louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00859352: AZD1981 Midazolam CYP4503A Induction Study
Official title: A Phase I, Open, Randomised, Non-Comparative, Parallel Group Study of a Potential Cytochrome P450 3A Induction After Repeat Twice Daily Oral Dosing With 100 and 500 mg AZD1981 Tablets for 14 Days to Healthy Male Volunteers With Single Oral Doses of Midazolam 7.5 mg.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Male Volunteer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-03-11
Enrollment: 28
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The primary objective of the study is to investigate if the exposure of midazolam is clinically significantly changed by 14 days of exposure to AZD1981 through possible enzyme induction of CYP3A.


Eligibility criteria: Inclusion Criteria:

* Provision of informed consent prior to any study specific procedures
* Have a body mass index between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
* Be a non-smoker or ex-smoker who has stopped smoking for \>6 months prior to Visit 1 (pre-entry)

Exclusion Criteria:

* Any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the result of the study, or the subject´s ability to participate
* Any clinically relevant abnormal findings in phys.examination, clinical chemistry, haematology, urinalysis, vital signs, or ECG at baseline which, in the opinion of the investigator, may put the subject at risk because of his participation in the study

Primary outcomes:
measure: PK samples for both AZD1981 and Midazolam.
timeFrame: Intense PK-sampling during 3 pre-defined study days for PK profiling and some sampling throughout the whole study period for confirmatory purposes
Secondary outcomes:
measure: Sampling of 4β-hydroxycholesterol
timeFrame: Taken at baseline and after steady state of AZD1981
measure: Safety variables (adverse events and laboratory safety lab)
timeFrame: Adverse events taken during study and safety lab at a few time points
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca R&D, Lund, Sweden
name: Eva Pettersson
role: STUDY_DIRECTOR
affiliation: Quintiles Hermelinen AB, Luleå, Sweden
name: Aslak Rautio
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00018252: The Effect of Exercise Training on Mental Stress-Induced Silent Ischemia
Official title: The Effect of Exercise Training on Mental Stress-Induced Silent Ischemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Ischemia
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2001-07-05
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED

Brief summary: Coronary artery disease (CAD) remains the leading cause of death in the elderly. Silent myocardial ischemia (SI) is a manifestation of CAD in which there is a transient alteration in myocardial perfusion, function, and/or electrical activity not accompanied by chest pain. Mental and emotional stress, in particular hostility and anger are potent inducers of SI, Individuals with SI are at a 3-5 fold higher risk for the development of angina, myocardial infarction and death than subjects without SI.

Detailed description: The hypothesis of this study is that older individuals with occult cad, mental stress/ emotional arousal (anger) increases sympathetic nervous system activity resulting in vasoconstriction thereby eliciting transient episodes of SI. Therefore an aerobic exercise intervention that reduces the response to anger/hostility and improves vascular compliance will decrease the ischemic burden in SI patients. The specific objectives are: To determine if non-smoking older individuals with exercise-induced SI have increased vasoreactivity (blood pressure, heart rate) responses to the laboratory presentation of mental stressors, decreased vascular compliance and brachial artery endothelial reactivity compared to matched non-ischemic controls; 2) To perform a randomized clinical trial that will examine the effects of 9 months of aerobic exercise training versus usual care on vasoreactivity, vascular compliance and ischemic burden on Holter monitor. Older individuals without a history of overt CAD will be recruited and evaluated for the presence of exercise-induced SI. Baseline cross-sectional comparisons of vasoreactivity and cardiovascular function will be performed between those with SI and non-ischemic controls. The individuals with SI will be enrolled in a randomized clinical trial of exercise vs usual care. Exercise treadmill testing with measurement of maximal aerobic capacity will be used to determine fitness. Vasoactivity will be quantified during a mental stress test with real time 2d echo imaging. Vascular function will be assessed using high frequency ultrasound measurements of flow-mediated brachial artery endothelial reactivity.

Eligibility criteria: Older individuals without a history of overt CAD.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: VA Maryland Health Care System
state: Maryland
Study officials:
References:
Clinical trial NCT03302052: Investigation About Advance Directives
Official title: Investigation About Advance Directives
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advance Directive
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2017-10-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Every medical and paramedical staff of St JOSEPH'S Hospital (Paris)

Brief summary: Advance directives are again in the heart of debate since the Leonetti-Claeys's law . These pieces of legislation allow everyone to decide by advance their wishes of the end of life.However, it does not seem that to legislate on a subject is enough to apply the text of law. High authority of health suggest that medical and paramedical staff have to participate to the elaboration of the questionnaire and the redaction of advance directives.

So the aim is that ,before asking patient about their knowledge on these advance directive, to evaluate if the staff knows about the law .


Eligibility criteria: Inclusion Criteria:

* nurse
* doctors
* paramedical staff

Exclusion Criteria:

* refusing participation

Primary outcomes:
measure: Scoring the degree of knowledge of the staffs and doctors of the GHPSJ
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile-de-France
Study officials:
References:
Clinical trial NCT04977752: Hirschsprung's Disease: Surgical Techniques and Quality of Life
Official title: Quality of Life in Patients With Hirschsprung's Disease in Relation to Surgical Technique: a Study of a Danish Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Quality of Life
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
First posted: 2021-07-27
Enrollment: 207
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with HD at OUH, department for general surgery between 1985 and 2012.

Brief summary: This is an observational study examining the long-term quality of life in patients with Hirschsprung's Disease in relation to the choice of surgical technique.

Detailed description: Hirschsprung's Disease (HD) is a developmental defect causing functional obstruction of bowel. It is a condition that almost always requires surgical intervention. This study aims to examine the relation between quality of life and surgical technique in patients with Hirschsprung's disease in hopes of providing insight into advantages and disadvantages of different surgical techniques employed at OUH, department for general surgery in the time between 1985 and 2012. This will be done based on answers given on a set of validated questionnaires that has been sent to all patients diagnosed with HD in the years 1985 to 2012 at OUH, department for general surgery.

Eligibility criteria: Inclusion Criteria:

* All patients diagnosed with HD at the Surgical Department at Odense University Hospital from 1985 to 2012 will be invited to enroll in the study.

Exclusion Criteria:

* lack of informed consent, pregnancy, wrong diagnosis and inability to understand or answer the questionnaires.

Primary outcomes:
measure: Hirschsprung Quality of life Questionnaire sub scales and total score
timeFrame: Day 1
measure: General Quality of Life
timeFrame: Day 1
measure: Type of Surgical Intervention
timeFrame: Day 1
Secondary outcomes:
measure: Rate of Complications
timeFrame: Day 1
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: University of Southern Denmark
state: Fyn
Study officials:
References:
Clinical trial NCT04409652: Head Position on Preventing Emergence Cough
Official title: Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gallbladder Diseases
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2020-06-01
Enrollment: 72
Sex: MALE
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to investigate the effect of head position on prevent the emergence cough followed by endotracheal extubation.

Detailed description: During endotrachl intubaion, the sniffing postion is most commonly recommended. However, the head position to reduce the emergence cough followed by endotracheal extubation was not confirmed yet. Considering the endotracheal tube vector, head elevation with pillow is thought to be acceptable more.

Eligibility criteria: Inclusion Criteria:

* Operation schedule of laparoscopic cholecystectomy
* Must be performed under general anesthesia

Exclusion Criteria:

* BMI \> 30 kg/m2
* Respiratory infection
* Uncontrolled hypertension

Primary outcomes:
measure: The severity of cough
timeFrame: during extubation
Secondary outcomes:
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
Study officials:
References:
Clinical trial NCT01340352: Is It Possible to Predict Pre Term Labor by Measuring Cervical Length in the Non-pregnant Uterus?
Official title: Is It Possible to Predict Pre Term Labor by Measuring Cervical Length in the Non-pregnant Uterus?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preterm Birth
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2011-04-22
Enrollment: 62
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HaEmek Medical Center delivery room.

Brief summary: Working hypothesis and aims:

To investigate the association between cervical length in non-pregnant women, and the risk of premature birth.

The participants will be recruited from the HaEmek Medical Center delivery room registration. Women delivered between 24-37 pregnancy weeks will be allocated to the study group. The investigators will invite them 3 month or more after delivery to ultrasound examination of the cervical length. The participants in the control group will be the women whom term delivery follows by chronological manner to those in study group. Data of the cervucal length will be collected at the time of the examination.

Detailed description: Women will be invited to undergo an examination in Ultrasound Unit of Department of Obstetrics and Gynecology, HaEmek Medical Center.

Ultrasound examination will be performed using the Voluson E8 device, General Electric.

The cervical length,between the external and internal orifice will be measured using conventional technologies available including: Doppler, three dimensional and two dimensional ultrasound.

Eligibility criteria: Inclusion Criteria:

* Nonpregnant women aged 18-40 years.
* Singelton last pregnancy.
* Last birth, spontaneous premature (24-37 week)
* Last birth at least 3 months ago.

Exclusion Criteria:

* Presence of uterine malformations.
* Sonographic pathologic findings.
* Technical failure (failed appropiate sonographic visualisation)
* Presence of fetal malformations ( in preterm delivery )
* Presence of comorbidities including diabetes, hypertension, collagen disease, thrombophilia
* Presence of risk factors for premature delivery (amniotic fluid infection,

  * cervical surgical treatments - conization, polyhydramnios, etc.).

Primary outcomes:
measure: length of the cervix in mm.
timeFrame: up to 20 month
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Dep. OB/GYN, Emek Medical Center
Study officials:
affiliation: haemek medical center
name: Etty Daniel-Spiegel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01766752: Performance of a Tablet Based Workflow and Decision Support System With Incorporated Software Algorithm Used for Glycaemic Management
Official title: An Open, Single-centre, Non-controlled Feasibility Study of the Performance of a Tablet Based Workflow and Decision Support System With Incorporated Software Algorithm Used for Glycaemic Management in Non-critically Ill Patients With Type 2 Diabetes at the General Ward
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2013-01-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: To investigate the performance (safety) of the GlucoTab system for glycaemic management in non-critically ill patients with type 2 diabetes at the general ward


Eligibility criteria: Inclusion Criteria:

* Informed consent obtained after being advised of the nature of the study
* Male or female aged 18 - 90 years (both inclusive)
* Type 2 diabetes treated with diet, oral agents, non-insulin injected anti-diabetic medicine, insulin therapy or any combination of the four

Exclusion Criteria:

* Impaired renal function (serum creatinine ≥3.0mg/dL)
* Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the patient
* Pregnancy
* Any mental condition rendering the patient incapable of giving his consent
* Terminally ill patients
* Participation in a trial within 3 months prior to this trial
* Known or suspected allergy to insulin

Primary outcomes:
measure: The primary endpoint is the percentage of actions the system supports either to capture BG values or provide insulin dose suggestions according to the REACTION algorithm.
timeFrame: duration of hospital stay (maximum three weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
Study officials:
References:
citation: Schaupp L, Donsa K, Neubauer KM, Mader JK, Aberer F, Holl B, Spat S, Augustin T, Beck P, Pieber TR, Plank J. Taking a Closer Look--Continuous Glucose Monitoring in Non-Critically Ill Hospitalized Patients with Type 2 Diabetes Mellitus Under Basal-Bolus Insulin Therapy. Diabetes Technol Ther. 2015 Sep;17(9):611-8. doi: 10.1089/dia.2014.0343. Epub 2015 Apr 30.
Clinical trial NCT05844852: P200TE US Reference Database Study
Official title: Optos P200TE US Reference Database Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Normal Eyes
Lead sponsor: Optos, PLC
Sponsor class: INDUSTRY
First posted: 2023-05-06
Enrollment: 800
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The objective of this study is to collect Optical Coherence Tomography (OCT) data to construct a reference database for the P200TE.

Detailed description: The objective of this study is to collect Optical Coherence Tomography (OCT) data on healthy eyes in order to develop a reference database for the P200TE device in order to determine the reference limits for the P200TE

Eligibility criteria: Inclusion Criteria:

1. Subjects 22 years of age or older on the date of informed consent
2. Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
3. Subjects presenting at the site with normal eyes (Cataracts, LASIK, PRK (photorefractive keratectomy), and peripheral pathology that does not affect the posterior pole region, for example lattice and peripheral drusen, are allowed.
4. BCVA (best corrected visual acuity) 20/40 or better(each eye)
5. Subject is able to comply with the study procedures

Exclusion Criteria:

1. Subjects unable to tolerate ophthalmic imaging
2. Subject has a condition or is in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
3. Subject with ocular media not sufficiently clear toobtain acceptable OCT images
4. .History of leukemia, dementia or multiple sclerosis

Primary outcomes:
measure: Retinal Thickness
timeFrame: 1 year
measure: GCC Thickness
timeFrame: 1 year
measure: RNFL Thickness
timeFrame: 1 year
measure: Optic Nerve Head
timeFrame: 1 year
Secondary outcomes:
measure: Adverse Events
timeFrame: 1 year
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Marshall B Ketchum University, Southern California College of Optometry
state: California
city: San Diego
country: United States
facility: Werner Optometry
state: California
city: San Diego
country: United States
facility: Eyecare of San Diego
state: California
city: Venice
country: United States
facility: Center for Sight
state: Florida
city: Chicago
country: United States
facility: Illinois College of Optometry
state: Illinois
city: Boston
country: United States
facility: New England College of Optometry
state: Massachusetts
city: Roslindale
country: United States
facility: New England College of Optometry
state: Massachusetts
city: New York
country: United States
facility: State University of New York, Clinical Vision Research
state: New York
city: Bellevue
country: United States
facility: Specialty Eye Care Centre
state: Washington
Study officials:
References:
Clinical trial NCT01119352: AZD7687 Multiple Ascending Dose Study
Official title: A Phase 1, Single Centre, Single-Blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AZD7687 After Administration of Multiple Ascending Doses in Overweight to Obese But Otherwise Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Overweight
Obese
Keywords: Safety
tolerability
PK
healthy
overweight
obese
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-05-07
Enrollment: 45
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD7687 following multiple ascending dose administrations in in overweight to obese but otherwise healthy male subjects


Eligibility criteria: Inclusion Criteria:

* Provision of signed and dated, written informed consent prior to any study specific procedures
* suitable veins for cannulation or repeated venepuncture.
* Have a body mass index (BMI) between 27 and 35 kg/m2

Exclusion Criteria:

* Fasting serum (S)-glucose ≥7.0 mmol/L or non-fasting S-glucose ≥11.1 mmol/L at screening.
* Any eating disorder or actively attempting to loose weight within 3 months prior to enrolment.
* Smoking more than 7 cigarettes per week from time of consent

Primary outcomes:
measure: Safety variables (adverse events, vital signs, physical examination, telemetry, digital electrocardiograms (dECGs), safety 12-lead paper electrocardiograms (pECG), and clinical laboratory assessments)
timeFrame: Before, during and after dosing.
Secondary outcomes:
measure: Pharmacokinetics: Plasma and urine concentrations of AZD7687 and plasma and urine pharmacokinetic parameters
timeFrame: Information will be collected from the time of day -2 throughout the study.
measure: Pharmacodynamic Biomarker sampling: (Triacylglycerol in serum, triacylglycerol, diacylglycerol, insulin and free fatty acids in plasma. Triacylglycerol and diacylglycerol in adipose tissue)
timeFrame: Information will be collected from the time of day -2 throughout the study.
measure: Genetic: Blood sampling at one occasion during the study.
timeFrame: Once during study
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Jan Eriksson
role: STUDY_DIRECTOR
affiliation: AstraZeneca
name: Mirjana Kucajcic
role: STUDY_CHAIR
affiliation: Quintiles, Inc.
name: Darren Wilbraham
role: PRINCIPAL_INVESTIGATOR
References: