Slovenia, Ljubljana, 1000, Slovenia

Summary:
Serious games for rehabilitation are delivered through systems that are either customised or non-customised. Custom serious games allow for control of feedback, setting of game speed and difficulty, while non-custom games are less adaptable but provide attractive graphics and sounds. The study compared the activity intensity and user experience of persons after stroke while playing custom and non-custom virtual reality balance games that were both game- and self-paced.

Primary Outcome Measures: Number of repetitions, Number of pelvic displacements in medio-lateral direction extracted from video-recording using specialised software, On the day of the intervention during each game (anticipated duration: 5 minutes)|Amplitude, Amplitude of pelvic displacements in medio-lateral direction extracted from video-recording using specialised software, On the day of the intervention during each game (anticipated duration: 5 minutes)
Secondary Outcome Measures: Users' enjoyment, Assessed using the Modified Physical Activity Enjoyment Scale (scale score expressed as percentage; higher scores mean a better outcome), On the day of the intervention after each game (anticipated: every 5 minutes)|Flow state, Assessed using the Flow State Scale for Occupational Tasks (scale score range 14-98; higher scores mean a better outcome), On the day of the intervention after each game (anticipated: every 5 minutes)|Likeability, Rated on a scale from 1 (least liked) to 6 (most liked), On the day of the intervention after each game (anticipated: every 5 minutes)|Perception of exertion, Assessed using the Borg's Scale (scale score range 6-20; higher scores mean a worse outcome), On the day of the intervention after each game (anticipated: every 5 minutes)
Primary Multiple Myeloma Who Achieved MRD Negativity After Induction Therapy, ASCT or Not
NCT Number: NCT06463717
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Multiple Myeloma|Minimal Residual Disease
Interventions: DRUG: Transplant, Autologous|DRUG: Chemotherapy drug
Sponsor: First Affiliated Hospital of Zhejiang University
Collaborators: First Affiliated Hospital of Wenzhou Medical University|The Affiliated Hospital of Medical College, Ningbo University|Dongyang People's Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 210
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-12-01
Completion Date: 2028-12
Locations: The First Affiliated Hospital of Zhejiang University, Hangzhou, Zhejiang, 310000, China

Summary:
The goal of this observational study is to compare the efficacy and safety of autologous hematopoietic stem-cell transplantation (ASCT) versus non ASCT regimens in primary multiple myeloma patients achieved MRD negativity after induction.

The main question it aims to answer is:

In primary multiple myeloma patients who achieved MRD negativity after induction, non ASCT regimens are not inferior to ASCT or not? Participants will receive ASCT or non ASCT regimen according to their own choice.

Researchers will compare ASCT and non ASCT group see if any significant difference in efficacy and safety.

Primary Outcome Measures: progression free survival, Progression-free survival is defined as the duration from diagnosis to the date of death, initial progression, or the last follow-up, 2-year
Secondary Outcome Measures: sustain MRD negativity, The proportion of patients who are still MRD negative at 1-year, 2-years after achieving MRD negativity after induction therapy, 1-year, 2-year|Number of Participants With Treatment-Related Adverse Events, All adverse events and second primary malignancies, Once enrolled, an average of 2 year
General Pre-Trial Screening Protocol for Infectious Diseases Research
NCT Number: NCT06463704
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Healthy Volunteers
Interventions: OTHER: There is no intervention
Sponsor: Beth Israel Deaconess Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 250
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-21
Completion Date: 2034-06
Locations: Beth Israel Deaconess Medical Center, Boston, Massachusetts, 02215, United States

Summary:
The purpose of this general screening protocol is to facilitate recruitment into studies conducted at the Center for Virology and Vaccine Research (CVVR) or Division of Infectious Diseases at Beth Israel Deaconess Medical Center. This general screening protocol will help to determine the eligibility of potential volunteers for any vaccine or therapeutic trials open for recruitment or soon to be opened.

Primary Outcome Measures: Distribution of demographic variables, Race, ethnicity, gender and sex at birth, At enrollment|Number of participants who subsequently enroll in another study, The number of participants in the general screening protocol who go on to enroll in another study, From date of enrollment until the date of enrollment in a subsequent study or up to 52 weeks, whichever comes first
Sonrotoclax, Zanubrutinib and CD20mab in Untreated MCL Patients
NCT Number: NCT06463691
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: MCL
Interventions: DRUG: BGB-11417|DRUG: BGB-3111|DRUG: CD20
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2029-07

Summary:
This is a an open-label, multi-center, single-arm study to evaluate the efficacy and safety of sonrotoclax, zanubrutinib and CD20mab in untreated MCL patients.

Primary Outcome Measures: CR (complete response) rate at cycle 12 by investigator (INV)., Complete response rate (CRR) of the study population from the initiation of the first cycle treatment. CRR is defined as the proportion of patients that achieved the best response of CR, determined by INV., From enrollment to the end of treatment at the end of cycle 12 (each cycle is 28 days)
Secondary Outcome Measures: ORR (Overall response rate), ORR is defined as the proportion of patients achieving complete response (CR) or partial response (PR), as determined by INV -PFS defined as time from the date of enrollment to the date of first confirmed disease progression or death due to any cause, whichever occurs first, as determined by INV., From enrollment to the end of treatment at the end of cycle 36 (each cycle is 28 days)|Overall survival (OS), Overall survival (OS) is defined as the duration from the date of initiation of the first cycle of treatment to the date of death because of any cause., From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Trial to Evaluate the Efficacy And Safety of IVIEW-1201 In the Treatment of Fungal Keratitis
NCT Number: NCT06463678
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Fungal Keratitis
Interventions: DRUG: IVIEW-1201|DRUG: NATACYN®
Sponsor: IVIEW Therapeutics Inc.
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-12-01
Completion Date: 2026-12-01

Summary:
A Phase II, Multi-center, Randomized, Masked, Parallel-Control Study to Evaluate the Clinical Efficacy and Safety of IVIEW-1201 (1.0% PVP-Iodine) Gel Forming Ophthalmic Solution in the Treatment of Fungal Keratitis.

Primary Outcome Measures: Clinical cure rate, Proportion of subjects with a score of 0/12.

This is manifested by the resolution of clinical symptoms, healing of corneal ulcers, negative fluorescein staining, corneal recovery to translucency or transparency, and resolution of hypopyon., Day 29 ± 1 day
Secondary Outcome Measures: Fungal clearance, Positive if fungal hyphae are visible on smear microscopy or confocal microscopy at baseline and negative if no fungal hyphae are visible on smear microscopy or confocal microscopy at the last visit., Day 29 ± 1 day|Best-corrected visual acuity, The best-corrected visual acuity and its distribution ratio with 0.3, 0.6 and 1.0 LogMAR as cut-offs of test eyes in the test and control groups at baseline and at the last visit. A stratified analysis is carried out to calculate the change in best-corrected visual acuity., Baseline (Day 1) and Day 29 ± 1 day
Using a Novel Skin Tag Removal Device
NCT Number: NCT06463613
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Achrochordon
Interventions: DEVICE: STR Skin Tag Removal device with diary and follow-up
Sponsor: UK Innovations GP LTD
Collaborators: Lindus Health|Advarra
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-03
Completion Date: 2024-08-07
Locations: Center for Dermatology Clinical Research, Inc., Fremont, California, 94538, United States

Summary:
The aim of this study is to investigate the use of a mechanical device to remove skin tags in adults.

The device ("Skin Tag Removal", or STR) utilizes the ligation method by applying a silicone band around the base of a skin tag, therefore restricting the blood supply, which is vital to its growth and survival. Because this method does not include freezing or burning of tissue in or around the skin tag, it could be considered less invasive and less risky than other options.

Primary Outcome Measures: Successful removal of skin tag, Number of successful removals of treated acrochordons using the STR device, Treatment, 1-14 days; Safety follow up on day 30
Secondary Outcome Measures: Comfort and Safety Issues, Amount and number of discomfort, issues or adverse events occurring during the study, Treatment, 1-14 days; Safety follow up on day 30
Tumour Localisation With Magnetic Clip Before Neoadjuvant Chemotherapy.
NCT Number: NCT06463600
Acronym: MagLocal
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breast Conserving Surgery
Interventions: DEVICE: Magseed|DEVICE: Metallic clip and guide wire
Sponsor: Sahlgrenska University Hospital, Sweden
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 44
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-02-01
Completion Date: 2025-12-31
Locations: Sahlgrenska Academy at Gothenburg University, Gothenburg, Göteborg, 41345, Sweden

Summary:
The feasibility of the use of magnetic clips for tumour localisation before preoperative chemotherapy in combination with superparamagnetic iron oxide nanoparticles (SPIO) as tracer for sentinel lymph node (SLN) detection and in combination with a magnetic clip in the index lymph node metastasis is studied.

Primary Outcome Measures: Specimen volume, The surgical specimen is weighed after removal., Perioperatively
Effect of Aging on Micro-tensile Bond Strength and Color Stability of Self-adhesive Resin Composite
NCT Number: NCT06463574
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Tooth Decay
Interventions: OTHER: self-adhesive resin restoration
Sponsor: Minia University
Sex: ALL
Age: ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT
Start Date: 2024-06
Completion Date: 2024-12
Locations: Faculty of Dentistry, Minya University., Minya, 61519, Egypt

Summary:
The objective of this study is to evaluate the micro-tensile bond strength of a newly self-adhesive resinous restorative material to dentin with and without application of universal bonding system (in-vitro) and to examine it's clinical performance by evaluation of it's color stability and marginal discoloration through a randomized clinical trial (in-vivo).

Primary Outcome Measures: Clinical evaluation of color stability and marginal discoloration of resin restorations after aging in the patient mouth., Clinical evaluation of degree of color change of resin restorations after aging in the patient mouth., 6 months
Irinotecan Hydrochloride Liposome Combined With Capecitabine and Lenvatinib in Patients With Biliary Tract Carcinoma
NCT Number: NCT06463548
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Biliary Tract Carcinoma
Interventions: DRUG: irinotecan hydrochloride liposome injection|DRUG: Capecitabine|DRUG: Lenvatinib
Sponsor: Yunpeng Liu
Collaborators: CSPC Ouyi Pharmaceutical Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2026-12-31
Locations: The First Hospital of China Medical University, Shenyang, 110000, China

Summary:
To evaluate the efficacy and safety of irinotecan hydrochloride liposome injection combined with Capecitabine and Lenvatinib for second-line treatment in Patients With advanced or metastatic biliary tract carcinoma.

Primary Outcome Measures: Progression-free survival (PFS), To evaluate the efficacy of anti-tumor, baseline up to approximately 6 month
Secondary Outcome Measures: Objective response rate (ORR), To evaluate the efficacy of anti-tumor, baseline up to approximately 6 month|overall survival (OS), To evaluate the efficacy of anti-tumor, baseline up to approximately 12 month|Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability], To identify the incidence of AE and SAE in clinical trial, From the initiation of the first dose to 14 days after the last dose|Time to treatment failure (TTF), To evaluate the efficacy of anti-tumor, baseline up to approximately 6 month|Quality of life (QoL), To identify the quality of life by QLQ-C30 V3.0, baseline up to approximately 12 months