Clinical trials: A
NTM Lung Infection Due to MAC
Open-label Safety Extension Study Assessing Safety and Tolerability of LAI in Patients Who Participated in Study INS-212
This is an open-label safety extension study to assess the safety and tolerability of once daily dosing of 590 mg Liposomal Amikacin for Inhalation (LAI) added to a multi-drug regimen in participants with nontuberculous…
- Trial name
- NCT02628600
- Testing
- LAI 590 mg, Multi-drug regimen
- Volunteers
- 163 people
- Sponsor
- Insmed Incorporated
Hepatic Insufficiency
The Influence of Hepatic Insufficiency on the Pharmacokinetics of Elbasvir (MK-8742) (MK-8742-009)
The purpose of this study is to evaluate the pharmacokinetics (PK) profile of elbasvir (MK-8742) after a single dose to participants with mild, moderate, or severe hepatic insufficiency compared with healthy controls.
- Trial name
- NCT01797536
- Testing
- Elbasvir
- Where
- 2 sites in United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Influenza
2010-2011 Trivalent Influenza Vaccine (TIV) in Pregnant Women
The purpose of this study is to see how much antibody (proteins produced by the immune system that help fight infections) the body makes after getting a flu vaccine.
- Trial name
- NCT01173211
- Testing
- Trivalent inactivated influenza vaccine
- Where
- 5 sites in United States
- Volunteers
- 183 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Homozygous Familial Hypercholesterolemia
A Study of ALN-PCSSC in Participants With Homozygous Familial Hypercholesterolemia (HoFH)
The purpose of this study is to assess the safety, tolerability, and efficacy of ALN-PCSSC in participants with homozygous familial hypercholesterolemia.
- Trial name
- ORION-2 (NCT02963311)
- Testing
- ALN-PCSSC, Standard of Care
- Where
- 3 sites in United States, Netherlands and 1 more
- Volunteers
- 9 people
- Sponsor
- The Medicines Company
Contraception
Study of the Contraceptive Efficacy and Safety of a NOMAC-E2 Combined Oral Contraceptive (COC)(P06448)
The purpose of this study was to assess the contraceptive efficacy of a nomegestrol acetate + 17ß-estradiol (NOMAC-E2) combined oral contraceptive (COC) in healthy, sexually-active American women at risk for pregnancy.
- Trial name
- NCT01656434
- Testing
- NOMAC-E2, NETA-EE, ethinylestradiol (EE)
- Volunteers
- 3,173 people, healthy volunteers welcome
- Sponsor
- Organon and Co
Cerebral Hemorrhage, Brain Hemorrhage
MIND: Artemis in the Removal of Intracerebral Hemorrhage
The primary objective of this multicenter randomized controlled study is to compare the safety and efficacy of minimally invasive hematoma evacuation with the Artemis Neuro Evacuation Device to best medical management for the…
- Conditions
- Cerebral Hemorrhage, Brain Hemorrhage, Cerebral Parenchymal Hemorrhage, Intracerebral Hemorrhage
- Trial name
- NCT03342664
- Testing
- Artemis + Medical Management, Best Medical Management Alone (MM)
- Where
- 33 sites in United States, Austria and 2 more
- Volunteers
- 236 people
- Sponsor
- Penumbra Inc.
Episodic Migraine
Study of Efficacy and Safety of AMG 334 in Adult Episodic Migraine Patients
This study is to evaluate the efficacy and safety of AMG334 in adult patients with episodic migraine
- Trial name
- EMPOwER (NCT03333109)
- Testing
- Erenumab
- Where
- 81 sites in Argentina, India and 9 more
- Volunteers
- 900 people
- Sponsor
- Novartis Pharmaceuticals
Rheumatoid Arthritis
An Observational Study of RoActemra/Actemra (Tocilizumab) in Monotherapy in Patients With Rheumatoid Arthritis
This multicenter observational study will evaluate the use of RoActemra/Actemra (tocilizumab) in monotherapy in patients with active moderate to severe rheumatoid arthritis unable to use methotrexate.
- Trial name
- NCT01669902
- Where
- 26 sites in Denmark, Norway and 1 more
- Volunteers
- 107 people
- Sponsor
- Hoffmann-La Roche
Chronic Lymphocytic Leukemia (CLL)
A Study Evaluating the Impact of Venetoclax on the Quality of Life for Subjects With Relapsed (Your Cancer Has Come Back) or Refractory (no Response to Previous Cancer Treatments) Chronic Lymphocytic Leukemia (CLL) While Receiving Venetoclax Monotherapy (a Single Agent).
The purpose of this open-label, single-arm study was to evaluate the impact of venetoclax on the quality of life of participants including those with with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL; a type of…
- Trial name
- VENICE II (NCT02980731)
- Testing
- Venetoclax
- Where
- 33 sites in Argentina, Australia and 8 more
- Volunteers
- 210 people
- Sponsor
- AbbVie
Head and Neck Cancer, Radiation Toxicity
Salivary Gland Surgery Before Radiation Therapy in Preventing Radiation-Caused Xerostomia in Patients With Head and Neck Cancer
RATIONALE: Moving a salivary gland out of the area that will undergo radiation therapy may protect the gland from side effects of radiation therapy and may prevent xerostomia (dry mouth).
- Conditions
- Head and Neck Cancer, Radiation Toxicity, Xerostomia
- Trial name
- NCT00068237
- Testing
- salivary gland transfer, Post-operative radiation therapy
- Where
- 12 sites in United States, Canada
- Volunteers
- 49 people
- Sponsor
- Radiation Therapy Oncology Group
Rheumatoid Arthritis
Development of a Normative Database for Rheumatoid Arthritis (RA) Imaging With Tc99m Tilmanocept
This study will establish a normative database of Tilmanocept Uptake Values (TUVjoint) in healthy controls age-matched to the RA population.
- Trial name
- NCT04947137
- Testing
- Tc99m tilmanocept
- Where
- 7 sites in United States
- Volunteers
- 134 people, healthy volunteers welcome
- Sponsor
- Navidea Biopharmaceuticals
Multiple Myeloma
Study Evaluating Safety, Tolerability and Clinical Activity of GSK2857916 in Combination With Pembrolizumab in Subjects With Relapsed/Refractory Multiple Myeloma (RRMM)
This is a phase I/II, single arm, open label, two-part study that will assess safety, tolerability and clinical activity of GSK2857916 given in combination with a programmed cell death-1 (PD-1) inhibitor pembrolizumab in subjects…
- Trial name
- DREAMM 4 (NCT03848845)
- Testing
- belantamab mafodotin, Pembrolizumab
- Where
- 12 sites in United States, Canada and 2 more
- Volunteers
- 41 people
- Sponsor
- GlaxoSmithKline
Multiple Sclerosis
A 12 Week Randomized Open Label Parallel Group Multicenter Study to Evaluate Bioequivalence of 20 mg Subcutaneous Ofatumumab Injected by Pre-filled Syringe or Autoinjector in Adult RMS Patients
The primary purpose of this study is to demonstrate pharmacokinetic bioequivalence of ofatumumab injected by Pre-filled Syringe (PFS) versus Auto-Injector (AI) devices and thereby establish a bridge between the ongoing Phase 3…
- Trial name
- NCT03560739
- Testing
- ofatumumab with PRF, ofatumumab with AI
- Where
- 41 sites in United States, Austria and 7 more
- Volunteers
- 284 people
- Sponsor
- Novartis Pharmaceuticals
Seborrheic Keratosis
A Randomized, Double-Blind, Vehicle-Controlled Study in Subjects With Seborrheic Keratosis
This is a randomized, double-blind, vehicle-controlled, parallel group study.
- Trial name
- SK (NCT02667275)
- Testing
- A-101 Solution, Vehicle Solution
- Where
- United States
- Volunteers
- 487 people
- Sponsor
- Aclaris Therapeutics, Inc.
Post-operative Pain
Buprenorphine Sublingual Spray for the Treatment of Moderate to Severe Pain
This is a phase 3, multicenter, randomized, double-blind, multiple-dose, parallel-group, placebo-controlled study to evaluate the safety and efficacy of up to 3 dosing regimens of Buprenorphine Sublingual (under the tongue) Spray…
- Trial name
- NCT02310581
- Testing
- Buprenorphine Sublingual Spray
- Where
- 3 sites in United States
- Volunteers
- 40 people
- Sponsor
- INSYS Therapeutics Inc
HIV Infections
The Safety and Immunogenicity of a Potential HIV Vaccine
The potential HIV vaccine has two components: a protein immunogen based on the coat protein of HIV; and an adjuvant which enhances the vaccinee's response to the immunogen.
- Trial name
- NCT01966900
- Testing
- CN54gp140 mixed with GLA-AF
- Where
- United Kingdom
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Imperial College London
Postural Orthostatic Tachycardia Syndrome
Efficacy and Safety Study of Efgartigimod in Adults With Post-COVID-19 POTS
The study aims to investigate the safety, tolerability, efficacy, pharmacodynamics (PD), pharmacokinetics (PK), and immunogenicity of efgartigimod compared to placebo in participants with post-COVID-19 postural orthostatic…
- Trial name
- POTS (NCT05633407)
- Testing
- Efgartigimod
- Where
- 11 sites in United States
- Volunteers
- 53 people
- Sponsor
- argenx
Cystic Fibrosis
Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis (CF) Patients With Pseudomonas Aeruginosa (PA)
The purpose of this study was to evaluate the safety and efficacy of multiple courses of AZLI in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).
- Trial name
- AIR-CF3 (NCT00128492)
- Testing
- AZLI 75 mg two times a day (BID)/ three times a day (TID)
- Where
- 65 sites in United States, Australia and 2 more
- Volunteers
- 274 people
- Sponsor
- Gilead Sciences
Fibrodysplasia Ossificans Progressiva
In-Home Evaluation of Episodic Administration of Palovarotene in Fibrodysplasia Ossificans Progressiva (FOP) Subjects
Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by painful, recurrent episodes of soft tissue swelling (flare-ups) that result in abnormal bone formation (heterotopic ossification…
- Trial name
- NCT02521792
- Testing
- Palovarotene
- Where
- 2 sites in United States
- Volunteers
- 6 people
- Sponsor
- Clementia Pharmaceuticals Inc.
Gastric Adenocarcinoma, Esophageal Adenocarcinoma
Trial of mFOLFOX6 + Trastuzumab + Avelumab in Gastric and Esophageal Adenocarcinomas
The initial intent of the study was to be a multi-center single-arm open-label Simon's two-stage Phase II clinical trial of first-line mFOLFOX6 + trastuzumab + avelumab in metastatic HER2-amplified gastric and esophageal…
- Conditions
- Gastric Adenocarcinoma, Esophageal Adenocarcinoma, Metastasis, HER-2 Gene Amplification
- Trial name
- NCT03783936
- Testing
- Oxaliplatin, Leucovorin, 5 fluorouracil
- Where
- 7 sites in United States
- Volunteers
- 18 people
- Sponsor
- Ashwin Somasundaram
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