louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03020485: The Glycaemic Effect of Isomaltulose Consumption in Healthy Participants
Official title: The Glycaemic Effect of Isomaltulose Consumption in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: Singapore Institute of Food and Biotechnology Innovation
Sponsor class: OTHER_GOV
First posted: 2017-01-13
Enrollment: 46
Sex: ALL
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The objective of this study is to determine the glycaemic effect of isomaltulose and sucrose in Chinese, Indian, Malay, and Caucasian individuals. The current study will provide important information on the potential health benefits of isomaltulose consumption in Asian population. It will also reveal how the three main ethnicities in Singapore respond to isomaltulose and whether the response differs from the Caucasians.

Detailed description: The objective of the present study is to investigate the glycaemic effect of isomaltulose in Chinese, Indians, Malays and Caucasians. This will be a single intervention. Up to fifty participants, consisting of at least ten Chinese, ten Malays, ten Indians, and ten Caucasians completed data sets, aged between 21 and 40 years will be recruited from the general public in Singapore. Participants will be asked to attend two test sessions for this study. Participants will consume either a sucrose drink or an isomaltulose drink (each containing 50 g of available carbohydrate).

Eligibility criteria: Inclusion Criteria:

* Chinese, Indian, Malay or Caucasian ethnic origin

Exclusion Criteria:

* People with major chronic disease such as heart disease, cancer or diabetes mellitus
* Individuals with food intolerances or allergies to isomaltulose or sucrose
* Individuals who are taking insulin or drugs known to affect glucose metabolism and body fat distribution
* People with a major medical or surgical event requiring hospitalization within the preceding 3 months
* Individuals with the presence of disease or drugs which influence digestion and absorption of nutrients
* Pregnant women

Primary outcomes:
measure: Change in post prandial Blood glucose for 180 minutes period
timeFrame: 180 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Clinical Nutrition Research Centre
name: Melvin Leow, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04274985: Reliability, Validity of The Turkish Version of Fonseca Anamnestic Index
Official title: Reliability, Validity of The Turkish Version of Fonseca Anamnestic Index
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Temporomandibular Joint Disorders
Keywords: Validity
Reliability
Temporomandibular Joint Disorders
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2020-02-18
Enrollment: 249
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with temporomandibular disorders between the ages of 18-50

Brief summary: The aim in this study is to determine the Turkish version validity and reliability of the Fonseca Anamnestic Index.

Detailed description: Approximately 60% of individuals with temporomandibular disorders (TMD) reported increased pain intensity from midlevel to severe. This was seen at the end of the intervention or work related activities in the quarter of individuals. Therefore, the correct diagnosis of TMD is very important to reduce the economic cost. Fonseca Anamnestic Index (FAI) is an easy and understandable questionnaire. This questionnaire consists of 10 questions that provide a versatile evaluation of the temporomandibular joint (TMJ) in the head and neck, whether there is pain during chewing, the presence of parafunctional habits, range of motion, joint sounds, malocclusion, and emotional stresses. The participants give one of the answers to the questions "Yes = 10 points, Sometimes = 5 points, No = 0 points". As a result of the total of the points, the participants are evaluated as "TMD-None = 0-15 points, Mild-TMD = 20-40 points, Moderate TMD = 45-60 points, Severe-TMD = 100 points". The aim of this study was to evaluate the validity and reliability of the Turkish version of FAI. The study of validity and reliability is planned with 50 individuals with TMD. The sociodemographic characteristics of the individuals will be questioned by the investigators and then the patients will be evaluated with FAI, Craniofacial Pain and Disability Inventory (CF-PDI), Neck Disability Index (NDI), Tampa Scale for Kinesiophobia (TSK), Pain Catastrophizing Scale (PCS), Headache Impact Test-6 (HIT-6), Jaw Functional Limitation Scale (JFLS) (Turkish version) and Visual Analogue Scale (VAS). The test-retest will be re-administered by face-to-face interview technique after 1 week. The results will be analyzed using the SPSS version 22.0 computer package program.

Eligibility criteria: Inclusion Criteria:

* Having a temporomandibular disorder
* Individuals who suited Temporomandibular Disorders/ Research Diagnostic Criteria classification

Exclusion Criteria:

* Pregnant,
* Canser,
* Trauma,
* Neurologic disorder,
* Infection,
* Trigeminal or postherpatic neuralgia

Primary outcomes:
measure: Fonseca Anamnestic Index (FAI)
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Halime ARIKAN
state: Yenimahalle
Study officials:
References:
Clinical trial NCT02408185: Optimization Dose Study on Pharmacokinetics and Pharmacodynamics of Colistin in Critically Ill Patients
Official title: Pharmacokinetics and Pharmacodynamics of Colistin in Critically Ill Patients With Severe Infections for Dose Optimization Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Critical Illness
Keywords: infections
multidrug resistant Gram negative bacteria (MDR-GNB)
Skin infections
Pneumonia
Bacteriemia
Nosocomial infections
Lead sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor class: OTHER
First posted: 2015-04-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Phase II clinical trial, open-labelled, prospective and single-center study directed to obtain blood samples in experimental detailed conditions in order to compare and optimize the dose of colistin in critically ill patients suffering from infections on which the indication of colistin would be accepted according to normal local protocols for severe infections treatment.


Eligibility criteria: Inclusion Criteria:

* More than 60 Kg of weigh
* Patients with directed treatment with colistin as the recommended antimicrobial treatment protocols in the hospital to treat some of the following serious infections caused by carbapenems resistant A. baumannii: (i) bacteremia; (ii) nosocomial pneumonia or (iii) infection of skin and soft tissue (cellulitis, abscesses or infected ulcers).
* Written informed consent form.

Exclusion Criteria:

* Refractory shock or other illness with an expectative of life ˂ 48 hours after the recruitment;
* Patient declared not to resuscitation maneuvers;
* Suspicion or demonstration of endocarditis, osteomyelitis, or meningitis;
* Known hypersensitivity to polymyxins;
* Pregnancy.

Primary outcomes:
measure: Pharmacokinetic profile; Cmax (maximum reach concentration)/ MIC( Minimum inhibitory concentration) >10
timeFrame: Day 1 and day 3 after treatment
Secondary outcomes:
measure: Number of drug adverse reactions
timeFrame: 21 days of follow-up
measure: Pharmacodynamic profile ("Monte-Carlo simulation" (statistical methodology) with MIC (Minimum inhibitory concentration) 50 y MIC (Minimum inhibitory concentration) 90 from samples isolation)
timeFrame: Day 1 and day 3 after treatment
Other outcomes:
Locations:
city: Seville
country: Spain
facility: Hospital Universitario Virgen del Rocío
Study officials:
affiliation: Instituto de Biomedicina de Sevilla (IBIS)
name: M. Eugenia Pachón, BD-PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospitales Universitarios Virgen del Rocío
name: José Miguel Cisneros, MD-PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06596785: Risk Factors and Deep Learning Model for CI-AKI
Official title: Investigation and Early Risk Prediction of Acute Kidney Injury Caused by Iodinated Contrast Agents: Development of CI-AKIDPi Model Based on Interpretable Deep Learning
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: AKI - Acute Kidney Injury
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: hospital

Brief summary: Contrast-associated acute kidney injury (CI-AKI) is a sudden and significant decline in renal function resulting from the use of a contrast agent.

Detailed description: Contrast-associated acute kidney injury (CI-AKI) is a sudden and significant decline in renal function resulting from the use of a contrast agent. Despite the frequent use of iodinated contrast agents in medical investigations, predictive models for CI-AKI are scarce. This study aimed to construct and validate interpretable deep learning models for the early risk prediction of acute kidney injury (AKI) associated with iodinated contrast agents.

Eligibility criteria: Inclusion Criteria:

* patients who received iodinated contrast agents during hospitalization
* age ≥ 18 years
* hospitalization length ≥ 48 hours
* at least two serum creatinine tests during hospitalization

Exclusion Criteria:

* patients with stage 4 or 5 chronic kidney disease prior to admission
* patients undergoing hemodialysis, hemofiltration or peritoneal before admission
* a history of nephrectomy or kidney transplantation during hospitalization
* incomplete clinical information
* Serum creatinine always ≤ 40 μmol/L during hospitalization

Primary outcomes:
measure: AKI
timeFrame: Completed through study, up to half a year
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: The First Affiliated Hospital of Shandong First Medical University &amp; Shandong Provincial Qianfoshan Hospital
state: Shandong
Study officials:
affiliation: Qianfoshan Hospital
name: Xiao Lii
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01905085: Energy Expenditure Methodology Infant
Official title: Energy Expenditure Methodology Infant
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
First posted: 2013-07-23
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy infants

Brief summary: Indirect calorimetry is valuable in determining resting energy expenditure in infants, children and adults. This measure will estimate the number of calories needed per day under resting conditions.

Adding physical activity measures will help estimate total energy requirements in individuals. With the rise in obesity, numerous programs of prevention are being developed. Being able to characterize carefully energy intake and energy expenditure is one of the challenges of most of these initiatives.


Eligibility criteria: Inclusion Criteria:

* 3 months old +/- 2 weeks
* Can fall asleep easily
* Usually sleeps more than 30 min
* Accept formula as an alternative feeding

Exclusion Criteria:

* Pulmonary or respiratory disorders

Primary outcomes:
measure: Measure Resting energy expenditure in infants
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01391585: Expanding Comparative Effectiveness Research (CER) Capability Through Complex Patient Relationship Management
Official title: Expanding Comparative Effectiveness Research (CER) Capability Through Complex Patient Relationship Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Hyperlipidemia
Keywords: Text
SMS
diabetes
self-monitoring
self-management
adherence
Lead sponsor: Denver Health and Hospital Authority
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2011-07-12
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The investigators are testing whether patients with diabetes can communicate with our health care system through text messaging. The investigators will look at how often they respond to prompts for blood pressures, blood sugars, and step counts. The investigators will also see if they come in for lab tests when prompted by text message. Also, for patients overdue for medication refills, the investigators will ask them why they have not yet called for the refill.

Detailed description: Patients will be sent text messages through a software interface, the Patient Relationship Manager (PRM). A registered nurse will also use PRM to receive incoming responses. Tasks will be created for her to outreach to patients who have out of range text responses or poor response rates. This intervention if a feasibility study to see if patients can communicate with the investigator's health care system and potentially utilize PRM to better manage their diabetes.

Eligibility criteria: Inclusion Criteria:

* age 18-75 years
* diabetes
* own a cell phone
* 2 primary care visits in last year
* English or Spanish speaking

Exclusion Criteria:

* End-stage disease with estimate of less than 6 months to live

Primary outcomes:
measure: response rate to home monitoring prompts
timeFrame: 4 months
Secondary outcomes:
measure: response rate to prompt for lab text by text message
timeFrame: 4 months
measure: response to barrier questions for non-adherence
timeFrame: 4 months
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver Health
state: Colorado
Study officials:
affiliation: Denver Health
name: henry h fischer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00410085: Renal Hemodynamics and Tubular Function in Patients With Obstructive Sleep Apnea and Healthy Controls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obstructive Sleep Apnea
Healthy
Lead sponsor: Regional Hospital Holstebro
Sponsor class: OTHER
First posted: 2006-12-12
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Nitrogen-oxide (NO) plays an important role for blood pressure regulation, renal hemodynamics, and the renal excretion of sodium. NO is synthesized from L-arginine in the vascular endothelium and have a very short half-life in plasma and is therefore very difficult to measure directly.

L-mono-methyl-L-arginine (L-NMMA) is an analogue to L-arginine and a competitive inhibitor of NO, and therefore can be used to study the effect of NO on the circulation. In normal subjects, infusion of L-NMMA will cause an increase in blood pressure, decreased renal plasma-flow, decreased glomerular filtration rate, and a decreased excretion of sodium.

Hypothesis: Patients with obstructive sleep apnea has a decreased activity in the NO-system. This is contributing to the hypertension often seen in these patients. Decreased activity in the NO-system can be revealed by diminished fall in renal hemodynamic and sodium excretion after infusion of L-NMMA.


