louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02819193: Using Mother's Raw Milk Could Improve Breastfeeding in Hospitalized Neonates
Official title: Using Mother's Raw Milk Could Improve Breastfeeding in Hospitalized Neonates
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breastfeeding
Keywords: Breastfeeding
mother's milk
breast milk
raw milk
neonate
Neonatal intensive care unit (NICU)
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-06-30
Enrollment: 665
Sex: ALL
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neonates from two French participating centres.

Brief summary: Despite the importance of breast milk for sick or preterm neonates, there is currently no consensus regarding the use of raw mother's own milk (MOM) in neonatal units. The aims of this study are to: (a) describe factors associated with the use of raw MOM; (b) investigate the association between early use of raw MOM and breastfeeding continuation at discharge and up to 6 months later.


Eligibility criteria: Inclusion Criteria:

* Admitted neonates between April 2012 and June 2013 are eligible if they are intended to be breastfeed and hospitalized ≥7 days

Exclusion Criteria:

- Neonates with parents not fluent in French.

Primary outcomes:
measure: Maternal breastfeeding
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Service de Réanimation Néonatale et Néonatologie, Hôpital Femme Mère Enfant, 32 Avenue Doyen Jean Lépine
Study officials:
affiliation: Service de Réanimation Néonatale et Néonatologie, Hôpital Femme Mère Enfant, Bron, France
name: Céline Fischer Fumeaux, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04913493: Use of Sublingual Microcirculation and FloTrac Monitoring During Major Vascular Surgery and Its Effect on Hospital LOS
Official title: Use of Sublingual Microcirculation and FloTrac Monitoring During Major Vascular Surgery and Its Effect on Hospital Length of Stay: a Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Carotid Artery Plaque
Aortic Aneurysm
Aneurysm
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2021-06-04
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the aim of this study is to determine whether an intraoperative optimization protocol using the enhanced flow-based hemodynamic parameters of the FloTrac/Vigileo device in combination with intraoperative measurement of the sublingual microcirculation with the Cytocam-IDF device would result in an improvement in outcome in high-risk patients undergoing major vascular surgery, measured by the hospital LOS in comparison with intraoperative FloTrac/Vigileo monitoring alone.

The FloTrac/Vigileo device only needs standard arterial access for enhanced, flow-based hemodynamic monitoring. It is reported to be easy to use and easy to set up and calculates the stroke volume (SV) on the basis of the arterial waveform in combination with demographic data. Cardiac index (CI), stroke volume index (SVI) as an indicator for fluid status and stroke volume variation (SVV) as an indicator for fluid responsiveness during mechanical ventilation and sinus rhythm will be continuously measured during major vascular procedures, including carotid endarterectomy (CEA), open abdominal aortic aneurysm (AAA) repair , endovascular aneurysm repair (EVAR), thoracic endovascular aneurysm repair (TEVAR) and fenestrated endovascular aneurysm repair (FEVAR).


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Males and females
* ASA III classification
* Written informed consent obtained by the patient
* Elective hospital admission for major vascular surgery procedures (CEA, open AAA, EVAR, TEVAR, FEVAR)

Exclusion Criteria:

* Age \< 18 years
* Presence of permanent cardiac arrythmias
* Weight \< 55kg and \> 140kg
* Pregnancy
* Emergency surgery
* Minor vascular procedures
* Refusal or inability to provide written informed consent (language barrier, mental retardation, dementia)

Primary outcomes:
measure: Number of hospitalisation days. (LOS)
timeFrame: up to 30 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: UZ Brussel
state: Brussel
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Hélène De Cuyper, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01406093: Early- and Late-onset Candidemia
Official title: Early- and Late-onset Candidemia: A Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Candidemia
Keywords: Candidemia
Early-onset
Late-onset
Health-care associated
Nosocomial
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2011-07-29
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The selection of patients for inclusion will be based on microbiological data (with suscesptibilty patterns of the various antifungals) extracted from the computerized archive with search for Candida spp. and "blood" either peripheral or from a central venous catheter. Candida isolated from a removed CVC tip will not be considered. The candidemia will also be defined early or late based on the time elapsed between hospital admission and diagnosis (≤ 10 days early, \> 10 days late candidemia).

Brief summary: A timing diagnosis of candidemia is as important as the correct choice of empiric or targeted antifungal therapy. In the last years a growing body of knowledge has better characterized health-care associated (HCA) infections, which have been described in 2002 in outpatients with MRSA bloodstream infections. So far there is no compelling evidence that patients with HCA infections may develop candidemia before the usual timing of around 20-25 days after admission. Risk factors associated with HCA infections are represented by admission from long term chronic care facilities (LTCF), haemodialysis, previous admission or parenteral broad spectrum antibiotics. There are few data HCA features and early onset candidemias in the published literature.

In this proposal, the investigators aim at studying early-onset candidemia in a retrospective study in one of the largest referral hospital in Italy with a consistent range of specialties ranging (bone marrow transplant, solid organ transplant, immunosuppressed patients, ICU, complex surgery). The investigators speculate that patients with candidemia diagnosed within 10 days (early-onset) by the admission have different risk factors and prognosis of those with a late diagnosis.


Eligibility criteria: Inclusion Criteria:

* Candidemia diagnosed with positive blood culture either from a peripheral vein or CVC

Exclusion Criteria:

* Candida isolated from a removed CVC tip will not be considered

Primary outcomes:
measure: Mortality
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Torino
country: Italy
facility: Hospital San Giovanni Battista - Molinette
Study officials:
affiliation: University of Turin, Italy
name: Giovanni Di Perri, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Turin, Italy
name: Francesco G De Rosa, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00005693: Computer Assisted Instruction Weight Management for Low Literacy Populations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Diseases
Obesity
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 develop and evaluate a computer assisted instruction (CAI) weight management program in an adult population with low literacy at Sheehan Memorial Hospital's Family Care Center (FCC), an outpatient clinic serving the inner city of Buffalo, New York.

Detailed description: BACKGROUND:

This was the first study in patient care informatics in which nutrient analysis methodology was used on a day-to-day basis to motivate low literate individuals to improve their food choice behavior and physical activity. The deliverables of this investigation included revised and enhanced software, professional documentation, and a participant workbook. These materials were designed so that they could be integrated into any risk factor reduction program for low literacy populations.

DESIGN NARRATIVE:

The CAI featured voice recognition, giant cursor movement, and a graphics-based environment using pictures to facilitate an exceptionally easy to use and understand software program and booklet. The voice recognition technology was linked with compact disk read only memory (CD ROM) to visually display food choices and physical activities for ease of recording data by the individual. The software was formatted so that health professionals could select preference levels which corresponded to the motivational level of the individual. The four-session CAI intervention had two planned maintenance sessions. The output was personalized and in color. It was designed to identify problematic foods in the diet, improve food selections, and increase physical activity. Stars were printed for adherence to individual goals.

One hundred and fifty (150) men and 150 women, between age 20 and age 44, with a reading level of 8th grade or less, who were between 20 percent and 40 percent over their ideal body weight, were randomly assigned to three groups. The design compared a control group without the intervention, a group experiencing the CAI intervention and hands-on computer use, and a group experiencing the intervention but not the CAI component or computer use. All groups were pretested, posttested, and follow-up tested at six months and twelve months following baseline. The primary outcome measures were weight loss, nutrient intake, and physical activity. Data were analyzed using a two-way analysis of covariance and appropriate t-tests.

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 NCT05517993: Effect of Gui-Lu-Er-Xian-Jiao-Wan on Intradialytic Hypotension
Official title: Effect of Gui-Lu-Er-Xian-Jiao-Wan on Intradialytic Hypotension: a Randomized Crossover Pilot Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Intradialytic Hypotension
Keywords: Intradialytic Hypotension
Chinese herbal medicine
Gui-Lu-Er-Xian-Jiao
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2022-08-26
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Intradialytic hypotension (IDH), a common complication during hemodialysis (HD) could increase patients' morbidity and mortality. Previous studies considered that some Chinese herbal medicine (CHM) plays a complementary role in reducing the frequency of IDH. This trial is aimed to investigate the effect of Gui-Lu-Er-Xian-Jiao-Wan (GLEXJW) in patients with intradialytic hypotension.


Eligibility criteria: Inclusion Criteria:

* End stage renal disease treated with hemodialysis for ≥3 months
* Receive a standard thrice-weekly hemodialysis schedule
* More than 25% of hemodialysis sessions complicated by intradialytic hypotension

Exclusion Criteria:

* Active malignancy
* Life-threatening conditions
* Pregnancy
* Recent participation in another clinical trial for intradialytic hypotension
* History of hypersensitivity or contraindication to herbal medicine

Primary outcomes:
measure: Intradialytic hypotension episode
timeFrame: Each time of dialysis during 12-weeks study period.
Secondary outcomes:
measure: Early termination of hemodialysis
timeFrame: Each time of dialysis during 12-weeks study period.
measure: SF-36
timeFrame: Baseline, 12 weeks, 28 weeks
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Chun-Ting Liu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00965393: The Effect of Ischaemic-Reperfusion and Remote Ischaemic Preconditioning in Man - A Bradykinin Dependent Pathway
Official title: The Effect of Ischaemic-Reperfusion and Remote Ischaemic Preconditioning in Man - A Bradykinin Dependent Pathway
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischaemic Heart Diseases
Keywords: Ischaemia reperfusion
Platelet activation
Endothelial function
Remote ischaemic preconditioning
Bradykinin
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: University of Aarhus
name: University of Oxford
First posted: 2009-08-25
Enrollment: 12
Sex: MALE
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: Heart attacks are usually caused by a blood clot blocking an artery supplying blood to the heart. Current treatments are designed at relieving this blockage as quickly as possible to minimize damage to the heart muscle. However in restoring the supply of blood local damage known as "ischaemia-reperfusion injury" may occur. The aim of this study is to assess how clot forming and clot dissolving pathways are affected during this process, and examine the role of a natural inflammatory hormone, bradykinin. This will help the investigators to understand the mechanism by which ischaemia-reperfusion injury may occur and to devise new treatments for heart attacks.


Eligibility criteria: Inclusion Criteria:

* Healthy males between 18-65 years of ages.
* Non-smokers.

Exclusion Criteria:

* Any concurrent illness or chronic medical condition.
* Concurrent use of vasoactive medication.
* Smoking history.

Primary outcomes:
measure: Change in forearm blood flow in response to vasodilators (ACh(, ischaemia reperfusion and ischaemic preconditioning
timeFrame: 20 fixed timepoints during each study visit (3hrs)
Secondary outcomes:
measure: Change in platelet-monocyte-binding after ischaemia reperfusion and ischaemic preconditioning
timeFrame: 4 fixed timepoints during each study visit (3hrs)
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: University of Edinburgh, 49 Little France Crescent
Study officials:
affiliation: University of Edinburgh
name: David E Newby, PhD, FRCP
role: STUDY_DIRECTOR
affiliation: University of Oxford
name: Rajesh K Kharbanda, PhD, FRCP
role: STUDY_DIRECTOR
References:
citation: Pedersen CM, Schmidt MR, Barnes G, Botker HE, Kharbanda RK, Newby DE, Cruden NL. Bradykinin does not mediate remote ischaemic preconditioning or ischaemia-reperfusion injury in vivo in man. Heart. 2011 Nov;97(22):1857-61. doi: 10.1136/heartjnl-2011-300323. Epub 2011 Aug 26.
Clinical trial NCT01539993: Prospective Liver Study
Official title: Prospective Analysis of Liver Cancer Treatment and Interventions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Cancer
Keywords: Hepatocellular carcinoma
Liver metastases
Cholangiocarcinoma
Percutaneous treatments
RFA
TACE
DEB
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2012-02-28
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients 18 yrs and older with a diagnosis of Hepatocellular carcinoma and elegible for percutaneous liver treatments

Brief summary: This study is designed for patients diagnosed with Liver cancer to collect information about the relationship between types of liver cancer, methods of treatment and outcomes over time.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with Hepatocellular carcinoma and referred for percutaneous liver treatment.

Exclusion Criteria:

* Severe liver disfunction
* Active uncontrolled infection
* Significant underlying medical of physical illness

Primary outcomes:
measure: Assess efficacy of percutaneous and transarterial treatments for liver cancer.
timeFrame: 1 month
Secondary outcomes:
measure: long term follow up
timeFrame: 3 months, 6 months 1year
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
affiliation: Emory University
name: Kevin S Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03557593: Optimizing Prescribing of Antipsychotics in Long-Term Care
Official title: Optimizing Prescribing of Antipsychotics in Long-Term Care (OPAL): A Randomized Trial to Reduce Inappropriate Antipsychotic Prescribing in Long-Term Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: Antipsychotic
Nursing home
Long-term care
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: Canadian Consortium on Neurodegeneration in Aging
name: Canadian Frailty Network
First posted: 2018-06-15
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Randomized, stepped-wedge cluster trial.
Primary purpose: TREATMENT

Brief summary: Inappropriate antipsychotic prescribing is a key quality indicator by which clinical outcomes might be monitored and improved in LTC. A multi component intervention to reduce inappropriate antipsychotic prescribing was evaluated in ten Canadian long-term care facilities.

Detailed description: Increasing numbers of older adults are affected by dementia, and many will eventually reside in long-term care (LTC), where antipsychotic use is relatively common. Inappropriate antipsychotic prescribing is a key quality indicator by which clinical outcomes might be monitored and improved in LTC but limited evidence exists on the most effective strategies for reducing inappropriate antipsychotic use.

The objective of the study was to evaluate a multicomponent approach to reduce inappropriate prescribing of antipsychotics in LTC.

A prospective, randomized stepped-wedge, study design was used to evaluate the effect of the intervention in 10 LTC facilities in Canada. The intervention consisted of an educational in-service, provision of evidence-based tools to assess and monitor neuropsychiatric symptoms (NPS) and monthly interprofessional team meetings.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of dementia
* Receiving an antipsychotic medication without a diagnosis of psychosis

Exclusion Criteria:

* Diagnoses of schizophrenia, Huntington's disease
* Presence of active hallucinations and/or delusions
* Individuals at end of live or receiving palliative care

Primary outcomes:
measure: Percentage of long-term care residents receiving any antipsychotic without a diagnosis of psychosis
timeFrame: 12-months
Secondary outcomes:
measure: Worsening of behavioral symptoms
timeFrame: 12-months
measure: Use of physical restraints
timeFrame: 12-months
measure: Depression: Proportion of residents whose mood from symptoms of depression worsened
timeFrame: 12-months
measure: Falls: Proportion of residents experiencing a fall in the 30 day
timeFrame: 12-months
measure: Pain: Proportion of residents who had pain
timeFrame: 12-months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04349293: Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways
Official title: Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2020-04-16
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Multicentric interventional prospective study with collection of biological samples as part of a routine care research


Eligibility criteria: Inclusion Criteria:

1. Age greater than or equal to 18 years.
2. Male and female sex.
3. Any patient with cancer (see list in the body of the protocol) requiring treatment by surgical resection and / or who will start treatment with mAb or BiTE.
4. Patient information and signed informed consent.
5. Subjects affiliated (or beneficiary) to a social security scheme

Patients treated for immune complications by immunosuppressants may be included (corticosteroids, etc.).

Exclusion Criteria:

1. History of severe systemic autoimmune disease.
2. Pregnant or breastfeeding patient
3. Impossibility or refusal to sign informed consent
4. Patient under guardianship or curatorship, or deprived of liberty by a judicial or administrative decision

Primary outcomes:
measure: Immunophenotyping of immune infiltrates by flow cytometry
timeFrame: Up yo one year
Secondary outcomes:
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Gustave Roussy
state: Val De Marne
Study officials:
References: