louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01614834: Validation of an Urticaria Control Test
Official title: Development (and Validation) of an Instrument to Assess Disease Control in Patients With Urticaria (Urticaria Control Test)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Urticaria
Keywords: urticaria
disease control
severity
test
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2012-06-08
Enrollment: 120
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients suffering from chronic forms of urticaria

Brief summary: The aim of this study is to validate a previously developed patient reported outcome instrument (in project UCT-D) to assess disease control in chronic urticaria patients (Urticaria Control Test - UCT) of age 12 and older.


Eligibility criteria: all patients suffering from chronic forms of urticaria are eligible

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Universitätshautklinik Mainz
state: Rheinland-Pfalz
city: Berlin
country: Germany
facility: Allergie-Centrum-Charite
Study officials:
References:
Clinical trial NCT04118634: A Registry Study on Biomarkers of Pulmonary Embolism
Official title: Evaluation of Performances of Biomarkers in Pulmonary Embolism
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Embolism
Lead sponsor: Beijing Institute of Heart, Lung and Blood Vessel Diseases
Sponsor class: OTHER
First posted: 2019-10-08
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting to the emergency department with suspected PE

Brief summary: The purpose of the study is to evaluate the value of biomarkers in the diagnosis and risk stratification of patients with suspected pulmonary embolism.

Detailed description: Management of patients with acute pulmonary embolism is a serious problem. The rapid and accurate diagnosis and risk stratification of these patients is an important unmet clinical need. The aim of the study is to evaluate the value of biomarkers, alone or in combination, in the diagnosis and risk stratification of patients with suspected pulmonary embolism presenting to the emergency department.

Eligibility criteria: Inclusion Criteria:

* Patient aged ≥ 18 years that presents to an emergency department
* With suspected PE defined as new onset of or worsening of shortness of breath or chest pain

Exclusion Criteria:

* Hemodynamic instability
* Life expectancy less than 3 months
* First symptoms 15 day or more before inclusion
* Inability to the follow-up visits
* Therapeutic anticoagulation for any indication

Primary outcomes:
measure: Area under the ROC curve of biomarkers for the diagnosis of PE
timeFrame: 2 years
measure: PE related death
timeFrame: 7 days
Secondary outcomes:
measure: Symptomatic recurrent venous thromboembolic events
timeFrame: 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital
state: Beijing
Study officials:
affiliation: Beijing Anzhen Hospital
name: Jie Du, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04671134: Evaluation of State and Shade of White Spot Lesions After Using Different Remineralizing Agents (An in Vivo Study)
Official title: Evaluation of State and Shade of White Spot Lesions After Using Different Remineralizing Agents (An in Vivo Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: White Spot Lesion
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the effect of Biomimetic remineralizing agent and resin modified glass ionomer varnish on color shade and state of white spot lesions immediately, after 3 months, and after 6 months. (An in vivo study).


Eligibility criteria: Inclusion Criteria:

1. Patients included in this clinical trial were less than 30 years old.
2. Patients with good general health.
3. Patients who will agree to the consent and will commit to follow-up period.
4. Fully erupted anterior teeth with no cavitated lesions.

Exclusion Criteria:

1. Patients with any systemic disease that may affect normal healing.
2. Patient with bad oral hygiene.
3. Tetracycline or florosis staining.
4. Patients who could/would not participate in all times of follow-up.
5. Untreated periodontal disease was not allowed.
6. Active caries or defective Restorations in 6 anterior teeth.
7. Bleaching history
8. Patients participating in more than 1 dental study.
9. Patient received fluoride varnish before.

Primary outcomes:
measure: state of lesions
timeFrame: 6 months.
Secondary outcomes:
measure: shade of lesions
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al-Azhar University
Study officials:
References:
Clinical trial NCT01029834: Treating Pre-School Children at Risk for Overweight in the Primary Care Setting
Official title: Treating Overweight Youth: A Family Based Approach in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Keywords: BMI >85%for age and gender
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2009-12-10
Enrollment: 105
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this study is to test, in the primary care setting, the efficacy of an innovative intervention program for children aged 2-5 years with a BMI over the 85th percentile and one overweight parent (BMI \>27 kg/m2.


