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NCT ID: NCT03358095 Withdrawn - Pancreatic Cancer Clinical Trials

Cancer of the Head of the Pancreas: Early Surgery or Preoperative Biliary Drainage?

Start date: November 26, 2017
Phase: N/A
Study type: Interventional

Surgical resection is the only option for cure for patients with a resectable tumor located at the head of the pancreas. At the time of diagnosis, these patients often suffer from jaundice. Studies have suggested, that jaundice might increase the risk of developing a serious postoperative complication. Preoperative biliary drainage is widely used, because it is considered to improve the surgical outcome and reduce the amount of postoperative complications. There are also studies that suggest the opposite. In these studies the overall complication rate with patients who underwent preoperative biliary drainage was higher than in the patients who were operated right away. A significant amount of these complications were related to the biliary drainage process itself. However, preoperative biliary decompression is widely used in many centers as many surgical centers don't possess the needed resources to arrange early surgery. The benefits and risks of this procedure remain unclear. This multicenter trial aims to compare the surgical outcome and the rate of serious complications in patients who proceed directly to early surgery and patients who have preoperative biliary drainage.

NCT ID: NCT03350763 Withdrawn - Pancreatic Cancer Clinical Trials

Biliary Drainage Preceding Possible Pancreaticoduodenectomy. Are Self-expandable Metallic Stents (SEMS) Superior to Plastic Stents?

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

This study looks in to the rate of biliary stent dysfunction for plastic and metallic stents in patients who need biliary drainage due to a tumor in pancreas before possible pancreaticoduodenectomy. Complications related to the biliary decompression, and possible post-surgical complications in all patients are also recorded. This trial aims to confirm whether metallic biliary stents really are superior to plastic stents as some previous studies suggest. Specific patient groups are also evaluated individually to see, whether patients with ongoing cholangitis at the time of diagnosis or patients receiving neoadjuvant treatments have less stent dysfunction cases and complications with metallic stents than with plastic stents.

NCT ID: NCT03191383 Withdrawn - Clinical trials for Respiratory Syncytial Virus Infections

A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of the GlaxoSmithKline (GSK) Biologicals' Respiratory Syncytial Virus (RSV) Investigational Vaccine (GSK3003891A) in Healthy Pregnant Women and Infants Born to Vaccinated Mothers

Start date: July 11, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety, reactogenicity and immunogenicity of the investigational GSK RSV vaccine in pregnant women aged 18 to 40 years and infants born to the vaccinated women

NCT ID: NCT03070691 Withdrawn - Clinical trials for Basal Cell Carcinoma

Efficacy, Safety and Tolerability of Topically Applied LDE225 Cream (Hedgehog Pathway Inhibitor) in Adult Patients With Nevoid Basal Cell Carcinoma Syndrome (NBCCS)

Start date: n/a
Phase: Phase 2/Phase 3
Study type: Interventional

This 22 week study will assess the efficacy, safety, and tolerability of LDE225 versus vehicle when applied topically to basal cell carcinoma (BCC) in patients with NBCCS. Patients will treat multiple BCCs for up to 12 weeks. Treatment success is defined as complete clinical clearance and complete histological clearance in BCCs.

NCT ID: NCT02974322 Withdrawn - Crohn Disease Clinical Trials

A Study of Efficacy and Safety of Mongersen (GED-0301) for the Treatment of Adult and Adolescent Subjects With Active Crohn's Disease

Start date: December 1, 2017
Phase: Phase 3
Study type: Interventional

The purpose of study is to test the effect of an experimental medication GED-0301(mongersen) and evaluate its safety in patients (≥ 12 years of age) with active Crohn's disease. The study will test GED-0301 compare to placebo for 12 weeks. The study treatment is blinded which means that patients and the study doctor will not know which treatment has been assigned. Patients in this study will be allowed treatment with stable doses of oral aminosalicylates, oral corticosteroids, immunosupressants and antibiotics for the treatment of Crohn's disease. Adolescent patients will also be allowed treatment with stable doses of exclusive enteral nutrition and growth hormone. All patients who complete the study will have the option to enter a long term active treatment study.

NCT ID: NCT02445170 Withdrawn - Clinical trials for Diabetes Complications

Heath-related Quality of Life of Diabetic Transmetatarsal Amputees and Below-knee Prosthetic Users

Start date: July 2015
Phase: N/A
Study type: Observational

The present study assesses the health-related quality of life of diabetic transmetatarstal and below-knee prosthetic user. The study design is cross-sectional with a retrospective review of patient hospital records and an assessment with patient-reported outcome measure.

NCT ID: NCT02397356 Withdrawn - Pain, Postoperative Clinical Trials

Inhaled Nebulised S(+)-Ketamine for Postoperative Analgesia

Start date: August 2018
Phase: Phase 4
Study type: Interventional

Ketamine has been administrated via the intravenous, intramuscular, subcutaneous, rectal, oral, transdermal, intranasal, sublingual, transmucosal, epidural, intrathecal, and intra-articular routes. Pharmacokinetic properties of inhaled ketamine have not been studied officially, but one of the investigators researchers has tested nebulized ketamine on himself with repeated painful stimulus and monitoring applied. Based on this experiment, analgesic effect is roughly estimated to begin in 3 minutes.Ketamine has been used successfully to treat acute pain in intranasal form. The primary purpose of this study is to evaluate whether nebulised S(+)-ketamine carries potential as a an analgesic bypassing first pass metabolism and without the need for intravenous access. Secondary aim is to assess the duration of analgesia obtained by nebulized S-ketamine. Thirdly, the aim is to evaluate whether inhaled nebulized ketamine decreases the need for rescue analgesia during PACU care. The subjects are recruited among patients coming in for a surgical intervention (orthopedic, gastrointestinal, plastic or urologic surgery) and needing further observation in postoperative care unit (PACU). It was calculated that sample size of 8 subjects per group would be required to achieve statistical power of 80% and detect a difference of 3 units in NRS-values with standard deviation of 2 units and type I error of 5%. To prepare for possible dropouts, total of 20 subjects will be recruited (10 in each group). Patients will receive either nebulized placebo (i.e. saline) or ketamine (Ketanest-S) when they require pain alleviation in the PACU. Dosage of ketamine is 1 mg/kg. Patients will be randomized into two groups so that other group's first inhalation contains ketamine and second inhalation placebo and in the opposite order.

NCT ID: NCT02026947 Withdrawn - Clinical trials for Attenuated or Transient Psychosis

Sodium Benzoate for Treatment of Attenuated/Transient Psychosis. A Randomized Placebo-controlled Trial.

AttenPsyc
Start date: February 2014
Phase: Phase 2
Study type: Interventional

The aim of this study is to investigate whether sodium benzoate is superior to placebo in decreasing symptoms among patients with attenuated/transient psychosis. A total of 140 patients will be randomized in 1:1 ratio to receive sodium benzoate 1 g/day or placebo for 12 weeks. Concerning statistical power, the number of patients is sufficient to obtain statistical significance for a clinically meaningful effect size of 0.40 (Cohen's d). The primary outcome measure is change in PANSS sum score of delusions, hallucinations, suspiciousness and conceptual disorganization (the PANSS items that are inclusion criteria) at week 12. Change in CGI score at week 12 is the other primary outcome measure. The secondary outcome measures are change in PANSS total score at week 12, CGI score at week 24, and GAF at weeks 12 and 24.

NCT ID: NCT01961492 Withdrawn - Ulcerative Colitis Clinical Trials

Fecal Microbiota Transplantation in Patients With Ulcerative Colitis

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

The purpose of this study is to find out whether a single fecal microbiota transplantation is an effective and safe treatment as an adjunct to standard therapy in patients with ulcerative colitis.

NCT ID: NCT01910675 Withdrawn - Clinical trials for Postpartum Haemorrhage

PCC and Fibrinogen Compared With FFP in PPH

Start date: July 2013
Phase: Phase 4
Study type: Interventional

The purpose of the study is to find out if the regimen of prothrombin complex concentrate (PCC) together with fibrinogen concentrate is as efficient as fresh frozen plasma (FFP) (plus fibrinogen if needed) during the early stages of the transfusion therapy in postpartum haemorrhage (PPH). The original protocol included the use of HES and the recruitment of patients was postponed while waiting the final decision by EMA. All HES solutions were abandoned at our institution in September and an amendment was made to change the protocol. HES solution are replaced by the use of hyperoncotic (20%) albumin.