louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04325126: Retinol-binding Protein 4 (RBP4) Metabolizm in Type 2 Diabetes Progression and Associated Cardiovascular Complications
Official title: Retinol-binding Protein 4 (RBP4) Metabolizm in Type 2 Diabetes Progression and Associated Cardiovascular Complications
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2020-03-27
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A total of 500 Chinese patients admitted to the First Affliated Hospital of Xi'an Jiaotong University (Xi'an, China) between March 2020 and March 2022 were recruited to investigate the RBP4 profles. The different groups were matched for age, sex and BMI.

Brief summary: Retinol-binding protein 4 (RBP4) may affects obesity development and the development of obesity-related diseases including insulin resistance, type 2 diabetes, steatohepatitis and cardiovascular disease. This study aims to examine the involvement of RBP4 in patients with diagnosed diabetes, diabetic cardiovascular disease, pre-diabetes (pre-DM) and healthy controls during the progression of T2DM, and to evaluate the ability of RBP4 to predict cases of diabetes with an elevated risk of cardiovascular complications . Along with animal experiment.

Detailed description: A total of 500 Chinese patients admitted to the First Affliated Hospital of Xi'an Jiaotong University (Xi'an, China) between March 2020 and March 2022 were recruited to investigate the RBP4 profles. Peripheral blood samples are drawn at the initial medical examination, in the morning after a fast of at least 8 h, and immediately stored at -80˚C until the sphingolipid measurements were performed.

Blood pressure, WC, hip circumference (HC), body weight and body height were measured by a trained physician. The participants enrolled in the study provided written informed consent.

Eligibility criteria: Inclusion Criteria:

T2DM:

* Fasting plasma glucose (FPG)≥7.0 mmol/l;
* 2 h plasma glucose (2hPG) ≥11.1 mmol/l;
* glycated hemoglobin (HbA1c) level ≥6.5%;
* random plasma glucose ≥11.1 mmol/l plus symptoms of hyperglycemia;
* T2DM diagnosed previously.

Pre-DM was defned as follows:

* FPG ≥5.6-6.9 mmol/l
* 2hPG 7.8-11.0 mmol/l
* HbA1c 5.7-6.4%.

Exclusion Criteria:

* type 1 diabetes
* liver or kidney disorders.

Primary outcomes:
measure: serum RBP4 level
timeFrame: 2022.3
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Jing Sui, doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05729126: The Discrepancy in Radiologists' Practice of Intravenous Contrast Imaging Studies Among Chronic Kidney Disease Patients
Official title: The Discrepancy in Radiologists' Practice of Intravenous Contrast Imaging Studies Among Chronic Kidney Disease Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Diseases
Chronic Kidney Disease 5D
Keywords: Chronic kidney disease
Hemodialysis
Intrevenous Contrast
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2023-02-15
Enrollment: 266
Sex: ALL
Minimum age (years): 24
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Radiology physicians

Brief summary: * There is a discrepancy between protocols used for intravenous imaging for chronic kidney disease including hemodialysis patients among different hospitals and even, among radiologists same selves.
* This questionnaire based study aims to quantify that discrepancy and describe the variables associated with the discrepancy.

Detailed description: * There is a discrepancy between protocols used for intravenous imaging for chronic kidney disease including hemodialysis patients among different hospitals and even, among radiologists same selves.
* This questionnaire-based study aims to quantify that discrepancy and describe the variables associated with the discrepancy.

Eligibility criteria: Inclusion Criteria:

* Practicing radiologist

Exclusion Criteria:

* retired radiologist

Primary outcomes:
measure: time from IV contrast study and next dialysis session
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Benha Faculty of Medicine
state: Qalubia
Study officials:
References:
Clinical trial NCT03801226: Zero Sodium Peritoneal Dialysate Protocol Pilot Study
Official title: Zero Sodium Peritoneal Dialysate Protocol in Human Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Potential Applications for Heart Failure
Volume Overload
Keywords: Peritoneal dialysis
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2019-01-11
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The following pilot study will be undertaken to determine the effects of use of a zero-sodium peritoneal dialysate solution (10% dextrose in sterile water) on sodium removal as compared to a standard peritoneal dialysis solution.

Detailed description: While heart failure (HF) is generally regarded as the inability of the heart to pump sufficient blood, on a population level, volume overload is the primary driver of morbidity and hospitalization. The signs and symptoms of volume overload are driven by water accumulation, which is initially driven by sodium retention. This overall goal of this study is to investigate the ability to remove sodium through use of a zero-sodium solution in peritoneal dialysis.

