louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02280460: ECMO: Optimization of Its Use
Official title: Extracorporeal Membrane Oxygenation(ECMO): Optimization of Its Use
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Extracorporeal Membrane Oxygenation Complication
Lead sponsor: Spectrum Health Hospitals
Sponsor class: OTHER
Collaborators: name: Spectrum Health Hospitals
First posted: 2014-10-31
Enrollment: 921
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to Spectrum Health requiring ECMO therarpy. For the control, patients in the Intensive Care Unit at Spectrum Health will be considered.

Brief summary: To create a local registry for ECMO patients.

Detailed description: To create a local registry of retrospective and prospective patients on ECMO at Spectrum Health, Butterworth campus in order to optimize the use of ECMO therapy and to create algorithms to estimate the prognosis. ECMO patients will be compared to a control group of patients. Patient mortality will be assessed in-house, at 48 hours, 3 months, and 1 year after the start of ECMO therapy.

Eligibility criteria: Inclusion Criteria:

* Age \>18
* requiring ECMO. For the control,Patients without ECMO admited to ICU.

Exclusion Criteria:

* Age\<18
* Known prisoner of the state

Primary outcomes:
measure: All cause mortality
timeFrame: 1 year
Secondary outcomes:
measure: all cause mortality
timeFrame: 48 hours
measure: In-house mortality
timeFrame: 30 day
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: Spectrum Health
state: Michigan
Study officials:
affiliation: Spectrum Health Hospitals
name: Renzo Loyaga-Rendon, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zapol WM, Snider MT, Hill JD, Fallat RJ, Bartlett RH, Edmunds LH, Morris AH, Peirce EC 2nd, Thomas AN, Proctor HJ, Drinker PA, Pratt PC, Bagniewski A, Miller RG Jr. Extracorporeal membrane oxygenation in severe acute respiratory failure. A randomized prospective study. JAMA. 1979 Nov 16;242(20):2193-6. doi: 10.1001/jama.242.20.2193.
citation: Peek GJ, Mugford M, Tiruvoipati R, Wilson A, Allen E, Thalanany MM, Hibbert CL, Truesdale A, Clemens F, Cooper N, Firmin RK, Elbourne D; CESAR trial collaboration. Efficacy and economic assessment of conventional ventilatory support versus extracorporeal membrane oxygenation for severe adult respiratory failure (CESAR): a multicentre randomised controlled trial. Lancet. 2009 Oct 17;374(9698):1351-63. doi: 10.1016/S0140-6736(09)61069-2. Epub 2009 Sep 15.
Clinical trial NCT00243360: Optimizing Antibiotic Use in Long Term Care
Official title: Optimizing Antibiotic Use in Long Term Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Tract Infection, Antibiotic Use
Keywords: Urinary tract infections,
antibiotic use,
long term care facilities
Lead sponsor: Agency for Healthcare Research and Quality (AHRQ)
Sponsor class: FED
First posted: 2005-10-24
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: ECT

Brief summary: The purpose of this study was to determine if a multi-faceted intervention to implement diagnostic and therapeutic algorithms for management of suspected urinary infection in nursing home residents could reduce antibiotic prescribing for urinary indications in this population.

Detailed description: Antibiotic use is intense in nursing homes and frequently inappropriate when prescribed for urinary indications. Evidence from randomized controlled trials suggests that treatment of asymptomatic bacteriuria, the presence of bacteria in the urine in the absence of urinary symptoms, is not beneficial. Despite this, one in three prescriptions for urinary indications are for asymptomatic bacteriuria. To improve antibiotic prescribing in this setting we conducted a cluster randomized trial of a strategy to implement diagnostic and treatment algorithms for urinary infection. 24 nursing homes were randomized to either the intervention (implemented at the nursing home level using a multi-faceted approach: small group interactive sessions for nurses, one-on-one interviews for physicians, videotapes, written material, and outreach visits) or to usual care.

Eligibility criteria: Inclusion Criteria:

1. Individuals- all residents eligible
2. Nursing homes

   * Free standing long term care facilities with \>100 beds
   * No stated policy for diagnosis or treatment of urinary tract infections
   * The facility agrees to refrain from introducing new strategies for antibiotic utilization or clinical pathways during study

Exclusion Criteria:

-

Primary outcomes:
measure: Antimicrobial prescriptions
Secondary outcomes:
measure: Urinary cultures,
measure: hospitalizations, deaths
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: McMaster University
name: Mark B Loeb, MD MSc FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06951360: Workload Evaluation (Via NASA Task Load Index) of Robotic Assisted and Laparoscopic Surgery
Official title: ENERGY Study - Workload Evaluation (Via NASA Task Load Index) of Robotic Assisted and Laparoscopic Surgery
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Workplace Stress
Lead sponsor: Otto-von-Guericke University Magdeburg
Sponsor class: OTHER
First posted: 2025-04-30
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: * involved medical stuff (surgeons, OR nurses, further professions)
* patients undergoing laparoscopic and robotic procedures fulfilling the inclusion criterias

Brief summary: workload evaluation (via NASA Task Load Index) of robotic- assisted and laparoscopic surgery

Detailed description: evaluation of individual and overall workload during robotic visceral surgeries using NASA Task Load Index and one additional question referring to difficulty level of the operation in comparison with laparoscopic procedures

Eligibility criteria: Inclusion Criteria:

* robotic and laparoscopic procedures

Exclusion Criteria:

* decline of participation (patients, medical stuff)
* paparoscopic appendectomies, laparoscopic cholecystectomies

Primary outcomes:
measure: Overall workload
timeFrame: 5 years
measure: surgical expertise
timeFrame: 5 years
Secondary outcomes:
measure: NASA Task Load Index subscales
timeFrame: 5 years
measure: procedure's difficulty level
timeFrame: 5 years
measure: patient factors
timeFrame: 5 years
measure: procedure characteristics
timeFrame: 5 years
Other outcomes:
Locations:
city: Magdeburg
country: Germany
facility: Otto-von-Guericke University Magdeburg
state: Saxony-Anhalt
Study officials:
References:
citation: Quan H, Li B, Couris CM, Fushimi K, Graham P, Hider P, Januel JM, Sundararajan V. Updating and validating the Charlson comorbidity index and score for risk adjustment in hospital discharge abstracts using data from 6 countries. Am J Epidemiol. 2011 Mar 15;173(6):676-82. doi: 10.1093/aje/kwq433. Epub 2011 Feb 17.
citation: Lowndes BR, Forsyth KL, Blocker RC, Dean PG, Truty MJ, Heller SF, Blackmon S, Hallbeck MS, Nelson H. NASA-TLX Assessment of Surgeon Workload Variation Across Specialties. Ann Surg. 2020 Apr;271(4):686-692. doi: 10.1097/SLA.0000000000003058.
Clinical trial NCT01536860: Glycemic Response Testing
Official title: Glycaemic Response Testing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glycemic Index
Glycemic Response
Lead sponsor: Mondelēz International, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Reading Scientific Services Ltd.
First posted: 2012-02-22
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to assess whether added food ingredient(s) affect glycemic responses to a liquid meal tolerance test (LMTT).


Eligibility criteria: Inclusion Criteria:

* Male or female (not less than 40% males or females
* Non-smoker
* Aged 18 to 55 years
* Have a body mass index between 18.5 to 29.99 kg/m2
* Healthy, non-diabetic, no gastric bypass surgery
* Not allergic to mustard, dairy or soy
* Having a fasting plasma glucose (finger stick) \<100 mg/dl (\<5.5 mmol/L)
* Willing and able to provide written informed consent

Primary outcomes:
measure: Glycemic Response Measured as the Positive Incremental Area Under the Time-concentration Curve(iAUC) Calculated From Individual Glucose Measurements Upon Consumption of Control and Experimental Test Food Products
timeFrame: 0-120 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Reading
country: United Kingdom
facility: Reading Scientific Services Limited (RSSL)
state: Berkshire
Study officials:
affiliation: RSSL
name: Valerie Hart, SCS, Dip, MICR
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05848960: Mediterranean Diet and Nutritional Support in Heart Failure Sarcopenia
Official title: Nutritional Support With Mediterranean Diet and Hyper Caloric, Hyperproteic Oral Supplements in Heart Failure Sarcopenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Keywords: Heart failure
Sarcopenia
Nutritional support
Lead sponsor: Maimónides Biomedical Research Institute of Córdoba
Sponsor class: OTHER
First posted: 2023-05-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Heart failure (HF) is a chronic disease with an increasing incidence; it represents the final stage of multiple cardiac diseases and significantly affects the QoL of the patients. Its prevalence is about 26 million people in the world, especially in elderly. Sarcopenia has been directly associated with the presence of increased comorbidity in patients with HF. In this study the investigators aim to compare the clinical evolution of patients with HF after receiving nutritional support with Mediterranean diet alone or in combination with a hypercaloric, hyperproteic oral nutritional Supplement

Detailed description: All participants will receive general counseling, education about MedDiet and vitamin D supplementation in order to reach levels of sufficiency (25OH vitamin D\>30 ng/dL) for avoiding confounding results. Participants (n=50) will be randomly allocated to MedDiet or MedDiet plus hypercaloric, hyperproteic standard oral nutritional supplement (ONS), 2 ONS per da). Participants will be evaluated at baseline, 12 and 24 weeks after nutritional support

Eligibility criteria: Inclusion Criteria:

* - Patients with a previous admission due to HF in the previous 12 months
* Moderate or severe LVEF
* Both sexs
* Age \>18 years old.

Exclusion Criteria:

* MDRD \<15 ml/min
* End-stage liver disease.

Primary outcomes:
measure: Muscle mass
timeFrame: 6 months
measure: Left ventricular ejection fraction
timeFrame: 6 months
Secondary outcomes:
measure: pro-BNP
timeFrame: 6 months
measure: Fat mass
timeFrame: 6 months
measure: Phase angle
timeFrame: 6 months
measure: Albumin
timeFrame: 6 months
measure: Preallbumin
timeFrame: 6 months
measure: Transferrin
timeFrame: 6 months
measure: CRP
timeFrame: 6 months
Other outcomes:
Locations:
city: Cordoba
country: Spain
facility: IMIBIC
Study officials:
References:
Clinical trial NCT02929160: Percutaneous Nephrostomy Versus Stent In Sepsis Trial
Official title: Optimal Method of Decompression of the Renal Collecting System in Acute Obstruction: a Prospective Randomised Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Ureteric Calculus
Sepsis
Hydronephrosis
Lead sponsor: The Adelaide and Meath Hospital, incorporating The National Children's Hospital
Sponsor class: OTHER
First posted: 2016-10-11
Enrollment: 0
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: Randomized control trial to compare the efficacy and safety of percutaneous nephrostomy with retrograde ureteric stenting for emergency renal decompression in cases of obstruction and sepsis associated with ureteric calculi.

Detailed description: The obstructed kidney in the setting of urosepsis is a urological emergency. Stone manipulation in the setting of active, untreated infection with concomitant urinary tract obstruction can lead to life-threatening sepsis. Therefore, urgent decompression of the collecting system is warranted.

There are two options for urgent decompression of an obstructed collecting system:

1. Image-guided percutaneous nephrostomy tube placement
2. Cystoscopic retrograde placement of a ureteric stent

This strategy allows drainage of infected urine and penetration of antibiotics to the affected renal unit. Definitive stone manipulation should be delayed until the infection is cleared following an appropriate course of antimicrobial therapy.

Both the European Association of Urology (EAU) and the American Urological Association (AUA) provide guidelines for management of an obstructed kidney. Both organisations provide evidence-based statements of the highest recommendation that urgent decompression of the kidney is mandated in the setting of sepsis. However, neither organisation recommend one decompression modality over the other. There is a lack of high quality up-to-date evidence to support a consensus view that one method of decompression is superior to the other.

This study aims to determine the most effective method of renal decompression in cases of obstruction and sepsis associated with ureteric calculi.

Eligibility criteria: Inclusion Criteria:

* Ureteric calculus with proximal hydronephrosis confirmed on CT KUB
* White cell count \>12,000mm3 and/or temperature \>38C

Exclusion Criteria:

* Uncorrected coagulopathy
* Urethral or ureteric stricture disease
* Urinary diversion
* Pregnancy

Primary outcomes:
measure: Time to normalisation of white cell count and/or temperature
timeFrame: Within 1 week
Secondary outcomes:
measure: Length of hospital stay
timeFrame: Within 1 week
Other outcomes:
Locations:
city: Tallaght
country: Ireland
facility: The Adelaide and Meath Hospital, incorporating The National Children's Hospital
state: Dublin
city: Dublin
country: Ireland
facility: St. James's Hospital
Study officials:
References:
Clinical trial NCT03489460: Research Exploring Sleep Education & Technology
Official title: Research Exploring Sleep Education & Technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Health
Keywords: sleep health
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-04-05
Enrollment: 1060
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A pilot study that seeks to develop a set of typologies of users of mobile sleep tracking technologies, and optimal sleep health educational strategies among users of mobile wearable technologies that track sleep.


Eligibility criteria: Inclusion Criteria:

* A current user of the OURA ring activity and sleep tracker device.

For Aim 3 MOST message testing, the inclusion criteria include the following:

* Health conscious.

Exclusion Criteria:

* Non English speakers.

Primary outcomes:
measure: Sleep time measured by wearable mobile sleep tracking technology
timeFrame: 15 Days
measure: Time in deep sleep measured by wearable mobile sleep tracking technology
timeFrame: 15 Days
measure: Dysfunctional Beliefs about Sleep (DBAS) scale
timeFrame: 1 Day
measure: Measure of motivation to change using the Change Assessment Scale (CAS)
timeFrame: 15 Days
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Girardin Jean-Louis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01211860: Pharmacokinetic Study of Diazoxide Choline in Hypertriglyeridemic Subjects
Official title: A Multiple-Dose Pharmacokinetic Study of Diazoxide Choline Controlled-Release Tablet (DCCR) in Subjects With Elevated Fasting Triglyceride Levels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertriglyceridmia
Keywords: DCCR
Diazoxide Chonline Controlled-Release Tablet = DCCR
Hypertriglyceridemia
Triglycerides
Pharmacokinetics
Lead sponsor: Essentialis, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Cetero Research, San Antonio
First posted: 2010-09-30
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Once a day oral administration with DCCR is the optimal dosing regimen

Detailed description: POPULATION The population will consist of generally healthy subjects with elevated fasting triglyceride levels in the range of ≥ 150 mg/dL and ≤ 1500 mg/dL at the Screening Visit.

Number of Subjects A total of 10 subjects will be enrolled in the study at 1 site in the USA.

Eligibility criteria: Inclusion Criteria:

Basic requirements

1. Healthy male and female subjects 18 to 75 years of age, inclusive at the time of dosing
2. Body mass index (BMI) between 22 and 35 kg/m2

   Specific laboratory test results
3. Fasting triglyceride ≥ 150 mg/dL and ≤ 1500 mg/dL
4. Fasting glucose ≤ 110 mg/dL
5. HbA1c ≤ 6.0 %

Exclusion Criteria:

Medications: recent, current, anticipated

1. Thyroid hormones or preparations within 1 month prior to Screening Visit (except in subjects on stable dose of replacement therapy for at least 1 month)
2. Thiazide diuretics within 2 weeks prior to Screening Visit

   History of allergic reaction or significant intolerance to:
3. Diazoxide
4. Thiazides
5. Sulfonamides

   Lifestyle changes
6. Subjects intending to change exercise habits, and/or quit smoking

   Specific diagnoses, medical conditions and history
7. Known type I or III hyperlipidemia
8. Known type 1 DM
9. Known type 2 DM
10. Any other clinically significant endocrine, cardiovascular, pulmonary, neurological, psychiatric, hepatic, gastrointestinal, hematological, renal, or dermatological disease interfering with the assessments of the investigational drug, according to the Investigator

    Specific laboratory test results
11. Any relevant biochemical abnormality interfering with the assessments of the investigational drug

Primary outcomes:
measure: Steady-state Pharmacokinetic profile of DCCR
timeFrame: 10 days
Secondary outcomes:
measure: Concentration-Time profile of major metabolite
timeFrame: 10 days
Other outcomes:
Locations:
city: Fargo
country: United States
facility: Cetero
state: North Dakota
Study officials:
affiliation: Cetero Research - Fargo, ND
name: Alan K Copa, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05234060: Study of People's Profile Living in France Who Could be Interested in the Use of a Nanohydroxyapatite Toothpaste
Official title: Study of People's Profile Living in France Who Could be Interested in the Use of a Nanohydroxyapatite Toothpaste
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Caries
Hydroxyapatite
Keywords: Cariostatic Agents
Toothpaste
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2022-02-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Peoples who lives in France

Brief summary: Nano-hydroxyapatite is an interesting candidate to be a substitute for fluor in toothpastes or a complement to fluorides in order to prevent caries. The objective of this transversal descriptive study is to evaluate the profiles of people living in France who could be interested in using a nano-hydroxyapatite based toothpaste.

Participants in this transversal descriptive study have been chosen by a self-administered method. Before answering 16 questions, the participants were asked to watch a short video describing the main concepts to know about fluoridated toothpastes and nano-hydoxyapatite toothpastes. Pros and cons of each one them were mentioned. In order to compare the answers, pivot tables have been produced.


Eligibility criteria: Inclusion criteria:

* Internet acces
* Interested in the Use of a Nanohydroxyapatite Toothpaste

Exclusion criteria:

* Age \< 18 years
* Peoples who no lives in France

Primary outcomes:
measure: Number of people interested in using toothpaste based on nano-hydroxyapatite
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Nicolas Giraudeau, PhD
role: STUDY_DIRECTOR
References: