Clinical trials: Reactions Adverse
Jejunostomy; Complications, Enteral and Supplement Feeds Adverse Reaction
Clinical Pilot Study of the Percutaneous Ultrasound Jejunostomy Procedure
The purpose of this study is to evaluate the feasibility and performance of the Percutaneous Ultrasound Jejunostomy (PUJ) procedure that utilizes a novel device (PUMA-J System) in conjunction with widely available ultrasound…
- Conditions
- Jejunostomy; Complications, Enteral and Supplement Feeds Adverse Reaction, Safety Issues
- Trial name
- NCT06095804
- Testing
- Percutaneous Ultrasound Jejunostomy
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- CoapTech
Rabies Vaccine Adverse Reaction, Safety and Efficacy
A Clinical Trial of Freeze-dried Human Rabies Vaccine (Vero Cells)
This clinical trial is carried out in two phases. The first phase adopts an open design, and the second phase adopts a randomized, blinded, and similar vaccine-controlled non-inferiority trial design.
- Trial name
- NCT04852068
- Testing
- Freeze-dried human rabies vaccine (Vero cells) Zhifeilongkoma - 5-dose program, Freeze-dried human rabies vaccine (Vero cells) Zhifeilongkoma - 4-dose program, Freeze-dried human rabies vaccine (Vero cells) Chengda - 5-dose program
- Where
- China
- Volunteers
- 2,480 people, healthy volunteers welcome
- Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Hypercholesterolemia, Atherosclerosis
Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) as Add-on to Ezetimibe Therapy in Patients With Elevated LDL-C (CLEAR Tranquility)
The purpose of this study is to determine if bempedoic acid (ETC-1002) added-on to ezetimibe therapy is effective and safe versus placebo in patients with elevated LDL cholesterol.
- Conditions
- Hypercholesterolemia, Atherosclerosis, Statin Adverse Reaction
- Trial name
- NCT03001076
- Testing
- Bempedoic acid, Ezetimibe
- Where
- United States
- Volunteers
- 269 people
- Sponsor
- Esperion Therapeutics, Inc.
HIV Infections
A Study to Investigate if Long Acting Cabotegravir (CAB) and Lenacapavir (LEN) Injections Are Tolerable and Acceptable When Administered to Healthy Adults Without HIV
This study will evaluate the tolerability and acceptability of injection site reactions (ISRs) of two long-acting (LA) injectables.
- Trial name
- NCT06970223
- Testing
- Cabotegravir long-acting, Lenacapavir long-acting
- Where
- United States
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
CVI - Common Variable Immunodeficiency
A Study to Evaluate the Benefit of RUCONEST® in Subjects Who Experience ADRs Related to IVIG Infusions
Patients receiving intravenous immunoglobulin (IVIG) therapy for primary immunodeficiency and neurologic conditions may experience adverse drug reactions (ADRs). The mechanism of the ADR is unknown.
- Trial name
- NCT03576469
- Testing
- C1-esterase inhibitor [recombinant] (C1-INH-R)
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- IMMUNOe Research Centers
Cervical Carcinoma Stage II, Cervical Carcinoma Stage III
Evaluation of Oncoxin-Viusid® in Cervical Cancer and Endometrial Adenocarcinoma.
The purpose of this study is to evaluate the efficacy of oral solution Oncoxin-Viusid in the reduction of acute toxicity of Radiotherapy (RTP) and Chemotherapy (QTP) in patients with histological diagnosis of cervical cancer and…
- Conditions
- Cervical Carcinoma Stage II, Cervical Carcinoma Stage III, Cervical Carcinoma Stage IV, Endometrial Adenocarcinoma Stage II
- Trial name
- NCT03540407
- Testing
- Oncoxin-Viusid®
- Where
- Cuba
- Volunteers
- 66 people
- Sponsor
- Catalysis SL
Diphtheria Vaccine Adverse Reaction, Tetanus Vaccine Adverse Reaction
Immunogenicity and Safety of DTP-HB-Hib Using New Hepatitis B Bulk (Bio Farma)
This bridging study is a randomized, double-blind, two arms parallel group, prospective intervention study. The primary objective of this study is to evaluate protectivity of DTP-HB-Hib Vaccine (Bio Farma) using new Hepatitis B…
- Conditions
- Diphtheria Vaccine Adverse Reaction, Tetanus Vaccine Adverse Reaction, Pertussis Vaccine Adverse Reaction, Haemophilus Influenzae Type B Vaccine Adverse Reaction
- Trial name
- NCT05482282
- Testing
- Recombinant Hepatitis B new Bulk vaccine, DTP-HB-Hib with Recombinant Hepatitis B new Bulk vaccine, Recombinant Hepatitis B vaccine (Registered BioFarma)
- Where
- 3 sites in Indonesia
- Volunteers
- healthy volunteers welcome
- Sponsor
- PT Bio Farma
Schizophrenia
Effectiveness and Adverse-effect Switch Evaluation of Xanomeline and Trospium Chloride (KarXT)
The purpose of this study is to describe real-world treatment patterns, effectiveness and adverse events of adults diagnosed with schizophrenia that have initiated xanomeline and trospium chloride (KarXT) treatment in the United…
- Trial name
- NCT07379827
- Testing
- Xanomeline and trospium chloride (KarXT)
- Where
- 55 sites in United States
- Volunteers
- 1,500 people
- Sponsor
- Bristol-Myers Squibb
Injection Site Reaction
Prospective Study to Assess Tissue Responses After Injection With Biostimulatory Products
The objective of this study is to identify and assess in vivo tissue responses after injection with various biostimulatory products at various timepoints.
- Trial name
- NCT06093815
- Testing
- Injection
- Where
- Spain
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Merz North America, Inc.
Drug-induced Liver Injury
Rechallenge, Potential Drug Induced Liver Injury (Kaiser)
Drug re-administration or rechallenge should be avoided after drug-induced liver injury (DILI) to avoid recurrent and fatal injury. Rechallenge outcomes vary considerably by drug and patient subjects.
- Trial name
- NCT01584765
- Testing
- Prescription drugs with known hepatotoxicity
- Volunteers
- 1 people
- Sponsor
- GlaxoSmithKline
COVID-19 Pneumonia, Bromelains Adverse Reaction
Nebulised BromAc in Healthy Volunteers
COVID-19 is a disease that has multiple facets including an inflammatory storm, it promotes blood clotting and causes kidney damage, mucinous secretions in the lung are of great importance to outcome.
- Conditions
- COVID-19 Pneumonia, Bromelains Adverse Reaction, Acetylcysteine Adverse Reaction, Mucus; Plug
- Trial name
- NCT05220605
- Testing
- BromAc
- Where
- Australia
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Mucpharm Pty Ltd
Drug-Induced Liver Injury
Efficacy and Safety Study of Magnesium Isoglycyrrhizinate Injection in Subjects With Acute Drug-induced Liver Injury
The purpose of this study is to investigate the safety, effective dosage and treatment of Magnesium Isolycyrrhizinate Injection to cure the acute drug-induced liver injury compared with the Tiopronin Injection.
- Trial name
- NCT02734966
- Testing
- Magnesium Isoglycyrrhizinate Injection 100mg OD, Magnesium Isoglycyrrhizinate Injection 200mg OD, Tiopronin Injection
- Where
- 8 sites in China
- Volunteers
- 174 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Smallpox Vaccine Adverse Reaction
VA-008 ACAM2000® Vaccination of Plasma Donors for the Production of VIGIV
Objectives: To vaccinate plasma donors with the ACAM2000 smallpox vaccine thereby inducing an immune response resulting in high anti-vaccinia antibody titers.
- Trial name
- NCT02443623
- Testing
- Vaccination with ACAM2000
- Where
- Canada
- Volunteers
- 3,032 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
Dyskinesia, Medication-induced, Dyskinesia, Drug-Induced
Safety and Tolerability of Single and Repeated Dose of IMM02-KORA in PD-associated Dyskinesia
The goal of this clinical trial is to test Safety and tolerability of single and repeated dose of IMM02-KORA in subjects with PD-associated dyskinesia.
- Trial name
- KORA-LID-1 (NCT07905976)
- Testing
- IMM02-KORA
- Volunteers
- 15 people
- Sponsor
- Immunis, Inc.
Allergic Rhinitis, Seasonal Allergic Rhinitis
Post Marketing Surveillance for Contac Bien Z in Japan
This is a post-marketing surveillance study on a marketed cetrizine hydrochloride formulation.
- Trial name
- NCT02020902
- Testing
- Cetrizine hydrochloride
- Where
- Japan
- Volunteers
- 1,552 people
- Sponsor
- GlaxoSmithKline
Type 2 Diabetes Mellitus
Examination of Dermatologic Effects From Subcutaneous Injections of ISIS 113715
10 healthy volunteers will be enrolled to each receive two subcutaneous injections of ISIS 113715 in the abdomen on Study Day 1. Each subject will receive their two injections within a 5-minute period.
- Trial name
- NCT00365781
- Testing
- ISIS 113715
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Ionis Pharmaceuticals, Inc.
Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis
Phase III Clinical Trial of NPB-01 in Patients With Stevens-Johnson Syndrome/ Toxic Epidermal Necrolysis Unresponsive to Corticosteroids.
Patients diagnosed with Stevens-Johnson syndrome and Toxic Epidermal Necrolysis were confirmed based on the investigators national diagnostic criteria.
- Trial name
- NCT01696500
- Testing
- Intravenous immunoglobulin
- Where
- Japan
- Volunteers
- 10 people
- Sponsor
- Nihon Pharmaceutical Co., Ltd
Acute Lymphoblastic Leukemia, Pediatric, Adverse Drug Event
Pharmacogenomic Analysis in Pediatric Acute Lymphoblastic Leukemia
This is a retrospective biobank study evaluating the impact of novel genetic variants in a population of 6-mercaptopurine treated pediatric acute lymphoblastic leukemia patients.
- Trial name
- NCT04770922
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Cipherome, Inc.
Adverse Drug Event
NOCDURNA PASS Study Using Registries in Denmark, Germany and Sweden
A study using medical records to evaluate safety issues for the NOCDURNA drug using national register data from Denmark and Sweden, and a health care register covering parts of Germany.
- Trial name
- NCT04740645
- Testing
- NOCDURNA Cohort, LUTS Cohort
- Where
- 3 sites in Denmark, Germany and 1 more
- Volunteers
- 1,099,551 people
- Sponsor
- Ferring Pharmaceuticals
Parkinson Disease, Dyskinesia, Drug-Induced
Open-label Safety Study of Dipraglurant (ADX48621) in Patients With Parkinson's Disease Receiving Levodopa-based Therapy
This open-label study is designed to assess the long-term safety and tolerability of dipraglurant in PD patients for up to 52 weeks (at doses of 150-300 mg per day) for patients that have completed an Addex sponsored double-blind…
- Conditions
- Parkinson Disease, Dyskinesia, Drug-Induced, Dyskinesias
- Trial name
- NCT05116813
- Testing
- Dipraglurant
- Where
- 7 sites in United States
- Volunteers
- 17 people
- Sponsor
- Addex Pharma S.A.