| 1 |
NCT03442010 |
Recruiting |
Adverse Drug Events at Emergency Department |
|
- Other: Detection of adverse drug events
|
Observational |
|
- University Hospital, Montpellier
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Number of adverse drug events
- number of variable associated with adverse drug events
|
13453 |
All |
18 Years and older (Adult, Senior) |
NCT03442010 |
RECHMPL18_0095 |
ADEsED |
November 1, 2011 |
November 1, 2018 |
May 1, 2019 |
February 22, 2018 |
February 22, 2018 |
|
- Uhmontpellier
Montpellier, France
|
| 2 |
NCT03272607 |
Recruiting |
Reducing Post-discharge Adverse Drug Events Amongst the Elderly: a Multi-centre Electronic Deprescribing Intervention |
|
- Other: Deprescribing opportunities
|
Interventional |
Not Applicable |
- McGill University Health Center
- Canadian Institutes of Health Research (CIHR)
- University Health Network, Toronto
- (and 5 more...)
|
Other |
- Allocation: Randomized
- Intervention Model: Sequential Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Supportive Care
|
- Adverse Drug Events within 30 days post-discharge (ascertained via telephone interviewer and adjudicated via clinician reviewers)
- In-hospital falls
- Length of stay
- (and 4 more...)
|
8400 |
All |
65 Years and older (Adult, Senior) |
NCT03272607 |
MedSafer
CIHR Application No. 365795 |
|
August 22, 2017 |
July 2019 |
October 2019 |
September 5, 2017 |
September 5, 2017 |
|
- Kingston General Hospital
Kingston, Ontario, Canada - McGill University Health Centre
Montreal, Quebec, Canada
|
| 3 |
NCT03093818 |
Recruiting |
PREemptive Pharmacogenomic Testing for Preventing Adverse Drug REactions |
|
- Other: Pharmacogenomic testing
|
Interventional |
Not Applicable |
- J.J.Swen
- University of Liverpool
- Medical University of Vienna
- (and 14 more...)
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Prevention
|
- Experience of at least one clinically relevant adverse drug reaction which is caused by the drug of inclusion
- Physician and pharmacist adherence to Dutch Pharmacogenomics Working Group guidelines
- Healthcare expenditure related to adverse events
- (and 5 more...)
|
8100 |
All |
18 Years and older (Adult, Senior) |
NCT03093818 |
668353 (U-PGx) |
PREPARE |
March 20, 2017 |
December 2019 |
December 2019 |
March 28, 2017 |
April 18, 2017 |
|
- Medical University of Vienna
Vienna, Austria - University of Patras
Patras, Greece - Centro di Riferimento Oncologico
Aviano, Italy - (and 4 more...)
|
| 4 |
NCT02059044 |
Recruiting |
Information Systems-enabled Outreach Program for Adverse Drug Events |
|
|
Interventional |
Not Applicable |
- Ottawa Hospital Research Institute
- Canadian Institutes of Health Research (CIHR)
- McGill University
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Health Services Research
|
- Failure to persist with medication regimen
- Proportion of patients experiencing an ADE
- Duration of symptoms attributable to the ADE from start to resolution
- (and 4 more...)
|
2200 |
All |
18 Years and older (Adult, Senior) |
NCT02059044 |
20130285
MOP125975 |
ISTOP-ADE |
October 2015 |
June 2019 |
January 2020 |
February 11, 2014 |
February 1, 2018 |
|
- McGill University
Montreal, Quebec, Canada
|
| 5 |
NCT03176342 |
Recruiting |
Drug Patch Tests in Patients With Severe Cutaneous Adverse Reaction to Drugs (SCARs) |
|
|
Interventional |
Not Applicable |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- Prevalence of positive drug patch test results.
- correlation of drug patch test results, ELIspot and lymphocyte transformation test.
|
30 |
All |
18 Years and older (Adult, Senior) |
NCT03176342 |
204/59 |
|
August 4, 2016 |
August 3, 2017 |
August 3, 2017 |
June 5, 2017 |
June 6, 2017 |
|
- Division of Dermatology, Faculty of Medicine, Chulalongkorn University
Bangkok, Thailand
|
| 6 |
NCT03156348 |
Recruiting |
Impact of Clinical Pharmacist on Adverse Drug Events in Older Adults |
- Drug-Related Side Effects and Adverse Reactions
|
- Other: Clinical Pharmacist Care
|
Interventional |
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Prevention
|
- Incidence of Adverse Drug Events at 90 days post discharge
- Adherence measured with Morisky & Green Scale
- Incidence of potentially inappropriate medication
- (and 6 more...)
|
611 |
All |
60 Years and older (Adult, Senior) |
NCT03156348 |
SA14ID0141 |
|
May 2, 2015 |
September 22, 2017 |
December 22, 2017 |
May 17, 2017 |
May 17, 2017 |
|
- Hospital Clínico de la Universidad de Chile
Independencia, Santiago, Chile
|
| 7 |
NCT00414115 |
Recruiting |
National Active Surveillance Network and Pharmacogenomics of Adverse Drug Reactions in Children |
- Adverse Drug Reaction (ADR)
|
|
Observational |
|
- University of British Columbia
- Genome Canada
- Genome British Columbia
- (and 12 more...)
|
Other / Industry |
- Observational Model: Cohort
- Time Perspective: Other
|
- Determine the role of genetic and clinical factors in adverse drug reactions to develop risk mitigation strategies.
|
7000 |
All |
Child, Adult, Senior |
NCT00414115 |
H04-70358
CW Health Centre of BC
W04-0138 |
|
August 2005 |
July 2019 |
July 2019 |
December 21, 2006 |
November 6, 2017 |
|
- Children's and Women's Health Centre of British Columbia
Vancouver, British Columbia, Canada
|
| 8 |
NCT02906657 |
Recruiting |
Medication Reconciliation Using Electronic Pharmaceutical Record: A Multicenter Study in the Hospitalized Elderly |
|
- Other: Medication reconciliation
|
Interventional |
Not Applicable |
- Assistance Publique - Hôpitaux de Paris
- Institut National de la Santé Et de la Recherche Médicale, France
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Health Services Research
|
- Proportion of patients with at least one ADE within the first 30 days of hospital stay.
- Distribution of the severity of adverse drug events
- Proportion of preventable adverse drug events
- (and 3 more...)
|
2000 |
All |
60 Years and older (Adult, Senior) |
NCT02906657 |
K14101 |
CONCIPAGE |
November 2016 |
November 2018 |
December 2018 |
September 20, 2016 |
May 3, 2017 |
|
- Hopital Saint-Antoine
Paris, France
|
| 9 |
NCT03475589 |
Recruiting
New |
Study on the Adverse Drug Reactions (ADRs) of Apatinib and Their Biomarker Correlations |
|
|
Interventional |
Phase 4 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
|
217 |
All |
18 Years and older (Adult, Senior) |
NCT03475589 |
A2018-002 |
|
March 2018 |
December 2019 |
December 2019 |
March 23, 2018 |
March 23, 2018 |
|
- Sun Yat-sen University Cancer Center
GuangZhou, Guangdong, China
|
| 10 |
NCT02297126 |
Recruiting |
A Prospective Trial to Assess Cost and Clinical Outcomes of a Clinical Pharmacogenomic Program |
|
- Device: Pharmacogenetic Intervention Arm (pharmacogenetic testing)
|
Interventional |
Not Applicable |
- Indiana University
- National Human Genome Research Institute (NHGRI)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- Financial impact on the total cost of patient care resulting from implementation of a Pharmacogenetics testing program within a safety-net and Academic healthcare system
- Impact of implementing a Pharmacogenetics program on Clinical Outcomes (incidence and severity of adverse events, frequency of healthcare visits, length of hospital stay, and readmissions) within a safety-net and Academic healthcare system
- Impact of implementing a Pharmacogenetics program on prescribing patterns within a safety-net healthcare system
|
6000 |
All |
18 Years and older (Adult, Senior) |
NCT02297126 |
1401206188
U01HG007762-01 |
INGenious |
January 2015 |
June 2018 |
June 2018 |
November 21, 2014 |
November 20, 2017 |
|
- Eskenazi Health System
Indianapolis, Indiana, United States
|
| 11 |
NCT03369509 |
Recruiting |
Allergic Versus Non Allergic Hypersensitivity Drug Reaction (BdDAllergo) |
- Allergic Hypersensitivity Drug Reaction Versus Non-allergic Hypersensitivity Drug Reaction Cross Reaction
|
|
Observational |
|
- University Hospital, Grenoble
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Allergic Versus Non Allergic Hypersensitivity Drug Reaction
- - To determine the proportion of drugs involved in in allergic hypersensitivity drug reaction for each pharmacotherapeutic class
- immediate allergic hypersensitivity and delayed allergic hypersensitivity on clinical, biological and chronological aspects
- (and 2 more...)
|
1200 |
All |
18 Years and older (Adult, Senior) |
NCT03369509 |
38RC17.038
2017-A00378-45 |
BdDAllergo |
May 29, 2017 |
May 28, 2022 |
May 28, 2022 |
December 12, 2017 |
December 12, 2017 |
|
- UniversityHospitalGrenoble
Grenoble, France
|
| 12 |
NCT03383133 |
Not yet recruiting |
Studies of Sulfur Metabolism in Humans |
- Metabolic Side Effects of Drugs
|
- Drug: SULT Allosteric Inhibition
|
Interventional |
Early Phase 1 |
- Albert Einstein College of Medicine, Inc.
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Acetaminophen and Dehydroepiandrosterone Conjugates
|
1 |
Male |
61 Years to 61 Years (Adult) |
NCT03383133 |
2017-8685 |
|
January 2018 |
March 2018 |
April 2018 |
December 26, 2017 |
December 27, 2017 |
|
|
| 13 |
NCT02374840 |
Not yet recruiting |
Pharmacogenomics Registry to Assess Clinical Utility |
|
|
Observational |
|
- Companion Dx Reference Lab, LLC
|
Industry |
- Observational Model: Cohort
|
- Meaningful Change
- Changes in target drug regimen
- Number of target drug adverse events (TDAE)
- (and 2 more...)
|
340778 |
All |
2 Years and older (Child, Adult, Senior) |
NCT02374840 |
CD-2014-102 |
PREACT |
|
February 2019 |
|
March 2, 2015 |
July 22, 2015 |
|
|
| 14 |
NCT03042286 |
Recruiting |
SAPhIRE Statin Adverse Drug Reaction |
|
|
Observational |
|
- National Heart Centre Singapore
- National University Hospital, Singapore
|
Other |
- Observational Model: Cohort
- Time Perspective: Other
|
- Statin drug and metabolite measurement
- Pharmacogenomics associated with statin
|
1500 |
All |
21 Years to 99 Years (Adult, Senior) |
NCT03042286 |
2014/00856 |
STATIN |
March 2015 |
May 2017 |
May 2017 |
February 3, 2017 |
February 3, 2017 |
|
- National Heart Centre Singapore
Singapore, Singapore
|
| 15 |
NCT03259399 |
Recruiting |
A Pharmacogenomics Study of Enalapril-Induced Adverse Drug Reaction |
- Enalapril Adverse Reaction
- Pharmacogenomics
- Accurate Medication
|
- Genetic: detection of genotype
|
Observational |
|
- Cui Yimin
- Peking University First Hospital
|
Other |
- Observational Model: Cohort
- Time Perspective: Other
|
- Incidence of dry cough
- Genotype detected by next generation sequencing
|
2200 |
All |
18 Years and older (Adult, Senior) |
NCT03259399 |
2016[1238] |
|
August 16, 2017 |
December 2017 |
December 2018 |
August 23, 2017 |
August 24, 2017 |
|
- Peking University First Hospital
Beijing, Beijing, China
|
| 16 |
NCT03261908 |
Not yet recruiting |
A Pharmacogenomics Study of Simvastatin-Induced Adverse Drug Reaction |
- Simvastatin Adverse Reaction
- Pharmacogenomics
- Accurate Medication
|
- Genetic: detection of genotype
|
Observational |
|
- Cui Yimin
- Peking University First Hospital
|
Other |
- Observational Model: Cohort
- Time Perspective: Other
|
- Incidence of hepatic impairment
- Incidence of myopathy
- Genotype detected by next generation sequencing
|
2200 |
All |
18 Years and older (Adult, Senior) |
NCT03261908 |
2016[1237] |
|
August 2017 |
December 2017 |
December 2018 |
August 25, 2017 |
August 25, 2017 |
|
- Peking University First Hospital
Beijing, Beijing, China
|
| 17 |
NCT03312647 |
Recruiting |
Adverse Drug Reactions to Anti-TB Drugs in the Treatment of Latent Tuberculosis Infection |
- Latent Tuberculosis Infection
|
|
Observational |
|
|
Other |
- Observational Model: Case-Control
- Time Perspective: Prospective
|
- The numbers of adverse drug reactions (ADR) during LTBI treatment
- The numbers of severe ADR during LTBI treatment
|
1000 |
All |
19 Years and older (Adult, Senior) |
NCT03312647 |
HYUMC_CM_002 |
|
June 19, 2017 |
May 2018 |
May 2018 |
October 18, 2017 |
October 18, 2017 |
|
- Sang-Heon Kim
Seoul, Korea, Republic of
|
| 18 |
NCT02520570 |
Recruiting |
Post-market Safety Reassessment of Ulinastatin for Injection |
|
|
Observational |
|
- Techpool Bio-Pharma Co., Ltd.
- Center for ADR Monitoring of Guangdong
|
Industry / Other |
- Observational Model: Other
- Time Perspective: Prospective
|
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability
|
10000 |
All |
Child, Adult, Senior |
NCT02520570 |
002/20140709 |
|
August 2014 |
June 2018 |
July 2018 |
August 13, 2015 |
January 17, 2018 |
|
- Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, China
|
| 19 |
NCT02036957 |
Recruiting |
MARY DUOL REPAIR BALM IN THE PREVENTION OR REDUCING ANTINEOPLASIC AGENTS' SKIN TOXICITY |
- Dermatitis, Adverse Drug Reaction
|
- Procedure: BALM ARM
- Procedure: PLACEBO ARM
|
Interventional |
Phase 1
Phase 2 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Prevention
|
- Percentage of patients who develop dermatologic toxicity.
- Need of pharmacological treatment to mitigate toxicity
- Quality of life
- Percentaje of patients who have reduces skin toxicity
|
86 |
Female |
Child, Adult, Senior |
NCT02036957 |
MD-01 |
B-DUOL |
February 2014 |
June 2017 |
June 2017 |
January 15, 2014 |
August 2, 2016 |
|
- University hospital of Araba
Vitoria-Gasteiz, Álava, Spain
|
| 20 |
NCT03270839 |
Recruiting |
Motion Sickness Medications and Vestibular Time Constant |
|
- Drug: Bonine 25Mg Chewable Tablet
- Drug: Kwells
- Drug: Placebo Oral Tablet
|
Interventional |
Phase 4 |
- Medical Corps, Israel Defense Force
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Crossover Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Other
|
- Vestibular Time Constant Change/differential
- Step Velocity Test Gain Change/differential
- Optokinetic After Nystagmus (OKAN) Gain Change/differential
- (and 5 more...)
|
80 |
Male |
18 Years to 40 Years (Adult) |
NCT03270839 |
1723-2016 |
|
June 1, 2017 |
March 1, 2018 |
May 1, 2018 |
September 1, 2017 |
September 1, 2017 |
|
- Israeli Navy Medical Institute
Haifa, Israel
|
| 21 |
NCT03296930 |
Not yet recruiting |
Effect Of DAAs For Treatment Of HCV On Normal Kidney |
- Antiviral Drug Adverse Reaction
|
- Drug: Sofosbuvir 400 MG Oral Tablet,
- Drug: Ombitasvir/paritaprevir/ritonavir
|
Interventional |
Phase 4 |
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Treatment
|
- Effect of the direct acting antiviral agents used for HCV treatment on the function of the normal kidney by measurement of serum creatinine.
|
100 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT03296930 |
DAAs on Normal Kidney |
|
October 1, 2017 |
September 30, 2018 |
October 31, 2018 |
September 29, 2017 |
September 29, 2017 |
|
|
| 22 |
NCT01715584 |
Recruiting |
Is There an Adverse Drug Reaction Between Renin-Angiotensin System Blockade and Inhaled Anesthetics |
|
- Other: Sevoflurane/oxygen/air/nitrous oxide
|
Interventional |
Phase 4 |
- Lawson Health Research Institute
- University of Western Ontario, Canada
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Systemic Vascular Resistance Index (SVRI)
- Heart Rate
- Systolic Blood Pressure
- (and 6 more...)
|
80 |
All |
40 Years and older (Adult, Senior) |
NCT01715584 |
5982 |
|
July 2012 |
December 31, 2019 |
December 31, 2019 |
October 29, 2012 |
August 23, 2017 |
|
- London Health Sciences Centre - Victoria Campus
London, Ontario, Canada
|
| 23 |
NCT03492242 |
Recruiting
New |
Immune CHeckpoint Inhibitors Monitoring of Adverse Drug ReAction |
- Arthritis
- Cancer
- Cardiac Disease
- (and 5 more...)
|
- Drug: Immune checkpoint inhibitor
|
Observational |
|
- Groupe Hospitalier Pitie-Salpetriere
- Institut National de la Santé Et de la Recherche Médicale, France
|
Other |
- Observational Model: Case-Only
- Time Perspective: Cross-Sectional
|
- Adverse drug reactions induced by ICIs and reported in the World Health Organization (WHO) or the Base Nationale de Pharmacovigilance (BNPV)
- Causality assessment of reported adverse drug reaction according to the WHO system
- Description of the type of adverse drug reaction depending on the category of ICIs
- (and 5 more...)
|
1000 |
All |
18 Years and older (Adult, Senior) |
NCT03492242 |
CIC1421-18-06 |
CHIMeRA |
February 1, 2018 |
May 1, 2018 |
May 1, 2018 |
April 10, 2018 |
April 11, 2018 |
|
- AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM.
Paris, France
|
| 24 |
NCT03166241 |
Not yet recruiting |
Serum Interleukin -21 Level in Patients With Severe Adverse Cutaneous Drug Reaction. |
- Adverse Cutaneous Reaction to Alternative Medical Therapy
|
- Diagnostic Test: serum interleukin 21
- Diagnostic Test: Complete Blood Picture
- Diagnostic Test: Liver function test
- (and 3 more...)
|
Interventional |
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- the patients with severe adverse cutaneous drug reaction who show change in serum interleukin 21 before and after therapy
|
30 |
All |
Child, Adult, Senior |
NCT03166241 |
ACDR |
|
July 2017 |
July 2018 |
December 2018 |
May 25, 2017 |
May 25, 2017 |
|
|
| 25 |
NCT03029897 |
Recruiting |
E-reporting of Adverse Drug Reactions by Patients in Relapsing-remitting Multiple Sclerosis |
|
|
Interventional |
Not Applicable |
- University Hospital, Caen
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- number of reports of adverse drug reactions
|
160 |
All |
18 Years and older (Adult, Senior) |
NCT03029897 |
16-135 |
VigiP-SEP |
May 5, 2017 |
July 2018 |
October 2018 |
January 24, 2017 |
January 25, 2018 |
|
|
| 26 |
NCT03420469 |
Not yet recruiting |
Bupropion Stereoselective Disposition and CYP2D6-mediated Drug Interactions in Healthy Volunteers |
- Adverse Effect of Drug Therapy Metabolism Medications (Diagnosis)
|
|
Interventional |
Not Applicable |
- Indiana University
- National Institute of General Medical Sciences (NIGMS)
|
Other / NIH |
- Intervention Model: Sequential Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
|
29 |
All |
18 Years to 55 Years (Adult) |
NCT03420469 |
1R01GM121707-01A1 |
|
June 1, 2018 |
May 1, 2020 |
May 1, 2020 |
February 2, 2018 |
March 14, 2018 |
|
|
| 27 |
NCT03212365 |
Recruiting |
Minimization of Bleeding Related Adverse Drug Events in Plastic & Reconstructive Surgery |
- Venous Thromboembolism
- Deep Venous Thrombosis
- Pulmonary Embolus
- Reconstructive Surgery
|
|
Interventional |
Phase 2 |
- University of Utah
- Stanford University
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Other
|
- Anti-Factor Xa levels
- Number of participants with Venous Thromboembolism Events
- Number of Patients with Bleeding Events
|
270 |
All |
18 Years and older (Adult, Senior) |
NCT03212365 |
100416 |
|
July 3, 2017 |
June 30, 2019 |
September 30, 2019 |
July 11, 2017 |
August 16, 2017 |
|
- Stanford University
Stanford, California, United States - University of Utah
Salt Lake City, Utah, United States
|
| 28 |
NCT03177174 |
Recruiting |
Different Chemotherapy Protocols Combined With Intensity Modulated Radiation Therapy in Patients With Locally Advanced Nasopharyngeal Carcinoma |
- Drug-Related Side Effects and Adverse Reactions
|
- Drug: Cisplatin
- Drug: Docetaxel
|
Interventional |
Not Applicable |
- Luo yanrong
- Chinese PLA General Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- changes in toxic reaction
- over survival
|
150 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT03177174 |
S2017-030-02 |
|
June 12, 2017 |
May 31, 2020 |
June 1, 2020 |
June 6, 2017 |
June 27, 2017 |
|
- Chinese PLA general hospital
Beijing, China
|
| 29 |
NCT02609919 |
Recruiting |
Assessment of Immediate Adverse Reactions From Dotarem in Children Under 2 Years of Age |
- Adverse Reaction to Drug
- Allergic Reaction to Contrast Media
|
|
Observational |
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- number and type of adverse drug events following the administration of gadoteric acid (Gd-DOTA or Dotarem) as well as when these reactions occur
- Image quality
|
200 |
All |
up to 2 Years (Child) |
NCT02609919 |
Dotarem Study
26250 |
|
January 2016 |
October 2018 |
October 2018 |
November 20, 2015 |
November 6, 2017 |
|
- Saint Louis University
Saint Louis, Missouri, United States
|
| 30 |
NCT02689076 |
Recruiting |
Regional Data Exchange to Improve Care for Veterans After Non-VA Hospitalization |
- Patient Readmission
- Adverse Drug Event
- Cost
|
- Other: HIE Notification
- Other: Care transitions intervention
|
Interventional |
Not Applicable |
- VA Office of Research and Development
|
U.S. Fed |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Health Services Research
|
- Hospital readmission
- Scheduled follow-up
- High-risk medication discrepancies
- Care Transitions Measure
|
975 |
All |
65 Years and older (Adult, Senior) |
NCT02689076 |
IIR 14-049 |
|
March 14, 2016 |
July 31, 2019 |
December 31, 2019 |
February 23, 2016 |
December 12, 2017 |
|
- Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana, United States - James J. Peters VA Medical Center, Bronx, NY
Bronx, New York, United States
|
| 31 |
NCT00817375 |
Recruiting |
Pharmacogenomic Study to Predict Antidepressant Responsiveness in Depressed Patients |
- Depression
- Adverse Reaction to Drug
|
- Drug: SSRI treated group
- Drug: non-SSRI treated group
|
Interventional |
Not Applicable |
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Antidepressant Response at 2,4,6 weeks A/E monitoring at 1,2,4,6 weeks
- Biological value at 0 and 6 weeks
|
1000 |
All |
19 Years to 89 Years (Adult, Senior) |
NCT00817375 |
2003-01-12 |
|
February 2003 |
December 2018 |
December 2018 |
January 6, 2009 |
December 31, 2015 |
|
- Samsung Medical Center
Kangnam, Seoul, Korea, Republic of
|
| 32 |
NCT02936934 |
Not yet recruiting |
Comparison of Adverse Drug Reactions Associated for Oxycodone and Morphine in Postoperative Pain After Abdominal Hysterectomy |
|
- Drug: Morphine
- Drug: Oxycodone
|
Interventional |
Phase 4 |
- Hospital Civil de Guadalajara
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Treatment
|
- Adverse drug reactions (questionnaire)
- Postoperative pain (Numeric Pain Rating Scale)
- systemic blood pressure (mmHg) (physiological parameter)
- (and 2 more...)
|
64 |
Female |
30 Years to 55 Years (Adult) |
NCT02936934 |
HospitalCG |
|
October 2016 |
December 2016 |
February 2017 |
October 18, 2016 |
October 18, 2016 |
|
|
| 33 |
NCT03084952 |
Not yet recruiting |
Phase 2 Trial to Evaluate 18-Methoxycoronaridine Efficacy, Safety and Tolerability in Cutaneous Leishmaniasis Patients |
- Leishmaniasis; American, Cutaneous
- Drug Side Effect
|
- Drug: 18-Methoxycoronaridine
- Drug: Glucantime
|
Interventional |
Phase 2 |
- Infan Industria Quimica Farmaceutica Nacional
- Evandro Chagas National Institute of Infectious Disease
|
Industry / Other |
- Allocation: Randomized
- Intervention Model: Sequential Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Lesion Reduction and Re-epithelization - Definitive Cure
- Lesion Reduction and Re-epithelization - Partial Cure
- Clinical Failure
|
52 |
All |
18 Years to 59 Years (Adult) |
NCT03084952 |
HB/F2-002/2016 |
|
November 2017 |
August 2018 |
September 2018 |
March 21, 2017 |
August 18, 2017 |
|
|
| 34 |
NCT02353455 |
Recruiting |
Cells of Monocytic Origin as Surrogate Markers for Individual Drug Effects and Hepatotoxicity |
- Drug-induced Disorder of Liver
- Adverse Reaction to Drug
|
- Procedure: Blood sampling
|
Observational |
|
- Andreas Benesic, MD
- Ludwig-Maximilians - University of Munich
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Reflection of individual drug hepatotoxicity in monocyte derived cells
|
300 |
All |
2 Years and older (Child, Adult, Senior) |
NCT02353455 |
055-13 |
|
March 2013 |
March 2020 |
August 2022 |
February 2, 2015 |
March 6, 2018 |
|
- Liver Center Munich®, Department of Internal Medicine II, LMU University Hospital, Campus Grosshadern
Munich, Bavaria, Germany - Chinese University of Hong Kong
Hong Kong, Hong Kong
|
| 35 |
NCT02559960 |
Recruiting |
Post-marketing Safety Surveillance of Breviscapine Powder-Injection : a Registry Study |
- Adverse Drug Event
- Adverse Drug Reaction
- Chinese Medicine
- Anaphylactic Reaction
|
- Drug: Breviscapine Powder-Injection
|
Observational |
|
- Zhong Wang
- China Academy of Chinese Medical Sciences
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- The incidence of anaphylactic reaction to Breviscapine Powder-Injection
- The incidence of severe adverse events (SAEs) to Breviscapine Powder-Injection
- The incidence of new SAEs to Breviscapine Powder-Injection
- (and 4 more...)
|
20000 |
All |
Child, Adult, Senior |
NCT02559960 |
Dengzhan-V1.0 |
|
September 2015 |
June 2018 |
|
September 25, 2015 |
November 30, 2017 |
|
- The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing, China - The People's Hospital of Zuanjiang District, Chongqing City
Chongqing, Chongqing, China - Mudanjiang City Second People's Hospital
Mudanjiang, Heilongjiang, China - (and 12 more...)
|
| 36 |
NCT03135470 |
Recruiting |
Pain Medication After Ambulatory Surgery |
- Pain, Postoperative
- Medication Adherence
- Adverse Drug Event
|
|
Observational |
|
- Helsinki University Central Hospital
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Medication
- Pain
- Adverse effects
- Sufficiency of pain medication
|
1200 |
All |
18 Years and older (Adult, Senior) |
NCT03135470 |
HUS235/2017 |
|
April 3, 2017 |
December 31, 2019 |
December 31, 2019 |
May 1, 2017 |
May 1, 2017 |
|
- Helsinki University (Central) Hospital, Peijas Hospital
Vantaa, Finland
|
| 37 |
NCT03051880 |
Recruiting |
Preventive Effect of EGF Cream for Cutaneous Adverse Event of EGFR Inhibitors |
- Drug-Related Side Effects and Adverse Reactions
- Epidermal Growth Factor
|
- Drug: Repair Control EGF®
- Drug: Cream without rhEGF
|
Interventional |
Not Applicable |
- The Catholic University of Korea
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- The change of acneiform eruption caused by use of EGFR inhibitor
- the change paronychia caused by use of EGFR inhibitor
- the change of skin hydration
- (and 4 more...)
|
40 |
All |
20 Years and older (Adult, Senior) |
NCT03051880 |
VC16EISE0180 |
|
November 2016 |
December 2017 |
December 2018 |
February 14, 2017 |
February 14, 2017 |
|
- St. Vincent's Hospital
Suwon, Gyeonggi-do, Korea, Republic of
|
| 38 |
NCT03047863 |
Recruiting |
Therapeutic Effect of EGF Cream for Cutaneous Adverse Event of EGFR Inhibitors |
- Drug-Related Side Effects and Adverse Reactions
- Epidermal Growth Factor
|
- Drug: Repair Control EGF®
- Drug: Cream without rhEGF
|
Interventional |
Not Applicable |
- The Catholic University of Korea
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- The change of severity of acneform eruption induced by EGFR inhibitors
- change of skin hydration
- change of sebum production
- (and 3 more...)
|
20 |
All |
20 Years and older (Adult, Senior) |
NCT03047863 |
VC16EISI0179 |
|
November 2016 |
August 2017 |
December 2017 |
February 9, 2017 |
February 10, 2017 |
|
- St. Vincent's Hospital
Suwon, Gyeonggi-do, Korea, Republic of
|
| 39 |
NCT03098680 |
Recruiting |
A Study of the Pharmacokinetic and Pharmacodynamic Responses in Healthy and Altered Human Cardiovascular Systems |
- Drug-Related Side Effects and Adverse Reactions
- Cardiovascular System Disease
|
- Drug: Albuterol Sulfate
- Drug: Nicardipine Hydrochloride
- Drug: Dobutamine Hydrochloride
- (and 4 more...)
|
Interventional |
Phase 1 |
- Cambridge University Hospitals NHS Foundation Trust
- University of Cambridge
- AstraZeneca
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Basic Science
|
- Heart rate
- Peripheral blood pressure
- Central blood pressure
- (and 7 more...)
|
32 |
Male |
18 Years and older (Adult, Senior) |
NCT03098680 |
PRIME (A094136) |
PRIME |
April 24, 2017 |
February 29, 2020 |
February 29, 2020 |
April 4, 2017 |
May 3, 2017 |
|
- Addenbrooke's Hospital
Cambridge, Cambridgeshire, United Kingdom
|
| 40 |
NCT02239237 |
Recruiting |
Post-marketing Safety Surveillance of Compound Kuh-seng Injection: a Registry Study |
- Safety Surveillance
- Adverse Drug Events
- Adverse Drug Reactions
- (and 2 more...)
|
- Drug: Compound Kuh-seng Injection
|
Observational |
|
- Zhong Wang
- Shanxi Zhendong pharmaceutical Co. LTD.
- China Academy of Chinese Medical Sciences
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- The incidence of severe adverse reactions (SAR) to the Compound Kuh-seng Injection
- The incidence of adverse drug reactions (ADR) to Compound Kuh-seng Injection
- The incidence of anaphylactic reaction to Compound Kuh-seng Injection
- (and 2 more...)
|
30000 |
All |
Child, Adult, Senior |
NCT02239237 |
Kuh-seng1.0 |
|
September 2014 |
June 2018 |
|
September 12, 2014 |
November 30, 2017 |
|
- HanDan Central Hospital
HanDan, Hebei, China - Handan First Hospital
Handan, Hebei, China - Bai Qiu'en International Peace Hospital
Shijiazhuang, Hebei, China - (and 27 more...)
|
| 41 |
NCT03125603 |
Recruiting |
Side Effects of Anti-PD-(L)-1 and Anti CTLA-A4 in the Non Small Cells Lung Cancer |
- Carcinoma, Non-Small-Cell Lung
- Drug-Related Side Effects and Adverse Reactions
|
- Other: Consultation of the patient's medical files at the hospital
|
Observational |
|
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
|
Other |
- Observational Model: Cohort
- Time Perspective: Other
|
- Census and monitor of the side-effects due to the immunotherapy treatment.
|
140 |
All |
20 Years to 85 Years (Adult, Senior) |
NCT03125603 |
2017/15MAR/137 |
|
April 13, 2017 |
December 31, 2018 |
December 31, 2018 |
April 24, 2017 |
April 24, 2017 |
|
- Cliniques Universitaires Saint-Luc
Brussels, Belgium
|
| 42 |
NCT03183908 |
Recruiting |
FLUAD vs. Fluzone High-Dose Study |
- Pain
- Quality of Life
- Injection Site Reaction
- (and 2 more...)
|
- Biological: FLUAD
- Biological: Fluzone High-Dose
|
Interventional |
Phase 4 |
- Duke University
- Centers for Disease Control and Prevention
- Boston Medical Center
|
Other / U.S. Fed |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Injection-Site Pain as Measured by visual analog scale
- Adverse Events of Clinical Interest
- Serious Adverse Events
- (and 9 more...)
|
900 |
All |
65 Years and older (Adult, Senior) |
NCT03183908 |
Pro00083845 |
|
August 28, 2017 |
September 2019 |
September 2019 |
June 12, 2017 |
September 26, 2017 |
|
- Centers for Disease Control and Prevention
Atlanta, Georgia, United States - Boston Medical Center
Boston, Massachusetts, United States - Duke University
Durham, North Carolina, United States
|
| 43 |
NCT03368391 |
Not yet recruiting |
: Pulpal Blood Flow With the Use of Intra-nasal Anesthetic |
- Local Anesthetic Drug Adverse Reaction
- Local Infiltration
- Pulp Disease, Dental
|
- Drug: tetracaine HCl and oxymetazoline HCL
- Drug: 2% Lidocaine with 1:100,000 epinephrine
- Drug: 3% Mepivacaine with 1:100,000 epinephrine
- (and 2 more...)
|
Interventional |
Phase 4 |
- Louisiana State University Health Sciences Center in New Orleans
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Other
|
- Change in Pulpal Blood Flow
- Pulp sensibility
- Pain
- (and 2 more...)
|
25 |
All |
18 Years to 30 Years (Adult) |
NCT03368391 |
9924 |
|
January 3, 2018 |
June 30, 2018 |
June 30, 2018 |
December 11, 2017 |
December 11, 2017 |
|
|
| 44 |
NCT03251144 |
Recruiting |
Relative Mitochondrial Toxicity of Tenofovir Alafenamide (TAF) vs. Tenofovir Disoproxil Fumarate (TDF) |
- HIV/AIDS
- Antiviral Toxicity
- Antiviral Drug Adverse Reaction
- Mitochondrial Alteration
|
- Drug: Switch to E/C/FTC/TAF daily
|
Interventional |
Phase 1
Phase 2 |
- University of California, Los Angeles
- Gilead Sciences
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Change in mitochondrial function [cellular oxygen consumption (COC)] over 12 months after switch of antiretrovirals.
- Change in mitochondrial function [membrane potential (Δψm)] over 12 months after switch of antiretrovirals.
- Change in mitochondrial function [mitochondrial reactive oxygen species (mito-ROS)] over 12 months after switch of antiretrovirals.
- (and 2 more...)
|
35 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT03251144 |
CO-US-311-4393 |
UCLACAREMITO |
January 8, 2018 |
January 8, 2020 |
July 31, 2020 |
August 16, 2017 |
August 16, 2017 |
|
- UCLA CARE Center
Los Angeles, California, United States
|
| 45 |
NCT02738047 |
Recruiting |
Reduction of Adverse Drug Events and Readmissions |
- Pharmacogenomic Testing for Medication Management
|
|
Observational |
|
|
Industry |
- Observational Model: Other
- Time Perspective: Other
|
|
280000 |
All |
25 Years and older (Adult, Senior) |
NCT02738047 |
10202016 |
RADAR-PGX |
March 2016 |
March 2019 |
June 2019 |
April 14, 2016 |
May 19, 2017 |
|
- MD@Home
York, Pennsylvania, United States
|
| 46 |
NCT03211208 |
Recruiting |
Assessing Antibiotic Induced Liver Injury for Stratification of Tuberculosis Patients |
- Drug-Induced Liver Injury
- Anti-Tuberculous Drug Reaction
- Tuberculosis
|
|
Observational |
|
- University of Edinburgh
- NHS Lothian
|
Other |
- Observational Model: Case-Control
- Time Perspective: Prospective
|
- Anti-tuberculosis drug-induced liver injury
|
540 |
All |
16 Years to 85 Years (Child, Adult, Senior) |
NCT03211208 |
AC16145 |
ALISTER |
May 22, 2017 |
April 2020 |
April 2020 |
July 7, 2017 |
July 7, 2017 |
|
- Royal Infirmary Edinburgh
Edinburgh, United Kingdom
|
| 47 |
NCT03071133 |
Recruiting |
Real-world Incidence Proportion of Hepatic Toxicity and All Adverse Drug Reactions (ADRs) in Japanese Patients Receiving Daclatasvir (DCV) Trio Therapy |
|
|
Observational |
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Incidence of Aspartate Aminotransferase (AST) elevation
- Incidence of Alanine Aminotransferase (ALT) elevation
- Incidence of Total Bilirubin (tBili) elevation
- (and 4 more...)
|
1000 |
All |
Child, Adult, Senior |
NCT03071133 |
AI443-144 |
|
February 27, 2017 |
November 20, 2019 |
November 20, 2019 |
March 6, 2017 |
December 13, 2017 |
|
- Local Institution
Tokyo, Japan
|
| 48 |
NCT03451734 |
Recruiting |
Individualized Optimal Therapy of Antipsychotics |
- Schizophrenia
- Efficacy
- Adverse Drug Effect of Antipsychotics and Neuroleptics
- Individualed Opitmal Therapy
|
- Drug: Olanzapine
- Drug: Risperidone
- Drug: Aripiprazole
- (and 3 more...)
|
Observational |
|
- Central South University
- Xiangya Hospital of Central South University
- Shanghai Mental Health Center
- (and 18 more...)
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Positive And Negative Syndrome Scale (PANSS)
- Clinical Global Impressions(CGI)
- Global Assessment Function(GAF)
- MATRICS Consensus Cognitive Battery (MCCB) composite score
|
3600 |
All |
17 Years to 65 Years (Child, Adult) |
NCT03451734 |
2016YFC1306900 |
|
December 9, 2016 |
October 1, 2018 |
December 31, 2020 |
March 2, 2018 |
March 2, 2018 |
|
- Mental Health Institute of 2nd Xiangya Hospital,CSU
Changsha, Hunan, China
|
| 49 |
NCT03338725 |
Recruiting |
Effect and Associated Factors of the Clinical Pharmacy Model in the Incidence of Medical Errors |
- Pharmaceutical Services
- Medication Errors
- Drug-Related Side Effects and Adverse Reactions
- Outcome Assessment (Health Care)
|
- Other: Clinical pharmacy model
|
Interventional |
Not Applicable |
- Universidad de Antioquia
- Hospital Pablo Tobón Uribe
|
Other |
- Allocation: Randomized
- Intervention Model: Sequential Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Health Services Research
|
- The probability of developing medication errors over a certain period of time and recommendations to avoid such errors.
- Problems related with the pharmacotherapy
- Factors that contribute to the occurrence of process and outcomes problems
- (and 2 more...)
|
720 |
All |
Child, Adult, Senior |
NCT03338725 |
0016052017JG |
EACPharModel |
February 1, 2018 |
January 30, 2019 |
November 1, 2019 |
November 9, 2017 |
February 9, 2018 |
|
- Hospital Pablo Tobon Uribe
Medellin, Antioquia, Colombia
|
| 50 |
NCT03501108 |
Recruiting
New |
Discontinuation of Long-term Medications in Older People Entering Nursing Home Care |
- Polypharmacy
- Frail Elderly Syndrome
- Inappropriate Prescribing
- Drug-Related Side Effects and Adverse Reactions
|
- Other: STOPPFrail deprescribing criteria
|
Interventional |
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Prevention
|
- Change in the Number of medications taken by participants from randomization to 3 months post- randomization
- Change in the number of patients prescribed neuroleptic antipsychotic medications from randomization to 3 months post randomization
- Number of patients transferred to emergency department since randomization
- (and 7 more...)
|
160 |
All |
75 Years and older (Senior) |
NCT03501108 |
1767 |
STOPPFrail |
March 27, 2018 |
June 30, 2019 |
June 30, 2019 |
April 17, 2018 |
April 17, 2018 |
|
- Cork University Hospital
Cork, Munster, Ireland
|
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