Eligibility criteria: Inclusion Criteria:

1. Patients actively undergoing peritoneal dialysis (PD) with a functioning PD catheter
2. PD vintage \< 3 years
3. As judged by treating nephrologist to be at or above optimal volume status (i.e., not dehydrated)

Exclusion Criteria:

1. Uncontrolled diabetes with frequent episodes of severe hyperglycemia
2. Systolic blood pressure \< 100 mmHg
3. Serum sodium \< 130 mEq/L
4. 1 or more episodes of peritonitis in the previous 6 months or active infection of the peritoneal dialysis catheter
5. Anemia with hemoglobin \<8 g/dL
6. Serum bicarbinate \< 18 mEq/L
7. Anuric renal failure
8. Inability to give written informed consent or follow study protocol

Primary outcomes:
measure: Safety and tolerability measured by protocol discontinuation due to patient discomfort or adverse event
timeFrame: Two hours
Secondary outcomes:
measure: Comparison of total sodium removed compared to baseline
timeFrame: Two hours
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
References:
citation: Rao VS, Turner JM, Griffin M, Mahoney D, Asher J, Jeon S, Yoo PS, Boutagy N, Feher A, Sinusas A, Wilson FP, Finkelstein F, Testani JM. First-in-Human Experience With Peritoneal Direct Sodium Removal Using a Zero-Sodium Solution: A New Candidate Therapy for Volume Overload. Circulation. 2020 Mar 31;141(13):1043-1053. doi: 10.1161/CIRCULATIONAHA.119.043062. Epub 2020 Jan 8.
Clinical trial NCT02290626: Elemental Diets vs. Semi-solid Diets on Gastric Excretion and Gastroesophageal Regurgitation
Official title: Randomized Comparison of Elemental Diets and Semi-solid Diets on Gastric Excretion and Gastroesophageal Regurgitation in Bedridden Gastrostomy-fed Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Gastro-oesophageal Reflux
Keywords: Elemental diet
semi-solid diet
gastric emptying
GER
PEG
Lead sponsor: Showa Inan General Hospital
Sponsor class: OTHER
First posted: 2014-11-14
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Study 1: A randomized, crossover trial using elemental or semi-solid diets containing contrast medium as a tracer given to bedridden PEG patients. The distribution of the administered diets is assessed at the distal esophagus, proximal and distal stomach using a plain CT before and 1 hour after the administration.

Study 2: A randomized, crossover trial using elemental or semi-solid diets containing 13C sodium acetate as a tracer given to bedridden PEG patients. 13C breath tests are performed to estimate gastric emptying.

Detailed description: Study 1: A mix of elemental or semi-solid diet (300 kcal/300 mL ) and contrast medium (5ml) is administered using PEG, respectively. Using a plain CT, the distribution of the administered diet is assessed at the distal esophagus, proximal and distal stomach before and 1 hour after the administration. The volume of the residual diet at the distal esophagus, proximal and distal stomach is compared between an elemental and semi-solid diet.

Study 2: Either the elemental diet or semi-solid diet (200 kcal/200 mL) is labeled with 100 mg \[13C\]sodium acetate (Cambridge Isotope Laboratories Inc, Cambridge, MA) and is administered in the first 15 min of the examination at the same speed using the PEG.

Eligibility criteria: Inclusion Criteria:

* Bedridden PEG patients are admitted for fever which is the most common reason for admission of PEG patients to our hospital.

Exclusion Criteria:

* Regular use of gastric acid blockers, motility drugs, benzodiazepines or opioids, any clinical evidence of acute infection, a history of abdominal surgery, and an American Society of Anesthesiologists physical status of class IV or V.

Primary outcomes:
measure: Gastroesophageal regurgitation
timeFrame: A half year
Secondary outcomes:
measure: Gastric excretion
timeFrame: A half year
Other outcomes:
Locations:
city: Komagane
country: Japan
facility: Showa Inan General Hospital
Study officials:
affiliation: Showa Inan General Hospital
name: Akira Horiuchi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02620826: Prospective Comparison of Indirect Pulp Therapy and Mineral Trioxide Aggregate Pulpotomy in Decayed Primary Molars
Official title: Prospective Comparison of Indirect Pulp Therapy and Mineral Trioxide Aggregate Pulpotomy in Decayed Primary Molars
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Pulp Capping
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2015-12-03
Enrollment: 110
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This prospective study compares the use of indirect pulp therapy and mineral trioxide aggregate pulpotomy for pulp therapy of the primary molar with dental caries approaching the pulp.


Eligibility criteria: Inclusion Criteria:

* Child with at least one primary molar with deep decay approaching the pulp.

Primary outcomes:
measure: Clinical assessment of pulp vitality
timeFrame: 10 years
Secondary outcomes:
measure: Radiographic assessment of pulp vitality
timeFrame: 10 years
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
References:
Clinical trial NCT00530426: Heart Failure Registry
Official title: ADHERE Core II - Acute Decompensated HEart Failure REgistry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure, Congestive
Keywords: Heart Failure, Congestive
Registry
Acute Decompensated Heart Failure
Dyspnea
Lead sponsor: Scios, Inc.
Sponsor class: INDUSTRY
First posted: 2007-09-17
Enrollment: 150000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE

Brief summary: The purpose of this registry is to compile a large clinical database on the medical management of patients hospitalized with acute heart failure, using information collected from acute care hospitals across the United States.

Detailed description: ADHERE is a phase IV, multicenter, observational, open-label registry of the management of patients treated in the hospital for acute heart failure (HF) in the United States. The target population consists of patients admitted to an acute care hospital who are treated actively for acute heart failure, where acute HF is defined as new-onset HF with decompensation; or chronic HF with decompensation. Patient eligibility is based upon the presence of an acute HF diagnosis and is not tied to the use of any specific therapeutic agent or regimen. Collect data on the episode of hospital care beginning with the point of initial care in the hospital and/or emergency department and ending with the patient's discharge, transfer out of the hospital, or in-hospital death.

N/A

Eligibility criteria: Inclusion Criteria:

* Received or is eligible to receive a principal hospital discharge diagnosis of HF or decompensated HF is present as determined clinically by the patient care team

Exclusion Criteria:

* Heart Failure is present as a co-morbid condition, but is not a principal focus of diagnosis or treatment during this hospitalization episode

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Scios, Inc.
name: Scios, Inc. Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Adams KF Jr, Fonarow GC, Emerman CL, LeJemtel TH, Costanzo MR, Abraham WT, Berkowitz RL, Galvao M, Horton DP; ADHERE Scientific Advisory Committee and Investigators. Characteristics and outcomes of patients hospitalized for heart failure in the United States: rationale, design, and preliminary observations from the first 100,000 cases in the Acute Decompensated Heart Failure National Registry (ADHERE). Am Heart J. 2005 Feb;149(2):209-16. doi: 10.1016/j.ahj.2004.08.005.
Clinical trial NCT01966926: Self-Weighing Instruction Feasibility Study
Official title: Self-Weighing Instruction Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Body Weight
Keywords: self monitoring
self weighing
weight tracking
psychosocial outcomes
feasibility
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2013-10-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Scant data have been reported on the effects of weight self-monitoring during weight control. The purpose of this pilot project was to consider the questions: Is it possible to assign participants to engage in daily weight self-monitoring, and are there differential effects on mood of daily versus weekly weighing?

Detailed description: This study tested the feasibility of assigning participants to daily or weekly weighing, monitored adherence to weighing instructions, and tracked additional behavioral and psychosocial indicators over a period of six months. It was hypothesized that there would be no differences in mood or adherence between daily versus weekly weighing conditions. Knowledge about the benefits of frequent self-weighing may shape public health recommendations for regular weighing as a weight reduction or obesity prevention strategy.

Eligibility criteria: Inclusion Criteria:

* Body mass index between 25 and 35 kg/m2

Exclusion Criteria:

* Current weight loss program participation
* Chronic health conditions (diabetes, cancer, heart disease, psychiatric disorders requiring medication)
* Current or past eating disorder
* Current pregnancy or pregnant in past year

Primary outcomes:
measure: Adherence to Weight Tracking Instructions
timeFrame: 6 months
Secondary outcomes:
measure: Changes in Depression Ratings
timeFrame: baseline to 6 months
measure: Changes in Anxiety
timeFrame: baseline to 6 months
measure: Changes in Body Image
timeFrame: baseline to 6 months
measure: Changes in Barriers to Weight Tracking
timeFrame: baseline to 6 months
measure: Changes in Perceptions of Weight Tracking
timeFrame: three to six months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Jennifer A Linde, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03409926: The Need for FibEr Addition in SympTomatic Heart Failure
Official title: The Need for FibEr Addition in SympTomatic Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Heart Disease
Cardiovascular Disease
Diet
Fiber
Microbiome
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2018-01-24
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: FEAST-HF is a single-centre clinical trial in ambulatory patients with chronic HF to evaluate whether dietary supplementation with acacia gum reduces HF-related biomarkers NT-proBNP and ST2 and how the gut microbiome responds to dietary supplementation with acacia gum. The hypotheses of this study are 1) that changes in the gut microbiome will be correlated with a reduction in NT-proBNP and ST2 in patients with HF after treatment with acacia gum, and 2) gut microbiome configurations (composition, diversity), stability and function (gene content) will be significantly altered in patients with HF in response to acacia gum.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Willing and able to provide informed consent
* Patients with established Heart Failure (as per their treating physician) including those with both reduced and preserved ejection fraction

Exclusion Criteria:

* Patients requiring a special diet that would prohibit the intervention (e.g. celiac disease, irritable bowel disease)
* Patients who do not control their own meals (e.g. meals-on-wheels, long-term care)
* Patients with conditions that would interfere with the analysis of the microbiome (e.g. chronic diarrhea, recent antibiotics within the past month)

Primary outcomes:
measure: NT-proBNP
timeFrame: 12 weeks
Secondary outcomes:
measure: Composite Clinical Outcomes
timeFrame: 12 weeks
measure: Quality of Life
timeFrame: 12 weeks
measure: NYHA Functional Class
timeFrame: 12 weeks
measure: 6-Minute Walk Test
timeFrame: 12 weeks
measure: Fecal Microbiome Characterization
timeFrame: Baseline, Week 6, Week 12
measure: ST-2
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Mazankowski Heart Institute
state: Alberta
Study officials:
affiliation: University of Alberta
name: Justin Ezekowitz, MBBCh
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01076426: Probiotics Use in the Chronic Peritoneal Dialysis Patients
Official title: The Clinical Use of Probiotics in the Uremia Patients Under Chronic Peritoneal Dialysis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Peritonitis
Malnutrition
Keywords: probiotic
peritoneal dialysis
peritonitis
nutrition status
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
Collaborators: name: Pro-bio Biotech Co. Ltd.
First posted: 2010-02-26
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether probiotics can improve the nutrition status and prevent peritonitis in the chronic peritoneal dialysis patients.

Detailed description: Peritoneal dialysis was one of therapies for uremia patient. However, peritoneal dialysis related peritonitis was a major complication for these patients. Severe and prolong peritonitis may led to membrane failure and drop out of peritoneal dialysis. Among the pathogens, G(+) bacteria came from skin surface and G(-) bacteria came from gastrointestinal tract. The later might be related to the pathogens in the gastrointestinal tract, and led to peritonitis if constipation or diarrhea developed. In addition, intestinal pathogens may be related to chronic inflammation in uremia patients. There was a MIA syndrome (malnutrition, inflammation and atherosclerosis) noted before, and chronic inflammation may be related to malnutrition. Today, we know that nutrition status and inflammation marker (CRP) may be associated with patients' outcome. Many gastrointestinal syndromes such as constipation suffer our patients. The dialysate in the abdominal cavity may further exacerbate the appetite. The probiotics was though to improve the pathogens in intestinal tract, improve gastrointestinal function. We want to decrease the incidence of peritonitis by using the probiotics. In addition, the improvement in gastrointestinal function can increase the nutrition status.

Eligibility criteria: Inclusion Criteria:

* 1. uremia patient under chronic peritoneal dialysis ≧ 3 months
* 2. Age between 16 and 75 years

Exclusion Criteria:

* 1. uremia patient with advanced malignance disease
* 2. uremia patient had more than 2 episode of G(+) peritonitis within the last one year
* 3. uremia patient with expected life ≦ 1 years
* 4. uremia patient with the history of drug or alcohol abuse
* 5. uremia patient with poor drug compliance
* 6. uremia patient with active infection disease
* 7. uremia patient with uncontrolled autoimmune disease such as SLE

Primary outcomes:
measure: peritonitis rate
timeFrame: one year
measure: nutrition status
timeFrame: 3, 6, 9, 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
Study officials:
affiliation: National Cheng-Kung University Hospital
name: An-Bang WU, MD
role: PRINCIPAL_INVESTIGATOR
References: