louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06414694: Inpatient Penicillin Delabeling for Low-Risk Patients
Official title: Inpatient Penicillin Delabeling for Low-Risk Patients
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE4
Conditions: Penicillin
Drug Allergy
Lead sponsor: University of Tennessee
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 25
Sex: ALL
Minimum age (years): 2
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study seeks to enroll patients admitted to a children's hospital with identified penicillin allergy. A screening checklist is performed to identify patients with very low or low risk histories of penicillin allergy to offer direct oral challenges to the antibiotic class to de-label patient's with drug allergies.

Detailed description: This is a pilot study looking to utilize a novel criterion to identify low risk penicillin allergies for patients admitted to a children's hospital to evaluate safety and efficacy of direct oral challenges to patients with very low or low risk histories as identified in novel criterion.

Eligibility criteria: Inclusion Criteria:

* Patients \>2 years
* Patients identified via EMR as having a penicillin, amoxicillin, amoxicillin/clavulanic acid allergy

Exclusion Criteria:

* Female patients aged \>8 years of age
* Patients with hemodynamic instability
* Patients identified with moderate or high risk histories per protocol
* Patients currently taking oral antihistamines in 48 hours prior to direct challenge
* Patients currently taking oral steroids in 48 hours prior to direct challenge
* Patients currently receiving medications for nausea, shortness of breath,

Primary outcomes:
measure: Direct Oral Challenge
timeFrame: 2 hours
Secondary outcomes:
measure: Follow-up at 48
timeFrame: 48 hours
measure: Follow-up at 6 months
timeFrame: 6 months
Other outcomes:
Locations:
city: Memphis
country: United States
facility: University of Tennessee Health Science Center
state: Tennessee
Study officials:
References:
Clinical trial NCT00877994: Nurture: A Program for Mothers With Histories of Disordered Eating
Official title: Breaking the Cycle of Risk: Intervention for Mothers With Eating Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eating Disorders
Keywords: Disordered Eating
Parenting
Mothers
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2009-04-08
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Nurture is a collaborative pilot study for mothers of children under the age of 3 who have suffered from disordered eating in the past. It is coordinated by the University of North Carolina at Chapel Hill, Duke University and Virginia Commonwealth University and sponsored by the National Institute of Mental Health. Nurture hopes to promote confident parenting and a positive meal times.

Detailed description: Mothers who have struggled with disordered eating or body image struggles are often concerned how best to provide proper nutrition to their child and/or model healthy eating behavior. We have developed a curriculum that provides information about how to establish healthy eating patterns and social support for mothers with children under three years of age. The curriculum will be delivered in a support group format led by co-therapists affiliated with the UNC Eating Disorder Program.

Eligibility criteria: Inclusion Criteria:

* Has met lifetime DSM-IV criteria for anorexia nervosa (AN), bulimia nervosa (BN), or eating disorder not otherwise specified (EDNOS: including subthreshold AN, BN, and purging disorder, but excluding BED)
* BMI \> 18.5 maintained for at least three months
* Has not met threshold criteria for AN or BN in the previous 28 days according to the Eating Disorders Examination, although subthreshold status or active residual symptomatology will not preclude entry
* Age 18 or older
* Has a child between the ages of 1 month and 2 years, 12 months old

Exclusion Criteria:

* Alcohol or drug dependence in the past year
* Current significant suicidal ideation reported during the assessment or on the BDI-II at baseline
* Developmental disability that would impair the ability of the participant to benefit from the intervention
* Psychosis, including schizophrenia, or bipolar I disorder
* Any families who have been the subject of social service inquiries

Primary outcomes:
measure: Parenting self-efficacy
timeFrame: 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Cynthia Bulik, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Nancy Zucker, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Virginia Commonwealth University
name: Suzanne Mazzeo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01390194: Rapid 10-Minute Liver MRI Protocol in Patients With Suspected Hepatocellular Carcinoma
Official title: Rapid 10-Minute Liver MRI Protocol in Patients With Suspected Hepatocellular Carcinoma: A Pilot Study to Assess the Image Quality (Multitransmit Body MRI Program)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Underlying Liver Disease
Hepatitis
Fibrosis of Liver
Cirrhosis With Suspicion of Liver Cancer
Lesion on a Prior Ultrasound, CT or Outside MRI
Keywords: liver disease
hepatocellular carcinoma
Lead sponsor: University of Nebraska
Sponsor class: OTHER
Collaborators: name: Philips Medical Systems
name: Bracco Diagnostics, Inc
First posted: 2011-07-08
Enrollment: 25
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with an underlying liver disease

Brief summary: The purpose of this study to assess the image quality of the rapid magnetic resonance imaging (MRI) compared to the standard MRI.

Detailed description: This is a pilot study to compare a rapid 10-minute liver magnetic resonance imaging (MRI) protocol to standard MRI in participants with suspected hepatocellular carcinoma.

Eligibility criteria: Inclusion Criteria:

1. underlying liver disease
2. have a lesion on a prior imaging study
3. must have prior standard MR

Exclusion Criteria:

1. Contra-indication for MR imaging including pacemaker, claustrophobia, pregnancy, electronic or vascular devices that are contraindicated;
2. patients with severe kidney dysfunction

Primary outcomes:
measure: image quality outcome
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Shahid Hussain, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04676594: Genentech Validation Tool for Pulmonary Fibrosis
Official title: Validation of a Radiologic Tool for Diagnosing Pulmonary Fibrosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Interstitial Lung Disease
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2020-12-21
Enrollment: 400
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of usual interstitial pneumonitis, Chronic hypersensitivity pneumonitis or nonspecific interstitial pneumonitis and a chest CT scan.

Brief summary: Radiology is an important component of the multidisciplinary team. The primary goal of this project will be to create a tool using findings on chest computed tomography (CT) for nearly 300 patients with the most common types of fibrosis. The tool will be tested using chest CT scans of an additional 100 patients with the 3 most common diagnoses of fibrosis. The second objective will be to further validate the tool by performing a reader study with 3 co-investigating radiologists and ask them to look at 100 CT scans of patients with fibrosis without tool and then with tool and see if accuracy of diagnosis improves compared to the working diagnosis when using the tool.


Eligibility criteria: Inclusion Criteria:

* Retrospective review of adults (age \> 21) with diagnosis of pulmonary fibrosis on chest CT and a pulmonologist report in electronic medical record confirming the working diagnosis from 1/1/2010 through 7/1/2019.

Exclusion Criteria:

* Failure to meet inclusion criteria including age \< 21 and lack of a pulmonologists report in the medical record with a working diagnosis of patient's type of pulmonary fibrosis.

Primary outcomes:
measure: Associations Between Patterns for CT Scan Features
timeFrame: Up to 6 months
Secondary outcomes:
measure: Cumulative Number of Accurate General Radiologist's Diagnoses of Fibrosis Type Without Diagnostic Tool
timeFrame: Up to 6 months
measure: Cumulative Number of Accurate General Radiologist's Diagnoses of Fibrosis Type With Diagnostic Tool
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Mary Salvatore, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00368394: Dose-Exposure-Response in Type 1 Diabetes Mellitus
Official title: Dose-Exposure-Response Relationship of Insulin Glulisine (HMR1964) in Subjects With Type 1 Diabetes Mellitus Assessed With the Euglycemic Clamp Technique Using the Biostator (TM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type I
Keywords: Insulin glulisine
Euglycaemic clamp
Diabetes mellitus Type 1
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-08-24
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To investigate the dose-exposure-response relationship of insulin glulisine (HMR1964) after single subcutaneous injections of 0.075, 0.15 and 0.3 U/kg body weight with the euglycaemic clamp technique using the Biostator (TM).


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes mellitus

Exclusion Criteria:

-

Primary outcomes:
measure: Outcome measures: Glucose infusion rate, insulin concentrations.
measure: Outcome:In T1DM, glulisine, like RHI, displays dose proportionality in exposure over the dose range 0.075 to 0.3 U/kg, which partly only translates into dose proportionality in glucodynamics.
Secondary outcomes:
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Sanofi-Aventis
Study officials:
affiliation: Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany
name: Klaus Rave Dr, med
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02708394: Molecular Mechanisms of Antipsychotic-induced Insulin Resistance
Official title: Molecular Mechanisms of Antipsychotic-induced Insulin Resistance in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Adverse Effect of Other Antipsychotics and Neuroleptics
Insulin Resistance
Lead sponsor: Wayne State University
Sponsor class: OTHER
First posted: 2016-03-15
Enrollment: 31
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study will investigate the molecular mechanisms of atypical-antipsychotic induced insulin resistance. This will be accomplished by administering olanzapine or placebo to healthy subjects for 7 days and analyzing genetic and protein changes in peripheral tissues known to play an important role in insulin resistance pathophysiology.


Eligibility criteria: We will include persons that meet the following criteria:

1. 21-45 years old
2. BMI 18.5-24.9kg/m2
3. No history of drug or alcohol dependence or abuse
4. No current or past history of psychiatric or neurologic disease
5. minimal exercise routine prior or during study (light walking allowed)
6. Normal liver function tests
7. minimal alcohol intake (\<1 drink per day).

The following persons will be excluded:

1. Has 1st degree relative with diabetes (I or II)
2. current or re-cent nicotine intake
3. presence of organic/physical disease that could affect glucose
4. currently taking prescription or over-the-counter medications that could affect glucose
5. currently pregnant or lactating
6. unwilling to take acceptable birth control method
7. current or previous exposure to antipsychotics
8. history of unstable weight
9. personal or family history of cardiac arrhythmias or seizures
10. current or past history of eating disorder(s) or restricted diet
11. allergy to lidocaine or drug excipients
12. history of difficulty with intravenous line placement
13. history of fainting.

Primary outcomes:
measure: Change in DNA methylation
timeFrame: Baseline (day 1) to endpoint of intervention (day 7)
Secondary outcomes:
measure: Change in protein levels
timeFrame: Baseline (day 1) to endpoint of intervention (day 7)
measure: Change in protein activity
timeFrame: Baseline (day 1) to endpoint of intervention (day 7)
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Wayne State University Clinical Research Center
state: Michigan
Study officials:
References:
Clinical trial NCT02926794: Reducing College Student Drinking by Integrating Self-Affirmation and Implementation Intentions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Drinking
Lead sponsor: University of California, Santa Barbara
Sponsor class: OTHER
First posted: 2016-10-06
Enrollment: 293
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

Brief summary: Two hundred and ninety-three college students who reported drinking in the past month were randomly assigned to condition in a 2 (self-affirmation: values vs. control writing task) x 2 (implementation intentions: formed vs. not formed) between-subjects factorial design. Participants first completed a self-affirmation or control writing task, then read an article describing the risks of drinking. Next, all participants reported their common drinking behaviors and contexts, and then selected two harm-reduction strategies making either general intentions to use the strategies or making implementation intentions to use the strategies. Alcohol consumption was measured 1 and 2 weeks after the experimental session.


Eligibility criteria: Inclusion Criteria:

* Must have reported drinking at least 1 drink in the last 30 days at time of first participation.

Exclusion Criteria:

-

Primary outcomes:
measure: Alcohol consumption
timeFrame: Past week drinking
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Ehret PJ, Sherman DK. Integrating Self-Affirmation and Implementation Intentions: Effects on College Student Drinking. Ann Behav Med. 2018 Jul 13;52(8):633-644. doi: 10.1093/abm/kax032.
Clinical trial NCT02899494: Effect of the "Adjusted Vocal Expression" Method on the Satisfaction of Parturients About Their Childbirth
Official title: Effect of the "Adjusted Vocal Expression" Method on the Satisfaction of Parturients About Their Childbirth (NaîtreEnchanté)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2016-09-14
Enrollment: 251
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To emit voluntarily sounds mastered during the childbirth is a practice found in certain cultures of country of Africa or Muslim or gypsy traditions. Today, because of the medical coverage and because of the childbirth in a hospital environment, this tradition is not anymore transmitted.

The emission of a sound vibration conjugated to a positive intention managed during the childbirth was experimented with around thirty mothers. In the term of this pilot study, most of the women expressed one felt very positive towards the new method, in particular when they compared it with a previous childbirth where this method was not used.

During these childbirths, the midwives also indicated a shortening of the working time.

The present study aim essentially is to confirm the positive effect of the method on the felt of the childbirth.


Eligibility criteria: Inclusion Criteria:

* Women of more than 18 years old
* Primipara
* Patients joining the antenatal classes dispensed by the midwives.
* Patients affiliated to a national insurance scheme or benefiting from such a diet
* Patients having given a written consent form

Exclusion Criteria:

* None

Primary outcomes:
measure: Childbirth Perception Questionnaire (CPQ) score
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pertuis
country: France
facility: Maternité Catherine BARET de Pertuis
city: Suresnes
country: France
facility: Hopital Foch
Study officials:
affiliation: Hopital Foch
name: Jean-Marc AYOUBI, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06929494: Candidemia in Critically Ill Patients
Official title: Candidemia in Critically Ill Patients: Risk Factors and Predictive Factors
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Sepsis
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2025-04-16
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the ICU from January 2014 to December 2024 and had at least one positive blood culture for candidemia

Brief summary: Candidal sepsis (candidemia) is a criticals problem in patients hospitalized in the intensive care unit, with a significant impact on morbidity and mortality. Risk factors for candidemia in intensive care patients included age, presence of a central venous catheter, inpatient surgery, and administration of parenteral nutrition (TPN). Mortality in patients with candidemia is estimated at 50-60%. Early identification and treatment, including control of the source of infection, are essential to improve morbidity and mortality in these patients.

In this study, we would like to identify risk factors for the development of candidemia in intensive care patients, including those who have not undergone abdominal surgery, and to examine what percentage of patients who developed candidemia were given empirical antifungal therapy and what factors influenced the decision to give or not to give such empirical therapy.

Study design: A retrospective study based on data collection from computerized systems will include patients who were hospitalized in the intensive care unit from January 2014 to December 2024 and were diagnosed with Candida in at least one blood culture.


Eligibility criteria: Inclusion Criteria: Patients admitted to the ICU from January 2014 to December 2024 and had at least one positive blood culture for candidemia -

Exclusion Criteria: Missing data

-

Primary outcomes:
measure: Identification of risk factors for candidemia
timeFrame: Throughout ICU stay (from admission to 28 days post ICU discharge)
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
References:
Clinical trial NCT04649294: The Effect of High Dose Glucocorticoid Steroids on Myocardial Function
Official title: The Effect of High Dose Glucocorticoid Steroids on Myocardial Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: High-dose Steroids, Myocardial Function, Longitudinal Strain
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2020-12-02
Enrollment: 23
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: patient with inflammatory disease who needs high dose steroids according to there disease severity and welling to participate in observation study to see the effect od steroids taken on the myocaridal functions duering hospital stay

Brief summary: Long term steroid exposure, as in Cushing's disease, causes myocardial dysfunction, hypertrophy and fibrosis in addition to causing obesity, hypertension and glucose intolerance. The aim of our study was to verify if short-term high-dose exogenous steroid therapy adversely effects the heart.

Detailed description: Patients eligible for high dose steroid therapy due to inflammatory diseases were offered to participate in this study. The minimal total intravenous dose was 375 mg prednisone, and the daily steroids were divided into 2-3 doses. To determine the steroids' effect on myocardial function the echocardiographic studies included estimation of global and segmental longitudinal strain. Each patient had a baseline echocardiographic study performed before high-dose steroid therapy was initiated and again immediately after it. A follow-up echo study was performed after completion of a 3-month low-dose steroid therapy period. The paired 2-tailed t-test was used to compare group means

Eligibility criteria: Inclusion Criteria:

* Age above 18
* Patient with rheumatic disease that need high dose steroids due to exacerbation
* Patient whom echocardiographic study can be performed with a good quality

Exclusion Criteria:

* age below 18

Primary outcomes:
measure: determine the steroids' effect on myocardial function the echocardiographic studies included estimation of global and segmental longitudinal strain
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Hospital
Study officials:
References: