louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00914303: Study to Evaluate Different Extended Release (ER)-Formulations and Multiple Ascending Dosing of AZD3241
Official title: A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Extended Release Tablets of AZD3241 After Administration of Multiple Ascending Doses in Healthy Male and Female Volunteers Including Food Effect
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Safety
tolerability
healthy
Healthy volunteer study
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-06-04
Enrollment: 77
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aims of the study are to assess the safety, tolerability and pharmacokinetics of ER tablets of AZD3241 following multiple ascending doses administered to healthy male and female subjects including the effect of food.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female subjects 30-65 years
* Body Mass Index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg

Exclusion Criteria:

* History of any clinically significant disease or disorder
* History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
* Previous history of frequent pre-syncope or syncope

Primary outcomes:
measure: Safety variables (adverse events, vital signs, ECG, safety lab)
timeFrame: Assessments performed at frequent timepoints during a 4-8 week period
Secondary outcomes:
measure: To characterize the pharmacokinetics of AZD3241 in plasma
timeFrame: Frequent sampling occasions during some study days for a 4-8 weeks period
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Research Site
Study officials:
affiliation: Medical Science Director AstraZeneca R&D Södertälje.
name: Rolf Karlsten, MD
role: STUDY_DIRECTOR
affiliation: Quintiles AB Phase I Unit, Uppsala, Sweden
name: Wolfgang Kuhn, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01364103: Study About Predicting Fluid Responsiveness in Children Undergoing Neurosurgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fluid Responsiveness
Keywords: pulse pressure variation
systolic pressure variation
central venous pressure
aortic blood flow velocity variation
pleth variability index
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2011-06-02
Enrollment: 33
Sex: ALL
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate static and dynamic parameters, echocardiographic parameters, and pleth variability index for predicting fluid responsiveness in children. Children who need volume expansion will receive colloid 10 mL/kg. Blood pressure, heart rate, central venous pressure, systolic pressure variation, pulse pressure variation, delta down, aortic blood flow velocity variation, inferior vena cava diameter variation, and pleth variability index will be measure before and after volume expansion. Patients will be classified as responders to volume loading if stoke volume index increase by at least 15%.


Eligibility criteria: Inclusion Criteria:

* neurosurgery under general anesthesia
* \< 8 years old

Exclusion Criteria:

* cardiac disease
* pulmonary, renal and hepatic disease
* infectious disease
* hematologic and muscular disease

Primary outcomes:
measure: stoke volume index
timeFrame: before and after volume loading (20 minutes)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul national university hospital
city: Seoul
country: Korea, Republic of
facility: Seoul national university hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jin-Tae Kim, MD, PhD
role: STUDY_CHAIR
References:
citation: Byon HJ, Lim CW, Lee JH, Park YH, Kim HS, Kim CS, Kim JT. Prediction of fluid responsiveness in mechanically ventilated children undergoing neurosurgery. Br J Anaesth. 2013 Apr;110(4):586-91. doi: 10.1093/bja/aes467. Epub 2012 Dec 18.
Clinical trial NCT05647603: Role of Parents Concerning Information of Adolescents About Contraception
Official title: Role of Parents Concerning Information of Adolescents About Contraception
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parents of Adolescent
Keywords: adolescents
contraception
information
Lead sponsor: Université de Reims Champagne-Ardenne
Sponsor class: OTHER
First posted: 2022-12-12
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parents of adolescents aged 12 to 18

Brief summary: Adolescence is a period of intensive physical and psychological changes, with notably the start of sexuality. During this period of sexual discovery, a lack or a misuse of contraception may be responsible for unwanted pregnancy.

So, sexual education and information about contraception are crucial. Teenagers often consult Internet or discuss with friends to have information but they can be not true or precise. They can also consult health professionals, however shyness and fear can hold them back. Information about contraception may also be given by their parents. The physical closeness and the trust that adolescents have in their parents can promote dialogue.

Detailed description: the aim of the study is to describe information about contraception given by parents to adolescents

Eligibility criteria: Inclusion Criteria:

* Parents (father or mother) of adolescents (boy or girl) aged 12 to 18
* agreeing to participate to the study

Exclusion Criteria:

-

Primary outcomes:
measure: Definition of contraception
timeFrame: Day 0
measure: Contraception methods
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Université de Reims Champagne Ardenne
Study officials:
affiliation: Université de Reims Champagne-Ardenne
name: Lapree Lucie
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04395703: Baby Friendly Initiative Implementation: Maternity Staff Experiences
Official title: Barriers, Challenges and Facilitators for the Unicef Baby Friendly Initiative (BFI): A Qualitative Study of Maternity Staff Experiences
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Experience, Life
Keywords: Staff experience,barriers,challenges,facilitators
Lead sponsor: Bournemouth University
Sponsor class: OTHER
Collaborators: name: Dorset County Hospital NHS Foundation Trust
First posted: 2020-05-20
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Maternity and neonatal staff who meet the inclusion criteria.

Brief summary: This qualitative, case study will explore the experiences of maternity staff in England when implementing the World Health Organisation and Unicef Baby Friendly Initiative (BFI) standards within a maternity organisation.

Detailed description: A range of maternity staff over 4 UK NHS hospitals will be recruited and interviewed by one chief investigator regarding their experiences of working with the BFI standards in their daily professional practice.

Eligibility criteria: Inclusion criteria

* Maternity staff who have had training in and with experience of working with the BFI.
* Senior neonatal staff working in the maternity unit.
* Maternity unit management.
* Staff in specialised infant feeding roles at local hospitals.
* Student midwives on placement at main study hospital site.
* English speaking.

Exclusion criteria

* Maternity staff with no BFI experience.
* Medical staff.
* Community maternity staff.
* Community nurses and health visitors.
* Student nurses.

Primary outcomes:
measure: To identify barriers to the successful implementation of Unicef Baby Friendly Initiative within a maternity organisation.
timeFrame: 2 years
measure: To identify challenges to the successful implementation of Unicef Baby Friendly Initiative within a maternity organisation.
timeFrame: 2 years
measure: To identify what facilitates the successful implementation of Unicef Baby Friendly Initiative within a maternity organisation.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Dorchester
country: United Kingdom
facility: Dorset County Hospital NHS Foundation Trust
state: Dorset
Study officials:
affiliation: Postgraduate Researcher and Midwife
name: Hazel Tennant
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00989703: GLPG0259 Multiple Ascending Dose and Methotrexate Drug-drug Interaction (DDI) in Healthy Subjects
Official title: Double Blind, Placebo Controlled, Dose Ranging and Methotrexate Interaction Study for the Assessment of Safety, Tolerability and Pharmacokinetics (PK) of Multiple Oral Doses of GLPG0259 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Safety
Tolerability
Pharmacokinetics
Lead sponsor: Galapagos NV
Sponsor class: INDUSTRY
First posted: 2009-10-05
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of the study is to evaluate the safety and tolerability of multiple increasing oral doses of GLPG0259 compared to placebo.

Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0259 after multiple increasing oral doses, and potential drug-drug interaction with single dose methotrexate will be assessed.


Eligibility criteria: Inclusion Criteria:

* healthy male, age 18-50 years
* BMI between 18-30 kg/m², inclusive.

Exclusion Criteria:

* significantly abnormal platelet function or coagulopathy
* smoking
* drug or alcohol abuse

Primary outcomes:
measure: Safety and tolerability of oral multiple ascending doses
timeFrame: up to 10 days postdose
Secondary outcomes:
measure: Pharmacokinetics of multiple oral doses
timeFrame: up to 10 days postdose
measure: To explore the pharmacokinetic interaction between GLPG0259 and methotrexate (MTX).
timeFrame: up to 10 days postdose
measure: To explore biomarkers of GLPG0259 activity after multiple oral administrations.
timeFrame: up to 24 hours postdose
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: SGS Stuivenberg
Study officials:
affiliation: Galapagos NV
name: Johan Beetens, PharmD, PhD
role: STUDY_DIRECTOR
affiliation: SGS Stuivenberg
name: Lien Gheyle, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03198403: The Effect of Popliteal Plexus Block on Pain After Total Knee Arthroplasty
Official title: The Effect of Popliteal Plexus Block on Postoperative Pain After Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Popliteal Plexus Block
Total Knee Arthroplasty
Lead sponsor: Regionshospitalet Silkeborg
Sponsor class: OTHER
First posted: 2017-06-26
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot Study
Primary purpose: TREATMENT

Brief summary: The study aims to investigate the effect of the Popliteal plexus block (PPB) on postoperative pain after total knee arthroplasty

Detailed description: Cadaver dissection studies have shown a spread of dye to the popliteal fossa and colored the popliteal plexus by injecting in the distal part of the adductor Canal.

The popliteal plexus is formed by contribution from the tibial and the obturator nerves.

Investigators hypothesized that a PPB may reduce postoperative pain after total knee arthroplasty.

Eligibility criteria: Inclusion Criteria:

* patients undergoing total knee arthroplasty in spinal anesthesia
* age \> or = 18 years
* American Society of Anesthesiologists (ASA) status I-III
* Informed consent

Exclusion Criteria:

* Patients unable to cooperate
* Patients not able to speak Danish
* Pregnancy
* Contraindication towards ana Medical product used in the study
* Preoperatively reduced sensation on the medial and lateral part of the lower leg
* Patients with diabetic requiring Medical treatment
* Preoperative daily intake of opioids

Primary outcomes:
measure: The percentage of patients with postoperative pain NRS
timeFrame: 0 - 60 minutes
Secondary outcomes:
measure: Percentage of patients having a femoral triangle block(FTB) reporting NRS > 3
timeFrame: Pain scores every 15 minutes (from end injection FTB to NRS>3 or 3 hours after full sensation of the leg)
measure: Onset time of PPB
timeFrame: NRS every 5 minutes after PPB (From 0 - 60 minutes after PPB)
measure: Turn off time of spinal anesthesia
timeFrame: Time from arrival in PACU and during maximum 6 hours
measure: Correlation between normal cutaneous sensation and developing of pain
timeFrame: From arrival in PACU and during maximum 6 hours
measure: The effect of the PPB on cutaneous sensation
timeFrame: NRS every 5 minutes after PPB (From 0 - 60 minutes after PPB)
measure: The effect of the PPB on muscle strength of the foot
timeFrame: Baseline and 1 hour after PPB
Other outcomes:
Locations:
city: Silkeborg
country: Denmark
facility: Silkeborg Regionalhospital
Study officials:
affiliation: University of Aarhus
name: Charlotte Runge, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02569203: Effect of Immune-enhancing Enteral Nutrition on Immunomodulation in Critically Ill Patients
Official title: Effects of Enteral Formula Including Immune-modulating Nutrients on Clinical Course and Immune Function in Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-10-06
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: To determine whether high-protein (24% of total calorie from protein) enteral nutrition of immune modulating nutrients (eg, ω-3 fatty acids and antioxidants) enriched with β-glucan stimulates immune functions compared with standard enteral nutrition (control: 20% of total calorie from protein) or high-protein (24% of total calorie from protein) enteral nutrition of immune modulating nutrients without β-glucan in critically ill patients.

Detailed description: To determine whether high-protein (24% of total calorie from protein) enteral nutrition of immune modulating nutrients (eg, ω-3 fatty acids and antioxidants) enriched with β-glucan stimulates immune functions compared with standard enteral nutrition (control: 20% of total calorie from protein) or high-protein (24% of total calorie from protein) enteral nutrition of immune modulating nutrients without β-glucan in critically ill patients. In a randomized double-blind placebo-controlled study, 30 patients consumed 1 of 3 enteral nutrition: control, enteral nutrition of immune modulating nutrients enriched with β-glucan (250mg/L) or enteral nutrition of immune modulating nutrients without β-glucan. Enteral nutrition was initiated within 24 hours of ICU admission and continued during the ICU stay for a 7 days.

Eligibility criteria: Inclusion Criteria:

* ICU patients

Exclusion Criteria:

* ICU patients who could not receiving enteral nutrition

Primary outcomes:
measure: Change from baseline NK cell activity at 7 days
timeFrame: at baseline and 7 days follow-up
Secondary outcomes:
measure: Change from baseline IL-12 at 7 days
timeFrame: at baseline and 7 days follow-up
measure: Change from baseline hs-CRP at 7 days
timeFrame: at baseline and 7 days follow-up
Other outcomes:
Locations:
Study officials:
affiliation: Dept. of Food and Nutrition, College of Human Ecology, Yonsei University, 50 Yonsei-ro, Seodaemun-gu, Seoul, 120-749, South Korea
name: Jong Ho Lee, Ph. D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee JG, Kim YS, Lee YJ, Ahn HY, Kim M, Kim M, Cho MJ, Cho Y, Lee JH. Effect of Immune-Enhancing Enteral Nutrition Enriched with or without Beta-Glucan on Immunomodulation in Critically Ill Patients. Nutrients. 2016 Jun 2;8(6):336. doi: 10.3390/nu8060336.
Clinical trial NCT06456203: Trial of Artificial Intelligence for Chest Radiography
Official title: Artificial Intelligence for Chest Radiography: Impact on Economics, Patient Outcomes and Radiology Service Delivery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pneumonia
Lung Cancer
Keywords: Radiology
artificial intelligence
triage
radiography
Lead sponsor: Duke-NUS Graduate Medical School
Sponsor class: OTHER
First posted: 2024-06-13
Enrollment: 10000
Sex: ALL
Minimum age (years): 14
Maximum age (years): 130
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Randomized Clinical Trial of the impact of Chest radiograph AI-assisted triage and report generation upon clinical outcomes and an economic analysis of impact of AI decision support on radiology service delivery.

Detailed description: Randomized, prospective selection of patients. Control group involves radiologists reporting chest radiographs as per reference standard clinical workflow Intervention group involves radiologists assisted with AI reporting an AI-triaged worklist of chest radiographs using an AI report generation tool Clinical outcomes on patients are studied at pre-determined study endpoints, including time to discharge from the hospital and re-admission rates.

Economic analysis on cost-avoidance from man-hours saved from report generation and triage.

Eligibility criteria: Inclusion Criteria:

* All patients attending radiography to have chest radiographs during the study period

Exclusion Criteria:

* age below 14
* deceased before discharge
* chest radiograph performed in non-standard projections

Primary outcomes:
measure: Report generation time
timeFrame: 12 months
measure: Turnaround Time
timeFrame: 12 months
measure: Time to discharge
timeFrame: 12 months
Secondary outcomes:
measure: 30-day patient readmission rate
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04007003: An Audit of the Impact of Tailored Information Delivered Via a Digital Learning Platform
Official title: An Audit of the Impact of Tailored Information Delivered Via a Digital Learning Platform
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Lead sponsor: Becton, Dickinson and Company
Sponsor class: INDUSTRY
First posted: 2019-07-05
Enrollment: 170
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 study intends to audit the impact of optimal insulin injection technique on clinical parameters and self-care behaviour of insulin treated diabetes patients in a prospective manner with a follow-up of 6 months. The optimal injection technique is delivered through education via a multimodal tailored approach augmented with a digital 'tailorable' patient learning platform .

The study is conducted in multiple sites across Belgium. Diabetes patients with or without lipohypertrophy will be entered into the audit. The end points will include the impact on use of insulin, long term blood glucose control (HbA1c), hypoglycaemia, glucose variability, needle reuse, patient injection habits and clinician education, training and information inputs.


Eligibility criteria: Inclusion Criteria:

* Type 1 Diabetes Mellitus, or Type 2 Diabetes Mellitus
* Injecting insulin for at least 1 year
* Self-managing injection therapy, including daily glucose monitoring
* Access to a device with internet
* Confident in navigating the internet

Exclusion Criteria:

* Pregnant or likely to become pregnant during study period
* Impaired cognitive ability which would prevent informed consent
* Syringe only user
* Insulin pump user
* Glucagon-Like Peptide (GLP)-1 receptor agonists therapy only

Primary outcomes:
measure: Change in Insulin Use
timeFrame: up to 6 months
Secondary outcomes:
measure: Change in Glycemic Control
timeFrame: up to 6 months
measure: Incidence of Hypoglycemic Events
timeFrame: up to 6 months
measure: Change in Needle Re-Use
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Bonheiden
country: Belgium
facility: Imeldaziekenhuis
city: Brussel
country: Belgium
facility: Universitair Ziekenhuis Brussel
city: Gent
country: Belgium
facility: UZ Gent
city: Hasselt
country: Belgium
facility: Virga Jesse Ziekenhuis
city: Kortrijk
country: Belgium
facility: AZ Groeninge
city: Sint-Niklaas
country: Belgium
facility: AZ Nikolaas
city: Turnhout
country: Belgium
facility: AZ Turnhout
city: Vilvoorde
country: Belgium
facility: AZ Jan Portaels
Study officials:
affiliation: University Hospital, Antwerp
name: Christophe De Block, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00096603: A Study to Evaluate the Safety of Raptiva in Adults With Plaque Psoriasis Previously Enrolled in Study ACD2600g
Official title: An Open Label, Multicenter Study to Evaluate the Safety of 1.0 mg/kg Subcutaneously Administered Efalizumab in Adults With Plaque Psoriasis Previously Enrolled in Study ACD2600g
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Keywords: Moderate to severe plaque psoriasis
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2004-11-15
Enrollment: 450
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: This is an open label, multicenter study designed to evaluate the safety and tolerability of efalizumab administered subcutaneously at weekly doses of 1.0 mg/kg in subjects with plaque psoriasis who previously participated in Study ACD2600g.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Previous participation in Study ACD2600g
* For women of childbearing potential, continued use of an acceptable method of contraception for the duration of the study

Exclusion Criteria:

* Any medical condition that, in the judgment of the investigator, would jeopardize the subject's safety following exposure to Efalizumab

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: