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NCT ID: NCT02292537 Completed - Clinical trials for Spinal Muscular Atrophy

A Study to Assess the Efficacy and Safety of Nusinersen (ISIS 396443) in Participants With Later-onset Spinal Muscular Atrophy (SMA)

CHERISH
Start date: November 24, 2014
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to examine the clinical efficacy of nusinersen (ISIS 396443) administered intrathecally to participants with later-onset Spinal Muscular Atrophy (SMA). The secondary objective is to examine the safety and tolerability of nusinersen administered intrathecally to participants with later-onset SMA.

NCT ID: NCT02292446 Completed - Polycythemia Vera Clinical Trials

Expanded Treatment Protocol (ETP) of Ruxolitinib in Patients With Polycythemia Vera Who Were Hydroxyurea Resistant or Intolerant and for Whom no Treatment Alternatives Was Available.

Start date: November 21, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this open-label, single arm, multi-center Expanded Treatment Protocol (ETP) was to provide early access to ruxolitinib and evaluate safety information in patients with polycythemia vera (PV) who were hydroxyurea (HU) resistant or intolerant and who had no other standard treatment option, nor did they qualify for another clinical study for PV

NCT ID: NCT02292277 Completed - Clinical trials for Myocardial Infarction

Ticagrelor Pharmacokinetics in NSTEMI

Start date: October 2014
Phase: N/A
Study type: Observational

Patients with myocardial infarction, which does not include all layers of the heart's muscle wall are common and they often receive pharmacological treatment with the platelet inhibiting drug ticagrelor. However, the drug uptake after an oral dose of 180mg ticagrelor has not been thoroughly studied in these patients. The present study will evaluate ticagrelor uptake and platelet aggregation after a 180 mg loading dose ticagrelor in these patients.

NCT ID: NCT02291406 Recruiting - Insulin Resistance Clinical Trials

Importance of Surgical Approach for Gynecological Surgery on Metabolic Effects and Subsequent Recovery

Start date: October 2014
Phase: N/A
Study type: Interventional

Insulin resistance is a key reaction to surgery and trauma and reflects the degree of metabolic stress. With greater degree of insulin resistance the development of complications increase, in particular infectious complications. The aim of this study is to determine if robotic assisted total laparoscopic hysterectomy induces less insulin resistance compared to abdominal hysterectomy. Insulin resistance is measured by the hyperinsulinemic normoglycemic clamp method. In addition inflammatory factors and clinical recovery will be measured.

NCT ID: NCT02291289 Completed - Colorectal Cancer Clinical Trials

A Study of Biomarker-Driven Therapy in Metastatic Colorectal Cancer (mCRC)

MODUL
Start date: April 17, 2015
Phase: Phase 2
Study type: Interventional

This randomized, multi-center, active-controlled, open-label, parallel-group study will investigate the efficacy and safety of biomarker-driven maintenance treatment for first-line mCRC. Participants with mCRC are eligible for entry and cannot have received any prior chemotherapy in the metastatic setting. The entire study duration is anticipated to be approximately 7.5 years.

NCT ID: NCT02290288 Completed - Clinical trials for Vaginal Vault Prolapse

Prospective Study for Vaginal Vault Prolapse After Hysterectomy: Comparison of Two Surgical Methods

Start date: October 2005
Phase: N/A
Study type: Interventional

The study is carried out at the Sahlgrenska University Hospital and the patient population consists of women referred with symptomatic and bothersome post-hysterectomy vaginal vault prolapse at least 1 cm above or beyond the hymeneal remnants. The interventions are either vaginal sacrospinousfixation or laparoscopic sacrocolpopexy following randomization to one of the types of surgery. The primary outcome is anatomical failure based on clinical assessment. Failure is defined clinically, according to the Pelvic Organ Prolapse Quantification system, as Ba, C or Bp at the hymen or below on maximum Valsalva maneuver one and two years after the surgery. Secondary outcomes are evaluation of continence, sexual function and prolapse symptoms based on validated questionnaires 1, 2, 5 and 10 years after the surgery.

NCT ID: NCT02290236 Enrolling by invitation - Clinical trials for Sleep Apnea, Obstructive

Monitored Saturation Post-ICU

Start date: September 2014
Phase: N/A
Study type: Observational

The overall aim with this project is to describe the correlation between measured and charted saturation after intensive care and also describe the saturation-pattern in these patients. The investigators will also correlate post-ICU desaturations measured as oxygen denaturation index and complications to pre-ICU obstructive sleep apnea and the STOP BANG screening questionnaire.

NCT ID: NCT02290080 Completed - Angina, Unstable Clinical Trials

Determination of the Role of Oxygen in Suspected Acute Myocardial Infarction by Biomarkers

DETO2X-bio
Start date: October 2014
Phase: Phase 3
Study type: Interventional

Oxygen treatment is widely used in acutely ill patients, both pre-hospital and in hospital. The indication for oxygen is sometimes unquestionable, such as in many hypoxic patients, but in other situations its use is more of a practise and much less based on scientific evidence. In particular, oxygen treatment is routinely used in patients with a suspected heart attack and variably recommended in guidelines, despite very limited data supporting a beneficial effect. Indeed, a few studies even indicate that oxygen treatment might be harmful. Immediate re-opening of the acutely blocked artery to the heart muscle is the treatment of choice to limit permanent injury. However, the sudden re-initiation of blood flow achieved with primary percutaneous coronary intervention (PCI), the reopening and stenting of the blocked vessel, can give rise to further endothelial and myocardial damage, so-called reperfusion injury. Ischemia and reperfusion associated myocardial injury (IR-injury) involves a wide range of pathological processes. Vascular leakage, activation of cell death programs, thrombocytes and white blood cells leading to extended inflammation and formation of clots are examples of those effects. The role of oxygen treatment on these pathological processes, on the extent of IR-injury and the final infarct size in patients with acute myocardial infarctions (AMI) has not previously been studied. In an ongoing national multicentre, randomized, registry based clinical trial, the DETO2X-AMI trial (NCT01787110), the effect of oxygen on morbidity and mortality in ACS patients is being investigated. The present DETO2X-biomarkers study is a substudy of the DETO2X-AMI trial, evaluating the effect of oxygen treatment on biological systems involved in the pathogenesis of reversible and irreversible myocardial damage and cell death in ACS.

NCT ID: NCT02288962 Recruiting - Adenoma Clinical Trials

Dopamine Agonist Treatment of Non-functioning Pituitary Adenomas

Start date: November 2014
Phase: Phase 3
Study type: Interventional

Due to lack of hormone overproduction in non-functioning pituitary adenomas (NFPAs), only the symptomatic adenomas or large adenomas with proven growth and risk for symptoms in near future will undergo pituitary surgery. The remaining adenomas are monitored regularly. Operation of these large adenomas will rarely remove all tumour tissue, and there is also a risk of worsening of pituitary function. Often, adenomas with the highest growth potential are operated several times and some also need radiation therapy, providing additional risk for pituitary failure. Unlike some of the hormone-producing adenomas, there is no established pharmacological treatment for NFPAs. However, there are a few non-randomized studies suggesting that treatment with dopamine agonists may slow growth, and also induce tumour shrinkage. At present, cabergoline is the dopamine agonist most widely used in the treatment of pituitary adenomas secreting prolactin. Aim is to study the effect of medical treatment with cabergoline in non-functioning pituitary adenomas on the change in tumour volume.

NCT ID: NCT02288247 Completed - Clinical trials for Metastatic Castration Resistant Prostate Cancer

A Study to Assess the Benefit of Treatment Beyond Progression With Enzalutamide in Men Who Are Starting Treatment With Docetaxel After Worsening of Their Prostate Cancer When Taking Enzalutamide Alone

PRESIDE
Start date: December 1, 2014
Phase: Phase 3
Study type: Interventional

The purpose of the study was to understand if there was benefit in continued treatment with a medicine called enzalutamide, when starting treatment with docetaxel and prednisolone (a standard chemotherapy for prostate cancer), after the prostate cancer had gotten worse when treated with enzalutamide alone.