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NCT ID: NCT03639649 Completed - Prostate Cancer Clinical Trials

STHLM3 - Prostate Cancer Diagnostic Trial

STHLM3
Start date: August 2013
Phase: N/A
Study type: Interventional

STHLM3 is a paired diagnostic trial aiming to assess whether a panel of biomarkers for prostate cancer can substantially reduce the proportion of men referred to biopsy whilst maintaining sensitivity for aggressive prostate cancer

NCT ID: NCT03639389 Completed - Postoperative Pain Clinical Trials

Postoperative Pain, Recovery and Discharge Following Robot-assisted Laparoscopic Prostatectomy

RAPID
Start date: January 1, 2019
Phase: Phase 3
Study type: Interventional

Prostate cancer is the commonest cancer form in men in Northern Europe. Management of the cancer often includes surgical removal of the primary tumor. In the last 5-10 years, robot assisted laparoscopic prostatectomy (RALP) has become common. Good pain relief is central to early mobilization and greater patient satisfaction. Randomized controlled studies on pain relief following RALP are few and the role of spinal analgesia in pain management following robotic surgery has not been described. Techniques available for pain relief following RALP include spinal anesthesia with or without opiates, intravenous analgesia with morphine or a multimodal pain management technique using a combination of several analgesics. Spinal anesthesia and analgesia reduces the surgical stress and inflammatory response following laparoscopic colorectal surgery and may offer similar benefit even during RALP. Early perioperative complications may cause postoperative morbidity following robotic surgery, and sometimes delay home discharge. Since all robotic operations in the pelvic region are performed in a deep Trendelenberg position, this can even have negative consequences for the heart, brain and the lungs. Cardiac complications in the form of minimal cardiac injury or mild heart failure have not been previously studied following RALP. Additionally, patients are sometimes delirious in the early postoperative period following RALP. The precise cause for this remains unclear and may be related to pain, cognitive dysfunction or an urge to pass urine despite a urinary catheter. In addition to good postoperative pain relief, early postoperative mobilization and home discharge are important milestones in recovery of full function following major surgery. With improvement in surgical technique, the time has come to evaluate if RALP can be performed on an ambulatory basis. The main aims of this study are: 1. Can RALP be performed on an ambulatory basis and patients ready to be discharged home at 8 pm? 2. To determine if spinal anesthesia reduces pre-discharge pain intensity, stress response and other perioperative side effects. 3. Is sufentanil or fentanyl the analgesic of choice when administered spinally together with bupivacaine as an analgesic. 4. To determine the frequency and severity of cardiac and respiratory complications in the steep Trendelenberg position during RALP. 5. To assess the quality of recovery, quality of life and activities of daily living following ambulatory RALP?

NCT ID: NCT03638791 Completed - Clinical trials for Obsessive-Compulsive Disorder

Microbiome in Obsessive-compulsive Disorder

MIO
Start date: December 5, 2018
Phase:
Study type: Observational [Patient Registry]

Background: Humans live in symbiosis with microbes and their implication for health and disease is evident. The importance of microbiome-gut-brain axis in psychiatric disorders is an area of increasing research interest. OCD is a promising target for microbiome research as Pediatric Acute-onset Neuropsychiatric Syndrome (PANS)/ Pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections (PANDAS) are reactions to infectious agents precipitating acute onset of severe OCD symptoms. Furthermore, preliminary evidence has associated probiotic treatment with alleviation of OCD symptoms. We propose the first clinical study on the microbiome and its effects on OCD patients. Aim: To analyze the gut microbiota in patients with OCD compared with healthy matched controls and assess changes in microbial composition following treatment. Outcome measures: Differences in alpha diversity, beta diversity, and taxa abundance of bacterial groups (at the phylum, class, order, family, genus and species levels) and severity of OCD symptoms. Moreover, functional profiling will be conducted. Methods: Our aim is to enroll 32 OCD patients and 32 matched controls. Shotgun metagenomic sequencing will be used. Sequenced data will be processed followed by non-parametric statistical testing. Significance: gut microbiome in patients with OCD beofre and after ERP treatment has never been done before. The microbial composition may impact on OCD symptoms, severity, and chronicity and could inform future therapeutic possibilities.

NCT ID: NCT03638440 Completed - Clinical trials for Opioid Induced Constipation

Real World Observational Study of Naloxegol for Patients With Cancer Pain Diagnosed With OIC.

NACASY
Start date: August 16, 2018
Phase:
Study type: Observational

This is a single-arm, open label, multinational, multicentre, prospective, real world observational study of Naloxegol in adult subjects with Opioid Induced Constipation (OIC) in patients receiving Naloxegol in routine clinical practice. Subjects who are receiving Naloxegol (prescribed by their physician according to the SmPC, which recommends that all currently used maintenance laxative therapy should be halted) during the enrolment period may be eligible for enrolment into the study.

NCT ID: NCT03637907 Recruiting - Stroke Clinical Trials

Spectral Computed Tomography With Photon Counting Detector of Brain and Vessels.

Start date: January 11, 2018
Phase:
Study type: Observational

Primary purpose of the study is to show wether computed tomography with photon counting detector has a diagnostic image quality as good as, or better than classic computed tomography in investigations concerning stroke work-up.

NCT ID: NCT03636347 Completed - COPD Clinical Trials

A 12-week Study Treating Participants Who Have alpha1-antitrypsin-related COPD With Alvelestat (MPH966) or Placebo.

ASTRAEUS
Start date: October 29, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate the effect of alvelestat (an oral neutrophil elastase inhibitor) on blood and sputum biomarkers in patients with PiZZ, null or rare variant phenotype/genotype alpha-1 anti-trypsin deficient lung disease. Change in a number of different blood and sputum biomarkers related to lung damage, inflammation and elastase activity will be measured over a 12 week period. The effect on lung function and respiratory symptoms will also be measured.

NCT ID: NCT03635983 Completed - Melanoma Clinical Trials

A Study of NKTR-214 Combined With Nivolumab vs Nivolumab Alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma

Start date: September 21, 2018
Phase: Phase 3
Study type: Interventional

The purpose of the study is to test the effectiveness (how well the drug works), safety, and tolerability of the investigational drug called NKTR-214, when combined with nivolumab versus nivolumab given alone in participants with previously untreated melanoma skin cancer that is either unable to be surgically removed or has spread

NCT ID: NCT03635437 Completed - Clinical trials for Type 1 Diabetes Mellitus

Evaluation of Safety and Diabetes Status Upon Oral Treatment With GABA in Patients With Longstanding Type-1 Diabetes

Start date: September 5, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

The main goal of this study is to find a reasonably safe and tolerable treatment for adult patients with type 1-diabetes and that regain some of the endogenous insulin secretion, improve the patients' quality of life (QoL) and reduce the risk of both short- and long-term complications. The hypothesis tested is that oral GABA treatment with the newly developed compound Remygen will be safe and induce regain of some endogenous insulin secretion in adult patients with type 1-diabetes diagnosis for more than five years. The first part of the study will include 6 patients and be performed as a Safety and Dose Escalation study in three steps. The main study is a three-arm, open label, single center, clinical trial. Eligible patients will be randomized into one of three active treatment arms to receive oral GABA treatment for 6 months.

NCT ID: NCT03634761 Completed - Clinical trials for Autism Spectrum Disorder

Early Intervention and Autism: Transformation From Research to Practice Through a Competency Based Model

AUT-TID
Start date: May 15, 2017
Phase: N/A
Study type: Interventional

This study evaluates the effect of a competency based model on program quality in Swedish preschools for Children with autism spectrum disorder (ASD). Half of the participating preschools will receive "treatment as usual" (Early Intensive Behavioral Intervention (EIBI) provided to a Child with ASD in the preschool, supervised by an external supervisor from a habilitation center), while the other half will receive the above as well as, in-service training and monthly on-site coaching sessions also involving preschool staff other than the paraprofessional (competency based model). It is hypothesized that the competency based model will improve program quality, child's engagement, preschool staff knowledge, allegiance and self-efficacy compared to the comparison group.

NCT ID: NCT03633617 Completed - Clinical trials for Eosinophilic Esophagitis

Study to Determine the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Esophagitis (EoE)

Start date: September 24, 2018
Phase: Phase 3
Study type: Interventional

The primary objectives of the study by study part are: Part A: To determine the treatment effect of dupilumab compared with placebo in adult and adolescent patients with EoE after 24 weeks of treatment as assessed by histological and clinical measures and to inform/confirm the final sample size determination for Part B. Part B: To demonstrate the efficacy of dupilumab treatment compared with placebo in adult and adolescent patients with EoE after 24 weeks of treatment as assessed by histological and clinical measures. Part C: To assess the safety and efficacy of dupilumab treatment in adult and adolescent patients with EoE after up to 52 weeks of treatment as assessed by histological and clinical measures. The secondary objectives of the study are: - To evaluate the safety, tolerability, and immunogenicity of dupilumab treatment for up to 52 weeks in adult and adolescent patients with EoE - To explore the relationship between dupilumab concentration and responses in adult and adolescent patients with EoE, using descriptive analyses - To evaluate the effects of dupilumab on transcriptomic signatures associated with EoE and type 2 inflammation - To demonstrate the efficacy of dupilumab treatment compared to placebo after 24 weeks and 52 weeks of treatment in adult and adolescent patients with EoE who have previously received swallowed topical corticosteroids