louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00610597: Study of T Cell Phenotype Activation Pathway in Human Alcoholic Liver Disease
Official title: Study of T Cell Phenotype Activation Pathway in Human Alcoholic Liver Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alcoholic Liver Disease
Chronic Hepatitis C Virus
Keywords: liver
alcohol
lymphocyte
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2008-02-08
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients of Erasme University Hospital

Brief summary: Alcoholic liver disease is characterized by circulating T cell activation and liver T cell infiltration but their phenotype is poorly studied. The aim of the study is to test the hypothesis that the (CD4+ T cell secreting Interleukin-17) Th17 pathway is involved in alcoholic liver disease.

Detailed description: Consecutive patients undergoing transjugular liver biopsies for alcoholic liver disease or hepatitis C virus infection will be included in the study to measure plasma cytokines levels, peripheral blood mononuclear cells cytokine release and liver T cell infiltrates.

Eligibility criteria: Inclusion Criteria:

* Alcohol excess intake and suspected liver disease
* Alcohol excess intake and clinical liver cirrhosis
* chronic hepatitis C virus infection and suspected liver disease
* chronic hepatitis C virus infection and clinical liver cirrhosis

Exclusion Criteria:

* bacterial or fungal infection
* immunosuppressive treatment
* other causes of liver disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Hopital Erasme - Dpt of Gastroenterology
Study officials:
affiliation: Erasme Hospital, Gastroenterology Dpt
name: Arnaud Lemmers, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lemmers A, Moreno C, Gustot T, Marechal R, Degre D, Demetter P, de Nadai P, Geerts A, Quertinmont E, Vercruysse V, Le Moine O, Deviere J. The interleukin-17 pathway is involved in human alcoholic liver disease. Hepatology. 2009 Feb;49(2):646-57. doi: 10.1002/hep.22680.
Clinical trial NCT01447797: A Bioequivalence Study Comparing Irbesartan/Atorvastatin Combination Tablet With Coadministration of Irbesartan and Atorvastatin
Official title: Single Dose Open-label Comparative Pharmacokinetic Study to Assess the Pharmacokinetic Characteristics of Irbesartan and Atorvastatin Between Irbesartan/Atorvastatin Combination Tablet and Coadministration of Irbesartan and Atorvastatin Tablets in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Irbesartan
Atorvastatin
combination
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2011-10-06
Enrollment: 52
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate pharmacokinetics and safety after oral administration of Irbesartan and Atorvastatin in combination as HCP0912


Eligibility criteria: Inclusion Criteria:

* Age between 20 and 45
* Signed informed consent form
* weight : over 45kg and in the range of ±20% of IBW

Exclusion Criteria:

* Has a medical history of hypersensitivity to atorvastatin or irbesartan
* severe Hypotension
* Not eligible for subject in health examination within 28 days of IP administration

Primary outcomes:
measure: AUC of Irbesartan
timeFrame: 0-48 hrs
measure: AUC of Atorvastatin and 2-hydroxy atorvastatin
timeFrame: 0-48 hrs
measure: Cmax of Irbesartan
timeFrame: 0-48 hrs
measure: Cmax of Atorvastatin and 2-hydroxy atorvastatin
timeFrame: 0-48 hrs
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
Study officials:
affiliation: Korea University Anam Hospital
name: Ji-Young Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01329497: The Effect of Systemic Dietary Instruction on Management of Plasma Phosphorus Levels in Peritoneal Dialysis (PD) Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hyperphosphatemia
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
First posted: 2011-04-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Hyperphosphatemia is highly prevalent in PD patients, and it is an independent risk factor for all-cause and cardiovascular mortality in these patients. Effective treatments are limited in suppressing plasma phosphorous. Because of the nearly linear relationship between protein and phosphorus intake, high dietary protein intake (DPI, 1.2-1.3g/kg/d recommended by KDOQI) would load high phosphorus burden in PD patients. It is suggested that hyperphosphatemia is hard to avoid under such a DPI level, even as the patients take sufficient phosphorus blinders and receive high PD dosage. The present study is to investigate whether systemic dietary instruction would show effects on control of hyperphosphatemia in PD patients.


Eligibility criteria: Inclusion Criteria:

1. Stable on PD for at least three month
2. Aged from 18 to 75 years old
3. Informed consent approval

Exclusion Criteria:

1. Malnutrition (based on SGA results)
2. Infection or inflammation within 1 month
3. Concurrent wasting disease (i.e. cancer, tuberculosis)

Primary outcomes:
measure: Plasma phosphorus levels
timeFrame: up to 1 year
Secondary outcomes:
measure: Plasma calcium levels
timeFrame: up to one year
measure: Carotid artery intima-media thicknesses
timeFrame: up to 1 year
measure: Plasma albumin levels
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine
state: Shanghai
Study officials:
affiliation: RenJi Hospital
name: Jiaqi Qian, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00723905: Remicade Infusion Management Program
Official title: Remicade Infusion Management Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn Disease
Arthritis, Rheumatoid
Keywords: Crohn's Disease, Rheumatoid Arthritis
Lead sponsor: Janssen Inc.
Sponsor class: INDUSTRY
First posted: 2008-07-29
Enrollment: 1630
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The data captured and reported in this registry will reflect a "real world" approach to the treatment of Rheumatoid Arthritis and Crohn's Disease with infliximab.

Brief summary: Janssen Inc. plans to collect data on about 3000 to 5000 infliximab infusions per year, starting in the third quarter of 2005. It is expected that about 12 sites from the Remicade Infusion Network (R.I.N.) will participate. This registry will be a multicentre, prospective, observational program that will gather and analyze data on subjects being treated with infliximab.


Eligibility criteria: Inclusion Criteria:

* Subject is a good candidate to receive infliximab as per the Product Monograph
* Subject is prescribed infliximab by an appropriate physician
* Subject receives infusion in a community infusion centre.
* Subject has signed the approved consent form.

Exclusion Criteria:

* Not specified in the protocol

Primary outcomes:
measure: Type and frequency of infusion reactions
timeFrame: Up to 7 years
measure: Pre-infusion treatments and efficacy
timeFrame: Up to 7 years
measure: Infusion reaction management approaches
timeFrame: Up to 7 years
measure: The number of subjects with adverse events
timeFrame: Up to 7 years
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
state: Quebec
city: Pointe-Claire
country: Canada
Study officials:
affiliation: Janssen Inc.
name: Janssen Inc. Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Choquette D, Faraawi R, Chow A, Rodrigues J, Bensen WJ, Nantel F. Incidence and Management of Infusion Reactions to Infliximab in a Prospective Real-world Community Registry. J Rheumatol. 2015 Jul;42(7):1105-11. doi: 10.3899/jrheum.140538. Epub 2015 Jun 15.
Clinical trial NCT04934605: Genotype-phenotype Correlation of SLC26A4 in CI Patients With EVA
Official title: A Genotype-phenotype Correlation of SLC26A4 Mutations in Cochlear-implanted Patients With Enlarged Vestibular Aqueduct
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sensorineural Hearing Loss
Enlarged Vestibular Aqueduct
Keywords: enlarged vestibular aqueduct
SLC26A4
cochlear implant
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-06-22
Enrollment: 60
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with sensorineural hearing loss and enlarged vestibular aqueduct.

Brief summary: To explore the genotype-phenotype correlation of SLC26A4 mutations in cochlear-implanted patients with enlarged vestibular aqueduct.

Detailed description: Enlarged vestibular aqueduct (EVA) is one of the most common forms of inner ear malformation that cause sensorineural hearing loss (SNHL). Some patients with EVA present delayed, fluctuating, and progressive hearing loss, while the others are with congenital or sudden hearing loss. Cochlear implants (CI) have been widely used in patients with severe-profound SNHL. However, it is difficult to define the optimal timing of CI operations for patients with EVA. Mutations in SLC26A4 are known to be responsible for EVA. This study is to explore the genotype-phenotype correlation of SLC26A4 mutations in cochlear-implanted patients with EVA.

Eligibility criteria: Inclusion Criteria:

1. Bilateral severe-to-profound sensorineural hearing loss who received cochlear implantation.
2. Bilateral or unilateral enlarged vestibular aqueduct (EVA) with or without Mondini malformation (IP-II) on temporal bone computed tomography (CT) and/or magnetic resonance imaging (MRI).

Exclusion Criteria:

1. Hearing loss that is associated with symptoms which meet the criteria of already known syndromes.
2. With other type of inner ear malformation.

Primary outcomes:
measure: Cochlear implant age
timeFrame: Immediately after cochlear implantation
measure: Duration of hearing loss
timeFrame: Immediately after cochlear implantation
Secondary outcomes:
measure: Type of initial hearing loss
timeFrame: On the 1 day of recruitment.
measure: Type of hearing loss progression
timeFrame: Immediately after cochlear implantation
Other outcomes:
Locations:
Study officials:
affiliation: Department of Otorhinolaryngology, 2nd Affiliated Hospital, School of Medicine, Zhejiang University
name: Xiao Liu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02020005: Evaluation of Cessation Preferences of Menthol Smokers
Official title: Evaluation of Cessation Preferences of Menthol Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: menthol cigarettes
smoking cessation
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2013-12-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The primary aim of this study is to determine menthol smokers' perception, product preference, and pattern of use across six products including, mint-flavored nicotine gum; non-flavored nicotine gum; mentholated nicotine inhaler; and non-menthol nicotine inhaler. Participants will undergo an orientation and baseline assessment followed by a 2-week product sampling phase. At the end of the 2 weeks of sampling, subjects will select a product to use during the following 2-week smoking cessation phase. This 2-week abstinence phase is followed by one week of abrupt withdrawal of the product. This study design was successfully used in a study we conducted that examined the smokers' preference for a variety or oral tobacco products.


Eligibility criteria: Inclusion Criteria:

* Self-identified as African American or Black;
* Aged 18 years or older;
* High school graduate or GED;
* Smoking at least 10 cigarettes daily for the past year;
* Usually smoked mentholated cigarette brand (greater than 80% of the time) in the past two years;
* Good physical health (no unstable medical condition);
* No contraindications for nicotine inhaler or gum use, such as mouth sores or significant dental or jaw problems;
* Stable, good health.

Exclusion Criteria:

* Recent unstable or untreated psychiatric diagnosis including substance abuse, as determined by the DSM-IV criteria;
* Currently using other tobacco or nicotine products other than cigarettes;
* Pregnant or nursing.

Primary outcomes:
measure: Product preference for nicotine replacement
timeFrame: 6 weeks
Secondary outcomes:
measure: Nicotine content preference
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota Masonic Cancer Center
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Kola Okuyemi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04708405: The Relationship Between Helicobacter Pylori Infection and Inflammatory Bowel Diseases: A Real-life Observation
Official title: The Relationship Between Helicobacter Pylori Infection and Inflammatory Bowel Diseases: A Real-life Observation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Diseases
Helicobacter Pylori Infection
Keywords: Inflammatory Bowel Diseases
Helicobacter Pylori
Egypt
Lead sponsor: Alexandria University
Sponsor class: OTHER
Collaborators: name: High Institute of Public Health, Egypt
First posted: 2021-01-14
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients diagnosed with inflammatory bowel disease condition

Brief summary: Numerous epidemiological studies have investigated the association between Helicobacter pylori (H. pylori) infection and inflammatory bowel disease (IBD) with various conflicting results. The main objective of this study is to further explore the possible association between H. pylori infection and IBD and its impact on disease course. The investigators sought to conduct a prospective observational study and enroll a total of 182 IBD patients who were screened for H. pylori infection. All the participants will be clinically evaluated at the initial visit and bimonthly for 3 months. Several factors will be explored such are diet, physical activity, life style and considering specific environmental exposures that impact the development of disease or its relapse.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with inflammatory bowel disease condition

Exclusion Criteria:

* Having irritable bowel disease
* Being younger than 18 years

Primary outcomes:
measure: Change in the inflammatory bowel disease condition
timeFrame: 3 months
measure: Change in the inflammatory bowel disease condition
timeFrame: 3 months
measure: Change in the inflammatory bowel disease condition
timeFrame: 3 months
measure: Change in the inflammatory bowel disease condition
timeFrame: 3 months
measure: Change in the inflammatory bowel disease condition
timeFrame: 3 months
measure: Change in the inflammatory bowel disease condition
timeFrame: 3 months
measure: Change in the inflammatory bowel disease condition
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: High Institute of Public Health
Study officials:
References:
Clinical trial NCT05159505: Interdisciplinary Scoliosis Correction Program.
Official title: Strategies for the Implementation of an Interdisciplinary Juvenile Scoliosis Correction Program Based on ERAS Principles. Before-after Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Scoliosis Idiopathic
Scoliosis; Juvenile
Scoliosis
ERAS
Complication,Postoperative
Complication of Surgical Procedure
Lead sponsor: Pomeranian Medical University Szczecin
Sponsor class: OTHER
First posted: 2021-12-16
Enrollment: 120
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Caucasian children undergoing orthopedics surgery (e.g. spine surgery for adolescent idiopathic scoliosis).

Brief summary: The aim of this study is to compare the outcomes after scoliosis surgery before and after the implementation of an interdisciplinary juvenile scoliosis correction program in teenager based on ERAS (enhanced recovery after surgery) principles.

Detailed description: Creating an optimal protocol for interdisciplinary care in the perioperative period in terms of therapeutic management (anesthesia and surgery schedule), as well as care, rehabilitation and ensuring mental well-being determines the real impact on the reduction of the risk of complications in the perioperative period. Enhanced recovery after surgery (ERAS) protocol has been found to result in reduced lenght of stay and complications in adult patients. Data in pediatric population remains modest. In addition to ERAS principles our terapeutic team has created a special educational application for better patient preparation for surgery. The purpose of the application is to explain the general rules of conduct in the process of preparing and carrying out surgery, anesthesia, prehabilitation and physiotherapy in children undergoing orthopedics surgery (e.g. spine surgery for adolescent idiopathic scoliosis).

Hypothesis: Implementing an interdisciplinary juvenile scoliosis correction program based on ERAS principles and special educational app. will improve patient outcomes leading to a statistically significant reduction in post-operative pain and opioids demand, complication rate, length of stay without increasing readmissions and cost.

Eligibility criteria: Inclusion Criteria:

* patient with age \< 18 years
* patient scheduled for idiopatic scoliosis surgery

Exclusion Criteria:

* patient with age \> 18years others type of scoliosis

Primary outcomes:
measure: type of complications
timeFrame: up to 4 weeks after surgery
Secondary outcomes:
measure: Postoperative length of hospital stay
timeFrame: up to 4 weeks after surgery
measure: Number of Analgetics consumption
timeFrame: up to 6 days after surgery
measure: Time to first bowel motion
timeFrame: up to 6 days after surgery
measure: Time to first verticalization
timeFrame: up to 6 days after surgery
Other outcomes:
Locations:
city: Szczecin
country: Poland
facility: Pomeranian Medical University
Study officials:
References:
Clinical trial NCT03586505: Tolerance to Light for Patients Suffering From Keratitis
Official title: Tolerance to Light for Patients Suffering From Keratitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Keratitis
Keywords: Keratitis
Eye Infection
Photophobia
Red light
Infrared light
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: University of Saint-Etienne
First posted: 2018-07-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Each patient is its own control
Primary purpose: BASIC_SCIENCE

Brief summary: In order to develop an innovative device to study infectious keratitis, we need to illuminate the cornea of patients suffering from an infectious keratitis with red or near-infrared light. Because of technical reasons the shortest possible wavelength (red) presents advantages.

Detailed description: The aim of this preliminary study is to measure the maximal intensity tolerated during illumination with 6 wavelength corresponding : 2 red, 2 far red and 1 near infrared lights in order to determine the shortest wavelength well tolerated by patients, in comparison with the standard blue light illumination.

Eligibility criteria: Inclusion Criteria:

* Social security insurance
* Suspected infectious keratitis (clinically defined. No lab testing required)
* Signed informed consent

Exclusion Criteria:

* Major Blepharospasm
* Aphakia (absence of lens)
* Pregnant woman
* Nursing mother

Primary outcomes:
measure: Light intensity
timeFrame: At the inclusion
Secondary outcomes:
measure: Severity of the keratitis
timeFrame: At the inclusion
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU de Saint-Etienne
Study officials:
affiliation: CHU de Saint-Etienne
name: Gilles THURET, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Courrier E, Lambert V, Renault D, Garcin T, Moine B, Herbepin P, Thuret G, Gain P. Tolerance to Light of Patients Suffering From Infectious Keratitis. Cornea. 2021 Jan;40(1):5-11. doi: 10.1097/ICO.0000000000002516.
Clinical trial NCT05795205: Delayed Dinner, Exercise and Glucose Metabolism
Official title: Impact of Exercise on Metabolic Health Following Delayed Dinner Consumption in Healthy Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Normal Dinner
Delayed Dinner
Exercise Plus Delayed Dinner
Keywords: late dinner
postprandial Glycaemia
Lead sponsor: National Taiwan Normal University
Sponsor class: OTHER
First posted: 2023-04-03
Enrollment: 12
Sex: MALE
Minimum age (years): 20
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 whether exercise can alleviate the impact of delayed dinner on metabolic health next morning in sedentary healthy adults


Eligibility criteria: Inclusion Criteria:

* Physical inactive males
* Weight stable for more than 3 months (no change in weight +/- 3%)
* Non-smoker
* Able to walk comfortably on a treadmill
* Dinner consumers with normal sleep pattern (cycles)

Exclusion Criteria:

* Personal history of/existing diabetes, cardiovascular disease, metabolic disease or dyslipidaemia
* Taking medications that may influence lipid or carbohydrate metabolism or immune system function
* Unable to take part in exercise for any reason (e.g., injury or disability) or a positive response to any questions on the Physical Activity Readiness questionnaire (PAR-Q)

Primary outcomes:
measure: Metabolic health (Oral glucose tolerance test, OGTT)
timeFrame: 120 minutes
measure: Metabolic health (Oral glucose tolerance test, OGTT)
timeFrame: 120 minutes
Secondary outcomes:
measure: Inflammation
timeFrame: Baseline
measure: Visual analogue scale (VSA)
timeFrame: 120 minutes
measure: Substate oxidation
timeFrame: 120 minutes
measure: Blood pressure
timeFrame: 120 minutes
measure: Appetite (lunch intake)
timeFrame: 30 minutes
measure: HRV
timeFrame: Baseline
measure: Gut hormones
timeFrame: 120 minutes
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan Normal University
Study officials:
References: