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NCT ID: NCT03140527 Completed - Cystic Fibrosis Clinical Trials

Study Assessing the Safety, Tolerability, Pharmacokinetics, Food Effect, and Drug-Drug Interactions of PTI-801 in Healthy Volunteers, and Safety, Tolerability, and Pharmacokinetics of PTI-801 in Subjects With Cystic Fibrosis

Start date: April 10, 2017
Phase: Phase 1
Study type: Interventional

This trial will consist of two parts: Part 1 and Part 2. Part 1 will enroll adult healthy volunteers (HV) into four treatment groups. The first group will enroll HV into a single ascending dose (SAD) treatment group consisting of three cohorts. The second group will enroll HV into a multiple ascending dose (MAD) treatment group consisting of three cohorts. The third group will enroll HV into a food effect (FE) treatment group consisting of one cohort. The fourth group will enroll HV into a drug-drug interactions (DDI) treatment group consisting of one cohort. Approximately 76 subjects will be enrolled in Part 1. Part 2 Cohorts 1 through 3 will enroll adult subjects with cystic fibrosis (CF) currently on stable ivacaftor/lumacaftor background therapy for a minimum of three months. Part 2 Cohorts 4 and Cohort 5 will enroll adult subjects with CF not currently receiving cystic fibrosis conductance regulator (CFTR) modulator therapy within 30 days prior to Day 1. Part 2 Cohort 6 will enroll adult subjects with cystic fibrosis on stable tezacaftor/ivacaftor background therapy. Approximately 104 subjects will be enrolled in Part 2.

NCT ID: NCT03138226 Completed - Cervical Cancer Clinical Trials

Living Donor Uterus Transplantation Between Identical Twins

UTx-twin
Start date: January 1, 2017
Phase:
Study type: Observational [Patient Registry]

Living donor uterus transplantation between identical twins, with IVF before and ET several months after transplantation. The donor should have completed childbirth.

NCT ID: NCT03138122 Active, not recruiting - Clinical trials for Cardiovascular Diseases

The Study of Men Born in 1943

Start date: February 9, 1993
Phase:
Study type: Observational

A random sample a random sample of half of all men born in 1943 and living in the city of Gothenburg, Sweden, have been investigated in 1993 at 50 years of age and will be followed continuously with repeated re-examinations and follow-up concerning mortality and cardiovascular diseased. Out of 1463 invited men, 798 (54.5%) accepted the invitation and is included in this longitudinal cohort study.

NCT ID: NCT03136952 Completed - Clinical trials for Anesthesia Complication

Cerebral Oxygenation, Different Measurement Points and Their Correlation in Pediatric Population

Start date: April 28, 2017
Phase:
Study type: Observational

Children who undergo surgery routinely for surgery that risk high levels of circulatory changes (eg heart surgery) is currently used routinely monitoring as regional oxygenation technology of the brain (NIRS). Near infrared spectroscopy (NIRS) is a technique for measuring regional oxygen saturation, indirect autoregulation of brain. We know that reduced oxygenation of the brain can occur with severe immediate blood loss. We in the research group has been able to note that in children who undergo surgery for cranioplasty interventions <1 year old, when they have ongoing excessive bleeding, decreases oxygenation in the brain and sometimes sharply before we can replace the loss of blood, even the blood pressure can be adequately maintained. Perioperative hypovolemia is a risk factor upset autoregulation of brain. Respect of which the mean arterial pressure (MAP) required to maintain intact autoregulation during general anesthesia still lacks a scientific consensus. By illuminating the skin and underlying tissue with infrared light in the spectra of 700 to 1100nm, it is possible to measure regional oxygen saturation in various tissues. At cerebral measuring sensor is placed frontally, just below the hairline. INVOS then returns the absolute values of cerebral oxygen saturation frontally in the area where the sensor is placed. A frontal placement may in some cases be impractical / impossible and thus limits the ability to monitor the brains of children with different types of surgery or body positions. At certain cranioplastic intervention surgery a frontal placement is not always possible, partly because of surgical technic reasons, but also that the child may have to lie prone during surgery. An alternative placement of INVOS sensor could mean greater opportunities to monitor cerebral oxygen saturation and thus increase patient safety within the mentioned categories of patients. An occipital location is practically possible in many cases. The purpose of this study is to investigate whether a occipital located sensor can measure cerebral oxygen saturation in a reliable manner.

NCT ID: NCT03136861 Completed - Spondyloarthritis Clinical Trials

SKIPPAIN - Speed of Onset of SecuKinumab-Induced Relief From Pain in Patients With AxIal SpoNdyloarthritis

SKIPPAIN
Start date: June 30, 2017
Phase: Phase 3
Study type: Interventional

The purpose of the study was to evaluate the efficacy and safety of secukinumab 150 mg compared to placebo in the early management (Baseline to Week 8) of spinal pain, disease activity, fatigue, and predictability of disease flares in patients with axial spondyloarthritis (axSpA) who had an inadequate response to prior non-steroidal anti-inflammatory drugs (NSAIDs). This study also explored the efficacy and safety of secukinumab 300 mg compared to secukinumab 150 mg from Week 8 to Week 24 in order to assess the potential additional benefits of dose escalation in patients with axSpA.

NCT ID: NCT03136536 Recruiting - Aortic Aneurysm Clinical Trials

Organ Failure After Advanced Endovascular Thoracoabdominal Aortic Surgery

ODEA
Start date: May 3, 2017
Phase:
Study type: Observational

The purpose of this study is to investigate the mortality and frequency of organ dysfunction in patients after endovascular thoracoabdominal aortic surgery, and to search for biomarkers of organ dysfunction, in particular the spinal cord, the kidneys and the gastrointestinal tract. All adult patients undergoing endovascular thoracoabdominal aortic surgery at Örebro University Hospital, Örebro, Sweden, are asked for participation in this study. All participating patients sign informed consent at the inclusion. During the operation and during the postoperative intensive care, the function of the spinal cord, the gastrointestinal tract and the kidneys are collected along with other clinical parameters. Plasma blood samples, urin samples and cerebrospinal fluid samples are collected from each patient during the operation and during the postoperative care at the intensive care unit. During the operation two microdialysis catheters are placed in the abdomen, and the samples are continuously collected and analyzed. The biomaterial samples are stored in a biobank for later determination of proteins and other molecules. Postoperative survival and the frequency of complications are analysed.

NCT ID: NCT03136484 Completed - Clinical trials for Diabetes Mellitus, Type 2

Efficacy and Safety of Semaglutide Versus Canagliflozin as add-on to Metformin in Subjects With Type 2 Diabetes

SUSTAIN 8
Start date: March 15, 2017
Phase: Phase 3
Study type: Interventional

This trial is conducted in Africa, Asia, Europe, North and South America. The aim of the trial is to compare the effect of once-weekly (OW) dosing of subcutaneous semaglutide (1.0 mg) versus once-daily dosing of oral canagliflozin (300 mg) on glycaemic control in subjects with type 2 diabetes (T2D) on a background treatment of metformin

NCT ID: NCT03135548 Completed - Psoriasis Clinical Trials

Initial Dosing of BI 655130 in Palmoplantar Pustulosis Patients

Start date: May 30, 2017
Phase: Phase 2
Study type: Interventional

The primary objective of this trial is to investigate the safety and efficacy of BI 655130 in patients with PPP following multiple intravenous administrations compared to placebo.

NCT ID: NCT03134469 Completed - Bloating Clinical Trials

Efficacy of Probiotics on Excessive Gas Accumulation

Start date: April 18, 2017
Phase: N/A
Study type: Interventional

Efficacy of probiotics on excessive gas accumulation

NCT ID: NCT03133325 Completed - Safety Clinical Trials

A Study to Evaluate the Safety Following Injection of GP0045 Compared to Restylane Lyft Lidocaine

Start date: April 19, 2017
Phase: N/A
Study type: Interventional

This is a study to assess the safety of GP0045 compared to Restylane Lyft Lidocaine. There is a 12-week follow-up period. AEs will be recorded throughout the study.