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NCT ID: NCT02842086 Active, not recruiting - Clinical trials for Pre-Exposure Prophylaxis of HIV-1 Infection

Study to Evaluate the Safety and Efficacy of Emtricitabine and Tenofovir Alafenamide (F/TAF) Fixed-Dose Combination Once Daily for Pre-Exposure Prophylaxis in Men and Transgender Women Who Have Sex With Men and Are At Risk of HIV-1 Infection

DISCOVER
Start date: September 2, 2016
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to assess the rates of HIV-1 infection in Men (MSM) and transgender women (TGW) who have sex with men and who are administered daily emtricitabine/tenofovir alafenamide (F/TAF) or emtricitabine/tenofovir disoproxil fumarate (F/TDF) with a minimum follow-up of 48 weeks and at least 50% of participants have 96 weeks of follow-up after randomization.

NCT ID: NCT02840630 Active, not recruiting - Clinical trials for Diabetes Mellitus, Type 2

Effect of FISH Intake on MEtabolic Health in a Diabetic South Asian popuLation (FISH MEAL)

FISHMEAL
Start date: September 2016
Phase: N/A
Study type: Interventional

The investigators will recruit non-diabetic volunteers (n=30) and diabetic volunteers controlled by diet and lifestyle (n=300). The non-diabetic volunteers will be in the non-diabetic group while the diabetic volunteers will be randomised to a diabetic control intervention group or a diabetic fish intervention group. Baseline data will be collected from all three groups but only diabetic control intervention group and diabetic fish intervention group will go through the 16-week study. This will allow the investigators to compare the metabolic health across South Asian population in people with and without diabetes. The recommended intake of EPA and DHA daily is ~450 mg per day for cardiovascular health, or approximately 3 g per week. Over the course of 16 weeks, subjects in the diabetic control intervention group will continue with their habitual diet, while subjects in the diabetic fish intervention group will receive two 125 g portion of tinned mackerel (containing 7.8 g n-3 LCPUFA26) every week, to replace a portion of red meat or poultry. Previous n-3 LCPUFA intervention study among South Asian people in the United Kingdom was able to reverse lipid abnormalities with supplementation of 2.5 g of EPA and DHA per day for 12 weeks. However, the same study also shows that their daily consumption of EPA and DHA is only 68±99 and 112±171 mg respectively. Therefore, only 1.1 g n-3 LCPUFA per day is given in this study to increase compliance. Recipe recommendations using mackerel will be provided. Non-diabetic volunteers will be recruited only to obtain baseline data in order to compare their metabolic profile with that of the diabetic volunteers. This will allow us to investigate the link between omega 3 status and glycaemic control in a South Asian population. Fish is chosen as an intervention as opposed to EPA and DHA supplements in order to capture the benefits of eating fish as an important source of not only n-3 LCPUFA, but also other key nutrients such as vitamin D, selenium and iodine.

NCT ID: NCT02839850 Active, not recruiting - Osteoarthritis Clinical Trials

14022 ATTUNE Cementless RP Clinical Performance Evaluation

Start date: September 1, 2016
Phase: N/A
Study type: Interventional

The primary objective of this study is to examine the change from pre-operative baseline to two year postoperative functional performance improvement for the ATTUNE primary, cementless TKA RP system as measured with the KOOS questionnaire (KOOS-ADL sub-score). This will be carried out for two configurations: cruciate retaining rotating platform (ATTUNE Cementless CR RP) and posterior stabilized rotating platform (ATTUNE Cementless PS RP).

NCT ID: NCT02828618 Active, not recruiting - Ovarian Cancer Clinical Trials

Trial on Radical Upfront Surgery in Advanced Ovarian Cancer

TRUST
Start date: July 2016
Phase: N/A
Study type: Interventional

This study consists of three parts, whereas Part 1 and Part 2 are performed in Germany only, and Part 3 is a multinational trial. All patients with suspicion of advanced ovarian cancer are detected in the participating study centers in a pre-screening. The study centers will register all patients with suspected ovarian cancer in a screening log. After the patients have given informed consent, they can be enrolled in different parts of the study. TRUST-Trial: This part compares two strategies in the therapy of advanced ovarian cancer. En detail, this part of the trial will evaluate if one of two strategies of timing surgery within the therapeutic procedures may show any significant advances in terms of overall survival over the other.

NCT ID: NCT02825836 Active, not recruiting - Clinical trials for Chronic Lymphocytic Leukemia

Phase I/II, FIH, Dose Escalation Trial of TL-895 and Expansion of TL-895 Monotherapy and Combination Therapy With Navtemadlin in Tx-Naïve and R/R CLL/SLL Subjects

Start date: August 26, 2016
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this research study is to determine the safety and tolerability of TL-895. There are 2 parts of this study. Part 1 tested increasing doses of TL-895 to identify the recommended safe dose for participants with relapsed/refractory (R/R) B cell malignancies who failed at least 1 but no more than 3 prior therapies. Part 1 of this study is no longer enrolling participants. Arms 1 & 2 of Part 2 of this study will test different doses of TL-895 in participants with R/R CLL or SLL who have failed at least 1 prior therapy. Arms 1 & 2 of Part 2 of this study is randomized (like the flip of a coin) to receive a specific treatment dose. If someone participates in arms 1 or 2 of Part 2, the dose they receive will be either 100mg twice a day or 150mg twice a day. Arms 3 and 4 of Part 2 of this study will test the 150mg and 100mg BID dose of TL-895, respectively in treatment naïve participants with CLL/SLL. Arms 5 and 6 of Part 2 will test 150mg TL-895 BID in combination with 240 mg navtemadlin QD in participants with relapsed/refractory and treatment naïve without 17p(del). Arm 7 will test 150mg TL-895 in combination with 240 mg navtemadlin QD in participants with relapsed/refractory CLL/SLL with 17p(del). Every participant in this study will receive TL-895.

NCT ID: NCT02820571 Active, not recruiting - Low Back Pain Clinical Trials

The Oxford Pain, Activity and Lifestyle (OPAL) Cohort Study

OPAL
Start date: October 4, 2016
Phase:
Study type: Observational

The OPAL study is about health outcomes in older adults. The investigators are surveying 4,000 adults across England to see how health and physical activity change over time. The information that is collected will help the investigators to understand how a person's health, including conditions such as back pain, affect their mobility as they age, and provide insight into improving the management of health in older adults.

NCT ID: NCT02819596 Active, not recruiting - Clinical trials for Renal Clear Cell Carcinoma

MEDI4736 Combinations in Metastatic Renal Cell Carcinoma

CALYPSO
Start date: January 2017
Phase: Phase 2
Study type: Interventional

This study is being carried out to see if the drugs MEDI4736, Savolitinib and Tremelimumab can be used alone or in combination to reduce the size of tumours in patients with kidney cancer. The drugs being tested in this study have an anti-tumour effect and have been tested in pre-clinical and human studies before. MEDI4736 and tremelimumab work with the immune system to help the body fight against tumour cells with immune cells. Savolitinib works to correct a faulty signal which causes tumour growth. If a patient is eligible for the study and decides to take part, they will be enrolled into one of 3 stages of the study. - First stage [CLOSED TO RECRUITMENT]: aims to find the optimal dose of MEDI4736+savolitinib. - Second stage [CLOSED TO RECRUITMENT]: patients with papillary cell cancer will be treated with MEDI4736+savolitinib. Patients with clear cell cancer will be randomised to one of four treatment arms and receive MEDI4736, savolitinib, MEDI4736+savolitinib, or MEDI4736+tremelimumab. - Third stage [NOT YET OPEN TO RECRUITMENT]: patients will be tested for biomarkers before enrolment, and depending on the results will be allocated to one of 2 treatments (MEDI4736 alone or MEDI4736+tremelimumab) to see if certain biomarkers are linked to drug efficacy.

NCT ID: NCT02816671 Active, not recruiting - Lobectomy Clinical Trials

MicroCutter Assisted Thoracic Surgery Hemostasis Registry

MATCH
Start date: June 2016
Phase:
Study type: Observational [Patient Registry]

The primary purpose of this prospective, open-label, multi-center observational registry with all-comers enrollment is to report on the use of the MicroCutter Stapler in a real world setting in thoracic surgical procedures. Procedures may be open or video assisted thoracic surgery (VATS) including robotic surgical cases. Clinicians will provide objective and subjective evaluation of the use of the stapler in their procedures.

NCT ID: NCT02816606 Active, not recruiting - Clinical trials for Anterior Cruciate Ligament Rupture

Anterior Cruciate Ligament Radiology Follow-up Study

Start date: June 2016
Phase:
Study type: Observational

Following recent advances in the understanding of successful anterior cruciate ligament (ACL) reconstruction, three important factors have been identified: femoral tunnel positioning, femoral tunnel aperture shape, and native remnant preservation. Accordingly, the researchers have adapted their technique to address these goals. This study is designed to assess the feasibility of evaluating these graft characteristics, on post-operative imaging, and the ability to show potential improvements with the researchers' technical changes. The study plans to use three-dimensional computer tomography (3D-CT) and magnetic resonance imaging (MRI) to assess these properties and the integration of the graft. In addition, the researchers will use their routine functional scores to monitor the patients' outcome. If successful, the research team hope to set-up a randomised control trial of this alternative technique versus conventional methods with assessment through the same imaging mediums and clinical follow-up.

NCT ID: NCT02811861 Active, not recruiting - Clinical trials for Renal Cell Carcinoma

Lenvatinib/Everolimus or Lenvatinib/Pembrolizumab Versus Sunitinib Alone as Treatment of Advanced Renal Cell Carcinoma

CLEAR
Start date: October 13, 2016
Phase: Phase 3
Study type: Interventional

The primary purpose of the study is to demonstrate that lenvatinib in combination with everolimus (Arm A) or pembrolizumab (Arm B) is superior compared to sunitinib alone (Arm C) in improving progression-free survival (PFS) (by independent imaging review [IIR] using Response Evaluation Criteria in Solid Tumors [RECIST 1.1]) as first-line treatment in participants with advanced renal cell carcinoma (RCC).