louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06528106: Removal of Erroneous Penicillin Allergy Labels: Implementation Study (REPeAL)
Official title: Removal of Erroneous Penicillin Allergy Labels: Implementation Study (REPeAL)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Penicillin Allergy
Lead sponsor: Royal Cornwall Hospitals Trust
Sponsor class: OTHER
First posted: 2024-07-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult (\>16) patients admitted to hospital over the study period with a penicillin allergy record preventing first line antibiotic use.

Brief summary: To test the implementation of penicillin allergy de-labelling delivered by the responsible clinical teams and the antimicrobial stewardship teams across all medical, surgical and critical care specialities in a UK hospital using the developed toolkit and a validated penicillin allergy decision support tool.

Detailed description: Aim:

To test implementation of the penicillin allergy de-labelling complex intervention in surgical, medical and critical care patient pathway.

Objectives:

* To use the Institute for Health Improvement (IHI) Model for Improvement methodology to implement the penicillin allergy de-labelling complex intervention in each setting (surgery, medicine, critical care)
* To measure the number of patients meeting inclusion criteria (\>16 with a penA not prescribed first line antibiotics) who have had their penicillin allergy record assessed by the wider clinical teams and separately by the AMS team.
* To measure the patient uptake of penicillin allergy record removal (i.e. the rate of patient declining de-label / DOC).

To interview 10-15 patients and 10-15 healthcare workers to gain insight into the penicillin allergy de labelling process.

Eligibility criteria: Inclusion Criteria:

All adult (\>16) patients admitted to hospital over the study period with a penicillin allergy record preventing first line antibiotic use.

Exclusion Criteria:

None

Primary outcomes:
measure: The proportion of patients admitted to adult medical, surgical and critical care specialities with a penicillin allergy record, where the allergy record is preventing first line antibiotic therapy, that are safely de-labelled.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital
state: Cornwall
Study officials:
References:
Clinical trial NCT00005406: Change in Coronary Heart Disease Risk Factors in Young Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Coronary Disease
Heart Diseases
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To prospectively examine changes in lipids, lipoproteins, and blood pressure among 295 young adults who had been followed for sixteen years in the Beaver County Lipid Study. The Beaver County Lipid Study tracked the cholesterol values of 295 children, ages 11 to 14 at baseline.

Detailed description: BACKGROUND:

Epidemiologic studies of coronary risk factors have been performed primarily in populations of middle-aged adults, children, and adolescents. Relatively little is known about these risk factors in men and women 20-29 years of age.

This study provided important insights into the determinants of coronary heart disease risk factors in young adults and bolstered the argument of those who favor the early identification of and intervention in the young coronary candidate.

DESIGN NARRATIVE:

Three cross-sectional examinations had been carried out: 1) 1972-1973; 2) 1980-1981; and 3) 1988-1989. The study examined the predictors of change in total cholesterol (from examination 1 to examination 3, and change in LDL-C, HDL-C, and triglycerides between examinations 2 and 3. It also investigated the stability in several health habits and behaviors such as cigarette smoking, alcohol use, adherence to a low fat/low cholesterol diet, and physical activity. Weight gain and oral contraceptive use had been shown in previous analyses to be strong predictors of several lipids and lipoproteins.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00542906: Functional Organization of Somatosensory Responses in the Secondary Somatosensitive Area and Insula
Official title: Functional Organization of Somatosensory Responses in the Secondary Somatosensitive Area (SII) and Insula : an fMRI Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: healthy volunteers
Somatosensory stimuli
fMRI
second somatosensory area
insular cortex
functional anatomy
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2007-10-12
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The implication of the second somatosensory area (SII) and the insular cortex in the processing of somatosensory inputs is now well established. However the functional anatomy of these areas hidden in the depth of the sylvian scissure remain mostly unknown.

The aim of this fMRI study is to determine the functional cartography of SII and insula. The localization of responses to different somatosensory stimuli (slight touch, warm, cold, heat pain and arthrokinesia) applied on the left hand of 25 healthy volunteers, will be compared.

Detailed description: Aims : Demonstrate that localization of the several types of somatosensory stimuli is different into SII and into insula. If possible, we'll determine a functional cartography of these areas.

Eligibility criteria: Inclusion Criteria:

* 25 healthy volunteers will be included ranging in age from 18 to 50 years
* contraception needed for women
* right handed
* All the subjects have to give their written informed consent.

Exclusion Criteria:

* pregnancy
* neurological or psychiatric disease
* drugs taken \<12h before fMRI
* contra-indications to fMRI : pacemaker, clip, metallic device
* Refusing to be informed of the presence of a cerebral abnormality, detected during MRI.

Primary outcomes:
measure: Comparison of euclidian distances between the centroids of clusters activations for the different types of stimulations into SII and insula.
timeFrame: one day
Secondary outcomes:
measure: Determine the Talairach coordinates of the centroids of clusters of activations for the different types of somatosensory stimuli into SII and insula
timeFrame: one day
Other outcomes:
Locations:
city: Saint-Etienne
country: France
facility: Service de Neurologie - CHU de Saint-Etienne
Study officials:
affiliation: CHU de Saint-Etienne
name: Laure Mazzola, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mazzola L, Isnard J, Mauguiere F. Somatosensory and pain responses to stimulation of the second somatosensory area (SII) in humans. A comparison with SI and insular responses. Cereb Cortex. 2006 Jul;16(7):960-8. doi: 10.1093/cercor/bhj038. Epub 2005 Sep 21.
citation: Peyron R, Schneider F, Faillenot I, Convers P, Barral FG, Garcia-Larrea L, Laurent B. An fMRI study of cortical representation of mechanical allodynia in patients with neuropathic pain. Neurology. 2004 Nov 23;63(10):1838-46. doi: 10.1212/01.wnl.0000144177.61125.85.
Clinical trial NCT01040806: Peer Coaching for Low-Income Patients With Diabetes in Primary Care
Official title: Peer Coaching for Low-Income Patients With Diabetes in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Type 2
Keywords: Diabetes
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: American Academy of Family Physicians
First posted: 2009-12-30
Enrollment: 300
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: Patients with diabetes who are counseled by a peer coach (another patient with diabetes) will have improved glycemic control compared with usual care patients.

Detailed description: Peer coaches have controlled diabetes, patient study subjects have poorly controlled diabetes.

Eligibility criteria: Inclusion Criteria:

* Diabetes with most recent HbA1c 8 or above in past 6 months.

Exclusion Criteria:

* Dementia,
* Life expectancy less than 6 months,
* Inability to speak English or Spanish.

Primary outcomes:
measure: HbA1c level
timeFrame: 6 months
Secondary outcomes:
measure: LDL cholesterol level
timeFrame: 6 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco General Hospital
state: California
Study officials:
affiliation: University of California, San Francisco
name: Thomas Bodenheimer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ghorob A, Vivas MM, De Vore D, Ngo V, Bodenheimer T, Chen E, Thom DH. The effectiveness of peer health coaching in improving glycemic control among low-income patients with diabetes: protocol for a randomized controlled trial. BMC Public Health. 2011 Apr 1;11:208. doi: 10.1186/1471-2458-11-208.
citation: Thom DH, Ghorob A, Hessler D, De Vore D, Chen E, Bodenheimer TA. Impact of peer health coaching on glycemic control in low-income patients with diabetes: a randomized controlled trial. Ann Fam Med. 2013 Mar-Apr;11(2):137-44. doi: 10.1370/afm.1443.
Clinical trial NCT02132806: Piezosurgery in the Treatment of Class II Furcation Involvement
Official title: Piezosurgery in the Treatment of Class II Furcation Involvement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Furcation Defects
Keywords: class II furcation involvement
piezoelectric surgery
regeneration
biomaterial
Lead sponsor: University of Trieste
Sponsor class: OTHER
First posted: 2014-05-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness of piezosurgery in the treatment of class II furcation involvement using biomaterials and new surgical techniques


Eligibility criteria: Inclusion Criteria:

* previous subgingival instrumentation with adequate plaque control (FMPS \< 20%) and bleeding on probing (FMBS \< 20%).
* one or more mandibular molar with buccal class-II furcation involvement

Exclusion Criteria:

* diabetes mellitus
* pregnancy and lactation period
* subjects smoking \> 10 cigarettes/day were excluded
* subjects in chronically treatment with calcium antagonist, immunosuppressive drugs and Antiepileptic Drugs

Primary outcomes:
measure: Horizontal probing depth (PH)
timeFrame: 180 days
Secondary outcomes:
measure: Plaque index (PI)
timeFrame: 180 days
measure: Bleeding on probing (BoP)
timeFrame: 180 days
measure: Pocket probing depth (PPD)
timeFrame: 180 days
measure: Furcation closure (FC)
timeFrame: 180 days
measure: Clinical attachment level (CAL)
timeFrame: 180 days
Other outcomes:
Locations:
city: Trieste
country: Italy
facility: Matteo Visintin
state: TS
Study officials:
affiliation: UCO Clinica Odontoiatrica e Stomatologica - Ospedale Maggiore Trieste
name: Matteo Visintin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05300906: The Effectiveness of Engagement-based Personalization of a Digital Mental Health Intervention
Official title: The Effectiveness of Engagement-based Personalization of a Two-week Digital Mental Health Intervention Targeting Wellbeing: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Well-being
Lead sponsor: University of Twente
Sponsor class: OTHER
First posted: 2022-03-29
Enrollment: 200
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: participants are randomized to either the personalized or the non-personalized intervention.
Primary purpose: PREVENTION

Brief summary: This study will investigate the effectiveness of an engagement-based personalized 2-week mobile wellbeing intervention, vs the effectiveness of a non-personalized 2-week mobile wellbeing intervention.


Eligibility criteria: Inclusion Criteria:

* at least mild depressive or anxiety complaints; \>4 Generalized Anxiety Disorder 7-item scale OR Patient Health Questionnaire 9-item scale
* access to smartphone with internet
* adequate English literacy

Exclusion Criteria:

* none

Primary outcomes:
measure: Change from baseline in wellbeing, measured with the Mental Health Continuum Short Form, at 3 weeks.
timeFrame: baseline, 3 weeks
measure: Change from baseline in depressive symptoms, measured with the Patient Health Questionnaire-9, at 3 weeks.
timeFrame: baseline, 3 weeks
measure: Change from baseline in anxiety symptoms, measured with the Generalized Anxiety Disorder 7-item scale, at 3 weeks.
timeFrame: baseline, 3 weeks
Secondary outcomes:
measure: Adherence
timeFrame: after 3 weeks
measure: Engagement, measured with the TWente Engagement with Ehealth Technologies Scale.
timeFrame: after 1 day
measure: Engagement, measured with the TWente Engagement with Ehealth Technologies Scale.
timeFrame: after 7 days
measure: Engagement, measured with the TWente Engagement with Ehealth Technologies Scale.
timeFrame: after 3 weeks
measure: Change from baseline in wellbeing, measured with the Mental Health Continuum Short Form, at 8 weeks.
timeFrame: baseline, 8 weeks
measure: Change from baseline in depressive symptoms, measured with the Patient Health Questionnaire-9, at 8 weeks.
timeFrame: baseline, 8 weeks
measure: Change from baseline in anxiety symptoms, measured with the Generalized Anxiety Disorder 7-item scale, at 8 weeks.
timeFrame: baseline, 8 weeks
Other outcomes:
Locations:
city: Enschede
country: Netherlands
facility: University of Twente
Study officials:
affiliation: University of Twente
name: Saskia M Kelders, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02213406: Neuronal and Sensory Perception of Fat
Official title: Fat and the Brain-Neuronal and Sensory Fat Perception
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fat Perception in the Brain
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2014-08-11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This project will examine neuronal and sensory fat perception. Our hypothesis is that subjects being either hypersensitive or hyposensitive for fat will show different brain activities. Therefore the investigators will conduct functional magnetic resonance imaging (fMRI) and fat detection threshold tests examining neuronal and sensory fat perception.


Eligibility criteria: Inclusion Criteria:

* healthy

Exclusion Criteria:

* lactose intolerance
* fMRI contraindications (metal implants,...)

Primary outcomes:
measure: Fat detection thresholds
timeFrame: each measurement day
Secondary outcomes:
measure: Brain activity
timeFrame: pre and post meal intake
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: University Clinic of Tuebingen, fMEG Center
Study officials:
References:
Clinical trial NCT05193006: Assessment of Histologic Prognostic Factors in Peritoneal Malignant Mesothelioma
Official title: Assessment of Histologic Prognostic Factors in Peritoneal Malignant Mesothelioma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Peritoneal Malignant Mesothelioma
Keywords: prognostic factors
peritoneal malignant mesothelioma
mesothelioma
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2022-01-14
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: squamous cell carcinoma of the oropharynx

Brief summary: Malignant peritoneal mesothelioma is a rare neoplasm. The most common type, the epithelioid type, has been further divided into histological patterns of tubulo-papillary, acinar, adenomatoid, micropapillary, or solid. Its prognosis is improved by the use of a locoregional treatment combining extensive cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC), which increases survival up to 50 months. Histology is one of the most important prognostic variable that, forms the basis for treatment decisions. However, the prognostic of the epithelioid type varies greatly due to its tumor heterogeneity. It is therefore necessary to find prognostic factors of malignant epithelioid peritoneal mesothelioma in order to better define the therapeutic strategy. Among histological factors, solid growth, tumor necrosis, nuclear atypia, and mitotic count were found to be independent prognostic factors in epithelioid malignant pleural mesothelioma. However, in epithelioid malignant peritoneal mesothelioma (EMPM), these factors were studied in small and heterogeneous series in terms of histological growth and definitions used for histological factors. The present large study was conducted to investigate the prognostic impact of several histologic factors in EMPM. Their prognosis impacts were assessed using overall survival (OS) and progression-free survival (PFS) in EMPM.


Eligibility criteria: Inclusion Criteria:

* - peritoneal malignant mesothelioma

Exclusion Criteria:

* opposition to reuse personnal data

Primary outcomes:
measure: Assessment of pronostic impact of nuclear grade in comparison with combined grade in peritoneal malignant mesothelioma
timeFrame: 3 months to 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: UZ Gent
city: Pierre-Bénite
country: France
facility: University Hospital of Lyon
city: Tübingen
country: Germany
facility: Institut f. Pathologie und Neuropathologie
city: Ahmedabad
country: India
facility: Zydus Hospitals
city: Oslo
country: Norway
facility: The Norwegian Radium Hospital
city: Lisboa
country: Portugal
facility: Fundação Champalimaud
Study officials:
References:
Clinical trial NCT06962306: Optimizing Perioperative Analgesia to Lower Pain Following Cleft Palate Surgery
Official title: Perioperative Methadone Use for Cleft Palate Repair: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Cleft Palate
Pain
Postoperative Care
Perioperative Care
Children
Keywords: Cleft palate surgery
Perioperative pain management
Analgesia
Methadone
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2025-05-08
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the use of short acting opioids (fentanyl/hydromorphone) with long acting opioids (methadone) for pain control following cleft palate surgery in infants and young children.

Detailed description: This is a single center, randomized, double blind, parallel-group dose escalation investigation in infants and children undergoing cleft palate surgery which will compare post operative pain control indices for patients receiving short acting versus long acting opioids as perioperative analgesics. Surgical and anesthesia care, except for opioid management, are not altered for study purposes. Subjects are randomized 2:1 to either long-duration (methadone) or short-duration opioid (fentanyl, hydromorphone) through the perioperative period. Exploratory data will be collected for up to 30 days post-operatively.

Eligibility criteria: Inclusion Criteria:

* Age 6 months to 4 years of age
* Primary cleft palate repair
* Signed informed consent by parent or legal guardian

Exclusion Criteria:

* History of chronic kidney or liver disease
* Planned admission to the Pediatric Intensive Care Unit (PICU)
* Additional procedures under general anesthesia for which opioids would be prescribed
* Any patient ineligible for study participation at the discretion of the investigators

Primary outcomes:
measure: Total amount of opioids medication administered
timeFrame: From PACU discharge through postoperative day 1 (POD1)
Secondary outcomes:
measure: Total amount of opioid medications administered
timeFrame: Up to 7 days after surgery
measure: Postanesthesia Care Unit (PACU) opioid medication administration
timeFrame: Up to 6 hours after surgery
measure: Area under the curve (AUC) pain trajectories
timeFrame: Through hospital discharge (up to 4 days)
measure: Average daily pain intensity
timeFrame: Up to 7 days after surgery
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Lisa M. Einhorn, M.D.
role: PRINCIPAL_INVESTIGATOR
References: