pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Sucrose as a Standard in Cesarean Section Surgical Wound Healing to Reduce Hospital Time
NCT Number: NCT06477770
Acronym: SAGRA
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Surgical Wound Infection|Cesarean Wound; Dehiscence
Interventions: PROCEDURE: Clorhexidine soap|OTHER: Sucrose
Sponsor: Universidad Nacional Autonoma de Honduras
Sex: FEMALE
Age: ADULT
Enrollment: 24
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-01
Completion Date: 2024-12-01
Locations: Hospital Escuela, Tegucigalpa, Francisco Morazan, 11101, Honduras

Summary:
It is a randomized, single-blind clinical trial, whose population to be studied will be randomized patients with a diagnosis of dehiscence and infection of a cesarean surgical wound who meet the inclusion and exclusion criteria.

H0: Sucrose does not reduce hospital days in patients with surgical wound dehiscence.

HA: Sucrose reduces hospital days in patients with surgical wound dehiscence.

Primary Outcome Measures: Changes of in-hospital days, from the intervention days, from the first intervention to delayed primary closure (by third intention), on average less than 14 days
Secondary Outcome Measures: Change of Satisfaction scale for scar assessment, Mesure with POSAS questionnaire (Patient and Observer Scar Assessment), The POSAS scale for the evaluation of scars is validated and shows advantages over other scales by integrating qualitative parameters and the opinion of the patient. It consists of six parameters to be evaluated on an ordinal scale from 1 to 10. The sum of all questions gives a final score (6 to 60 points). All items are rated on a scale ranging from 1 ("similar to normal skin") to 10 ("Very different from normal skin").

Less points means a better outcome., 3 months
Inflammatory Response and Oxidative Stress in Cardiac Surgery: Min. Invasive vs. Conventional Extracorporeal Circulation
NCT Number: NCT06477757
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Oxidative Stress|Systemic Inflammatory Response Syndrome|Extracorporeal Circulation; Complications
Interventions: PROCEDURE: Minimally Invasive Extracorporeal Circulation|PROCEDURE: Conventional Extracorporeal Circulation
Sponsor: University Medical Centre Maribor
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-07-29
Completion Date: 2026-12-31
Locations: UMC Maribor, Maribor, Slovenia

Summary:
The goal of our research project is to measure and compare oxidative stress markers, and systemic inflammatory response in patients undergoing open heart surgery with either conventional or minimally invasive extracorporeal circulation as well as develop pharmacokinetic profiles of different oxidative stress markers for further research on inflammatory response after open heart surgery. The main questions our study aims to answer are :

* Does the type of extracorporeal circulation affect the levels of different oxidative stress markers?
* Can preoperative and postoperative oxidative stress marker levels be of prognostic values?
* Do preoperative and postoperative oxidative stress markers correlate with the clinical outcomes in patients?

Researchers will compare the effect of conventional and minimally invasive extracorporeal circulation on clinical outcomes, oxidative stress marker levels, and systemic inflammatory response.

Participants will be randomised into two groups (one undergoing arrested-heart surgery with the use of conventional extracorporeal circulation, and the second group undergoing arrested-heart surgery with the use of minimally invasive extracorporeal circulation) and laboratory data, oxidative stress markers, and clinical data will be collected until discharge.

Primary Outcome Measures: Oxidative stress biomarker levels, Oxidative stress biomarker levels will be analyzed from blood samples collected at predetermined time-frames., From enrollment until discharge, assessed up to 100 weeks.
Secondary Outcome Measures: Incidence of postoperative atrial fibrillation, Atrial fibrillation will be monitored by continuous telemetry following cardiac surgery, until discharge., From enrollment until discharge, assessed up to 100 weeks.|Incidence of postoperative acute kidney failure, Kidney function will be monitored by measuring urine secretion and glomerular filtration rate at predetermined time frames, and evaluated according to Kidney Disease: Improving Global Outcomes (KDIGO) system., From enrollment until discharge, assessed up to 100 weeks.
Waiting Time in the Premedication Room on Anxiety
NCT Number: NCT06477731
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Total Anesthetic Consumption
Interventions: BEHAVIORAL: total anesthetic consumption
Sponsor: Istinye University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 130
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-20
Completion Date: 2024-07-30
Locations: Istinye Üniversity, Istanbul, Merkez Mahallesi, 34250, Turkey

Summary:
The primary purpose of the study is to determine the total anesthetic consumption required to reach the optimal depth of anesthesia (BIS 50) depending on the anxiety of the waiting period in the preoperative waiting room and the degree of anxiety.

Primary Outcome Measures: total anesthetic consumption, The primary purpose of the study is to determine the total anesthetic consumption required to reach the optimal depth of anesthesia (BIS 50) depending on the anxiety of the waiting period in the preoperative waiting room and the degree of anxiety., 1 month
Genomic Signatures for Patients With Initially Unresectable Colorectal Liver Metastases
NCT Number: NCT06477718
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Genomic Instability|Prognostic Cancer Model
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 286
Study Design: Observational Model: |Time Perspective: p
Start Date: 2016-01-01
Completion Date: 2023-12-01

Summary:
A retrospective cohort of 286 patients with synchronous CRLM underwent conversion therapies based on next-generation sequencing (NGS) results. All cases were categorized into a successful conversion therapy group (SCTG) if they achieved no evidence of disease (NED) status through surgery after conversion therapy, and a failed conversion therapy group (FCTG) otherwise. Clinical risk factors and genomic mutations were analyzed for association with conversion therapy outcomes and survival.

Primary Outcome Measures: Overall survival, 5 year overall survival, 5 year
Invert-Prospective Phase II Randomized Trial of Involved Nodal Versus Elective Neck RadioTherapy
NCT Number: NCT06477692
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Head and Neck Cancer
Interventions: DRUG: ENI using IMRT with or without chemotherapy|RADIATION: INRT|RADIATION: ENI
Sponsor: University of Texas Southwestern Medical Center
Collaborators: National Cancer Institute (NCI)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2028-07-01
Locations: UT Southwestern Medical Center, Dallas, Texas, 75390, United States

Summary:
To determine the risk of solitary elective volume recurrence following involved nodal radiotherapy (INRT) versus elective nodal irradiation (ENI)

Primary Outcome Measures: The probability at two years: SEVR in INRT versus ENI patients, The probability at two years will be compared between the arms using a one- sided Fisher's exact test (probability of SEVR between the arms)., 2 years
Secondary Outcome Measures: Secondary: Dermatitis and Dysphagia, Acute grade 2+ dermatitis and grade 3+ dysphagia, 2 years
Velopharyngeal Insufficiency Evaluation Post Cleft Palate Repair. Furlow With Buccinator Myomucosal Flap Versus Two Flap Palatoplasty
NCT Number: NCT06477679
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cleft Palate
Interventions: PROCEDURE: • Furlow with buccinators myomucosal flap|PROCEDURE: • Two flap palatoplasty as von langenbeck technique
Sponsor: Sohag University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06
Completion Date: 2026-02
Locations: Sohag university Hospital, Sohag, Egypt

Summary:
Cleft palate is one of the most common congenital abnormalities of the orofacial region throughout the world. This condition can cause facial deformity, feeding problems, frequent middle ear infections, dental defects, speech abnormalities and emotional problems . Early surgical repair of this congenital anomaly prevents the psychological and functional problems associated with the deformity . Patients may develop various complications after primary palatoplasty including palatal fistula and velopharyngeal insufficiency (VPI) which are relatively common .

The main goal of cleft palate repair is to achieve normal speech and adequate velopharyngeal function with minimal effect on facial growth. The primary objective in the surgical repair of a cleft palate is the development of normal speech. Speech quality remains the most important standard for assessing clinical outcomes and the success of surgical procedures. Many surgical techniques for palate correction have been described determining the most effective technique for the surgical repair of palatal clefts continues to cause controversy .

The incidence of VPI post cleft palate repair is 20-30% of patients . If there is significant velopharyngeal dysfunction during normal speech development, many children learn to compensate for the lack of intraoral pressure. They produce a hoarse voice because of vocal fold adduction and sudden release. Compared with the adductor vocal fold palsy .

Primary Outcome Measures: Velopharyngeal Insufficiency Evaluation, Velopharyngeal gap size in centimeters using nasopharyngoscopy., 20 months
Home Rehabilitation Improves Cardiac Effort in Pulmonary Arterial Hypertension
NCT Number: NCT06477640
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pulmonary Arterial Hypertension PAH
Interventions: BEHAVIORAL: Exercise|BEHAVIORAL: Standard of Care
Sponsor: University of Rochester
Collaborators: United Therapeutics|Mayo Clinic
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-29
Completion Date: 2025-12-31
Locations: University of Rochester Medical Center, Rochester, New York, 14642, United States

Summary:
The purpose of this study is to evaluate whether a home rehabilitation program for patients diagnosed with Pulmonary Arterial Hypertension (PAH) will decrease Cardiac Effort (number of heart beats used during 6-minute walk test/walk distance) and improve quality of life. Ultimately, this information could help improve the management of patients with PAH.

Primary Outcome Measures: Mean change in cardiac effort, Cardiac effort is the number of heartbeats used during the a six minute walk test divided by walk distance, baseline to 3 months
Secondary Outcome Measures: Mean change in six minutes walk distance, The amount of distance walked in six minutes, baseline to 3 months
The Coastal Exposome: a Study of Sea Air Inhalation and Possible Links to Health
NCT Number: NCT06477627
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Immune Suppression|Exposure
Interventions: OTHER: change of environment|OTHER: no intervention
Sponsor: University Ghent
Sex: ALL
Age: ADULT
Enrollment: 67
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-06-19
Completion Date: 2028-12-31
Locations: Ghent University, Ghent, Oost-Vlaanderen, 9000, Belgium

Summary:
The research aims to understand oceans as crucial contributors to human health in coastal environments. Oceans produce marine spray aerosols that contain a mixture of microbiota and natural biological molecules (biogenics).

Primary Outcome Measures: nose swabs: respiratory microbiome and biogenics profile, DNA from the nose swabs will be analysed for microbiota and biogenics on the swabs will be analysed as well, to get an idea of what molecules and microbiota from the sea air are inhaled., 4 times during the 8 week study period|VAMS blood samples: cytokines, Cytokines (IL-6, TNF-alfa, IL-10) will be measured in blood samples to link the sea air exposure to the human health, 4 times during the 8 week study period
Anti-cancer DC Cell Vaccination to Treat Solid Tumors
NCT Number: NCT06477614
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Solid Tumor, Adult|DC
Interventions: BIOLOGICAL: DC cell Vaccine
Sponsor: Second Affiliated Hospital of Guangzhou Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-05
Completion Date: 2035-12-30
Locations: The Second Affiliated Hospital of Guangzhou Medical University, Guanzhou, Guangdong, 51260, China

Summary:
Placental or tumor-derived heat shock protein gp96 is collected, purified, and stored. The DC cells are isolated from the patient's blood and then cocultured with the gp96 to obtain the activated DC cell product. The manufactured DC cells are subcutaneously or intra-tumor injected into the patient. Clinical studies will be performed to test anti-cancer function of the DC vaccination for immunotherapy of cancer patients. In this phase I study, the safety, tolerance, and preliminary efficacy of the DC vaccine immunotherapy on advanced cancers will firstly be evaluated.

Primary Outcome Measures: Number of Patients with Dose Limiting Toxicity, A dose limiting toxicity is defined as any toxicity that is considered to be primarily related to the vaccine, which is irreversible, or life threatening or hematologic or non-hematologic Grade 3-5., Six months
Secondary Outcome Measures: Percent of Patients with best response as either complete remission or partial remission., Response rates will be estimated as the percent of patients whose best response is either complete remission or partial remission by combining the data from the patients. To compare with historical data, a 95% confidence interval will be calculated for the response rate., Six months
Cooling Agent Pilot Among Adult Menthol Smokers
NCT Number: NCT06477601
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Tobacco Dependence
Interventions: OTHER: Assigning cooling agent type cigarettes|OTHER: Assigning traditional tobacco type cigarettes|OTHER: Assigning menthol type cigarettes
Sponsor: University of Kansas Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-06-24
Completion Date: 2024-12-15
Locations: University of Kansas Tobacco Treatment Center, Kansas City, Missouri, 64130, United States

Summary:
Recent studies and market monitoring have shown that in places where menthol cigarettes are no longer available, tobacco companies have started marketing "non-menthol cooling cigarettes". Little is known about what current menthol smokers think of these non-menthol cooling cigarettes and how they compare to regular menthol cigarettes. By doing this study, the investigators hope to learn what menthol smokers think of these cigarettes and how they impact how menthol smokers smoke.

Primary Outcome Measures: Cigarette changes from baseline to week 3, 4.1 The primary study endpoint is changes in total cigarettes per day from baseline to week 3., 3 weeks
Effectiveness of Technology-based Interventions for the Improvement of Cognitive Processes in ADHD.
NCT Number: NCT06477575
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: ADHD, Deficits in Motor Control and Perception
Interventions: DEVICE: neurocognitive therapy based on new technologies|OTHER: conventional neurocognitive therapy
Sponsor: University of Extremadura
Sex: ALL
Age: CHILD
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-03-01
Completion Date: 2024-06-21
Locations: Berta Caro Puértolas, Badajoz, Spain

Summary:
To scientifically demonstrate the improvements in cognitive functions and core symptoms of children and adolescents diagnosed with ADHD through the implementation of a cognitive rehabilitation program based on the use of the most relevant technologies found in the systematic review carried out during the first phase.

Two intervention groups will be randomly assigned for the study:

G1: composed of 20 patients who will receive neurocognitive therapy based on new technologies. This will be the experimental group.

G2: composed of 20 patients who will receive conventional neurocognitive therapy for ADHD treatment. This group will be the control group

Primary Outcome Measures: WisC-V (Wechsler intelligence scale for children), provides primary intelligence index scores that reflect intellectual functioning in different cognitive areas: verbal comprehension, visuospatial, fluid reasoning, working memory and processing speed., 8 weeks|STROOP (Colors and Words Test), reference test for the detection of neuropsychological problems and brain damage. It allows to evaluate the phenomenon of interference, intimately linked to inhibitory control processes., 8 weeks|CARAS-R(Difference perception test), evaluates the ability to quickly and correctly perceive similarities and differences in partially ordered patterns of stimulation. It measures perceptual and attentional skills by means of 60 graphic items consisting of schematic drawings of faces with elementary strokes., 8 weeks
Surveillance Endoscopy After Proximal Gastriectomy With Double Tract Reconstruction.
NCT Number: NCT06477562
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Gastric Cancer|Proximal Gastric Adenocarcinoma
Interventions: OTHER: Endoscopy
Sponsor: Saint Vincent's Hospital, Korea
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 160
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-02-15
Completion Date: 2024-06-01
Locations: Jiwon Seo, Suwon, Gyeong-Gi-Do, 16247, Korea, Republic of

Summary:
The primary purpose of surveillance endoscopy after gastric cancer surgery is to detect malignancy recurrence in the remnant stomach. This study aims to analyze the rate of proper remnant stomach observation following proximal gastrectomy(PG) with double tract reconstruction (DTR). Data from patients who underwent PG with DTR for gastric cancer at six institutions in South Korea from 2011 to 2023 were included. Clinicopathological and serial endoscopic data were retrospectively reviewed and analyzed. Successful surveillance endoscopy was defined as obtaining an endoscopic image of the pyloric antrum. Factors associated with successful endoscopy were analyzed using a mixed-effects logistic regression model. A total of 634 surveillance endoscopies were performed on 160 patients after PG with DTR. The median duration from surgery to the endoscopy was 17.5 months (range, 0-137 months). The success rate of the endoscopies was 75.6%, with a mean time of 271.7±300.5 seconds to reach the pyloric antrum. The average total procedure time for successful endoscopic examinations was 439.4±336.0 seconds, compared to 373.7±326.0 seconds for failed examinations. (p=0.033). Among patients who underwent the procedure twice or more, 6.5% had all endoscopic examinations fail, while 2.8% of those who underwent the procedure three times or more experienced failure in all examinations. Factors associated with successful endoscopy included longer procedure time (OR 1.32, 95% CI 1.01-1.72), endoscopy performed by a non-surgeon (OR 0.19, 95% CI 0.11-0.36), longer duration after surgery (OR 1.33, 95% CI 1.02-1.72) and younger age (OR 0.70, 95% CI 0.49-0.97). Understanding the anatomic alterations after PG with DTR is crucial for the success of surveillance endoscopy. Additionally, the duration from surgery to endoscopy is associated with the success of the examination, and the rate of failure across all serial endoscopies is very low. Therefore, clinicians should perform endoscopies with sufficient procedure time and conduct endoscopies regardless of the failure of previous examinations.

Primary Outcome Measures: Successful surveillance endoscopy, Obtaining an endoscopic image of the pyloric antrum., Routine endoscopic surveillance was performed 6 months after surgery.
Long-Term Safety and Efficacy of HB0034 in Subjects With Generalized Pustular Psoriasis
NCT Number: NCT06477536
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2|PHASE3
Conditions: Generalized Pustular Psoriasis
Interventions: DRUG: HB0034
Sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 33
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-30
Completion Date: 2026-06-30

Summary:
This is a Phase IIb, long term extension study to evaluate the safety and efficacy of HB0034 in adult subjects with generalized pustular psoriasis (GPP).

Primary Outcome Measures: Safety endpoints include the proportion of subjects with TEAEs, The safety assessment includes monitoring for AEs, SAEs (including SAEs related to protocol procedures from signing of ICF until before the first dose of the study drug) from the first dose of the study drug to end of study (EOS) , as well as changes from baseline in laboratory tests, vital signs, physical examination, and 12-lead electrocardiogram (ECG)., 0-24 weeks
Secondary Outcome Measures: The recurrence of GPP flare during the study, The Proportion of patients who have at least once GPP flare during the study, 0-24 weeks
Evaluation of Effect of Non-surgical Periodontal Treatment on Patient's Self Perception of Esthetics
NCT Number: NCT06477510
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Periodontitis
Interventions: PROCEDURE: non-surgical periodontal therapy
Sponsor: Postgraduate Institute of Dental Sciences Rohtak
Sex: ALL
Age: ADULT
Enrollment: 48
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2025-12-01
Locations: Post Graduate Institute of Dental Sciences, Rohtak, Haryana, 124001, India

Summary:
Non-surgical periodontal treatment is a fundamental part of periodontal therapy,including supportive therapy. It has been proven to be efficacious in reducing inflammation, probing pocket depth and number of diseased sites in patients affected by periodontitis, often limiting the need for additional treatment approaches. However,despite being such a widely administered treatment, the effect of non-surgical periodontal treatment on patient reported outcomes has remained restricted to parameters such as pain and sensitivity only, with patient's perception of aesthetics remaining largely unexplored.

Focusing only on physical periodontal measurements, leaves the true impact of periodontitis as well as its treatment on patient's well-being largely under recognized. With the development of the periodontal aesthetics perception scale (PAPS), it is possible to assess the results in a standardized manner.Therefore, the goal of this study (prospective-interventional ) is to to assess the patient's self-perception of aesthetics using a standardized tool after non surgical periodontal treatment and how much of changes in aesthetics are perceived by the patient. This would be helpful in understanding and managing patient expectations. Also, utilizing a standardized tool would reduce heterogeneity bias by providing comparable data between studies for future research on understanding patient preferences.

Primary Outcome Measures: Patient's perception of aesthetics by PAPS score (Periodontal Aesthetic Perception Scale), Assess Patient's perception of aesthetics by PAPS score (Periodontal Aesthetic Perception Scale) in Indian population, 12-18 months|Patient's perception of aesthetics by Numeri rating scale, Assess Patient's perception of aesthetics by Numeric rating scale, 12-18 months|Patient's perception of aesthetics by Global transition scale, Assess Patient's perception of aesthetics by Global transition scale, 12-18 months
Secondary Outcome Measures: To correlate self-reported perception of esthetics with clinical periodontal parameters (CAL, BOP, PPD, gingival phenotype, gingival recession, interdental papillary height, gingival pigmentation and gingival display)., To correlate self-reported perception of esthetics with clinical periodontal parameters (CAL, BOP, PPD, gingival phenotype, gingival recession, interdental papillary height, gingival pigmentation and gingival display) in Indian population, 12-18 months
The Application of Comprehensive Prevention and Treatment Strategy of Placenta Accreta Spectrum Disorders
NCT Number: NCT06477497
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Placenta Accreta Spectrum
Sponsor: Peking Union Medical College Hospital
Collaborators: National Key Research and Development Program of China
Sex: FEMALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 33
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2025-11-30

Summary:
Placenta accreta spectrum (PAS) disorders are pathological attachment of the placenta to myometrium, where trophoblastic cells invade the uterine placental interface. PAS can lead to severe postpartum hemorrhage or even maternal death. Prenatal diagnosis of PAS is essential for optimal obstetric management to improve the pregnancy outcomes. However, in some low resource regions in China, less than 20% PAS are detected before delivery.

To explore the feasibility and universality of the bundled prevention and treatment strategy for placenta accreta spectrum disorders in different levels of medical institutions, and to investigate its effectiveness in improving the specialized disease management capabilities of medical institutions at all levels. We will conduct a regional, cluster-randomized trial to assess a multicomponent PAS management strategy to improve the prepartum detection rate of PAS.

Primary Outcome Measures: antepartum diagnosis rate of PAS, through study completion, an average of 1.5 year
Blood Biomarkers for Screening of Alzheimer's Disease
NCT Number: NCT06477484
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Alzheimer's Disease|Blood Biomarkers
Interventions: DIAGNOSTIC_TEST: Blood biomarker
Sponsor: Peking University First Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 180
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-18
Completion Date: 2026-03-26
Locations: Peking University First Hospital, Beijing, Beijing, 100034, China

Summary:
The goal of this observational study is to estimate the screen performance of blood biomarkers of interest (Aβ40 and Aβ42, P-Tau181, P-Tau217, GFAP and NfL) in patients with Alzheimer's disease (AD), mild cognitive impairment due to AD, and cognitively normal individuals. The main questions it aims to answer are:

* to identify core blood biomarker suitable for early screening of AD.
* to establish a comprehensive model for the early identification of AD.

Primary Outcome Measures: Evaluate the diagnostic accuracy of blood biomarkers of Aβ42, Aβ40, Aβ42/Aβ40, P-Tau181, P-Tau217, GFAP and NfL., 2 years
Secondary Outcome Measures: Evaluate the diagnostic accuracy of a comprehensive model combined with core blood biomarkers and clinical information., 2 years
Deep Learning for Preoperative Pulmonary Assessment in Thoracic CT
NCT Number: NCT06477458
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Elective Thoracic Surgery|Pulmonary Function|Deep Learning
Interventions: OTHER: Single inspiratory phase computed tomography.|OTHER: Respiratory dual-phase computed tomography.
Sponsor: The First Affiliated Hospital of Guangzhou Medical University
Collaborators: GE Healthcare
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 2000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-10-01
Completion Date: 2024-12-30
Locations: Department of Cardiothoracic Surgery, the First Affiliated Hospital of Guangzhou Medical College, Guangzhou, Guangdong, 510120, China

Summary:
The trial was designed as a single-centre, non-interventional prospective observational study to utilize deep learning technology combined with computed tomography (CT) images to precisely predict the pulmonary function indicators of thoracic surgery preoperative patients.

Primary Outcome Measures: Mean Absolute Error（MAE）, Used to assess the discrepancy between pulmonary function predictions made by the deep learning algorithm and actual results obtained from pulmonary function tests (measured with a spirometer)., 2 years
Secondary Outcome Measures: Concordance Correlation Coefficient（CCC）, Used to assess the discrepancy between pulmonary function predictions made by the deep learning algorithm and actual results obtained from pulmonary function tests (measured with a spirometer)., 2 years
Visual Feedback Balance Training System Combined with RFE in Stroke
NCT Number: NCT06477445
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stroke
Sponsor: Nanjing Mingzhou Rehabilitation Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2024-10

Summary:
The goal of this clinical trial is to learn if visual feedback balance training system combined with repetitive facilitative exercise (RFE) work to treat stroke in adults. The main questions it aims to answer are:

Does visual feedback balance training system combined with RFE reduce the fall risk of participants? Can the combination of intelligent rehabilitation robot training system and RFE achieve better effects?

Researchers will compare 3 groups (RFE, visual feedback balance training system under RFE, and conventional therapy) to see if visual feedback balance training system and RFE works to treat stroke.

Participants will:

Receive treatment for 4 weeks Receive scale and instrument testing before and after treatment

Primary Outcome Measures: time up and go test (TUG), From enrollment to the end of treatment at 4 weeks|10-meter walk test (10-MWT), From enrollment to the end of treatment at 4 weeks|Center of gravity loss index, Use the Libra parameters evaluation system included with visual feedback balance training system, From enrollment to the end of treatment at 4 weeks|Deviation of bilateral center of gravity movement area, Use the Libra parameters evaluation system included with visual feedback balance training system, From enrollment to the end of treatment at 4 weeks
Secondary Outcome Measures: functional ambulation category scale (FAC), From enrollment to the end of treatment at 4 weeks|Fugl-Meyer Assessment (FMA), From enrollment to the end of treatment at 4 weeks|Berg balance scale (BBS), From enrollment to the end of treatment at 4 weeks
A Study of Sacituzumab Govitecan in People With Mesothelioma
NCT Number: NCT06477419
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Mesothelioma|Mesotheliomas Pleural|Mesothelioma; Pleura
Interventions: DRUG: Sacituzumab govitecan-hziy
Sponsor: Memorial Sloan Kettering Cancer Center
Collaborators: Gilead Sciences
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 33
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-21
Completion Date: 2029-06-21
Locations: Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, 07920, United States|Memorial Sloan Kettering Monmouth, Middletown, New Jersey, 07748, United States|Memorial Sloan Kettering Bergen, Montvale, New Jersey, 07645, United States|Memorial Sloan Kettering Cancer Center @ Commack, Commack, New York, 11725, United States|Memorial Sloan Kettering Westchester, Harrison, New York, 10604, United States|Memorial Sloan - Kettering Cancer Center, New York, New York, 10021, United States|Memorial Sloan Kettering Nassau, Uniondale, New York, 11553, United States

Summary:
Participants will receive sacituzumab govitecan until their disease gets worse (progresses), they have severe side effects and cannot continue study treatment, or the participants or the study doctor thinks it's in your best interest to stop treatment.

Primary Outcome Measures: Overall Response Rate, Clinical efficacy of Sacituzumab Govitecan/SG determined by overall response rate by modified (m)RECIST criteria v1.1. Overall response rate defined as participants who achieve complete response or partial response as best overall response by modified RECIST v1.1 criteria for mesothelioma, 2 years
The ACCEPT Study: Improving the Process of Disclosing Adverse Childhood Experiences in Community Mental Health
NCT Number: NCT06477380
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Adverse Childhood Experiences
Interventions: BEHAVIORAL: ACCEPT intervention
Sponsor: King's College London
Collaborators: Sussex Partnership NHS Foundation Trust
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SCREENING
Start Date: 2024-06
Completion Date: 2026-08
Locations: Sussex Partnership Foundation Trust, Worthing, West Sussex, BN11 1HS, United Kingdom|IoPPN, Kings College London, London, SE5 8AF, United Kingdom

Summary:
Experiences of abuse, neglect, domestic violence, severe bullying and community violence in childhood are very common among people who use mental health services. These often have serious and long lasting impacts on people's mental health.When a person decides to disclose or talk about these traumatic experiences it can help healing. However, mental health staff often lack confidence and organisational support to ask about childhood traumatic events and struggle to know how to respond to disclosures or how best to offer follow up support.

A research method called experience-based co-design will be used to find different ways of supporting staff to safely have conversations about childhood trauma with service users. Experience-based co-design involves;

1. Exploring experiences of service users' and staff through in-depth interviewing, observations and group discussions;
2. Creating a short film of service users' experiences which helps staff and service users work together to identify areas for improvement and explore potential solutions;
3. Staff and service users working together in teams to develop the ideas into actionable changes to service delivery

The co-designed intervention could include:

* A training package for community mental health team staff
* A toolkit for clinicians to help them to safely talk about childhood trauma with service users.
* Changes to the physical environment to make it feel safer
* A reflective practice group for staff

Anticipated impacts:

For service users: Improved experience of disclosing ACEs; improved access to trauma treatment; improved therapeutic relationships; improved mental health outcomes.

For staff: Improved confidence and competence to sensitively explore ACEs; improved compassion; greater job satisfaction

Primary Outcome Measures: Intervention acceptability and feasibility, Interview and focus groups will be carried out with staff and service users to explore the acceptability and feasibility of the intervention, 6 months post intervention|Therapeutic relationship, The STAR-C measure will be used to assess clinicians therapeutic relationships with their patients pre and post intervention (https://pubmed.ncbi.nlm.nih.gov/17094819/), baseline, 3 months and 6 months|Professional Quality of Life (ProQOL), The ProQOL will be used to measure clinicians compassion satisfaction and compassion fatigue (inc. burn out and indirect trauma), baseline, 3 months and 6 months
ACEMg for Hearing Preservation and Tinnitus Mitigation
NCT Number: NCT06477354
Acronym: ACEMgRWD
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Sensorineural Hearing Loss|Tinnitus|SNHL|Inner Ear Hearing Loss
Interventions: DIETARY_SUPPLEMENT: ACEMg
Sponsor: Keep Hearing, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 2000
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-09-15
Completion Date: 2026-12-31
Locations: Visit keephearing.org or soundbites.com to participate at home, Ann Arbor, Michigan, 48104, United States

Summary:
This study is a secondary analysis of real-world data from 24-week tests of the ACEMg neuroprotectant biomedicine available as Soundbites softgel capsules. The study aims to validate findings from the previous two-year real-world study demonstrating ACEMg (Soundbites) preserved or improved auditory function (hearing) for 75.3% of participants who used it daily, with most improvement occurring within six months. Additionally, this study aims to assess the potential of ACEMg to relieve tinnitus symptoms in people with tinnitus. SNHL and tinnitus are related but tinnitus relief was not measured in the previous two-year study.

The study aims to answer two questions. First, does the real-world data demonstrate that hearing loss is stabilized or improved at the end of the test among participants with sensorineural hearing loss (SNHL or inner ear hearing loss) at the beginning? Second, do participants who self-report tinnitus symptoms at the start of their test report reduced symptoms at the end?

Participants must be eighteen years of age and older. The test starts with a baseline hearing assessment. Participants with tinnitus complete a baseline tinnitus survey. Then, each participant takes ACEMg softgel capsules daily, repeating the hearing assessment and the tinnitus survey after about 12 and 24 weeks. Assessment scores at the beginning of the study will be compared with scores at the end.

Primary Outcome Measures: Subjective measure of preservation or improvement of inner ear auditory function, Hearing assessments using the hearWHO digits-in-noise test, Time point zero; 12 and 24 weeks.|Objective measure of preservation or improvement of inner ear auditory function, Hearing assessments using OAE examinations, Time point zero; 12 and 24 weeks.|Tinnitus symptom relief, Subjective assessment of tinnitus symptoms using the tinnitus survey, Time point zero; 12 and 24 weeks.
The Effect of Active Nutritional Support On Quality Of Life In Patients With Head And Neck Cancer Receiving Radiotherapy
NCT Number: NCT06477341
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Head and Neck Neoplasms
Interventions: DIETARY_SUPPLEMENT: various available nutrition as those contain high protein content as ensure milk
Sponsor: Assiut University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 47
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2023-01-01
Completion Date: 2026-03-30
Locations: Reham mohamed, Assiut, Egypt

Summary:
note effect of appropriate nutrition on head and neck cancer patients receiving radiotherapy

Primary Outcome Measures: nutritional status of patients, Follow up improvement by evaluating weight in kg and height in meters to calculate body mass index in kg / m\^2, two years
Evaluating Chronic Obstructive Pulmonary Disease (COPD) Patients' Treatment Compliance and Quality of Life Via Telemedicine
NCT Number: NCT06477328
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Telehealth|Copd
Interventions: PROCEDURE: Telemedicine
Sponsor: Ankara Etlik City Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 74
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SCREENING
Start Date: 2022-07-01
Completion Date: 2023-10-15
Locations: Gazi University, Ankara, Turkey

Summary:
The Covid-19 pandemic has disrupted the follow-up and treatment processes for patients, and telemedicine has emerged as an important alternative method. Our aim was to test compare COPD Assessment Test (CAT) scores, inhaler treatment techniques and adherence between telemedicine-mediated healthcare and healthcare provided face-to-face.

Primary Outcome Measures: Inhaler adherence, At the end of 3 months, inhaler adherence was compared. A 6-item Inhaler Adherence Scale (IAS) was used to evaluate inhaler treatment compliance. If the patient answered "yes" to even one of the items, they were deemed non-compliant.

The questions:

''During the last 3 months;

* have you at times been careless about using your inhaler or nebulizer?,
* have you ever forgotten to use your inhaler or nebulizer?
* have you ever stopped using your inhaler because you felt better?
* have you ever stopped using your inhaler or nebulizer because you felt worse?
* have you ever used your inhaler or nebulizer less than the doctor prescribed because you felt better?
* have you ever used your inhaler or nebulizer more than the doctor prescribed because you felt you were having an attack?''., 3 months
Secondary Outcome Measures: COPD Assesment Test (CAT) score, The aim of the investigator's study is to test whether telemedicine is a safe and effective method for the follow-up of patients with advanced-stage COPD after exacerbations, to see if there is a difference in treatment adherence after 3 months of observation compared to face-to-face healthcare services, and to evaluate if there is a difference in CAT scores.

The COPD Assessment Test (CAT) is a questionnaire for people with COPD. It is designed to measure the impact of COPD on a person's life, and how this changes over time.

Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life., 3 months
Scale of Therapeutic Adherence to Respiratory Rahabilitation for Lung Cancer
NCT Number: NCT06477302
Acronym: STA-RR-LC
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Lung Cancer
Interventions: BEHAVIORAL: Scale of Therapeutic Adherence to Respiratory Rahabilitation for Lung Cancer (STA-RR-LC)
Sponsor: Instituto Nacional de Cancerologia de Mexico
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 281
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-06-23
Completion Date: 2026-06-23
Locations: Instituto Nacional de Cancerologia, Mexico City, 14080, Mexico

Summary:
The goal of this non experimental, transversal instrument study is to Construct and determine the reliability and validity of the Scale of Therapeutic Adherence for Respiratory Rehabilitation in Lung Cancer in Mexican patients with a lung cancer diagnosis.

The main question it aims to answer is: What is the reliability and validity of the Scale of Therapeutic Adherence for Respiratory Rehabilitation in Lung Cancer of the patients with this diagnosis that are currently undergoing an assessment or follow up program of Respiratory Rehabilitation?

The Scale of Therapeutic Adherence for Respiratory Rehabilitation in Lung Cancer (STA-RR-LC) will be psychometrically valid and reliable for the evaluation of therapeutic adherence on patients with lung cancer that are undergoing an assessment or follow up of Respiratory Rehabilitation.Participants will be asked to fill out an Identification card and fill out the fifty-six items presented on the STA-RR-LC.

Primary Outcome Measures: Contruction of the Scale of Therapeutic Adherence for Respiratory Rehabilitation in Lung Cancer (STA-RR-LC), The validity of the construction is carried out with an exploratory factor analysis using the Maximum Likelihood extraction method and the oblique rotation (direct Oblimin). Confiability is determitated using the Alpha of Cronbach coefficient., the STA-RR-LC will be applied for one time and as soon as the patient has completed one month attending the Respiratory Rehabilitation Service.
Secondary Outcome Measures: Verify the concurrent validity of the instrument, It will be verified using the current scores of the European Organisation for Research and Treatment of Cancer, specifically the Module of Lung Cancer (EORTC-QLQ-LC29)., the STA-RR-LC will be applied one time, as soon as the patient has completed one month attending the Respiratory Rehabilitation Service
Amygdala TIS for Depression
NCT Number: NCT06477276
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Major Depressive Disorder
Interventions: DEVICE: Nervio-X
Sponsor: Ruijin Hospital
Collaborators: Tianjin Anding Hospital|Shanghai East Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 92
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-24
Completion Date: 2025-05-01
Locations: Ruijin Hospital, Shanghai, Shanghai, 200025, China|Shanghai East Hospital, Shanghai, China|Tianjin Anding Hospital (Mental Health Center of Tianjin Medical University), Tianjin, China

Summary:
The current investigation employs a directed neuromodulation technique, specifically targeting the right amygdala, to ascertain its therapeutic efficacy in managing depressive episodes. The intervention's safety and efficacy will be evaluated using an assessment incorporating depressive symptomatology, cognitive abilities, and daily functions.

Primary Outcome Measures: Hamilton Depression Rating Scale (17-item version), Baseline, 1 week, 4 weeks and 8 weeks
Secondary Outcome Measures: Hamilton Depression Rating Scale (6-item version), treatment completion day|Snaith-Hamilton Pleasure Scale, The SHAPS is a questionnaire that used to measure the severity of anhedonia, a common symptom in various mental health conditions., Baseline, 1 week, 4 weeks and 8 weeks|Quick Inventory of Depressive Symptomatology - Self-Report (16-item version), Baseline, 1 week, 4 weeks and 8 weeks|Hamilton Anxiety Rating Scale, Baseline, 4 weeks and 8 weeks|Pittsburgh Sleep Quality Index, Baseline, 4 weeks and 8 weeks|36-Item Short Form Health Survey, Baseline and 8 weeks|World Health Organization Quality of Life Assessment - Brief Version, Baseline and 8 weeks