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NCT ID: NCT02454400 Completed - Spinal Stenosis Clinical Trials

Pre-surgery Physiotherapy for Patients With Specific Low Back Pain

PREPARE
Start date: September 2012
Phase: N/A
Study type: Interventional

The aim is to study if pre-surgery physiotherapy improves function, pain and health in patients with specific low back pain scheduled for surgery. Patients are followed over a two year period. A secondary aim is to study what factors predict short and long term outcomes.

NCT ID: NCT02453425 Completed - Acute Kidney Injury Clinical Trials

The Effects of Blood Pressure on Renal Function and Oxygenation in Septic Shock

Start date: May 2011
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate renal effects of 3 different levels of mean arterial pressure in early case of septic shock. In 8 patients diagnosed with early septic shock, we will adjust mean arterial pressure (MAP) to three different levels, using norepinephrine. At each level of MAP, central and renal hemodynamics and oxygenation states will be measured. Analysis will be made to describe the pathophysiology at MAP 75 mmHg, and then to evaluate at which MAP renal function and oxygenation is least affected negatively.

NCT ID: NCT02453048 Completed - Pertussis Clinical Trials

Study of BPZE1 (High Dose) Nasal Live Attenuated B. Pertussis Vaccine

Start date: September 2015
Phase: Phase 1
Study type: Interventional

This study evaluates the safety and immunogenicity of a higher dose formulation of a new live attenuated vaccine, BPZE1, intended to prevent Bordetella pertussis nasopharyngeal colonization and pertussis disease, and investigates whether higher doses of BPZE1 induce the live vaccine to colonize subjects' nasopharynx. The study is a Phase Ib (high dose), single centre, dose-escalating, placebo-controlled study of the live attenuated B. pertussis strain BPZE1 given as a single intranasal dose to healthy adult volunteer.

NCT ID: NCT02452372 Completed - Clinical trials for Acute Intermittent Porphyria

A Phase 1 Study of Givosiran (ALN-AS1) in Patients With Acute Intermittent Porphyria (AIP)

Start date: May 6, 2015
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of givosiran (ALN-AS1) in AIP patients as well as to characterize pharmacokinetics (PK) and pharmacodynamics (PD) of ALN-AS1 in AIP patients.

NCT ID: NCT02450097 Completed - Obesity Clinical Trials

Metabolic and Hormonal Effects of 5:2 Intermittent Fasting

Start date: December 2013
Phase: N/A
Study type: Interventional

The aim of the present study is to investigate in subjects with and without type 2 diabetes the effect of calorie restriction (CR) according to the 5:2 method for 6 months (every week two days caloric fasting with 500 calories for women and 600 calories for men and five days of normal caloric intake) on risk markers for cardiovascular disease and certain cancers (hyperinsulinemia, insulin resistance, IGF-1, IGFBP-1, IGFBP-2, glucose, HbA1c, blood lipids, markers of inflammation and oxidative stress) and on peptides regulating glucose metabolism and appetite as well as the effect on blood pressure, body composition, waist- and hip- circumference. DNA will also be analysed at the start and after 6 months to investigate any epigenetic effects. After completed study there will be a follow up after additional 6 months.

NCT ID: NCT02450071 Completed - Clinical trials for Traumatic Brain Injury

Pre-Hospital Advanced Airway Management in the Nordic Countries

PHAST
Start date: May 1, 2015
Phase: N/A
Study type: Observational

Pre-Hospital Advanced Airway Management (PHAAM) is a potentially lifesaving intervention. A recent Danish multicentre single country study demonstrated a 99,7% incidence of successful anaesthesiologist pre-hospital endotracheal intubation, with a PHAAM-related complication rate of 7.9%. A London study revealed a significantly higher intubation failure rate among non-anaesthesiologist physicians. In Scandinavia different types of emergency medical services (EMS) and professions provide PHAAM. The success rate of prehospital endotracheal intubation (PHETI), incidence of difficult intubation and complications in the Nordic countries is not known. The aim of this study is to define PHAAM success rate and complications in different types of Nordic EMS organisations and physician critical care teams. The study is a prospective observational study with collection of PHAAM data according to the template by Sollid et al. in the 12 participating Nordic Countries EMS/HEMS centres and physician critical care teams. The primary endpoint is PHETI success on ≤2 attempts and no complications.

NCT ID: NCT02449447 Completed - Clinical trials for Major Depressive Disorders

Blended Depression Therapy: Cognitive Behaviour Therapy Face-to-face and Via Internet

E-compared
Start date: February 2015
Phase: N/A
Study type: Interventional

To asses the clinical effectiveness of blended cognitive behavior therapy (CBT): face-to-face and internet-based treatment for adults with Major Depressive Disorder (MDD) in primary care compared to treatment as usual.

NCT ID: NCT02448914 Completed - Parkinson's Disease Clinical Trials

A Study to Compare Plasma Levels of Levodopa, Carbidopa and Entacapone After TRIGEL or Duodopa Infusion in PD Patients

Start date: May 2015
Phase: Phase 1
Study type: Interventional

This study evaluates the continuous addition of entacapone to infused levodopa and carbidopa on the pharmacokinetic (PK) profile in patients with advanced Parkinson's disease. All patients will receive both study drugs, i.e. TRIGEL (levodopa, carbidopa, and entacapone) and Duodopa (levodopa and carbidopa), in randomized order.

NCT ID: NCT02447666 Completed - Clinical trials for Myelodysplastic Syndrome

Study With Azacitidine in Pediatric Subjects With Newly Diagnosed Advanced Myelodysplastic Syndrome (MDS) and Juvenile Myelomonocytic Leukemia (JMML)

Start date: September 15, 2015
Phase: Phase 2
Study type: Interventional

Indication Treatment of pediatric subjects with newly diagnosed advanced myelodysplastic syndrome (MDS) or juvenile myelomonocytic leukemia (JMML) prior to hematopoietic stem cell transplantation (HSCT). Objectives Primary Objective The primary objective is to assess the treatment effect on response rate (MDS: either complete remission [CR], partial remission [PR], or marrow CR; JMML: either clinical complete remission [cCR] or clinical partial remission [cPR]); at Cycle 3 Day 28 (each cycle is 28 days) and to compare against standard therapy using a matched-pairs analysis of historical data. Secondary Objective The secondary objective is to further evaluate safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of azacitidine in this subject population. Study Design This is a prospective, open-label, Phase 2 study consisting of 2 parallel experimental arms, one for each disease group: MDS and JMML. Each arm is designed based on Simon's Optimal 2 stage study design. The sample size has been calculated to allow evaluation of the response rate at 28 day-Cycle 3 Day 28 in each of the 2 disease groups. Each of the experimental arms will also individually be compared against a historical control arm using data retrospectively collected from the European Working Group of MDS in childhood (EWOG-MDS) registry by means of a matched-pairs analysis; matched for predefined subject baseline characteristics defined before any results from this study are known post Stage 1. If matched pair is not viable then other methodologies will be explored to evaluate and compare response rates reported in literature and also in registry database Twenty subjects with MDS and 35 JMML subjects evaluable for the primary endpoint (ie, subjects that receive at least 1 dose of investigational product [IP]) will be enrolled at approximately 45 centers in Europe. Each experimental arm has 1 interim analysis planned (at the end of Stage 1). If, during Stage 1 evaluation, less than 2 subjects are observed with a CR, PR, or marrow CR after 3 months of azacitidine in the first 9 subjects with MDS, then enrollment will be stopped. Similarly, if less than 3 subjects are observed with a cPR or cCR after 3 months of azacitidine in the first 18 subjects with JMML, then enrollment will be stopped.

NCT ID: NCT02447172 Completed - Infection Clinical Trials

Study of a Topical Gentamicin-Collagen Sponge Along With Systemic Antibiotic in Infected Diabetic Foot Ulcers

COACT-2
Start date: June 2015
Phase: Phase 3
Study type: Interventional

This is a phase 3, randomized, controlled, blinded, multicenter study conducted in 3 parallel cohorts of diabetic patients with at least 1 infected foot ulcer. Patients will be randomized to receive 1 of 3 study treatments; systemic antibiotic therapy and standard ulcer care with either (A) daily application of a gentamicin-sponge, (B) daily application of a placebo-sponge or (C) no-sponge, in the ratio 2:1:1. Patients will be treated for approximately 28 days and return to the clinic weekly for safety and efficacy assessments. After completing treatment, patients will return to the clinic for scheduled follow-up visits approximately 10, 30, 60 and 90 days after treatment is stopped.