Eligibility criteria: Inclusion Criteria:

* Obstructive sleep apnea

Exclusion Criteria:

* Drug or alcohol abuse
* Pregnancy
* Disease of the heart, lungs, liver, kidney or endocrine organs
* Cerebral infarction
* Diabetes
* Gastrointestinal disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Holstebro
country: Denmark
facility: Department of Medical Research, Holstebro Hospital
state: Ringkoebing County
Study officials:
affiliation: Regional Hospital Holstebro
name: Erling B Pedersen, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT00351585: A Study to Evaluate the Effect of Vildagliptin on the Maximum Insulin Secretion in Patients With Type 2 Diabetes
Official title: A Double-blind, Placebo-controlled, Randomized, Parallel-group Study to Evaluate the Effects of Vildagliptin on the Maximum Insulin Secretion in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: Vildagliptin
Type 2 diabetes
Insulin secretion
Beta cell
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-07-13
Enrollment: 39
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Type 2 diabetes results when the body does not produce enough insulin to regulate blood sugar. This study is designed to measure the effect of vildagliptin on the maximum insulin secretion by the pancreas.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with type 2 diabetes for at least 6 months
* Patients whose diabetes is controlled by diet and exercise only or patients taking metformin
* BMI in the range 22-45
* Blood glucose criteria must be met

Exclusion Criteria:

* Pregnancy or lactation
* Type 1 diabetes or diabetes resulting from pancreatic injury
* Cardiovascular complications as defined by the protocol
* Significant diabetic complications as defined by the protocol

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Change from baseline in maximal insulin secretory capacity at 12 weeks
measure: Durability of this effect after a 2-week washout
Secondary outcomes:
measure: Change from baseline in beta-cell sensitivity to glucose at 12 weeks
measure: Durability of this effect after a 2-week washout
measure: Chance from baseline in glucagon secretion at 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of Cincinnati
name: David D'Alessio, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: D'Alessio DA, Denney AM, Hermiller LM, Prigeon RL, Martin JM, Tharp WG, Saylan ML, He Y, Dunning BE, Foley JE, Pratley RE. Treatment with the dipeptidyl peptidase-4 inhibitor vildagliptin improves fasting islet-cell function in subjects with type 2 diabetes. J Clin Endocrinol Metab. 2009 Jan;94(1):81-8. doi: 10.1210/jc.2008-1135. Epub 2008 Oct 28.
Clinical trial NCT05686785: Agreement and Reliability of Transient Elastography
Official title: Agreement and Reliability of Transient Elastography in Patients With Chronic Viral Hepatitis - a Cross-sectional Test-retest Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Viral Hepatitis
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2023-01-17
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic viral hepatitis, i.e. chronic hepatitis B (with or without chronic hepatitis D), of chronic hepatitis C.

Brief summary: The aim of this study is to assess agreement, smallest detectable change, and reliability of repeated measurements of liver stiffness of transient elastography in patients with chronic viral hepatitis, and to explore factors associated with disagreement.

Detailed description: Previous studies have reported excellent test-retest reliability for transient elastography (TE) in viral hepatitis. Reliability refers the ability of an instrument to discriminate between study subjects and may be excellent even if considerable measurement-error exists, if the population is heterogenous. Agreement, in contrast, refers to differences of measurements on the original scale (kPa for TE). Whether agreement is acceptable is situation-dependent and can be related to the smallest detectable change (SDC).

Agreement metrics or SDC have not been addressed in previous studies for chronic viral hepatitis. The aim of this study is to assess agreement, SDC, and reliability of repeated measurements of liver stiffness of TE in patients with chronic viral hepatitis, and to explore factors associated with disagreement.

Eligibility criteria: Inclusion Criteria:

* Patients at the departments of infectious diseases in Malmö, Lund and Helsingborg with chronic viral hepatitis.
* Adult patients
* Signed informed consent to participate in the study.

Exclusion Criteria:

* suspected or confirmed pregnancy.
* patients unable to speak Swedish
* inability to sign informed consent.

Primary outcomes:
measure: Disagreement defined as a difference in TE results between operators in KPa of ≥ 33%, as well as the smallest detectable change, SDC95.
timeFrame: Assessed at a 30 min visit to the outpatient clinic
Secondary outcomes:
measure: Reliability, estimated using the intra-class correlation
timeFrame: Assessed at a 30 min visit to the outpatient clinic
measure: Patient and exam characteristics associated with inter-rater differences above our prespecefied threshold.
timeFrame: Assessed at a 30 min visit to the outpatient clinic
Other outcomes:
Locations:
city: Helsingborg
country: Sweden
facility: Oskar Ljungquist
state: Skåne
Study officials:
affiliation: Division of Infection Medicine, Department of Clinical Sciences, Lund University, Lund.
name: Oskar Ljungquist, MD, PhD.
role: PRINCIPAL_INVESTIGATOR
References: