louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02339792: E-learning to Improve the Quality of Drug Prescribing in Hospitalized Elderly Patients
Official title: Effect of an Integrated E-learning Intervention, Focused on Comprehensive Geriatric Assessment to Improve the Quality of Drug Prescribing in Hospitalized Elderly Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug Use
Keywords: COMPREHENSIVE GERIATRIC ASSESSMENT (CGA)
MEDICATION APPROPRIATENESS PRESCRIBING
DRUG INTERACTIONS
E-LEARNING
Lead sponsor: Mario Negri Institute for Pharmacological Research
Sponsor class: OTHER
Collaborators: name: Agenzia Italiana del Farmaco
First posted: 2015-01-15
Enrollment: 697
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized controlled pragmatic study is aimed to set-up, assess and implement an integrated e-learning program of medical education in an hospital setting, focused on teaching and implementing CGA added to geriatric pharmacological notions (GPNs) to improve the quality of drug prescribing in elderly patients

Detailed description: The integrated e-learning program (intervention group) is focused on teaching and implementing knowledge on CGA and GPNs to help clinicians to improve the quality of drug prescribing in the elderly.The GPNs is focused on pharmaco-epidemiological issues of drug prescribing, pharmacokinetic and pharmacodynamic changes during aging, topics in evaluating and managing polypharmacy, criteria to review the appropriateness of drug therapies and the clinical relevance of PDDI in the elderly. The control group receives only GPNs.

Eligibility criteria: Inclusion Criteria:

* people aged 75 years or older

Exclusion Criteria:

* people aged 75 years or older
* refusal of consent to participate
* a life expectancy of less than 6 months

Primary outcomes:
measure: Improvement of drug prescribing
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 12 days
Secondary outcomes:
measure: clinical outcomes (lenght of hospitalization, mortality, rehospitalization)
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
citation: Franchi C, Tettamanti M, Djade CD, Pasina L, Mannucci PM, Onder G, Gussoni G, Manfellotto D, Bonassi S, Salerno F, Nobili A; ELICADHE Investigators. E-learning in order to improve drug prescription for hospitalized older patients: a cluster-randomized controlled study. Br J Clin Pharmacol. 2016 Jul;82(1):53-63. doi: 10.1111/bcp.12922. Epub 2016 Apr 5.
Clinical trial NCT00232492: Ketamine on Acute Pain in Females and Males
Official title: Effect of Racemic Ketamine on Pain in Females and Males After Surgical Removal of Third Molars
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Mouth and Tooth Diseases
Tooth, Impacted
Keywords: Wisdom
Tooth
Teeth
Third
Molar
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University of Oslo
First posted: 2005-10-04
Enrollment: 128
Sex: ALL
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine whether equal subanesthetic doses of racemic ketamine is equally effective on females and males after surgical removal of third molars

Detailed description: Ketamine is assumed to be a NMDA receptor antagonist which provides analgesia from acute postoperative pain(and other types of pain) subanesthetic doses. Gender differences in ketamine analgesia are not known. This placebo-controlled,randomised, parallel group study investigates the analgesic dose-response effect of ketamine in subanesthetic doses in female and male patients following surgical removal of third molars.

Comparisons: Placebo and ketamine in females and males.

Eligibility criteria: Inclusion Criteria:

* Indication for removal of third molar
* Between 20 and 30 years of age
* ASA Class 1

Exclusion Criteria:

* Psychiatric family (father/mother) or own anamnestic history
* Hypersensitivity towards NSAIDS or other rescue analgesics
* Verified or suspected pregnancy
* Lactating females
* Surgery lasting over 60 min