Eligibility criteria: Inclusion Criteria:

* 2-5 year old with a BMI greater than the 85th% for age and sex
* one overweight parent (BMI\>27kg/m2)
* child with normal developmental milestones
* history of adherence to 90% of scheduled primary care visits
* parent must be at 5th grade reading and speaking of English language or the spanish language
* no plans on moving out of the area for the 2 years subsequent to enrollment

Exclusion Criteria:

* child with a height 2 SD below the mean for age and sex and/or pathological growth velocity
* SGA
* any chronic disorders influencing energy intake and/or growth
* any orthopedic disorder preventing the child or the parent from ambulation normally and performing the activity prescribed by the program
* any medication known to have the potential of affecting weight changes
* parent or child with psychiatric and/or eating disorder
* participating mother who is pregnant or planning a pregnancy
* parent being acquainted with the parent of a previously randomized study participant

Primary outcomes:
measure: Percent BMI overweight for child and parent
timeFrame: baseline-6,12,18, 24 months
Secondary outcomes:
measure: Reduction in number of sugared drinks, high energy food and sedentary activities. Increase in fruit, vegetable and physical activity
timeFrame: baseline, 6,12,18,24
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: WNY urban practices
state: New York
city: Williamsville
country: United States
facility: WNY suburban practices
state: New York
Study officials:
affiliation: University at Buffalo/Women and Children's Hospital of Buffalo
name: Teresa Quattrin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Quattrin T, Roemmich JN, Paluch R, Yu J, Epstein LH, Ecker MA. Treatment outcomes of overweight children and parents in the medical home. Pediatrics. 2014 Aug;134(2):290-7. doi: 10.1542/peds.2013-4084.
citation: Quattrin T, Roemmich JN, Paluch R, Yu J, Epstein LH, Ecker MA. Efficacy of family-based weight control program for preschool children in primary care. Pediatrics. 2012 Oct;130(4):660-6. doi: 10.1542/peds.2012-0701. Epub 2012 Sep 17.
Clinical trial NCT06188234: The Prescription Patterns and Clinical Efficacy of Tenero Tab/Tenero M SR Tab
Official title: Observational Study on the Prescription Patterns and Clinical Efficacy of Tenero Tab/Tenero M SR Tab in Korean Type 2 Diabetes Mellitus Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes Mellitus, Type 2
Keywords: Metformin HCI
Teneligliptin hydrochloride
Lead sponsor: Hanlim Pharm. Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-01-03
Enrollment: 3000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients prescribed Tenero Tab/Tenero M SR Tab for diabetes treatment.

Brief summary: This study is to observe the prescription patterns and clinical efficacy of patients prescribed with Tenero Tab/Tenero M SR Tab for diabetes treatment in routine clinical practice.

Detailed description: This study is to observe the clinical efficacy by analyzing the prescription patterns in routine clinical practice and changes in HbA1c, FPG, PP2G, etc., of patients prescribed with Tenero Tab/Tenero M SR Tab for diabetes treatment. Additionally, the study intends to assess patient satisfaction based on these observations.

Eligibility criteria: Inclusion Criteria:

1. Adults over 19 years of age
2. Individuals diagnosed with type 2 diabetes.
3. Individuals who, at the clinical discretion, are prescribed Tenero Tab or Tenero M SR Tab for the purpose of diabetes treatment for the first time.
4. Individuals who have voluntarily provided written consent to participate in this study.

Exclusion Criteria:

1. Pregnant or breastfeeding women.
2. Individuals who are contraindicated according to the approved indications of Tenero Tab/Tenero M SR Tab.
3. Other cases where the principal investigator and study personnel deem individuals ineligible for participation in this clinical trial.

Primary outcomes:
measure: Change in HbA1c at 6 months of prescribing Tenero Tablet/Tenero Emextended Release Tablet compared to baseline
timeFrame: after 6 months of prescription for Tenero Tab/Tenero M SR Tab compared to baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Cheonan
country: Korea, Republic of
facility: Cheonan Endo Medical Clinic
Study officials:
affiliation: CHEONAN ENDO MEDICAL CLINIC
name: Seokgi Yoon
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03820934: FibroScan ® Study: Assessing Liver Fibrosis in Patients Using Methotrexate for Psoriasis
Official title: A Prospective, Validation Study of FibroSURE™ and FibroScan® as Screening, Detection, and Monitoring Alternatives to Liver Biopsy for Methotrexate-induced Hepatic Fibrosis and Cirrhosis in Patients With Psoriasis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Psoriasis
Keywords: Methotrexate
FibroScan
FibroSure
Cirrhosis
Fibrosis
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2019-01-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The purpose of this study is to validate FibroScan and FibroSURE™ as equal or superior alternatives to liver biopsy for the monitoring and detection of methotrexate-induced hepatic fibrosis and cirrhosis in patients with moderate-to-severe psoriasis.

