pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Lung Ultrasound in Pediatric Acute Chest Syndrome
NCT Number: NCT06497153
Acronym: Lupacs
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Sickle Cell Disease
Interventions: PROCEDURE: lung ultrasound
Sponsor: Assistance Publique - Hôpitaux de Paris
Sex: ALL
Age: CHILD
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-30
Completion Date: 2026-09-30
Locations: Robert Debré hOSPITAL, Paris, 75019, France

Summary:
Sickle-cell disease is a common disease with serious complications, in particular acute chest syndrome (ACS), which can be life threatening. The pathophysiology of ACS is poorly understood, but alveolar hypoventilation appears to play an important role. Pulmonary ultrasound is increasingly used in pediatrics to diagnose ACS. The management of ACS is complex, including oxygen therapy, antibiotics, spirometry, transfusions and ventilatory support. ACS and acute vaso-occlusive pain are the main reasons for hospitalisation in pediatric intensive care units. The aim of this study was to identify the pulmonary indicators correlated with ventilation time in these children, and to study the correlations between the results of lung ultrasound (LUS) and the clinical severity of the episode. The inclusion criteria for this study are the presence of an ACS in a child aged between 1 month and 17 years hospitalised in the pediatric intensive care unit at Robert-Debre Hospital who has not expressed any opposition and without opposition from their legal representative. The study will run for 2 years, with a target of 60 patients. Each patient included in the study will have multiple LUS during their care, in accordance with a protocol, and their clinical, biological and radiological data will be collected during their stay in the department.

Primary Outcome Measures: Correlation coefficients between LUS scores (lung ultrasound) at H0, H8, H24, H48, H72 and duration of ventilation (invasive and non-invasive combined), length of stay in intensive care unit (15 days)
A Study in Patients With Mixed Dyslipidemia
NCT Number: NCT06497127
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Mixed Dyslipidemia
Interventions: DRUG: BW-00112
Sponsor: Shanghai Argo Biopharmaceutical Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 132
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-31
Completion Date: 2025-09-30

Summary:
A Phase 2 in Patients With Mixed Dyslipidemia

Primary Outcome Measures: Percent change in fasting TG, Percent change in fasting TG from baseline to Day 180, From baseline to Day 180
Secondary Outcome Measures: Percent change in fasting TG, Percent change in fasting TG from baseline to Day 15, 30, 60, 90, 135, 225, and 270, From baseline to Day 15, 30, 60, 90, 135, 225, and 270
Validity and Reliability of the Egyptian-Arabic Version of ABILHAND-Kids
NCT Number: NCT06497114
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cerebral Palsy
Interventions: OTHER: ABILHAND-Kids questioner
Sponsor: Horus University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-01
Completion Date: 2024-10-01
Locations: Horus University, Damietta, Egypt

Summary:
HYPOTHESES It is hypothesized that the Egyptian-Arabic ABILHAND-Kids 21-item will be psychometrically appropriate to be used with Egyptian children with cerebral palsy.

Primary Outcome Measures: ABILHAND-Kids, parent-reported outcome measure that quantifies the manual ability of children with CP., 4 months
Effectiveness Trial of Temperament Based Therapy With Support (TBT-S)
NCT Number: NCT06497101
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Anorexia Nervosa
Interventions: BEHAVIORAL: Temperament Based Therapy with Support (TBT-S)
Sponsor: Oslo University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 140
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2028-09-01
Locations: Oslo University Hospital, Regional Department for Eating Disorders, Oslo, Norway

Summary:
The main aim of this project is to determine the short and long-term effectiveness of an out-patient treatment for patients with anorexia nervosa. Specifically, we will measure whether TBT-S in addition to treatment as usual (TAU) will be more effective than TAU alone in reducing eating disorder psychopathology. Assessments will be conducted at four timepoints; pre and post TBT-S, and at 3 and 12 months follow-up. Primary outcome measure is eating disorder psychopathology, with the hypothesis that patients receiving TBT-S in addition to TAU will show significantly greater reduction in eating disorder psychopathology from TBT-S treatment admission to 3 month follow-up, compared to controls.

Primary Outcome Measures: Eating Disorder Psychopathology, Eating Disorders Examination Questionnaire (EDE-Q). Participants report symptomatology on a 7-point Likert scale from 0 (no days) to 6 (everyday). The EDE-Q contains 4 subscales: Restraint, Weight Concern, Eating Concern, and Shape Concern. Subscale scores are calculated by finding the averages of the subscale items. A global score is also calculated by averaging the subscale scores. Scores range from 0 to 6; higher scores indicate higher levels of eating disorder pathology., Baseline, after 1 week and at 3 and 12 months follow-up
A Clinical Study to Evaluate the Ultrasonic Detection of a Novel Nasogastric Tube in the Human Body.
NCT Number: NCT06497088
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Nasogastric Tube Placement
Interventions: DEVICE: Nasotrak System
Sponsor: Nasotrak Medical Pte Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-08-01
Completion Date: 2025-06-30
Locations: Parkview Regional Medical Center, Fort Wayne, Indiana, 46845, United States

Summary:
The purpose of this study is to evaluate the safety, efficacy and accuracy of the Nasotrak System in an adult patient population.

