Clinical Trials Logo

Filter by:
NCT ID: NCT04165447 Completed - Food Selection Clinical Trials

Evaluating the Effectiveness of Within Versus Across-Category Front-of-Package Lower-Calorie Labelling on Food Demand

Start date: October 1, 2017
Phase: N/A
Study type: Interventional

The important role that diet plays in health and disease is well established, as is its association with rising rates of obesity—a phenomenon of increasing concern in Singapore. Changes in lifestyle patterns, including a movement towards a more western-style diet with an emphasis on pre-packaged and fast food, have contributed to the upward trend in weight. This study aims to test two competing approaches for calorie labelling in efforts to reduce total calories purchased. In Arm 1 (termed across category labelling) a low calorie logo will be displayed on the 20% of products on the web store that are lowest in calories per serving. Arm 2 will display this logo on the 20% of products that are lowest in calories per serving within each product category (termed within category labelling). Arm 3 is the Control condition which will not display any logo on any products. For our primary outcome, the investigators hypothesize that the proportion of labelled products (or those that would have been labelled if not in control arm) purchased in each intervention arm will be greater than in control. For secondary hypotheses the investigators expect the following ordering across the three (Control, Within category, Across category) arms: 1. total calories (adjusted for household size): C > A > W 2. calories per serving: C > A > W 3. calories per dollar spent: W > A > C 4. total dollars spent (adjusted for household size) : W > A > C

NCT ID: NCT04156555 Completed - Clinical trials for Antibiotic-associated Diarrhea

Antibiotic-Associated Diarrhea and the Role of Microorganisms in the Gut

Start date: August 1, 2019
Phase: Phase 4
Study type: Interventional

Amoxicillin-clavulanate is an antibiotic commonly prescribed to treat a myriad of community-acquired infections. One of the most common adverse effects of amoxicillin-clavulanate is antibiotic-associated diarrhea (AAD). Studies have shown that administration of antibiotics can cause disruption and changes in the diversity of microorganisms within the gut (gut microbiome), with overgrowth of "harmful" bacteria as a possible driver for AAD. How antibiotics specifically affect the gut microbiome to cause AAD in humans, however, remains unknown. The overall goal of the study is to characterize the changes in the gut microbiome over time, in subjects who develop AAD after antibiotic ingestion, and to further demonstrate that resolution of AAD is due to return of "friendly, anti-diarrhea bacteria". The study investigators will also measure the proteins produced by the gut bacteria, as a potential tool to help predict which individuals are at risk of AAD. The investigators plan to recruit 30 healthy adult volunteers who will receive 3 days of oral amoxicillin-clavulanate, a very commonly prescribed antibiotic. Stool and blood samples will be collected throughout the study up to 28 days after antibiotic administration. The study investigators will measure and compare the changes in the gut microbiome and metabolic responses in order to identify the relationship between these changes and the onset of AAD. The results from this study will not only yield important scientific knowledge about the pathogenesis of AAD, but will also provide new leads to understand the interplay between the gut microbiome, immune-metabolism and AAD. These findings also have the potential to identify clinically important biomarkers to allow pre-identification of individuals at risk of AAD. If successful, this study could pave the way for personalized medicine for management of bacterial infections. This will help to prevent premature stoppage of antibiotic therapy due to diarrhea side effects, and reduce the risk of bacterial resistance from suboptimal treatment.

NCT ID: NCT04154956 Active, not recruiting - Clinical trials for Non-small Cell Lung Cancer Metastatic

SAR408701 Versus Docetaxel in Previously Treated, Carcinoembryonic Antigen-related Cell Adhesion Molecule 5 (CEACAM5) Positive Metastatic Non-squamous Non-small-cell Lung Cancer Patients

CARMEN-LC03
Start date: February 6, 2020
Phase: Phase 3
Study type: Interventional

Primary Objectives: - Study is designed with two primary endpoints that will be analyzed on randomized participants at the time of the cut-off date for each given analysis (progression free survival [PFS] and overall survival [OS]) - Study success is defined either on PFS or OS - The primary objective is to determine whether tusamitamab ravtansine improves the progression free survival (PFS) when compared to docetaxel in participants with metastatic non-squamous non-small-cell lung cancer (NSCLC) expressing CEACAM5 greater than or equal to 2+ in intensity in at least 50% of the tumor cell population and previously treated with standard-of-care platinum-based chemotherapy and an immune checkpoint inhibitor (ICI) - The primary objective is to determine whether tusamitamab ravtansine improves the overall survival (OS) when compared with docetaxel in participants with metastatic non-squamous NSCLC expressing CEACAM5 greater than or equal to 2+ in intensity in at least 50% of the tumor cell population and previously treated with standard-of-care platinum-based chemotherapy and an immune checkpoint inhibitor. Secondary Objectives: - To compare the objective response rate (ORR) of tusamitamab ravtansine with docetaxel - To compare the health-related quality of life (HRQOL) of tusamitamab ravtansine with docetaxel - To evaluate the safety of tusamitamab ravtansine compared to docetaxel - To assess the duration of response (DOR) of tusamitamab ravtansine as compared with docetaxel

NCT ID: NCT04154189 Completed - Osteosarcoma Clinical Trials

A Study to Compare the Efficacy and Safety of Ifosfamide and Etoposide With or Without Lenvatinib in Children, Adolescents and Young Adults With Relapsed and Refractory Osteosarcoma

Start date: March 23, 2020
Phase: Phase 2
Study type: Interventional

This Is a Multicenter, Randomized, Open-Label, Parallel-Group, Phase 2 Study to Compare the Efficacy and Safety of Lenvatinib in Combination with Ifosfamide and Etoposide Versus Ifosfamide and Etoposide in Children, Adolescents, and Young Adults with Relapsed or Refractory Osteosarcoma.

NCT ID: NCT04142437 Recruiting - Clinical trials for Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion

Study to Learn More About the Safety and Effectiveness of the Drug VITRAKVI During Routine Use in Patients With TRK Fusion Cancer Which is Locally Advanced or Spread From the Place Where it Started to Other Places in the Body

ON-TRK
Start date: April 3, 2020
Phase:
Study type: Observational

In this observational study researcher want to learn more about the effectiveness of drug VITRAKVI (generic name: larotrectinib) and how well the drug is tolerated during routine use in patients with TRK fusion cancer which is locally advanced or spread from the place where it started to other places in the body. TRK fusion cancer is a term used to describe a variety of common and rare cancers that are caused by a change to the NTRK (Neurotrophic Tyrosine Kinase) gene called a fusion. During this fusion, an NTRK gene joins together, or fuses, with a different gene. This joining results in the activation of certain proteins (TRK fusion proteins), which can cause cancer cells to multiply and form a tumor. VITRAKVI is an approved drug that blocks the action of the NTRK gene fusion. This study will enroll adult and paediatric patients suffering from a solid tumor with NTRK gene fusion for whom the decision to treat their disease with VITRAKVI has been made by their treating physicians. During the study, patients' medical information such as treatment information with VITRAKVI, other medication or treatments, changes in disease status and other health signs and symptoms will be collected within the normal medical care by the treating doctor. Participants will be observed over a period from 24 to 60 months.

NCT ID: NCT04140500 Recruiting - Clinical trials for Non-small Cell Lung Cancer

Dose Escalation Study of a PD1-LAG3 Bispecific Antibody in Patients With Advanced and/or Metastatic Solid Tumors

Start date: November 11, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This is a first-in-human, open-label, multicenter, Phase I multiple-ascending dose (MAD) study of RO7247669, an anti PD-1 (programmed death-1) and LAG-3 (Lymphocyte-activation gene 3) bispecific antibody, for participants with advanced and/or metastatic solid tumors. This study aims to establish the maximum tolerated dose (MTD) and/or define the recommended phase 2 dose (RP2D) based on the safety, tolerability, pharmacokinetic (PK) and/or pharmacodynamic (PD) profile of RO7247669, and to evaluate preliminary anti-tumor activity in participants with solid tumors. An expansion part of the study is planned to enroll tumor-specific cohorts to evaluate anti-tumor activity of the MTD and/or RP2D of RO7247669 and to confirm safety and tolerability in participants with selected tumor types.

NCT ID: NCT04138914 Active, not recruiting - Prostate Cancer Clinical Trials

Phase II Trial of Focal Cryotherapy for Prostate Cancer

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

The current standard of care treatment for prostate cancer confined to the prostate is surgical removal or irradiation of the entire prostate gland. This is effective at curing cancer but result in damage to critical adjacent structures such as the urinary sphincter muscle and erectile nerves resulting in impaired urinary continence and erectile dysfunction. The concept of focal therapy is to treat just the dangerous focus of cancer in the prostate while monitoring the rest of the gland, thus avoiding impairment of urinary continence and erectile function. We aim to evaluate the degree of preservation of continence and erectile function and early oncological outcomes in patients undergoing focal therapy of the prostate using cold energy or cryo- ablation. In this study, we seek to evaluate patient reported outcomes in urinary, sexual, bowel and general health areas at fixed time points after focal cryo-ablation in selected patients with low-volume, localized cancer. The primary goal of this study is to demonstrate whether there is a deterioration of scores in these health areas over 1 year of follow-up. The secondary goal is to measure cancer control at 1 year re-biopsy. Further goals include longer follow-up to monitor cancer progression rates and impact on patient survival.

NCT ID: NCT04138862 Completed - Clinical trials for Markedly Reduced Food Intake

The Reduced Calorie Food and Mood Study

Start date: September 9, 2017
Phase: N/A
Study type: Interventional

Health- and nutrient-related labelling is often used to draw consumer's attention to the potential benefits of consuming one product over another. However, research suggests that products believed to be 'healthier' and/or lower calorie are often experienced as less satiating, and may actually prompt people to consume more or these foods, or others. The current research aimed to whether consuming a reduced-calorie product labelled "Healthier Choice" affects compensatory eating behaviour (relative to an unlabelled product), and the extent to which this depends on the product's sensory characteristics. A two-session randomised study was used to test the satiety value of a reduced-calorie beverage - characterised as changes in rated appetite and later food intake (kcal) relative to an original-calorie version - consumed in one of four contexts varying in label and sensory cues. The beverage-contexts were assessed in a non-crossover manner.

NCT ID: NCT04137510 Completed - Clinical trials for Coronary Artery Disease

Bioflow-DAPT Study

Start date: February 24, 2020
Phase: Phase 4
Study type: Interventional

BIOFLOW-DAPT is a prospective, multi-center, international, two-arm randomized controlled clinical study. A total of 1'948 subjects will be randomized 1:1 to receive either Orsiro Mission or Resolute Onyx. After index procedure, all patients will receive DAPT (ASA + P2Y12 inhibitor) for 30 days, followed by monotherapy with either P2Y12 inhibitor or ASA only until the end of the study. Clinical follow-up visits will be scheduled at 1, 6 and 12 months post-procedure.

NCT ID: NCT04129502 Active, not recruiting - Clinical trials for Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)

TAK-788 as First-Line Treatment Versus Platinum-Based Chemotherapy for Non-Small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations

Start date: January 10, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the effectiveness of TAK-788 as first-line treatment with that of platinum-based chemotherapy in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors has epidermal growth factor receptor (EGFR) exon 20 insertion mutations. Participants will be randomly assigned to one of the two treatment groups- TAK-788 group or Platinum-based chemotherapy group. Participants will receive TAK-788 orally and pemetrexed/cisplatin or pemetrexed/carboplatin via vein until the participants experience worsening disease (PD) as assessed by blinded independent review committee (IRC), intolerable harmful effects or another discontinuation criteria.