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NCT ID: NCT03737409 Not yet recruiting - Clinical trials for Fibrotic Interstitial Lung Disease

PFOX: Pulmonary Fibrosis Ambulatory Oxygen Trial

PFOX
Start date: January 1, 2019
Phase: N/A
Study type: Interventional

The fibrotic interstitial lung diseases (fILD) are characterised by lung scarring, distressing breathlessness and poor health-related quality of life. Exertional desaturation (low blood oxygen during exercise) is a hallmark of fILD, occurring in over 50% of patients. It is sometimes treated with ambulatory oxygen therapy (AOT), which involves breathing supplemental oxygen during physical activity. However the absence of clinical trials has given rise to marked variations in policy and practice globally. Even where AOT is available, treatment adherence using the traditional delivery method of cylinder gas is poor. Recently new devices called portable oxygen concentrators (POCs), have become available, which are lighter and more maneuverable than a cylinder. This may enhance adherence and maximize treatment benefits. This trial will determine the clinical benefits and societal costs of AOT for people with fILD and exertional desaturation. A randomised controlled trial with blinding of participants, assessors and clinicians, and an embedded economic evaluation will be conducted. A total of 260 participants with fILD and exertional desaturation will be randomly assigned to use either AOT or air delivered using a POC for 6 months. If this trial demonstrates clinical and economic benefits of AOT then the findings can be rapidly translated into practice.

NCT ID: NCT03736122 Not yet recruiting - Clinical trials for Malignant Pleural Effusion

A Study of Syngenon (BSG-001) for Inhalation in Subjects With Malignant Pleural Effusion and/or Malignant Ascites

Start date: January 2019
Phase: Phase 1/Phase 2
Study type: Interventional

Malignant pleural effusion and/ or malignant ascites is generally defined by presence of malignant cells in the effusion fluid. The first-line therapies are mostly intrusive, medically demanding and inefficient, and therefore, it is important to study and develop new therapeutic option to address the unmet need. This protocol for BSG-001 is developed for the treatment of malignant pleural effusion and/ or malignant ascites. BSG-001 is an immune-modulator primarily exerts its effect via Toll-like receptor. The purpose of this study is to assess the safety and tolerability of BSG-001. All eligible subjects will receive BSG-001 for at least 12 weeks (3 cycles).

NCT ID: NCT03733301 Not yet recruiting - Atopic Dermatitis Clinical Trials

A Study of Baricitinib (LY3009104) in Combination With Topical Corticosteroids in Adults With Moderate to Severe Atopic Dermatitis

BREEZE-AD7
Start date: November 8, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of baricitinib in combination with topical corticosteroids (TCS) in participants with moderate to severe atopic dermatitis.

NCT ID: NCT03732820 Not yet recruiting - Clinical trials for Metastatic Castration-resistant Prostate Cancer

Study on Olaparib Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer

Start date: October 31, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety (including evaluating side effects) of combination of olaparib and abiraterone versus placebo and abiraterone in patients with metastatic castration-resistant prostate cancer (mCRPC) who have received no prior cytotoxic chemotherapy or new hormonal agents (NHAs) at metastatic castration-resistant prostate cancer (mCRPC) stage.

NCT ID: NCT03732677 Not yet recruiting - Clinical trials for Muscle Invasive Bladder Cancer

Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC

NIAGARA
Start date: November 28, 2018
Phase: Phase 3
Study type: Interventional

A Global Study to Determine the Efficacy and Safety of Durvalumab in Combination with Gemcitabine+Cisplatin for Neoadjuvant Treatment and Durvalumab Alone for Adjuvant Treatment in Patients with Muscle-Invasive Bladder Cancer

NCT ID: NCT03730662 Not yet recruiting - Clinical trials for Type 2 Diabetes Mellitus

A Study of Tirzepatide (LY3298176) Once a Week Versus Insulin Glargine Once a Day in Participants With Type 2 Diabetes and Increased Cardiovascular Risk

SURPASS-4
Start date: November 19, 2018
Phase: Phase 3
Study type: Interventional

The purpose of the trial is to assess the efficacy and safety of tirzepatide taken once a week to insulin glargine taken once daily in participants with type 2 diabetes and increased cardiovascular risk. The study will last about 108 weeks and may include up to 30 visits.

NCT ID: NCT03729856 Active, not recruiting - Sedentary Lifestyle Clinical Trials

A Novel Intervention to Promote Engagement in Physical Activity for Individuals With Whiplash Associated Disorder

Start date: May 7, 2018
Phase: N/A
Study type: Interventional

Approximately 50% of adults who have a whiplash injury experience ongoing pain and disability from whiplash associated disorder (WAD). Causes are multifactorial, with considerable variation. Studies evaluating interventions for this population have used group-level design and analysis and, to date, findings have been equivocal and optimal treatment remains a challenge. In addition to pain and disability, patients are frequently insufficiently active for good health, increasing their risk of preventable morbidity and mortality, and compounding the effects of WAD. The proposed study will evaluate an intervention with two novel features. Firstly, the focus is not directly on the reduction of neck pain and disability, but aims to evaluate whether evidence-based health promotion/behavior change strategies can be successfully applied to increase physical activity promotion in this population. The investigator's hypothesis is that the intervention will not only increase participation in health enhancing physical activity, but through that engagement, patients will gain increased confidence to engage in activity in the presence of neck pain, thereby reducing pain-related disability. Secondly, the Single Case Experimental Design enables individual level analysis that is not possible with typical group level designs, including identification of characteristics of responders and non-responders.

NCT ID: NCT03729245 Not yet recruiting - Clinical trials for Renal Cell Carcinoma

A Study of NKTR-214 in Combination With Nivolumab Compared With the Investigator's Choice of a Tyrosine Kinase Inhibitor (TKI) Therapy (Either Sunitinib or Cabozantinib Monotherapy) for Advanced Metastatic Renal Cell Carcinoma (RCC)

Start date: December 2018
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to compare the overall response rate (ORR) and overall survival (OS) of NKTR-214 combined with nivolumab to that of a tyrosine kinase inhibitor (TKI) monotherapy (sunitinib or cabozantinib) in intermediate and poor-risk participants with previously untreated advanced renal cell carcinoma (RCC).

NCT ID: NCT03725202 Not yet recruiting - Clinical trials for Giant Cell Arteritis (GCA)

A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis

Start date: December 12, 2018
Phase: Phase 3
Study type: Interventional

This study consists of two periods. The objective of Period 1 is to evaluate the efficacy of upadacitinib in combination with a 26-week corticosteroid (CS) taper regimen compared to placebo in combination with a 52-week CS taper regimen, as measured by the proportion of participants in sustained remission at Week 52, and to assess the safety and tolerability of upadacitinib in participants with giant cell arteritis (GCA). The objective of period 2 is to evaluate the safety and efficacy of continuing versus withdrawing upadacitinib in maintaining remission in participants who achieved remission in Period 1.

NCT ID: NCT03720678 Recruiting - Colorectal Cancer Clinical Trials

A Study to Evaluate the Safety and Tolerability of Immunotherapy Combinations in Participants With Gastrointestinal (GI) Malignancies

Start date: October 15, 2018
Phase: Phase 1
Study type: Interventional

This is a Phase 1/1b, open-label, dose-escalation, and dose-expansion study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and clinical activity of AB928 in combination with mFOLFOX in participants with advanced metastatic gastroesophageal Cancer (GEC) or colorectal cancer (CRC).