louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04607161: External Validation of Models for Predicting Inadequate Bowel Preparation
Official title: External Validation of Two Prediction Models for Adequate Bowel Preparation in Asia: A Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colonoscopy
Predictive Model
External Validation
Lead sponsor: Ningbo No. 1 Hospital
Sponsor class: OTHER
First posted: 2020-10-29
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients undergoing colonoscopy

Brief summary: In order to obtain the risk level of patients with intestinal insufficiency through simple indicators, many foreign scholars have studied and developed their own prediction models. However, the current guideline indicates that there is insufficient evidence to recommend the use of a specialized predictive model for clinical practice.There are few studies on external validation of existing prediction models.


Eligibility criteria: Inclusion Criteria:

* patients undergoing colonoscopy.
* patients older than 18 years.

Exclusion Criteria:

* Emergency colonoscopy.
* Have a serious medical condition, such as heart failure, acute liver failure, severe kidney disease (dialysis or predialysis patients) or New York heart association class iii-iv.
* Pregnant or breastfeeding.
* No bowel preparation or poor compliance (no bowel preparation as instructed or laxatives \< 90% of prescribed dose).
* Refuse to sign informed consent.
* The patient was rescheduled after the previous colonoscopy due to insufficient bowel preparation.
* Temporarily change to colonoscopy for other reasons.
* Incomplete colonoscopy due to insufficient parenteral preparation.
* Lack of complete data.

Primary outcomes:
measure: discrimination
timeFrame: cross-sectional analyses in 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Ningbo
country: China
facility: Ningbo first hospital
state: Zhejiang
Study officials:
References:
citation: Yuan X, Gao H, Liu C, Wang W, Xie J, Zhang Z, Xu L. External validation of two prediction models for adequate bowel preparation in Asia: a prospective study. Int J Colorectal Dis. 2022 Jun;37(6):1223-1229. doi: 10.1007/s00384-022-04156-0. Epub 2022 Apr 25.
Clinical trial NCT02458261: Pharmacokinetics and Pharmacodynamics of Extended-Infusion Cefepime in Continuous Renal Replacement Therapy
Official title: Pharmacokinetics and Pharmacodynamics of Extended-Infusion Cefepime in Continuous Renal Replacement Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Drug Mechanism
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: Children's Hospital Medical Center, Cincinnati
First posted: 2015-06-01
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill patients on continuous renal replacement therapy who are being initiated on cefepime 2000 mg IV every 8 hours with a four-hour infusion

Brief summary: This prospective, multi-center study aims to determine the pharmacokinetics and pharmacodynamics of extended-infusion cefepime in continuous renal replacement therapy (CRRT).

Detailed description: This prospective, multi-center study aims to determine the pharmacokinetics and pharmacodynamics of extended-infusion cefepime in CRRT. Patients on CRRT who are being initiated on cefepime 2000 mg IV every eight hours with a four-hour infusion will be considered for enrollment. Pre- and post-membrane serum levels will be drawn at scheduled intervals for both the first dose and again during another dose at steady state. Concomitant effluent and urine levels will also be obtained. A pharmacokinetic analysis will be performed and Monte Carlo simulations will be used to determine the probability of target attainment for various pharmacodynamic endpoints. Documented organism MICs will be used to determine the cumulative fraction of response.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Admission to medical intensive care unit (MICU), surgical intensive care unit (SICU), neuroscience intensive care unit (NSICU), or cardiovascular intensive care unit (CVICU), at the University of Cincinnati Medical Center, or the mixed ICU at West Chester Hospital
* Patients receiving continuous venovenous hemofiltration or continuous venovenous hemodialysis
* Receiving empiric or definitive cefepime 2 g IV every 8 hours with a four-hour infusion

Exclusion Criteria:

* Prisoners
* Pregnant women
* Patients with cystic fibrosis
* Burns patients
* 24-hour urine output \> 400 mL or unknown

Primary outcomes:
measure: Composite pharmacokinetic and pharmacodynamic profile of extended-infusion cefepime in CRRT
timeFrame: up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01305161: Flow Cytometry Applied to the Diagnosis of Peri-anaesthesic Reactions
Official title: Diagnostic Accuracy of Flow Cytometry Applied to the Diagnosis of Peri-anaesthesic Reactions Induced by Neuromuscular Blockers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allergy
Keywords: 1Allergy
2 Neuromuscular blockers
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2011-02-28
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To assess diagnostic accuracy of flow cytometry applied to the diagnosis of allergy to neuro-muscular blockers and to the determination of the neuro-muscular blocker (NMB) which may be used for an ulterior anaesthesia in case of allergy to one given NMB.

Detailed description: The flow cytometric protocol used for this study, was based on basophil selection by an anti- CCR3 and the analysis of basophil activation by the respective up and down regulation of the CD63 and IgE markers as described previously. Basophil activation was expressed in percentage CD63 expression on activated basophils and in activation index involving IgE and CD63 markers and calculated by a specific algorithm developed by our group.. Our aim is to test a sufficient number of patients in order to be able to establish the ROC curves related to the allergen type tested and validate the use of an allergen mixture (NMB mix containing the 7 usual NMB at the optimal activation concentrations). Patients will be included during the post-anaesthetic consultation on the basis of the diagnosis of an IgE dependant per-anaesthetic reaction. The allegro-anaesthetist diagnostical habits won't be changed.

Eligibility criteria: Inclusion Criteria:

* patients aged at least 18 years,
* patients having experienced an IgE dependant per-anaesthetic reaction
* affiliated to a social security

Exclusion criteria:

* patients having taken anti-histamine drugs and corticoids during the last 8 days
* patients submitted to a juridical protection

Primary outcomes:
measure: Allergy diagnosis assessed by cytometry flow data
timeFrame: At Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: Service d'Allergologie
city: Bordeaux
country: France
facility: Service d'Immuno-allergologie
city: Limoges
country: France
facility: Laboratoire Immunologie et Immunogénétique
city: Nancy
country: France
facility: Service d'Anesthésie Réanimation
Study officials:
References:
Clinical trial NCT05361161: Transarterial Chemoembolization With Lipiodol in the Treatment of Initial Unresectable Gastric Cancer (GC)
Official title: Transarterial Chemoembolization With Lipiodol in the Treatment of Initial Unresectable Gastric Cancer (GC)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Gastric Cancer
Embolization
Lead sponsor: The First Affiliated Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2022-05-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, open-labelled study to evaluate the efficacy and safety of sequential transarterial chemoembolization with lipiodol and neoadjuvant chemotherapy in the treatment of Initial unresectable gastric cancer.


Eligibility criteria: Inclusion Criteria:

1. Pathological and imaging diagnosis of gastric adenocarcinoma with initial unresectable R0;
2. Age (18-80 years old) and gender are not limited;
3. No extragastric organ transfer;
4. No serious diseases of the heart, liver, lung, kidney and other organs;
5. Expected survival time \> 3 months;
6. Physical performance status score ECOG ≤1 point;
7. Females of reproductive age must have a negative pregnancy test; or male and female patients must agree to use effective contraception during treatment and within 1 year thereafter.

Exclusion Criteria:

1. Poor coagulation function, INR\>1.5, or ongoing anticoagulation therapy or known bleeding diseases;
2. WBC \<3000/mm3 or platelet count \<50000/mm3;
3. AST and/or ALT \> 3 times the upper limit of normal;
4. Comorbidities or social environment that can cause subjects to fail to follow the research plan or even endanger patient safety;
5. The patient has other primary tumors.

Primary outcomes:
measure: Efficacy evaluation
timeFrame: up to 3 years
measure: Surgical resection rate
timeFrame: up to 3 years
measure: PFS
timeFrame: up to 3 years
measure: OS
timeFrame: up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00974961: Levobupivacaine on Heart Rate Variability (HRV) in Spinal Anesthesia
Official title: Comparison of the Effects of Levobupivacaine and Bupivacaine on Heart Rate Variability in Spinal Anesthesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Spinal Anesthesia
Keywords: Levobupivacaine
HRV
Spinal Anesthesia
Responses of ANS to these two drugs
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2009-09-11
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare if the effect of levobupivacaine on autonomic nervous system smaller than that of bupivacaine.

Detailed description: Obtain the heart rate variability (in means and standard deviation, including the high frequency, low frequency and its ratio) data of before and after spinal anesthesia with ECG (and Heart Rate Variability Analyzer) in 2 groups. Meanwhile, record the blood pressure on each subject.

Eligibility criteria: Inclusion Criteria:

* Indicated for spinal anesthesia

Exclusion Criteria:

* Allergic reaction to local anesthetics
* Coagulopathy
* Severe spinal deformity
* Cardiac diseases
* Metabolic diseases (such as DM, thyroid or adrenal diseases)

Primary outcomes:
measure: HRV values
timeFrame: 5 minutes after drug administration
Secondary outcomes:
Other outcomes:
Locations:
city: Yun-Lin county
country: Taiwan
facility: Department of Anesthesiology, National Taiwan University Hospital, Yun-Lin Branch
Study officials:
name: Shih-Yu Chen
role: STUDY_CHAIR
References:
Clinical trial NCT05662761: Assessment of the Relationship Between Severity of Chronic Venous Obstruction and Venous Claudication
Official title: Assessment of the Relationship Between Severity of Chronic Venous Obstruction and Venous Claudication
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Venous Insufficiency
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2022-12-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with obstruction in the common femoral vein, external iliac vein, common iliac vein, or inferior vena cava

Brief summary: Assessment of the Relationship between Severity of Chronic Venous Obstruction and Venous Claudication

Detailed description: The postthrombotic syndrome (PTS) occurs in about 20-50% of patients after a deep Venous thrombosis and significantly affects the quality of life of patients. With the patency rates of 73-100% are achieved with endovascular procedures. At 58% of patient ulcer healing was achieved. Neglen et al. could a significant demonstrate an improvement in quality of life. Aim of the study: To show the influence of the increased inflow to venous Objectively review recanalization for patient symptoms and walking performance. Therefore, before and after venous interventions, to assess walking performance and pain-free Measure the walking distance of the patient on the treadmill and compare it to get a possible identifying relevant and/or significant changes.

Eligibility criteria: Inclusion Criteria:

1. Patients with an obstruction in the femoral vein communis, V. iliaca externa, V. iliaca communis or V. cava inferior
2. Age: 18-80 years old
3. Signed informed consent form
4. Persons who are legally competent and mentally capable, to follow the instructions of the staff

Exclusion Criteria:

1. Patients under 18 years of age.
2. Patients who are unable to consent and/or not in are able to appreciate the nature, importance and scope of the study understand and give their consent in writing.
3. Persons acting by administrative or judicial order are housed in a facility
4. Patients who abuse drugs
5. Peripheral arterial disease stage IIb, III and IV -

Primary outcomes:
measure: pain -free walking distance
timeFrame: 2022-2025
Secondary outcomes:
measure: Stent openness rate
timeFrame: 2022-2025
measure: 2
timeFrame: 2022-2025
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Universitätsklinikum Aachen
state: NRW
Study officials:
affiliation: Universitätsklinikum Aachen Klinik für Gefäßchirurgie
name: Houman Jalaie, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04165161: Performance Diagnosis of a Patent Foramen Ovale During Lung Transplantation Using Transesophageal Echocardiography
Official title: Performance Diagnosis of a Patent Foramen Ovale During Lung Transplantation Using Transesophageal Echocardiography: Comparison of the Injection of Contrast in the Upper and Lower Caval Territories (FOP-TP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Transplant; Complications
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2019-11-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: For each patient the 4 tests will be performed in a randomized order to limit bias
Primary purpose: OTHER

Brief summary: The investigators hypothesis is that an injection into the inferior vena cava associated with a provocation maneuver should allow to increase the incidence of FOP found by transesophageal echocardiography in a population of patients undergoing lung transplantation.


Eligibility criteria: Inclusion Criteria:

* Aged 18 years old minimum
* Benefiting from a lung transplant
* Having an upper vena cava catheter and a lower vena cava catheter set up as part of the usual care
* Having signed a consent form
* Affiliated to a insurance scheme or beneficiary (excluding AME)

Exclusion Criteria:

* Pregnant or lactating women
* Having a contraindication to the insertion of the esophageal ultrasound probe
* deprived of liberty or under guardianship

Primary outcomes:
measure: Incidence of transatrial passage of contrast media
timeFrame: 1 day after lung transplantation
Secondary outcomes:
measure: Size of PFO, existence of an atrial septal aneurysm
timeFrame: 1 day after lung transplantation
measure: Number of postoperative days with mechanical ventilation
timeFrame: 30 days after lung transplantation
measure: Incidence of pulmonary graft dysfunction, incidence of stroke, incidence of myocardial ischemia
timeFrame: 30 days after lung transplantation
measure: Mortality during the stay in the intensive care unit
timeFrame: 30 days after lung transplantation
measure: Mortality during the stay in the hospital
timeFrame: 30 days after lung transplantation
measure: Mortality at the postoperative 30-day
timeFrame: 30 days after lung transplantation
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hopital Foch
Study officials:
affiliation: Hopital Foch
name: Maxime Davignon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02741661: Influence of Myocardial Shortening on Coronary Tortuosity
Official title: Determinants of Coronary Tortuosity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Vessels
Coronary Artery Disease
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2016-04-18
Enrollment: 70
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Retrospective study of subjects who have undergone clinically-indicated coronary arteriography who also have an echocardiogram that was performed within 3 months of the angiogram.

Brief summary: This study is a retrospective analysis where coronary arteriograms are being analyzed to determine whether the presence of tortuous coronary arteries correlate with any specific measures of left ventricular mass or left ventricular function on echocardiography.


Eligibility criteria: Inclusion Criteria:

* subjects referred for angiography
* echocardiography performed within 3 months.

Exclusion Criteria:

* connective tissue disease
* severe LV dysfunction
* prior coronary artery bypass surgery
* major adverse coronary event between angiogram and echo procedures
* moderate or greater valve disease
* acute coronary syndrome

Primary outcomes:
measure: Degree of longitudinal shortening
timeFrame: 3 months
Secondary outcomes:
measure: LV mass
timeFrame: 3 months
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU
state: Oregon
Study officials:
References:
Clinical trial NCT06900361: Use of Mobile Phone Application for Asthma Sele Management
Official title: Feasibility and Acceptability of Asthma Self-Management Delivered Through a Mobile Phone Application: A Pilot Study in Malawi
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma Self Management
Keywords: Asthma Self Management
Lead sponsor: Kamuzu University of Health Sciences
Sponsor class: OTHER
First posted: 2025-03-28
Enrollment: 17
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All asthma patients aged 10 years and over attending pediatric outpatient clinic.

Brief summary: This study aimed to assess the feasibility and acceptability of self-management provided through a mobile application.

Detailed description: The chronic nature of asthma management requires a long-term approach taking into account the variability of disease symptoms, triggers and exacerbations. Several current guidelines advocate for self-management as part of standard care. Low-income countries (LMICs) such as Malawi are experiencing an increase in the burden of disease which hinders delivery of self-management services. Mobile phone health applications (mHealth) has been reported as an effective and cost-effective tool in the monitoring and management of asthma.

Eligibility criteria: Inclusion Criteria:

1. Be aged 10 years and over
2. Have a Physician diagnosis of asthma and be prescribed a salbutamol inhaler
3. Reside in Blantyre
4. Participants should be able to read and write either English or Chichewa with Minimum standard 5 eductaion

Exclusion Criteria:

1. Cognitively impaired
2. Presence of coormobities
3. Refues to consent
4. Presence of active lung disease other than athsma

Primary outcomes:
measure: GINA Symptom Control Assessment
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Blantyre
country: Malawi
facility: Kamuzu University of Malawi
Study officials:
References:
citation: Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention,2019. Available from www.ginasthma.org
Clinical trial NCT03651661: Pupillography as Screening Tool for Brain Insulin Resistance
Official title: Pupillographie Als Screeningtest für Cerebrale Insulinresistenz
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2018-08-29
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Cerebral insulin action is important in the regulation of whole body glucose metabolism. However, the cerebral insulin action differs between individuals - there is a so called cerebral insulin resistance. The influence of central insulin action on peripheral metabolism seems at least partially mediated via the autonomous nervous system. A noninvasive method to measure autonomic function is the pupillography. The aim of the study is to find out whether pupillography can be used to assess central insulin activity. Thus, pupillography will be performed in 30 normal weight and 30 overweight subjects before and after application insulin intranasally.


Eligibility criteria: Inclusion Criteria:

* voluntary adults
* HbA1c \<5.8%
* Age between 18 and 60 years
* written consent

Exclusion Criteria:

* There is a pregnancy or pregnancy can not be excluded
* lactating women
* Minors or non-consenting subjects are also excluded
* Acute illness or infection within the last 4 weeks
* Neurological and psychiatric disorders
* intake of centrally acting drugs
* Subjects with hemoglobin levels Hb \<12g / dl (in females), Hb \<14g / dl (males)
* Allergic diseases against one of the substances used

Primary outcomes:
measure: Measurements of autonomic nervous system activity by pupillography
timeFrame: Measurements baseline and change to baseline 15 minutes and 30 minutes after spray application
measure: Measurements of latency of pupil response to light stimulation.
timeFrame: Measurements baseline and change to baseline 15 minutes and 30 minutes after spray application
measure: Measurements of amplitude of pupil response to light stimulation.
timeFrame: Measurements baseline and change to baseline 15 minutes and 30 minutes after spray application
measure: Measurements of re-dilation behaviour of pupil response to light stimulation.
timeFrame: Measurements baseline and change to baseline 15 minutes and 30 minutes after spray application
Secondary outcomes:
measure: Autonomic nervous system
timeFrame: Measurements baseline and change to baseline 15 minutes and 30 minutes after spray application
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: University of Tuebingen, Department of Internal Medicine IV
Study officials:
References: