louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01066013: Antimicrobial De-escalation Strategy in Medical Patients
Official title: Antimicrobial De-escalation Strategy in Medical Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infections
Keywords: Antimicrobial De escalation
Meropenem
Piperacillin tazobactam
Medical patients
Appropriate use
Cost savings
Antimicrobial De-escalation strategy
Lead sponsor: Fraser Health
Sponsor class: OTHER
Collaborators: name: Vancouver Foundation
First posted: 2010-02-10
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this pilot study is to assess the impact of an antibiotic de-escalation strategy on the clinical outcomes (clinical cure or improvement) of medical patients related to the usage of of broad-spectrum antimicrobial agents.

Detailed description: This is an open-label, case-control, pilot study involving medical patients with serious infections who are prescribed meropenem or piperacillin/tazobactam, at Surrey Memorial Hospital. Patients in the experimental arm (cases) will be required to provide an informed consent. A team consisting of an infectious diseases specialist, medical microbiologist and clinical pharmacists will prospectively assess antimicrobial therapy in the enrolled subjects in the prospective arm and make recommendations for antimicrobial de-escalation.

The control group will consist of subjects drawn from historic data of patients on the same medical unit(s) who will be matched based on age, sex, use of broadspectrum antibiotics (meropenem or piperacillin/tazobactam) and infectious diseases diagnosis.

Eligibility criteria: Inclusion Criteria:

* Age 19 years and over
* Suspected or confirmed infection for which a Meropenem and/or Piperacillin/Tazobactam is prescribed. This will include any patient who is other concomitant antibiotic(s) such as Vancomycin
* Subject admitted to SMH medical unit(s)
* Pregnant patient (or patients wishing to become pregnant)

Exclusion Criteria:

* Age less than 19 years
* Granulocytopenia (\< 1x109/L)
* Allergy or intolerance to meropenem or piperacillin-tazobactam.
* Febrile Neutropenia
* Cystic Fibrosis

Primary outcomes:
measure: Number of patients who had therapy with meropenem or piperacillin/tazobactam de-escalated by the de-escalation team.
timeFrame: 7 days
Secondary outcomes:
measure: Clinical efficacy (clinical improvement or complete resolution of infection)
timeFrame: 7 days
measure: Appropriateness of broadspectrum antibiotic (meropenem or piperacillin/tazobactam) prior to de-escalation
timeFrame: 7 days
measure: Cost and consumption (usage data) of antibiotics
timeFrame: 7 days
measure: All cause mortality
timeFrame: 14 days
measure: Length of stay in the hospital
timeFrame: 14 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05331313: The Aim is to Identify Recurrent Genomic Mutations and/or Predisposing Polymorphisms in Patients With Sporadic Cases of Multiple Myeloma
Official title: Analysis of Genomic Alterations in Sporadic Cases of Multiple Myeloma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Myeloma
Keywords: genetic predisposition
mutations
sporadic
multiple myeloma
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2022-04-15
Enrollment: 1000
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 samples will be accrued from Intergroupe Francophone du Myélome (IFM) centers in France, in the context of primary care clinics. The investigators aim to collect up to 1,000 samples.

Brief summary: There is a growing body of data suggesting that the the risk of developing multiple myeloma, or myelomagenesis, is associated with genetic alterations occurring in the tumor cells. A limited number of candidate genes and polymorphisms have been reported in patients with this disease. In this study the investigators will compare the genetic information obtained on purified abnormal plasmocytes obtained from patients with multiple myeloma with available public databases in an effort to identify and if possible validate the role of certain mutations and/or polymorphisms in myelomagenesis. Plasmocytes will be obtained by immunomagnetic enrichment using CD138+ beads.


Eligibility criteria: Inclusion Criteria:

* diagnosis of multiple myeloma
* availability of abnormal plasmocytes

Exclusion Criteria:

- none

Primary outcomes:
measure: DNA mutations associated with the existence of multiple myeloma
timeFrame: baseline, pre-intervention/procedure/surgery
measure: DNA mutations associated with the existence of multiple myeloma
timeFrame: during the intervention/procedure/surgery
measure: DNA mutations associated with the existence of multiple myeloma
timeFrame: immediately after the intervention/procedure/surgery
measure: DNA mutations associated with the existence of multiple myeloma
timeFrame: at 1 year
measure: DNA mutations associated with the existence of multiple myeloma
timeFrame: up to 24 weeks
measure: DNA mutations associated with the existence of multiple myeloma
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Pierre Benite
country: France
facility: Hospices Civils de Lyon
Study officials:
References:
Clinical trial NCT03239418: NMES to Improve Eyelid Functions in Cranial Nerve (CN) III and VII Palsy
Official title: A Novel Treatment Using Neuromuscular Electrical Stimulation to Improve Eyelid Function in Patients With CN III and CN VII Palsy.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Blepharoptosis
Lagophthalmos
Keywords: NMES
Lead sponsor: Brooks Rehabilitation
Sponsor class: OTHER
First posted: 2017-08-04
Enrollment: 26
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Active treatment vs. Sham control
Primary purpose: TREATMENT

Brief summary: Traumatic brain injury, stroke and other neurological conditions may result in weakness of the muscles that either open or close the eye. This is generally a result of impaired functioning of the oculomotor or facial cranial nerves. Current treatments to improve eye opening or closing are either invasive or largely ineffective. This study tests a noninvasive means of improving eyelid opening and closing by applying a previously demonstrated safe and effective neuromuscular electrical stimulation (NMES) intervention to the muscles controlling eyelid movement. Participants in this study will either receive the investigational NMES protocol 30 min per day for five days or a sham NMES for the same period. The primary outcome for this study is the participants' ability to open or close their affected eye. Secondary outcomes include additional measures of eye and corneal health.


Eligibility criteria: Inclusion Criteria:

* Cranial nerve III (oculomotor nerve) and/or cranial nerve IV (facial nerve) palsy.
* Able to read and communicate in English.

Exclusion Criteria:

* Idiopathic onset of CN III and/or CN IV palsy.
* Traumatic injury to the eye or eyelid.
* Active wounds in the treatment area.
* Presence of swelling or infection in or surrounding the affected eye.
* Diminished sensation in the area to be treated.

Primary outcomes:
measure: Marginal reflex distance-1 (MRD-1)
timeFrame: Within 1 week of last treatment session.
measure: Palpebral fissure height
timeFrame: Within 1 week of last treatment session.
Secondary outcomes:
measure: World Health Organization Quality of Life - BREF (WHOQOL-BREF)
timeFrame: Within 1 week of last treatment session.
measure: Upper eyelid crease distance
timeFrame: Within 1 week of last treatment session.
Other outcomes:
measure: Distance visual acuity
timeFrame: Within 1 week of last treatment session.
measure: Distance alternate cover test.
timeFrame: Within 1 week of last treatment.
measure: Pupil test
timeFrame: Within 1 week of last treatment session.
measure: Oculomotor exam
timeFrame: Within 1 week of last treatment session.
measure: Cornea, Static Asymmetry, Dynamic Function, Synkinesis Classification Scale (CADS).
timeFrame: Within 1 week of last treatment session.
Locations:
city: Jacksonville
country: United States
facility: Brooks Rehabilitation
state: Florida
Study officials:
affiliation: Brooks Rehabilitation
name: Kenneth Ngo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01557218: Increasing the Variety of Vegetables and Fruits Served to Preschool Children at a Snack
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Feeding Behaviors
Keywords: Dietary variety
Vegetable intake
Fruit intake
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2012-03-19
Enrollment: 61
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Intake of vegetables and fruits in preschool children is less than recommended amounts. Although offering a variety of foods has been shown to increase intake, this effect has not been well studied for low-energy-dense foods. The purpose of this study was to test whether increasing the variety of vegetables and fruits served to preschool children affected the amount eaten. The hypotheses were that increasing the variety of vegetables and fruits would increase both the amount selected and the amount eaten.


Eligibility criteria: Inclusion Criteria:

* attenders at the relevant child care center

Exclusion Criteria:

* allergy or sensitivity to any test food

Primary outcomes:
measure: Intake of vegetables and fruit
timeFrame: One month
Secondary outcomes:
Other outcomes:
Locations:
city: University Park
country: United States
facility: Penn State University Laboratory for the Study of Human Ingestive Behavior
state: Pennsylvania
Study officials:
affiliation: Penn State University
name: Barbara J. Rolls, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roe LS, Meengs JS, Birch LL, Rolls BJ. Serving a variety of vegetables and fruit as a snack increased intake in preschool children. Am J Clin Nutr. 2013 Sep;98(3):693-9. doi: 10.3945/ajcn.113.062901. Epub 2013 Jul 31.
Clinical trial NCT01243918: Evaluation of Oxygen Therapy Delivery Systems in Hypoxemic Acute Respiratory Failure
Official title: Evaluation of Oxygen Therapy Delivery Systems in Hypoxemic Acute Respiratory Failure
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Respiratory Failure
Keywords: Acute respiratory failure
Oxygen therapy delivery systems
Non invasive ventilation
High concentration mask
Hypoxemic pneumonia
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2010-11-19
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The main objective of this study is to evaluate the efficiency of the oxygen therapy delivery system Optiflow® compared to 2 others standard oxygen therapy delivery systems (Ospal®, non invasive ventilation).12 immunocompetent patients will compare the successive use of oxygen therapy delivery systems Optiflow®/Ospal® and 12 immunodeficient patients will compare the successive use of systems Optiflow®/Non invasive ventilation.


Eligibility criteria: Inclusion Criteria:

* Patient hospitalized in the intensive care unit of Nantes University Hospital
* Signed informed consent
* Patient with not hypercapnic acute hypoxemic respiratory failure
* Immunocompetent and immunodeficient patient

Exclusion Criteria:

* Age \< 18 years
* Pregnancy
* Contra-indication to non invasive ventilation
* Allergy to xylocaine
* Coagulation troubles
* Tracheotomized patient
* Urgent indication to intubation
* Hypercapnic acute respiratory failure
* Acute pulmonary edema
* Face or nose malformation

Primary outcomes:
measure: Calcul of the ratio PaO2/FiO2
timeFrame: one hour after each system used
Secondary outcomes:
measure: number of participants with adverse events
measure: measure of respiratory frequency and blood gas
measure: measure of positive and expiratory pressure
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
affiliation: Nantes University Hospital
name: Noëlle BRULE, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01073618: Non-Interventional Post Marketing Surveillance Study To Observe The Safety And Efficacy Of Vfend® IV
Official title: Post Marketing Surveillance Study To Observe The Safety And Efficacy Of Vfend® IV
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Serious Fungal Infections
Keywords: voriconazole
Korea
invasive fungal infection
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-02-23
Enrollment: 692
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are indicated for VFEND according to drug package insert.

Brief summary: This is non-interventional study of voriconazole IV formulation in clinical use, which was mandated by the Korean government agency following the approval of Vfend in the Republic of Korea.


Eligibility criteria: Inclusion Criteria:

* Invasive aspergillosis and other serious fungal infections.

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Percentage of Participants With Categorical Clinical Response: Cure, Improvement, Failure, or Unevaluable
timeFrame: Baseline (Day 1) up to 2 years
Secondary outcomes:
measure: Percentage of Participants With Cultivated Strain Mycological Response: Eradication, Persistence, Superinfection, or Not Evaluable
timeFrame: Baseline (Day 1) up to 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05522218: Eluvia DES for the Patients with Femoropopliteal Artery Lesions.
Official title: Clinical Effectiveness and Health Economic Evaluation of Eluvia Drug-eluting Stent in the Treatment of Femoropopliteal Artery Lesions
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Vascular Diseases
Stent Complication
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2022-08-30
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: peripheral arterial disease patients implanted with Eluvia stent

Brief summary: This study is a multicenter, prospective, observational study, aiming to enroll 400 patients with peripheral arterial disease in the femoral-popliteal segment implanted with Eluvia stent. Each patient was followed up for 2 years. The technical success rate, target lesion patency rate, quality of life improvement, cost of Eluvia stent implantation, and other outcomes will be analysed.


Eligibility criteria: Inclusion Criteria:

1. Rutherford Stage 2-5.
2. At least 90% stenosis or occlusion of the femoropopliteal artery.
3. Eluvia stents are used for target lesions.
4. Agree and sign the informed consent form

Exclusion Criteria:

1. Life expectancy is less than 1 year.
2. Those with severe infection and gangrene of the limbs or those with tissue defects beyond the plane of the toes (ie major tissue loss), who may undergo major amputation even if the blood vessels are opened.
3. Patients and their families are reluctant to join the observational study, or have difficulty in communication and are unable to assess the quality of life.
4. Patients with in-stent restenosis of the femoral popliteal artery.
5. Patients with acute arterial thrombosis.

Primary outcomes:
measure: The change of Rutherfor classification
timeFrame: 24 months
measure: F-TLR
timeFrame: 24 months
measure: limb salvage rate
timeFrame: 24 months
Secondary outcomes:
measure: Technical success rate
timeFrame: 1 month
measure: the patency target lesion
timeFrame: 24 months
measure: mortality rate
timeFrame: 24 months
measure: the life quality change
timeFrame: 24 months
measure: the life quality change
timeFrame: 24 months
measure: Economics Evaluation
timeFrame: 24 months
measure: Wound Healing Evaluation
timeFrame: 24 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: First Affiliated Hospital of Zhejiang University
state: Zhejiang
Study officials:
References:
Clinical trial NCT04334018: Multi Point Pacing vs. Conventional STUDY PROTOCOL
Official title: Observational, Multicentre, Investigator and Patient Blinded, Prospective, Randomized Comparator Study of Cardiac Resynchronization Therapy (CRT) Multi Point Pacing (MPP) Compared to Conventional CRT Pacing Response in Heart Failure Patients.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Compare Two Programming Modalities for CRT Devices in Heart Failure Patients With an Indication for Cardiac Resynchronization Therapy
Lead sponsor: CMC Ambroise Paré
Sponsor class: OTHER
First posted: 2020-04-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The Purpose of this study is to compare two programming modalities for CRT devices in Heart Failure patients with an indication for Cardiac Resynchronization Therapy


Eligibility criteria: Inclusion Criteria:

* Patients with indication for CRT (-P or -D) as per ESC guidelines. Ability to provide written informed consent. Optimal Medical Therapy for at least 3 months

Exclusion Criteria:

* \< 18 years and younger
* Pregnant or breastfeeding patients
* Non-LBBB patients (RBBB, intra-ventricular delay)
* Non-ambulatory NYHA class IV effort tolerance
* Myocardial infarction within 40 days before enrolment
* Cardiac surgery or revascularization procedure within 3 months before enrolment, or scheduled in the following 6 months
* Atrial Fibrillation (AF) patients unless AV node ablation is performed, or complete AV block is present (to ensure optimal CRT delivery)
* Patients with life expectancy of less than 12 months due to other medical conditions
* Patients who are involved in another investigational study (device or medical)

Primary outcomes:
measure: Outcome 1
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Antibes
country: France
facility: PHc hôpital d'Antibes la Fontonne
city: Cannes
country: France
facility: Centre hospitalier de Cannes
city: Neuilly sur seine
country: France
facility: CMC Ambroise Paré
city: Nice
country: France
facility: CHU Nice
city: Perpignan
country: France
facility: Centre Hospitalier de Perpignan
city: Monaco
country: Monaco
facility: Centre Hospitalier Princesse Grace
Study officials:
References:
Clinical trial NCT04471818: Ketamine or Placebo in Patients With Major Depression and Advanced Cancer
Official title: Ketamine Versus Placebo as Adjuvant Treatment for Major Depressive Disorder and Wish to Hasten Death in Advanced Cancer Patients Undergoing Palliative Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Major Depressive Disorder
Advanced Cancer
Lead sponsor: Instituto Nacional de Cancerologia de Mexico
Sponsor class: OTHER
First posted: 2020-07-15
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Major depression (MD) is a psychiatric disorder characterized by a persistent feeling of sadness, anhedonia or a decreased perception of pleasurable experiences, as well as appetite alterations and weight variations, sleep disorders, altered psychomotor skills, fatigue, guilt, decreased self-worth, suicidal thoughts and difficulty concentrating in a task (1).

MD is a frequent complication in patients who are diagnosed with advanced cancer.


Eligibility criteria: Inclusion Criteria:

1. Age: 18 to 65 years of age
2. Sex: Male or female
3. Major depressive disorder (MDD) diagnosis as per Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
4. Palliative stage cancer diagnosis (advanced-disease stage)
5. Who can read and write in spanish
6. Eastern Cooperative Oncology Group (ECOG) 0-2
7. Karnofsky ≥ 50
8. Palliative prognostic index A
9. Not currently undergoing systemic oncologic treatment
10. Patients who agree to participate in the study by signing an informed consent.

Exclusion Criteria:

1. Comorbidities including other psychiatric diseases (additional to MDD, generalized anxiety or panic disorder).
2. Magnetic resonance or computerized tomography with major structural alterations.
3. Pregnant or breastfeeding women.
4. Patients with hypersensitivity to ketamine
5. Cardiac insufficiency
6. Patients with a history of psychosis
7. Patients with first-degree relatives with a history of psychosis
8. Patients with uncontrolled glaucoma
9. Current neurological illness

Primary outcomes:
measure: Brief Edinburg Depression Scale (BEDS) score
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Instituto Nacional de Cancerología (INCan)
Study officials:
References: