pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Mycetoma Retrospective Data Collection
NCT Number: NCT06512714
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Mycetoma
Interventions: OTHER: A diagnosis of mycetoma in a medical, radiologic, or laboratory record.
Sponsor: Drugs for Neglected Diseases
Collaborators: Cheikh Anta Diop University, Senegal|Post Graduate Institute of Medical Education and Research, Chandigarh
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 1600
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-20
Completion Date: 2024-08-31
Locations: Postgraduate Institute of Medical Education and Research, Chandigarh, 160012, India|Universite Cheikh Anta Diop de Dakar, Dakar, Senegal

Summary:
The goal of this retrospective observational study is to describe mycetoma cases detected in health care facilities in India and Senegal in a 10-year period. The main objectives are to:

* Determine the number of mycetoma cases diagnosed per year and trends over time.
* Describe characteristics of diagnosed mycetoma cases.

  1. Describe demographic characteristics of patients with mycetoma.
  2. Describe clinical characteristics of patients with mycetoma upon initial presentation and over time.
* Assess etiology of mycetoma cases.
* Characterize clinical management of mycetoma cases.

  1. Characterize approaches to diagnosis of mycetoma.
  2. Investigate types and durations of treatments (including medical and surgical approaches) utilized to treat mycetoma cases.
  3. Describe clinical outcomes among patients with mycetoma.

The study team will review all available medical, laboratory and radiologic records of identified mycetoma cases and use data collection forms to extract relevant data.

Primary Outcome Measures: Presence of mycetoma disease as evidenced by patient diagnosis, Sources: Medical records and/or laboratory records and/or radiologic records., Over 10 years
Secondary Outcome Measures: Lesion size in centimeters, Sources: Medical records and laboratory records, Over 10 years|Presence of mycetoma disease after treatment or surgery, Sources: Medical records and laboratory records, Over 10 years
Study on the Correlation Between Fat Soluble Vitamins and Non-alcoholic Fatty Liver Disease
NCT Number: NCT06512701
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Non-Alcoholic Fatty Liver Disease|Fat Soluble Vitamin Deficiencies and Disorders
Interventions: OTHER
Sponsor: First Affiliated Hospital of Zhejiang University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 4000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-03
Completion Date: 2026-07-10
Locations: First Affiliated Hospital of Zhejiang University, Hangzhou, Zhejiang, 310003, China

Summary:
Excessive or insufficient levels of vitamins in the body can affect health. With the prevalence of obesity and MetS, NAFLD has become the leading cause of chronic liver disease and abnormal liver biochemical indicators in health examinations in China. The current research results on serum vitamin A, D, and E levels in NAFLD patients are controversial. Therefore, this study mainly explores the correlation between serum FSV levels and NAFLD, providing reference for nutrition and clinical management of NAFLD patients.

Primary Outcome Measures: non-alcoholic fatty liver disease prevanlence, Day 1|serum vitamin A, Day 1|serum vitamin D, Day 1|serum vitamin E, Day 1|serum vitamin k, Day 1
Establishing Reference Ranges for Fat-Soluble Vitamins in Healthy Chinese Adults
NCT Number: NCT06512688
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Fat Soluble Vitamin Deficiencies and Disorders
Interventions: OTHER
Sponsor: First Affiliated Hospital of Zhejiang University
Collaborators: Huizhou Municipal Central Hospital|Affiliated Hospital of Jiaxing University|Zhejiang Provincial Tongde Hospital|Yueqing People's Hospital|Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University|Zhejiang Provincial People's Hospital|Affiliated Hangzhou First People's Hospital|Ningbo Medical Center Lihuili Hospital|Lu'an People's Hospital of Anhui Province|Shandong Provincial Hospital|Second Affiliated Hospital of Nanchang University|The First Affiliated Hospital of Nanchang University|Nanfang Hospital, Southern Medical University|The Third Xiangya Hospital of Central South University|Changzhi Medical College|LinFen People's Hospital|The Second Affiliated Hospital of Chongqing Medical University|Yulin No.2 Hospital|Hanzhong Central Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-03
Completion Date: 2026-08-02
Locations: First Affiliated Hospital of Zhejiang University, Hangzhou, Zhejiang, 310003, China

Summary:
Vitamins are essential micronutrients required for maintaining normal physiological functions and metabolism in humans. Among them, fat-soluble vitamins (FSV) such as vitamins A, D, E, and K are absorbed in the intestines in the presence of fat. Both deficiencies and excesses of these vitamins can affect health. Current global studies on FSVs in healthy populations are often limited to specific types or regions, and comprehensive data on all four FSVs in the healthy Chinese population are lacking. This study aims to fill this gap by collecting and analyzing FSV levels from healthy adults across multiple regions in China, establishing a reference range for clinical evaluation and early disease intervention.

Primary Outcome Measures: serum vitamin A, day 1|serum vitamin D, day 1|serum vitamin E, day 1|serum vitamin K, day 1
Effects of an Exercise Program on Reaction Time and Mouse Accuracy in Esports Athletes
NCT Number: NCT06512675
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Quality of Life
Interventions: OTHER: Resistance combined with cardiovascular training
Sponsor: University of Miami
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 15
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-10-01
Completion Date: 2025-06-01
Locations: University of Miami, Miami, Florida, 33146, United States

Summary:
This study is intended to evaluate the effects of an exercise program on the change of electronic sports (esports) athletes' reaction time and mouse click accuracy. The benefits of participation are directly related to exercise, and include improved thinking, performance, sleep, and quality of life.

Primary Outcome Measures: Change in participants' physical reaction time, Participants' reaction time will be measured in milliseconds using open-source software "Open-source open-access reaction time test", Baseline and up to 6 weeks after starting the program|Change in percentage of participants' mouse click accuracy, Participants' mouse click accuracy will be measured as a percentage using a web-based program, "Mouse Accuracy", Baseline and up to 6 weeks after starting the program
Secondary Outcome Measures: Change in participants' number of target efficiency, Change in participants' number of target efficiency will be calculated as number of hits divided by possible targets using "Mouse Accuracy", Baseline and up to 6 weeks after starting the program|Change in participants' clicks per second, Change in participants' clicks per second will be measured by counting actual mouse clicks per second using "Mouse Accuracy", Baseline and up to 6 weeks after starting the program
A Decade-Long Dance With Diplopia: Unraveling the Enigma of Recurrent 6th Nerve Palsy
NCT Number: NCT06512636
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Neurologic Manifestations
Sponsor: College of Medical Sciences, Bharatpur
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 1
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-15
Completion Date: 2024-06-15
Locations: Kamal Raj Baral, Bharatpur, Bagmati, 123, Nepal

Summary:
Abstract:

Introduction and Importance:

Recurrent diplopia poses a diagnostic challenge, necessitating a thorough evaluation to elucidate its underlying etiology and guide its management. We present the case of a 39-year-old farmer with recurrent 6th nerve palsy for over a decade, highlighting the complexity and persistence of this condition.

Case Presentation:

A 39-year-old farmer presented with recurrent diplopia attributed to 6th nerve palsy, with eight episodes over 14 years. Despite systemic steroid treatment, the symptoms recurred every 12-18 months. Clinical examination revealed right eye abduction impairment;-, no other abnormalities were detected. Magnetic resonance imaging (MRI) indicated rhinosinusitis, and the results of the autoimmune antibody test were negative.

Clinical Discussion:

This case challenges conventional diagnostic approaches, underscoring the need for a comprehensive evaluation and tailored management strategies. Despite extensive investigations, the etiology remains elusive, emphasizing the complexity of recurrent diplopia.

Conclusion:

Continued monitoring and further investigation are warranted to unravel the enigma of recurrent diplopia in this unique case, highlighting the importance of individualized approaches to guide optimal management.

Primary Outcome Measures: A Decade-Long Dance with Diplopia: Unraveling the Enigma of Recurrent 6th Nerve Palsy, As this is only a case report. No primary outcome was present., 6 months
Efficacy and Safety of PJ009 in Patients With Short Bowel Syndrome Requiring Parenteral Nutrition
NCT Number: NCT06512584
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Short Bowel Syndrome
Interventions: DRUG: PJ009|DRUG: PJ009 Placebo
Sponsor: Chongqing Peg-Bio Biopharm Co., Ltd.
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 72
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-16
Completion Date: 2026-04-27
Locations: Beijing Tsinghua Changgung Hospital, Beijing, Beijing, 102218, China|Chongqing General Hospital, Chongqing, Chongqing, 401147, China|The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, 510655, China|The Third Xiangya Hospital of Central South University, Changsha, Hunan, 410013, China|General Hospital of Eastern Theater Command, Nanjing, Jiangsu, 210016, China|The Affiliated Hospital of Qingdao University, Qingdao, Shandong, 266000, China|Shanghai Tenth People's Hospital, Shanghai, Shanghai, 200072, China|The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shanxi, 710061, China

Summary:
The main aim of this clinical trial is to assess the efficacy and safety of PJ009 in patients aged ≥14 with short bowel syndrome (SBS) requiring parenteral nutrition. The main questions it aims to answer are:

* How effective is PJ009 in treating short bowel syndrome?
* Is PJ009 safe in these patients? Researchers will compare PJ009 to a placebo (a look-alike substance that contains no drug) to see if PJ009 works to treat SBS.

Participants will

* Receive daily subcutaneous injections of PJ009 or placebo according to weight for 24 weeks, and then the participants receive placebo will be switched to receive PJ009 for another 12 weeks, while participants receive PJ009 continued the same treatment until the end of 36 weeks,
* Visit the clinic at the end of week 1(w1), w2, w4, w8, w12, w16, w20, w24, w30 and w36 for assessment,
* Keep a diary of the amount of their parenteral nutrition/ intravenous fluids (PN/IV), enteral nutrition and urine volume.

Primary Outcome Measures: Percentage of responders, A responder's PN/IV volume per week shows a reduction of at least 20% from baseline from week 20 to 24 in treatment period., Week 20 to 24 of treatment period
CVI Alterations in FD: a Prospective, Multicenter, Observational Cohort Study
NCT Number: NCT06512571
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Fabry Disease, Cardiac Variant
Sponsor: China National Center for Cardiovascular Diseases
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2026-07-31
Locations: Fuwai Hospital, National Centre for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100037, China

Summary:
Fabry disease (FD) is a rare X-linked lysosomal storage disorder caused by α-galactosidase A (GLA) gene mutations leading to reduced or undetectable α galactosidase A (α-Gal A) enzyme activity, resulting in progressive accumulation of globotriaosylceramide (GL3) and its deacylated form globotriaosylsphingosine (Lyso-GL-3) in multiple organs, causing neural, renal, cardiac, dermatological, gastrointestinal and ophthalmic manifestations, even leading to life-threatening complications. Cardiovascular and cerebrovascular complications (i.e. heart failure, stroke, etc.) or end-stage renal disease even premature death can be seen in severe cases. The life expectancy of male patients is reduced by 15\~20 years, while that of female patients is reduced by 6\~10 years.

The exact prevalence of FD is currently unknown. Based on an estimated prevalence of 1:60,000, there are approximately 23,000 affected FD patients in China. The clinical manifestations of FD are diverse and non-specific, which may lead to misdiagnosis in patients with non-typical clinical manifestations in the absence of a family history of FD. Cardiac involvement can be recognized in up to 68% patients with FD, significantly higher than in other organs, and the positive screening rate for FD in adults with unexplained left ventricular hypertrophy (LVH)/hypertrophic cardiomyopathy was 0.9%.

Cardiovascular disease is the leading cause of death in patients with FD cardiomyopathy (40.2%). The 2020 Expert Consensus Document on the Management of Cardiovascular Manifestations of Fabry Disease recommends early screening in patients with suspected LVH for early diagnosis. Therefore, strengthened screening strategy in high-risk patients with LVH will improve the diagnosis and treatment of FD in China.

Primary Outcome Measures: Cardiovascular deaths, Including sudden cardiac death or equivalent events, heart failure-related death, stroke-related death and death from other cardiovascular causes., 12 months
Secondary Outcome Measures: Heart failure, NYHA progression to level III/IV, 12 months|Stroke, Including ischemic stroke and hemorrhagic stroke, 12 months|Myocardial infarction, Including ST-segment elevation myocardial infarction and non-ST-segment elevation myocardial infarction, 12 months|All-cause deaths, Death from all causes, 12 months
Augmented Reality Feasibility for Non-invasive Preoperative Tracking in Breast Cancer Surgery
NCT Number: NCT06512558
Acronym: AR-GBS
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Subclinical Breast Cancer Lesion
Interventions: PROCEDURE: Additional MRI with gadolinium injection and 3D camera imaging
Sponsor: Centre Jean Perrin
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2025-07-01

Summary:
Breast cancer is diagnosed by imaging at a non-palpable stage in more than half of all cases. Surgical removal requires preoperative guidance. Generally, preoperative guidance is performed using a metal guide under local anaesthetic and radiological control. This type of guidance has several limitations. For the patient, it can be painful and traumatic. The procedure involves two departments: radiology and the operating theatre, which poses logistical constraints. What's more, between 10% and 40% of patients require repeat surgery for unhealthy margins, raising the question of the effectiveness of the tracking procedure. The investigators propose to develop a non-invasive intraoperative guidance system: Augmented Reality, which will provide a 3D vision with virtual transparency of the breast during surgery, thanks to real-time fusion of preoperative imaging with video from a camera located in the operating room. The process is illustrated below.

Illustration of the general principle of the augmented reality system for locating non-palpable breast lesions. The images above represent a preliminary test carried out on the computer outside the operating room. This is an initial research prototype which has not yet been validated and is not suitable for routine use.

Primary Outcome Measures: Feasibility of the study, The feasibility of the study will be considered to have been achieved if the investigators obtain at least 4 successes among the 5 patients who benefited from the augmented reality procedure pre- and intraoperatively.

Success is defined at both preoperative and intraoperative levels. Success in the preoperative phase is defined by: visibility of registration landmarks (clavicle, sternal fork, sternum, xyphoid process and areolar-nipple plate).

Success in the intraoperative phase is defined by: non-prolongation of anesthesia time due to the study procedure., 1 year
Secondary Outcome Measures: Time measurement of the study procedure, Measurement of the time required to complete the various stages of the study procedure and surgery : device set-up, marking of registration marks on the patient's bust with a dermographic pencil, 3D acquisition of the patient's bust using a 3D camera, duration of the procedure, anesthesia time., 1 year|Creating a phantom, Success of creating a phantom is deemed to have been achieved if the breast Phantom including all clinical features, 1 year
Modified Second Haplo-transplantation for Graft Failure
NCT Number: NCT06512545
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Graft Failure|Stem Cell Transplant Complications
Interventions: OTHER: second allogeneic stem cell transplantation
Sponsor: Peking University People's Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 12
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2026-06
Locations: Peking University People's Hospital, Beijing, Beijing, 100044, China

Summary:
Graft failure is a fatal complication following allogeneic stem cell transplantation where a second transplantation is usually required for salvage. We previously reported encouraging results with a novel Flu/Cy regimen. However, there are still around 20% patients developed delayed platelet recovery. We designed a modified regimen to further improve the hematopoietic reconstitution after second transplantation. This prospective, single-arm study aims to investigate the safety and efficacy of this modified regimen.

Primary Outcome Measures: Engraftment of neutrophils, Engraftment of neutrophils was defined as the first of 3 consecutive days when the absolute neutrophil count achieved 500/uL., 28 days after second transplantation
Secondary Outcome Measures: Engraftment of Platelet, Platelet engraftment was defined as the first of 7 consecutive days that platelet counts ≥20 × 10\^9/L in the absence of platelet transfusion, 100 days after second transplantation|TRM at 28 day, treatment-related mortality(TRM) was defined as death from any cause other than relapse., 28 days after second transplantation|TRM at 100 day, treatment-related mortality (TRM) was defined as death from any cause other than relapse, 100 days after second transplantation|GVHD, Both acute and chronic GVHD was diagnosed and graded according to international criteria., Participants will be followed for an expected average of 1 year|OS, Overall survival (OS), Participants will be followed for an expected average of 1 year|LFS, Leukemia-free survival (LFS) was defined as the survival period with continuous CR., Participants will be followed for an expected average of 1 year|CIR, The cumulative incidence of relapse (CIR), Participants will be followed for an expected average of 1 year
Fireworks Eye Injuries During Festivals in Upper Egypt
NCT Number: NCT06512532
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Ocular Injury|Blast Injuries
Interventions: OTHER: fireworks eye injury
Sponsor: Assiut University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-01
Completion Date: 2024-12-31
Locations: Assiut university hospital, Assiut, 71515, Egypt

Summary:
The aim of this study is to explore and report the epidemiology and outcome of fireworks ocular injuries in Upper Egypt.

Primary outcome : type and severity of injury of fireworks eye trauma during festives.

Secondary outcome: demography, complications, and final visual outcome of fireworks eye injury.

Primary Outcome Measures: epidemiology and outcome of fireworks eye injury, Age, gender, laterality, type of eye injury, complications, final visual outcome, through study completion, an average of 1 year
Prospective Cohort Study of Arthroscopic Treatment of Hip Dysplasia
NCT Number: NCT06512506
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Developmental Dysplasia of the Hip
Interventions: OTHER: non-intervention
Sponsor: Peking University Third Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 47
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-01-01
Completion Date: 2024-12-31
Locations: Peking University Third Hospital Medicial Science Research Ethics Committee, Beijing, China

Summary:
On the basis of the database established in the previous stage, a cohort analysis was conducted on patients with BDDH complicated by hip arthroscopy for minimally invasive treatment of glenoid and lip injury, according to which the indications of minimally invasive surgery for BDDH patients were optimized and surgical measures were improved. Achieve accurate and rapid repair, rehabilitation and functional recovery, serve national fitness, and treat people's injuries

Primary Outcome Measures: Improved Harris hip score, It is suitable for the evaluation of therapeutic effect of various hip diseases. The Harris score includes pain, function, deformity and range of motion. The lower the improved Harris score, the worse the postoperative effect., Preoperative, 24 months after surgery|PRO rating, Based on Patient-Reported Outcome (PRO) : Questionnaires were completed through face-to-face or telephone interviews. Patients' symptoms, function (activity restriction), pain score, quality of life and time to return to activity were evaluated comprehensively. The lower the PRO score, the worse the postoperative effect., Preoperative, 24 months after surgery|Cartilage damage outerbridge grading, The patient underwent hip joint MR Examination at 12 months post-operative follow-up with T2 weighted intrachondral defect and high signal, Preoperative, 24 months after surgery
South East (Zuid Oost) Netherlands Heart Registry
NCT Number: NCT06512493
Acronym: ZON-HR
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Coronary Artery Disease|Acute Coronary Syndrome|Chronic Coronary Syndrome
Sponsor: Radboud University Medical Center
Collaborators: Maastricht Universitair Medisch Centrum|Zuyderland Medisch Centrum|VieCuri Medical Centre
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 99999
Study Design: Observational Model: |Time Perspective: p
Start Date: 2020-11-01
Completion Date: 2050-01-01
Locations: ZuyderlandMC, Heerlen, Limburg, 6419PC, Netherlands|MaastrichtUMC+, Maastricht, Limburg, 6229 HX, Netherlands|VieCuri, Venlo, Limburg, 5912 BL, Netherlands|Radboud University Medical Centre, Nijmegen, Netherlands

Summary:
Rationale: Patients undergoing percutaneous coronary intervention (PCI) for chronic coronary syndrome (CCS) or acute coronary syndrome (ACS) have a residual risk of ischemic events after PCI due to the progression of atherosclerosis in and outside the stented segments. The residual risk is affected by thrombotic, lipid, inflammation and diabetic risk factors. Secondary prevention after PCI is therefore of major importance to reduce complications and improve the patients' prognosis.

Objective: To provide an extensive overview on the quality of secondary prevention and personalized medicine, a consortium in the South East Netherlands has created a PCI registry, the "Zuid Oost Nederland Hart Registratie" (ZON-HR).

Primary Outcome Measures: Number of patients with, * all- cause mortality
* Myocardial infarction
* Stent thrombosis
* Stroke
* Revascularisation
* All bleeding events requiring medical evaluation, 1 or 2 years
Colorectal Surgery, a New Robotic Platform (Hugo Ras)
NCT Number: NCT06512480
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Colorectal Surgery
Interventions: PROCEDURE: colonic resection
Sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-09
Completion Date: 2027-07-09
Locations: General University Hospital of Elche, Elche, Alicante, 03203, Spain

Summary:
A novel robotic platform -Hugo Robotic Assisted Surgery (RAS)- has been introduced with several innovations that may prove advantageous for surgeons such as an open console and four interchangeable modular arms. Our study aims to evaluate the safety, efficacy and potential impact of this platform in the surgical treatment of colorectal pathology.

Primary Outcome Measures: Evaluate the results of a modular and open robotic platform (System of robotic-assisted surgery (RAS) Hugo™) in colorectal surgery (CRC) by complying with the quality indicators recommended by the Spanish Association of Coloproctology (AECP)., In the descriptive analysis, the appropriate estimators will be used according to the type of variables: means or medians, standard deviation (SD) or ranges, for the quantitative variables, and percentages (%) for qualitative variables. In the analysis bivariate, the Chi-square test will be used for qualitative variables, and for the quantitative variables the Student's t test if the distribution is normal and the Mann-Whitney U when such normality cannot be assumed (the normal distribution of the variables will be analyzed using the test of Kolmogorov-Smirnov).

In all estimates, 95% confidence intervals will be calculated and a p value less than 0.05 will be considered significant., 1 year
Donafenib Combine With Sintilimab and HAIC in Neoadjuvant of Resectable Hepatocellular Carcinoma
NCT Number: NCT06512467
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Hepatocellular Carcinoma
Interventions: DRUG: Donafenib|DRUG: Sintilimab|OTHER: HAIC
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-30
Completion Date: 2026-12-31

Summary:
The investigators design a phase IIB clinical study to explore the efficacy and safety of Donafenib combined with Sintilimab and HAIC in neoadjuvant of resectable Hepatocellular Carcinoma.

Primary Outcome Measures: MPR(Major Pathological Response), After neoadjuvant therapy, the proportion of residual tumor cells was less than 30%., 1 year
Secondary Outcome Measures: ORR(Objective Response Rate), The rate of participants that achieve either a complete response (CR) or a partial response (PR)., 1 year|DCR(Disease Control Rate), The percentage of cases with remission (PR + CR) and stable lesions (SD) after treatment was assessable., 3 year|RFS(Recurrence-free Survival), The time experienced from the enrollment date until tumor recurrence or death from any cause, if the subject died before the disease recurred. Survival subjects whose tumor recurrence was not confirmed by the database deadline were deleted according to the date of the last imaging tumor assessment. The date of tumor recurrence was the date of the first imaging confirmation of tumor recurrence., 1 year|OS(Overall Survival), Overall survival is defined as time from the start of treatment until death due to any reason.

R0 resection： The tumor was completely resected, and the submicroscopic margin was negative, that is, no tumor remained., 3 year|pCR(Pathological Complete Response), No residual tumor was found pathologically in patients with neoadjuvant therapy induced tumor regression., 1 year
Vitamin B6 Aids in Treating Inflammatory Bowel Disease
NCT Number: NCT06512441
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Inflammatory Bowel Diseases
Interventions: DRUG: Vitamin B6 Tablets|DRUG: Placebo
Sponsor: Changhai Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 220
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-01
Completion Date: 2025-12-30
Locations: Changhai Hospital, Shanghai, Shanghai, China

Summary:
Patients with IBD are randomized to oral administration of VitaminB6 and placebo based on the standard treatment, exploring whether VitaminB6 can increasee the clinical remission rateand improve the treatment effect of IBD patients.

Primary Outcome Measures: Clinical remission rate, To evaluate the improvement effect of clinical remission rate (Mayo score ≤ 2 points and no single sub-score\>1 point; CDAl score\<150) in IBD patients after 3 weeks of oral Vitamin B6 while taking routine treatment., Through study completion, an average of 6 months .
Secondary Outcome Measures: Disease activity score of IBD patients, Modified Mayo score or CDAl score, Through study completion, an average of 6 months .|Histological remission, Based on the Geboes scale. No or slight increase of chronic inflammatory infiltration in lamina propria, no neutrophils in lamina propria or epithelium, no persistent clinicai response of erosion, ulcer or granulation tissue., Through study completion, an average of 6 months .|Clinical response, Modified Mayo score decreased by 2 points and 30% from baseline+rectal bleeding score decreased by 1 point or absolute rectal bleeding score decreased by 1 point., Through study completion, an average of 6 months .
A Study of Simmitinib Plus Irinotecan in Advanced Esophageal Squamous Cell Carcinoma
NCT Number: NCT06512428
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Advanced Esophageal Squamous Cell Carcinoma
Interventions: DRUG: simmitinib plus irinotecan liposome|DRUG: irinotecan liposome|DRUG: irinotecan
Sponsor: Shanghai Runshi Pharmaceutical Technology Co., Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 138
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-03-15
Completion Date: 2026-01-30
Locations: Harbin Medical University Cancer Hospital, Heilongjiang, Harbin, 150076, China

Summary:
To evaluate the safety and efficacy of simmitinib plus irinotecan liposome in the treatment of advanced esophageal squamous cell carcinoma, and to evaluate the PK of the drug and the correlation between biomarkers and clinical efficacy of simmitinib plus irinotecan liposome.

Primary Outcome Measures: Dose Escalation Phase: DLT, Dose Limited Toxicity, From Cycle 1 Day 1 to Cycle 1 Day 28 (each cycle is 28 days)|Dose Escalation Phase: AE, Incidence rate of Adverse Event, From first dose to 30 days post the last dose|Randomized controlled study phase: ORR, Objective Response Rate (ORR) evaluated by investigators based on RECIST 1.1, 2 years
Secondary Outcome Measures: DCR, Disease Control Rate, 2 years|PFS, Progression-free Survival, 2 years|OS, Overall Survival, 2 years|DOR, Duration of Objective Response, 2 years|Area under plasma concentration (AUC), Area under the plasma concentration versus time curve (AUC) of simmitinib, 2 years|Peak Plasma Concentration (Cmax), Peak Plasma Concentration (Cmax) of simmitinib, 2 years|Time of peak plasma concentration (Tmax), Time of peak plasma concentration (Tmax) of simmitinib, 2 years
10 Vs.15 mcg Norepinephrine Bolus in Severe Maternal Hypotension During Cesarean Delivery
NCT Number: NCT06512415
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hypotension|Spinal Anesthesia|Cesarean Section
Interventions: DRUG: 10 mcg Norepinephrine|DRUG: 15 mcg Norepinephrine
Sponsor: Cairo University
Sex: FEMALE
Age: ADULT
Enrollment: 184
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2024-12
Locations: Cairo University, Cairo, Egypt

Summary:
Data regarding the optimum dose of norepinephrine for management of severe maternal hypotension is lacking. A previous report showed that the use of 10-mcg norepinephrine bolus was not superior to the 5-mcg bolus in the management of severe hypotension in addition the incidence of reactive bradycardia and hypertension was comparable in the two doses. Therefore, we hypothesize that using a higher dose of norepinephrine (15 mcg) would increase the success rate of management of severe hypotensive episode.

Primary Outcome Measures: the incidence of successful management of severe post-spinal hypotension, systolic blood pressure \>80% of baseline after drug bolus, 1 min after spinal anesthesia until 5 min after the delivery
Secondary Outcome Measures: time to severe hypotensive episode, min, 1 min after spinal anesthesia until 5 min after the delivery|reactive bradycardia, heart rate \<55 beat/min, 1 min after spinal anesthesia until 5 min after the delivery|reactive hypertension, systolic blood pressure \>120% of baseline, 1 min after spinal anesthesia until 5 min after the delivery|umbilical blood pH, umbilical artery sample, 5 min after delivery|Apgar score, assess Breathing effort, Heart rate, Muscle tone, Reflexes, Skin color, Each category is scored with 0, 1, or 2, 5 min after delivery|systolic blood pressure, mmHg, baseline, 1 min after spinal anesthesia until 5 min after the delivery|heart rate, beat/min, baseline, 1 min after spinal anesthesia until 5 min after the delivery
Epinephrine Vs Norepinephrine Infusion During Caesarean Delivery
NCT Number: NCT06512402
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hypotension|Spinal Block|Cesarean Section
Interventions: DRUG: Norepinephrine|DRUG: Epinephrine
Sponsor: Cairo University
Sex: FEMALE
Age: ADULT
Enrollment: 212
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-08
Completion Date: 2024-12
Locations: Cairo University, Cairo, Egypt

Summary:
Epinephrine is a well-known vasoactive agent in medical practice. However, its use is obstetric population is still scanty. Few studies evaluated the use of epinephrine during Cesarean delivery and a recent randomized controlled dose-finding trial reached an acceptable incidence of hypotension (13%) with the use of 0.03 mcg/kg/min as prophylaxis.

Being a newly introduced vasoactive agent in obstetric practice, it is essential to be adequately compared with other vasopressors using the optimum dosage and appropriate outcomes.

There are no data, till date, comparing epinephrine versus norepinephrine infusion during Cesarean delivery using a composite outcome of hypotension, hypertension, and bradycardia. The aim of this study is to compare epinephrine versus norepinephrine infusion for prophylaxis against post-spinal hypotension during Caesarean delivery

Primary Outcome Measures: incidence of post-spinal hemodynamic instability, the occurrence of either, hypotension, hypertension, bradycardia, and/or tachycardia, 1 min after spinal anesthesia until 5 min after the delivery
Secondary Outcome Measures: umbilical pH, from umbilical artery, 5 min after delivery|Apgar, assessment of Breathing effort, Heart rate, Muscle tone, Reflexes, Skin color; Each category is scored with 0, 1, or 2, 5 min after delivery|heart rate, beat/min, 1 min after spinal anesthesia until 5 min after the delivery|systolic blood pressure, mmHg, 1 min after spinal anesthesia until 5 min after the delivery
Hereditary Cerebral Small Vessel Diseases Registry-Trial Ready Cohort
NCT Number: NCT06512376
Acronym: HCSVD-TRC
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cerebral Small Vessel Diseases|Hereditary
Sponsor: Beijing Tiantan Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-07-19
Completion Date: 2027-07-19
Locations: Beijing Tiantan Hospital, Beijing, 100050, China

Summary:
We took hereditary cerebral small vessel disease (hCSVD) patients as our main subjects, aiming to establish a platform for a comprehensive evaluation and long-term follow-up. Deeply explore the pathophysiological mechanism of hCSVD, which may render the theoretical basis for the treatment and management of hCSVD.

Primary Outcome Measures: The epidemiological features, Any epidemiological informations, at baseline|The clinical features, Clinical symptoms and physical examination, 5 years|The radiography features, Neuroimaging markers collected by MRI, at baseline|A novel pathogenic gene for hereditary cerebrovascular disease in the Chinese population, Genetic testing with the blood sample, at baseline
Secondary Outcome Measures: Etiology and pathogenesis, This study will collect etiology and pathogenesis information among participants., at baseline|Long-term changes of radiography features, Neuroimaging markers collected by MRI, 5 years
A Study of Ramelteon in Chinese Patients With Chronic Insomnia
NCT Number: NCT06512363
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Chronic Insomnia
Interventions: DRUG: Ramelteon|DRUG: Ramelteon placebo
Sponsor: Nanjing Chia-tai Tianqing Pharmaceutical
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 280
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2026-12

Summary:
The purpose of this study is to assess the efficacy and safety of Ramelteon in chinese patients with chronic insomnia.

Efficacy will be evaluated on objective and subjective sleep parameters.

Primary Outcome Measures: Mean Latency to Persistent Sleep Assessed by Polysomnography, Week 1
Secondary Outcome Measures: Mean Latency to Persistent Sleep Assessed by Polysomnography, Week 5|Total Sleep Time Assessed by Polysomnography, Weeks 1 and 5|Sleep Efficiency Assessed by Polysomnography, Weeks 1 and 5|Awake Time after Persistent Sleep Assessed by Polysomnography, Weeks 1 and 5|Number of Awakenings after Persistent Sleep Assessed by Polysomnography, Weeks 1 and 5|Subjective Sleep Latency Assessed by Sleep Diary Questionnaire, Weeks 1, 3 and 5|Subjective Total Sleep Time Assessed by Sleep Diary Questionnaire, Weeks 1, 3 and 5|Subjective Sleep Quality Assessed by Sleep Diary Questionnaire, Weeks 1, 3 and 5|Subjective Awake Time Assessed by Sleep Diary Questionnaire, Weeks 1, 3 and 5|Subjective Number of Awakenings Assessed by Sleep Diary Questionnaire, Weeks 1, 3 and 5|Subjective Ease of Falling Back to Sleep Assessed by Sleep Diary Questionnaire, Weeks 1, 3 and 5|Insomnia Severity Index Score Assessed by ISI Questionnaire, Weeks 3 and 5
Identifying Patterns in the Breath of Individuals With Breast Cancer
NCT Number: NCT06512350
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Breast Cancer
Sponsor: Breathe BioMedical Inc
Collaborators: Mayo Clinic|George Washington University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08
Completion Date: 2025-12

Summary:
The goal of this observational collection protocol is to develop a machine learning model capable of differentiating between the breath profiles of individuals with breast cancer and those without breast cancer.

The purpose of this collection protocol is:

* To further develop Breathe BioMedical's technology and machine learning algorithms to detect breast cancer in women with dense breast tissue.
* To identify patterns of compounds that are either over- or under-represented in the breath of women with breast cancer compared to the breath of women without breast cancer.
* To assess performance characteristics (e.g. sensitivity, specificity, false negative rate, and false positive rate) including subgroup analyses.
* To pool and analyze de-identified data from this, previous, and future breath analysis studies.

Researchers will compare the breath profiles of women with breast cancer and those without to determine whether there are disease-specific patterns that can be leveraged to facilitate breast cancer detection.

Women with mammogram-confirmed dense breast tissues undergoing standard-of-care breast cancer screening will be invited to participate. Those who provide informed consent will provide one breath sample and fill out a questionnaire about their medical history with help from the research coordinators. Breath samples will be collected prior to standard of care biopsy or MRI, and patients will be stratified into the case or control group based on their test results.

Primary Outcome Measures: Compare the breath spectra from patients with breast cancer and from healthy controls using mathematical/statistical models to further develop Breathe BioMedical's technology and machine learning algorithms., Using exhaled alveolar breath and the subsequent spectral data produced by Breathe BioMedical's infrared cavity ring-down spectrometer, the goal is to identify patterns of VOCs that are either over- or under-represented in the breath profiles of subjects with breast cancer compared to the breath profiles of healthy controls. Machine learning performance characteristics will also be assessed (e.g., sensitivity, specificity, false negative rate, and false positive rate) including subgroup analyses. This will allow for the determination of the feasibility of detecting breast cancer in women with dense breast tissue., 12 months
A Observational Study to Evaluate Deucravacitinib in Patients With Moderate Plaque Psoriasis in China
NCT Number: NCT06512337
Acronym: ADMIRE
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Plaque Psoriasis
Interventions: DRUG: Deucravacitinib
Sponsor: Bristol-Myers Squibb
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2025-01-01
Completion Date: 2026-08-31
Locations: Hangzhou Tigermed Consulting Co., Ltd., HangZhou, China

Summary:
The purpose of this study is to collect and evaluate real-world data on the effectiveness of deucravacitinib treatment in adults with moderate plaque psoriasis in China.

Primary Outcome Measures: Number of participants achieving Static Physician's Global Assessment (sPGA) 0/1 score, Week 16|Participant psoriasis Body Surface Area (BSA) involvement, Week 16|Number of participants achieving absolute Psoriasis Area and Severity Index (PASI) score ≤ 3, Week 16
Secondary Outcome Measures: Number of participants achieving Psoriasis Area and Severity Index (PASI) 75 response and PASI 90 response, Baseline and Weeks 4, 12, 24, 36, and 52|Number of participants achieving absolute Psoriasis Area and Severity Index (PASI) score ≤1, ≤2, ≤3, and ≤5, Baseline and Weeks 4, 12, 24, 36, and 52|Participants change in Participant Absolute Psoriasis Area and Severity Index (PASI) score from baseline, Weeks 4, 12, 16, 24, 36, and 52|Number of participants achieving psoriasis Body Surface Area (BSA) involvement of ≤1% and ≤3%, Baseline and Weeks 4, 12, 16, 24, 36, and 52|Change in Body Surface Area (BSA) involvement from baseline to follow-up, Weeks 4, 12, 24, 36, and 52|Static Physician's Global Assessment (sPGA) 0/1 response at follow-up, Weeks 4, 12, 24, 36, and 52|Participants change in Static Physician's Global Assessment (sPGA) score from baseline, Baseline and Weeks 4, 12, 16, 24, 36, and 52|Number of participants achieving a Dermatology Life Quality Index (DLQI) 0/1 score, Baseline and Weeks 4, 12, 16, 24, 36, and 52|Number of participants achieving a Dermatology Life Quality Index (DLQI) ≤ 3 score, Baseline and Weeks 4, 12, 16, 24, 36, and 52|Change in participant Dermatology Life Quality Index (DLQI) score from baseline, Baseline and Weeks 4, 12, 16, 24, 36, and 52
Personalized Targeted Glioblastoma Therapies by ex Vivo Drug Screening
NCT Number: NCT06512311
Acronym: ATTRACT
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Glioblastoma
Interventions: DIAGNOSTIC_TEST: CBMed Drug Screening Plattform
Sponsor: Medical University of Vienna
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 240
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-07-10
Completion Date: 2031-12-31
Locations: AKH Vienna, Department for Internal Medicine I, Oncology, Vienna, 1090, Austria

Summary:
Patient derived cell line (PDC) -based drug screening will be applied to formulate a personalized treatment approach.

Primary Outcome Measures: Overall survival time, Change in overall survival in patients receiving extensive diagnostic work up including the standard histology analysis and PDC- based drug screening in addition (interventional arm) compared to patients receiving only standard histology diagnostic work up (standard arm), From date of randomization until date of death from any cause or last follow up whichever came first, assessed up to 144 months
Secondary Outcome Measures: Feasibility of PDC-based drug screening, Number not interpretable results of the PDC-based drug screening; Number of interpretable results of the PDC-based drug screening, From date of randomization until date of communication of the tumor board outcome, asses up to 144 months|Comparison of Quality of life measurements, Difference between the interventional and the standard arm using the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ- C30) and the brain cancer specific questionnaire (QLQ-BN20). The scale is from 0 to 100, with higher values reporting better quality of life., From date of randomization until date of death from any cause or last follow up whichever came first, assessed up to 144 months|Comparison of neurocognitive function scale, differences in neurocognitive function between the interventional and standard arms using the Neurologic Assessment in Neuro-Oncology (NANO) scale, From date of randomization until date of death from any cause or last follow up whichever came first, assessed up to 144 months
Identification of Oxygen Desaturation in Patients Admitted Following Adenotonsillectomy'
NCT Number: NCT06512285
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Obstructive Sleep Apnea
Interventions: DIAGNOSTIC_TEST: Continuous Pulse Oximetry
Sponsor: Baylor College of Medicine
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-25
Completion Date: 2025-12-31
Locations: Texas Childrens Hospital, Houston, Texas, 77030, United States

Summary:
Sleep apnea has become exceedingly recognized in children. The primary treatment for sleep apnea in children is surgery in the form of adenotonsillectomy. The majority of children that undergo adenotonsillectomy are discharged following their immediate recovery in the post anesthesia care unit.

Primary Outcome Measures: Continuous pulse oximetry following adenotonsillectomy, Use of a continuous capture pulse oximeter to identify oxygen desaturations postoperatively, 1 day