louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02839811: Medical Device for Drug Allergy Diagnosis
Official title: Compact Biophotonic Platform for Drug Allergy Diagnosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug Hypersensitivity
Keywords: Betalactams
In vitro diagnosis
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: European Commission
First posted: 2016-07-21
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The COBIOPHAD project targets the development of a highly sensitive, selective, and multiplexed diagnostic device to provide a quick and inexpensive in vitro test to address the most prevalent drug hypersensitivity to betalactams antibiotics, (BLCs). During a retrospective study, BLC structures involved in drug hypersensitivity will be identified from sera of allergic patients (versus controls) and coupled on the device.

A prospective study will be performed for the recruitment of samples corresponding to patients with known IgE hypersensitivity to BLCs based on results from allergy tests and clinical history. Controls will include: non-allergic individuals with known tolerance to betalactams. The samples will be used for the validation of the COBIOPHAD device in real settings.


Eligibility criteria: Inclusion Criteria:

- patients with known hypersensitivity to BLC (proven by means of in vivo tests) (cases)

Exclusion Criteria:

* patients with contraindications to BLC allergy work-up
* patient refusal to enter the study
* vulnerable patients according to French regulation

Primary outcomes:
measure: Sensitivity of the COBIOPHAD device in diagnosing immediate hypersensitivity to BLC
timeFrame: up to 1 hour
measure: Specificity of the COBIOPHAD device in diagnosing immediate hypersensitivity to BLC
timeFrame: up to 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University hospital of Montpellier
Study officials:
References:
Clinical trial NCT03185611: Effectiveness of Rifaximin Combined With Thiopurine on Preventing Postoperative Recurrence in Crohn's Disease
Official title: Effectiveness of Rifaximin Combined With Thiopurine on Preventing Postoperative Endoscopic Recurrence in Crohn's Disease Patients With Risk Factor for Recurrence: A Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Crohn Disease
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital, Sun Yat-Sen University
name: Peking Union Medical College Hospital
name: Xijing Hospital
name: Shanghai 10th People's Hospital
name: RenJi Hospital
name: Sir Run Run Shaw Hospital
First posted: 2017-06-14
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Some studies have shown that rifaximin is effective in the management of Crohn's Disease. Meanwhile, its adverse effect is tolerable. But no study has been conducted to assess its effect on preventing postoperative recurrence. Thus, we conduct a randomised controlled study to assess the effect of rifaximin combined with thiopurine on preventing postoperative endoscopic recurrence in Crohn's disease, compared with thiopurine. The primary endpoint is the rate of endoscopic recurrence at 6 months.


Eligibility criteria: Inclusion Criteria:

1. Consecutive patients with Crohn's disease undergoing intestinal resection of all macroscopic diseased bowel, with an endoscopically accessible ileocolic anastomosis;
2. Enrolled patients must have one or more risk factor for the development of postoperative recurrence including penetrating disease behaviour, prior bowel resection, and active smoking.

Exclusion Criteria:

1. Severe comorbidities;
2. With a stoma;
3. With malignancy;
4. Pregnancy;
5. Intolerant of thiopurine drugs;
6. With contraindication of using rifaximin or thiopurine drugs.

Primary outcomes:
measure: difference of incidence of endoscopic recurrence
timeFrame: 6 months after surgery
Secondary outcomes:
measure: Adverse effect
timeFrame: 6 months after surgery
Other outcomes:
Locations:
city: Guanzhou
country: China
facility: The Sixth Affiliated Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT01194011: Study on Nation-wide Health Care Quality Information Openness and Transparency Mechanism Establishment
Official title: Study on Nation-wide Health Care Quality Information Openness and Transparency Mechanism Establishment
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Valuable Suggestions to Improve Health Care Quality Transparent and Accessible Medical Care
Keywords: Health care quality, information openness, health care information website
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2010-09-02
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: Research objectives To provide people with sufficient information regarding health care and to improve its quality, this research endeavors to discuss the establishment of a health care information openness and transparency mechanism within the framework of the National Health Insurance system. This research also evaluates whether the transparency of health care quality information makes care givers provide better quality. Meanwhile, when appropriate information and quality index are presented to patients, patients shall have more knowledge about what they are dealing with, hence less misunderstanding between hospitals and patients would occur.

Research Methods

1. To revise indicators based on international trends, related literature and the need of people.
2. To present 50 sets of quality indicator statistically on the website, and provide updated information about the first 10 sets.
3. To analyze and explain the outcome and purposes of the indicator to the public.
4. To estimate the possible trend for the coming year, and provide adaptive strategy.
5. To promote the website, and hold workshops in all six regions of Taiwan.
6. To make the website linked to the top 5 most populated official and unofficial websites.
7. To respond to questions on the forum of the website daily, and maintain the system, update the website regularly.
8. To complete the acceptability survey on health care institutions and people.


Eligibility criteria: Inclusion Criteria:

* Outpatient ; healthy subjects patients

Exclusion Criteria:

* The plan excluded child / children and other minors who were the target respondents, mainly to investigate the medical information for public acceptance of the site, child / children is not suitable, so as to adults as the main investigation.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Taiwan College of Healthcare Executives
name: Lan-Chi Tai, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05772611: Characterization of Immune-response in Autoimmune Encephalitis and Paraneoplastic Neurological Syndromes
Official title: Characterization of Immune-response in Autoimmune Encephalitis and Paraneoplastic Neurological Syndromes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Autoimmune Encephalitis
Paraneoplastic Neurological Syndrome
Keywords: autoimmune encephalitis
paraneoplastic neurological syndromes
genetic
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2023-03-16
Enrollment: 180
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: Patient with auto-immune encephalitis suspected and antibody characterized or not.

Brief summary: Autoimmune encephalitis (AE) and paraneoplastic neurological syndromes (PNS) are rare neuroimmune syndromes with a wide range of clinical presentation but without pathognomonic clinical sign facilitating the diagnosis. A lot of differential diagnoses are possible such as neurodegenerative diseases or viral infections. Although rare the diagnosis of AE or PNS is essential because despite severe neurological symptoms, patients can be cured by appropriate immunotherapy. Autoantibodies highly specific of AE and PNS has been described in the serum and cerebrospinal fluid of the patients and can be used as biomarkers of the disease. Their presence can predict an autoimmune origin and in many cases a good prognosis after immunotherapy. However, if some autoantibodies are now well-characterized and industrial kits have been developed to detect them, in numerous cases of highly suspect AE or PNS no specific autoantibodies are identified leading frequently to an inappropriate treatment. Furthermore, as the mechanisms of AE and PNS is still unknown, treatments are not optimal and in some cases inefficient. There is no prognosis biomarker able to predict the patient's sensitivity to immunotherapy and there are only few clues to know how the immune system can provoke the neuropsychiatric symptoms observed in the patients.


Eligibility criteria: Inclusion Criteria:

* Patient with neurological disorder
* Patient with antibodies or not in sera or CSF

Exclusion Criteria:

- No available clinical data

Primary outcomes:
measure: Correlation between biological results and clinical data
timeFrame: Through study completion, an average of 1year
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites autoimmunes
Study officials:
References:
Clinical trial NCT00332111: Infectious Outcomes Following Pancreas Transplantation
Official title: Infectious Outcomes Following Pancreas Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Transplantation
Keywords: transplant
pancreas
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2006-06-01
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with pancreatic and kidney transplants

Brief summary: The proposed protocol aims to characterize the infectious episodes in pancreas transplant recipients under the current medical care. Knowing these patients infectious risks, the types of infections that commonly affect them and the morbidity and mortality associated with it will provide valuable information in the evaluation of the safety and efficacy of the current practices. The information generated by this study will also serve as the basis for development of strategies targeting prophylaxis of infectious episodes.

Detailed description: The objectives of the study are:

1. To determine what is the frequency of infectious complications following pancreas transplantation
2. Characterize the clinical and microbiological aspects of the infectious complications following pancreas transplantation
3. Identify predictors for infection following pancreas transplantation
4. Determine the frequency of graft loss and associated mortality of infectious complications following pancreas transplantation

Eligibility criteria: Inclusion Criteria:

* Patients who underwent pancreas with or without kidney transplantation at the University of Pittsburgh Medical Center from January 1st 2002 to December 31st 2005
* Patients must be above 18 years of age
* Patients undergoing retransplantation may be included.

Exclusion Criteria:

* History of pancreas transplantation at another institution

Primary outcomes:
measure: 30 day outcomes after transplantation
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Fernanda Silveira, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04619511: Risk Factors for Post-ESWL and Post-ERCP Pancreatitis
Official title: Risk Factors for Post-ESWL and Post-ERCP Pancreatitis in Patients With Chronic Pancreatitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pancreatitis
Risk Factors
ERCP
ESWL
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2020-11-06
Enrollment: 714
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: Consecutive CP patients treated with both ESWL and subsequent ERCP during the same hospitalization between October 2016 and July 2019 were included.

Brief summary: The study aimed to identify risk factors for post-ERCP pancreatitis(PEP) after ESWL, and the relationship between the occurrence of post-ESWL pancreatitis and PEP.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with chronic pancreatitis and treated with both ESWL and subsequent ERCP

Exclusion Criteria:

* Patients with isolated pancreatic tail stone
* Patients with suspected or established malignancy
* Patients with pancreatic ascites
* Patients attending other interventional clinical trials
* Patients with non-correctable coagulation disorder
* Patients with pregnancy

Primary outcomes:
measure: post endoscopic retrograde cholangiopancreatography(ERCP) pancreatitis
timeFrame: up to 1 months
measure: post pancreatic extracorporeal shock wave lithotripsy (ESWL) pancreatitis
timeFrame: up to 1 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Ru N, Qian YY, Zhu JH, Chen H, Zou WB, Hu LH, Pan J, Guo JY, Li ZS, Liao Z. Post-ESWL and post-ERCP pancreatitis in patients with chronic pancreatitis: Do they share the same risks? J Hepatobiliary Pancreat Sci. 2021 Sep;28(9):778-787. doi: 10.1002/jhbp.1013. Epub 2021 Jul 22.
Clinical trial NCT02475928: Zinc Supplementation in Cirrhotic Patients
Official title: Zinc Supplementation as Treatment of Dysgeusias in Cirrhotic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dysgeusia
Liver Cirrhosis
Lead sponsor: Fundación Clínica Médica Sur
Sponsor class: OTHER
First posted: 2015-06-19
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of zinc supplementation in the treatment for dysgeusia, progression disease and quality of life in patients with liver cirrhosis.

Detailed description: Taste disorders are symptomatologies in patients with cirrhosis, these have a direct effect in modification of food consumption, increasing weight loss, anorexia and malnutrition, which impacts in decompensation rates and mortality.

It has been proposed that zinc deficiency is one of the causes for development of taste disorders. The aim of this study is to describe the presence of taste disorders in patients with cirrhosis and evaluate the effect of zinc supplementation in treatment of taste disorders, and in progression of chronic liver disease.

Eligibility criteria: Inclusion Criteria:

* Cirrhotic patients by any etiology, with any dysgeusia

Exclusion Criteria:

* Patients with hepatic encephalopathy at the time of dysgeusia evaluation
* Patients with any neurological disease
* Patients with respiratory diseases ath the time of dysgeusia evaluation
* Patients with active alcohol consumption

Primary outcomes:
measure: Dysgeusia
timeFrame: Presence of any taste disorder at 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Medica Sur Clinic & Foundation
Study officials:
affiliation: Medica Sur Clinic & Foundation
name: Norberto C Chávez-Tapia, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medica Sur Clinic & Foundation
name: Eva Juárez-Hernández
role: STUDY_DIRECTOR
References:
Clinical trial NCT04172428: Comparison of Compact 3T, Conventional 3T, and 7T Scanners Using Task Based and Resting State fMRI
Official title: Comparison of Compact 3T, Conventional 3T, and 7T Scanners Using Task Based and Resting State fMRI
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-11-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Young healthy volunteers ages 18-55, English must be primary language

Brief summary: Comparison of 3 MRI scanners.

Detailed description: Comparing the strengths and weaknesses of 3 different MRI scanners in their performance of a functional MRI (an MRI that shows which areas in the brain are active during some sort of task).

Eligibility criteria: Inclusion Criteria:

1) Men and Women aged 18-55

Exclusion Criteria:

1. Patients with safety contraindications to MRI scanning at 3T.
2. Patients unable to adequately perform the fMRI task due to physical, neurological, or cognitive disability.
3. Patients that demonstrate 3 mm or greater translational head motion during scanning of the fMRI rhyming task data sets.
4. Pregnant women.
5. Patients that have implanted medical devices or other safety contraindications for a 7T or 3T MRI exam.

Primary outcomes:
measure: Statistical maxima of fMRI language and motor area activations.
timeFrame: Approximately 6 months after last subject is scanned
measure: Signal to noise ratio assessment of resting state.
timeFrame: Approximately 6 months after last subject is scanned
Secondary outcomes:
measure: Neuroradiologist preference for scanner array.
timeFrame: Approximately 6 months after last subject is scanned
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: David F Black, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02056028: Bile Leak After Liver Surgery
Official title: Validation of Our Policy of Long-term Drains Maintenance After Hepatic Resection: Results of a Prospective Cohort Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bile Leak
Hepatic Resection
Liver Resection
Hepatectomy
Biliary Fistula
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2014-02-05
Enrollment: 475
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The records of 475 consecutive patients who were submitted to hepatectomy between 2004-2012 were reviewed.

Brief summary: The definition of biliary fistula is heterogeneous and the more accepted is that proposed by the ISGLS. We devised a precise definition of post-resectional biliary fistula and a well-established policy both for its disclosure and management.Aim was the validation of our definition, and management of biliary fistula after hepatic resection in a large prospective cohort of patients and its comparison with that of the International Study Group of Liver Surgery (ISGLS).

Detailed description: Data on abdominal drains and on clinical, pathological and short-term outcome were reviewed in a prospective cohort of patients who underwent hepatic resection between 2004 and 2012. Drains were maintained at least 7 days, and the bilirubin levels were measured in POD3, 5, and 7. Drains were removed if the bilirubin level in POD7 was inferior than in POD5, and less than 10 mg/dl. Statistical analysis on prognostic factors for biliary fistula was performed.

Eligibility criteria: Inclusion Criteria:

* any patient submitted to hepatic resection at our Unit between the established frame time

Exclusion Criteria:

* any patient with incomplete data or follow-up

Primary outcomes:
measure: Bile leak
timeFrame: 7 days
Secondary outcomes:
measure: ISGLS definition
timeFrame: 7 days
measure: ISGLS definition
timeFrame: 90 days
Other outcomes:
Locations:
city: Rozzano, Milan
country: Italy
facility: Humanitas Research Hospital
Study officials:
References:
citation: Torzilli G, Olivari N, Del Fabbro D, Gambetti A, Leoni P, Gendarini A, Makuuchi M. Bilirubin level fluctuation in drain discharge after hepatectomies justifies long-term drain maintenance. Hepatogastroenterology. 2005 Jul-Aug;52(64):1206-10.
citation: Donadon M, Costa G, Cimino M, Procopio F, Del Fabbro D, Palmisano A, Torzilli G. Diagnosis and Management of Bile Leaks After Hepatectomy: Results of a Prospective Analysis of 475 Hepatectomies. World J Surg. 2016 Jan;40(1):172-81. doi: 10.1007/s00268-015-3143-0.
Clinical trial NCT00138528: Other Effects of Fluvastatin Are Investigated in Patients With Metabolic Syndrome
Official title: Other Effects of Fluvastatin Are Investigated in Patients With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Metabolic Syndrome
Keywords: Metabolic Syndrome, fluvastatin
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-08-30
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Other effects of fluvastatin are investigated in German patients with metabolic syndrome.


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Male and female patients, aged between 18 and 75 years
* Metabolic syndrome according to National Cholesterol Education Program Adult Treatment Panel III (NCEP ATPIII)

Exclusion Criteria:

* History of heart failure
* HIV positive
* Stroke

Other protocol defined inclusion and exclusion criteria may apply.

Primary outcomes:
measure: Change from baseline in circulating marker of inflammation (C-reactive protein) after 5 weeks
Secondary outcomes:
measure: Change from baseline in low density lipoprotein cholesterol after 5 weeks
measure: Change from baseline in non high density lipoprotein cholesterol after 5 weeks
measure: Change from baseline in total cholesterol after 5 weeks
measure: Change from baseline in high density lipoprotein cholesterol after 5 weeks
measure: Change from baseline in oxidized low density lipoprotein cholesterol after 5 weeks
Other outcomes:
Locations:
city: Nürnberg
country: Germany
facility: Novartis
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Westphal S, Abletshauser C, Luley C. Fluvastatin treatment and withdrawal: effects on endothelial function. Angiology. 2008 Oct-Nov;59(5):613-8. doi: 10.1177/0003319708316005. Epub 2008 Apr 14.