louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01186172: Ethanol Lock for the Salvage of Infected Long-term Vascular Access
Official title: Lock Con Etanolo Per il Salvataggio di Dispositivi Vascolari a Lungo Termine. Un Trial Clinico Multicentrico Controllato Randomizzato
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Bacteremia
Keywords: ethanol
lock therapy
vascular access
central venous catheter
sepsis
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
First posted: 2010-08-23
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Long-term venous devices (e.g.Ports, tunneled catheters,...) may become infected. Sometimes it is very difficult to treat the infection and it is necessary to remove the device. The purpose of this study is to determine the efficacy of instilled ethanol ("ethanol lock therapy") versus instilled antibiotics ("antibiotic lock therapy") to save long-term venous device when infected, preventing their removal.


Eligibility criteria: Inclusion Criteria:

* Age: \>1 year and 10 Kgs
* Long-term vascular device in place at least for 7 days
* Catheter-related infection (at least presumed)
* Will to save the infected device (expected high risk access)

Exclusion Criteria:

* Known ethanol-allergy
* Known antabuse-like drugs in use
* Religious refusal
* S.aureus or Candida spp. as main pathogens (except in the unusual and documented scenarios when replacement of vascular access device proved to be very difficult)
* Tract or pocket infection
* Complicated infection (septic shock, infectious thrombosis, osteomyelitis, endocarditis)

Primary outcomes:
measure: Ratio of saved devices
timeFrame: 7 days
Secondary outcomes:
measure: Number of participants with adverse events linked to ethanol lock as a measure of safety and tolerability
timeFrame: 60 days
measure: Number of patients with proper parenteral therapy
timeFrame: 7 days
measure: Ratio of saved devices
timeFrame: 15-30-60 days
measure: Time for next bacteriemic episode
timeFrame: 30 days after the end of lock
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico "San Matteo"
state: PV
Study officials:
affiliation: Fondazione IRCCS Policlinico San Matteo, Pavia, Italy
name: Michele Pagani, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maiefski M, Rupp ME, Hermsen ED. Ethanol lock technique: review of the literature. Infect Control Hosp Epidemiol. 2009 Nov;30(11):1096-108. doi: 10.1086/606162.
Clinical trial NCT01561872: Assessment of an Automated Telesurveillance System on Serious Falls Prevention in an Elderly Suffering From Dementia Specialized Care Unit: the URCC
Official title: Assessment of an Automated Telesurveillance System on Serious Falls Prevention in an Elderly Suffering From Dementia Specialized Care Unit: the URCC. GET-BETTER Study (Geriatric Environmental Telecare - Behavioral Engineering Technology To Enhance Rehabilitation)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mentally Ill Old Subjects
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2012-03-23
Enrollment: 350
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: demented old subjects

Brief summary: 2 URCC in the Limousin region will be equipped with the automated telesurveillance system. Patient will be selected by ward's geriatrician and randomized into two groups after informed consent. One group will have cameras installed and the other will not and will act as a comparison group. Patient will be assessed twice during the study, at admission in (inclusion visit) and at outcome from the URCC (end of study visit). Each assessment implies a standard geriatric assessment, a fall questionnaire, a Neuropsychiatric inventory for behavioral disturbances and a quality of life questionnaire (EQ5D). Every fall will be considered as adverse events and will therefore be listed along the study and characterized in types and number.


Eligibility criteria: Inclusion Criteria:

* Patient aged more than 65 years old
* Patient admitted in Limoges or Brive's URCC
* Patient informed consent and/or proxy consent
* Patient covered by the French health insurance

Exclusion Criteria:

* Patient without national health insurance coverage
* Patient with a short term prognosis pathology

Primary outcomes:
measure: The impact of the automated telesurveillance system
timeFrame: 6 months
Secondary outcomes:
measure: The impact of the system on the global rate of falls
timeFrame: 6 months
Other outcomes:
Locations:
city: Limoges
country: France
facility: Limoges University Hospital
Study officials:
affiliation: University Hospital, Limoges
name: Thierry DANTOINE, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01516112: Meir Medical Center Home Monitoring Clinic Registry
Official title: Meir Medical Center Home Monitoring Clinic Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patients Implanted With an ICD or CRTD.
Keywords: ICD, home monitoring, cardiomessenger, implant
Lead sponsor: Meir Hospital, Kfar Saba, Israel
Sponsor class: OTHER
First posted: 2012-01-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients implanted with an ICD or CRTD.

Brief summary: The purpose of the registry is to assess workload of a Home Monitoring based follow up for Biotronik ICD and CRTD patients.


Eligibility criteria: Inclusion Criteria:

* Approved indication for ICD or CRTD
* Implanted with or replaced with a Biotronik Lumax device
* Patient willing and able to sign consent form
* Willing and able to attend clinic visits and follow up schedule
* Transmission of more than 80% at 3-month follow up
* Patient older than 18 years

Exclusion Criteria:

* no indication for ICD or CRTD implant
* Life expectancy shorter than 12 months
* Pregnancy
* Participation in other clinical studies

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kefar Saba
country: Israel
facility: Meir MC
Study officials:
References:
Clinical trial NCT02415712: Specified Drug-use Survey of Fomepizole Intravenous Infusion (All-case Surveillance)
Official title: Specified Drug-use Survey of Fomepizole Intravenous Infusion "Takeda" (All-case Surveillance)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ethylene Glycol Poisoning, Methanol Poisoning
Keywords: Pharmacotherapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2015-04-14
Enrollment: 147
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: Ethylene glycol poisoning or methanol poisoning

Brief summary: The objective of this survey is to evaluate the safety and efficacy of fomepizole intravenous infusion in Japanese patients with ethylene glycol and methanol poisonings in daily medical practice.

Detailed description: Clinical studies for fomepizole intravenous infusion have not been conducted in Japan, and there are few reports of data on drug-use, including in the literature, in Japanese patients; therefore, an evaluation of the safety and efficacy of fomepizole intravenous infusion is required.

This specified drug-use survey for fomepizole intravenous infusion (Fomepizole Intravenous Infusion 1.5 g "Takeda," hereinafter referred to as "the drug") was planned to evaluate the safety and efficacy of the drug in patients with ethylene glycol and methanol poisoning in daily medical practice.

Eligibility criteria: Inclusion Criteria:

-All patients who have been confirmed as receiving the drug

Exclusion Criteria:

-None

Primary outcomes:
measure: Number of Participants Reporting One or More Adverse Events (AEs)
timeFrame: From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days)
measure: Number of Participants Who Had One or More Adverse Drug Reactions
timeFrame: From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days)
measure: Number of Participants Reporting One or More Serious Adverse Events (SAEs)
timeFrame: From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days)
measure: Number of Participants Who Had One or More Serious Adverse Drug Reactions
timeFrame: From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days)
measure: Arterial Blood pH
timeFrame: Baseline, 4 hours after the first dose, and 24 hours after the last dose (Up to approximately 11 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: Takeda Sponsored Site
city: Tokyo
country: Japan
facility: Takeda Sponsored Site
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00534612: Diagnostic Accuracy of Fine Needle Aspiration in Parotid Tumors
Official title: Accuracy of Fine Needle Aspiration Biopsy in the Pre-Operative Diagnosis of Malignancy in Patients With Parotid Gland Masses
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Parotid Gland Neoplasms
Keywords: Parotid gland neoplasms
Lead sponsor: National Institute of Cancerología
Sponsor class: OTHER_GOV
First posted: 2007-09-26
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: DIAGNOSTIC

Brief summary: Liberal use of fine needle aspiration biopsy of parotid gland masses is controversial. All information regarding this procedure has been retrospective. Our objective is to evaluate prospectively the diagnostic accuracy of the test, alone and when associated to clinical and/or radiologic data.

Detailed description: This is a prospective diagnostic test study. Inclusion criteria are all consecutive patients with parotid gland masses referred for treatment at our center, from January 2003 to December 2007.

The gold standard for the diagnosis of malignancy is the surgical pathology report of the parotidectomy specimen.

Cytologist and pathologist will be blind. Diagnostic accuracy is determinded by Bayesian analysis.

Eligibility criteria: Inclusion Criteria:

* Consecutive patients with parotid gland masses

Primary outcomes:
measure: Diagnosis of malignancy
timeFrame: three years
Secondary outcomes:
measure: Specific histopathologic diagnosis
timeFrame: three years
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: National Cancer Institute
state: D.f:
Study officials:
affiliation: Instituto Nacional de Cancerologia de Mexico
name: Jose F Carrillo, M.D:
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05222412: Managed Access Programs for LNP023, Iptacopan
Official title: Managed Access Programs for LNP023, Iptacopan
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: C3 Glomerulopathy (C3G)
Paroxysmal Nocturnal Hemoglobinuria (PNH)
Keywords: C3 glomerulopathy (C3G)
Paroxysmal nocturnal hemoglobinuria (PNH)
MAP
Manage access program
Iptacopan
LNP023
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2022-02-03
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The purpose of this registration form is to list all Managed Access Programs (MAPs) related to LNP023, Iptacopan

Detailed description: * CLNP023B12004M - Available - Managed Access Program (MAP) Cohort Treatment Plan CLNP023B12004M to Provide Access to Iptacopan (LNP023) for Complement 3 Glomerulopathy in Native and Transplanted Kidneys.
* CLNP023N12001M - Available - Managed Access Program (MAP) Cohort Treatment Plan CLNP023N12001M to provide access to Iptacopan for patients with paroxysmal nocturnal hemoglobinuria (PNH).

Eligibility criteria: Inclusion Criteria:

* An independent request should be received from a licensed physician (in some instances from Health Authorities, Institutions or Governments).
* The patient has a serious or life-threatening disease or condition and no comparable or satisfactory alternative therapy is available for diagnosis, monitoring or treatment; patient is not medically eligible for available treatment alternatives or has exhausted all available treatment options.
* The patient is not eligible or able to enroll in a Novartis clinical trial or continue participation in a Novartis clinical trial.
* There is a potential patient benefit to justify the potential risk of the treatment use, and the potential risk is not unreasonable in the context of the disease or condition to be treated.
* The patient must meet any other medical criteria established by the medical experts responsible for the product or by the Health Authority in a country (as applicable).
* Provision of the product will not interfere with the initiation, conduct or completion of a Novartis clinical trial or overall development program.
* Managed access provision is allowed per local laws/regulations.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03436212: Real-Life Home Glucose Monitoring Over 14 Days in T2D Patients With Intensified Therapy Using Insulin Pump.
Official title: Real-Life Home Glucose Monitoring Over 14 Days in T2D Patients With Intensified Therapy Using Insulin Pump. The CLOSE Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Air Liquide Santé International
Sponsor class: INDUSTRY
First posted: 2018-02-19
Enrollment: 24
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study aims at describing the glucose level by automated glucose sensors and correlating it with insulin delivery and meals over 14 days in insulin-requiring T2D patients living in real-life conditions.


Eligibility criteria: Selection criteria:

* Type 2 Diabetes diagnosed for at least 5 years
* Treated with insulin pump for at least 6 months
* 7.5% ≤ HBA1c ≤ 10% (last available value dated less than 3 months)
* Having given his/her free, express and informed consent to participate to the study

Inclusion Criteria:

* 7.5% ≤ HBA1c ≤ 10% (result of the dosage performed at selection visit)
* Daily insulin requirement ≤ 1.5U/kg/day
* Having been compliant to take pictures of his/her meals and snacks over the 3 days prior to the inclusion visit

Non-selection/Non-inclusion criteria:

* Pregnant or breastfeeding woman
* Comorbidity which, in the investigator's opinion, could jeopardize the study completion
* Patient with difficulties to understand the study procedures or deemed unfit, by the Investigator, to comply with operating instructions of CGM equipment.

Primary outcomes:
measure: Relationships between glucose levels and insulin doses
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU de Caen, Service Endocrinologie, Diabétologie
Study officials:
affiliation: CHU CAEN
name: Yves Reznik, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04360512: Dose-response of Talus Mobilizations
Official title: Dose-response of Posterior Talus Mobilizations on Ankle Range of Motion and Overall Mobility in Older Adults
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Aging Problems
Keywords: ROM
Manual therapy
Dose-response
Mobilization
Ankle
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 42
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Ankle mobility limitations are common in older adults. A possible treatment to restore joint mobility is manual therapy based on mobilization techniques, in this case, applied on the ankle joint. Previous research had proposed different treatment volumes (one to twelve sessions), but shown a different and non-consistent degree of effectiveness according to such factor. Therefore, this work aims to determine the dose-response relationship of manual therapy (talus mobilizations) on ankle range of motion in the older adult. Secondarily, this research will appraise whether a likely improvement in ankle mobility may have an impact on the overall mobility (i.e. gait, get up from a chair).


Eligibility criteria: Inclusion Criteria:

* Community-dwelling older adults
* Over 60 years
* Limited ankle dorsiflexion range of motion

Exclusion Criteria:

* Not willing to participate or signing a consent form
* Lower limb injury in the three months prior to the study (ex. sprain)
* Diagnosed condition that may influence mobility assessments (i.e. stroke)

Primary outcomes:
measure: Treatment dose
timeFrame: Change from baseline to end of intervention (2 weeks)
Secondary outcomes:
measure: The Lunge test
timeFrame: Change from baseline, to end of intervention (2 weeks) and follow-up (10 weeks)
measure: Active ankle range of motion
timeFrame: Change from baseline, to end of intervention (2 weeks) and follow-up (10 weeks)
measure: Timed up and go test (TUG)
timeFrame: Change from baseline, to end of intervention (2 weeks) and follow-up (10 weeks)
Other outcomes:
measure: Euro Quality of Life Five Dimensions (EQ-5D)
timeFrame: Change from baseline, to follow-up (10 weeks)
Locations:
city: Valencia
country: Spain
facility: Universidad de Valencia
Study officials:
affiliation: University of Valencia
name: José-María Blasco, PT, PhD
role: STUDY_DIRECTOR
affiliation: University of Valencia
name: David Hernández-Guillén, PT, PhD
role: STUDY_CHAIR
affiliation: University of Valencia
name: Catalina Tolsada-Velasco, PT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01273012: Cost-effectiveness of Infloran (TM) in Treating Acute Childhood Diarrhea in Phramongkutklao Hospital
Official title: Cost-effectiveness of Infloran (TM) in Treating Acute Childhood Diarrhea in Phramongkutklao Hospital
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Diarrhea
Keywords: probiotic
cost-effectiveness
diarrhea
children
Sum of the monetary cost of the hospitalization
Lead sponsor: Phramongkutklao College of Medicine and Hospital
Sponsor class: OTHER
First posted: 2011-01-10
Enrollment: 128
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to determine whether the probiotic Infloran is cost-effective in treating acute childhood diarrhea.

Detailed description: Probiotics have been proved to shorten duration of diarrhea in children; whether they are cost-effective is less clear. We'd like to validate the use of Infloran, a proprietary probiotic sold in Thailand, in terms of its cost-effectiveness compared to standard diarrhea care in our hospital setting.

Eligibility criteria: Inclusion Criteria:

* Children 3 months to 6 years of age
* Hospitalized due to acute diarrhea

Exclusion Criteria:

* History of probiotic treatment in this episode of illness
* History of use of other anti-diarrheal medications
* Chronic gastrointestinal disease(s)
* Severe dehydration
* Severe systemic disease(s)

Primary outcomes:
measure: monetary cost of hospitalization in Thai Baht
timeFrame: from admission to discharge date, approximately 1-7 days
Secondary outcomes:
measure: days of hospitalization
timeFrame: from admission to discharge date, approximately 1-7 days
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Department of Pediatrics, Phramongkutklao Hospital
Study officials:
affiliation: Department of Pediatrics, Phramongkutklao
name: Nopaorn Phavichitr, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02146612: Amino Acid Usage Patterns in Daily Practice
Official title: An Observational Study to Evaluate Amino Acid Usage Patterns in Daily Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wounds
Lean Body Mass
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2014-05-26
Enrollment: 354
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: Subjects receiving amino acid supplement prior to enrollment

Brief summary: The present study aims to evaluate the patient profile including medical conditions who use a nutritional supplement along with a balanced and varied diet in Turkey.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old.
* Consuming amino acid containing oral nutritional supplement before enrolment for malnutrition for hard-to-heal wounds or malnutrition due to primary disease.
* Followed by internal medicine or surgery departments.

Exclusion Criteria:

* History of allergy or hypersensitive reaction to any ingredient in the amino acid containing oral nutritional supplement.
* History of any food allergy or intolerance

Primary outcomes:
measure: Frequencies of Medical Conditions
timeFrame: Baseline
Secondary outcomes:
measure: Intake of Amino Acid containing Nutrition Supplement
timeFrame: Baseline and Week 8
measure: Anthropometrics
timeFrame: Change from Baseline to Week 8
measure: Laboratory Parameters
timeFrame: Change from Baseline to Week 8
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Adana Numune Eğitim ve Araştırma Hastanesi
city: Adana
country: Turkey
facility: Çukurova Üniversitesi Tıp Fakültesi
city: Ankara
country: Turkey
facility: ANKARA ATATÜRK Eğitim ve Araştırma Hastanesi
city: Ankara
country: Turkey
facility: Ankara Numune Eğitim ve Araştırma Hastanesi
city: Ankara
country: Turkey
facility: Dışkapı Yıldırım Beyazıt Eğitim ve Araştırma Hastanesi
city: Ankara
country: Turkey
facility: Gazi Üniversitesi Tıp Fakültesi
city: Bursa
country: Turkey
facility: Bursa Çekirge Devlet Hastanesi
city: Bursa
country: Turkey
facility: Uludağ Üniversitesi Tıp Fakültesi
city: Eskişehir
country: Turkey
facility: Acıbadem Eskişehir Hospital
city: İstanbul
country: Turkey
facility: Fatih Sultan Mehmet Eğitim ve Araştırma Hastanesi
city: İstanbul
country: Turkey
facility: GÜLHANE ASKERİ TIP AKADEMİSİ - İstanbul
city: İstanbul
country: Turkey
facility: İstanbul Üniversitesi İstanbul Tıp Fakültesi
city: İstanbul
country: Turkey
facility: T.C.Bezmiâlem Vakıf Üniversitesi Tıp Fakültesi Hastanesi
city: İzmir
country: Turkey
facility: Dr. Suat Seren Gogus Hastaliklari Hastanesi
city: İzmir
country: Turkey
facility: Ege Üniversitesi Tıp Fakültesi
city: Kayseri
country: Turkey
facility: Erciyes Üniversitesi Tıp Fakültesi
city: Samsun
country: Turkey
facility: Ondokuz Mayıs Üniversitesi Tıp Fakültesi
city: Trabzon
country: Turkey
facility: Karadeniz Teknik Üniversitesi Tıp Fakültesi
Study officials:
affiliation: Abbott Nutrition Turkey
name: Tahsin Ozcagli, MD
role: STUDY_CHAIR
References: