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NCT ID: NCT03579901 Active, not recruiting - Breast Implants Clinical Trials

Study of the Safety and Effectiveness of Motiva Implants®

Start date: April 6, 2018
Phase: N/A
Study type: Interventional

This study evaluates the safety and effectiveness Motiva Implants® in women who are undergoing primary breast augmentation, primary breast reconstruction or revision breast surgery.

NCT ID: NCT03570099 Active, not recruiting - Opioid Abuse Clinical Trials

Naloxone Treatment in Skåne County - Effect on Drug-related Mortality and Overdose-related Complications

Start date: June 11, 2018
Phase:
Study type: Observational [Patient Registry]

Death in overdose is the single most common cause of death in people using heroin. In Sweden, the number of drug-related overdose deaths has increased gradually since the early 1990s. The purpose of the study is to investigate the effects of a Naloxone distribution program in Skåne County. The primary issue is whether the project had an effect on overdose mortality and overdose related injuries.

NCT ID: NCT03569891 Active, not recruiting - Hemophilia B Clinical Trials

HOPE-B: Trial of AMT-061 in Severe or Moderately Severe Hemophilia B Patients

Start date: June 27, 2018
Phase: Phase 3
Study type: Interventional

This is an open-label, single-dose, multi-center, multinational trial to demonstrate the efficacy of AMT-061 and to further describe its safety profile. The study drug is identified as AAV5-hFIXco-Padua (AMT- 061). AMT-061 is a recombinant adeno-associated viral vector of serotype 5 (AAV5) containing the Padua variant of a codon-optimized human FIX complementary deoxyribonucleic acid (cDNA) under the control of a liver-specific promoter. The pharmaceutical form of AMT-061 is a solution for intravenous infusion administered at a dose of 2 x 10^13 gc/kg.

NCT ID: NCT03568188 Active, not recruiting - Prostate Cancer Clinical Trials

Efficacy Evaluation of Focused HIFU (High Intensity Focused Ultrasound) Therapy in Patients With Localized Intermediate Risk Prostate Cancer

FOCALE
Start date: September 28, 2018
Phase: Phase 2
Study type: Interventional

The aim of the focal treatment HIFU is to destroy the cancer without causing side effects in contrast to radical treatments. Radical treatments (surgery or radiation therapy) are the standard therapies for patient with intermediate risk localized prostate cancer and good life expectancy (prostatectomy if life expectancy10 years) By destroying only the part of the gland that harbors cancer, it may indeed be possible to provide efficient cure of the disease while minimizing treatment-induced morbidity (incontinence and loss of potency). Around 20% of patients presented with a unilateral tumor: this patients are currently treated radically. No study published papers reported outcomes of a large population (>100) with intermediate risk cancers treated with Focal-HIFU (conducted with the Focal One® device). Focal therapy must be only offer within clinical trial setting (EAU (European Association of Urology) Guidelines ). The aim of this cohort will be to determine the success rate of Focal-HIFU in this intermediate risk population. The result the study will be used for calculation the arms of a future random study

NCT ID: NCT03567538 Active, not recruiting - Lung Cancer Clinical Trials

National Register Studies in Thoracic Surgery

Start date: January 1, 2018
Phase:
Study type: Observational

The overall project aim is to study risk and outcomes following thoracic surgery by cross-linking high-quality national Swedish health-data registers for population-based investigations of individual level clinically relevant patient data.

NCT ID: NCT03556839 Active, not recruiting - Clinical trials for Carcinoma of the Cervix, Stage IVB

Platinum Chemotherapy Plus Paclitaxel With Bevacizumab and Atezolizumab in Metastatic Carcinoma of the Cervix

BEATcc
Start date: September 25, 2018
Phase: Phase 3
Study type: Interventional

The study will integrate the efficacy of combining the anti programmed death-ligand 1 (anti-PD-L1) agent atezolizumab with the current standard of care in Stage IVB , persistent or recurrent carcinoma of the cervix, namely cisplatin or carboplatin/paclitaxel/bevacizumab. It will be explored the combination of bevacizumab plus atezolizumab, with no patient selection based on PD-L1 expression, allowing an all-comer assessment of atezolizumab activity. The study is a randomized open label phase III trial to investigate the impact of atezolizumab in combination with bevacizumab and cisplatin or carboplatin /paclitaxel chemotherapy on overall survival and will employ the intent to treat principle, and random assignment to one of the 2 arms will be balanced according to disease histology (squamous cell carcinoma vs adenocarcinoma), prior platinum therapy as a radiation sensitizer (no prior cis-Radiotherapy (RT) versus prior cis-RT) and chemotherapy backbone (cisplatin vs carboplatin). This trial will be run in an open label design due to the following considerations: the control arm is the standard of care for women diagnosed with metastatic, persistant or recurrent cervical cancer because of its impact on overall survival and the primary endpoint of the study is overall survival (OS), so blinding is not needed to ensure a robust assessment.

NCT ID: NCT03549624 Active, not recruiting - Peritonitis Clinical Trials

Standardized Perioperative Management of Patients Operated With Acute Abdominal Surgery in a High-risk Emergency Setting

SMASH
Start date: February 26, 2018
Phase:
Study type: Observational

The objective of the study is to handle patients with the need for an acute laparotomy according to a standardised perioperative protocol and to document the measurement as they are performed (i.e. adherence to the protocol) and to measure the outcome with regard to both short- (30 days) and long-term (3 and 12 months) mortality. Several secondary endpoints will be measured, such as: hospital stay, length of stay at an Intensive Care Unit (ICU), readmission to ICU and surgical complications according to the Clavien-Dindo score. These results will then be compared to published rates of mortality from the literature and to similar outcomes for a cohort of all patients operated at NÄL on the same indication the years prior to the project/study.

NCT ID: NCT03540420 Active, not recruiting - Clinical trials for Small-cell Lung Cancer

Atezolizumab After Concurrent Chemo-radiotherapy Versus Chemo-radiotherapy Alone in Limited Disease Small-cell Lung Cancer

ACHILES
Start date: July 31, 2018
Phase: Phase 2
Study type: Interventional

Some patients with limited disease small-cell lung cancer (LD SCLC) are cured after chemo-radiotherapy, but the majority relapse and die from their cancer. Better therapy is needed. Immunotherapy represents the largest advance in cancer therapy in recent years and has demonstrated promising activity in SCLC. In this study we will investigate whether atezolizumab prolongs survival in LD SCLC patients who have undergone chemo-radiotherapy.

NCT ID: NCT03539744 Active, not recruiting - Multiple Myeloma Clinical Trials

A Study Designed to Evaluate the Safety and Efficacy of Venetoclax Plus Dexamethasone (VenDex) Compared With Pomalidomide Plus Dexamethasone (PomDex) in Participants With t(11;14)-Positive Relapsed or Refractory Multiple Myeloma.

Start date: October 22, 2018
Phase: Phase 3
Study type: Interventional

A study designed tocompare progression-free survival (PFS) in participants with t(11;14)-positive MM treated with venetoclax in combination with dexamethasone versus pomalidomide in combination with dexamethasone.

NCT ID: NCT03535740 Active, not recruiting - Clinical trials for ALK-positive Advanced NSCLC

A Study of Brigatinib in Participants With Anaplastic Lymphoma Kinase-Positive (ALK+), Advanced Non-Small-Cell Lung Cancer (NSCLC) Progressed on Alectinib or Ceritinib

ALTA-2
Start date: January 31, 2019
Phase: Phase 2
Study type: Interventional

The primary purpose of this study is to determine the efficacy of brigatinib by confirmed objective response rate (ORR) by response evaluation criteria in solid tumors (Response Evaluation Criteria in Solid Tumors [RECIST]), in participants with ALK+ locally advanced or metastatic NSCLC whose disease has progressed on therapy with alectinib or ceritinib.