Primary Outcome Measures: Evaluate the effectiveness of detecting Nasotrak's nasogastric tube's distal tip using Nasotrak's ultrasound verification algorithm compared to X-ray., All patients will receive placement verification per institutional practice, 1 year
Phase II Study of Sonrotoclax Combined With Chemotherapy in the Treatment of Newly Diagnosed Acute Myeloid Leukemia
NCT Number: NCT06497062
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Acute Myeloid Leukemia
Interventions: DRUG: sonrotoclax|DRUG: idarubicin/daunorubicin|DRUG: Cytarabine|DRUG: Azacitidine|PROCEDURE: allo-HSCT
Sponsor: Shanghai Jiao Tong University School of Medicine
Collaborators: Ruijin Hospital|BeiGene
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 47
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-04
Completion Date: 2028-06-30
Locations: Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China

Summary:
This single-armed study aims to investigate the safety and efficacy of sonrotoclax in combination with intensive chemotherapy in subjects with newly diagnosed AML. Subjects will be stratified based on the genetic risk classification of 2022 European LeukemiaNet (ELN) recommendations and MRD status to receive specific consolidation therapy after the induction therapy.

Primary Outcome Measures: EFS, event free survival rate, 2-year
Secondary Outcome Measures: Composite complete remission rate, Complete remission/complete remission with partial hematological recovery/complete remission with incomplete hematological recovery, Up to cycle 2 (each cycle is 28 days)|The complete remission rate of MRD negative, The complete remission rate of MRD negative, Up to cycle 2 (each cycle is 28 days)|RFS, relapse free survival rate, Only for subjects who have achieved CR, CRh, or CRi; The time from the first attainment of eligible remission (CR, CRh, or CRi) after the start of treatment to the recording of disease recurrence or death, whichever occurs first. Up to 24 months|OS, overall survival rate, up to 24 months|AE, SAE, Adverse event，Serious adverse events, up to 24 months|Early mortality rate, Mortality within 30 days after first study medication and within 60 days after first study medication, Within 30 and 60 days after the first study medication
Other Outcome Measures: MRD and long-term survival, Evaluate the correlation with EFS and OS by grouping different remission states of MRD at the end of induction therapy and consolidation therapy, up to 24 months|HSCT rate, HSCT rate and exploration of the association between HSCT and EFS and OS, up to 24 months
Open Randomized Study of Comparative Pharmacokinetics and Biosimilarity of GP40221 (GEROPHARM LLC, Russia) and Ozempic®.
NCT Number: NCT06497049
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Pharmacokinetics|Safety Issues|Bioequivalence
Interventions: DRUG: GP40221|DRUG: ozempic
Sponsor: Geropharm
Sex: MALE
Age: ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-06-30
Completion Date: 2024-05-05
Locations: Yarosslavl Clinical Hospital #3, Yaroslavl, Russian Federation

Summary:
Study of comparative pharmacokinetics and biosimilarity of drugs containing semaglutide - GP40221 and Ozempic® in healthy volunteers.

Primary Outcome Measures: AUC 0-t, Total area under the "concentration of an active substance - time" curve in the time interval from 0 (the moment of drug administration) to the collection of the last blood sample with a determined concentration of the active substance at time point t, -60, -30, 0 minutes and 2, 4, 8, 10, 12, 16, 24, 36, 48, 60, 72, 96, 144, 192, 240, 288 hours after injection|Cmax, Maximum concentration of the active substance in the blood plasma of volunteers during the observation period, -60, -30, 0 minutes and 2, 4, 8, 10, 12, 16, 24, 36, 48, 60, 72, 96, 144, 192, 240, 288 hours after injection
Secondary Outcome Measures: tmax, Time to reach the maximum concentration (Cmax) of an active substance in the blood plasma of volunteers, -60, -30, 0 minutes and 2, 4, 8, 10, 12, 16, 24, 36, 48, 60, 72, 96, 144, 192, 240, 288 hours after injection|t1/2, half-life of an active substance, -60, -30, 0 minutes) and 2, 4, 8, 10, 12, 16, 24, 36, 48, 60, 72, 96, 144, 192, 240, 288 hours after injection|λz, constant of elimination of an active substance, -60, -30, 0 minutes) and 2, 4, 8, 10, 12, 16, 24, 36, 48, 60, 72, 96, 144, 192, 240, 288 hours after injection|AUC0-∞, total area under the "concentration of an active substance - time" curve in the time interval from 0 (the moment of drug administration) to infinity, -60, -30, 0 minutes) and 2, 4, 8, 10, 12, 16, 24, 36, 48, 60, 72, 96, 144, 192, 240, 288 hours after injection
Study of Efficacy, Safety and Immunogenicity of GP40141 (GEROPHARM, Russia) in Patients With Immune Thrombocytopenia
NCT Number: NCT06497036
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Drug Effect|Safety Issues|Immunogenicity
Interventions: DRUG: GP404141|DRUG: Nplate
Sponsor: Geropharm
Collaborators: Pharm-Holding|I.M. Sechenov First Moscow State Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 160
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: BASIC_SCIENCE
Start Date: 2023-04-04
Completion Date: 2028-03-31
Locations: Kaluga Regional Clinical Hospital, Kaluga, 248007, Russian Federation|City Clinical Hospital S.P. Botkin of the Moscow City Health Department, Moscow, 125284, Russian Federation|National Medical Research Center in name of V.A. Almazov " of the Ministry of Health of the Russian Federation, Saint-Petersburg, 194156, Russian Federation|Samara State Medical University" of the Ministry of Health of the Russian Federation, Samara, 443099, Russian Federation|Oncological dispensary No. 2 of the Ministry of Health of the Krasnodar Territory, Sochi, 354057, Russian Federation|Federal State Budgetary Educational Institution Bashkir State Medical University of the Ministry of Health of the Russian Federation, Ufa, 450008, Russian Federation

Summary:
The goal of this clinical trial is to demonstrate equivalent efficacy and comparable safety of the drug GP40141 (GEROPHARM, Russia) in comparison with the drug Nplate® (Amgen, the Netherlands). the main questions are

1. Assess the effectiveness of GP40141 in comparison with Nplate®.
2. Assess the immunogenicity of GP40141 in comparison with the drug Nplate®.
3. Assess the safety of GP40141 in comparison with the drug Nplate®.
4. Assess the safety of changing romiplostim and eltrombopag to GP40141.
5. Assess the pharmacokinetic parameters of the study drugs in patients with primary immune thrombocytopenia.

Participants divided into 2 cohorts (naïve or treated with a thrombopoietin receptor agonist) will receive romiplostim and platelet response, immune response and adverse reactions will be assessed.

Primary Outcome Measures: Proportion of subjects with platelet response, Blood platelet count ≥50×10\*9/L after 10 weeks of therapy (at Visit 11), or blood platelet count ≥200×10\*9/L at the last assessment if the study was terminated early., 10 weeks|Number of adverse events (AEs), AEs including ones of special interest: bleeding, thrombotic and thromboembolic events., 10 weeks|Proportion of subjects experiencing AEs,, AEs including ones of special interest: bleeding, thrombotic and thromboembolic events., 10 weeks|Proportion subjects with a immune response to romiplostim, Proportion of initially immunonaive subjects with a documented immune response to romiplostim at Visits 8 and 26 (weeks 8 and 26)., 26 weeks|Proportion subjects with a immune response to endogenous thrombopoietin, Proportion of initially immunonaive subjects with a documented immune response to endogenous thrombopoietin at Visits 8 and 26 (weeks 8 and 26)., 26 weeks
Radiomics Model Based on DCE-MRI and Ultrasound Images for Breast Lesion Classification
NCT Number: NCT06497023
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Breast Diseases
Sponsor: Ma Zhe
Sex: FEMALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 550
Study Design: Observational Model: |Time Perspective: p
Start Date: 2018-01-01
Completion Date: 2024-03-30
Locations: QianfoshanH, Jinan, Shandong, 250014, China

Summary:
To develop and compare multi-modality radiomics models based on DCE-MRI, B-mode ultrasound (BMUS) and strain elastography (SE) images for classifying benign and malignant breast lesions.

Primary Outcome Measures: Accuracy of different diagnostic models, The accuracy of nine diagnostic models, including four single-modality radiomics models (DCE-3D, DCE-2D, BMUS, and SE), four multi-modality radiomics models (BMUS + SE, DCE-3D + BMUS, DCE-3D + SE, and DCE-3D+SE+BMUS),and the combination diagnostic model is the ratio of the sum of True Positive and True Negative to the total of True Positive, True Negative, False Positive, and False Negative., Immediately evaluated after the radiomcis diagnostic model was built
Secondary Outcome Measures: Sensitivity of different diagnostic models, The sensitivity of nine diagnostic models, four single-modality radiomics models (DCE-3D, DCE-2D, BMUS, and SE), including four multi-modality radiomics models (BMUS + SE, DCE-3D + BMUS, DCE-3D + SE, and DCE-3D+SE+BMUS), and the combination diagnostic model is the ratio of True Positive to the sum of True Positive and False Negative., Immediately evaluated after the radiomcis diagnostic model was built
Other Outcome Measures: Specificity of different diagnostic models, The specificity of nine different diagnostic models, including four single-modality radiomics models (DCE-3D, DCE-2D, BMUS, and SE), four multi-modality radiomics models (BMUS + SE, DCE-3D + BMUS, DCE-3D + SE, and DCE-3D+SE+BMUS), and the combination diagnostic model is the ratio of True Negative to the sum of True Negative and False Positive., immediately evaluated after the combination diagnostic model was built|PPV of different diagnostic models, The PPV of nine different diagnostic models, including four single-modality radiomics models (DCE-3D, DCE-2D, BMUS, and SE), four multi-modality radiomics models (BMUS + SE, DCE-3D + BMUS, DCE-3D + SE, and DCE-3D+SE+BMUS),and the combination diagnostic model is the ratio of True Positive to the sum of True Positive and False Positive., immediately evaluated after the combination diagnostic model was built|NPV of different diagnostic models, The NPV of nine different diagnostic models, including four single-modality radiomics models (DCE-3D, DCE-2D, BMUS, and SE), four multi-modality radiomics models (BMUS + SE, DCE-3D + BMUS, DCE-3D + SE, and DCE-3D+SE+BMUS), and the combination diagnostic model is the ratio of True Negative to the sum of True Negative and False Negative., immediately evaluated after the combination diagnostic model was built
An Exploratory Study of Individualized Neo-antigen mRNA Cancer Vaccine InnoPCV in Advanced Solid Tumor Treatment
NCT Number: NCT06497010
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Advanced Solid Tumor
Interventions: DRUG: Biological: Tislelizumab|DRUG: Biological: InnoPCV
Sponsor: The Affiliated Hospital Of Guizhou Medical University
Collaborators: Innovac Therapeutics
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2026-12
Locations: The Affiliated Hospital of Guizhou Medical University, Guiyang, China/Guizhou, China

Summary:
This is an open-label, prospective, exploratory clinical study, which is divided into two phases: dose escalation phase (Phase Ia) and expansion phase (Phase Ib). After completing the dose-escalation phase (Stage Ia) (5-11 patients), the investigator will select the dose group (RP2D) based on safety, tolerability, and preliminary immune-related characteristics and efficacy data, and choose 2-3 advanced solid tumors to enter the expansion phase (Stage Ib).

Primary Outcome Measures: Recommended Phase 2 Dose (RP2D), Baseline through 90 days after last InnoPCV dose
Secondary Outcome Measures: Number of Participants with Adverse Events, Baseline through 90 days after last tislelizumab dose|Neoantigen-specific T cell Response rate, Baseline through 26 weeks after last InnoPCV dose|Overall Response Rate (ORR): Number of Participants with Tumor Response (Partial or Complete), ORR is defined as the proportion of participants whose best overall response is complete response (CR) or partial response (PR)., Baseline through disease progression by Response Evaluation Criteria of Solid Tumors Version 1.1 (RECIST 1.1), start of new anti-cancer therapy, withdrawal of consent, death and last safety follow-up visit (up to approximately 2 years)|Duration of Response (DoR), DoR is defined as time from first tumor response (partial or complete) until either radiological disease progression, clinical/symptomatic disease progression or death (whichever is sooner)., Baseline through disease progression by Response Evaluation Criteria of Solid Tumors Version 1.1 (RECIST 1.1), start of new anti-cancer therapy, withdrawal of consent, death and last safety follow-up visit (up to approximately 2 years)|Progression Free Survival (PFS), PFS is defined as time between the date of first dose of pembrolizumab and the date of either radiological disease progression, clinical/symptomatic disease progression or death (whichever is sooner)., From baseline to disease progression by Response Evaluation Criteria of Solid Tumors Version 1.1 (RECIST 1.1) or death (up to approximately 2 years)|Overall Survival (OS), OS is defined as time between the date of the first dose of study drug and the date of death due to any cause., From baseline to approximately 2 years
A Comparative Study of Glucocorticoids Efficacy in Acute Respiratory Distress Syndrome
NCT Number: NCT06496997
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2|PHASE3
Conditions: Acute Respiratory Distress Syndrome
Interventions: DRUG: Methylprednisolone|DRUG: Dexamethasone|DRUG: Hydrocortisone
Sponsor: Fayoum University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-09

Summary:
The aim of the work is to compare the efficacy of equivalent doses of methylprednisolone, dexamethasone and hydrocortisone in patients with ARDS

Primary Outcome Measures: 28-day mortality after enrolment, From enrollment to the end of treatment at 28 days
Secondary Outcome Measures: The number of patients needing invasive mechanical ventilation, From enrollment to the end of treatment at 28 days|The Number of ventilator-free days, From enrollment to the end of treatment at 28 days|Duration of the ICU stay, From enrollment to the end of treatment at 28 days|Duration of hospitalization, From enrollment to the end of treatment at 28 days|Incidence of serious adverse events, including secondary infections, hyperglycemia, clinically important gastrointestinal bleeding, and hypertension, From enrollment to the end of treatment at 28 days
Valutazione All'Ingresso Del Rischio Nutrizionale in Pazienti Ricoverati Nel Reparto di Medicina Interna (AMIDO)
NCT Number: NCT06496984
Acronym: AMIDO
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Malnutrition|Hospitalized Patient
Interventions: OTHER: Nutritional intervention
Sponsor: Azienda Sanitaria Locale di Alessandria
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 268
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2023-01-01
Completion Date: 2023-12-31
Locations: Azienda Sanitaria Locale di Alessandria (ASL AL), Alessandria, Piedmont, 15121, Italy

Summary:
The aim of this study is to identify the risk of malnutrition in patients admitted to the Internal Medicine departments using the MUST screening tool. Additional aspects are to evaluate malnourished patients' characteristics and effectiveness of an early nutritional programme started during hospitalization.

Primary Outcome Measures: Risk of malnutrition, Assessment of patients' risk of malnutrition on admission through the MUST questionnaire., Before the intervention (Baseline/T0) and at the hospital discharge, an average of 8 days after (Final/T1)
Secondary Outcome Measures: Clinical conditions and malnutrition, Correlation between clinical outcomes of enrolled patients and level of malnutrition on admission, measured by MUST questionnaire, Before the intervention (Baseline/T0) and at the hospital discharge, an average of 8 days after (Final/T1)|Gender and malnutrition, Correlation between gender of enrolled patients and nutritional status at the time of admission, measured by MUST questionnaire, Before the intervention (Baseline/T0) and at the hospital discharge, an average of 8 days after (Final/T1)
Water Exchange and CO2 Insufflation With Abdominal Compression Device to Reduce Manual Assistance
NCT Number: NCT06496958
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Manual Pressure|Repositioning|Colonoscopy|Colon Polyp
Interventions: DEVICE: CO2 insufflation with an abdominal compression device|DEVICE: CO2 insufflation with a sham abdominal compression device|DEVICE: Water exchange colonoscopy
Sponsor: Evergreen General Hospital, Taiwan
Collaborators: E-Da Dachange Hospital, Kaohsiung, Taiwan|The Sepulveda Ambulatory Care Center, VAGLAHS, UCLA in the USA
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 400
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: PREVENTION
Start Date: 2024-09-01
Completion Date: 2026-09-30

Summary:
The goal of this trial is to evaluate whether water exchange colonoscopy and CO2-insufflation colonoscopy with an abdominal compression device (Maxbelt me3 type, Nippon Sigmax Co., Tokyo, Japan) can achieve a significantly lower proportion of patients requiring manual abdominal pressure during colonoscopic insertion compared with CO2 insufflation alone.

Primary Outcome Measures: Frequency of manual pressure, The proportion of patients who need at least one application of manual abdominal pressure during colonoscopic insertion., One day
Secondary Outcome Measures: Frequency of repositioning, The proportion of patients who need at least one application of position change during colonoscopic insertion., One day|Ergonomic pain of after colonoscopy, The musculoskeletal pain experienced by the assisting nurse will be reported based on a 5-point visual analogue scale score immediately after a procedure by using a questionnaire., One day|Colonoscopy difficulty, The colonoscopy difficulty assessed by the endoscopist will be reported using a 5-point visual analogue scale score immediately after completion of the procedure by using a questionnaire., One day|Post-colonoscopy abdominal pain, The pain experienced by the patient will be recorded in the recovery room post-procedure via a questionnaire using a 5-point visual analogue scale score., One day|Cecal intubation time, The cecal intubation time is defined as the time spanning from anal insertion to colonoscopic intubation of cecum., One day|Withdrawal time, The withdrawal time is defined as the time spanning from cecal intubation to colonoscope withdrawal from the anus., One day|Adenoma detection rate, The proportion of patients with at least one conventional adenoma of any size., One week (after the colonoscopy procedure, when pathology report is released)
Music for Anxiety Management in Cesarean Delivery
NCT Number: NCT06496932
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pregnancy
Interventions: OTHER: Listen to music
Sponsor: Aydin Adnan Menderes University
Sex: FEMALE
Age: ADULT
Enrollment: 32
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2023-09-01
Completion Date: 2024-02-15
Locations: Adnan Menderes University, Aydın, Turkey

Summary:
A randomized controlled trial will be conducted to determine examine the effects of music played during cesarean delivery on maternal anxiety and vital signs.

Primary Outcome Measures: anxiete level, State-Trait Anxiety Inventory: It can be applied to individuals over the age of 14. It consists of 20 items that determine how an individual feels at a certain moment and under certain conditions. The highest score that can be obtained from the scale is 80 and the lowest score is 20. The higher the calculated total anxiety score, the higher the anxiety level of the person filling out the inventory., 37th gestational weeks]
A Real-world Research on the Prevention and Treatment of Peritoneal Metastasis and Malignant Ascites by Intraperitoneal Infusion of rmhTNF in Gastric and Colorectal Malignant Tumors
NCT Number: NCT06496919
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Gastric Cancer
Interventions: DRUG: Recombinant Mutant Human Tumor Necrosis Factor
Sponsor: Wuhan University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2027-07-31
Locations: Zhongnan Hospital of Wuhan University, Wuhan, Hubei, 430000, China

Summary:
Peritoneal metastasis is the main factor leading to poor prognosis in patients with gastric cancer or colorectal cancer. Although current systemic treatment regimens can prolong the time to peritoneal metastasis, the long-term survival rate is still poor. This is mainly due to the presence of the peritoneal plasma barrier, which limits the penetration of anti-tumor drugs and thus restricts the efficacy. In contrast, the use of intraperitoneal infusion chemotherapy allows anti-tumor drugs to directly reach the abdominal cavity, exposing metastatic nodules to high concentrations of drugs, and has a significant therapeutic effect on peritoneal metastases, resulting in better therapeutic effects Tumor necrosis factor (TNF) is a small molecule protein secreted by macrophages. There are two types of TNF - α: α and ß. TNF - α is produced by activated monocytes and macrophages, also known as cachectin. TNF - α is produced by activated lymphocytes, also known as lymphotoxins, and the two have similar activity. Previous studies have shown that rmhTNF is safe for intraoperative perfusion in gastrointestinal tumors.

In this real-world study, we will observe the safety and effectiveness of rmhTNF intraperitoneal perfusion in actual clinical settings.

Primary Outcome Measures: Event-Free Survival (EFS), Postoperative peritoneal implantation metastasis rate of gastric and colorectal adenocarcinoma, after radical surgery for 1-3 years|Progression-Free Survival （PFS）, Survival without peritoneal implant metastasis after radical surgery for gastric and colorectal adenocarcinoma, after radical surgery for 3 years|Objective Response Rate, Objective Response Rate of peritoneal metastasis in gastric and colorectal adenocarcinoma, after radical surgery for 3 years|Disease Control Rate, Disease Control Ratel rate of malignant ascites in gastric and colorectal adenocarcinoma, 4 weeks after administration
Secondary Outcome Measures: Overall Survival（OS）, Time from the first study treatment until death from any cause, after radical surgery for 3 years|Regional recurrence rate, Regional recurrence rate after radical surgery for gastric and colorectal adenocarcinoma (Local recurrence after radical surgery for gastric cancer refers to the recurrence of the duodenal stump, tumor bed, and residual stomach after anastomosis, Bi II style anastomosis, as well as the recurrence of regional lymph nodes), after radical surgery for 3 years|Adverse events, The safety of rmhTNF intraperitoneal perfusion therapy, 24 hours after administration
Clinical and Radiographic Comparison of Two Minimally Invasive Tooth Extraction Systems
NCT Number: NCT06496906
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Tooth Extraction Status Nos
Interventions: PROCEDURE: Tooth extraction|DEVICE: Benex|DEVICE: Physics Forceps|DEVICE: Conventional Extraction Forceps
Sponsor: Plovdiv Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 116
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-09-01
Completion Date: 2023-01-01
Locations: Department of Oral Surgery, Faculty of Dental Medicine, Medical University - Plovdiv, Plovdiv, Pl, 4000, Bulgaria

Summary:
The aim of the study is to compare the effectiveness of the vertical extraction system Benex and Physics forceps with the conventional extraction tools (extraction forceps and elevators) in the early wound healing period after tooth extraction, as means for minimally invasive tooth extraction.

All patients aged 18 years and over who require closed tooth extraction with good oral hygiene were eligible for participation.

Participants were randomly allocated to tooth extraction with either Benex, Physics forceps or conventional extraction tools using box randomization. Patients are followed up during the recovery period to assess pain and early wound healing, while at the time of extraction, success and buccal cortical plate fracture were evaluated.

Primary Outcome Measures: Extraction success, The scale suggested by Choi was used to assess each of the extraction systems.

Scored from 1 to 5. Higher is better., From the beginning of the extraction to the completion of the procedure|Alveolar bone buccal cortical plate preservation, The difference between the height of the alveolar bone buccal cortical plate is measured before and after the tooth extraction.

Scored in milimeters missing. Lower is better., From the beginning of the extraction to the completion of the procedure|VAS pain score, Patients were asked to rate their pain experience on a visual analog scale (VAS).

Measured in centimeters on 10cm line. Lower is better., 0, 1, 3, 7 day|Early wound healing, Landry's early wound healing index was used to evaluated the extraction healing process.

Scores from 1 to 5. Higher is better., 3, 7, 10 day
Prescribing Lorazepam for IUD Insertion: Pilot Feasibility Study
NCT Number: NCT06496854
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Pain|IUD
Interventions: DRUG: Lorazepam 1 mg|DRUG: Ibuprofen 800 mg
Sponsor: University of Wisconsin, Madison
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 25
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09
Completion Date: 2024-10
Locations: UW Family Medicine Residency Clinics, Madison, Wisconsin, 53715, United States

Summary:
The objective of this pilot study is to discuss the feasibility of prescribing lorazepam prior to IUD insertion and of measuring effect of lorazepam on anxiety and pain with Intrauterine Device (IUD) insertion. The target population for this study will be 25 adult participants scheduled for an IUD insertion at a UW Family Medicine residency clinic. Participants will be followed for 1 appointment visit.

Primary Outcome Measures: Visual Analogue Scale for Pain, Participant will be asked to rate their pain on a scale of 0 (no pain) to 10 (severe pain)., before and after the procedure (up to 1 hour)|Visual Analogue Scale for Anxiety, Participant will be asked to rate their anxiety on a scale of 0 (no anxiety) to 10 (severe anxiety)., before and after the procedure (up to 1 hour)
Secondary Outcome Measures: Mean Pain Scores for Nulliparous and Multiparous Participants, Comparison of mean pain scores between participants that have never had childbirth to those who have., before and after the procedure (up to 1 hour)|Mean Anxiety Scores for Nulliparous and Multiparous Participants, Comparison of mean anxiety scores between participants that have never had childbirth to those who have., before and after the procedure (up to 1 hour)|Number of Participants Recruited, Feasibility will in part be measured with recruitment rates., up to 2 months (estimated time period of recruitment)|Number of Participants with lorazepam prescription adherence, Feasibility will in part be measured with adherence rates., up to 2 months (estimated time period of recruitment)|Number of Participants Who Completed All Surveys, Feasibility will in part be measured with survey completion rates., up to 2 months (estimated time period of recruitment)|Qualitative Measure: Participant Experience, Participants will be asked questions about their experience taking lorazepam and to provide feedback about the study. Participant answers will be coded and themed to report as participant counts., post-procedure (up to 1 hour)
Transnasal Versus Suprazygomatic SPG Block in Persistant Idiopathic Facial Pain
NCT Number: NCT06496841
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Headache|Persistent Idiopathic Facial Pain
Interventions: DRUG: Transnasal Sphenopalatine ganglion block|DRUG: Ultrasound-guided suprazygomatic sphenopalatine ganglion block
Sponsor: Diskapi Teaching and Research Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-10-01
Completion Date: 2023-04-02
Locations: Ankara Etlik City Hospital, Ankara, Yenimahalle, 06100, Turkey

Summary:
The International Headache Society defines persistent idiopathic facial pain (PIFP) as persistent facial pain that does not have the characteristics of cranial neuralgia, is blunt, persistent, persistent, bothersome and not attributable to another disorder. The management of persistent idiopathic facial pain (PIFP) is complex. The sphenopalatine ganglion (SPG) has been the target of interventional treatment of many facial pain syndromes. The sphenopalatine ganglion can be accessed by transnasal access and ultrasound or scopy guidance. In this study, datas compared the efficacy of transnasal approach and ultrasound-guided suprazigomatic approach in sphenopalatine ganglion block in patients with persistent idiopathic facial pain.

Primary Outcome Measures: Numerical Rating Scale (NRS), NRS is a pain screening Scale, in time using a 0-10 Scale, with zero meaning ''no pain'' and 10 meaning ''the worst pain imaginable''., Change from baseline to 1st hour, 1st week and 4th weeks after treatment
Secondary Outcome Measures: HIT-6 (Headache impact test), HIT-6 is a self-report questionnare designed to evaluate the impact of headache on quality of life. 49 or less: little or no impact, 50-55: some impact, 56-59. substantial impact, 60-78: severe impact, Change from baseline to 1st hour, 1st week and 4th weeks after treatment
Donafenib Combined With Immunotherapy and Local Therapy for Unresectable Hepatocellular Carcinoma That Has Failed in Previous Therapy
NCT Number: NCT06496815
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Unresectable Hepatocellular Carcinoma
Interventions: DRUG: Donafenib|PROCEDURE: transhepatic arterial embolization chemotherapy or hepatic arterial infusion chemotherapy|DRUG: PD-1,PD-L1
Sponsor: Tongji Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 32
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2027-07-30

Summary:
The goal of this clinical trial is to learn if donafenib combined with or without immunotherapy and local therapy works to treat unresectable hepatocellular carcinoma that has failed in previous therapy.

It will also learn about the safety of donafenib combined with immunotherapy and local therapy.

The main questions it aims to answer are:

The Objective Response Rate (mRecist） and Progression-Free Survival of the participants treated by donafenib combined with immunotherapy and local therapy.

The disease control rate and overall survival of the participants treated by donafenib combined with immunotherapy and local therapy.

The safety of donafenib combined with immunotherapy and local therapy in the participants.

Participants will:

Replace the original targeted drug with donafenib (0.2g bid), while continuing immunotherapy and local therapy as previous therapy (if have).

The observation period was 1 year.

Primary Outcome Measures: Objective Response Rate (mRecist）(ORR), According to mRECIST to evaluate the proportion of patients with CR and PR in the total number of patients., an average of 1 year|Progression-free survival, Patients' progression-free survival after switching to the new treatment regimen is the time between the start of the change and tumor recurrence or death, whichever occurs first, an average of 1 year
Secondary Outcome Measures: Disease control rate (DCR), Disease control rate (DCR), an average of 1 year|Overall Survival (OS), The time from the date of initiation of the drug donafenib until the date of death from any cause, an average of 1.5 year|Incidence of adverse events and serious adverse events, Incidence of adverse events and serious adverse events., an average of 1.5 year
Prognostic Significance of Preoperative Nutritional Status on Postoperative Acute Kidney Injury
NCT Number: NCT06496802
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Acute Kidney Injury|Pneumonectomy
Interventions: OTHER: no intervention
Sponsor: Wanmin Liao
Sex: ALL
Age: OLDER_ADULT
Enrollment: 1880
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07
Completion Date: 2024-09-15

Summary:
The incidence of postoperative acute kidney injury (AKI) is high in patients undergoing lung resection surgery, especially in the elderly. Early identification of high-risk postoperative AKI patients can help develop prevention and treatment management strategies.

Primary Outcome Measures: Postoperative acute kidney injury, In accordance with the KDIGO creatinine criteria: a serum creatinine increases of 26.5 mmol/L within 48 hours or 1.5 times baseline within 7 days after surgery., Within 7 days after surgery
Neoadjuvant Serplulimab in Combination With Chemotherapy in Locally Advanced Gastric or Gastro-esophageal Junction Cancer
NCT Number: NCT06496789
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Gastric Adenocarcinoma
Interventions: DRUG: Serplulimab+SOX
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 35
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-05-27
Completion Date: 2024-12-31
Locations: Tianjin Medical University Cancer Institute & Hospital, Tianjin, China

Summary:
evaluate efficacy and safety of neoadjuvant Serplulimab in Combination With Chemotherapy in Locally Advanced Gastric or Gastro-esophageal Junction Cancer

Primary Outcome Measures: PCR, Pathological complete regression rate, 3 months after the last subject participating in
The Effect of a Suturing Technique on the Gingival Tissues Around Dental Implants
NCT Number: NCT06496776
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Edentulous Jaw|Missing Teeth|Gingival Diseases
Interventions: PROCEDURE: Choukroun's technique
Sponsor: Damascus University
Collaborators: Al-Wataniya University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 14
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-09-15
Completion Date: 2023-04-15
Locations: Department of Oral and Maxillofacial Surgery, Hama, 332H 67A, Syrian Arab Republic

Summary:
There is general agreement that a thick zone of the keratinized tissues around implants promotes accurate prosthetic procedures, permits oral hygiene maintenance, resists recession, and enables esthetic blending with surrounding tissues. A new procedure called Choukroun's technique has been suggested, and it consists of a combination of horizontal apical mattress suture with regular suture to increase the keratinized tissue in the mandibular arch during the first stage after implantation. The proposed procedure has not been evaluated yet in a cohort of patients. Therefore, this study aimed to evaluate the impact of Choukroun's technique on the width and thickness of the keratinized gingiva after oral surgery.

Primary Outcome Measures: Change in the width of the keratinized gingiva, The width of the attached gingiva will be measured using a periodontal probe (William's probe). This measurement will be made at the mesial, distal, and middle positions within the surgical area (from the crest of the alveolar ridge to the mucogingival junction), and the mean of these measurements will be recorded., This variable will be measured at one day before surgery (T0), at one month (T1) and two months (T2) after the implant surgical insertion.|Change in the thickness of the keratinized gingiva, To measure the thickness of the keratinized gingiva, an endodontic file equipped with a rubber tip will be used to penetrate the gingiva at various points within the surgical area until it reaches the bone surface. These points are located midway between the mid-crestal of keratinized gingiva and the mucogingival junction, spaced 2 millimeters apart, and extending from the mesial to the distal aspects of the surgical area. The thickness will be then measured using a ruler, and the mean of these values will be recorded., This variable will be measured at one day before surgery (T0), at one month (T1) and two months (T2) after the implant surgical insertion.
Assessment of an Automated Optical Coherence Tomography and Camera : Effectiveness of Vision-700
NCT Number: NCT06496763
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Normal Subject|Glaucoma|Retinal Disease|Cornea
Interventions: DEVICE: Vision-700
Sponsor: Crystalvue Medical Coporation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 159
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-09-01
Completion Date: 2023-07-31
Locations: Tri-Services General Hospital, Taipei county, Taiwan

Summary:
The objective of study is to assess the repeatability and agreement of the retina and cornea measurement by Vision-700 in comparison with those by 3D OCT-1.

Primary Outcome Measures: The Precision of Vision-700 in Retinal and Cornea Measurement, The Precision included the repeatability and reproducibility., 2022/9/1|The Precision of 3D OCT-1 in Retinal and Cornea Measurements, The Precision included the repeatability and reproducibility., 2022/9/1|The Agreement of Vision-700 and 3D OCT-1 in Retinal and Cornea Measurements, the agreement study, 2022/9/1
Ketamine for Methamphetamine Use Disorder
NCT Number: NCT06496750
Acronym: KMD
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Substance Use Disorders|Substance Use|Methamphetamine Abuse
Interventions: DRUG: Ketamine Hydrochloride|DRUG: Midazolam Hydrochloride
Sponsor: University of Texas Southwestern Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-03
Completion Date: 2027-04-01
Locations: UT Southwestern Medical Center, Dallas, Texas, 75247, United States

Summary:
This study aims to determine whether treatment response with IV ketamine is superior to treatment response with IV midazolam in adults with moderate to severe MUD.

The study design is a 12-week randomized, double-blind, controlled trial comparing intravenous (IV) ketamine against IV midazolam, delivered over six weeks in 120 adults with moderate to severe methamphetamine use disorder (MUD).

Primary Outcome Measures: Treatment Response, Defined as having at least three methamphetamine-negative urine samples out of four samples obtained during Weeks 3 and 4., 2 weeks
Secondary Outcome Measures: Non-serious adverse outcomes associated with IV ketamine treatment for methamphetamine use, Defined by non-serious adverse events (associated with the IV ketamine treatment) reported during the study intervention phase (weeks 1 to 6). Participants will be assessed for adverse events at each study visit., 6 weeks|Adherence to treatment, Defined by completion of at least five out of eight IV ketamine or IV midazolam infusions., 6 weeks|Total abstinence, Defined as four out of four methamphetamine-negative urine samples obtained during Weeks 3 and 4 (since missing urine drug screens will be counted as positive)., 2 weeks|Abstinence from methamphetamine use, Defined by the self-reported days of methamphetamine use as reported on the Timeline Followback (TLFB) from Week 1 to Week 4, Week 5 to Week 6, and Week 7 to Week 12., 12 weeks|Differences in methamphetamine-negative urine samples from Weeks 1 to 6 and between ketamine and midazolam arms., Urine samples will be collected twice a week at in-person visits., 6 weeks|Differences in methamphetamine-negative urine samples from Weeks 1 and 2 versus Weeks 3 and 4., Urine samples will be collected twice a week at in-person visits., 4 weeks