Clinical trials: sponsored by Fudan University
Autism Spectrum Disorder, Therapy
Strategies for Toddler ASD With Remote-therapy (STAR) Model for ASD
The project aims to develop and implement the Strategies for Toddler Autism spectrum disorder(ASD) with Remote-therapy (STAR) model for early toddlers with ASD in local community sites in Shanghai.
- Trial name
- NCT05901558
- Testing
- Strategies for Toddler ASD with Remote-therapy (STAR), Community intervention
- Where
- China
- Volunteers
- 110 people
- Sponsor
- Children's Hospital of Fudan University
Beta-Thalassemia
A Long-term Follow-up Study in Participants Who Received CS-101
This is a study to evaluate the long-term safety and efficacy of CS-101 in participants who received CS-101 in study CS -101-03 (NCT06065189)
- Trial name
- NCT06479616
- Testing
- CS-101
- Where
- China
- Volunteers
- 5 people
- Sponsor
- Children's Hospital of Fudan University
Congenital Heart Disease, Acute Kidney Injury
Effects of Anesthetic Techniques on Renal Function
This study evaluates Different effects of two anesthetic techniques on renal function during the perioperative period of cardiac surgery in children.
- Trial name
- NCT04030481
- Testing
- inhalation anesthesia, Total intravenous anesthesia
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Children's Hospital of Fudan University
Premature Infant
A Study of Family-integrated Care for Reducing Uncertainty
To explore the intervention effect of family participatory nursing on the uncertainty of illness of parents of hospitalized premature infants, and to evaluate the uncertainty level of parents of premature infants in different…
- Trial name
- NCT04648787
- Testing
- family-integrated care, traditional nursing
- Where
- China
- Volunteers
- 68 people
- Sponsor
- Children's Hospital of Fudan University
Intervention
Effect of Developmental Care on Very Low Birth Weight Infants
The goal of this clinical trial is to learn if developmental care works when implemented in very low birth weight infants. The main questions it aims to answer are: Does developmental care shorten the length of hospital stay in…
- Trial name
- NCT06515574
- Testing
- developmental care
- Where
- 2 sites in China
- Volunteers
- 1,600 people
- Sponsor
- Children's Hospital of Fudan University
Breast Cancer
Phase I/II Study of Intrathecal/Ommaya T-DXd in HER2-Expressing Breast Cancer With Leptomeningeal/Brain Metastases
Multiple trials confirm systemic T-DXd efficacy in HER2+ breast cancer with leptomeningeal/brain metastases, yet median LM survival remains 3-4 months, highlighting unmet needs.
- Trial name
- INOVATE (NCT07134153)
- Testing
- T-DXd
- Where
- 2 sites in China
- Volunteers
- 139 people
- Sponsor
- Fudan University
Influenza Vaccination
Family Physician Nudges for Influenza Vaccination Among Older Adults
The goal of this clinical trial is to learn if a family-physician nudge intervention works to improve influenza vaccination among adults aged 65 years and older in China.
- Trial name
- NCT07864597
- Testing
- Family Physician Influenza Vaccination Nudge
- Volunteers
- 3,060 people, healthy volunteers welcome
- Sponsor
- Fudan University
Peritoneal Mesothelioma, First-line Therapy
First-line Treatment With Dual Immunotherapy Combined With Anti-angiogenesis for Unresectable Advanced Malignant Peritoneal Mesothelioma
This is a prospective, multicenter, single-arm, Phase II clinical study evaluating the efficacy and safety of sintilimab in combination with ipilimumab N01 and bevacizumab as first-line treatment in patients with unresectable…
- Trial name
- PeM (NCT07893340)
- Testing
- Sintilimab, Ipilimumab N01, Bevacizumab
- Where
- China
- Volunteers
- 19 people
- Sponsor
- Fudan University
Endometrial Neoplasm Malignant Stage I
Gonadotropin-releasing Hormone Agonist (GnRHa) Plus Letrozole In Young Women With Early Endometrial Cancer
To see if Gonadotropin-releasing hormone analogue (GnRHa) combined with aromatase inhibitors (AIs) will achieve better complete response rate than megestrol acetate or medroxyprogesterone acetate (MA/MPA) alone as…
- Trial name
- NCT05247268
- Testing
- Megestrol Acetate 160 MG Oral Tablet, Medroxyprogesterone Acetate 500 MG, Triprorelin Acetate
- Where
- China
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- Fudan University
Triple-negative Breast Cancer
Reverse Triple Negative Immune Resistant Breast Cancer
This is a Phase II, open-label, nine-arm parallel study evaluating the efficacy and safety of combined treatment (sodium cromoglicate, choline, efavirenz, SHR 1811, SHR 2102, mecapegfilgrastim, theophylline, mifepristone) with…
- Trial name
- Renaissance (NCT05076682)
- Testing
- Choline, anti-PD-1 antibody and chemotherapy, Sodium Cromoglicate
- Where
- China
- Volunteers
- 90 people
- Sponsor
- Fudan University
Tinnitus
Multidimensional Phenotyping of Patients With Tinnitus Using Electronic Health Records and a Specialty Database
This retrospective observational study will use historical electronic health record and tinnitus specialty database data from adult patients with tinnitus seen at the Eye and ENT Hospital of Fudan University between January 2015…
- Trial name
- NCT07887932
- Volunteers
- 225,792 people
- Sponsor
- Eye & ENT Hospital of Fudan University
Kawasaki Disease
Efficacy and Safety of Immunoglobulin Plus Firsekibart in Patients With Kawasaki Disease
This study evaluates the efficacy and safety of the addition of Firsekibart to standard initial treatment (intravenous immunoglobulin [IVIG] plus aspirin) in children with Acute Kawasaki Disease (KD) .
- Trial name
- NCT07686770
- Testing
- IVIG, Aspirin, Firsekibart
- Where
- 2 sites in China
- Volunteers
- 90 people
- Sponsor
- Children's Hospital of Fudan University
Mobilization of Hematopoietic Stem Cells (HSC) to Peripheral Blood (PB), Hematopoetic Stem Cell Transplantation
G-CSF Combined With IL-11 on Hematopoietic Reconstitution After Autologous Hematopoietic Stem Cell Transplantation
Autologous hematopoietic stem cell transplantation(auto-HSCT) plays an important role in treating hematologic malignancies. Mobilization and collection of peripheral blood stem/progenitor cells is the key to successful autologous…
- Conditions
- Mobilization of Hematopoietic Stem Cells (HSC) to Peripheral Blood (PB), Hematopoetic Stem Cell Transplantation, Hemato-oncologic Patients
- Trial name
- NCT07362810
- Testing
- G-CSF+IL-11, G-CSF Granulocyte-Colony Stimulating Factor
- Where
- 7 sites in China
- Volunteers
- 224 people
- Sponsor
- Fudan University
Kawasaki Disease, Pilot Study
Model-informed Dose Optimization for Rivaroxaban in Children With Giant Coronary Artery Aneurysm After Kawasaki Disease
Based on a population pharmacokinetic model-based dose optimization study, a 15 mg-equivalent, age-, and bodyweight-adjusted dosing regimen for Chinese children with giant coronary artery aneurysms after Kawasaki disease was…
- Conditions
- Kawasaki Disease, Pilot Study, Coronary Artery Aneurysm, Rivaroxaban
- Trial name
- NCT06978439
- Testing
- Rivaroxaban (Xarelto)
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Children's Hospital of Fudan University
Mindfulness Skills, Psychosocial Education
Mindfulness Intervention for Psychological and Family Dynamics in Children With Body-Focused Repetitive Behaviors
This is a single-center, randomized, controlled intervention study designed to evaluate the effectiveness of mindfulness intervention on reducing body-focused repetitive behaviors (BFRBs) in children aged 8-18, such as…
- Trial name
- MIND-BFRB (NCT06777212)
- Testing
- Mindfulness Training Program, Psychosocial Education Program
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Children's Hospital of Fudan University
Breast Cancer, TNBC - Triple-Negative Breast Cancer
Thymalfasin Combined With Chemotherapy and Immunotherapy in TNBC Neoadjuvant Treatment
This is a prospective, open-label, single-center, phase II, randomized controlled clinical trial involving patients with triple-negative breast cancer who meet the criteria for neoadjuvant chemotherapy (T > 2 cm, N+).
- Conditions
- Breast Cancer, TNBC - Triple-Negative Breast Cancer, Immunotherapy
- Trial name
- NCT07884201
- Testing
- Thymalfasin
- Volunteers
- 572 people
- Sponsor
- Fudan University
Metastatic Colorectal Cancer
Becotatug Vedotin Plus Pucotenlimab for Metastatic Colorectal Cancer
The BECOME trial will study whether becotatug vedotin combined with pucotenlimab can shrink tumors and how safe this treatment is in adults with colorectal cancer that has returned or spread after at least two prior lines of…
- Trial name
- NCT07884188
- Testing
- Becotatug Vedotin (MRG003), Pucotenlimab
- Where
- China
- Volunteers
- 31 people
- Sponsor
- Fudan University
Microsatellite Stable Metastatic Colorectal Cancer
Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy (PULSAR ) Combined With Anti-PD1，Chemotherapy and Target Therapy for Metastatic Colorectal Cancer
To improve the survival in patients with microsatellite stable metastatic colorectal cancer (MSS mCRC) by loco-regional therapy with personalized ultra-fractionated radiation plus immunotherpy.
- Trial name
- iPULSAR-CRC (NCT06841159)
- Testing
- Ultra-fractionated radiation therapy, Sintilimab, Standard systemic therapy
- Where
- China
- Volunteers
- 116 people
- Sponsor
- Fudan University
Gastric Adenocarcinoma, Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma or Esophageal Carcinoma
Efficacy of Tirellizumab Combined With Oral, Intravenous and Abdominal Chemotherapy in Peritoneal Metastatic Gastric/Gastroesophageal Junction Adenocarcinoma
For peritoneal metastatic gastric/gastroesophageal junction adenocarcinoma (cT3-4NanyM1), PD-1 antibody combined with chemotherapy and hyperthermic intraperitoneal chemotherapy (HIPEC) can downstage tumor stage, increase the…
- Conditions
- Gastric Adenocarcinoma, Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma or Esophageal Carcinoma, Peritoneal Metastasis
- Trial name
- NCT06914687
- Testing
- Tislelizumab, S-1, Oxaliplatin
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Fudan University
Locally Advanced Colon Cancer, pMMR
Chemotherapy Combined With or Without Short-Course Radiotherapy Versus Chemotherapy Alone as Neoadjuvant Therapy for High-Risk Locally Advanced Colon Cancer With pMMR/MSS
Locally advanced colon cancer, particularly T4 disease or colon cancer with bulky nodes, carries a poor prognosis and limited efficacy with neoadjuvant chemotherapy.
- Trial name
- TORCH-C2 (NCT07877597)
- Testing
- short-course radiotherapy, Serplulimab, CapOx(Capecitabine+ Oxaliplatin)
- Where
- China
- Volunteers
- 480 people
- Sponsor
- Fudan University
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