louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02593201: The Efficacy of Prolonged Antibiotic Therapy for the Prevention of Relapsing Peritonitis in Peritoneal Dialysis Patients With High Dialysis Effluent Bacterial DNA Fragment Levels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Peritoneal Dialysis
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2015-11-01
Enrollment: 358
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Peritoneal dialysis (PD) is the first-line treatment of end stage renal disease (ESRD) in Hong Kong. Despite the advances in antibiotic therapy and connecting system, recurrent peritonitis remains the major cause of peritoneal failure. A recent study showed that an elevated bacterial DNA fragment levels in PD effluent 5 days prior to the completion of antibiotics predicts the development of relapsing or recurrent peritonitis episodes. We hypothesize that prolonged antibiotic therapy in PD patients with peritonitis and high PD effluent bacterial DNA fragment levels could prevent the development of relapsing and recurrent peritonitis. We plan to conduct a randomized control study of 360 patients with PD peritonitis. After inform consent, they will be randomized to receive one additional week of the effective antibiotic treatment (the Preemptive Treatment Group) or no additional treatment (the Control Group). Specimens of PD effluent will be collected 5 days prior to the completion of antibiotics for the measurement of bacterial DNA fragments. All patients will be followed for 6 months after completion of antibiotic therapy for the development of relapsing, recurrent, or repeat peritonitis episodes. Our study will determine the efficacy of a test-before-treat algorithm that could reduce the incidence of relapsing and recurrent peritonitis and, at the same time, minimize the unnecessary use of prolonged antibiotic treatment.


Eligibility criteria: Inclusion Criteria:

* Patients with peritoneal dialysis-related peritonitis

Exclusion Criteria:

* Patients with fungal peritonitis
* Patients with obvious surgical problems and require laparotomy

Primary outcomes:
measure: relapsing peritonitis episodes
timeFrame: 6 months
measure: repeat peritonitis episodes
timeFrame: 6 months
measure: recurrent peritonitis episodes
timeFrame: 6 months
Secondary outcomes:
measure: peritonitis that requires hospitalization
timeFrame: 6 months
measure: need of catheter removal
timeFrame: 6 months
measure: need of conversion to long-term hemodialysis
timeFrame: 6 months
measure: death due to peritonitis
timeFrame: 6 months
measure: all cause mortality
timeFrame: 6 months
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: Department of Medicine & Therapeutics, Prince of Wales Hospital
Study officials:
References:
Clinical trial NCT01744301: Acid Suppressing Drug Seizure Epidemiology Study
Official title: A Cohort Study With a Nested Case Control Analysis on the Association Between Acid-suppressing Drugs and Seizures Using THIN Database in the UK
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Seizure
Keywords: Seizure
Acid-suppressing drugs
Epidemiology
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2012-12-06
Enrollment: 8605
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All individuals aged 20-84 years from 1 January 2005 to 31 December 2011, who have been enrolled with their primary care physician for at least 2 years and have a computerized prescription history of at least 1 year. Patients will have to be free of acid-suppressing drugs (PPI or H2RA) for at least one year, and never have a diagnosis of cancer, alcohol abuse or alcohol-related disease, or drug abuse.

Brief summary: The purpose of this study is

1. to estimate the incidence of seizure in the general population and stratified by epilepsy status
2. To estimate the relative risk of seizure associated with use of proton pump inhibitors and histamine 2 receptor antagonist and stratified by epilepsy status

Detailed description: A cohort study with a nested case control analysis on the association between acid-suppressing drugs and seizures using THIN database in the UK

Eligibility criteria: Inclusion Criteria:

* Primary care physician for at least 2 years.
* Computerized prescription history of at least 1 year.
* Patients will have to be free of acid-suppressing drugs (PPI or H2RA) for at least one year.
* No diagnosis of cancer.
* No alcohol abuse or alcohol-related disease- No drug abuse.

Exclusion Criteria:

* Patients with at least 1 prescription of PPI or H2RA in the year prior to start date.
* Cancer before start date.
* Alcohol abuse or alcohol-related disease before start date.
* Drug abuse before start date.

Primary outcomes:
measure: Incidence of seizure in the general population and stratified by epilepsy status.
timeFrame: Participants will be followed for the duration of the study period 1 January 2005-31 December 2011, an expected average of 3 years.
measure: Follow-up of safety outcomes: First recorded entry of seizure.
timeFrame: Participants will be followed for the duration of the study period 1 January 2005-31 December 2011, an expected average of 3 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Research Site
Study officials:
affiliation: CEIFE (Centro Espanol de Investigacion Farmacoepidemiologica - Spanish Centre for Pharmacoepidemiologic Research )
name: Luis a Garcia Rodriguez, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Saez ME, Gonzalez-Perez A, Gaist D, Johansson S, Nagy P, Garcia Rodriguez LA. Risk of seizure associated with use of acid-suppressive drugs: An observational cohort study. Epilepsy Behav. 2016 Sep;62:72-80. doi: 10.1016/j.yebeh.2016.06.039. Epub 2016 Jul 21.
Clinical trial NCT05787301: Study of Epidemiologic Investigation and Mechanism of Brain Network of Otologic and Cognitive Function With Post-COVID-19
Official title: Study of Epidemiologic Investigation and Mechanism of Brain Network of Otologic and Cognitive Function With Post-COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Cognitive Decline
Otological Disease
Keywords: COVID-19
Epidemiologic Investigation
Brain network
Otological Symptoms
Cognitive Function
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2023-03-28
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A total of 748 patients with novel coronavirus were surveyed from December 2022 to February 2023.

Brief summary: The purpose of this study was to analysis the incidence of ear symptoms, cognitive function decline and emotional disorders in Chinese people who were infected with COVID-19, exploring the impact of COVID-19 on the auditory system, cognitive function and emotional function, and analyzing the changes in functional connectivity of brain network after COVID-19 infection.


Eligibility criteria: Inclusion Criteria:

* Confirmed cases of COVID-19 that test positive for nucleic acid or antigen
* After infection with COVID-19, the patient has experienced hearing loss, tinnitus, ear tightness, ear pain, vertigo and other ear symptoms, memory loss, depression and so on

Exclusion Criteria:

* Diagnosed cognitive disability
* Patients with confirmed Meniere's disease, auditory neuropathy, and heavy noise exposure
* Those with incomplete basic information or for other reasons are unable to complete questionnaires and other listening and cognitive assessments

Primary outcomes:
measure: The correlation between the peak of COVID-19 transmission and the popularity of related online terms
timeFrame: through study completion, an average of 3 months
measure: Symptom incidence
timeFrame: through study completion, an average of 3 months
measure: Pure tone average
timeFrame: through study completion, an average of 3 months
measure: Mini-Mental State Examination score and grade
timeFrame: through study completion, an average of 3 months
measure: Montreal Cognitive Assessment score and grade
timeFrame: through study completion, an average of 3 months
measure: Pittsburgh Sleep Quality Interview score and grade
timeFrame: through study completion, an average of 3 months
measure: Hamilton depression score and grade
timeFrame: through study completion, an average of 3 months
measure: Resting state of Electroencephalogram data
timeFrame: through study completion, an average of 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT06745401: Remote Monitoring of Cancer Patients With Outpatient Treatment
Official title: Remote Monitoring of Cancer Patients With Outpatient Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer Patients With Outpatient Treatment
Keywords: Remote patient monitoring
Cancer patients
outpatient treatment
Caaring
real-world data
DTx
patient-reported data
Digital Health
PROMs
Lead sponsor: Persei Vivarium
Sponsor class: OTHER
Collaborators: name: Effice Servicios Para la Investigacion S.L.
First posted: 2024-12-20
Enrollment: 34
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: Cancer Patients from the Hospital HM Sanchinarro diagnosed who meet the selection criteria and sign the informed consent will be included.

Brief summary: This project focuses on studying the use of digital platforms for monitoring, between medical visits, parameters such as toxicities and therapeutic adherence.

The goal of this observational study is to know the degree of usability of the Caaring® digital platform in cancer patients undergoing outpatient oral treatment. This will allow in the future to design comparative studies that demonstrate the advantages of using this application in the management of these patients.

Participants will fill out various questionnaires in the Caaring app related to their symptoms, adherence to treatment, quality of life and physical activity, among others.


Eligibility criteria: Inclusion Criteria:

* Cancer patients with adjuvant or metastatic oncological treatment
* Cancer patients with oral oncological treatment
* Patients who are able to complete the study questionnaires
* Patients who are able to handle the application on a smart mobile phone.
* Informed consent is obtained from the patient.

Exclusion Criteria:

* Patients who will not be able to commit to carrying out the follow-ups or do not have adequate technological skills.
* Patients with inability to give adequately the informed consent.

Primary outcomes:
measure: Usability of Caaring® for the management of oncology patients in outpatient oral treatment
timeFrame: Day 0 up to 3 months
Secondary outcomes:
measure: Degree of completion of data relating to treatment adherence
timeFrame: Weekly up to 3 months
measure: Degree of completion of data related to the toxicity of their treatment
timeFrame: Weekly up to 3 months
measure: Quality of the care process through impact on the patient's quality of life: WHOQOL
timeFrame: Day 0 and week 12
measure: Quality of the care process through impact on the patient's quality of life: IPAQ
timeFrame: Day 0 and week 12
measure: Patient workload
timeFrame: Week 12
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital HM Sanchinarro
Study officials:
References:
Clinical trial NCT01355601: Effect of Carbohydrates From Nutritional Beverages in Children
Official title: Effect of Carbohydrates From Nutritional Beverages in Children
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Concentration
Learning
Lead sponsor: Mead Johnson Nutrition
Sponsor class: INDUSTRY
First posted: 2011-05-18
Enrollment: 88
Sex: ALL
Minimum age (years): 33
Maximum age (years): 39
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This clinical trial will determine the effect of varying types of carbohydrates on children's concentration.


Eligibility criteria: Inclusion Criteria:

* Children 33 months - 39 months

Primary outcomes:
measure: Concentration
Secondary outcomes:
measure: Attention
measure: Short-Term Memory
measure: Rule Learning
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Early Cognition Laboratory
state: Kansas
Study officials:
References:
Clinical trial NCT05971901: A Combinatorial Biomarker for Infection Diagnosis in Children
Official title: A Combinatorial Biomarker for Infection Diagnosis in Children
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Respiratory Tract Infections
Fever
Lead sponsor: Universität des Saarlandes
Sponsor class: OTHER
First posted: 2023-08-02
Enrollment: 770
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients for whom the treating physicians request the determination of the BV score from the patient's serum due to a suspected infection can be included in this study, provided that they meet the above inclusion criteria, are capable of giving consent and agree to participate in the study (or, in the case of incapacitated patients, written consent is obtained from their legal guardian, health care proxy or custodian).

Brief summary: To describe the epidemiology, clinical presentation, diagnosis, therapy, and treatment outcomes of patients in whom the combination biomarker BV (combination of TRAIL, IP-10, and CRP) is used, and to compare them with control patients without BV measurement.

Secondary objectives:

* Qualitative evaluation of indication as well as adherence to the test result.
* Comparison of antimicrobial therapy, performed diagnostics, hospitalization, and outcomes between patients with high BV score (bacterial) and patients with low BV score (viral).


Eligibility criteria: Inclusion Criteria:

* Suspicion of acute bacterial or viral infection
* Requirement of at least one BV test during medical presentation

Exclusion Criteria:

* lack of informed consent

Primary outcomes:
measure: Antibiotics
timeFrame: up to 30 days
Secondary outcomes:
measure: Antibiotic duration
timeFrame: up to 30 days
measure: Hospitalization
timeFrame: up to 30 days
measure: Complications
timeFrame: up to 30 days
measure: Tests
timeFrame: up to 30 days
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Sana Kliniken
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
city: Homburg
country: Germany
facility: Saarland University
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg
Study officials:
affiliation: Universität des Saarlandes
name: Cihan Papan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06036901: Asan Medical Center CCTA Registry
Official title: Assessment of Coronary Artery Disease in Asymptomatic Population Undergoing Coronary Computed Tomography Angiography: A Single Center, Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Risk Factor
Computed Tomography
Lead sponsor: CardioVascular Research Foundation, Korea
Sponsor class: OTHER
First posted: 2023-09-14
Enrollment: 6343
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals aged 20 years and older had undergone self-referral CCTA evaluation as part of a general health examination in the Health Screening and Promotion Center at Asan Medical Center from January 2007 to December 2011.

Brief summary: A total of 9269 adults who received CCTA scans for coronary disease evaluation during a general medical checkup at the Health Screening and Promotion Center in Asan Medical Center, Seoul, Korea between January 2007 and December 2011 were initially selected. All participants were provided with information about the potential benefits and risks of CCTA and made the decision to undergo the procedure at their own expense. They were also informed that their clinical and radiological data would be used for this study and gave their consent. Of these individuals, 7129 agreed to participate, and 6343 were enrolled in this CCTA registry.


Eligibility criteria: Exclusion Criteria:

1. a previous history of angina or myocardial infarction;
2. abnormal rest electrocardiographic results, i.e., pathological Qwaves, ischemic ST segments or T wave changes, or left bundle-branch blocks;
3. insufficient medical records;
4. structural heart diseases;
5. a prior history of open heart surgery or percutaneous coronary intervention;
6. a previous cardiac procedure; or
7. renal insufficiency (creatinine N1.5 mg/dL)

Primary outcomes:
measure: The prevalence of CAD
timeFrame: 5 years
Secondary outcomes:
measure: All cause mortality
timeFrame: 5 years
measure: cardiovascular mortality
timeFrame: 5 years
measure: myocardial infarction
timeFrame: 5 years
measure: Revascularization
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02187601: Equivalence of New Breath AnalyzerCompared to Currently BreathID System in Assessment of Liver Function
Official title: Beta Study to Evaluate Functionality and Equivalence of MPBA (Multi Purpose Breath Analyzer-new Generation Exalenz Breath Analyzer) Compared to Currently Approved BreathID System in Assessment of Liver Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Liver Disease (CLD)
Healthy Volunteers
Keywords: CLD
Lead sponsor: Meridian Bioscience, Inc.
Sponsor class: INDUSTRY
First posted: 2014-07-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the study is to confirm that the new generation state of the art breath analyzer gives equivalent results to the previous model of the Exalenz breath analyzer.

Detailed description: Healthy and chronic liver disease subjects of all grades will be tested to see that the two devices give equivalent results in both devices. Subjects will be connected to both devices at the same time and will be tested for one hour.

The breath test includes automatic baseline breath collection, 13C-Methacetin ingestion in solution and breath collection post ingestion.

Eligibility criteria: Inclusion Criteria:

1. Over 18 years of age
2. Ability and willingness to sign the Informed Consent Form

   For patient group:
3. a. Known chronic liver disease (based on medical history)

For healthy volunteers:

3.b. No known liver disease (based on medical history)

Exclusion Criteria:

1. Gastric bypass surgery or extensive small bowel resection
2. Total parenteral nutrition
3. Pregnant or breast feeding
4. Allergy to acetaminophen and/or other related medications.
5. Documented drug-related concurrent hepatotoxicity or drug-related silent steatosis or drug-related fibrosis (e.g. amiodarone, methotrexate and tamoxifen).
6. Uncontrolled malabsorption or diarrhea
7. Placement of a transjugular intrahepatic portosystemic shunt (TIPS)
8. Subject should not have taken any of the following for at least 48 hours prior to the breath test: Acyclovir, allopurinol, carbamazepine, cimetidine, ciprofloxacin, daidzein, (herbal) disulfiram, echinacea, enoxacin, famotidine, fluvoxamine, methoxsalen, mexiletine, montelukast, norfloxacin, phenylpropanolamine, phenytoin, propafenone, rifampin, terbinafine, ticlopidine, thiabendazole, verapamil, zileuton or oral contraceptives or any medication that might interfere with Methacetin metabolism or might affect CYP 1A2
9. Subject should not have taken amiodarone within the last 30 days prior to the breath test

Primary outcomes:
measure: DOB Peak
timeFrame: One hour
Secondary outcomes:
measure: Number of subjects with adverse events related to breath test substrate
timeFrame: 48 hours
Other outcomes:
Locations:
city: Tzrifin
country: Israel
facility: Assaf Harofe Medical Center
Study officials:
affiliation: Hadassah Medical Organization
name: Saleh Daher, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02504801: Efficacy of Nebulized Pulmicort Respules in Primary Lung Cancer Patients With COPD
Official title: Efficacy of Nebulized Pulmicort Respules on Post Operation Pulmonary Complication During Pulmonary Single Lobectomy Surgery in Primary Lung Cancer Patients With COPD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Post Operative Complication, Pulmonary
Lung Cancer
COPD
Keywords: primary lung cancer patients
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2015-07-22
Enrollment: 73
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To test the hypothesis that nebulized Pulmicort Respules could reduce post operation pulmonary complication incidence in primary lung cancer patients with COPD. Compare post-operation pulmonary complication incidence in two treatment arms among primary lung cancer patients with COPD required single lobectomy from 3days before operation to 7 days after operation.


Eligibility criteria: Inclusion Criteria:

1. Newly diagnosed or existing COPD defined by GOLD, and FEV1 of\<80% predicted and FEV1/FVC\<70%
2. Diagnosed as primary lung cancer by China guidelines on diagnosis and treatment of primary lung cancer
3. .Consistent with indication of operation of pulmonary single lobectomy surgery by China guidelines on diagnosis and treatment of primary lung cancer
4. General anesthesia and double cavity intubation was used during operation
5. ASA Classification of Anesthesia Risk is in category 1-3 both in baseline
6. age from 40-80 years old
7. Smoking cessation more than two weeks before operation
8. SP O2\>90% before surgery
9. Hemoglobin \> 10g/dl
10. Estimated duration of surgery \< 4 hours
11. 18.5\<BMI \< 28

Exclusion Criteria:

1. Patients who had taken systemic corticosteroids in the preceding 1month before baseline
2. Patients who had pneumonia in the preceding 1month before baseline
3. Patients with a history of recent myocardial infarction, heart failure, tuberculosis
4. Subject with known or suspected human immunodeficiency virus infection

Primary outcomes:
measure: The incidence of post-operation pulmonary complication in two arms among primary lung cancer patients with COPD
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: