louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01271517: Basal Analog Study - Comparison of Lantus or Levemir With NPH Insulin From T1DM Diagnosis
Official title: Effects of New Longacting Insulin Analogs on Metabolic Control, Endogenous Insulin Production, GH/IGF-I Axis and Quality of Life - Comparison of NPH, Glargine Och Detemir Insulin From the Debut of Type 1 Diabetes Mellitus in Adolescents
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diabetes Mellitus Type 1
Keywords: Basal insulin
long acting insulin analogs
metabolic control
HbA1c
C-peptide
IGF-I
GH
IGFBP
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2011-01-06
Enrollment: 120
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hypothesis: Basal insulin analogs with continuous 24-hour delivery of insulin improve glycemic control during the first year of treatment of children/adolescents with type 1 diabetes mellitus (T1DM)by preserving endogenous insulin production and a close to normal balance of the GH-IGF-axis.

This a randomized, open-label, parallel-group trial of 120 children, 7 - 17 years of age, newly diagnosed with T1DM. The investigators will investigate whether the use of long-acting basal insulin analogs Lantus (Glargine) or Levemir (Detemir) during the first year of treatment results in improved glycemic control (HbA1c) compared with Insulatard (NPH insulin) when given in a meal insulin therapy regimen with rapid acting Novorapid (insulin aspart). The investigators will explore possible mechanisms of action by determining remaining endogenous insulin production and changes in the GH-IGF-axis. The investigators will also assess changes in body composition and evaluate quality of life in each treatment arm.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of diabetes and novel to insulin therapy
* Age 7 - 17 years
* Informed consent

Exclusion Criteria:

* Moderate to severe ketoacidosis (pH\<7.2 and/or standard bicarbonate \<10 mmol/l)
* Suspected non-type 1
* IA2 and GAD65: all-antibody negative
* Celiac disease or other chronic disease
* Hypothyroidism, if not well controlled
* Syndromes
* Previous anorexia nervosa
* Neuro-psychiatric disease
* Malignancy

Primary outcomes:
measure: HbA1c
timeFrame: 1 year
Secondary outcomes:
measure: Stimulated C-peptide
timeFrame: 2 weeks and 3, 6 and 12 month
measure: IGF-I
timeFrame: diagnosis, 2 weeks, 3,6,9 and 12 month
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Division of Pediatrics, Karolinska University Hospital
Study officials:
References:
Clinical trial NCT02042417: Comparison of POC-test-equipment With the Laboratory
Official title: Comparison of POC-test-equipment With the Standard Method (Laboratory) at ICU-patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: INR-POC-testing
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2014-01-22
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: We compare two POC-tests (INRario2 and CoaguChek) for the INR with the laboratory. Therefore, we take bloodsamples (capillary and venous blood) and put it on the tool. After the measuring, a number is shown = INR.

We develop a Bland-Altman-plot for the correlation between the tool value and the laboratory value to illustrate the applicability in the clinical daily routine.

Detailed description: Including criteria: ICU-patients from 18-99 years

Eligibility criteria: Inclusion Criteria:

18-99 years, ICU patients

Exclusion Criteria:

Lupus erythematodes Anti-Phospholipid-Antikörper

Primary outcomes:
measure: Comparison of POC-test-equipment with the standard method (laboratory) at ICU-patients
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: MUVienna
Study officials:
References:
Clinical trial NCT04841941: A Feasibility Study to Assess the Visual Performance and Comfort of Hanita G4 Multifocal Soft Contact Lenses for Presbyopia at Normal Daily Routine Use
Official title: A Feasibility Study to Assess the Visual Performance and Comfort of Hanita G4 Multifocal Soft Contact Lenses for Presbyopia at Normal Daily Routine Use.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Presbyopia
Lead sponsor: Hanita Lenses
Sponsor class: INDUSTRY
First posted: 2021-04-12
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The G4 Multi multifocal contact lens is a soft contact lens intended to correct far, intermediate, and near vision for individuals with presbyopia. The lens covers the cornea and part of the sclera. The lenses can be used for daily wear for up to 1 year.

Detailed description: Study Design:

A clinical performance study without a control group to compare the G4Multi contact lens to other approved soft contact lenses for presbyopia

Study Objectives:

1. To assess the multifocal vision in the various ranges of the HANITA G4 Multi.
2. To rate the comfort of the lenses in individuals with presbyopia

Study population:

Healthy men and women above the age of 18 diagnosed with presbyopia who have used contact lenses in the past

Recruitment :

A total of 30 subjects completing at least 1 month of participation.

Eligibility criteria: Inclusion Criteria:

1. Presbyopia participants with healthy eyes who are not using any ocular medications, aged 18 years and over and who have used contact lenses in the past
2. Lens powers within the range available for the test lenses
3. Best spectacle-corrected visual acuity equal or greater than 20/25 (less than or equal to Log MAR 0.1)

Exclusion Criteria:

1. Anterior segment infection, inflammation, or abnormality
2. Any active anterior segment ocular disease that would contraindicate contact lens wear
3. The use of systemic or ocular medications that would contraindicate contact lens wear
4. History of herpetic keratitis
5. History of refractive surgery or irregular cornea
6. Slit lamp findings that are more serious than grade 1
7. Corneal vascularization greater than 1 mm of penetration
8. Pathologically dry eye;
9. Participation in a contact lens or contact lens care product clinical trial within the previous 30 days

Primary outcomes:
measure: Assess visual acuity
timeFrame: 11-12 months
Secondary outcomes:
measure: Assess subjective degree of comfort while wearing the lenses
timeFrame: 11-12 months
measure: SLIT LAMP EXAM
timeFrame: 11-12 months
Other outcomes:
Locations:
city: Ra'anana
country: Israel
facility: CLC
city: Ramat Gan
country: Israel
facility: Bar Ilan
Study officials:
References:
Clinical trial NCT03374241: A First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15211(Efocipegtrutide)
Official title: A First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single Ascending Dose of HM15211(Efocipegtrutide) in Healthy Obese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2017-12-15
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Single ascending dose of HM15211 in healthy obese subjects.

Detailed description: A First-in-human study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics after single ascending dose of HM15211 in healthy obese subjects.

Eligibility criteria: Inclusion Criteria:

* Female subjects must be non-pregnant and non-lactating

Exclusion Criteria:

* Participation in an investigational study within 30 days prior to dosing

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Hanmi Investigative Site
state: California
Study officials:
affiliation: Hanmi Pharmaceuticals
name: Hanmi Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT03753841: FEES to Determine Neurological Intensive Care Patients' Oral Diet
Official title: Flexible Endoscopic Evaluation of Swallowing (FEES) to Determine Neurological Patients' Oral Diet
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysphagia
Aspiration Pneumonia
Deglutition Disorders
Intensive Care Neurological Disorder
Keywords: Dysphagia
Aspiration
Management of Dysphagia
Deglutition Disorders
Deglutition
FEES
Intensive Care Neurological Disorder
Lead sponsor: University of Giessen
Sponsor class: OTHER
First posted: 2018-11-27
Enrollment: 125
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dysphagia is associated with high rates of mortality and morbidity. Adjusting the oral diet of ICU-patients based on flexible endoscopic evaluation of swallowing (FEES) findings might reduce pneumonia rate, mortality and need for intubation/tracheotomy.

Detailed description: Dysphagia, a common complication in neurological disorders, leads to high rates of mortality and morbidity. It is prevalent in critically ill patients, especially those who need mechanical ventilation. The investigators therefore investigate the effect of adjusting the oral diet of our intensive care unit (ICU) patients based on flexible endoscopic evaluation of swallowing (FEES) findings, thereby assessing the impact of FEES on a neurological ICU. All patients treated on the investigators neurological ICU will be eligible for this study.

The investigators will correlate findings with baseline data, disability status, pneumonia and duration of hospitalisation, as well as a need for mechanical ventilation or a tracheotomy.

Eligibility criteria: Inclusion Criteria:

* Treatment on neurological ICU
* Clinical suspicion of Dysphagia

Exclusion Criteria:

* none

Primary outcomes:
measure: Pneumonia Rate
timeFrame: Up to 130 days
measure: Mortality
timeFrame: Up to 130 days
Secondary outcomes:
measure: Length of stay in hospital
timeFrame: Up to 130 days
measure: Intubation/Tracheotomy
timeFrame: Up to 130 days
Other outcomes:
Locations:
city: Gießen
country: Germany
facility: Universitätsklinikum Gießen
state: Hessen
Study officials:
affiliation: University of Giessen
name: Tobias Braun, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04646941: Diabetic Complications and Obstructive Sleep Apnea
Official title: Diabetic Complications and Obstructive Sleep Apnea in Type 2 Diabetic Patients: A Longitudinal Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetic Complications and Obstructive Sleep Apnea
Keywords: Type 2 diabetes
diabetic complications
Obstructive Sleep Apnea
Lead sponsor: The First Affiliated Hospital of Xiamen University
Sponsor class: OTHER
First posted: 2020-11-30
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Type 2 diabetes

Brief summary: To follow up the progress of chronic complications in T2DM patients who had undergone anthropometric measurements, laboratory testing and standard overnight polysomnography monitor from 2013 to 2018.

Detailed description: Obstructive sleep apnea (OSA) is a common chronic sleep disorder and a frequent comorbidity in patients with type 2 diabetes. There has been increasing recognition that OSA is highly prevalent in persons with type 2 diabetes. This study is to explore the relationship between OSA and the progress of chronic diabetes-related complications in type 2 diabetes who had undergone anthropometric measurements, laboratory testing and standard overnight polysomnography monitor from 2013 to 2018 in the Department of Endocrinology and Diabetes, The First Affiliated Hospital of Xiamen University, Xiamen, China.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* Age：18-80

Exclusion Criteria:

* Patients with non type 2 diabetes mellitus
* Preparation for pregnancy
* Lactation patients
* Patients with uncontrolled thyroid disease
* Patients with severe cardiovascular disease
* Patients with severe hepatic and renal insufficiency
* Patients with oral and maxillofacial malformations and upper respiratory tract malformations
* Patients with pulmonary infection or COPD
* Patients who are not willing to accept the questionnaire survey
* Unable to sign informed consent

Primary outcomes:
measure: the progress of diabetic complications
timeFrame: From January 1, 2013 to December 31, 2020
measure: the new onset and types of tumor in T2DM patients
timeFrame: From January 1, 2013 to December 31, 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Xiamen
country: China
facility: The first affiliated hospital of Xiamen university
state: Fujian
Study officials:
References:
Clinical trial NCT03644641: The Influence of Prone Position for Spinal Surgery on Visual Acuity
Official title: The Influence of Prone Position for Spinal Surgery on Visual Acuity, a Comparison of Volatile Anesthesia With Desflurane to Total Intravenous Anesthesia With Propofol
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Vision; Disorder, Loss
Keywords: Desflurane
Near-infrared spectroscopy
Propofol
Spinal surgery
Prone position
Visual acuity
Visual loss
Lead sponsor: University Hospital Hradec Kralove
Sponsor class: OTHER
First posted: 2018-08-23
Enrollment: 60
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: TREATMENT

Brief summary: This study investigated the effect of desflurane and propofol anesthesia on visual acuity in patients in prone position for spinal surgery. Many trials have investigated the effects of different anesthetic agents on intraocular pressure, propofol may reduce intraocular pressure more than other intravenous anesthetics.

Detailed description: Perioperative increase in intraocular pressure can be caused by prone positioning. In addition to surgical factors, patients with glaucoma, uncontrolled hypertension, arthrosclerosis, and morbid obesity are at risk for potentially damaging optic nerve and loss of optic nerve function. Some studies found that intraocular pressure values were significantly lower in patients undergoing propofol total intravenous anesthesia than in patients undergoing desflurane anesthesia during intraoperative positional changes. Pronounced vasodilatation caused by desflurane might produced hyperaemia with higher intraocular pressure. Hemodynamic response to prone position measured by near-infrared spectroscopy (NIRS) on the prefrontal cortex could determine changes caused by prone position.

Eligibility criteria: Inclusion Criteria:

* Glasgow Coma scale 15
* American Society of Anesthesiologists (ASA) Physical Status Classification System I-III
* spinal surgery in duration less than 3 hours
* sinus rhythm

Exclusion Criteria:

* postoperative artificial ventilation
* serious neurological disease
* lung disease with hypercapnia
* propofol allergy

Primary outcomes:
measure: Visual injury
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Hradec Kralove
country: Czechia
facility: University Hospital Hradec Kralove
Study officials:
affiliation: Hradec Kralove, Czechia 50005
name: Pavel Dostal, MD, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02530541: Antimicrobial Efficacy of 2% CHG (Chlorhexidine Gluconate)
Official title: Pilot Trial Assessment of the Antimicrobial Efficacy of Medline 2% CHG Cloth Preoperative Skin Preparation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Healthy
Lead sponsor: Medline Industries
Sponsor class: INDUSTRY
First posted: 2015-08-21
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pilot study to evaluate and compare activity of preoperative preparation with comparator

Detailed description: Evaluate and compare similar preoperative surgical preparations in healthy volunteers. Various application times were evaluated. Efficacy was assess using TFM criteria.

Eligibility criteria: Inclusion Criteria:

* Healthy
* No dermatological conditions

Exclusion Criteria:

* Sensitivity to CHG
* Sensitivity to natural latex rubber or adhesive skin products

Primary outcomes:
measure: Log Reduction of Bacterial Flora on the Abdomen and Groin
timeFrame: 10 min, 6 hr and 8 hr
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Bioscience Labs
name: Esther Campbell
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05953441: Artificial Intelligence Versus Human-controlled Doctor in Virtual Reality Simulation for Sepsis Team Training
Official title: Artificial Intelligence Versus Human-controlled Doctor in Virtual Reality Simulation for Sepsis Team Training: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sepsis
Keywords: artificial intelligence
team training
virtual reality simulation
health care education
Lead sponsor: National University of Singapore
Sponsor class: OTHER
Collaborators: name: Ministry of Education, Singapore
First posted: 2023-07-20
Enrollment: 65
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective 2-arm randomized controlled trial with a pretest-posttest study design
Primary purpose: OTHER

Brief summary: The purpose of the study is to compare the effectiveness of Artificial Intelligence virtual doctor with human-controlled virtual doctor avatars on nursing students' sepsis care and interprofessional communication.


Eligibility criteria: Inclusion Criteria:

1. All Year 3 NUS nursing students in Academic Year 2022
2. Individuals 20 years old and above; and
3. Consent to be video and/or audio-recorded

Exclusion Criteria:

1. Year 1, 2 and 4 NUS nursing students;
2. Incapable of giving informed consent;
3. Unable to understand and/or speak in English language;
4. Have visual, speech, and/or hearing impairment; and
5. Do not agree to be video and/or audio-recorded.

Primary outcomes:
measure: Change from Baseline in Sepsis Knowledge on the 18-item sepsis knowledge test immediately after interventions.
timeFrame: Baseline and immediately after 2-hour VRS
Secondary outcomes:
measure: Change from Baseline in Team Communication Knowledge on the 8-item communication knowledge test immediately after interventions.
timeFrame: Baseline and immediately after 2-hour VRS
measure: Change from Baseline in Team Communication Self-Efficacy on the 6-item Patient Clinical Information Exchange and Interprofessional Communication Self-Efficacy Scale immediately after interventions.
timeFrame: Baseline and immediately after 2-hour VRS
measure: Sepsis Care Performance through a 15-minute video-recorded simulation-based assessment within 2 weeks of postintervention.
timeFrame: Within 2 weeks of postintervention.
measure: Team Communication Performance through a 15-minute video-recorded simulation-based assessment within 2 weeks of postintervention.
timeFrame: Within 2 weeks of postintervention.
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Alice Lee Centre for Nursing Studies
Study officials:
affiliation: National University of Singapore
name: Sok Ying Liaw
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00789841: Gastrointestinal Motility in Patients With Neuroendocrine Tumors
Official title: Gastrointestinal Motility in Patients With Neuroendocrine Tumors-Effects of Sandostatin LAR
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuroendocrine Tumor
Keywords: Neuroendocrine tumor
Carcinoid syndrome
Motility
Transit time
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Novartis
name: The Danish Medical Research Council
First posted: 2008-11-13
Enrollment: 13
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We are scheduling 12 subjects (30-80 years of age) with NET and carcinoid syndrome with diarrhea. Patients are recruited through the Department of Medicine V, Aarhus University Hospital.

Brief summary: We will study the total gastrointestinal transit time (GITT), gastric emptying and small intestine motility in NET patients before and after treated with somatostatin analogues and compare these to healthy subjects. For this we will use radio-opaque markers and the newly developed Motility Tracking System (MTS).

Hypothesis: Patients with NET and carcinoid syndrome have decreased GITT, gastric emptying and small bowel transit time and an increase in phase III MMC activity compared to healthy subjects. Treatment with somatostatin analogues increase transit times and decrease phase III MMC activity and improves the clinical symptoms.


Eligibility criteria: Inclusion Criteria:

* NET confirmed by histology
* Diarrhea, (at least 3 loose or watery bowel movements per day) as part of carcinoid syndrome.
* Newly referred patients without previous somatostatin analogue treatment or
* NET patients who are pausing somatostatin analogue treatment due to other treatment or examination.

Exclusion Criteria:

* Subjects unable to understand the information
* Severe diabetes with late complications or known metabolic disorder
* Inflammatory bowel disease
* Known clinically significant stenosis of the bowel
* Bile acid malabsorption due to intestinal surgery
* Small bowl bacterial overgrowth

Primary outcomes:
measure: Gastrointestinal transit time in NET patients
timeFrame: End of the study
Secondary outcomes:
measure: Gastric emptying in NET patients
timeFrame: End of the study
measure: Small intestinal transit time
timeFrame: End of the study
measure: Small intestinal velocity
timeFrame: End of the study
measure: Changes in carcinoid symptoms and biomarkers
timeFrame: End of the study
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Analfysiologisk afsnit, Aarhus University Hospital, Tage Hansensgade, entrance 11A
Study officials:
References: