louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01960166: Active vs Passive Distraction on Procedural Pain in the Pediatric Emergency Department
Official title: Impact of Active vs Passive Distraction on Procedural Pain/Distress in the Pediatric Emergency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Response
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2013-10-10
Enrollment: 47
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators proposed study will investigate the efficacy of tablet computer distraction as an analgesic for the pain associated with various painful procedures in the emergency department. Since prior studies have shown that distraction by a parent or nurse can be an effective analgesic, there is reason to believe that tablet computer distraction will similarly reduce pain. Participants in the control group will receive a cartoon on the TV monitor in the patient room, while participants in the study group will receive a more immersive distraction of playing a game or watching a cartoon (for children too young to play a game) on a tablet computer. Data from this study will help inform best practices for administering painful procedures in a way that minimizes pain.


Eligibility criteria: Inclusion Criteria:

Healthy pediatric patients in the University of Chicago emergency department who are undergoing insertion of a peripheral intravenous line, intramuscular injection, fingerstick, subcutaneous injection, laceration repair (sutures, tissue adhesive, and staples), nail avulsion, or abscess incision and drainage.

Exclusion Criteria:

Non-English speaking, over the age of 18 trauma, have come in for asthma-related complaints, are being resuscitated, are neurosurgical/neurology/seizure patients, or patients in whom use of distraction would interfere with the procedure

Primary outcomes:
measure: Score on pain scale
timeFrame: after procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: U of Chicago Medical Center
state: Illinois
Study officials:
affiliation: University of Chicago
name: Lawrence Gray, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00847366: Open Label Trial of Perifosine in Patients Currently Being Treated on Perifosine Trials in Solid Tumors or Multiple Myeloma
Official title: An Open Label Trial of Perifosine in Patients Currently Being Treated on Perifosine Trials in Solid Tumors or Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non Small Cell Lung Cancer
Solid Tumors
Metastatic Breast Cancer
Sarcomas
Keywords: Perifosine
Lead sponsor: AEterna Zentaris
Sponsor class: INDUSTRY
First posted: 2009-02-19
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is an open label trial for patients currently enrolled in other perifosine trials.

Detailed description: Perifosine is an oral anticancer agent with limited toxicity and a novel mechanism of action that is distinctly different from cytotoxic chemotherapies. It has been shown to inhibit and otherwise modify signaling through a number of pathways including Akt, p21, and JNK. Perifosine has been tested in Phase I and Phase II settings in a variety of dosing schedules including daily, weekly, and daily following a loading dose. In general, it has been well tolerated with dose-related nausea, vomiting, diarrhea, and fatigue being the most commonly observed toxicities.

Perifosine has induced partial responses or stable disease in solid tumors including but not limited to renal cell, sarcoma, and hepatocellular carcinoma. Perifosine is currently being studied in multiple diseases as a single agent as well as in combination with other cancer therapies. As studies are closed there are patients that have achieved a partial response or stable disease.

Eligibility criteria: Inclusion Criteria:

* Patients must be currently receiving treatment with perifosine on a previously approved protocol.
* Patients must have had at least one evaluation following the initiation of treatment and have stable disease, partial response or complete response.
* Patient is willing to sign a new consent Regarding the protocol no exclusion criteria are described.

Primary outcomes:
measure: To evaluate the safety and tolerability
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Keryx Biopharmaceuticals, Inc., NY 10022-9819
name: Eric Grossman, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03472066: Measurement of the Cervix During Pregnancy According to Age of Conization
Official title: Measurement of the Cervix During Pregnancy According to Age of Conization
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cervix; Pregnancy
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2018-03-21
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Including 84 evaluable patients for the primary endpoint would show a Pearson correlation of at least 0.3 between cervical size and age at conization. These calculations were carried out with a 5% risk of first bilateral species and 80% power. Taking into account the risk of incomplete data, we plan to include 90 patients. A control group of 90 patients will also be recruited.

Brief summary: Treatment of precancerous lesions of the cervix by conization has been shown to increase the risk of premature delivery and premature rupture of the membranes. It has now been clearly established that the cervix is a growing organ during adolescence and early adulthood, It has been hypothetized that cervical conization during the growth phase reduced its growth potential, and induced shorter cervix during the upcoming pregnancy. No studies have been conducted investigating the age at which conization no longer had an impact on cervical size during pregnancy. This will help to identify the age at conisation below which patients will be identified as being at risk event, and thus offer increased monitoring and possibly prophylactic management by programmed strapping. We propose to measure the length of the cervix of pregnant patients who have benefited from conization, which is currently recommended by the Collège National des Gynécologues Obstetriciens Français .In addition, the investigators will use a control group consisting of non-con conical, parity-matched pregnant patients in whom a cervical measurement will also be performed.


Eligibility criteria: Inclusion Criteria:

1. Patient referred since January 2008 with pregnancy between 2008 and 2017
2. Pregnancy after conisation
3. Cervix size between 21 and 24 SA before any obstetric event
4. Control group: parity matching, asymptomatic patients

Exclusion Criteria:

1. Threat of late miscarriage,
2. Premature rupture of membranes before cervical echography,
3. Other pregnancies after study of 1st pregnancy after conisation,
4. No measurement of the conization specimen,
5. Lost to follow-up,
6. Age \<18
7. Twin Pregnancies
8. Patient under guardianship

Primary outcomes:
measure: The main objective is to study the correlation between the size of the cervix and the age at conization. age at conization
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens-Picardie
Study officials:
References:
Clinical trial NCT00705666: Treatment of Patients With Chronic Hepatitis C With PegIntron as Monotherapy or in Combination With Ribavirin (Study P04437)(COMPLETED)
Official title: Real Situation Observational Study of VIRAFERONPEG® in Patients With Chronic Hepatitis C
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C, Chronic
Hepacivirus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-06-26
Enrollment: 789
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult participants with chronic hepatitis C treated with PegIntron as monotherapy or in combination with ribavirin at academic centers, clinics, and private practices in France.

Brief summary: In February 2002, a French Consensus Conference on the management of patients with chronic hepatitis C in France was organized. The jury issued several recommendations on pegylated alpha interferon/ribavirin treatment strategy. Three years after these recommendations, it is of interest to understand the evolution of hepatitis C management in France in real clinical practice. This observational study will permit the identification of patients who are treated and will provide information on the use of PegIntron/ Ribavirin.

Detailed description: To assure a good representation of participants treated for hepatitis C, participants who meet the inclusion criteria will be enrolled on a consecutive basis.

Eligibility criteria: Inclusion Criteria:

* Adult participants starting a treatment with PegIntron for the treatment of chronic hepatitis C.

Exclusion Criteria:

* Concomitant participation in a clinical trial for the treatment of hepatitis C.

Primary outcomes:
measure: The Number of Participants Receiving the Recommended Treatment Duration (24 Weeks for Genotypes 2 and 3 and 48 Weeks for Genotype 1 According to the French 2002 Consensus Meeting).
timeFrame: Physicians will complete a questionnaire at these visits: treatment initiation; 12 and 24 weeks after treatment initiation and 24 weeks after the end of treatment; and 36 and 48 weeks after treatment initiation for participants treated for 48 weeks.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT07013266: Burnout Syndrome Among Anesthesiologists in Turkey: A Cross-sectional Study
Official title: Burnout Syndrome Among Anesthesiologists in Turkey: A Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Burnout, Professional
Burnout, Psychological
Lead sponsor: Uludag University
Sponsor class: OTHER
First posted: 2025-06-10
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Anesthesiology and Reanimation specialists currently practicing in the Republic of Turkey.

All anesthesiology and reanimation specialists registered with the Turkish Society of Anesthesiology and Reanimation will be contacted via email through the society. An online survey link will be provided to participants within this email. Participants who agree to take part in the survey and meet the inclusion criteria will be included in the study, and their responses to the questions will be evaluated.

Brief summary: Burnout syndrome is a condition in which an individual experiences loss of self-esteem, chronic fatigue, feelings of helplessness, and hopelessness in their professional work life and human relationships. This study aims to evaluate the prevalence of burnout syndrome among anesthesiologists working in Turkey, analyze the potential causes and adverse consequences of this syndrome's increase, and provide recommendations for its reduction.


Eligibility criteria: Inclusion Criteria:

I. Agreed to participate by completing the online survey form. II. Proficient in the Turkish language. III. Anesthesiology and Reanimation specialists currently practicing in the Republic of Turkey.

Exclusion Criteria:

I. Users who do not provide consent to share the requested information in the survey form.

Primary outcomes:
measure: Prevalence of Burnout Syndrome as measured by the Maslach Burnout Inventory
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Uludağ Üniversitesi
name: Selcan Akesen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00921466: Pilot Study to Assess Feasibility, Reliability and Validity of the e-SSRS-IVR
Official title: Pilot Study to Assess Feasibility, Reliability and Validity of the e-SSRS-IVR
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy
Keywords: Evaluate the clinical content of the e-SSRS-IVR
Lead sponsor: Rogers Center for Research & Training, Inc.
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2009-06-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study subjects will be recruited from a single clinical site (Rogers Memorial Hospital, Milwaukee WI). Half of the subjects will be recruited through public advertisement for Rogers Hospital employees and the other half will be recruited from recent inpatient psychiatric admissions.

Brief summary: The proposed study is designed to evaluate the clinical contents of the e-SSRS-IVR with respect to 1.the intent of the instrument (assess face and content validity), 2. system validation with respect to programming integrity, 3. implementation feasibility in clinical ill and healthy patient populations, and 4. criterion/predictive validity to discriminate patient population with known clinical status differences.


Eligibility criteria: Inclusion Criteria:

* English speaking adults, able/willing to read and provide written consent

Exclusion Criteria:

* Dementia, delirium, psychosis or deafness.
* Control subjects will be excluded for any MINI lifetime MDD or dysthymia diagnosis of a DSM-IV disorder except for specific phobia or dependence on nicotine and caffeine.
* Inpatients not admitted with suicidal ideations

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Rogers Center for Research and Training, Inc
state: Wisconsin
Study officials:
affiliation: Rogers center for Research and Training, Inc
name: John H Greist, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06972966: NEUROvascular NAVgation With Remotely Controlled Deflectable Guidewire, Study II (NeuroNAV Study II)
Official title: NEUROvascular NAVgation With Remotely Controlled Deflectable Guidewire, Study II (NeuroNAV Study II)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Unruptured Cerebral Aneurysm
Lead sponsor: Artiria Medical
Sponsor class: INDUSTRY
First posted: 2025-05-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of the study is to confirm the safe and successful use of the SmartGUIDE guidewire, when used in neuro interventions. The performance of the SmartGUIDE guidewire in terms of safe and successful navigation within the neurovasculature will be compared to standard of care guidewire on the market.


Eligibility criteria: Inclusion Criteria:

* \>18 years of age
* Informed consent signed by the patient
* Confirmed cerebral unruptured aneurysm treatable via transcatheter approach

Exclusion Criteria:

* Pregnancy or lactation
* Known disorder of vascular fragility with propensity to vascular injury (e.g., Ehlers-Danlos syndrome)
* Known prior vascular stenosis or dissection or injury to vessels intended to be catheterized during study procedures
* Acute phase myocardial infarction or uncontrolled cardiac arrhythmia
* Uncontrolled serum electrolyte imbalance
* Bleeding disorder which limits the use of antiplatelet and/or anticoagulant therapy
* Known contraindication to intravascular contrast material that cannot be adequately controlled with pre-medication
* Known hypersensitivity to Nickel
* Subjects currently enrolled in another investigational device or drug study that clinically interferes with the current study endpoints

Primary outcomes:
measure: Performance
timeFrame: During index procedure
Secondary outcomes:
measure: Usability
timeFrame: During index procedure
measure: Procedural times
timeFrame: During index procedure
measure: Intra-procedural adverse events
timeFrame: During index procedure and up to 48 hours post procedure
measure: Intra-procedural device deficiencies
timeFrame: During index procedure
Other outcomes:
Locations:
city: Warszawa
country: Poland
facility: Państwowy Instytut Medyczny MSWiA
Study officials:
affiliation: Państwowy Instytut Medyczny MSWiA
name: Dr hab.n.med Michał Zawadzki
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00449566: Magnetic Resonance Imaging of Brain Development in Autism
Official title: Magnetic Resonance Imaging of Brain Development in Autism
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Autism
Keywords: Magnetic Resonance Imaging
Diffusion Tensor Imaging
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2007-03-20
Enrollment: 300
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE

Brief summary: The purpose of this study is to investigate brain development in autism by longitudinally assessing children with autism, as well as typically developing controls, using advanced MR techniques. We will use longitudinal diffusion tensor imaging (DTI) measures to investigate the protracted development of long-range white matter fibers in autism. In addition, we will investigate the effect of autism risk genes on brain development.


Eligibility criteria: Inclusion Criteria:

1. Aged 6 - 18 years at initial MRI

Inclusion criteria for subjects with autism

1) DSM-IV (APA, 1994) diagnosis of autism, according to ADI-R interview

Inclusion criteria for controls

1. no DSM-IV (APA, 1994) diagnosis, according to DISC interview
2. no scores in the clinical range on the Child Behavior Checklist (CBCL) and Teacher Rating Form (TRF)
3. IQ \> 70

Exclusion Criteria:

1. major illness of the cardiovascular, the endocrine, the pulmonal or the gastrointestinal system
2. presence of metal objects in or around the body (pacemaker, dental braces)
3. history of or present neurological disorder
4. for individuals over 12 years of age: legal incompetence, defined as the obvious inability to comprehend the information that is presented by the investigator and is outlined in the Information letter and on which the decision to participate in the study is to be based

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: Dept. of Child and Adolescent Psychiatry, UMC Utrecht
Study officials:
affiliation: Rudolf Magnus Institute of Neuroscience, University Medical Center Utrecht
name: Sarah Durston, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Rudolf Magnust Institute of Neuroscience, UMC Utrecht
name: Herman van Engeland, M.D. Ph.D.
role: STUDY_CHAIR
References:
citation: Langen M, Durston S, Staal WG, Palmen SJ, van Engeland H. Caudate nucleus is enlarged in high-functioning medication-naive subjects with autism. Biol Psychiatry. 2007 Aug 1;62(3):262-6. doi: 10.1016/j.biopsych.2006.09.040. Epub 2007 Jan 16.
Clinical trial NCT04041466: Validation Study of a Watch for the Detection of Atrial Fibrillation
Official title: Validation of the Watch Withings HWA08 for the Detection of Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Arrythmia, Cardiac
Keywords: Atrial Fibrillation
Arrhythmias, Cardiac
Cardiovascular diseases
Heart diseases
Wearable Electronic Devices
Electrocardiography
Lead sponsor: Withings
Sponsor class: INDUSTRY
Collaborators: name: Clinact
First posted: 2019-08-01
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The proposed clinical study aims at validating the diagnostic performance, in comparison with a reference ECG, of Withings HWA08 watch for the automatic identification of atrial fibrillation (AF).


Eligibility criteria: Inclusion Criteria:

* adults, men or women, at least 18 years old
* person having signed the informed consent form
* person affiliated to a social security system

Exclusion Criteria:

* vulnerable subject according to current regulation:

  * pregnant woman, parturient or breastfeeding
  * subject deprived of freedom by judicial, medical or administrative decision
  * subject legally protected or unable to express his consent
  * subject non-beneficiary of healthcare
  * subject falling into more than one of the above categories
* subject who refused to participate in the study
* subject in linguistic or psychic incapacity to sign a written informed consent form
* subject in physical incapacity to wear a watch on their wrist
* subject with electrical stimulation by pacemaker

Primary outcomes:
measure: AF and SR classification accuracy
timeFrame: 1 visit (30 minutes)
Secondary outcomes:
measure: Quality of the 1-lead ECG strips
timeFrame: 1 visit (30 minutes)
measure: safety evaluation
timeFrame: 1 visit (30 minutes)
Other outcomes:
Locations:
city: Aix-en-Provence
country: France
facility: Clinique AXIUM Centre de cardiologie
city: Saint-Denis
country: France
facility: Centre Cardiologique du Nord
Study officials:
References:
Clinical trial NCT00738166: Content, Bioavailability and Health Effects of Trace Elements and Bioactive Components in Organic Agricultural Systems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: diet, organic, health
healthy people
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2008-08-20
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Trace elements, bioactive secondary metabolites and vitamins are among the most important quality parameters in plants. Yet, very little information is available on their content, bioavailability and health effects of organically grown plant food products. The main objective of the project is to study the impact of different agricultural management practises relevant for organic farming on the ability of cereal and vegetable crops to absorb trace elements from the soil and to synthesise bioactive compounds (secondary metabolites, antioxidant vitamins and phytates) with health promoting effects. Field experiments with a rigidly controlled design will be implemented together with state-of-the-art analytical techniques allowing solid conclusions to be drawn on the variability and optimum levels of bioactive compounds. The multitude of analytical data from plant and soil samples will be analysed by multivariate statistical methods in order to reveal differences between the cultivation systems used. Finally, the relationship between bioavailability of the nutrients studied and the elemental fingerprint of plants will be extracted by the statistical methods.


Eligibility criteria: Inclusion Criteria:

* Healthy adults aged 18-45 years
* BMI 20-30 kg/m2
* Non-vegetarian

Exclusion Criteria:

* Physical activity \> 10 h/week
* Intake of dietary supplements
* Regular use of drugs
* Chronic diseases
* Smoking
* Excessive intake of alcohol

Primary outcomes:
measure: Bioavailability of trace elements and secondary metabolites
timeFrame: 3 x 12 days
Secondary outcomes:
measure: Health factors
timeFrame: 3 x 12 days
Other outcomes:
measure: miRNA
timeFrame: 1 year
Locations:
city: Frederiksberg
country: Denmark
facility: IHE-LIFE
Study officials:
References: