louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05503238: The Effects of Mother-infant Skin-to-skin Contact on Stress Response of Preterm Infants
Official title: The Effects of Mother-infant Skin-to-skin Contact on Cumulative Stress of Preterm Infants in the Neonatal Intensive Care Unit : A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Preterm Infant
Keywords: Stress response
Skin-to-skin contact
Cortisol
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2022-08-16
Enrollment: 0
Sex: ALL
Minimum age (years): 0
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will evaluate the effect of maternal-infant skin-to-skin contact (SSC) versus routine care on general stress in preterm infants in the neonatal intensive care unit (NICU).

Detailed description: Primary outcome of this trial to investigate the effects daily skin-to-skin contact on cumulative stress through measures salivary cortisol. The intervention group will receive mother-infant skin-to-skin contact at least 1 continuous hour everyday from infant 3 days of life until discharge. The control group will receive routine neonatal care during hospitalization except skin-to-skin contact. The concentration of salivary cortisol and other infant and parental outcomes will be measured in both groups.

Eligibility criteria: Inclusion Criteria:

* 31 weeks≤gestational age\<37 weeks;
* Birth weight ≥ 1500g;
* Admission age \< 24h;
* No congenital malformations;
* Vital signs are stable and does not use ventilator and other auxiliary life support systems.

Exclusion Criteria:

* Severe periventricular / intraventricular hemorrhage (grade III);
* Receiving sedation or vasopressor or analgesics opiodis and corticosteroids;
* Mother unable to communicate and communicate normally; Mother has a history of depression.

Primary outcomes:
measure: Changes on the concentration of cortisol of preterm infants
timeFrame: From 3 days of life (baseline) to 7 days of life
Secondary outcomes:
measure: Changes on the level of cortisol during heel lancet
timeFrame: At the preterm infants 7 days of life
measure: Score of Edinburgh Postnatal Depression Scale
timeFrame: Through study completion, an average of 40 days
measure: Length of hospital stays
timeFrame: Through study completion, an average of 40 days
measure: Crying time
timeFrame: At the preterm infants 7 days of life
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Children's Hospital of Fudan University
name: Xiaojing Hu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02130908: A Study on the Possible Health Effects of Lean Fish, Fatty Fish and Lean Meat Intake in Non-obese Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Disorders
Obesity
Lead sponsor: University of Bergen
Sponsor class: OTHER
Collaborators: name: Bergen Medical Research Foundation
name: Skretting ASA
name: Leroy Seafood Group ASA
First posted: 2014-05-06
Enrollment: 45
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study is a pilot study to investigate whether intake of lean or fatty fish, or lean meat would affect parameters related to health in healthy non-obese adults, and will serve as basis for future calculation of group sizes in coming studies. Participants consumed 750g/week of fillets of fish or meat for 4 weeks.

Hypothesis:

High intake of either lean or fatty fish will not affect serum concentrations of lipids and inflammatory markers as well as improve glucose tolerance during the 4 week intervention period when compared to lean meat intake.


Eligibility criteria: Inclusion Criteria:

* adults
* non-obese
* healthy

Exclusion Criteria:

* diabetes
* diagnosed diseases of the intestine or cardiovacular system

Primary outcomes:
measure: Changes in metabolic parameters (lipids, glucose, inflammatory markers) measured in serum
timeFrame: Endpoint after 4 weeks intervention
Secondary outcomes:
measure: Changes in body weight
timeFrame: Endpoint after 4 weeks intervention
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
Study officials:
References:
Clinical trial NCT01963338: A Study to Assess the Acceptability and Usability of a New Device for Intradermal Vaccination
Official title: A Randomized Controlled Study to Assess the Acceptability and Usability of New Delivery Device for Intradermal Vaccination in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Vaccination Adverse Event
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
First posted: 2013-10-16
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study was to assess the acceptability and usability of a newly developed intradermal device in healthy adults


Eligibility criteria: Inclusion Criteria:

* healthy adults

Exclusion Criteria:

* people who have regular experience with needle injections, e.g. diabetic patients
* pregnant women

Primary outcomes:
measure: Acceptability (e.g. pain) of an injection with an intradermal vaccine delivery device compared to an intramuscular injection with syringe and needle
timeFrame: 1 day (directly after the injections)
measure: Adverse events after an injection with an intradermal delivery device and/or intramuscular injection with syringe and needle
timeFrame: during 5 days after the injections
Secondary outcomes:
measure: Usability (e.g. handling) of an injection with an intradermal vaccine delivery device compared to an intramuscular injection with syringe and needle
timeFrame: Within one day after administering the injections
Other outcomes:
Locations:
city: Wilrijk
country: Belgium
facility: University of Antwerp
state: Antwerp
Study officials:
affiliation: Universiteit Antwerpen
name: Pierre Van Damme, Prof.
role: STUDY_DIRECTOR
References:
citation: Van Mulder TJ, Verwulgen S, Beyers KC, Scheelen L, Elseviers MM, Van Damme P, Vankerckhoven V. Assessment of acceptability and usability of new delivery prototype device for intradermal vaccination in healthy subjects. Hum Vaccin Immunother. 2014;10(12):3746-53. doi: 10.4161/21645515.2014.979655.
Clinical trial NCT00243438: DaVinci Registry(Distinctly Assess Vision in Coronary Intervention)
Official title: Distinctly Access Vision In Coronary Interventions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Disease
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2005-10-24
Enrollment: 1300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diabetes and/or complex coronary artery disease who are treated with a Multi-Link Vision™ Stent.

Brief summary: Prospective Internet-Registry, Postmarketing-Surveillance, Registration and Follow-up of patients after Multi-Link VISION™ - Stent Implantation

Detailed description: A Non-Randomized prospective evaluation of the Multi-Link Rx Vision TM Coronary Stent System in the treatment of patients with De novo native coronary artery lesions

Eligibility criteria: Inclusion Criteria:

* Women and Men Age \>18 years, Intention to treat all stenosis with Multi-Link VisionTM Stents, documented patient consent

Exclusion Criteria:

* No Multi-Link Vision™ Stent implanted, life expectation \>9 M, cardiogenic shock, STEMI, NSTEMI or unstable angina pectoris with pathologic markers within the last 48 hours, intolerance of Clopidogrel/ Tiklopidin

Primary outcomes:
measure: TVF
timeFrame: 9 months
Secondary outcomes:
measure: Mode of death
measure: Time to first MI
measure: TVR
measure: CABG
Other outcomes:
Locations:
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik
Study officials:
affiliation: Kerckhoff-Klinik/ Benekestr. 2-8/ 61231 Bad Nauheim
name: Christian Hamm, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04664608: Pediatric EEG Monitoring
Official title: Evaluation of a Wireless EEG Monitor for Pediatric Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric ALL
Epilepsy
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2020-12-11
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children between the ages of 0 and 18 years of age who are prescribed an EEG while admitted to the pediatric intensive care unit (PICU) or Epilepsy Monitoring Unit (EMU)

Brief summary: The purpose of this study is to understand if a new, smart, wireless EEG developed by our team can be used to monitor the continuous electrical activity of the brain in the ICU and EMU and whether it works as well as the current standard, wired EEGs.

Detailed description: The investigators propose to 1) optimize these devices for use in pediatric ICU patients, 2) demonstrate safety, reliability, and accuracy of these devices for continuous ICU EEG signal measurements, and 3) demonstrate these devices are preferred by patients and parents to current EEG devices. Once validated, such sensors could fundamentally change the way patients are monitored by EEG in the ICU, allowing wireless, continuous, real-time detection of brain wave activity in ICU patients, reducing limitations in mobility as well as access by staff and caregivers to the patient, and ultimately offering opportunity to reduce morbidity and mortality in ICU patients.

Eligibility criteria: Inclusion Criteria:

* Participants must be admitted to the PICU or EMU at Lurie Children's and are prescribed an EEG as part of their standard of care.

Exclusion Criteria:

* Anyone with a skin abnormality that would potentially increase the risk of device use will be excluded.
* Ages 18 years or older.
* Any patient or family determined by an attending physician or bedside care team to be too unstable (patient) or experiencing too much stress (family) will not be approached for recruitment.

Primary outcomes:
measure: Percent Agreement
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
Study officials:
References:
Clinical trial NCT00153608: WT1 Peptid Vaccination in Carcinomas
Official title: Phase II Study of WT1 126-134 Peptide Vaccination in Combination With Adjuvants GM-CSF and KLH in Carcinomas
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: WT1 Expressing Carcinoma
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this trial HLA-A2+ patients with WT1 expressing carcinomas are vaccinated with a peptide from the leukemia associated antigen WT1 together with immunological adjuvants KLH as T-helper protein and GM-CSF


Eligibility criteria: Inclusion Criteria:

* Metastatic cancer, no standard treatment option
* Resected cancer with minimal residual disease, no standard treatment option
* WT-1 expression
* HLA-A2

Exclusion Criteria:

* Concurrent chemotherapy

Primary outcomes:
measure: Clinical efficacy
Secondary outcomes:
measure: Immune response
measure: Safety
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Hem&Onc Charité CBF
Study officials:
affiliation: Charité CBF
name: Ulrich Keilholz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Keilholz U, Menssen HD, Gaiger A, Menke A, Oji Y, Oka Y, Scheibenbogen C, Stauss H, Thiel E, Sugiyama H. Wilms' tumour gene 1 (WT1) in human neoplasia. Leukemia. 2005 Aug;19(8):1318-23. doi: 10.1038/sj.leu.2403817.
Clinical trial NCT02307708: Reeducation of Chronic Achilles Tendinopathy by Wearing Shoes Inclined Versus Reeducation by Kinesitherapy
Official title: Reeducation of Chronic Achilles Tendinopathy by Wearing Shoes Inclined Versus Reeducation by Kinesitherapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Tendinopathy
Rupture of Achilles Tendon
Chronic Disease
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2014-12-04
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study is to compare the treatment by wearing shoes inclined at kinesitherapy because it is the first treatment offered by primary care physicians in chronic Achilles tendinopathy.


Eligibility criteria: Inclusion Criteria:

* Age: 18-75 years
* Disease: chronic Achilles tendinopathy de novo or recurrent confirmed by ultrasound
* Patients having signed the informed consent for the study participation
* Patients covered by medical insurance
* Patients having no behavioral disorders

Exclusion Criteria:

* History of rupture of the Achilles tendon (= stage 4)
* Antibiotic treatment tendinotoxique (Quinolones, ...)
* Inability to walk more than 30 minutes per day.
* Haglund Syndrome
* Treatment of tendinopathy or being older than six months
* Minors
* Major trust

Primary outcomes:
measure: Evolution of the American Orthopaedic Foot and Ankle Score (AOFAS)
timeFrame: at Day 0 and 12 weeks
Secondary outcomes:
measure: Evolution of amplitude to the tibio-tarsal
timeFrame: at 12 weeks
measure: Pain Scores on the Visual Analog Scale
timeFrame: at 12 weeks
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU de Nantes
city: Nantes
country: France
facility: Nouvelles cliniques Nantaises
Study officials:
affiliation: Nantes University Hospital
name: Bertrand Rousseau
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02773108: Somatic Comorbidities in Psychiatric Patients
Official title: Somatic Comorbidities in Psychiatric Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Major Depression Disorder
Bipolar Affective Disorder
Lead sponsor: Sveti Ivan Psychiatric Hospital
Sponsor class: OTHER
First posted: 2016-05-16
Enrollment: 1061
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Psychiatric patients

Brief summary: Prevalence of somatic comorbidities in psychiatric patients hospitalized in Psychiatric hospital or treated ambulatory or in daily hospital. Comparison of prevalence of somatic comorbidities in psychiatric patients population and the general Croatian population.


Eligibility criteria: Inclusion Criteria:

* treatment in psychiatric hospital

Exclusion Criteria:

* acute suicidality
* dementia
* mental retardation
* acute psychosis
* intoxication
* inability to answer the questionnaire by themselves

Primary outcomes:
measure: Prevalence of somatic comorbidities
timeFrame: 12 months
Secondary outcomes:
measure: Clinical Global Impression- Improvement scale (CGI-I), Change from diagnosis
timeFrame: from baseline to 12 months
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: PB Sveti Ivan
Study officials:
References:
citation: Jelec V, Bajic Z, Simunovic Filipcic I, Portolan Pajic I, Sentija Knezevic M, Miloloza I, Radic-Kristo D, Benjak T, Jaksic N, Sagud M, Wang W, Filipcic I. Utilization of somatic healthcare in Croatian patients with schizophrenia spectrum disorder, major depression, PTSD and the general population. BMC Psychiatry. 2019 Jun 28;19(1):203. doi: 10.1186/s12888-019-2190-8.
Clinical trial NCT04454008: RCT of EF Family Training for P ADHD
Official title: Executive Functioning Family Training for Preschool Children With Attention Deficit Hyperactivity Disorder - a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ADHD
Keywords: ADHD
executive function
preschool
intervention
RCT
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2020-07-01
Enrollment: 100
Sex: ALL
Minimum age (years): 48
Maximum age (years): 71
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To explore the effect of executive function family training for preschool children with ADHD, providing early social psychological intervention for aiming the core impairments of ADHD.

Detailed description: 100 preschool children with ADHD will be randomly divided into the intervention group and the waiting group. The waiting group received regular clinical intervention, while the intervention group received 12-week training. The intervention program includes executive function training for ADHD children and parenting guidance for parents by two therapists respectively, which were carried out in two meeting rooms in Xinhua Hospital. Therapists are psychiatrists with a background in child psychiatry and psychotherapists with training in ADHD area. After 12 weeks, the improvement of ADHD core symptoms and executive function was compared.

Eligibility criteria: Inclusion Criteria:

* Meet the diagnostic criteria for preschool ADHD, based on the the DSM-5 criteria by the attending physician or above;
* Age 4 months 0 to 5 years 11 months;
* Total IQ is above 80 assessed by WPPSI.

Exclusion Criteria:

* Attention deficit disorders resulting from organic neurological diseases, extensive developmental disorders, mental retardation, childhood schizophrenia, mood disorders, epilepsy, and other organic diseases or other primary mental disorders;
* parent or guardian with a serious mental illness, such as schizophrenia, mood disorder (onset), etc., and Educational level is lower than junior middle school;
* Participants who failed to attend more than 80% of the intervention sessions (at least 9 sessions).

Primary outcomes:
measure: ADHD core symptoms
timeFrame: 12 weeks after baseline
Secondary outcomes:
measure: Executive function-Inhibition
timeFrame: 12 weeks after baseline
measure: Executive function-working memory
timeFrame: 12 weeks after baseline
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xinhua Hospital
Study officials:
affiliation: Director of department of psychology, xinhua hospital
name: Jinsong Zhang, Doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02563808: Impact of Anticipated Regret Incorporation Into Patient Decision Aids
Official title: Impact of Anticipated Regret on Decision-Making in Preference Sensitive Care for Breast and Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Regret
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2015-09-30
Enrollment: 189
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to investigate the impact of incorporating "anticipated regret " into standard patient decision aids. Participants in the Wharton Behavioral Lab will be administered a standard patient decision aid and an "anticipated regret" augmented decision aid. Participants will complete a computerized survey about their experiences with each version, and their answers will be assessed for potential differences associated with the incorporation of "Anticipated Regret."

Detailed description: Participants will be recruited through the Wharton Behavioral Lab. Upon arrival males will be provided with two decision aids focusing on prostate cancer, while females will be provided with two decision aids focusing on early breast cancer. One of these decision aids will be a standard version, and one of these will be the anticipated regret-augmented version. Participants will be randomized to which version they receive first to minimize the effect of presentation order. After reviewing the materials, participants will immediately complete a computerized survey at their work stations that will ask them to answer questions based on the materials presented as well as how any hypothetical treatment decisions they would be asked to make would have been influenced by them. Because these are healthy subjects participating in a hypothetical decision-making process for sole purpose of research, the intervention can neither be categorized as experimental or as the standard of care.

Eligibility criteria: Inclusion Criteria:

* Healthy females ages 18 years or older

Exclusion Criteria:

* Under age 18 years

Primary outcomes:
measure: Difference in Consideration of Regret
timeFrame: 11 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: UPenn, Chairman, Anesthesiology & Critical Care
name: Lee Fleisher, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Speck RM, Neuman MD, Resnick KS, Mellers BA, Fleisher LA. Anticipated regret in shared decision-making: a randomized experimental study. Perioper Med (Lond). 2016 Mar 2;5:5. doi: 10.1186/s13741-016-0031-6. eCollection 2016.
Clinical trial NCT03355508: Impact of the Arteriovenous Fistula Puncture Technique On the Hemodialysis Session For Patient and Caregiver
Official title: Impact of the Arteriovenous Fistula Puncture Technique On the Hemodialysis Session For Patient and Caregiver
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Arterio-venous Fistula, Puncture, Chronic Desease
Lead sponsor: Poissy-Saint Germain Hospital
Sponsor class: OTHER
First posted: 2017-11-28
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: 40000 patients are hemodialysis each year in France .

In the case of chronic care, 78% of patients have an arteriovenous fistula. In order to perform the hemodialysis session, 2 techniques of puncture of the fistula are possible:

* Bevel puncture upwards then flipping the needle
* or puncture bevel down. At present, there is no consensus or study on the technique of puncture fistula which generates different professional practices.


Eligibility criteria: Inclusion Criteria:

* Patient in chronic renal failure treated by hemodialysis with native arteriovenous fistula as a vascular approach.
* Adult of age and sex indifferent.
* Normal puncture of the fistula with two needles (bipuncture).
* Fistula use for more than 3 months.
* Beneficiary of Medicare or State Medical Aid.
* No opposition to participation in the study.

Exclusion Criteria:

* Patient who does not speak and does not understand French.
* Hemodialysis patient awaiting a transplant by a living donor.
* Patient with more than 2 AVF dilatations in the last 6 months.
* Patient with prosthetic arteriovenous fistula.

Primary outcomes:
measure: Compression time required for hemostasis
timeFrame: period of 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Poissy
country: France
facility: CH Poissy st Germain
Study officials:
References: