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NCT ID: NCT03039127 Terminated - Breast Neoplasms Clinical Trials

Immunostimulating Interstitial Laser Thermotherapy in Breast Cancer

Start date: June 2016
Phase: N/A
Study type: Interventional

Thermotherapy is a technology aiming at destroying tissue, for example tumor tissue. Immunostimulating Interstitial Laser Thermotherapy (imILT) is a specific form of thermotherapy, which, in addition to destroying tumor tissue, has been optimized to cause a tumor specific immunologic response. In laboratory animals the imILT method has also been shown to induce a so called abscopal effect. This means that when one tumor is treated with imILT other, untreated, tumors also decrease in size. The immunologic response has previously been characterized in breast cancer patients after receiving imILT treatment , and presumed abscopal effects induced by imILT have also been described in a malignant melanoma patient. The purpose of this trial is to investigate the functionality and safety of the imILT treatment method in patients diagnosed with breast cancer. The treatment method has successfully been used for treatment of patients with breast cancer and malignant melanoma. Treatment of breast cancer patients caused an increase of cytotoxic T lymphocytes in the treated tumor, as well as activated dendritic cells at the tumor border. Regulatory T lymphocytes decreased in the regional lymph nodes. This trial is explorative, prospective, open and non-randomized. Five breast cancer patients will be treated in this trial, which is estimated to be carried out during a time period of 9 months.

NCT ID: NCT03038750 Terminated - Clinical trials for Cardiovascular Diseases

Molecular Investigation of Genetic Factors in CArDiovascular Diseases Using an BIOresource of Healthy Volunteers

CADBIO
Start date: August 14, 2017
Phase:
Study type: Observational

The risk of cardiovascular disease is determined by the complex interplay between an individual's genetic make-up, lifestyle, and the environment. We are investigating three potential genetic risk factors in this observational, cross-sectional, epidemiology pilot study to investigate if and how functional variants identified in large-scale genome wide association studies can explain a predisposition to cardiovascular disease. By determining the molecular mechanisms that are regulated at the EDNRA, PNPLA3 and PROCR CVD risk loci, we hope to translate findings from this study into the clinical setting for better diagnosis, prevention and treatment for patients suffering with cardiovascular disease. Volunteers will enter into one of the study's three arms based on their genotype: EDNRA locus (Arm 1), PNPLA3 locus (Arm 2), or PROCR locus (Arm 3). Members of the Cambridge Bioresource who match for the target alleles will be invited to participate and will enter into one of the three study arms. All study assessment visits will take place at Addenbrooke's Hospital in collaboration with the University of Cambridge. Volunteers will participate in the study for a maximum of 12 months and depending on study arm they are assigned to, they will complete procedures including a medical, demographic and lifestyle factors questionnaire; height, weight and body fat assessments; in addition to blood pressure/heart rate measurements. Minimally invasive procedures including forearm blood flow and venepuncture will be performed to assess the primary objectives of the study. The hypothesis for arm 1 is that the genetic variant we are investigating at the EDNRA gene locus alters the function of the endothelin receptor A leading to an increased risk of coronary artery disease and large artery stroke. For study arm 2, we hypothesize that the genetic variant we are investigating in PNPLA3 will increase the risk of Non-alcoholic fatty liver disease but reduce the risk of Coronary Heart Disease. For study arm 3, we hypothesize that the genetic variant we are investigating in the PROCR locus triggers molecular events that potentially increase the risk of Venous Thrombosis/Venous Thromboembolism nut reducing blood pressure. Furthermore we aim to investigate the anti-inflammatory effects to see if there is an effect on explaining reduced risk of CHD. This study is funded from the BHF Cambridge Center of Excellence and the Wellcome Trust Institutional Strategic Support Fund.

NCT ID: NCT03033511 Terminated - Clinical trials for Small Cell Lung Cancer

A Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First- Line Platinum-Based Chemotherapy in Participants With Extensive Stage Small Cell Lung Cancer (MERU)

MERU
Start date: February 7, 2017
Phase: Phase 3
Study type: Interventional

This is a Phase 3, randomized, double-blind, placebo-controlled, multinational, and multicenter study to evaluate the efficacy of rovalpituzumab tesirine as maintenance therapy following first-line platinum-based chemotherapy.

NCT ID: NCT03029832 Terminated - Clinical trials for Urothelial Carcinoma

A Study of MOXR0916 in Combination With Atezolizumab Versus Atezolizumab Alone in Participants With Untreated Locally Advanced or Metastatic Urothelial Carcinoma Who Are Ineligible for Cisplatin-Based Therapy

Start date: April 27, 2017
Phase: Phase 2
Study type: Interventional

This is a Phase II, multicenter, randomized, placebo-controlled, double-blind study to evaluate the safety and efficacy of MOXR0916 in combination with atezolizumab versus placebo and atezolizumab in participants with locally advanced or metastatic urothelial carcinoma (UC) who have not received prior systemic therapy in the locally advanced/metastatic setting and who are ineligible to receive cisplatin-based therapy.

NCT ID: NCT03028740 Terminated - Clinical trials for Nonalcoholic Steatohepatitis

AURORA: A Study for the Efficacy and Safety of Cenicriviroc (CVC) for the Treatment of Liver Fibrosis in Adults With Nonalcoholic Steatohepatitis (NASH)

AURORA
Start date: April 5, 2017
Phase: Phase 3
Study type: Interventional

The AURORA study will be conducted to confirm the efficacy and safety of cenicriviroc (CVC) for the treatment of liver fibrosis in adult participants with NASH.

NCT ID: NCT03024996 Terminated - Clinical trials for Renal Cell Carcinoma

A Study of Atezolizumab as Adjuvant Therapy in Participants With Renal Cell Carcinoma (RCC) at High Risk of Developing Metastasis Following Nephrectomy

IMmotion010
Start date: January 3, 2017
Phase: Phase 3
Study type: Interventional

This is a Phase III, multicenter, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of atezolizumab versus placebo in participants with RCC who are at high risk of disease recurrence following nephrectomy.

NCT ID: NCT03016195 Terminated - Stoma Ileostomy Clinical Trials

Evaluation of the Normal Range of Urinary Sodium Levels in Healthy Newborn Babies

USALTI
Start date: October 2016
Phase: N/A
Study type: Observational

Oral sodium supplementation is currently administered in cases of poor weight gain in infants particularly in patients who have undergone gastrointestinal surgical procedures. The decision to start oral supplementation is based on urinary sodium levels although the level at which to start treatment is variable as the range in normal, healthy infants is unknown. This study aims to ascertain the normal range of sodium in urine specimens collected from healthy newborn babies. It is believed that by increasing the level of salt in the intestine, glucose can be more easily be absorbed and therefore weight gain improved. Babies with conditions where they are at risk of salt depletion (i.e. those with a stoma) are currently administered oral sodium supplementation if they are failing to gain weight and have an associated 'low' urinary sodium level. Low levels of urinary sodium are considered to represent a state of low body sodium levels, as the kidneys attempt to reabsorb most of the sodium in the urine before it is excreted. Current practice varies widely as to the level below which treatment should be instigated. Some centres advise below 20 mmol/L (Birmingham Children's Hospital and Nottingham Children's Hospital guidelines), others below 10 mmol/L (University Children's Hospital, Zurich). In Glasgow, babies with poor weight gain are given sodium supplementation if urinary sodium levels are below 40 mmol/L. There are no documented ranges for the levels of urinary sodium in healthy, newborn babies. By determining the reference range of urinary sodium levels in healthy, term babies who are gaining weight appropriately, the investigators hope to be able to have a better understanding about both the level below which supplementation should be considered and the target range that should be aimed for.

NCT ID: NCT03009058 Terminated - Metastatic Cancer Clinical Trials

Study of IMM 101 in Combination With Standard of Care in Patients With Metastatic or Unresectable Cancer

MODULATE
Start date: May 24, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

During this open label study patients will receive IMM-101 in conjunction with a recognised standard of care for metastatic or unresectable cancer for the patient's specific tumour type. The primary objective of the study is to provide safety data for IMM-101 in combination with a number of selected standard of care regimens.

NCT ID: NCT03001219 Terminated - Clinical trials for Rheumatoid Arthritis

A Study of RO7123520 to Evaluate the Safety and Efficacy in Participants With Moderately To Severely Active Rheumatoid Arthritis (RA) Who Are Inadequately Responding to Anti-Tumor Necrosis Factor (TNF)-Alpha Therapy

Start date: December 22, 2016
Phase: Phase 2
Study type: Interventional

This is a Phase IIa/b double-blind, placebo-controlled, randomized, parallel group, multicenter study to evaluate the safety and efficacy of RO7123520 as adjunctive therapy in participants with RA who are inadequately responding to standard-of-care (methotrexate and anti-TNF-alpha therapy). Part 1 of the study will evaluate safety. Part 2 will evaluate efficacy and safety. Part 3 will evaluate dose-ranging efficacy. Participants will have the option of continuing to the extension period of the study.

NCT ID: NCT03000153 Terminated - Clinical trials for Mental Health Impairment

Effectiveness of Tracking Goals in Counselling

Goals in MIND
Start date: October 19, 2017
Phase: N/A
Study type: Interventional

Recent evidence suggests that focusing on positive goals rather than problems to avoid, may be associated with better psychological health and attainment of goals. In addition, the advantages of using personalised measures have been highlighted in a number of studies. The Goals Form is a new measure that comprises both elements. It invites clients, in collaboration with their therapist, to identify up to seven goals for therapy typically at a first assessment session and then to rate them on a 1-7 Likert scale, with 1 being not at all achieved and 7 being completely achieved. This research is important for clinical practice as it provides the foundations to identify what might be a helpful factor in counselling and psychotherapy. The aim of the study is to test whether the use of the Goals Form leads to better clinical outcomes in counselling and psychotherapy. Participants in this study are counsellors and service users at Tower Hamlets Mind. The design of this study is a trial, which looks at comparing outcome measure scores in 'therapy as usual' and 'therapy using the Goals Form' when participants are randomly assigned to one of the two conditions. Interventions in this study involve using the Goals Form at the start of every session and taking part in a 30 minute interview once therapy has ended to give feedback about using the form in therapy . In addition to assessing outcome, the study also serves to compare satisfaction scores across the two conditions. It is a pilot to determine the feasibility of such trial including recruitment rates over a period of a year, adherence of counsellors and clients to the protocol, and the ethical issues raised.