Detailed description: The goals of this study are to validate FibroScan and FibroSURE™ as equal or superior alternatives to liver biopsy. The goal is to evaluate the monitoring and detection of methotrexate-induced hepatic fibrosis and cirrhosis in patients with moderate-to-severe psoriasis.

Eligibility criteria: Inclusion Criteria:

* Male or female greater than or equal to 18 years of age
* Must have a diagnosis of moderate-to-severe psoriasis
* Newly starting methotrexate

Exclusion Criteria:

* Allergy to methotrexate
* History of chronic alcohol abuse
* Diagnosis of liver disease

Primary outcomes:
measure: Fibrosis Score Correlation
timeFrame: 5 years
Secondary outcomes:
measure: Fibrosis Score Validity to Liver Biopsy Results
timeFrame: 5 years
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Neil Korman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01976234: Stored RBC Transfusion and Immonomodulation
Official title: Infective Complication After Surgery and Transfusion of Allogenic RBC Fresh or Stored
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infections
Lead sponsor: Università degli Studi di Ferrara
Sponsor class: OTHER
First posted: 2013-11-05
Enrollment: 181
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Transfusion of RBC is associated with post operative infections. Our hypothesis is that stored blood could be related with increased post operative infection risk. Surgical patients transfused during the operation or immediately after will be included in our study. Patients will receive fresh or old blood during the whole recovery.


Eligibility criteria: Inclusion Criteria:

* Patients transfused during or in 24h after surgical operation

Exclusion Criteria:

* Patients transfused during the 30 days before the operation
* Immunodepressed patients
* Infections during the 30 days before operations
* Emergency surgery

Primary outcomes:
measure: Incidence of infections
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: Sant'Anna Hospital
Study officials:
affiliation: Università degli Studi di Ferrara
name: Savino Spadaro
role: PRINCIPAL_INVESTIGATOR
References:
citation: Juffermans NP, Vlaar AP, Prins DJ, Goslings JC, Binnekade JM. The age of red blood cells is associated with bacterial infections in critically ill trauma patients. Blood Transfus. 2012 Jul;10(3):290-5. doi: 10.2450/2012.0068-11. Epub 2012 Feb 22.
Clinical trial NCT05734534: Effects of BFR Interventions in Healthy Individuals and Individuals With COPD
Official title: Effects of BFR Interventions on Muscle Function and Adaptations in Healthy Individuals and Individuals With COPD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
COPD
Keywords: BFR
COPD
Exercise
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to investigate the effect of different blood flow restriction (BFR) interventions on muscle function and adaptations both in healthy well-trained individuals and individuals diagnosed with COPD.


Eligibility criteria: Inclusion criteria for participants with COPD group are:

* Diagnosis with COPD

Exclusion criteria participants in the COPD group are

* Having experienced an acute exacerbation of COPD within the last 6 weeks (Study A)
* Taking part in pulmonary rehabilitation within the last 3 months (Study A)
* Presenting with a history of thromboembolic event in the lower limbs.

Inclusion criteria for healthy participants are:

* Age between 18 and 40 years.
* Maximal oxygen uptake (VO2max) of \>55 ml O2/kg/min for men and \>50 ml O2/kg/min for women
* BMI of \<26 and normal ECG and blood pressure.

Exclusion criteria for healthy participants are:

* Smoking
* chronic disease,
* Use of prescription medication
* Pain due to current or previous musculoskeletal injury
* Resistance training more than once per week in the 12 months leading up to the intervention.

Primary outcomes:
measure: Muscle strength
timeFrame: Change assessed from before to after the intervention (6 weeks in study A, on average 7 days in study B)
Secondary outcomes:
measure: Lean mass
timeFrame: Change assessed from before to after the 6 week intervention
measure: Maximal oxygen consumption
timeFrame: Change assessed from before to after the 6 week intervention
measure: Skeletal muscle mitochondrial respiration
timeFrame: Change assessed from before to after the intervention (6 weeks in study A, on average 7 days in study B)
measure: Fiber cross-sectional area
timeFrame: Change assessed from before to after the intervention (6 weeks in study A, on average 7 days in study B)
measure: Myonuclei
timeFrame: Change assessed from before to after the intervention (6 weeks in study A, on average 7 days in study B)
measure: Functional exercise capacity
timeFrame: Change assessed from before to after the 6 week intervention (only in individuals with COPD)
measure: Satellite cells
timeFrame: Change assessed from before to after the intervention (6 weeks in study A, on average 7 days in study B)
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: August Krogh Building
Study officials:
References:
Clinical trial NCT05943834: Early Detection of Alzheimer's Disease and Affective Disorders by Automated Voice and Speech Analysis (PLATA)
Official title: Early Detection of Alzheimer's Disease and Affective Disorders by Automated Voice and Speech Analysis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neurocognitive Disorders
Keywords: Alzheimer's disease
Mood disorder
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2023-07-13
Enrollment: 100
Sex: ALL
Minimum age (years): 50
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: Participants will be recruited through the Memory Clinic at the Geriatric Hospital in Nice (Centre de Mémoire de Ressources et de Recherche, CHU de Nice, Institut Claude Pompidou 10 rue Molière, 06 100 NICE) with a minor or major neurocognitive disorder whose etiology is either:

* Probable Alzheimer's disease (positive AD biomarkers)
* Mood disorder
* Not related to a mood disorder and with negative AD biomarkers

Brief summary: PLATA aims to develop an algorithm to identify vocal biomarkers of Alzheimer's dementia.

Using data collected as part of routine care, speech patterns will be compared to known biomarkers of Alzheimer's disease, such as amyloid 1-42 and p-Tau in CSF (cerebrospinal fluid).

If biomarkers of speech can be identified in Alzheimer's disease, it is possible that patients and research participants will no longer need to undergo need to undergo the intensive and invasive baseline biomarker methods currently used, such as lumbar punctures and PET scans.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 50 years
* Diagnosis relevant biomarker and neuropsychological data already available
* Cognitively healthy to very mild dementia (CDR score max. 0.5)
* Sufficient knowledge of the study language to understand study information, non opposition form,and questionnaires
* Expression of non opposition

Exclusion Criteria:

* Hearing problems
* Patient protected by law, under guardianship or curator ship, or not able to participate in a clinical study according to the article L.1121-16 of the French Public Health Code

Primary outcomes:
measure: Build and validate speech-based machine learning models for relevant Phenotype detection through access to phenotyped patients from reference memory center.
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Eric ETTORE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02479334: Acute Effects of Spices on Pathways Associated With Glucose Homeostasis and Inflammation on PBMCs of Healthy Subjects
Official title: Acute Effects of Spices on Pathways Associated With Glucose Homeostasis, Oxidative Stress and Inflammation in Healthy Subjects - Molecular Insights Through Transcriptomics of Peripheral Blood Mononuclear Cells (PBMC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Healthy
Keywords: Spices
Functional food
Cardiometabolic risk
Metabolic syndrome
Inflammation
Peripheral blood mononuclear cell
Acute
Lead sponsor: Lund University
Sponsor class: OTHER
Collaborators: name: Food for Health Science Centre, Lund University
First posted: 2015-06-24
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study aims to investigate the effect of spices on gene expression of pathways associated with glucose homeostasis, oxidative stress and inflammation, in the postprandial phase in healthy human subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy males and females
* BMI 20-28 kg/m2
* Must be able to accept spices
* Agreed and signed informed consent

Exclusion Criteria:

* Below 18 years old
* Uncomfortable speaking English and/or difficulties in understanding spoken English
* Smoking or using snuss
* Vegetarian or vegan
* Stressed by venous blood sampling or previous experience of being difficult to be cannulated
* Receiving any drug treatment that may influence the study outcomes
* Pregnancy or breastfeeding

Primary outcomes:
measure: Change from Baseline (0 hr) in untargeted PBMC gene expression profile at 2 hr and 4 hr
timeFrame: Prior to the initial intervention at 0 hr and after intervention at 2 hr and 4 hr.
Secondary outcomes:
measure: Subjective appetite ratings using standard subjective 100 mm VAS
timeFrame: Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 and 240 min.
measure: Metabolic biomarkers
timeFrame: Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 and 240 min.
measure: Metabolite profile
timeFrame: Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 and 240 min.
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Food for Health Laboratory - Lund University
state: Skane
Study officials:
affiliation: Lund University
name: Yoghatama Cindya Zanzer, MSc
role: STUDY_CHAIR
affiliation: Lund University
name: Elin Östman, PhD
role: PRINCIPAL_INVESTIGATOR
References: