louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03188757: The Influence of Acute Hyperglycaemia on Brain in T1D
Official title: The Influence of Acute Hyperglycaemia on Oxidative Stress, Inflammation, Neurochemical Profile in Brain and Executive Functions of Adolescents With Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperglycemia
Type 1 Diabetes Mellitus
Lead sponsor: University of Ljubljana, Faculty of Medicine
Sponsor class: OTHER
First posted: 2017-06-15
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The study is going to include 20 adolescents, 5-10 years after onset of T1D, aged 12-20 years, on insulin pump. The participants are going to have MRI of the head in euglycaemic and hyperglycaemic state. During both MRI, the participants are going to preform Flanker test, Tower of London test and Spatial memory test. The investigators are going to evaluate the response of inflammation markers and oxidative stress marekers in blood during hypreglycaemia.

Detailed description: The study is going to include 20 patientswith T1D. The group of patients is going to be homogeneous. The inclusion criteria are going to be: duration of T1D approximately 5 - 10 years, age between 10 and 24 years, without associated clinical complications of T1D, similar value of HbA1c and BMI within the normal range (depending on the percentile for age and sex), treatment with an insulin pump. Only the patients who are going to give written consent to participate in the form "Declaration of conscious and free consent" are going to be included.

All selected clinical data to determine the phenotypic characteristics of the patient will be obtained from available medical records or. at their regular outpatient reading.

After 12-hour fasting overnight, the patients will undergo 2h hyperglycaemic clamp.

During hyperglycemia a sample of venous blood for the evaluation of oxidative stress, inflammatory response and the expression of non-coding RNA is going to be drawn.

Subjects will have 1H-MRS in hyperglycaemic and euglycaemic state and evaluation of executive function (using psychological tests) is going to be preformed. For 1H-MRS, the MRI of the head in order to obtain anatomical data is going to be preformed at first .

Eligibility criteria: Inclusion Criteria:

* T1D on insulin pump, no diabetic complication, normal BMI and blood pressure

Exclusion Criteria:

-

Primary outcomes:
measure: prolonged reaction time
timeFrame: during the MRI in hyperglycaemia
Secondary outcomes:
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: Medical Faculty - University of Ljubljana
Study officials:
References:
citation: Suput Omladic J, Slana Ozimic A, Vovk A, Suput D, Repovs G, Dovc K, Bratina N, Avbelj Stefanija M, Battelino T. Acute Hyperglycemia and Spatial Working Memory in Adolescents With Type 1 Diabetes. Diabetes Care. 2020 Aug;43(8):1941-1944. doi: 10.2337/dc20-0171. Epub 2020 May 29.
Clinical trial NCT01700257: Lung Cancer Screening Study With Low-dose CT Scan and Blood Biomarker
Official title: Different Strategies Using Autoantibodies and/or CT Scan Detection of Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High Risk of Developing Lung Cancer
Keywords: Lung cancer screening
Smokers or former smokers
Family history of lung cancer
Lead sponsor: National Jewish Health
Sponsor class: OTHER
First posted: 2012-10-04
Enrollment: 1361
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Lung cancer is the number one cancer killer in the USA. Early stage lung cancer is asymptomatic. Most patients with lung cancer are usually symptomatic at diagnosis and already have advanced stage disease. Low dose CT screening (LDCT) for high risk individuals has recently been shown to decrease lung cancer mortality by 20%. However, 4 out of 5 lung cancer deaths are not prevented with LDCT screening alone.

Detailed description: In this trial, the addition of a blood biomarker test is being combined with early LDCT to determine if screening with combination may result in detection of more lung cancer at an earlier stage of disease.The study will also assess if the blood test is able to detect lung cancers in high risk individuals when the LDCT is negative for cancer. There will be health-economic costs included in the final analysis of study data.

Eligibility criteria: Inclusion Criteria:

* Smokers or former smokers
* At least 20 pack year history of smoking
* Ages 50 - 75

Exclusion Criteria:

* Had a CT scan of chest within last 24 months
* History of any cancer within 10 yrs (except skin cancer or cervical cancer)
* A serious illness that decreases life expectancy to less than 5 years
* Any current use of Oxygen
* Uncontrolled congestive heart failure or cardiac arrhythmia that would prevent surgery for a lung lesion
* Severe COPD or dyspnea that would prevent lung surgery or stereotactic body radiotherapy

Primary outcomes:
measure: CT alone vs. both Early CDT-Lung test and CT scan.
timeFrame: One year
Secondary outcomes:
measure: Value of Early CDT-lung test in detecting cancer
timeFrame: One year
Other outcomes:
measure: Health Economics
timeFrame: One Year
Locations:
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
Study officials:
affiliation: National Jewish Health
name: James R Jett, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02295657: Double Lumen Tube Intubation
Official title: Comparison of Techniques for Double-lumen Tube Intubation: Standard Double-lumen Tube or VivaSight Double Lumen Tube by Paramedics. A Randomized Crossover Manikin Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endotracheal Intubation
Cardiac Arrest
Lead sponsor: International Institute of Rescue Research and Education
Sponsor class: OTHER
First posted: 2014-11-20
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this study was to compare time, success rates of different double-lumen tubes in intubation in a standardized manikin model.


Eligibility criteria: Inclusion Criteria:

* give voluntary consent to participate in the study
* minimum 1 year of work experience in emergency medicine
* experienced emergency medicine personnel (physicians, nurses, paramedics)

Exclusion Criteria:

* not meet the above criteria
* wrist or low back diseases

Primary outcomes:
measure: Success of intubation
timeFrame: 1 day
Secondary outcomes:
measure: Intubation time
timeFrame: 1 day
measure: Cormack-Lehane grading
timeFrame: 1 day
measure: Preferred ETI device
timeFrame: 1day
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: International Institute of Rescue Research and Education
state: Masovia
Study officials:
affiliation: Institute of Cardiology
name: Lukasz Szarpak
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06202157: Metabolic Differences Between Dihydroberberine and Micellar Berberine
Official title: Metabolic Differences Between Dihydroberberine and Micellar Berberine in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Phase I and Phase II Metabolites of Berberine
Keywords: metabolites
berberine
micellar
dihydroberberine
pharmacokinetics
Lead sponsor: Factors Group of Nutritional Companies Inc.
Sponsor class: INDUSTRY
Collaborators: name: Isura
First posted: 2024-01-11
Enrollment: 9
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Differences in metabolites of dihydroberberine (DHB) and micellar berberine (LipoMicel®, LMB) are investigated through a randomized study involving human volunteers. Over a 24-hour period, blood samples are collected and subjected to Ultra High-Performance Liquid Chromatography-High Resolution Mass Spectrometry (UHPLC-HRMS) analysis to quantify the concentrations of berberine and its metabolites.


Eligibility criteria: Inclusion Criteria:

* Age 21 or older
* healthy, good physical condition

Exclusion Criteria:

* Pregnancy or breast-feeding
* Gastrointestinal conditions
* Acute or chronic liver disease
* Acute or chronic kidney disease
* Acute or chronic cardiovascular disease
* Hematological disease
* Diabetes
* Allergy or Intolerance to gluten
* Allergy or Intolerance to Berberine
* Use of any form of nicotine or tobacco
* Alcohol and substance abuse history
* Use of medications (e.g., blood sugar-lowering agents, or statins)
* Use of Berberine supplements
* Participation in another investigational study

Primary outcomes:
measure: AUC: the area under the concentration-time curve
timeFrame: at baseline (t=0 hours; before intervention), at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours post-intervention.
measure: Cmax: the maximum blood concentration
timeFrame: at baseline (t=0 hours; before intervention), at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours post-intervention.
measure: Tmax: the time at which Cmax is reached
timeFrame: at baseline (t=0 hours; before intervention), at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours post-intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: Burnaby
country: Canada
facility: ISURA
state: British Columbia
Study officials:
References:
Clinical trial NCT01587157: Capnography During Percutaneous Transhepatic Cholangiodrainage (PTCD) (HepaBreath)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Apnea
Hypoxemia
Complications
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2012-04-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Capnography provides noninvasive monitoring of ventilation and can allow early recognition of altered respiration patterns and apnea. The aim of this prospective study was to compare the detection of apnea and the prediction of oxygen desaturation and hypoxemia by capnography versus clinical surveillance during procedural sedation for percutaneous transhepatic cholangiodrainage (PTCD).


Eligibility criteria: Inclusion Criteria:

* Age\>=18
* Scheduled for PTCD with midazolam and propofol sedation

Exclusion Criteria:

* age less than 18 years
* ASA class V
* allergy to narcotic drugs
* pregnancy
* pre-existing hypotension, bradycardia or hypoxemia

Primary outcomes:
measure: mean cumulative duration of detected apnea episodes per patient (capnographic vs. clinical surveillance)
Secondary outcomes:
measure: overall number of detected episodes of apnea
measure: the occurrences of oxygen desaturation and hypoxemia
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Klinikum rechts der Isar
state: Bavaria
Study officials:
References:
Clinical trial NCT05801757: Continuous Infusion of Remidazolam for Colonoscopic Polypectomy in Elderly Patients
Official title: Sedative Effect of Remidazolam Besylate Continuous Pump Infusion for Colonoscopic Polypectomy in Elderly Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon Disease
Keywords: colonoscopic polypectomy
elderly patients
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2023-04-06
Enrollment: 114
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single blind, prospective, randomized controlled study
Primary purpose: TREATMENT

Brief summary: To observe the sedative effect of continuous infusion of remidazolam in elderly patients undergoing colonoscopic polypectomy.

Detailed description: To observe the sedative effect of continuous infusion of remidazolam in elderly patients undergoing colonoscopic polypectomy, and to screen the optimal dose of remidazolam, in order to provide a more reasonable and safe sedative and analgesic drug regimen for elderly outpatients undergoing colonoscopic polypectomy.

Eligibility criteria: Inclusion Criteria:

* Age 60-80 years old;
* ASA Level I - III;
* Operation time: 15min\~1h;
* BMI18.0-29.9；

Exclusion Criteria:

* Emergency surgery;
* Patients with high risk of gastric satiety and reflux aspiration;
* Allergies to benzodiazepines and opioids;
* Those who have taken sedative, analgesic, or antidepressant drugs within 24 hours;
* Abnormal liver and kidney function;
* Previous drug use history;
* Recently participated in other clinical studies;
* Patients who cannot cooperate with communication.

Primary outcomes:
measure: Sedation success rate
timeFrame: 1 day
Secondary outcomes:
measure: Intraoperative time record
timeFrame: Intraoperative
measure: Drug usage
timeFrame: 1 day
measure: The incidence of adverse reactions during surgery
timeFrame: 1 day
measure: Incidence of postoperative adverse reactions
timeFrame: 24 hours after surgery
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: aihua Du, Dr.
role: STUDY_CHAIR
References:
Clinical trial NCT00317057: Outpatient Management of Patients With Exacerbation of Chronic Obstructive Pulmonary Disease
Official title: Outpatient Management of Patients With Exacerbation of Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: chronic obstructive pulmonary disease
Outpatient management
nurse-lead patient education
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
First posted: 2006-04-24
Enrollment: 1500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: ECT

Brief summary: Patients admitted to the hospital with chronic obstructive pulmonary disease are evaluated with regard to early follow-up by a specialized nurse in the home after discharge.

Detailed description: Patients admitted to Department of Internal Medicine M, Glostrup University hospital, with Chronic Obstructive Pulmonary Disease (COPD) are evaluated with regard to early follow-up by a specialized nurse in the home after discharge. Eligible patients receive education about disease management. The intervention is evaluated by comparing the number of readmissions for COPD and the duration of admissions during the study period to the the period prior to the implementation of this intervention.

Eligibility criteria: Inclusion Criteria:

* Admission for chronic obstructive pulmonary disease

Exclusion Criteria:

* Other severe acute or chronic diseases

Primary outcomes:
measure: the number of readmissions for chronic obstructive pulmonary disease
Secondary outcomes:
measure: the duration of admissions for chronic obstructive pulmonary disease
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Internal Medicine, Glostrup University Hospital
state: Glostrup
Study officials:
affiliation: Glostrup University Hospital, Copenhagen
name: Susanne Vest, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Glostrup University Hospital, Copenhagen
name: Allan Linneberg, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05102357: Scapholunate Ligament Partial Tears; Tear Localization, Extrinsic Ligament Injury Association and Conservative Treatment Responses Prior to Instability
Official title: Retrospective Trial, Scapholunate Ligament Partial Tears in Stable Wrist
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Scapholunate Ligament Partial Tears
Keywords: Scapholunate interosseous ligament, Extrinsic wrist ligaments, Carpal instability, MRI of wrist, Wrist ligamentous injury,
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2021-11-01
Enrollment: 104
Sex: ALL
Minimum age (years): 12
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 109 of 311 patients admitted with radial sided wrist pain had SLL and/or extrinsic ligament injury on MRI, 49,5% (n:55) were female, 50,5% (n:56) male with mean age 34 ± 10 (age range, 12-67 years).

Brief summary: The purpose of this study is to investigate scapholunate ligament partial tears regarding tear localization, extrinsic ligament accompaniment in stable wrist and accordingly to scrutinize conservative treatment response.

Detailed description: Patients admitted with radial sided wrist pain without carpal instability were retrospectively evaluated. Scapholunate interosseous ligament (SLIOL) tear localization, grade of injury and associated extrinsic ligament injuries were examined on MRI. Patients treated conservatively and recalled at their first year for re-evaluation.

Eligibility criteria: Inclusion Criteria:

* Scapholunate ligament Injury
* Wrist Extrinsic Ligament Injury

Exclusion Criteria:

* Scapholunate Dissociation
* Radiological and clinical instable wrist
* Carpal bone fracture
* MRI imaging artefact

Primary outcomes:
measure: Change in visual analog scale for pain, disabilities of the arm, shoulder and hand questionnaire and Patient-Rated Wrist Evaluation scores from baseline and at first year
timeFrame: Baseline and 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Başakşehi̇r
country: Turkey
facility: Banu Karaalioğlu
state: Istanbul
Study officials:
affiliation: Medipol University Hospital Department of Orthopedics
name: Adnan Kara
role: STUDY_DIRECTOR
affiliation: Medipol University Hospital Department of Radiology
name: Banu Karaalioğlu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004457: Determinants of Disease Severity in Amyotrophic Lateral Sclerosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Amyotrophic Lateral Sclerosis
Keywords: amyotrophic lateral sclerosis
motor neuron disease
neurologic and psychiatric disorders
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: Massachusetts General Hospital
First posted: 1999-10-19
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: OBJECTIVES:

I. Determine specific clinical features, molecular abnormalities, and laboratory-based biological markers of free radical stress that are associated with amyotrophic lateral sclerosis and influence disease severity.

Detailed description: PROTOCOL OUTLINE: This is a screening and diagnostic study. Blood and urine samples are collected from patients every 2 months for 1 year. All samples are evaluated for measures of free radical damage and levels of the body's own antioxidant activity.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Clinically diagnosed probable or definite, sporadic or familial amyotrophic lateral sclerosis

--Patient Characteristics-- Pulmonary: No artificial ventilation required Other: No other neurodegenerative diseases No concurrent or history of unstable medical illness

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Massachusetts General Hospital
name: Merit E. Cudkowicz
role: STUDY_CHAIR
References:
Clinical trial NCT03023657: Detection of Arousal With Facial Micro-expression in Severe Brain-damaged Patient
Official title: Detection of Arousal With Facial Micro-expression in Severe Brain-damaged Patient
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Consciousness Disorder
Keywords: arousal
Consciousness Disorders
vegetative state
minimally conscious state
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2017-01-18
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Severe brain injuries lead to disorders of consciousness after coma. During this awakening period, detection of arousal is critical to the adaptation of medical strategy, but global paralysis, including facial expression, make the clinical assessment very difficult. Emotional facial expressions are a significant part of this clinical assessment. They are both a landmark of the internal state of the patient (comfort versus discomfort) and a landmark of the relational level with his environment. Visible emotional facial expression is a large temporal phenomenon lasting a couple of seconds, while a microexpression is barely noticeable and very brief. These micro expressions are usually produced when one tried to voluntary hide emotional expressions. In this study, we hypothesize that some patients awakening from coma could still produce microexpression before being able to produce visible emotional facial expressions. This ability to produce micro-expression could be an early landmark of relational awakening in severe brain lesions.


Eligibility criteria: Inclusion Criteria:

* Brain-damaged patient (stroke, traumatic brain injury, anoxia)
* Disorder of consciousness (CRS-R≤ 10) more than 48h after stopping sedation
* Patient without spontaneous or stimulated facial expressions

Exclusion Criteria:

* Medically unstable patient

Primary outcomes:
measure: facial micro expression found in at least one patient on one video recording
timeFrame: Every day for a week then once a week for four weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Etienne
country: France
facility: Chu Saint-Etienne
city: Saint Etienne
country: France
facility: Clinique Mutualiste Saint Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Pascal GIRAUX, MDPhD
role: PRINCIPAL_INVESTIGATOR
References: