louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01288326: Observational Study on Effectiveness and Safety of Liraglutide in Subjects With Type 2 Diabetes
Official title: A Multicentre, Open Label, Observational, Non-interventional Study to Evaluate the Effectiveness and Safety of Liraglutide in Subjects With Type 2 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-02-02
Enrollment: 254
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with type 2 diabetes mellitus for whom physicians determine that liraglutide is an appropriate new treatment.

Brief summary: The study is conducted in Europe. The aim of this observational study is to assess glycaemic control while using liraglutide under normal clinical practice conditions in Belgium.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* Insufficiently controlled after 3 months of treatment with OADs (oral anti-diabetic drugs)

Exclusion Criteria:

* Previously treated with liraglutide
* Hypersensitivity to liraglutide or to any of the excipients (Disodium phosphate dihydrate, propylene glycol, phenol, water for injections)
* Pregnant, breast feeding or have the intention of becoming pregnant

Primary outcomes:
measure: Percentage of participants with a decrease in HbA1c (glycosylated haemoglobin A1c) of at least 1%
timeFrame: month 12
measure: Percentage of participants reaching the treatment target of a HbA1c (glycosylated haemoglobin A1c) decrease of at least 1%
timeFrame: month 12
Secondary outcomes:
measure: HbA1c
timeFrame: month 12
measure: Fasting blood glucose (FBG)
timeFrame: month 12
measure: Incidence of serious adverse events (SAEs)
timeFrame: months 0-12
measure: Incidence of adverse drug reactions (ADRs)
timeFrame: months 0-12
measure: Frequency of hypoglycaemic episodes (frequency of episodes with low blood sugar)
timeFrame: months 0-12
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Buysschaert M, D'Hooge D, Preumont V; Roots Study Group. ROOTS: A multicenter study in Belgium to evaluate the effectiveness and safety of liraglutide (Victoza(R)) in type 2 diabetic patients. Diabetes Metab Syndr. 2015 Jul-Sep;9(3):139-42. doi: 10.1016/j.dsx.2015.05.001. Epub 2015 May 8.
Clinical trial NCT02518126: Leukemia Inhibitory Factor Level in Intrauterine Growth Restriction Neonates
Official title: Comparison of LIF (Leukemia Inhibitory Factor) Level Between Neonates Who Are IUGR (Intra Uterine Growth Restriction) and Those Who Are AGA (Average for Gestational Age)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: to Compare LIF Level in Cord Blood of Embryo's That Are IUGR to Those That Are AGA
Keywords: LIF IUGR
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2015-08-07
Enrollment: 40
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women with fetuses who are AGA and those with fetuses that are IUGR

Brief summary: To see if there is a relationship between the level of LIF in IUGR fetuses and compared to the level of LIF in AGA fetuses

Detailed description: During embryonic development, there are several cytokines such as: LIF (Leukemia inhibitory factor), ciliary neurotrophic factor (CNTF), epidermal growth factor family (EGF), neuregulin 1 (NRG1) and transforming growth factor β (TGFβ) that were found are associated with neurogenesis and differentiation of brain cells .

LIF is a cytokine that is essential for the development of the central nervous system, and has recently been shown in rats that maternal LIF stimulates placental ACTH that in turn promotes secretion of fetal LIF from nRBC , which in turn promotes brain development of the fetus Other studies on IUGR (Intra Uterine Growth Restriction) have shown that IUGR fetuses have more CP (Cerebral palsy) than those who were AGA (Average for Gestational Age) The hypothesis is that LIF is related to the proper development of the nervous system in the fetus and by testing cord blood of embryos IUGR and the placenta we will find changes in LIF and ACTH compared with AGA fetuses level.

Studies have also shown a relationship between CP and IUGR, but the mechanism for this relationship is unclear.

The purpose of our research is to see if there is a relationship between the level of LIF in IUGR fetuses and compared to the level of LIF in AGA fetuses, in one of two ways:

* Changes in the secretion of ACTH in placenta
* Changes in levels of LIF in the umbilical cord blood

Eligibility criteria: Inclusion Criteria:

* Women that the Fetal weight estimate puts the fetus bellow the 10th percentile and those that the fetal weight estimate are between 20th and 80th percentiles

Exclusion Criteria:

* Women who do not agree
* known Genetic diseases of abnormalities in the fetus

Primary outcomes:
measure: LIF Protein Level in IUGR Neonates vs. AGA neonates
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05705726: Fascia Iliaca Block Versus Intravenous Dexmedetomidine and Ketamine for Positioning Fracture Femur
Official title: Ultrasound Guided Fascia Iliaca Block Versus Intravenous Dexmedetomidine and Ketamine for Positioning Fracture Femur Patients During Spinal Anesthesia: Randomized Comparison Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain
Analgesia
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2023-01-31
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: PREVENTION

Brief summary: Proximal femur fractures are one of the commonest fractures especially in the elderly population. Early surgical fixation is the best analgesic for associated pain. Spinal anesthesia has been favored by many anesthesiologists due to the simplicity of the technique, the better analgesic profile, and the lower incidence of complications like delirium and thromboembolic events. However, severe pain, encountered during positioning for spinal anesthesia, can complicate the technique and worsen the patient experience.

the study aim to compare the analgesic effect of intravenous dexmedetomidine and fascia iliaca block preoperatively to assist positioning patients for performance of spinal anesthesia.


Eligibility criteria: Inclusion Criteria:

1. Aged 18-60 years.
2. Hip fractures
3. Both sexes.

Exclusion Criteria:

1. Patient refusal
2. Allergy to local anesthetics
3. Bleeding diathesis or history of anticoagulant use.
4. impaired cognition or dementia
5. . Infection of the skin at the site of needle punctures area
6. multiple fractures
7. Any previous analgesic administration during the last 12 hours

Primary outcomes:
measure: Behavioral pain scale
timeFrame: during spinal anesthesia
Secondary outcomes:
measure: Quality of patient's position
timeFrame: before spinal anesthesia
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Minia University Hospital
Study officials:
affiliation: Minia University, faculty of medicine
name: hassan m. hetta, lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05786326: Multihole Fully Covered Metallic Stents in the Management of Malignant Biliary Obstruction
Official title: The Use of Multi Holes Fully Covered Metallic Stents Versus Uncovered and Partially Covered Metallic Stents in the Management of Malignant Biliary Obstruction: Randomized Parallel Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malignant Biliary Obstruction
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2023-03-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: multiholes fully covered metallic stents in the management of malignant biliary obstruction

Detailed description: Malignant biliary obstruction is still a diagnostic and therapeutic challenge requiring a multidisciplinary approach. Most cases are inoperable at the time of diagnosis. Relieving the obstruction and normalizing the serum bilirubin level is usually the first step by biliary catheterization and stent placement.

Biliary stent placement has largely replaced surgical bypass for the palliation of malignant biliary obstruction. Rigid plastic stents, despite it is cheap and easily removed, but with limited duration of stent patency. Self-expandable metal stents (SEMS) have larger luminal diameters and provide longer patency time than rigid plastic stents. SEMS are composed of a variety of metals and can be uncovered, partially covered, or fully covered.

Uncovered stents are prone to obstruction by tumor growths; however, covered stents may block bile duct branches and are at risk of migration. A multihole self-expandable metallic stent was developed to prevent the obstruction of bile duct branches. In addition, the holes may prevent migration due to small ingrowths which reduce the tension of the membrane

Eligibility criteria: Inclusion criteria:

* Clinical diagnosis of malignant obstructive jaundice.
* Patient not eligible for surgery.
* Age above 18 years, any gender.

Exclusion criteria:

* Benign obstructive jaundice.
* Patient eligible for surgery.
* Failure to stent insertion.
* Patient not fit for ERCP and/or anaesthesia.
* Surgical and anatomical abnormalities interfere with endoscopy.

Primary outcomes:
measure: Efficacy of multi holes fully covered metallic stents in management of malignant biliary obstruction
timeFrame: at 3 and 6 months follow up after stents ineration
Secondary outcomes:
measure: Stent dysfunction (obstruction or migration)
timeFrame: after 3 and 6 months from stents insertion
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University
state: Sharkia Governorate
Study officials:
affiliation: Zagazig University
name: Mohamed I Magdy, profeesor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03560726: Telehealth Cognitive Behavioral Stress Management for Adults With Cystic Fibrosis
Official title: Telehealth Cognitive Behavioral Stress Management for Adults With Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Depression
Stress
Coping Skills
Cystic Fibrosis
Lead sponsor: National Jewish Health
Sponsor class: OTHER
First posted: 2018-06-18
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study to to assess the feasibility, acceptability, and satisfaction of a telehealth cognitive behavioral stress management (CBSM) intervention among adults with cystic fibrosis (CF) who exhibit elevated anxiety and/or depression symptoms.


Eligibility criteria: Inclusion Criteria:

* At least 18 years old
* Fluent in English
* Diagnosed with Cystic Fibrosis
* Colorado resident
* Access to personal device (smart phone, computer, tablet) with 1) reliable internet connection, and 2) a built-in web camera and microphone or the capability to install a study-provided web camera and microphone
* Regular access to a private location with sufficient lighting that is free from distractions or intrusions to use during telehealth sessions
* Access to private email to complete surveys
* Mild anxiety and/or depression symptoms (i.e., a score of 5 or higher on the Generalized Anxiety Disorder 7 Item Scale (GAD-7) and/or the Patient Health Questionnaire 9 Item Scale (PHQ-9))

Exclusion Criteria:

* Currently receiving therapy or counseling with an outside provider for a mental health condition
* Currently in treatment for alcohol or substance abuse
* Unstable medical condition (not including cystic fibrosis)
* Neurological disease
* Pregnant women
* Active suicidal intent or plan (a score of 1 or higher on the Suicide Severity Scale)

Primary outcomes:
measure: Feasibility (patient perspective)
timeFrame: Week 0 (baseline)
measure: Feasibility (clinician perspective)
timeFrame: Week 8
measure: Acceptability (patient perspective 1 of 2)
timeFrame: Week 8
measure: Acceptability (patient perspective 2 of 2)
timeFrame: Week 8
measure: Satisfaction (patient perspective 1 of 2)
timeFrame: Week 8
measure: Satisfaction (patient perspective 2 of 2)
timeFrame: Week 8
Secondary outcomes:
measure: Anxiety symptom improvement
timeFrame: Week 0, 2, 4, 6, 8, 20
measure: Depression symptom improvement
timeFrame: Week 0, 2, 4, 6, 8, 20
Other outcomes:
Locations:
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
Study officials:
affiliation: National Jewish Health
name: CJ Bathgate, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bathgate CJ, Kilbourn KM, Murphy NH, Wamboldt FS, Holm KE. Pilot RCT of a telehealth intervention to reduce symptoms of depression and anxiety in adults with cystic fibrosis. J Cyst Fibros. 2022 Mar;21(2):332-338. doi: 10.1016/j.jcf.2021.07.012. Epub 2021 Aug 5.
Clinical trial NCT02696226: Frequency of Reduced Leaflet Motion After Surgical Aortic Valve Replacement and Transcatheter Aortic Valve Replacement.
Official title: A Pilot Study of Subclinical Leaflet Thrombosis in Bioprosthetic Aortic Valves: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Aortic Valve Disorder
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2016-03-02
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This is a prospective, randomized pilot study in patients undergoing Sugical Aortic Valve Replacement (SAVR) and Transcatheter Aortic Valve Replacement (TAVR) to estimate the incidence of reduced leaflet motion and assess the impact of perioperative anticoagulation on the incidence of reduced leaflet motion.

Detailed description: This will be a pilot prospective randomized controlled trial.The study will enroll 50 adult patients scheduled to undergo SAVR and 50 adult patients scheduled to undergo TAVR. Subjects who satisfy Inclusion/Exclusion Criteria will be approached for informed consent. Those who give informed consent will be enrolled. After induction of anesthesia, a computer program will be used to randomize patients to one of the 2 treatment groups.

1. SAVR patients will get either Warfarin or aspirin
2. TAVR patients will get either Warfarin or aspirin.

Patients will be seen at 4-6 weeks postoperatively for Transthoracic ECHO (TTE), 4 dimensional (4D), Multidetector computed tomography (MDCT) scan and review of medical history. Phone follow up at 6,9 and 12 months post-operatively.

Data from this pilot study will enable us to determine the feasibility of a larger randomized controlled clinical trial to investigate the phenomenon of reduced leaflet motion/subclinical valve thrombosis and, possibly, its clinical importance

Eligibility criteria: Inclusion Criteria:

Scheduled for SAVR or TAVR

* Age \> 18 years
* Able and willing to give informed consent
* Able and willing to return for follow up

Exclusion Criteria:

* Contraindications to warfarin, Plavix or aspirin
* Pre-existing medical indication for warfarin, Plavix or aspirin
* History of previous cardiac surgery
* History of previous coronary artery stenting
* Requirement for concomitant coronary artery bypass grafting or mitral valve surgery or surgical treatment of an ascending aortic aneurysm
* Contraindications to contrast-enhanced MDCT including anaphylactic iodine allergy, uncontrolled atrial fibrillation, renal dysfunction (GFR \< 60 ml/min).

Primary outcomes:
measure: Leaflet Motion
timeFrame: 4-6 weeks post procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Douglas Johnston, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05115526: PEEP Setting in COVID19-related ARDS
Official title: Positive End-expiratory Pressure Setting in COVID-19 Related ARDS : Comparison Between Electrical Impedance Tomography, PEEP/ Fraction of Inspired Oxygen Tables, and Transpulmonary Pressure.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ARDS Due to Severe Acute Respiratory Syndrome Coronavirus 2
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2021-11-10
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive adult patients under mechanical ventilation following COVID19-ARDS

Brief summary: The best way to titrate positive end-expiratory pressure (PEEP) in patients suffering from acute respiratory distress syndrome is still matter of debate. Electrical impedance tomography (EIT) in a non-invasive technique that could guide PEEP setting based on an optimized ventilation homogeneity.

Detailed description: COVID-19 related ARDS patients admitted to the ICU in March 2021 requiring mechanical ventilation were enrolled. Patients were monitored by an esophageal catheter and a 32-electrode EIT device. Within 48 hours after the start of mechanical ventilation, different levels of PEEP were applied based upon PEEP/ Fraction of inspired oxygen tables, positive end-expiratory transpulmonary (PL)/ FiO2 table, and EIT. Respiratory mechanics variables were recorded.

Eligibility criteria: Inclusion Criteria:

* COVID19-related ARDS under invasive mechanical ventilation

Exclusion Criteria:

* none

Primary outcomes:
measure: Value of PEEP
timeFrame: a single determination, within 24-48 hours after mechanical ventilation initiation
Secondary outcomes:
measure: Respiratory mechanics
timeFrame: a single determination, within 24-48 hours after mechanical ventilation initiation
Other outcomes:
Locations:
city: Nancy
country: France
facility: Service de Réanimation Médicale, Hôpital Central
Study officials:
References:
Clinical trial NCT01498926: Comparison of Two Insulin Detemir Formulations in Healthy Volunteers
Official title: A Randomised, Single Centre, Two-period, Cross-over, Glucose Clamp Trial to Test for Bioequivalence Between Two Insulin Detemir Formulations Containing Mannitol and Glycerol as Isotonic Agents Respectively, in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-12-26
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to compare two formulations of insulin detemir containing an isotonic agent in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator
* Body mass index (BMI) between 18 and 27 kg/m\^2, inclusive
* Non-smoker
* Fasting plasma glucose maximum 6 mmol/L

Exclusion Criteria:

* Known or suspected allergy to trial products or related products
* Previous participation in this trial
* Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures (intrauterine device (IUD) that has been in place for at least 3 months, sterilisation, the oral contraceptive pill (which should have been taken without difficulty for at least 3 months) or an approved hormonal implant)
* The receipt of any investigational drug within the last 3 months prior to this trial

Primary outcomes:
measure: Area under the serum insulin detemir concentration curve
measure: Maximum serum insulin concentration
Secondary outcomes:
measure: Area under the glucose infusion rate curve
measure: Time to maximum serum insulin concentration
measure: Terminal serum insulin half life
measure: Area under the serum insulin detemir concentration curve
measure: Maximum glucose infusion rate
measure: Time to maximum glucose infusion rate
measure: Adverse events
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT06354426: Short-term Mortality Prediction by the SOFA Score in Acute Decompensated Heart Failure
Official title: Short-term Mortality and Readmission Rate Prediction by the Sequential Organ Failure Assessment Score in Acute Decompensated Heart Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Decompensated Heart Failure
Keywords: SOFA score
Acute decompensated heart failure
Lead sponsor: Hanoi Heart Hospital
Sponsor class: OTHER
First posted: 2024-04-09
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This was a single-centre, prospective study conducted from July 2022 to August 2023 at Hanoi Heart Hospital (Hanoi, Vietnam).

Brief summary: Data on the use of sequential organ failure assessment (SOFA) in patients with cardiovascular disease are increasing. Several studies demonstrated that the SOFA score can identify short-term mortality in patients with acute decompensated heart failure (ADHF). This study was conducted to determine the prognostic value of the admission SOFA score in patients hospitalised for ADHF and to assess its ability in predicting the 30-day readmission rate.


Eligibility criteria: Inclusion Criteria:

* All patients over 18 years old who were hospitalised for acute heart failure were included (either new-onset acute heart failure or ADHF).

Exclusion Criteria:

* Patients with septic shock or pulmonary infarction were excluded.

Primary outcomes:
measure: Mortality
timeFrame: Within 30 days from the day of hospitalization
Secondary outcomes:
measure: Re-admission rate
timeFrame: Within 30 days
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Hanoi Heart Hospital
state: Hoan Kiem
Study officials:
References: