pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Diet Supplementation With Prebiotics to Improve Gut Health in Egyptian Children
NCT Number: NCT06561724
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Microbial Colonization|Gut Microbiota
Interventions: DIETARY_SUPPLEMENT: Biscuits maltodextrin|DIETARY_SUPPLEMENT: Biscuits includes prebiotics tartoufa inulin|DIETARY_SUPPLEMENT: Biscuits includes prebiotics chicory inulin
Sponsor: National Research Centre, Egypt
Collaborators: Wright State University
Sex: ALL
Age: CHILD
Enrollment: 72
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-06-01
Completion Date: 2025-03-01
Locations: Mosab Gad, Dokki, Giza, 12622, Egypt

Summary:
The study described herein seeks to assess the extent to which diet supplementation of young Egyptian children, one of the most vulnerable groups to the risk of diarrhea, with prebiotic fiber can improve their gut health.

Primary Outcome Measures: Fecal secretory immune globulin A (sIgA), Fecal secretory s-IGA was assayed by the Chrom ELISA kit (Bio Vender research Diagnostics, Cat # RIC6100, Germany) and the instruction of the manufacturer was followed. Aliquots (80-120 mg) of the thawed fecal samples collected above at baseline and at the termination of the trial were suspended in 10-fold exes (15 m) shitoog a phspaste burier protered and entrifuged at 3o0 omn for s min. Tipes were simultaneously run in the ELISA and the concentration of s-IgA was read at 405 mm in ELISA reader against a standard curve and the results were expressed as mg faecal S-IgA per 100 gram stool., 2 months
Secondary Outcome Measures: Fecal Short-chain fatty acids, The dry fecal sample was resuspended in 5ml 0.5 % ortho-phosphoric acid in the presence of 250 μl of the pure isobutyric acid as internal standard. Aliquots (60 μl) of the clear supernatant was aspirated and pipetted in a dry clean centrifuge tube containing 240 μl of 0.5% aqueous ortho-phosphoric acid, followed by the addition of 300 μl absolute butanol. Following vigorous shaking, the tubes were centrifuged and the clear supernatant was filtered through a Sartorius membrane filter of 0.25 microns. Aliquots (2 μl) were injected in Gas Chromatograph with a flame ionization detector (FID). The short-chain fatty acid concentrations were expressed in micromoles per gram of dry feces., 3 months|16s rRNA, Metagenomic analysis will be performed. Weighed aliquots (150 mg) of the thawed fecal samples were used for the genomic DNA extraction using the commercial fecal DNA Miniprep Zymo Research kit. The instruction of the manufacturer was followed. The concentration of the harvested DNA in the elute was determined by measuring the optical densities at 230 /260 nm using a nano spectrophotometer. The gnomic DNA is saved at -800C until metagenomic analysis. Standard protocols will be followed with the technical collaboration of Dr Oleg Paily., 3 months
Optimization of Minocycline for Helicobacter Pylori Rescue Treatment
NCT Number: NCT06561711
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Helicobacter Pylori Infection
Interventions: DRUG: Vonoprazan|DRUG: Bismuth Potassium Citrate|DRUG: Tetracycline,Metronidazole|DRUG: Minocycline,Metronidazole
Sponsor: Shanghai Jiao Tong University School of Medicine
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 476
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-21
Completion Date: 2026-08-30
Locations: Peking University Third Hospital, Beijing, Beijing, 100191, China|Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, Shanghai, 200127, China|Songjiang Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, Shanghai, China|The Second Affiliated Hospital of Zhejiang University school of Medicine, Hangzhou, Zhejiang, China

Summary:
The efficacy of bismuth-containing quadruple therapy with minocycline and metronidazole was not inferior to classical bismuth quadruple therapy for refractory H. pylori infection, though also accompanied with high occurrence of adverse events (55.4%). Optimization of minocycline-based regimen to achieve high eradication rate with fewer adverse events is imperative. This study aimed to compare the efficacy and tolerability of a 14-day bismuth-containing quadruple rescue therapy with different dosage of minocycline and metronidazole compared to classical bismuth quadruple therapy.

Primary Outcome Measures: Helicobacter pylori eradication rate, Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was defined as negative result from urea breath test (\<4‰) (4‰ as the cutoff value)., Six weeks after completion of therapy
Secondary Outcome Measures: Rate of adverse effects, The subjects were asked to grade the severity of adverse events according to their influence on daily activities, experienced as "mild" (transient and well tolerated), "moderate" (causing discomfort and partially interfering with daily activities), or severe" (causing considerable interference with daily activities). In addition, blood test were messured to access function of liver and kidney., Within 7 days after completion of therapy|Compliance rate, Compliance was defined as poor when they had taken less than 80% of the total medication, Within 7 days after completion of therapy
High-dose Dual Therapy and Minocycline-cotaining Quadruple Therapy for Helicobacter Pylori Infection
NCT Number: NCT06561698
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Helicobacter Pylori Infection
Interventions: DRUG: Vonoprazan|DRUG: Amoxicillin|DRUG: Bismuth Potassium Citrate|DRUG: Minocycline,Metronidazole
Sponsor: Shanghai Jiao Tong University School of Medicine
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-21
Completion Date: 2026-08-30
Locations: Hebi People's Hospital, Hebi, Henan, China|Jiaozuo People's Hospital, Jiaozuo, Henan, China|Luoyang central Hospital, Luoyang, Henan, China|The first people's hospital of ping ding shan, Pingdingshan, Henan, China|Xuchang central Hospital, Xuchang, Henan, China|The Second Affiliated Hospital of Henan University of science and technology, Zhengzhou, Henan, China|The Third People's Hospital of Zhengzhou, Zhengzhou, Henan, China|Zhengzhou People's Hospital, Zhengzhou, Henan, China|Zhoukou Central Hospital, Zhoukou, Henan, China|Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, Shanghai, 200127, China

Summary:
This study is a multicentra, prospective study. The enrolled patients are HP positive. They are diagnosed as HP positive by rapid urease test and/or 13C urea breath test. According to the declaration of Helsinki, 200 patients will be included in this study. After obtaining the written informed consent of the patients, HP culture and drug sensitivity test will be conducted on all the selected patients with the success rate, adverse reactions, compliance, antibiotic resistance of HP and its impact on HP eradication.

Primary Outcome Measures: Helicobacter pylori eradication rate, Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was defined as negative result from urea breath test (\<4‰) (4‰ as the cutoff value)., Six weeks after completion of therapy
Secondary Outcome Measures: Rate of adverse effects, The subjects were asked to grade the severity of adverse events according to their influence on daily activities, experienced as "mild" (transient and well tolerated), "moderate" (causing discomfort and partially interfering with daily activities), or "severe" (causing considerable interference with daily activities), Within 7 days after completion of therapy|Compliance rate, Compliance was defined as poor when they had taken less than 80% of the total medication, Within 7 days after completion of therapy
Paracetamol Plus Tramadol Versus Fentanyl As Preemptive Analgesia For Enhanced Recovery After Day Case Surgeries
NCT Number: NCT06561672
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Preemptive Paracetamol Plus Tramadol and Preemptive Fentanyl
Interventions: DRUG: tramadol plus paracetamol|DRUG: Fentanyl|DRUG: propofol and muscle relaxant (cisatracurium)|DRUG: Propofol
Sponsor: Zagazig University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 102
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2025-06-20
Locations: Aculty of Medicine,Zagazig University, Zagazig, El Sharkia, 44519, Egypt

Summary:
Implementation of enhanced recovery in day case surgeries using either preemptive intravenous paracetamol plus tramadol or preemptive intravenous fentanyl.

Primary Outcome Measures: Enhanced recovery score, A 40-item questionnaire that provides a score (QoR-40) that measure quality of recovery after surgery and anesthesia (enhanced recovery) according to five aspects will be recorded at the end of 24 hours after surgery: Emotional state(n=9) physical comfort(n=12) Psychological support (n=7) physical independence(n=5) pain(n=7)

- Each one of the 40 questions gets a score from one to five at which one is the worst response and five is the best response. When the individual score of all questions are added together we get a total score that ranges from 40 to 200., at the end of 24 hour after surgery.
Secondary Outcome Measures: The duration of PACU stay, time from patient admission to the PACU till discharge from the PACU, 2 days postoperative|Duration of postoperative hospital stay, time from patient admission to the PACU till the hospital discharge admission to the PACU till the hospital discharge, 2 days postoperative|Postoperative pain severity, (a 10-cm line labeled with "worst pain imaginable" on the right border and "no pain" on the left border)., recorded upon arrival to recovery room and at 1, 2, 4, 6 and 12hours postoperatively based|postoperative agitation score, Score Term Description

* 4 Combative Overtly combative, violent, immediate danger to staff
* 3 Very agitated Pulls or removes tubes (s) or catheter(s); aggressive
* 2 Agitated Frequent non-purposeful movement
* 1 Restless Anxious, but not aggressive or vigorous 0 Alert and calm

  * 1 Drowsy Not fully alert but has sustained awakening (eye opening or eye contact) to voice (\< 10 seconds)
  * 2 Light sedation Briefly awaken with eye contact to voice (\> 10 seconds)
  * 3 Moderate sedation Movement or eye opening to voice (but no eye contact)-4 Deep sedation No response to voice, but movement or eye opening to physical stimulation
  * 5 Unarousable No response to voice or physical stimulation, immediately after extubation, on arrival to PACU, 10 minutes and 20 minutes after arrival to PACU:
To Evaluate the Effectiveness and Safety of the Single-port Robotic-assisted Breast Surgery in Breast Cancer
NCT Number: NCT06561646
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breast Cancer
Interventions: PROCEDURE: single-port robotic-assisted nipple-sparing mastectomy and sentinel lymph node biopsy|PROCEDURE: single-port robotic-assisted nipple-sparing mastectomy and axillary lymph node dissection
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-21
Completion Date: 2028-12-31
Locations: The First Affiliated Hospital with Nanjing Medical University, Nanjing, Jiangsu, 210009, China

Summary:
The new technology of robotic surgery system, as an emerging technology, has shown certain application prospects in breast surgery. However, the new technology of robotic surgery system in China in the treatment of breast cancer is still in the exploratory stage and needs to be further improved. This prospective, single-center, single-arm clinical study was conducted to use the abdominal endoscopic surgery system and evaluate the effectiveness and safety of the single-port robotic-assisted breast surgery in breast cancer.

Primary Outcome Measures: Local recurrence free survival rate, Local recurrence refers to the recurrence of the chest wall or breast on the same side as the surgical site., Ten years
The Influence Factors of Bispectral Index Values Increment Caused by Sugammadex
NCT Number: NCT06561633
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: BIS
Interventions: DRUG: Sugammadex administration
Sponsor: Jun Zhang
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 135
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08
Completion Date: 2024-09
Locations: Fudan University Shanghai Cancer Center, Shanghai, Shanghai, 200032, China

Summary:
Sugammadex administration may increase the bispectral index (BIS) values during general anesthesia. The purpose of this study was to investigate the influence factors leading to increase in BIS value caused by sugammadex administration when continuous use of general anesthetics.

Primary Outcome Measures: BIS value, BIS value at 5th min after sugammadex administration, 5 minutes
Befotertinib Adjuvant Therapy in Stage IA2-IB NSCLC Patients
NCT Number: NCT06561620
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: 3-year Disease-free Survival
Interventions: DRUG: Befotertinib
Sponsor: Fudan University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 592
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-01
Completion Date: 2029-05-01
Locations: Fudan University Cancer Center, Shanghai, Shanghai, 200032, China

Summary:
To evaluate 3-year disease-free survival after complete resection in patients with MRD-positive EGFR-sensitive mutations in Stage IA2-IB NSCLC treated with adjuvant befortinib and under routine observation (3y-DFS).

Primary Outcome Measures: 3-year disease-free survival, 3-year disease-free survival after complete resection in patients with MRD-positive EGFR-sensitive mutations in Stage IA2-IB NSCLC, 3 years
To Evaluate Recombinant Human Follicle Stimulating Hormone-CTP Fusion Protein Injection or Placebo Combined With Chorionic Gonadotropin for Injection
NCT Number: NCT06561594
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Idiopathic Hypogonadotropic Hypogonadism
Interventions: DRUG: recombinant human follicle-stimulating hormone-CTP Fusion protein injection|DRUG: recombinant human follicle-stimulating hormone-CTP Fusion protein injection Placebo
Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
Sex: MALE
Age: CHILD
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-20
Completion Date: 2026-12-23
Locations: Anhui Children's Hospital, Hefei, Anhui, 230022, China|Beijing Children's Hospital, Capital Medical University, Beijing, Beijing, 100045, China|Peking Union Hospital, Chinese Academy of Medical Sciences, Beijing, Beijing, 100730, China|The First Affiliated Hospital of Sun Yat-sen University, GuangZhou, Guangdong, 510080, China|Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong, 510120, China|Women and Children's Medical Center Affiliated to Guangzhou Medical University, Guangzhou, Guangdong, 510623, China|Shenzhen Children's Hospital, Shenzhen, Guangdong, 518026, China|Henan Children's Hospital Zhengzhou Children's Hospital, Zhengzhou, Henan, 450018, China|Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, 430030, China|Nanjing Children's Hospital, Nanjing, Jiangsu, 210093, China|Jiangxi Children's Hospital, Nanchang, Jiangxi, 330200, China|Shengjing Hospital affiliated to China Medical University, Shenyang, Liaoning, 110004, China|Affiliated Hospital of Jining Medical College, Jining, Shangdong, 272100, China|Shanghai Children's Hospital, Shanghai, Shanghai, 200062, China|Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine, ShangHai, Shanghai, 200125, China|Affiliated Pediatric Hospital of Fudan University, Shanghai, Shanghai, 201102, China|Chengdu Women and Children's Central Hospital, Chengdu, Sichuan, 610073, China

Summary:
This study was conducted to evaluate recombinant human follicle stimulating hormone-CTP fusion protein injection or placebo combined with chorionic gonadotropin for injection

Primary Outcome Measures: Change from baseline in testicular volume (the sum of the volumes of the left and right testes measured on ultrasonography) after 64 weeks, 64 weeks after administration
Additional Effects of Kinesio Taping on Knee Joint Proprioception and Spatiotemporal Gait Parameters in Patient With Chrondromalacia Patellae
NCT Number: NCT06561568
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chondromalacia
Interventions: DIAGNOSTIC_TEST: Conventional physical therapy|OTHER: Kinesiotaping
Sponsor: Foundation University Islamabad
Sex: ALL
Age: CHILD, ADULT
Enrollment: 46
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-10
Completion Date: 2024-12-30
Locations: Foundation University College of Physical Therapy, Rawalpindi, 46000, Pakistan

Summary:
Chondromalacia patellae (CMP), also known as runner's knee, is characterized by anterior knee pain (AKP) and typically occurs in youngsters. Causes of chondromalacia patellae include micro trauma wear and tear, post traumatic injuries and muscular imbalance. In Chondromalacia patella pain is behind or around the patella caused by stress in the patellofemoral joint that usually provoked by climbing stairs, squatting, and sitting with flexed knees for longer time periods. Patients of CMP presents with patellar mal-tracking, muscular weakness, proprioceptive deficit. Exercise training has been proven beneficial for CMP patients but additive effect of kinesio taping along with exercise have not been seen yet in these patients. The study will help people with chondromalacia patellae to improve their quality of life. The findings will contribute to future research in chondromalacia patellae management.

Primary Outcome Measures: Proprioception, Proprioception will be measured using goniometer., 4 weeks|Pain intensity, Pain will be measured using numeric pain rating scale (NPRS) It is a self-rated scale where patient rate their pain from 0-10. 0 shows no pain where 10 shows worst pain., 4 weeks|Functional status, Functional status is assessed by lower extremity functional scale LEFS. The LEFS is scored on a scale of 0 to 80, with higher scores indicating better lower limb function. The interpretation of the scores is based on following categories. 0-20 Severe Functional limitation.21-40 moderate functional limitation and 41 and above is good functional status., 4 weeks|Gait Speed, Gait analysis will be done to analyze speed.. A greater speed signifies positive outcome and prognosis. Speed = distance(m) x time(s), 4 Weeks|Gait cadence, Gait analysis will be done to analyze cadence. A greater cadence signifies positive outcome and prognosis. Cadence(steps/min) = steps countedx60/ time(s), 4 Weeks|Gait cycle time, Gait analysis will be done to analyze cycle time. A greater cycle time signifies positive outcome and prognosis. Cycle time(s)=time(s) x2/steps counted, 4 weeks|Stride length, Gait analysis will be done to analyze stride length. A greater stride length signifies positive outcome and prognosis. Stride Length(m)=Speed(m/s)xcycle time(s), 4 weeks
A Study on the Efficacy of Disitamab Vedotin in Advanced HER2-positive Paget's Disease.
NCT Number: NCT06561555
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Mammary or Extramammary Paget's Disease
Interventions: DRUG: RC48
Sponsor: Fudan University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 36
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-15
Completion Date: 2027-08-15

Summary:
This study is a single-center, phase II clinical trial. Patients with HER2-positive advanced breast and extramammary Paget's disease who met the eligibility criteria were enrolled after signing an informed consent form. All patients received treatment with 2mg/kg of trastuzumab deruxtecan intravenous infusion every 3 weeks until disease progression. Follow-up was conducted until disease progression, withdrawal of informed consent by the subject, loss to follow-up, or death. Clinical tumor imaging assessments were performed using RECIST during the treatment process.

Primary Outcome Measures: Objective Response Rate, ORR includes two categories:

Complete Response (CR): All target lesions in the patient have completely disappeared, and no new lesions have appeared for a certain time.

Partial Response (PR): The tumor in the patient has reduced in size by at least 30%, and this reduction has been maintained for a certain period., every 6 weeks,up to 24 weeks
Secondary Outcome Measures: Progression free survival, Progression-Free Survival (PFS) is a clinical endpoint used primarily in oncology to measure the effectiveness of a treatment in delaying the progression of a disease. It is defined as the length of time during which a patient's disease does not get worse after starting a treatment. PFS takes into account the time from the start of treatment until the first occurrence of disease progression, or the patient's death if it occurs before progression., through study completion, an average of 2 year|advance events, advance events, through study completion, an average of 2 year
A Phase I Study of LX22001 for Injection in Healthy Subjects
NCT Number: NCT06561542
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy
Interventions: DRUG: LX22001 for Injeciton|DRUG: Tegoprazan tablet|DRUG: Esomeprazole sodium for injection
Sponsor: Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.
Sex: ALL
Age: ADULT
Enrollment: 70
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-08-05
Completion Date: 2025-11-21
Locations: Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, Beijing, 100730, China

Summary:
Study to evaluate the safety and tolerability, pharmacokinetics/pharmacodynamics (PK/PD) parameters of an escalating, single dose/repeat doses of LX22001 for injection in healthy subjects.

Primary Outcome Measures: Number of Participants With Adverse Events, 7 days from dosing
Secondary Outcome Measures: Area Under the Concentration-Time Curve From Time 0 to the 24-Hour Time Point (AUC0-24), pre-dose to Day1 post-dose|Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC0-inf), pre-dose to Day1 post-dose|Maximum Observed Plasma Concentration (Cmax), pre-dose to Day1 post-dose|Terminal elimination half-life(t1/2), pre-dose to Day1 post-dose|Apparent total body clearance (CL), pre-dose to Day1 post-dose|Apparent volume of distribution(Vd), pre-dose to Day1 post-dose|Area Under the Concentration-Time Curve During a Dosing Interval (AUCtau) at Steady State, Day 3 post-dose|Cmax at Steady State (Cmax,ss), Day 3 post-dose|Percentage of Time Gastric pH above 4 over 24h, baseline, Day 1 and Day 3|Percentage of Time Gastric pH above 6 over 24h, baseline, Day 1 and Day 3|Mean Gastric pH over 24h, baseline, Day 1 and Day 3
the Gastric Bypass Stent System as a Treatment for Hepatic Fibrosis in Obese Patients in European Region
NCT Number: NCT06561529
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Fibrosis|Liver
Interventions: DEVICE: Gastric Bypass Stent System
Sponsor: MDCECRO LLC
Collaborators: Hangzhou Tangji Medical Technology Co., Ltd.
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-13
Completion Date: 2025-03
Locations: Digestive Diseases Centre "GASTRO", Riga, LV-1079, Latvia|REUH, hospital "lnfectology center of Latvia", Riga, LV1013, Latvia

Summary:
The Gastric Bypass Stent System is intended to be used in weight loss treatment for obesity and holds potential as a non-invasive technique for managing hepatic fibrosis. This pilot, prospective, single-arm, clinical investigation aims to evaluate the safety and performance of the Gastric Bypass Stent System for hepatic fibrosis treatment in Europe. This clinical investigation and the ongoing clinical investigation (Protocol number: BL-RD08-040) will be used to evaluate the safety and performance of the investigational device for the intended use.

Primary Outcome Measures: Extra Weight Loss Percentage, Body mass index (BMI) will be measured using the following calculation:

Body weight (kg) / Height (m2) The investigational site will use the same calibrated weighting scales for all weight measurements. Body weight measurements and BMI will be recorded in the eCRF.

Body weight measurements will be used to assess the primary endpoint: mean EWL% at 3 months after enrollment. Mean EWL% will be calculated using the following formula:

(Pre-procedure weight - Weight at follow-up) / (Pre-procedure weight - Body weight at BMI of 25 kg/m2) \* 100%, 9 months|NAFLD activity score [NAS], The NAS scoring system comprised 14 histological features, 4 of which were evaluated semi-quantitatively: steatosis (0-3), lobular inflammation (0-2), hepatocellular ballooning (0-2), and fibrosis (0-4). In patients with NAFLD, NAS score of ≥ 5 strongly correlated with a diagnosis of "definite NASH" whereas NAS ≤ 3 correlated with a diagnosis of "not NASH"., 9 months|SAF-A (steatosis, activity, and fibrosis) score, SAF-A is the activity part of the Steatosis Activity Fibrosis \[SAF\] histological score, calculated as the sum of lobular inflammation score and ballooning score, 9 months
Effects of Red Ginseng on Gastrointestinal Symptoms and Microbiota After Surgery for Gastrointestinal Cancer
NCT Number: NCT06561516
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stomach Cancer|Pancreatobiliary Cancer|Colorectal Cancer
Interventions: PROCEDURE: Arm I (Red ginseng)
Sponsor: Gangnam Severance Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2022-06-14
Completion Date: 2023-07-14
Locations: Gangnam Severacne Hospital Yonsei University College of Medicine, Seoul, Korea, Republic of

Summary:
After surgery for gastrointestinal cancer (stomach cancer, pancreaticobiliary cancer, colorectal cancer), many patients experiences various symptoms such as weight loss, diarrhea, constipation and excessive gas due to structural and functional changes in the gastrointestinal tract. These changes are thought to be influenced by alterations in gut microbiota following surgery, but prospective studies are still lacking. It is anticipated that the prebiotic effects of red ginseng may lead to positive changes in total gut bactera after gastrointestinal caner surgery.

Through this study, Investigators aim to investigate the impact of red ginseng consumption on gut microbiota composition, gastrointestinal symptoms, and nutritional status improvement following surgery for gastrointestinal cancer.

Primary Outcome Measures: Changes in microbiome composition based on the consumption or non-consumption of red ginseng following gastrointestinal cancer surgery., We observe changes in total gut bacteria following gastrointestinal cancer surgery based on the consumption of red ginseng through analysis of fecal microbiome., 4 months after surgery
Secondary Outcome Measures: Improvement of gastrotintestinal symptoms, EORTC QLQ-30 questionaire: gas expulsion level and discomfort caused by gas expulsion), 4 months after surgery|Improvement of bowel habits, Bowel habit questionnaire, 4 months after surgery|Nutritional Indicators, Blood test- lymphocyte counts, 4 months after surgery|Nutritional Indicators, Blood test- albumin level, 4 months after surgery|Nutritional Indicator, Blood test- total protein level, 4 months after surgery
Evaluation of Health Related Quality of Life in Patients With Intoxication-type Inherited Metabolic Diseases in Sohag University Hospital
NCT Number: NCT06561503
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Intoxication-type Inherited Metabolic Diseases
Sponsor: Sohag University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2025-08-01
Locations: Sohag university Hospital, Sohag, Sohag, Egypt

Summary:
Intoxication-type Inherited Metabolic disease (IT-IMD) are a group of rare, chronic diseases. They share the pattern of intoxication by a substance, which accumulates due to a genetically determined enzyme failure. In many IT-IMD, brain toxicity is predominant. Treatment mostly encompasses a lifelong natural protein-restricted diet, supplementation of amino acid solutions and specific medication.(1) The diseases are by definition chronic but according to their characteristics they can be subdivided into having or having not acute, crisis-like episodes. Patients with ITIMD such as urea cycle disorders (UCD) or organic acidurias (OA) may be challenged by life-threatening metabolic crises and acute exacerbations (acute IT-IMD). Many acute IT-IMD patients develop neurocognitive and behavioural problems, often despite sufficient treatment adherence. Furthermore, difficulties to adhere to diet and medication, nausea and vomiting are major every-day complaints.(2) Phenylketonuria (PKU), an inborn error of phenylalanine (Phe) metabolism is a non-acute IT-IMD, patients generally have no metabolic crises or short-term disease exacerbations. Accumulating Phe is toxic to the brain and causes severe, irreversible cognitive impairment. Mainstay of treatment in classical PKU is a lifelong protein-restricted diet complemented with amino acid supplementation.(3)With good metabolic control, classical PKU patients usually achieve normal cognitive functioning, but complaints such as attention problems, anxiety, or depression occur frequently.(2) Acute and non-acute IT-IMD patients face considerable burdens of disease and treatment, which may impair health-related quality of life (HrQoL). HrQoL is 'a patient's perception of the impact of disease and treatment on functioning in a variety of dimensions, including physical, psychological, and social domains.(1,4) Research on the subjective burden of IT-IMD remains sparse. . Previous research suggests that pediatric patients' and their parents' everyday life is significantly affected by the considerable disease and treatment burdens of E-IMD.(5) Studies with appropriate sample sizes are needed to make valid statements about health-related quality of life (HrQoL) in children and adolescents with IT-IMD

Primary Outcome Measures: Health-related quality of life (HrQoL) questionnaire, quality of life in patients with Intoxication-type Inherited Metabolic Diseases, 1 year
Placental Thickness And Volume Nomogram In Normal Singleton Pregnancies Between 11th And 18th Week Gestational Age
NCT Number: NCT06561490
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Placental Volume
Interventions: RADIATION: sonographic assesment of placental thickness and volume
Sponsor: Sohag University
Sex: FEMALE
Age: CHILD, ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-15
Completion Date: 2025-02-01

Summary:
Measurement of placental thickness and volume has a great importance in predicting adverse outcome specially in combination with other markers.

In order to determine abnormalities in placental thickness and volume, we should have a normal range of values and this can be achieved by a nomogram

Primary Outcome Measures: placental thickness, placental thickness in normal singleton pregnancy between 11th and 18 th week gestational age, 6 months|placental volume, placental volume in normal singleton pregnancy between 11th and 18 th week gestational age, 6 months
Role of ICCO Score in Predicting Outcome in ICU Patients
NCT Number: NCT06561477
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Liver Cirrhosis
Interventions: OTHER: Intensive care cirrhosis outcome (ICCO) score
Sponsor: Assiut University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 123
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-01
Completion Date: 2026-03

Summary:
This study aims at calculating a specific score to cirrhotic patients admitted at ICU (ICCO score) and use this score to predict mortality and outcome for admitted patients.

Primary Outcome Measures: Testing the validity of ICCO score in predicting mortality in critically ill patients with cirrhosis admitted to the ICU., ICCO score will be calculated to all participants based on the formula The ICCO score was 0.3707 + (0.0773 x bilirubin (mg/dl)) - (0.00849 x cholesterol (mg/dl)) -(0.0155 x creatinine clearance (ml/min)) + (0.1351 x lactate (mmol/l)). and then correlation between ICCO score and ICU mortality will be tested, baseline
Secondary Outcome Measures: Compare ICCO score with other established ICU scoring systems regarding their ability to predict mortality in ICU cirrhotic patients., each score of these scores will be calculated to all patients at time of ICU admission, follow up will be done until end of ICU stay, then statistical analysis will be done to compare the effectiveness of each score in prediction of mortality., baseline|Evaluate the utility of ICCO score in guiding clinical decision-making and resource allocation in ICU settings., after statistical analysis of collected data, if the ICCO score has good predictive value, then it can be used to make clinical decision for admission of patients to ICU or not depending of the prediction of their outcomes using the ICCO score., baseline|Assess the correlation of ICCO score with severity of liver disease and other organ dysfunctions., ICCO score value will be calculated to all participants and statistical analysis will be done to find any correlation between ICCO score and degree of severity of liver disease., baseline
Evaluation of Oxygen Delivery Methods in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)
NCT Number: NCT06561464
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Obstructive Pulmonary Disease Exacerbation
Interventions: DEVICE: EzPAP®|DEVICE: Non-invasive mechanical ventilation (NIMV)
Sponsor: Ankara Etlik City Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2023-11-01
Completion Date: 2024-06-01
Locations: Ankara Etlik City Hospital, Ankara, Yenimahalle, 38000, Turkey

Summary:
To examine the effects of oxygen therapy methods applied as indicated in COPD acute exacerbations on blood gas results and spirometric measurements.

Primary Outcome Measures: Arterial blood gas and spirometry values will be examined before and after treatment administration to patients., Patients meeting the inclusion criteria will be enrolled in the study after obtaining informed consent.

1. Before treatment, the following parameters will be assessed:

   * Blood pressure (mmHg)
   * Oxygen Saturation (%)
   * Respiratory rate /min,
   * Heart rate/min
   * pH
   * pCO2-mmHg
   * PaO2-mmHg
   * HCO3-mEq/L
   * Lactate-mmol/L
   * FEV1-Liter
   * FVC-Liter
2. After treatment, the following parameters will be assessed:

   * Blood pressure (mmHg)
   * Oxygen Saturation (%)
   * Respiratory rate /min,
   * Heart rate/min
   * pH
   * pCO2-mmHg
   * PaO2-mmHg
   * HCO3-mEq/L
   * Lactate-mmol/L
   * FEV1-Liter
   * FVC-Liter
   * PEF-L/min, Patients will receive 2-hour treatment (EzPAP and NIMV) and then measurements will be taken 30 minutes after the completion of treatment in both groups.|Evaluation of the patient's mortalite after treatment., - 30-day mortality of the patients will be evaluated., The 30-day mortality of the patients will be evaluated.
Live Birth Rate Between ICSI and AOA and ICSI Alone in Patients With Severe Teratospermia
NCT Number: NCT06561451
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Male Infertility|Teratospermia
Interventions: PROCEDURE: intracytoplasmic sperm injection and artificial oocyte activation|PROCEDURE: intracytoplasmic sperm injection
Sponsor: ShangHai Ji Ai Genetics & IVF Institute
Sex: ALL
Age: ADULT
Enrollment: 208
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-30
Completion Date: 2026-08-30
Locations: ShangHai JIAI Genetics &I VF Institute, Shanghai, China

Summary:
The goal of this clinical trial is to compare the live birth rate between intracytoplasmic sperm injection (ICSI) and artificial oocyte activation (AOA) vs intracytoplasmic sperm injection alone in patients with teratospermia. The hypothesis is the live birth rate following ICSI and AOA is significantly higher than that by ICSI alone in patients with teratospermia. This is a randomized controlled trial. Participants will be randomly assigned into one of the two groups:

ICSI+AOA group: a single sperm will be injected within 4 hours after the follicular aspiration. All injected oocytes will be incubated in the calcium ionophore A23187 activation solution (C9275-1MG, Sigma, USA) for 10 min, and cultured in the cleavage medium (Cleavage Medium , Cook, United States) under standard conditions.

ICSI alone group: a single sperm will be injected within 4 hours after the follicular aspiration.

Primary Outcome Measures: Live birth, Delivery ≥22 weeks of gestation with heartbeat and breath., 1 year after embryo transfer
Secondary Outcome Measures: Fertilization rate, Fertilized oocytes with two pronuclei per MII oocyte injected, 1 day after oocyte retrieval|High-quality embryos on Day 3, Seven or eight blastomeres of equal-size and \<20% fragmentation by volume, 3 days after oocyte retrieval|hCG positivity, Serum hCG level ≥10mIU/mL, 14 days after embryo transfer|Number and grading of embryos/blastocysts, Number and grading of embryos/blastocysts suitable for freezing and transfer, 6 days after oocyte retrieval|Clinical pregnancy, the presence of an intrauterine gestational sac on transvaginal ultrasound at 6 gestational weeks., 6 weeks of gestation|Ongoing pregnancy, a viable pregnancy beyond 12 weeks of gestation, 12 weeks of gestation|Multiple pregnancy, presence of more than one intrauterine sac at 6 weeks of gestation, 6 weeks of gestation|Cumulative live birth rate (within 6 months after randomization), Any live birth arising from embryo transfer within 6 months after randomization, 1.5 years after the randomization|Miscarriage rate, A clinically recognized pregnancy loss before 22 weeks of pregnancy. The denominator is the clinical pregnancy., 22 weeks of pregnancy|Birth weights of the newborns, Birth weights of the newborns, 1 year after embryo transfer
Postoperative Pain Management Following Laparoscopic Cholecystectomy
NCT Number: NCT06561438
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Postoperative Pain
Interventions: DRUG: Vortioxetine 20Mg Tab
Sponsor: Future University in Egypt
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 86
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-21
Completion Date: 2025-05
Locations: National Hepatology and Tropical Research Institute, Cairo, 11617, Egypt

Summary:
Postoperative pain management is essential and the inability to treat acute pain appropriately in the first 48 postoperative hours represents a risk factor for developing chronic pain. No. study has investigated Vortioxetine as an adjuvant to standard care for postoperative pain management in patients undergoing LC

Primary Outcome Measures: VAS score (Visual analogue scale), Pain intensity: VAS score from 0 to 100 mm In which 0 means no pain, and 100 means the worst pain possible, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours
Secondary Outcome Measures: Time to analgesic request, Time to analgesic request, 24 hours|Quality of life (QoL) after laparoscopic cholecystectomy (LC), Gastrointestinal Quality of Life Index questionnaire for QOL assessment with calculation of the score; most desirable option: 4 points, least desirable option: 0 points and GIQLI score: sum of the point. GIQLI ranges from 0 to 80 with higher scores indicating a better quality of life., 3 months
A Study Evaluating the Safety and Efficacy of GLPG5101 (19CP02) in Participants With Non-Hodgkin Lymphoma
NCT Number: NCT06561425
Acronym: Atalanta-1
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Relapsed/Refractory B-cell Non-Hodgkin Lymphoma|Lymphomas Non-Hodgkin's B-cell
Interventions: GENETIC: GLPG5101
Sponsor: Galapagos NV
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 195
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-03-09
Completion Date: 2029-05-31
Locations: Tufts Medical Center, Boston, Massachusetts, 02111, United States|Beth Israel Deaconess Medical Center Clinical Laboratories, Boston, Massachusetts, 02215, United States|Antwerp University Hospital, Edegem, 2650, Belgium|UZ Leuven, Leuven, 3000, Belgium|CHU De Liège, Liège, 4000, Belgium|Cliniques Universitaires Saint-Luc, Woluwe-Saint-Lambert, 1200, Belgium|Academisch Medisch Centrum, Amsterdam, 1105 AZ, Netherlands|Leiden University Medical Center, Leiden, 2333 ZA, Netherlands|Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC), Rotterdam, 3015 GD, Netherlands

Summary:
This study is evaluating whether an experimental treatment called GLPG5101 helps to treat non-Hodgkin lymphoma (NHL) and if it is safe to use.

This study will be carried out in 2 phases:

* The first phase is to see which dose of GLPG5101 works best with the least number of side effects.
* In the second phase, all participants will get the best dose of the first phase.

Primary Outcome Measures: Phase 1: Number of participants with adverse events (AEs) and serious adverse events (SAEs), 2 years|Phase 1: Number of participants with Dose-Limiting Toxicities (DLTs), From first dose up to Day 28|Phase 2: Number of participants with best objective response (OR) per the Lugano Classification or International Primary central nervous system lymphoma Collaborative Group (IPCG) criteria, 2 years
Secondary Outcome Measures: Phase 2: Number of participants with AEs and SAEs, 2 years|Number of participants with AEs of special interests, 2 years|Number of participants with best OR per the Lugano Classification or IPCG criteria, 2 years|Duration of response (DOR), 2 years|Number of participants with metabolic complete response (mCR), 2 years|Event-free survival (EFS), 2 years|Progression-free survival (PFS), 2 years|Overall survival (OS), 2 years|Number of participants without minimal Residual Disease (MRD), 2 years|Pharmacokinetics (PK): Levels of anti-CD19 CAR T cells in blood, 2 years|PK: Levels of anti-CD19 CAR T cells in bone marrow, 2 years|PK: Levels of anti-CD19 CAR T cells in cerebrospinal fluid (CSF), 2 years|Pharmacodynamics (PD): Levels of chemokines in serum over time, Day 7 before infusion, Day 0, Day 1, Day 4, Day 7, Day 10, Day 14, Day 21, Day 28|PD: Levels of cytokines in serum over time, Day 7 before infusion, Day 0, Day 1, Day 4, Day 7, Day 10, Day 14, Day 21, Day 28|Percentage of successfully manufactured GLPG5101 products within the predefined release specifications, From leukapheresis to infusion
Triple Therapy Sequential Radiotherapy in Unresectable HCC (TALENP003)
NCT Number: NCT06561399
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Hepatocellular Carcinoma Non-resectable
Interventions: COMBINATION_PRODUCT: TACE, Lenvatinib combination with Sintilimab sequential radiotherapy
Sponsor: Fujian Provincial Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 28
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-15
Completion Date: 2028-07-01
Locations: First Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, China|Fujian Provincial Hospital, Fuzhou, Fujian, China|Fujian provincial hospital, Fuzhou, Fujian, China|Mengchao Hepatobiliary Hospital of Fujian Medical University, Fuzhou, Fujian, China

Summary:
This is an Open-label, Multicenter, Phase II clinical trial to evaluate the efficacy and safety of Transcatheter arterial chemoembolization (TACE), Lenvatinib combination with Sintilimab (Triple Therapy) sequential radiotherapy in patients with Unresectable Hepatocellular Carcinoma (uHCC).

Primary Outcome Measures: Objective response rate, ORR, The objective response rate (ORR) was defined as the complete response (CR) rate + the partial response (PR) rate according to RECIST 1.1., 4 weeks after the initiation of medication until the day before surgery
Secondary Outcome Measures: Progression free survival, PFS, The Progression free survival (PFS) was defined as the time between the start of treatment and the progression of intrahepatic and/or extrahepatic tumors, or the occurrence of death or loss of follow-up for any reason., From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months|Overall survival, OS, The Overall survival (OS) was defined as the time between receiving treatment and observing death or loss of follow-up for any reason., From date of randomization until the date of death from any cause, whichever came first, assessed up to 60 months|Objective response rate, ORR, The objective response rate (ORR) was defined as the complete response (CR) rate + the partial response (PR) rate according to mRECIST., 4 weeks after the initiation of medication until the day before surgery|Conversion resection rate, CRR, The Conversion resection rate (CRR) was defined as the patient who reach the resectable criterion after treatment and accepted operation., 3 months|Major pathological response rate, MPR rate, The major pathological response (MPR) rate was defined as less than 10% active tumor cells in the excised tissue sample in patients accept operation., Immediately after surgery|Toxicity Adverse events, Grade 1-5 AEs according to NCI-CTCAE V5.0., through study completion, assessed up to 60 months