Clinical trials: SDS
Age-related Cataract, Vision Loss
Long-term Safety & Performance of REVISYON SDS100 in Mild to Moderate Cataract: Extension Study (EB-CE-02)
A non-interventional, extension study on the long-term maintenance of safety and performance of the REVISYON SDS 100 medical device in subjects with mild-to-moderate cataract.
- Conditions
- Age-related Cataract, Vision Loss, Cataract, Mild Cataract
- Trial name
- EB-CE-02 (NCT07246915)
- Where
- 6 sites in Romania
- Volunteers
- 47 people
- Sponsor
- Edinburgh Biosciences Ltd
COVID19
Evaluation of the AudibleHealth Dx AI/ML-Based Dx SaMD Using FCV-SDS in the Diagnosis of COVID-19 Illness
The AudibleHealth Dx is a diagnostic software as a medical device (Dx SaMD) consisting of an ensemble of software subroutines that interacts with a proprietary database of Signal Data Signatures (SDS), using Artificial…
- Trial name
- NCT05175690
- Testing
- Diagnostic Software as Medical Device
- Where
- United States
- Volunteers
- 1,126 people, healthy volunteers welcome
- Sponsor
- AudibleHealth AI, Inc.
2019 Novel Coronavirus Disease, 2019 Novel Coronavirus Infection
Evaluation of the AudibleHealth Dx AI/ML-Based Dx SaMD Using FCV-SDS in the Diagnosis of COVID-19 Illness: Clinical Validation
The AudibleHealth Dx is a diagnostic software as a medical device (Dx SaMD) consisting of an ensemble of software subroutines that interacts with a proprietary database of Signal Data Signatures (SDS), using Artificial…
- Conditions
- 2019 Novel Coronavirus Disease, 2019 Novel Coronavirus Infection, 2019-nCoV Disease, COVID-19 Pandemic
- Trial name
- NCT05364268
- Testing
- Diagnostic Test: Diagnostic Software as Medical Device
- Where
- United States
- Volunteers
- 514 people, healthy volunteers welcome
- Sponsor
- AudibleHealth AI, Inc.
Healthy
Pharmacokinetics and Safety of BILR 355 in Healthy Male Volunteers
Study to determine the single dose, relative BA of new SDS-containing formulations of BILR 355 (150 mg and 200 mg capsules and 150 mg tablet), compared to the current SDS tablet formulation (50 mg tablet)
- Trial name
- NCT02253940
- Testing
- BILR 355 - Treatment A (current tablet formulation), BILR 355 - Treatment B (new tablet formulation), BILR 355 - Treatment C (new capsule formulation)
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Heart Failure With Reduced Ejection Fraction
Synchronized Diaphragmatic Stimulation in Symptomatic Heart Failure
RECOVER HF is a clinical study designed to evaluate the safety and efficacy of Synchronized Diaphragmatic Stimulation delivered using the VisONE System in the treatment of patients with heart failure.
- Trial name
- RECOVER-HF (NCT06552637)
- Testing
- Synchronized Diaphragmatic Stimulation
- Where
- 5 sites in United States, Georgia
- Volunteers
- 270 people
- Sponsor
- VisCardia Inc.
Blood Glucose Kinetics
Plasma Glucose Kinetics and Cereal Product Content in Slowly Digestible Starch (SDS) in Healthy Volunteers
The present study aims at investigating the effect of ingesting 2 cereal products differing by their SDS content on the kinetics of glucose in healthy volunteers.
- Trial name
- NCT02323542
- Testing
- Nutrition intervention with cereal products
- Where
- Canada
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Mondelēz International, Inc.
Healthy
Single Rising Oral Doses of BI 207127 NA as Powder in the Bottle in Healthy Male Subjects
The objective of this trial was to investigate the safety, tolerability, pharmacokinetics, and relative bioavailability of BI 207127 NA as powder in the bottle (PIB) and solid oral dosage form (tablets) without and with food.
- Trial name
- NCT02182388
- Testing
- BI 207127 NA powder for solution, BI 207127 NA tablet
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Sedation to be Moderate for a Diagnostic Gastrointestinal Endoscopy and Gastrointestinal Endoscopic Polypectomy
Phase III Study of ICI35,868 (Diprivan) With and Without EES0000645/A (SDS) on Gastrointestinal Endoscopy
This study is designed as a multi-centre, randomised, parallel-group, placebo-controlled, phase III confirmatory study. The study will be partially double-blinded: the comparison between Group 1 (placebo group) and Group 2…
- Trial name
- Kagami_SDS (NCT01961349)
- Testing
- Intralipid, ICI35,868 (Diprivan), ICI35,868 (Diprivan) + EES0000645/A (SDS)
- Where
- 3 sites in Japan
- Volunteers
- 279 people
- Sponsor
- AstraZeneca
Neutropenia
A Study of Mavorixafor in Participants With Congenital and Acquired Primary Autoimmune and Idiopathic Chronic Neutropenic Disorders Who Are Experiencing Recurrent and/or Serious Infections
The purpose of this study is to demonstrate the efficacy and evaluate the safety and tolerability of mavorixafor in participants with congenital or acquired primary autoimmune and idiopathic chronic neutropenic disorders who are…
- Trial name
- NCT06056297
- Testing
- Mavorixafor
- Where
- 114 sites in United States, Argentina and 23 more
- Volunteers
- 176 people
- Sponsor
- X4 Pharmaceuticals
Coronary Artery Disease
NEXUS Study for the Treatment of de Novo Native Coronary Artery Lesions
The objective of this study is to evaluate the effectiveness and safety of the CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-Wire (OTW) Stent Delivery System (SDS) in patients with de novo native coronary…
- Trial name
- NCT00231283
- Testing
- CYPHER NxT SES ON BX SONIC OTW STENT DELIVERY SYSTEM (SDS)
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Cordis US Corp.
Metabolic Disorder; Carbohydrate, Absorption, Intestine
Determination of the Postprandial Responses to Two Cereal Foods Differing by Their SDS Content Consumed Alone.
This study aimed at determining the 4-hours postprandial blood glucose and insulin responses to the ingestion of cereal product differing by their SDS content.
- Trial name
- NCT02538653
- Testing
- Sandwich biscuit high in SDS, Co-extruded cereal low in SDS
- Where
- Australia
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Mondelēz International, Inc.
Metabolism and Nutrition Disorders
Determination of the Postprandial Responses to Two Cereal Foods Differing by Their SDS Content and GI Consumed Alone.
This is a laboratory-based research study conducted in two parts. Open cross-over design. 2 test sessions per subject included in the study.
- Trial name
- NCT02538640
- Testing
- High-SDS biscuit, Low-SDS extruded cereals
- Where
- Australia
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Mondelēz International, Inc.
Aged Skin
Assessment of the Efficacy and Barrier Protection of Two Cosmetic Products
The aim of the study was to assess the long-term efficacy and barrier protection properties of two cosmetic products on the volar forearms of 20 elderly subjects after four weeks of treatment compared to two untreated test areas.
- Trial name
- NCT03629405
- Testing
- C - pH 4 Cosmetic Product WO 3741, D - pH 5.8 Cosmetic Product WO 4081-1
- Where
- Germany
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Dr. August Wolff GmbH & Co. KG Arzneimittel
Primary Immune Deficiency Disorders, Hemophagocytic Lymphohistiocytosis
Safety Study of Gene Modified Donor T Cell Infusion After Stem Cell Transplant for Non-Malignant Diseases
The purpose of this study is to determine a safe dose of BPX-501 gene modified T cells infused after a haplo-identical stem cell transplant to facilitate engraftment and the safety of Rimiducid (AP1903) on day 7 to prevent GVHD.
- Conditions
- Primary Immune Deficiency Disorders, Hemophagocytic Lymphohistiocytosis, Inherited Bone Marrow Failure Syndrome, Hemoglobinopathies
- Trial name
- NCT02231710
- Testing
- BPX-501 and Rimiducid
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Bellicum Pharmaceuticals
Heart Failure With Reduced Ejection Fraction
RECOVER-HF Pilot Study of SDS in Heart Failure
The RECOVER HF pilot is a feasibility study for evaluating a randomized, doubled-blinded study design to determine the benefits and risks of chronically delivering Synchronized Diaphragmatic Stimulation (SDS) in Heart Failure…
- Trial name
- NCT05592392
- Testing
- Synchronized Diaphragmatic Stimulation
- Where
- 2 sites in Georgia, Uzbekistan
- Volunteers
- 35 people
- Sponsor
- VisCardia Inc.
Healthy
Dose Escalation Study of Pharmacokinetics, Safety and Tolerability After Single Dose Administration of BILR 355 (SDS) Plus Low-dose Ritonavir in Healthy Volunteers
The primary objective was to explore the relative bioavailability of increasing doses of BILR 355 BS, as a sodium dodecyl sulfate-containing solid formulation (SDS), in combination with ritonavir 100 mg and to explore the…
- Trial name
- NCT02253927
- Testing
- BILR 355 - D1, BILR 355 - D2, BILR 355 - D3
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Insulin Resistance
Impact of Starch Digestibility on Glycemic Variability and Control, Cardiometabolic and Inflammatory Profiles, Microbiota and Intestinal Health in Subjects With Insulin Resistance
To study the potential impact of a diet rich in both Slowly Digestible Starch (SDS) and Resistant Starch (RS), we propose a 2-month nutritional intervention study in which we will study the evolution of carbohydrate variability…
- Trial name
- GLYMICARE (NCT07408479)
- Testing
- Balanced diet high in Slowly Digestible Starch and Resistant Starch, Balanced diet low in Slowly Digestible Starch and Resistant Starch
- Where
- France
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Mondelēz International, Inc.
Type2 Diabetes
Cardio-metabolic and Inflammatory Impact of Starch Digestibility in Type 2 Diabetic Patients
This is a monocentric, randomized, single-blind and controlled study with a parallel design (2 arms). The research hypothesis is that the diet high in Slow Digestible Starch (SDS) content (H-SDS) will lower the daylong glycemic…
- Trial name
- NCT03847701
- Testing
- Balanced diet high in Slowly Digestible Starch, Balanced diet low in Slowly Digestible Starch
- Where
- France
- Volunteers
- 53 people
- Sponsor
- Mondelēz International, Inc.
Age-related Cataract
Study On The Performance And Safety Of The REVISYON SDS 100 Device On Visual Acuity In Subjects With Cataract
Single arm, unmasked study to evaluate the performance and safety of the REVISYON SDS 100 Device for the non-invasive treatment of vision loss in age-related cataract.
- Trial name
- NCT05396547
- Testing
- Treated with REVISYON SDS 100 Device
- Where
- 11 sites in Latvia, Lithuania and 1 more
- Volunteers
- 114 people
- Sponsor
- Edinburgh Biosciences Ltd
Type2 Diabetes
Evaluation of 2 Diets With Different Starch Digestibility Profiles on Daily Glycemic Profile, in T2D Patients
The study is a randomized cross-over pilot study. The research hypothesis is that the diet high in SDS content (H-SDS) will lower the daylong glycemic response and improve the glycemic control in patients with type 2 diabetes…
- Trial name
- NCT03289494
- Testing
- Balanced diet high in Slowly Digestible Starch, Balanced diet low in Slowly Digestible Starch
- Where
- France
- Volunteers
- 9 people
- Sponsor
- Mondelēz International, Inc.