Clinical trials: Perioperative Patient Safety
Congenital Heart Diseases
Ulinastatin Injection in in Pediatric Patients Undergoing Open Heart Surgery
1. Explore the efficacy of Ulinastatin use in improving post-operative pulmonary insufficiency and safety in pediatric patients undergoing scheduled CPB open heart surgery to treat Complex Congenital Heart Disease 2.
- Trial name
- NCT02527811
- Testing
- Ulinastatin
- Where
- 5 sites in China
- Volunteers
- 450 people
- Sponsor
- Techpool Bio-Pharma Co., Ltd.
Laparoscopic Cholecystectomy, Pain
A Randomized, Double-Blind Study of the Efficacy and Safety of Valdecoxib Compared to Placebo for Treatment of Post- Cholecystectomy Surgery Pain
To evaluate the analgesic efficacy, general safety, and effects on health outcome measures and opioid-related symptoms of 2 valdecoxib dosing regimens compared with placebo in patients with moderate or severe pain following…
- Trial name
- NCT00661635
- Testing
- valdecoxib
- Where
- 65 sites in United States
- Volunteers
- 490 people
- Sponsor
- Pfizer
Heart; Dysfunction Postoperative, Cardiac Surgery
VolulyteTM in Cardiac Surgery
The study will compare the efficacy and safety of VolulyteTM and human albumin in elective open-heart surgery in adult patients.
- Trial name
- NCT01553617
- Testing
- 6% hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution (VolulyteTM), Human serum albumin
- Where
- 5 sites in Canada
- Volunteers
- 133 people
- Sponsor
- Fresenius Kabi
Post-operative Pain
HSK16149 for Perioperative Analgesia in Orthopedic Surgery
This study will compare the effect and safety of HSK16149 with placebo on perioperative analgesia in orthopedic surgery, and explore the dosage of HSK16149 capsules for orthopedic analgesia during perioperative period.
- Trial name
- NCT06007066
- Testing
- HSK16149 capsule
- Where
- 21 sites in China
- Volunteers
- 235 people
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Gliomas Harboring IDH1 and/or IDH2 Mutations
Phase I Study of HMPL-306 for the Treatment of Gliomas With IDH1 and/or IDH2 Mutations
This study is a multicenter, randomized controlled Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of HMPL-306 in patients with gliomas harboring IDH1…
- Trial name
- NCT07025018
- Testing
- HMPL-306
- Where
- China
- Volunteers
- 52 people
- Sponsor
- Hutchmed
Osteoarthritis, Pain
Celebrex Total Knee Arthroplasty Study
This study will investigate the benefits of administering celecoxib (Celebrex), a selective cyclooxygenase -2 (COX-2) inhibitor, in treating osteoarthritis (OA) subjects undergoing elective unilateral primary total knee…
- Trial name
- NCT00359151
- Testing
- Celecoxib
- Where
- 7 sites in United States
- Volunteers
- 22 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Muscle Invasive Bladder Cancer
Treatment Combination of Durvalumab, Tremelimumab and Enfortumab Vedotin or Durvalumab and Enfortumab Vedotin in Patients With Muscle Invasive Bladder Cancer Ineligible to Cisplatin or Who Refuse Cisplatin
A global phase 3, multicenter, randomized, trial, to Determine the Efficacy and Safety of Durvalumab in combination with Tremelimumab and Enfortumab Vedotin or Durvalumab in combination with Enfortumab Vedotin for Perioperative…
- Trial name
- VOLGA (NCT04960709)
- Testing
- Durvalumab, Tremelimumab, Enfortumab Vedotin
- Where
- 196 sites in United States, Argentina and 23 more
- Volunteers
- 712 people
- Sponsor
- AstraZeneca
Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma
A Phase III Clinical Study of Cadonilimab Plus SOX as Perioperative Treatment for Patients With Resectable G/GEJ Adenocarcinoma
This study investigates treatment of cadonilimab or placebo combined with SOX chemotherapy (oxaliplatin + tegafur-gimeracil-oteracil potassium) given before surgery (neoadjuvant) and cadonilimab or placebo combined with SOX…
- Trial name
- NCT07023315
- Testing
- Cadonilimab, SOX chemotherapy
- Where
- 6 sites in China
- Volunteers
- 760 people
- Sponsor
- Akeso
Pediatric Perioperative Blood Pressure Management
Assessment of Efficacy, Safety and Dosing of Clevidipine in Pediatric Participants Undergoing Surgery (PIONEER)
Evaluate the efficacy, safety, and dosing of clevidipine as an intravenous (IV) infusion for blood pressure (BP) management in paediatric participants in the perioperative setting.
- Trial name
- PIONEER (NCT01938547)
- Testing
- clevidipine
- Where
- 2 sites in United States
- Volunteers
- 22 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Urothelial Carcinoma
9MW2821 Combined With Toripalimab in Perioperative Patients With Urothelial Cancer
This is a single arm, open-label, multicenter phase II clinical study to evaluate the safety and efficacy of 9MW2821 combined with Toripalimab in perioperative patients with urothelial cancer.
- Trial name
- NCT07314723
- Testing
- 9MW2821, Toripalimab Injection
- Where
- China
- Volunteers
- 90 people
- Sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.
Gastrointestinal Cancer
To Test the Food for Special Medical Purpose in Perioperative Patients With Gastrointestinal Cancer
This is a prospective, randomized, open label, active-controlled, multi-centre, non-inferiority clinical trial. Aim of the study is to evaluate the efficacy and safety of Fresubin Support Drink in patients with gastrointestinal…
- Trial name
- NCT05606848
- Testing
- Nutrition Emulsion (TPF-T), Foods for special medical purposes [FSMP] for patients with tumors
- Where
- 14 sites in China
- Volunteers
- 350 people
- Sponsor
- Fresenius Kabi Sino-Swed Pharmaceutical Corp. Ltd
Pain
Double-Blind, Randomized Study Of The Analgesic Efficacy And Safety Of Valdecoxib 20 Mg Daily And Valdecoxib 20 Mg Twice Daily Compared To Placebo For Management Of Acute Postsurgical Pain In Anterior Cruciate Ligament (ACL) Reconstruction
The primary objective was to evaluate the analgesic efficacy of valdecoxib 20 mg daily and valdecoxib 20 mg twice daily compared with placebo in outpatients with moderate-severe pain after arthroscopic anterior cruciate ligament…
- Trial name
- NCT00650039
- Testing
- valdecoxib
- Where
- 81 sites in United States, Canada
- Volunteers
- 488 people
- Sponsor
- Pfizer
Post Operative Endophthalmitis
Effectiveness and Safety of 0.5% Moxifloxacin Hydrochloride Ophthalmic Solution in Perioperative Sterilization in Patients Undergoing Ophthalmic Surgery
This is a non-interventional, uncontrolled, prospective, multicenter, post marketing surveillance study.
- Trial name
- NCT05413980
- Testing
- Moxifloxacin hydrochloride ophthalmic solution
- Where
- 9 sites in India
- Volunteers
- 102 people
- Sponsor
- Novartis Pharmaceuticals
Muscle-Invasive Bladder Cancer (MIBC)
A Prospective, Multi-Center, Phase 4, Single Arm Study To Assess The Safety and Tolerability of Perioperative Durvalumab in Combination With Neoadjuvant Gemcitabine Plus Cisplatin in Indian Patients With Muscle-Invasive Bladder Cancer Cle-Invasive
This is a Phase 4, Single Arm Study To Assess The Safety and tolerability of Perioperative Durvalumab in Combination with Neoadjuvant Gemcitabine Plus Cisplatin Treatment Followed by radical cystectomy and Durvalumab alone as…
- Trial name
- SERENE (NCT07876817)
- Testing
- Durvalumab, Gemcitabine, Cisplatin
- Volunteers
- 50 people
- Sponsor
- AstraZeneca
Hemophilia A
A Clinical Study of Recombinant Human Coagulation Factor VIII for Injection in Patients With Severe Hemophilia A
This study is a single arm, open, multicenter clinical trial in which the previous treated severe hemophilia A patients receive recombinant human coagulation factor VIII for injection to evaluate the efficacy and safety of…
- Trial name
- NCT06297655
- Testing
- Recombinant human activated coagulation factor VIII for injection
- Where
- 12 sites in China
- Volunteers
- 60 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.