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NCT ID: NCT02940808 Completed - Caffeine Clinical Trials

Effects of Caffeine on EEG Theta/Beta Ratio and Cognitive Control

Start date: May 2016
Phase: N/A
Study type: Interventional

Cognitive control driven by the prefrontal cortex (PFC) of the brain is thought to be important for goal-directed control over stimulus-driven processes. EEG-measured spontaneous theta/beta ratio (TBR) may potentially be used as an electrophysiological marker for this PFC-mediated cognitive control. In the present study the investigators further examine TBR as an electrophysiological marker for cognitive control, by administering caffeine to forty healthy female participants. After a first training session, participants will visit the lab twice in separate weeks, during which they will orally consume one capsule containing 200mg of caffeine, and one capsule containing a placebo substance (double-blind and random order of administration). EEG will be measured before and after capsule consumption, and cognitive control tasks will be administered after capsule consumption. Generally, the investigators expect that caffeine will decrease TBR and thereby increase cognitive control. Additionally, the investigators expect that individual differences in baseline frontal (reflected by TBR) and central dopaminergic (reflected by spontaneously-measured eye-blink rates; EBR) activity will moderate the relationship between caffeine and cognitive control. Furthermore, the effects of caffeine on specifically hypervigilance for threatening distractors (taking into account a possible moderating role of trait anxiety) were examined as a separate research question.

NCT ID: NCT02939183 Completed - Clinical trials for Relapsed or Refractory Multiple Myeloma

Phase 1b Study Evaluating OPomD in Relapsed or Refractory Multiple Myeloma

INTREPID-1
Start date: January 17, 2017
Phase: Phase 1
Study type: Interventional

A study evaluating two new formulations of oprozomib plus pomalidomide and dexamethasone in patients with relapsed refractory multiple myeloma.

NCT ID: NCT02938520 Active, not recruiting - HIV Infections Clinical Trials

Study to Evaluate the Efficacy, Safety, and Tolerability of Long-acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch From an Integrase Inhibitor in HIV-1 Infected Therapy Naive Participants

Start date: October 27, 2016
Phase: Phase 3
Study type: Interventional

The First Long-Acting Injectable Regimen (FLAIR) study is being conducted to establish if human immunodeficiency virus type-1 (HIV-1) infected adult participants whose virus is virologically suppressed on an integrase inhibitor single tablet regimen (INI STR) will remain suppressed after switching to a two-drug intramuscular (IM) long-acting (LA) regimen of cabotegravir (CAB) and rilpivirine (RPV). In this study, the INI STR will be limited to abacavir/dolutegravir/lamivudine (ABC/DTG/3TC). FLAIR is a Phase 3, multi-phase, randomized, open label, active-controlled, multicenter, parallel-group, non-inferiority study in HIV-1, anti-retroviral therapy (ART)-naïve adult participants. This study is designed to demonstrate the non-inferior antiviral activity of switching to a two drug CAB LA 400 mg + RPV LA 600 mg regimen every 4 weeks (Q4W: monthly) compared to remaining on ABC/DTG/3TC over 48 weeks (4 weeks oral CAB + RPV, 44 weeks LA therapy). Participants who are HLA-B*5701 positive at Screening may enroll into the study and receive DTG plus a non-abacavir containing dual nucleoside reverse transcriptase inhibitor (NRTI) regimen. Eligible participants will enroll into the Induction Phase of the study and receive ABC/DTG/3TC for 20 weeks (Week [-20] to Day 1). Participants who have an HIV 1 ribose nucleic acid (RNA) <50 copies per milliliter (c/mL) at Week (-4) will be randomized (1:1) into the Maintenance Phase at Day 1 to either continue ABC/DTG/3TC or to discontinue ABC/DTG/3TC and begin oral therapy with CAB 30 mg + RPV 25 mg once daily for approximately 4 Weeks, followed by monthly CAB LA + RPV LA injections from visit Week 4b until study completion or withdrawal. Participants who successfully complete Week 100 (without meeting study defined withdrawal criteria and who remain virologically suppressed through Week 96: HIV-1 RNA <50 c/mL) will be given the option to switch to the LA arm in the Extension Phase (using an optional oral lead-in with CAB + RPV) or be withdrawn from the study. Participants will continue to receive injections every 4 weeks during the Extension Phase until CAB LA and RPV LA are either locally approved and commercially available, the participant no longer derives clinical benefit, the participant meets a protocol-defined reason for discontinuation, or until development of either CAB LA or RPV LA is terminated.

NCT ID: NCT02938286 Completed - Clinical trials for Local Anesthesia of the Skin

Fractional Laser Assisted Delivery of Anesthetics III

Start date: March 2016
Phase: Phase 4
Study type: Interventional

The purpose of this study is to compare the effect of pretreatment with two different ablative laser modalities, a CO2 laser and an Er:YAG laser, and to assess the role of laser density in fractional laser assisted topical anesthesia.

NCT ID: NCT02938273 Completed - Clinical trials for Carcinoma, Squamous Cell of Head and Neck

Bioimmunoradiotherapy (Cetuximab/RT/Avelumab)

Start date: February 1, 2017
Phase: Phase 1
Study type: Interventional

This is an open-label phase IB trial with Bioimmunoradiotherapy, i.e. concurrent radiotherapy with intravenous administration of cetuximab and avelumab followed by avelumab maintenance therapy in patients with locally advanced head and neck cancer, unfit for cisplatin.

NCT ID: NCT02938143 Active, not recruiting - Tendinopathy Clinical Trials

Exercise Therapy for Patellar Tendinopathy Evaluated With Advanced UTE-MRI

Start date: January 2017
Phase: N/A
Study type: Interventional

Patellar tendinopathy is a frequent overuse injury that causes pain and impaired performance in jumping athletes. Exercise therapy is considered the best initial treatment option for tendinopathies as clinical improvements in pain and function have been demonstrated. Although painful eccentric exercise protocols have been promoted as standard care based on positive results in early studies, a recent systematic review demonstrated that these are not associated with improved tendon structure and are ineffective when applied in-season. Progressive tendon-loading exercise therapy for patellar tendinopathy constitutes a novel concept in sports medicine. A recent study advocates a progressive 4-stage criteria-based exercise protocol as it results in a less reactive tendon and ability to restore collagen alignment. This protocol consists of progressive isometric, isotonic, plyometric, and sport-specific exercises. Isometric exercises have been shown to reduce pain and decrease motor cortex inhibition of the quadriceps. This approach would enable jumping athletes to resume sports within the limits of pain, with improved muscle function, and sufficient tendon structure re-organization. The diagnostic imaging work-up of patellar tendinopathy typically consists of ultrasound, magnetic resonance imaging (MRI), or a combination of both. Ultrashort echo time (UTE) MRI is an advanced MRI technique, which enables assessment of tissues with short T2-time, such as tendon, the structure of which is invisible on regular MRI. UTE has been shown to quantitatively depict changes in tendon microstructure and therefore allows in-vivo evaluation of tendon regeneration. It is currently unknown whether quantitative UTE MRI parameters change after exercise treatment, are related to clinical symptoms of patellar tendinopathy, have prognostic value for exercise treatment response, and offer additional value over ultrasound

NCT ID: NCT02937883 Completed - Dementia Clinical Trials

Empowerment Intervention for Persons With Young Onset Dementia

Start date: October 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the effects of an empowerment intervention for community-dwelling persons with young onset dementia and their informal caregivers.

NCT ID: NCT02937454 Completed - Heart Failure Clinical Trials

Study to Compare Ferric Carboxymaltose With Placebo in Patients With Acute Heart Failure and Iron Deficiency

Affirm-AHF
Start date: April 3, 2017
Phase: Phase 4
Study type: Interventional

Study to Compare Ferric Carboxymaltose With Placebo in Patients With Acute Heart Failure and Iron Deficiency (Affirm-AHF)

NCT ID: NCT02936778 Completed - Clinical trials for Childhood Asthma With Status Asthmaticus

Status Asthmaticus on the Intensive Care Prospective - STATIC PRO

Start date: August 2016
Phase:
Study type: Observational

This study will prospectively assess the impact and relevance of several risk factors for children with severe acute asthma (SAA) or acute wheeze that have been identified in retrospective studies. Secondary we will assess short-term medical and psychosocial functioning in patient (and parents) admitted to a PICU for SAA/acute wheeze versus a control group admitted to a MC for SAA/acute wheeze.

NCT ID: NCT02936635 Completed - Clinical trials for Amyotrophic Lateral Sclerosis (ALS)

A Study for Patients Who Completed VITALITY-ALS (CY 4031)

VIGOR-ALS
Start date: October 17, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the long-term safety and tolerability of tirasemtiv in patients with ALS who had completed the double-blind placebo-controlled study of tirasemtiv in ALS (CY 4031).