louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03458858: Berry Components and Blood Sugar & Fat Metabolism
Official title: Berry Components and Blood Sugar & Fat Metabolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: USDA Beltsville Human Nutrition Research Center
Sponsor class: FED
First posted: 2018-03-08
Enrollment: 36
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The primary objective of this study is to determine which components of berries improve glucose metabolism and increase fat oxidation in humans.

Detailed description: The aim of this study is to improve understanding of how diet can regulate glucose metabolism and fuel use. Previous human and animal studies have demonstrated that berries can improve gluco-regulation and increase fat oxidation. The aim of this study is to determine which component of berries is conveying this health benefit.

Eligibility criteria: Inclusion Criteria:

* Healthy non-smoker
* able to understand consent

Exclusion Criteria:

* Body Mass Index less than 25 kg/m2
* pregnant, lactating, having given birth in the past year
* allergy to berries
* blood glucose greater than 125 mg/dL
* history of bariatric surgery or nutrient malabsorption disease
* diagnosis or treatment of cancer in past three years
* type 2 diabetes requiring the use of diabetes pills, insulin, or non-insulin shots

Primary outcomes:
measure: Glucose Metabolism Phase 1
timeFrame: Day 8
measure: Glucose Metabolism Phase 2
timeFrame: Day 29
measure: Glucose Metabolism Phase 3
timeFrame: Day 50
measure: Glucose Metabolism Phase 4
timeFrame: Day 71
Secondary outcomes:
measure: Insulin sensitivity
timeFrame: Day 8, 29, 50, 71
measure: Fat trafficking
timeFrame: Day 8, 29, 50, 71
measure: Peripheral mononuclear blood cells energetics
timeFrame: Day 8, 29, 50, 71
measure: Metabolic Fuel Use
timeFrame: Day 7-8, 28-29, 49-50, 70-71
Other outcomes:
measure: Metabolomics in blood
timeFrame: Day 8, 29, 50, 71
Locations:
city: Beltsville
country: United States
facility: USDA-ARS Beltsville Human Nutrition Research Center
state: Maryland
Study officials:
References:
Clinical trial NCT04442958: Effectiveness of Convalescent Immune Plasma Therapy
Official title: Effectiveness of Convalescent Immune Plasma Therapy in Severe COVID-19 Patients With Acute Respiratory Distress Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Respiratory Distress Syndrome
Lead sponsor: Bagcilar Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2020-06-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the safety, improvement of clinical symptoms and laboratory parameters of convalescent immune plasma treatment in severe Covid-19 patients with ARDS.

Detailed description: The aim of the study is to evaluate the safety, improvement of clinical symptoms with hypoxemia, metabolic and laboratory parameters of patients with convalescent immune plasma treatment in severe Covid-19 patients followed up in critical care unit.

Eligibility criteria: Inclusion Criteria Clinical diagnosis of Covid-19

Exclusion Criteria Age lower than 18 Lower plasma IgA levels PaO2/FiO2 higher than 300 mmHg SpO2 higher than 90

Primary outcomes:
measure: Plasma ferritin level
timeFrame: 7. day
measure: Lymphocyte count
timeFrame: 7. day
measure: D-Dimer level
timeFrame: 7. day
measure: C-Reactive protein level
timeFrame: 7. day
measure: Plasma procalcitonin level
timeFrame: 7. day
measure: Plasma fibrinogen level
timeFrame: 7. day
Secondary outcomes:
measure: Fractional Inspired Oxygen Level
timeFrame: 7. day
measure: Partial Oxygen Saturation level
timeFrame: 7. day
measure: Arterial Oxygen level
timeFrame: 7. day
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Bagcılar Training and Research Hospital
Study officials:
affiliation: Istanbul Bagcılar Training and Research Hospital
name: Salih SS Sevdi, Md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04446858: Non-invasive Evaluation of the Predictive Value of CEUS and SWE in ACLF, Renal Failure and Hepatorenal Syndrome
Official title: Non-invasive Evaluation of the Predictive Value of CEUS and SWE in Patients With and Without TIPS With ACLF, Renal Failure and Hepatorenal Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Kidney Failure, Acute
Keywords: transjugular intrahepatic portosystemic shunt (TIPS)
non-invasive assessments
circulating biomarkers
Transthoracic echocardiography (TTE) with Speckle-tracking
Elastography
Contrast-enhanced ultrasound
Computer tomography scan (CT-scan)
Magnetic resonance imaging (MRI)
Urine biomarker
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2020-06-25
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with portal hypertension and kidney failure are eligible for inclusion

Brief summary: Evaluation of non-invasive prognostic parameters in patients developing ACLF and renal failure in patients receiving and not receiving transjugular intrahepatic portosystemic shunt (TIPS). Patients are cared according to the local standardized follow up program. Clinical and laboratory data from standard patient care are evaluated for potential prognostic value.

Detailed description: NECTAR consists of patients with ACLF and renal failure with and without receiving transjugular intrahepatic portosystemic shunt (TIPS) at the Department of Internal Medicine I, University of Bonn, Germany and receiving a structured routine evaluation and follow up program. The diagnosis of cirrhosis was based on clinical, hemodynamic and biochemical parameters, and ultrasound and/or biopsy criteria.

Eligibility criteria: Inclusion Criteria:

* All patients with portal hypertension and kidney failure

Exclusion Criteria:

* no consent, no kidney failure, no portal hypertension

Primary outcomes:
measure: Survival
timeFrame: up to 10 years
Secondary outcomes:
measure: Ascites
timeFrame: up to 10 years
measure: Hepatic Encephalopathy
timeFrame: up to 10 years
measure: Variceal Bleeding
timeFrame: up to 10 years
measure: Liver Failure
timeFrame: up to 10 years
measure: Acute-on-Chronic Liver Failure
timeFrame: up to 10 years
measure: Kidney Failure
timeFrame: up to 10 years
measure: Organ Failures
timeFrame: up to 10 years
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: University Hospital Bonn
Study officials:
affiliation: University Hospital, Bonn
name: Michael Praktiknjo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06883058: Implementation of the Caregivers-Patients Support Coping with Advanced-Cancer (CASA) Intervention.
Official title: Implementation of the Caregivers-Patients Support Coping with Advanced-Cancer (CASA) Intervention.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Advanced Cancer
Caregivers
Patients
Stage III Cancer
Stage IV Cancer
Lead sponsor: Ponce Medical School Foundation, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2025-03-19
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This pre-pilot aims to prepare the PI to receive hands-on experience in implementation and dissemination and design and lead pilot studies in palliative care. The catchment area communities experience lower cancer health outcomes and are more likely to be diagnosed with advanced cancer when compared to other surrounding areas. The PI's catchment area experiences advanced cancer, and their caregivers are at an increased risk for unmet psychosocial needs; this pre-pilot will allow the PI to focus on this critical gap in equal healthcare. The research goal of this proposal is to refine and pre-pilot an intervention titled Caregivers Patients Support to Cope with Advanced Cancer (CASA), a five-session, 60-minute telehealth series for patient-caregiver dyads. The rationale for this project is that it will lay the groundwork for a Randomized Control Trial (RCT) testing the efficacy of CASA. It will also assess the implementation of an innovative method to deliver the CASA intervention. This study aims to use the collaborative intervention planning framework and ORBIT model to modify and assess the feasibility and preliminary effect of the CASA intervention. The overall impact of this study is to improve access to psychosocial, culturally adapted interventions in the proposed catchment area.


Eligibility criteria: Inclusion Criteria:

* Cancer patients must be stage III and IV solid tumor patients who report distress \>4 on the Distress Thermometer
* Caregivers. Identified caregivers by distressed patients.

Exclusion Criteria:

* (1) diagnosed with a major disabling medical or psychiatric condition, (2) unable to understand the consent procedure, or (3) too ill to participate, all as reported by the participant and/or determined by the investigator's judgment.

Primary outcomes:
measure: FACIT-Sp
timeFrame: 5 minutes
Secondary outcomes:
measure: PHQ-9
timeFrame: 5 minutes
measure: GAD-7
timeFrame: 5 minutes
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01907958: Management of Albuminuria in Hypertensive Diabetics
Official title: A Multicentre Study to Evaluate the Management of Microalbuminuria in Hypertensive Patients With Type 2 Diabetes: Improving Clinical Practice
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Microalbuminuria
Hypertension
Type 2 Diabetes
Keywords: Microalbuminuria
Hypertensive
Diabetics
urine albumin
Lead sponsor: Medpharmgene, Inc.
Sponsor class: INDUSTRY
First posted: 2013-07-25
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 18 years and older Uncontrolled blood pressure Type 2 diabetes

Brief summary: Multicenter stepped wedge cluster randomized trial of family practice clinics in Quebec and Ontario comparing the effect of introducing a Point of Care testing (POCT) for urine albumin to usual practice on quality of care in hypertensive patients with Type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Male or female 18 years and older and able to visit the study sites every 3 months
* T2D patients with ongoing anti-diabetic therapy for at least 5 years
* Uncontrolled hypertension according to 2012 CHEP recommendations for management of hypertension in diabetic patients ( i.e. BP\> 130/80 mmHg)
* Able and agreeing to provide informed consent.

Exclusion Criteria:

* Type 1 diabetes patients
* Ongoing therapy with perindopril,
* Known hypersensitivity or allergies to ACEI or sulfonamide derivatives,
* A history of angioedema related or not to previous treatment with ACEI,
* Impaired renal function defined as serum creatinine levels \> 177 µmol/L, eGFR \<30 mL/min,
* Hyperkalemia or hypokalemia,
* Severe hepatic impairment,
* Use of non-antiarrhythmic agents causing torsade de pointes,
* Pregnant or lactating women, or who are planning to become pregnant,
* Any conditions which may impact on participation according to treating physician.

Primary outcomes:
measure: Stabilisation or improvement of urine albumin excretion status by at least one stage
timeFrame: 1 year
Secondary outcomes:
measure: Microalbuminuria (or further stages of CKD) after 12 months
timeFrame: 12 months
Other outcomes:
measure: Demographics, medical history and medication Diabetes and hypertension status Blood pressure measurements
timeFrame: 12 months
Locations:
city: Montreal
country: Canada
facility: Medpharmgene
state: Quebec
Study officials:
References:
Clinical trial NCT04721158: CGM Use in Children With Type 2 Diabetes
Official title: IMPlementation of Continuous Glucose Monitoring in Children With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Hyperglycemia Due to Type 2 Diabetes Mellitus
Keywords: continuous glucose monitoring (CGM)
Hemoglobin A1c
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 41
Sex: ALL
Minimum age (years): 5
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this prospective study is to determine if trial use of a Dexcom G6 CGM system for a 10 day wear period in pediatric Type 2 diabetes patients improves short term time in range glucose control and 3-6 month glycemic control.

Detailed description: The purpose of this prospective study is to determine if trial use of a Dexcom G6 CGM system for 10 days has an impact on short and long term glycemic control and behavior in youth onset Type 2 diabetes.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes, diabetes duration \>3 months

Exclusion Criteria:

* Prior use of CGM

Primary outcomes:
measure: Percentage of Time in Range Glucose Control
timeFrame: 5 days, 10 days
measure: Hemoglobin A1c
timeFrame: Baseline, 3 - 6 months
measure: More Frequent Insulin Administration
timeFrame: 10 days from CGM placement
measure: More Frequent Glycemic Control Monitoring
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Pediatric Diabetes Center
state: Maryland
Study officials:
affiliation: Johns Hopkins School of Medicine
name: Risa M Wolf, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00411658: Devitalized Non-valved Pulmonary Artery Allograft Implant for the Repair of Congenital Cardiac Abnormalities
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: NA-Study Withdrawn
Lead sponsor: LifeNet Health
Sponsor class: INDUSTRY
First posted: 2006-12-14
Enrollment: 0
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: Study no longer required



Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00728858: The Efficacy, Safety and Genetic Polymorphism of Hypoca and Adalat OROS in Hypertensive Patients
Official title: An Open-Label, Randomized Clinical Study to Evaluate the Efficacy, Safety and Genetic Polymorphism of Hypoca(Barnidipine)and Adalat OROS(Nifedipine) in Mild to Moderate Hypertensive Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: Hypertension
SNP
Nifedipine
Barnidipine
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2008-08-06
Enrollment: 43
Sex: ALL
Minimum age (years): 22
Maximum age (years): 87
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hypertension patients living in Taiwan

Brief summary: Nifedipine and barnidipine act as calcium channel blockers, and are widely prescribed for pressure control of prehypertension and stage 1 hypertension.

CYP3A4 is responsible for the metabolism of nifedipine and nifedipine, while the contribution of CYP3A5 remains ambiguous. This study is aimed to analyze the association between antihypertensive effects of nifedipine as well as barnidipine and single nucleotide polymorphisms of CYP3A4, CYP3A5 and calcium channels.

Detailed description: For each drug, 20 patients will be enrolled. Patients' blood pressure and heart rates will be measured at first visit, followed by visits at week4 , week 8 and week 12. Blood samples will be drawn at week 4 and week 12 for following analyses of drug plasma concentrations. SNPs in CYP3A4, CYP3A5 and calcium channel v 1.2 will be genotyped using SNPstream.

The differences in the decrease of blood pressures and the durg plasma concentrations between genotypes will be analyzed.

Eligibility criteria: Inclusion Criteria:

* 20\~90 years old patient
* mild to moderate hypertensive patients
* can finish this study
* can sign agreement

Exclusion Criteria:

* severe hypertension
* Heart failure, Arrhythmia
* Liver or kidney failure
* pregnant women
* allergy to dihydropyridines
* attend other clinical trials in past 3 month

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National Taiwan University Hospital
name: FU-TIEN CHIANG, Doctor
role: STUDY_CHAIR
References:
Clinical trial NCT04327258: The Influence of NPPA/NPPB Haplotype on Natriuretic Peptide Plasma Levels
Official title: The Influence of NPPA/NPPB Haplotype on Natriuretic Peptide Plasma Levels
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Surgical Procedure, Operative
Keywords: genetic association study
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2020-03-31
Enrollment: 437
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for elective surgery

Brief summary: Crosssectional study to analyse the genetic influence on levels of cardiac biomarkers (BNP, NT-proBNP).

Detailed description: Background

Natriuretic peptides play an important role in risk stratification and management of patients undergoing non-cardiac surgery. However, due to genetic variability, the levels of these biomarkers may differ in individual patients with cardiac derangement. In the preoperative setting, genetic contribution to natriuretic peptide plasma level variability has not yet been determined.

Objective

The aim of this study is to assess genetic contribution to NP plasma level variability in a Swiss cohort.

Methods

Cross-sectional association study in a cohort of non-cardiac surgery patients.

This study is a Subproject of a prospective cohort study registered under the ID 041/09.

Eligibility criteria: Inclusion Criteria:

* 18 years and older
* Written informed consent
* Scheduled surgery

Exclusion Criteria

* No informed consent
* Cognitive impairment

Primary outcomes:
measure: Influence of NPPA/NPPB haplotype on natriuretic peptide plasma levels
timeFrame: Blood samples collected at start of anesthetic procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern
Study officials:
affiliation: Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern
name: Frank Stüber, Prof. MD
role: STUDY_CHAIR
affiliation: Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern
name: Ulrike M Stamer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00178958: Evaluation of QTc Interval by Continuous Holter ECG Recording in Antipsychotic Drug-treated Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Schizoaffective
Bipolar Disorder
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The aim of this study is to evaluate the utility of continuous Holter ECG recording with automated, computerized data analysis for measuring antipsychotic-related QTc prolongation during a 24-h period under clinical conditions


Eligibility criteria: Inclusion Criteria:

1. Subjects will be males or females between 18 - 65 years of age.
2. Patient subjects will have a definite diagnosis by DSM-IV criteria, schizophrenia, schizoaffective disorder, or bipolar disorder.
3. Patient subjects are currently under treatment with any antipsychotic, any mood stabilizer, any antidepressant or any combination of the above at the therapeutic dose for at least 3 months.
4. Patients have a history of taking the medications listed in item 3 as prescribed.
5. The subjects must be able to provide written informed consent

Exclusion Criteria:

1. Subjects with a DSM-IV diagnosis of substance dependence as defined by DSMN within three months prior to selection.
2. Subjects who are currently taking other medications that have been shown to prolong the QTc, including tricyclic antidepressants (e.g. amitriptyline, imipramine, maprotiline), fluoroquinolones, or antiarrhythmics (e.g. quinidine, procainamide, amiodarone, sotalol).

   -

Primary outcomes:
measure: The aim of this study is to evaluate the utility of continuous Holter ECG recording with automated, computerized data analysis for measuring antipsychotic-related QTc prolongation during a 24-h period under clinical conditions.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Vanderbilt University Medical Center
name: Herbert Y Meltzer, M.D.
role: PRINCIPAL_INVESTIGATOR
References: