Clinical trials: Acute-Phase Response
SARS-CoV Infection, Covid19
A Study to Evaluate the Efficacy, Immune Response, and Safety of a COVID-19 Vaccine in Adults ≥ 18 Years With a Pediatric Expansion in Adolescents (12 to<18 Years) at Risk for SARS-CoV-2
This is a phase 3, randomized, observer-blinded, placebo-controlled study to evaluate the efficacy, safety, and immunogenicity of SARS-CoV-2 rS with Matrix-M1 adjuvant in adult participants and adolescent participants.
- Trial name
- NCT04611802
- Testing
- SARS-CoV-2 rS/Matrix-M1 Adjuvant (Initial Vaccination Period), SARS-CoV-2 rS/Matrix-M1 Adjuvant (Crossover Vaccination period), SARS-CoV-2 rS/Matrix-M1 Adjuvant (Booster Vaccination)
- Where
- 154 sites in United States, Mexico and 1 more
- Volunteers
- 33,000 people, healthy volunteers welcome
- Sponsor
- Novavax
Cardiogenic Shock, Acute Myocardial Infarction
Clinical Evaluation of NIRSense Tissue Oximetry Sensor Monitoring to Early Detect Cardiogenic Shock
This is a prospective, single-center, observational pilot study of the investigational NIRSense Tissue Oximetry Sensor System (Envello Core), a noninvasive wearable sensor patch that uses near-infrared spectroscopy (NIRS) and…
- Conditions
- Cardiogenic Shock, Acute Myocardial Infarction, Acute Decompensated Heart Failure
- Trial name
- NCT07825363
- Testing
- NIRSense Tissue Oximetry Sensor System
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- NIRSense Inc.
Migraine Disorders, Migraine
Treximet (Sumatriptan/Naproxen Sodium), Formerly Known as Trexima, In The Acute Treatment Of Multiple Migraine Attacks
The purpose of this study is to determine the consistency of response for Treximet (sumatriptan/naproxen sodium), formerly known as Trexima, when treating four acute migraine attacks at the mild pain phase and within 1 hour of…
- Trial name
- NCT00240630
- Testing
- sumatriptan succinate/naproxen sodium
- Where
- 50 sites in United States
- Volunteers
- 646 people
- Sponsor
- GlaxoSmithKline
Coronavirus Disease 2019 (COVID-19) Pneumonia
Phase 3 Study to Evaluate Efficacy and Safety of Lenzilumab in Patients With COVID-19
The primary objective of this study is to assess whether the use of lenzilumab in addition to current standard of care can alleviate the immune-mediated cytokine release syndrome (CRS) and improve ventilator-free survival in…
- Trial name
- NCT04351152
- Testing
- Lenzilumab, Standard of Care
- Where
- 29 sites in United States, Brazil
- Volunteers
- 520 people
- Sponsor
- Humanigen, Inc.
Skin and Subcutaneous Tissue Bacterial Infections
A Study to Assess Objective Endpoint Measurements of Response in Bacterial Skin Infections
The purpose of this study is to compare clinical response to the measurement techniques of several objective measures of clinical efficacy for use in future ABSSSI (Acute Bacterial Skin and Skin Structure Infection) clinical…
- Trial name
- NCT01283581
- Testing
- Delafloxacin, Linezolid, Vancomycin
- Where
- 31 sites in United States
- Volunteers
- 256 people
- Sponsor
- Melinta Therapeutics, Inc.
Opioid Dependence, Acute Opioid Withdrawal Syndrome
Efficacy, Safety and Dose-Response Study Followed by Open-Label Study of Lofexidine Treatment of Opioid Withdrawal
The purpose of this study is to look at the efficacy and safety for lofexidine hydrochloride, an alpha-2 adrenergic agonist under development for the treatment of acute withdrawal from short-acting opioids.
- Trial name
- NCT01863186
- Testing
- Lofexidine HCl, Open Label Lofexidine HCL
- Where
- 18 sites in United States
- Volunteers
- 603 people
- Sponsor
- USWM, LLC (dba US WorldMeds)
SARS-CoV-2 Infection, Coronavirus Disease 2019 (COVID-19)
COVID-19: A Trial Studying the SARS-CoV-2 mRNA Vaccine CVnCoV to Learn About the Immune Response, the Safety, and the Degree of Typical Vaccination Reactions When CVnCoV is Given at the Same Time as a Flu Vaccine Compared to When the Vaccines Are Separately Given in Adults 60 Years of Age and Older
The most recently discovered coronavirus (SARS-CoV-2) may cause illness in humans ranging from the common cold to serious illness, also referred to as Coronavirus disease 2019 (COVID-19).
- Trial name
- CV-NCOV-011 (NCT04848467)
- Testing
- SARS-CoV-2 mRNA Vaccine (CVnCoV), Quadrivalent influenza vaccine (QIV)
- Volunteers
- healthy volunteers welcome
- Sponsor
- Bayer
Acute Renal Failure
Open-Label Study To Evaluate the Safety and Efficacy of the Renal Assist Device In Patients With Acute Renal Failure
Although conventional hemodialysis removes waste products and corrects fluid imbalance, it does not replace critical absorptive, metabolic, endocrine, and immunologic functions performed by healthy renal tubule cells.
- Trial name
- NCT00511407
- Testing
- Renal tubule assist device
- Where
- 13 sites in United States
- Volunteers
- 58 people
- Sponsor
- RenaMed Biologics
Sepsis, Acute Kidney Injury
A Study Looking at the Use of Biomarkers to Provide Early Indication of Acute Kidney Injury in Patients With Sepsis (Limiting AKI Progression In Sepsis)
Biomarkers that provide an early indicator of kidney stress could be useful in clinical practice to detect silent episodes of acute kidney injury (AKI) or for early identification of subjects at risk of AKI.
- Conditions
- Sepsis, Acute Kidney Injury, Septic Shock
- Trial name
- LAPIS (NCT04434209)
- Testing
- Subject management guided by NephroCheck® test, Standard of Care
- Where
- 12 sites in United States, Belgium and 2 more
- Volunteers
- 19 people
- Sponsor
- BioMérieux
Uncomplicated Urinary Tract Infections, Urinary Tract Infections
Safety, Tolerability, Pharmacokinetic and Microbiological Investigation of GSK3882347 in Female Participants With Urinary Tract Infections
This phase 1b study is a double-blind, double-dummy, nitrofurantoin-controlled study designed to evaluate microbiological response at the test of cure (ToC) visit along with safety, tolerability and pharmacokinetic (PK) response…
- Trial name
- NCT05138822
- Testing
- GSK3882347, Nitrofurantoin
- Where
- 15 sites in United States
- Volunteers
- 140 people
- Sponsor
- GlaxoSmithKline
Leukemia
A Study of Imatinib and Nilotinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase
The extension study followed the core study CAMN107ECN02 (NCT01275196). which is an open-label, two armed study. All patients enrolled in this extension study were able to benefit from the treatment given in CAMN107ECN02 per…
- Trial name
- NCT02272777
- Testing
- Imatinib, Nilotinib
- Where
- 12 sites in China
- Volunteers
- 225 people
- Sponsor
- Novartis Pharmaceuticals
Acute Bipolar Mania
Study of the Broad Clinical Benefit for Seroquel XR With Flexible Dose as an add-on Therapy in the Treatment of Acute Bipolar Mania Patients With Partial Response to Current Therapy
The primary objective of this study is to evaluate the broad clinical benefit of dosing Seroquel XR with flexible in the treatment of acute bipolar mania patients with partial response to existing therapy.
- Trial name
- RELEASE (NCT01128114)
- Testing
- Quetiapine fumarate (Seroquel XR)
- Where
- 11 sites in South Korea
- Volunteers
- 32 people
- Sponsor
- AstraZeneca
Opioid Withdrawal
Dexmedetomidine in the Treatment of Symptoms Of Acute Opioid Withdrawal
This Phase 1b/2 inpatient study assessed the safety, pharmacokinetics, and early signs of efficacy of escalating doses of BXCL501 versus placebo following discontinuation of morphine maintenance.
- Trial name
- NCT04470050
- Testing
- Dexmedetomidine
- Where
- 3 sites in United States
- Volunteers
- 225 people
- Sponsor
- BioXcel Therapeutics Inc
Respiratory Distress Syndrome, Adult
Evaluation of Safety & Efficacy of BIO-11006 Inhalation Solution in Patients With ARDS
This Phase IIa pilot study is a placebo controlled, multicenter study to evaluate safety and efficacy of aerosolized BIO-11006 Inhalation Solution in ARDS patients.
- Trial name
- NCT03202394
- Testing
- BIO-11006
- Where
- 5 sites in United States
- Volunteers
- 38 people
- Sponsor
- BioMarck Pharmaceuticals, Ltd.
Acute Kidney Injury Due to Sepsis
Pharmacokinetics and Safety of TIN816 in Patients With Sepsis-associated Acute Kidney Injury
The purpose of this study was to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profile and to evaluate the safety and tolerability of TIN816 in hospitalized adult participants in an intensive care setting with a…
- Trial name
- NCT05507437
- Testing
- TIN816 70 mg lyophilisate powder
- Where
- 7 sites in Belgium, France and 3 more
- Volunteers
- 20 people
- Sponsor
- Novartis Pharmaceuticals
Blast Phase Philadelphia Chromosomes Positive (Ph+) Chronic Myelogenous Leukemia (CML), Philadelphia Chromosome Positive (Ph+) Acute Lymphocytic Leukemia (ALL)
Growth Factor Signature (GFS) Pilot Study (MK0000-098)(COMPLETED)
This study will evaluate a gene expression signature (Growth Factor Signature [GFS]) as a biomarker for response/resistance to BRC-ABL oncogene inhibitors.
- Trial name
- NCT00860535
- Testing
- Comparator: Biomarker evaluation
- Volunteers
- 9 people
- Sponsor
- Merck Sharp & Dohme LLC
Severe COVID-19 Disease
RAPA-501-Allo Therapy of COVID-19-ARDS
The first-in-human Phase 1 study component will evaluate two dose levels of RAPA-501-ALLO off the shelf cells in patients with COVID-19-related ARDS, with key endpoints of safety, biologic and potential disease-modifying effects.
- Trial name
- NCT04482699
- Testing
- RAPA-501-Allo off-the-shelf Therapy of COVID-19
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Rapa Therapeutics LLC
Philadelphia Chromosome Positive (PH+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
A Randomized Phase III Study to Assess the Effect of a Longer Duration of Consolidation Treatment With Nilotinib on TFR in CP CML.
This study aimed to assess the optimal duration of nilotinib 300 mg twice daily (BID) consolidation treatment in patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML), in order that patients remained…
- Trial name
- ENESTPath (NCT01743989)
- Testing
- Nilotinib
- Where
- 208 sites in Austria, Belgium and 19 more
- Volunteers
- 620 people
- Sponsor
- Novartis Pharmaceuticals
Ovarian Serous Adenocarcinoma, Undifferentiated Carcinoma of Ovary
Development of Immunological Assays for the Evaluation of Tumor Antigen Specific Immunity
This study is a clinical study aiming at establishing immunological assays for the qualitative and quantitative evaluation of WT-1, Survivin and HPV16 E7-specific immune responses in cancer patients.
- Conditions
- Ovarian Serous Adenocarcinoma, Undifferentiated Carcinoma of Ovary, Cervical Cancer, Cervical Intraepithelial Neoplasia, Grade 3
- Trial name
- NCT02016833
- Testing
- Blood Sampling
- Where
- Australia
- Volunteers
- 15 people
- Sponsor
- PX Biosolutions
COVID-19
A Study to Evaluate OP-101 (Dendrimer N-acetyl-cysteine) in Severe Coronavirus Disease 2019 (COVID-19) Patients
The primary purpose of Stage-I of this study is to evaluate the safety and tolerability of OP-101 in patients with severe COVID-19 and of Stage 2 of this study is to evaluate the efficacy of OP-101 in patients with severe…
- Trial name
- PRANA (NCT04458298)
- Testing
- OP-101
- Where
- 8 sites in United States
- Volunteers
- 28 people
- Sponsor
- Ashvattha Therapeutics, Inc.