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NCT ID: NCT05154500 Completed - Potato Clinical Trials

Iron and Zinc Bioavailability From Biofortified Potatoes

Start date: August 29, 2018
Phase: N/A
Study type: Interventional

Two of the most common nutritional deficiencies are anemia and zinc deficiency. One strategy for combating nutritional deficiencies is biofortification. The primary objective of the proposed research is to determine in humans the bioavailability of iron and zinc from biofortified potatoes as compared to a non-fortified local variety. The secondary objective is to use the data obtained from the human studies to model the potential impact of the introduction of biofortified potatoes to the alleviation of iron and zinc deficiencies in the Andean Highlands and low and middle-income countries elsewhere. Iron bioavailability studies: The investigators will compare bioavailability of iron from a non-fortified potato variety with a biofortified potato that has significantly higher iron content though the use of a randomized cross-over intervention study. Female volunteers will consume both biofortified potato extrinsically labelled with 58FeSO4 and a nonfortified potato labelled with 57FeSO4. Thirty women with marginal iron status (plasma ferritin < 25 ng/ml) will be selected from an initial screening of 180 women. Every woman will receive 2 different types of test meals in a series of 20 servings for 10 days each. Blood samples will be collected during screening and on days 1, 15, 26 and 40 and the amount of 58Fe and 57Fe incorporated into hemoglobin and serum ferritin quantified. Zinc bioavailability study: The investigators will compare bioavailability of zinc from a non-fortified potato variety with that of a biofortified potato that has significantly higher zinc content (p<0.001) with a crossover study. Forty volunteers will be randomly assigned to receive first either the biofortified or the non-fortified potato and receive the second meal 30 days later. Zinc absorption from two meals will be measured using the double stable isotope technique. Every volunteer will be given an i.v. infusion of 70zinc and two test meals of 250 g cooked potato labelled extrinsically with 67zinc separated by 3-4 hr. A spot urine sample will be collected 96 hours after each set of test meal and the ratio of the two isotopes measured to calculate absorption of zinc from the test meal. Modelling and Impact assessment: Data on bioavailability will be used in a Disability Adjusted Life Year model to assess the potential impact of biofortified potatoes to alleviate iron and zinc deficiencies in the Andean Highlands and low and middle-income countries elsewhere.

NCT ID: NCT05138133 Recruiting - Lupus Nephritis Clinical Trials

Phase 3 Study of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis

IRIS
Start date: February 15, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of IV antifrolumab in adult patients with Active Proliferative Lupus Nephritis

NCT ID: NCT05117788 Active, not recruiting - Clinical trials for Tuberculosis, Multidrug-Resistant

Bioneer IRONqPCR ™ RFIA Kit Kit Clinical Evaluation

Start date: February 23, 2022
Phase:
Study type: Observational

Evidence of the clinical diagnostic accuracy and operational characteristics of the Bioneer IRONqPCR ™ RFIA Kit is needed to comprehensively evaluate Bioneer RFIA validity and inform global and national policy decision-making. The rapid diagnosis and appropriate treatment of M/XDR-TB is essential to prevent significant morbidity, mortality and further transmission of disease. The FQ are key components of the new bedaquiline-containing 6-9 month regimen, and so it is necessary to rule-out resistance to these compounds prior to treating patients with the shorter regimen. Currently there are no WHO endorsed tests that can identify resistance to both first and second-line drugs in one reaction.

NCT ID: NCT05113251 Active, not recruiting - Breast Cancer Clinical Trials

Trastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early Breast Cancer

Start date: October 25, 2021
Phase: Phase 3
Study type: Interventional

This study will look at the efficacy and safety of trastuzumab deruxtecan (T-DXd) in a neoadjuvant setting, in high-risk, HER2-positive early non-metastatic breast cancer.

NCT ID: NCT05103709 Recruiting - Clinical trials for Iron Deficiency Anemia

Effect of Multiple Micronutrient Fortified Bread Consumption on Iron Deficiency Anemia in Women of Reproductive Age

Start date: August 3, 2021
Phase: N/A
Study type: Interventional

The project aims to assess if consuming two slices of multi-fortified bread daily for 120 days is effective in reducing iron deficiency anemia in women of reproductive age through a three-arm randomized trial.

NCT ID: NCT05097989 Recruiting - Lupus Nephritis Clinical Trials

Study of ALXN2050 in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)

Start date: January 14, 2022
Phase: Phase 2
Study type: Interventional

This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study of ALXN2050 (120 and 180 milligrams [mg]) in addition to background therapy consistent with the standard of care in adult participants (≥ 18 to ≤ 75 years of age) with either LN or IgAN. The study will consist of an up to 6-week Screening Period, a 26-week blinded Initial Evaluation Period, a 24-week blinded Extended Treatment Period, and an Open-label Extension (OLE) Period of up to 2 years. Safety will be monitored throughout the study.

NCT ID: NCT05093933 Active, not recruiting - Clinical trials for Chronic Heart Failure With Reduced Ejection Fraction

A Study of Vericiguat (MK-1242) in Participants With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF) (MK-1242-035)

VICTOR
Start date: November 2, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of vericiguat in participants with chronic heart failure with reduced ejection fraction (HFrEF), specifically those with symptomatic chronic HFrEF who have not had a recent hospitalization for heart failure or need for outpatient intravenous (IV) diuretics. The primary hypothesis is that vericiguat is superior to placebo in reducing the risk of cardiovascular death or heart failure hospitalization.

NCT ID: NCT05083117 Withdrawn - Clinical trials for COVID-19 Acute Respiratory Distress Syndrome

Safety and Efficacy of Inhaled XW001 For Hospitalized COVID-19 Patients Requiring Oxygen Therapy

Start date: October 30, 2021
Phase: Phase 2
Study type: Interventional

This is a multiregional, randomized, double-blind, placebo-controlled Phase 2 study in patients with confirmed symptomatic COVID-19, designed to evaluate the safety, tolerability, efficacy, and PK of XW001 (IL-29 analog) inhalation solution. The purpose of this study is to evaluate whether treatment with XW001 reduces the likelihood of worsening disease in patients with severe COVID-19. Hospitalized patients on oxygen therapy by mask or nasal prongs (WHO-OSCI score 4) will be enrolled.

NCT ID: NCT05052801 Recruiting - Gastric Cancer Clinical Trials

Bemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression

FORTITUDE-101
Start date: March 7, 2022
Phase: Phase 3
Study type: Interventional

The main objective of this study is to compare efficacy of bemarituzumab combined with oxaliplatin, leucovorin, and 5-fluorouracil (5-FU) (mFOLFOX6) to placebo plus mFOLFOX6 as assessed by overall survival (OS) in participants with FGFR2b ≥10% 2+/3+ tumor cell staining (FGFR2b ≥10% 2+/3+TC)

NCT ID: NCT05039619 Recruiting - Lupus Nephritis Clinical Trials

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescents With Active Class III or IV Lupus Nephritis and the Safety and PK of Obinutuzumab in Pediatric Participants

POSTERITY
Start date: May 12, 2022
Phase: Phase 2
Study type: Interventional

This phase II, randomized, double-blind, placebo-controlled study is designed to evaluate the safety, efficacy and pharmacokinetics (PK) of obinutuzumab in adolescent participants (AP) aged 12 to less than 18 with biopsy-confirmed proliferative lupus nephritis (LN). It will also evaluate open label safety and PK of obinutuzumab in pediatric participants (PP), aged 5 to <12 with LN.