louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01114152: AZD9742 Single and Multiple Ascending Dose Study in Healthy Male and Female Japanese Subjects
Official title: A Phase I, Single Center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Intravenous AZD9742 in Healthy Male and Female Japanese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: AZD9742
Japanese Healthy Volunteers
Phase I
Single and Multiple Ascending Dose
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-04-30
Enrollment: 35
Sex: ALL
Minimum age (years): 23
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase I randomized double-blind, placebo-controlled, single and multiple ascending dose study to assess the safety, tolerability and pharmacokinetics of AZD9742 in healthy male and female Japanese subjects


Eligibility criteria: Inclusion Criteria:

* female (non-childbearing potential)
* Body mass index (BMI) : 17 to 27 kg/m 2

Exclusion Criteria:

* History of 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 results or the subject's ability to participate in the study
* History or presence of gastrointestinal, hepatic, or renal disease or any otherHistory or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
* Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational product

Primary outcomes:
measure: Safety variables (adverse events, vital signs, physical examinations, clinical laboratory assessments, 12-lead ECG, digital ECG, telemetry)
timeFrame: collected prior to treatment, during treatment and follow-up for a total of 18-22 days
Secondary outcomes:
measure: Characterize the Pharmacokinetics of AZD9742 in blood and urine
timeFrame: PK-sampling during 14 pre-defined study days for PK profiling
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Research Site
state: California
Study officials:
affiliation: California Clinical Trials
name: Mark Yen, M..D.
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca
name: David Melnick
role: STUDY_DIRECTOR
References:
Clinical trial NCT03422952: Stress Response in Emergency Among Physicians in Helicopter and Ambulance Based Emergency Medical Systems
Official title: Hormonal and Physiological Stress Response of Medical Doctors Working in Rescue Helicopter or Van
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hormone Disturbance
Stress Reaction
Stress Related Disorder
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2018-02-06
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Medical Doctor working in rescue helicopter or van

Brief summary: Stress reactions in emergency physicians will be measures using cortol-awakening-reaction, heart-rate-variability and standardised stress questionnaires

Detailed description: In a field study with within-subject design, there will be conducted the hormonal and physiological stress strain of emergency physicians working in rescue helicopters or van on different days of service on different headquarters. The investigation of the parameter of stress will be conducted on two days of rescue service, on two days of clinical service and as a control on two days off. The quantification of the hormonal stress strain will be carried out with the cortisol awakening response, there will be conducted 3 saliva samples with identical interval after getting up within 30 minutes. While the labour time on the rescue service and on the clinical service and the whole day off, the heart rate variability will show the degree of physiological stress. This will be measured with a pulse-belt on the chest, which the participant will carry the whole day. In addition, participants will fill out a set of questionnaire on the first day of measurement.

Eligibility criteria: Inclusion Criteria:

* Medical Doctor working in rescue helicopter or van

Exclusion Criteria:

* Metabolic disease
* Autoimmune disease
* Heart disease
* Blood disease
* Mental disease
* Endocrinologic disease
* BMI\>30
* \>10 cigarettes/day
* Taking cortisone medication

Primary outcomes:
measure: Cortisol-awakening-response (CAR)
timeFrame: 30 min each day, six days
measure: Heart rate variability
timeFrame: six days
measure: Stress questionnaire
timeFrame: first day
Secondary outcomes:
Other outcomes:
measure: Possible factors that may affect the measured parameter
timeFrame: six days
Locations:
city: Bern
country: Switzerland
facility: Bern University Hospital and University of Bern
Study officials:
affiliation: attending anaesthesiologist
name: Lorenz Theiler, PD Dr. med
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01948752: Clinical Trial of Menu Labeling
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Calorie Consumption
Keywords: Nutrition policy
food labelling
diet
obesity
health behavior
Lead sponsor: University of Waterloo
Sponsor class: OTHER
Collaborators: name: Canadian Cancer Society (CCS)
First posted: 2013-09-24
Enrollment: 661
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The current study sought to examine the effect of menu labeling on food ordering and food consumption, including the effect of displaying calories along with other nutrients, such as sodium, fat, and sugar, as well as in different formats, such as traffic lights.

The investigators hypothesize significant differences in the calorie amount of menu selections and food consumption across experimental conditions. The investigators anticipate that calorie amounts will be significantly higher in the no calorie information) compared to each of the other 3 conditions, and significantly lower in the Traffic Light conditions compared to calories only condition.

2) Individuals in Condition 1 (no calorie information) will be significantly more likely to underestimate the calorie content of their meals compared to individuals in the intervention conditions.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older,
* able to speak and read English

Exclusion Criteria:

- no food allergies to gluten or other grain products

Primary outcomes:
measure: Calorie consumption.
timeFrame: Calorie consumption was recorded for the meal consumed during the visit to the laboratory, approximately 30 minutes after the start of the study. No additional follow-up was conducted after the laboratory visit.
Secondary outcomes:
measure: Calorie content of meals ordered by participants.
timeFrame: Calorie content was recorded for the meal consumed during the visit to the laboratory, approximately 30 minutes after the start of the study. No additional follow-up was conducted after the laboratory visit.
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: School of Public Health, University of Waterloo
state: Ontario
Study officials:
affiliation: University of Waterloo
name: David Hammond, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hammond D, Goodman S, Hanning R, Daniel S. A randomized trial of calorie labeling on menus. Prev Med. 2013 Dec;57(6):860-6. doi: 10.1016/j.ypmed.2013.09.020. Epub 2013 Oct 7.
Clinical trial NCT01645852: A Phase II Study of the Effect of a Low Calorie Diet on Patients Undergoing Liver Resection
Official title: A Randomized Phase II Study of the Effect of a Low Calorie Diet on Patients Undergoing Liver Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nonalcoholic Fatty Liver Disease
Hepatic Steatosis
Steatohepatitis
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2012-07-20
Enrollment: 65
Sex: ALL
Minimum age (years): 18
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 is to measure the effect of a short-term low calorie diet on patients with a Body Mass Index (BMI) over 25 who are undergoing liver surgery.


Eligibility criteria: Inclusion Criteria:

* Age 18 or greater
* Clinical indication for a therapeutic liver resection
* BMI of 25 kg/m2 or greater
* Informed Consent

Exclusion Criteria:

* Inability to comply with the pre-op diet
* Patients who have lost 5% or more of their usual body weight over the preceding one month
* Female patients of childbearing age who have a positive pregnancy test

Primary outcomes:
measure: The effect of a low calorie diet on intra-operative blood loss, technical ease of hepatic transection, complication rates (including infectious complications), length of stay and mortality in patients undergoing liver surgery.
timeFrame: 30 days post-operatively
Secondary outcomes:
measure: The effect of a low calorie diet on steatosis and steatohepatitis.
timeFrame: 30 days post-operatively
measure: The mechanism of decreased steatosis in patients undergoing a low-calorie pre-op diet by measuring levels of expression of molecules involved in the de novo synthesis, hepatic uptake and degradation of lipids.
timeFrame: 30 days post-operatively
Other outcomes:
Locations:
city: Worcester
country: United States
facility: UMass Memorial Medical Center
state: Massachusetts
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Burlington
country: United States
facility: Fletcher Allen Health Care
state: Vermont
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Richard J. Barth, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04741152: Blinded Resection in Case of the Pancreatic Insulinoma
Official title: Blinded Resection Avoided in Case of the Pancreatic Insulinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Insulinoma; Pancreas
Keywords: Insulinoma
Hypoglicemia
Blind resection
Hidden Insulinoma
ASVS
Lead sponsor: Vishnevsky Center of Surgery
Sponsor class: OTHER
First posted: 2021-02-05
Enrollment: 197
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients surgically treated in case of pancreatic insulinoma/proinsulinoma

Brief summary: The blinded resection avoided in case of pancreatic insulinoma

Detailed description: Despite of the technique and technology developement there are still a lot of troubles to verify small benign-looking pancreatic NETs. It can be especially important in case of insulinoma. The organic hyperilsulinism and severe hypoglicemia causeb by the insulin/proinsulin - producing lesion can lead to severe complications and evem death.

There are some cases of the blinded resections of the pancreas in patients with the "hidden" insulinoma when the tumor can't be revealed during the preoperative diagnostics and intraoperatively. Unfortunately, blind resection do not solve the problem of the hypoglicemia but also cause the specific pancreatic complications.

Eligibility criteria: Inclusion Criteria:

The blinded resection of the insulinoma

Exclusion Criteria:

Other tumors

Primary outcomes:
measure: No hidden insulinomas
timeFrame: 2010 June - 2020 June
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06093152: Video Assisted Study of Salbutamol Response in Viral Wheezing
Official title: Video Assisted Study of Salbutamol Response in Viral Wheezing
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Wheezing
Lead sponsor: University of Oulu
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants are 6-24 months old children presenting to the emergency department for wheezing.

Brief summary: The study is video assisted cross-over study evaluating the effect of inhaled salbutamol in wheeze in children 6-24 months old.

Detailed description: The object of the study is to evaluate the effect of inhaled salbutamol in wheeze in children 6-24 months old.

In despite of the lack of evidence of salbutamol, it is considered the gold standard in acute wheezing. Placebo-controlled study would be unethical so all participants are treated with salbutamol based on current guidelines. Instead, participants serve as control subjects of their own which is executed by a type video assisted cross-over study.

Participants are filmed before and after the treatment. Afterwards a panel of pediatricians not participating in the treatment of the participants independently evaluates the difficulty of the wheeze. Videos are randomly arranged and members of the panel are blinded to the time point (before/after) of videos.

In addition, collected videos are analyzed using machine vision. Biosignals are collected from the videos and evaluated using algorithms in order to show that machine vision can be utilized to evaluate the difficulty of wheezing. The machine vision analysis is compared to the evaluation of the panel of pediatricians.

Eligibility criteria: Inclusion Criteria:

* Wheezing
* Salbutamol-treatment in emergency department prescribed

Exclusion Criteria:

* Need for immediate resuscitation
* Immediate transfer to ICU
* Suspicion of pneumonia based on the auscultation finding
* Suspicion of airway foreign body

Primary outcomes:
measure: Change in modified RDAI
timeFrame: Within 3 hours of study entry
Secondary outcomes:
measure: Change in saturation of peripheral oxygen
timeFrame: Within 3 hours of study entry
measure: Change in auscultation finding
timeFrame: Within 3 hours of study entry
measure: Change in the difficulty of the respiratory distress
timeFrame: Within 3 hours of study entry
measure: Machine-vision assisted analysis of respiratory status
timeFrame: Within 3 hours of study entry
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Department of Pediatrics, Oulu University Hospital
Study officials:
affiliation: University of Oulu
name: Terhi Tapiainen, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02594852: Laser - a New Possibility in Fertility Treatment - a Pilot Study
Official title: Laser - a New Possibility in Fertility Treatment - a Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Infertility
Exposure Laser
Lead sponsor: Regionshospitalet Viborg, Skive
Sponsor class: OTHER
First posted: 2015-11-03
Enrollment: 20
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study the investigators want to investigate if the pregnancy rate in conjunction with fertility treatment increases with concomitant use of laser therapy.

Detailed description: Furthermore the investigators want to examine the participants general mental and physical wellbeing during the experimental period using a VAS-scale.

Eligibility criteria: Inclusion Criteria:

1. BMI : 18-32
2. long agonist/short antagonist IVF/intracytoplasmatic sperm injection (ICSI)treatment
3. 1-2 IVF/ICSI treatments without obtaining pregnancy.
4. signed consent

Exclusion Criteria:

1. uterine malformations
2. Uterine fibroids/polyps
3. need of an interpreter.
4. D.M, epilepsy, liver-kidney-heart disease
5. endometrial biopsy
6. cancer former cancer disease
7. acupuncture
8. metal in the body
9. suspicious naevi and tatoo´s

Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: up to24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Skive
country: Denmark
facility: the Fertility clinic, Regional Hospital Skive
state: Central Jutland
Study officials:
affiliation: The Fertility clinic Skive
name: Helle Elbaek, M.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT03512652: Clinical Study to Assess the Effectiveness of the Device Patello
Official title: Clinical Study to Assess the Effectiveness of the Device Patello
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Passiv Continuous Patella Mobilisation
Lead sponsor: University of Applied Sciences and Arts of Southern Switzerland
Sponsor class: OTHER
First posted: 2018-05-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: One randomly selected knee is treated by the intervention device Patello
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The device "Patello" was designed to passively mobilize the Patella in cranial-caudal direction. Its application field lays in the rehabilitation of any knee pathology where knee range of motion may be restricted due to the Patella mobility.

Detailed description: The effectiveness of the device Patello has not been tested so far. This clinical study aims to assess and proof the effectiveness of this device. The aim is to objectify the movement of the Patella induced by the device Patello in cranial / caudal direction. As outcome parameter serve ultrasound measurements of a bony reference point of the femur and the Patella and its displacement / distance after mobilization.

Eligibility criteria: Inclusion Criteria:

* no operation and / or actual problems (pain at rest or during strain) of the muscular or bony parts of the lower extremities
* closed and intact skin conditions in the area of the knees and thighs
* no fear of the intervention
* willingness to participate on all 2 measurement days

Exclusion Criteria:

* operation and / or actual problems (pain at rest or during strain) of the muscular or bony parts of the lower extremities
* open skin conditions in the area of the knees and thighs
* fear of the intervention
* no willingness to participate on all 2 measurement days

Primary outcomes:
measure: Range of motion
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Landquart
country: Switzerland
facility: SUPSI Landquart
state: GR
Study officials:
References:
Clinical trial NCT00000452: Naltrexone Treatment of Alcohol Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alcoholism
Lead sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Sponsor class: NIH
First posted: 1999-11-03
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The long-range goal of this ongoing research program is to find more effective treatments for alcohol dependence by combining medication with the appropriate psychosocial support. This proposal has three specific aims: (1) to compare the effectiveness of naltrexone (Revia) in three types of treatment settings; (2) to assess the effects of psychosocial support on medication compliance and treatment retention; and (3) to investigate the individual characteristics that may predict who is likely to benefit from additional psychosocial support versus simple medication management.


Eligibility criteria: Inclusion Criteria:

* Meets criteria for current diagnosis of alcohol dependence.
* Subjects used more than 15 standard alcohol drinks (average)/week with at least 1 day of 5 or more drinks in the past 30 days.
* Successful completion of medical detoxification.
* Lives within a commutable distance to the Treatment Research Center and agrees to follow-up visits.
* Understands and signs the informed consent.

Exclusion Criteria:

* Current diagnosis of any substance dependence other than alcohol, nicotine, or marijuana.
* Evidence of opiate use in the past 30 days.
* Current treatment with psychotropic medications, including disulfiram (Antabuse) (excluding short-term use of benzodiazepines for detoxification).
* History of unstable or serious medical illness, including need for opioid analgesics.
* Severe physical or medical illnesses such as AIDS, active hepatitis, significant hepatocellular injury as evidenced by elevated bilirubin levels, and current severe psychiatric symptoms.
* Use of an investigation medication in the past 30 days.
* Female subjects who are pregnant, nursing, or not using reliable method of contraception.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Treatment Research Center, University of Pennsylvania
state: Pennsylvania
Study officials:
References: