Clinical trials: sponsored by Radboud University Medical Center
Hiv
Study on PhArmacokinetics of First liNe Antiretrovirals in Healthy Breastfeeding Volunteers
No to little data exists on penetration of antiretroviral drugs in breastmilk. Too high concentrations may lead to infant toxicity and too low concentrations may lead to development of resistance in case the infant inadvertently…
- Trial name
- PANNA-B PK (NCT05648201)
- Testing
- Doravirine 100Mg Tab, Biktarvy 50/200/25 Tab
- Where
- Netherlands
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
Covid19, Severe Acute Respiratory Syndrome
Safety and Tolerability of COVID-19 Vaccine (ABNCoV2)
This phase 1 trial aims to assess the safety and tolerability of two doses of ABNCoV2, formulated with and without the adjuvant MF59, in healthy adult volunteers and to identify the dosage and formulation that optimizes the…
- Conditions
- Covid19, Severe Acute Respiratory Syndrome, SARS-CoV-2 Infection
- Trial name
- COUGH-1 (NCT04839146)
- Testing
- ABNCoV2 Vaccine
- Where
- Netherlands
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
Parkinson Disease, COPD
The ADAPT-study: Measuring Physical Performance Using Wearable Sensors in Parkinson's Disease and COPD (ADAPT)
The aim of this study is to investigate whether a smartwatch can measure the physical capacity of patients with Parkinson's Disease and COPD in the physiotherapy practice and at home.
- Trial name
- ADAPT (NCT05756075)
- Testing
- Aerobic exercise training
- Where
- 28 sites in Netherlands
- Volunteers
- 154 people
- Sponsor
- Radboud University Medical Center
Malaria, Malaria,Falciparum
Safety and Efficacy of R0.6C Vaccine
This is a first-in-human phase I, open-label, single-site, dose escalation study to determine the safety, tolerability and Plasmodium falciparum transmission reducing activity of the R0.6C vaccine in two different adjuvant…
- Trial name
- STOP-TRANS (NCT04862416)
- Testing
- R0.6C transmission blocking vaccine
- Where
- Netherlands
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
Quality of Life, Postoperative Complications
Low Pressure Pneumoperitoneum and Deep Neuromuscular Block vs. Standard During RARP to Improve Quality of Recovery; a Randomized Controlled Study.
Intra-abdominal pressure (IAP) needed to create sufficient workspace during laparoscopic surgery affects the surrounding organs with ischemia-reperfusion injury and a systemic immune response.
- Conditions
- Quality of Life, Postoperative Complications, Acute Pain, Immune System Tolerance
- Trial name
- RECOVER-2 (NCT04250883)
- Testing
- Low intra-abdominal pressure, Deep neuromuscular blockade (NMB), Standard intra-abdominal pressure
- Where
- Netherlands
- Volunteers
- 97 people
- Sponsor
- Radboud University Medical Center
Depressive Disorder, Major
Mindfulness Based Cognitive Therapy for Recurrent Depression
The purpose of this study is to investigate the effectiveness and possible mediating factors of Mindfulness Based Cognitive Therapy (MBCT) for recurrent depression.
- Trial name
- NCT01038765
- Testing
- Mindfulness Based Cognitive Therapy
- Where
- Netherlands
- Volunteers
- 220 people
- Sponsor
- Radboud University Medical Center
Malaria,Falciparum, Controlled Human Malaria Infection
Safety and Efficacy of NF135 CPS Immunization
This is an open label, randomized, controlled clinical trial. The primary aim of this project is to determine the safety and tolerability of NF135.C10 sporozoite immunization under chemoprophylaxis against homologous and…
- Conditions
- Malaria,Falciparum, Controlled Human Malaria Infection, Immunization; Infection
- Trial name
- CPS135 (NCT03813108)
- Testing
- CPS-immunization, malaria challenge infection, P. falciparum NF135.C10, malaria challenge infection, P. falciparum NF54
- Where
- Netherlands
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
Malaria,Falciparum
Safety, Tolerability, and Pharmacokinetics and Pharmacodynamics of TB31F
This phase 1 study aims to assess the safety and tolerability of monoclonal antibody TB31F administered intravenously or subcutaneously at escalating dose levels in healthy, malaria naïve, adults.
- Trial name
- TB31F (NCT04238689)
- Testing
- TB31F
- Where
- Netherlands
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
Malaria,Falciparum, Plasmodium Falciparum
Safety and Protective Efficacy of Pb(PfCS@UIS4)
In the underlying study, a genetically modified P. berghei parasite is used. P. berghei is one of the four Plasmodium species that causes malaria in rodents. The hypothesis is that immunization of humans with P.
- Conditions
- Malaria,Falciparum, Plasmodium Falciparum, Plasmodium Berghei, Controlled Human Malaria Infection (CHMI)
- Trial name
- PbVac (NCT03138096)
- Testing
- Pb(PfCS@UIS4)-infected mosquitoes, Challenge infection P. falciparum
- Where
- 2 sites in Netherlands
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
Parkinson's Disease
Real-PD Trial: Development of Clinical Prognostic Models for Parkinson's Disease
Background: Long-term management of Parkinson's disease (PD) does not reach its full potential due to lack of knowledge about disease progression.
- Trial name
- NCT02474329
- Testing
- Clinical assessment, Fox Insight self-monitoring android app and falls detector
- Where
- Netherlands
- Volunteers
- 304 people
- Sponsor
- Radboud University Medical Center
Q Fever, Fatigue Syndrome, Chronic
The Qure Study: Q-fever Fatigue Syndrome - Response to Treatment
The objective of this study is to assess the efficacy of two treatment strategies for fatigue and disabilities in QFS: long term treatment with doxycycline or cognitive behavioral therapy (CBT).
- Conditions
- Q Fever, Fatigue Syndrome, Chronic, Coxiella Infection
- Trial name
- Qure (NCT01318356)
- Testing
- Cognitive behavioral therapy, Doxycycline
- Where
- Netherlands
- Volunteers
- 156 people
- Sponsor
- Radboud University Medical Center
Malaria,Falciparum, Gametocytes
Controlled Human Malaria Infection Model for Evaluation of Transmission-blocking Interventions - Study 2
This is a single-center, open label study. The primary aim of this project is to develop a controlled human malaria infection transmission model ("CHMI-trans") or "challenge model" to evaluate the capacity of vaccines, biologics…
- Conditions
- Malaria,Falciparum, Gametocytes, Controlled Human Malaria Infection, Transmission
- Trial name
- CHMI-trans2 (NCT03454048)
- Testing
- Piperaquine (low dose), Piperaquine (high dose), Sulfadoxine pyrimethamine
- Where
- Netherlands
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
Chronic Hepatitis c
'Fibrosis in the Lost Hepatitis C Population - Track, Trace and Treat'
Objective: To coordinate active tracing of chronic hepatitis C patients lost to follow-up to inform them about there disease severity and treatment options.
- Trial name
- Track&Trace (NCT03088917)
- Where
- Netherlands
- Volunteers
- 106 people
- Sponsor
- Radboud University Medical Center
Neuromuscular Block, Renal Transplant Donor of Left Kidney
Deep Versus Moderate Muscle Relaxation During Laparoscopic Donor Nephrectomy in Enhancing Postoperative Recovery
Postoperative recovery after live donor nephrectomy (LDN) is largely determined by the consequences of postoperative pain and analgesia consumptions.
- Conditions
- Neuromuscular Block, Renal Transplant Donor of Left Kidney, Renal Transplant Donor of Right Kidney, Surgery
- Trial name
- RELAX (NCT02838134)
- Testing
- Rocuronium, No additional Rocuronium
- Where
- 2 sites in Netherlands
- Volunteers
- 101 people
- Sponsor
- Radboud University Medical Center
Innate Immune Response, Immune Tolerance
The Effects of Preceding LPS Administration on the Fluenz-induced Immune Response
To evaluate the bacterial-viral interactions between LPS and Fluenz as a model for sepsis (bacterial) and Influenza (viral) infections which are common and associated with high mortality rates in the ICU.
- Trial name
- LPS-Fluenz (NCT02642237)
- Testing
- Fluenz, LPS
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
HIV
Effects of Raltegravir Based Regimen on Platelet Reactivity, Platelet-monocyte Aggregation and Immune Activation
Cardiovascular disease (CVD) has emerged as a leading cause of morbidity and mortality in HIVinfected individuals. The precise mechanisms underlying this increased cardiovascular risk remain to be elucidated.
- Trial name
- RAPID (NCT02383355)
- Testing
- Raltegravir, Continuation of own regimen
- Volunteers
- 40 people
- Sponsor
- Radboud University Medical Center
Head and Neck Cancer
Nurse-led Follow-up Care for Head and Neck Cancer Patients
The purpose of this study is to conduct an early evaluation of a nurse-led follow up intervention added to the usual medically oriented follow up care.
- Trial name
- NCT01167179
- Testing
- nurse-led consultation
- Where
- Netherlands
- Volunteers
- 160 people
- Sponsor
- Radboud University Medical Center
Pelvic Organ Prolapse
Performance of Tension Free Vaginal Mesh (Prolift) Versus Conventional Vaginal Prolapse Surgery in Recurrent Prolapse.
Pelvic organ prolapse is a common problem. A lot of women have surgery for prolapse. The recurrence rate op pelvic organ prolapse after surgical treatment is high.
- Trial name
- NCT00372190
- Testing
- Tensionfree vaginal mesh kit (Prolift), classic vaginal prolapse surgery (fascia plication)
- Where
- 13 sites in Netherlands
- Volunteers
- 194 people
- Sponsor
- Radboud University Medical Center
Innate Immune Response
γ-irradiated BCG to Train Innate Immunity
Rationale: The live attenuated Bacillus Calmette-Guerin (BCG) vaccine protects against extrapulmonary infection with Mycobacterium tuberculosis and leprosy.
- Trial name
- NCT02259608
- Testing
- BCG vaccine SSI
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
Cancer
Hd-bronchoscopy, Comparison to Standard White Light and Autofluorescence Bronchoscopy
Through technological improvement a new technique has become available in the form of high-definition (HD-) bronchoscopy. Current normal video white light bronchoscopy is the standard, and video-autofluorescence bronchoscopy…
- Trial name
- NCT01676012
- Where
- Netherlands
- Volunteers
- 32 people
- Sponsor
- Radboud University Medical Center