Primary outcomes:
measure: Sum pain NRS
timeFrame: 60 min
Secondary outcomes:
measure: Several subjective variables assessing psychotomimetic effects
timeFrame: 0, 15, 60
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Department of Oral and Maxillofacial Surgery, Ullevaal University Hospital
Study officials:
affiliation: Section of Dental Pharmacology and Pharmacotherapy, Faculty of Dentistry, POB 1119 Blindern, University of Oslo, N-0317 Oslo, Norway
name: Lasse A Skoglund, DDS, PhD
role: STUDY_CHAIR
affiliation: Section of Dental Pharmacology and Pharmacotherapy, Faculty of Dentistry, POB 1119 Blindern, University of Oslo, N-0317 Oslo, Norway
name: Olav Hustveit, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Oye I, Mathisen LC. The effect of CPP in neurogenic pain: inhibition of spinal or cortical NMDA receptors? Pain. 1993 Jun;53(3):358. doi: 10.1016/0304-3959(93)90234-G. No abstract available.
citation: Øye I, Hustveit O, Maurset A, Ratti Moberg E, Paulsen O, Skoglund LA. The chiral forms of ketamine as probes for NMDA receptor functions in humans. In: NMDA receptor related agents: Biochemistry, pharmacology and behaviour. Kameyama T, Domino E (eds). NPP Books, Ann Arbor, 1991.
Clinical trial NCT02334592: Vitamin D Production Levels Achieved by Sunbed Tanning
Official title: The Impact of Health Canada's Sunbed Exposure Time Guidelines on Serum 25(OH)D Concentrations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: the effect of tanning
vitamin D production
Lead sponsor: Vitamin D Society
Sponsor class: OTHER
First posted: 2015-01-08
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Health Canada's Radiation Emitting Devices (RED) Act provides exposure time guidelines for sunbed use. These guidelines are intended to protect sunbed users from overexposure to UV radiation. Overexposure is defined as "exposure that exceeds the amount needed for vitamin D production and could lead to skin or eye damage. Acute overexposure induces sunburn." However, the effect of the recommended time exposure schedule on serum 25(OH)D response has not been characterized. Further, it is unknown if the maximum time exposures are required to reach and/or maintain optimal 25(OH)D levels. The aim of the current study is to characterize serum 25(OH)D response to regular sunbed use following the time exposure schedule recommended by Health Canada.


Eligibility criteria: Inclusion Criteria:

* 18 years and older, male or female

Exclusion Criteria:

* History of skin cancer, granulomatous disease, liver disease, or kidney disease
* Photosensitive medications
* Pregnancy
* Vitamin D supplementation within last 60 days
* Sunbed use within last 60 days
* Planned travel to sunny destination during study period (January to April 2014)

Primary outcomes:
measure: To characterize serum 25(OH)D response to regular sunbed use, when performed according to the RED Act exposure time guidelines
timeFrame: 12 weeks
Secondary outcomes:
measure: To characterize serum 25(OH)D response with respect to sunbed lamp output (100W, 160W and High Pressure).
timeFrame: 12 weeks
measure: To characterize serum 25(OH)D level with respect to skin lightness.
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: Kimball SM, Lee J, Vieth R. Sunbeds with UVB radiation can produce physiological levels of serum 25-Hydroxyvitamin D in healthy volunteers. Dermatoendocrinol. 2017 Oct 17;9(1):e1375635. doi: 10.1080/19381980.2017.1375635. eCollection 2017.
Clinical trial NCT00888992: Technology-Enhanced Quitline Services to Prevent Smoking Relapse
Official title: Technology-Enhanced Quitline Services to Prevent Smoking Relapse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: Smoking
Cessation
Quitline
Counseling
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Consumer Wellness Solutions
name: Kaiser Foundation Hospitals, Center for Health Research
name: University of Washington
First posted: 2009-04-28
Enrollment: 1785
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to see if automated telephone monitoring will enhance existing quitline services, such as Alere Wellbeing's Quit For Life program, and help people quit smoking. If successful, this intervention could be incorporated into existing quitline protocols and delivered to millions of people who are trying to quit smoking.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Enrolled in Free \& Clear, Inc. services
* Self-reported abstinence for at least 24 hours at the quit date call
* Able to read and speak English
* Personal access to a touch-tone telephone or cellular telephone

Exclusion Criteria:

* Have not stopped smoking for 24 hours
* Currently incarcerated
* Currently participating in any other smoking cessation research
* Live in same household as another study participant
* Participated in the Alere Wellbeing Quit for Life Program within the last 6 months
* Were previously enrolled in this study even if they repeat the smoking cessation program during the accrual period
* Hearing impaired enrollees receiving Free \& Clear services via telecommunications devices for the deaf (TDD) will be excluded from the study as the IVR technology currently does not have this capability

Primary outcomes:
measure: Participant smoking status.
timeFrame: 6 and 12 month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Alere Wellbeing (formally known as Free & Clear, Inc.)
state: Washington
Study officials:
affiliation: Indiana University
name: Anna M McDaniel, PhD RN FAAN
role: PRINCIPAL_INVESTIGATOR
affiliation: Consumer Wellness Solutions
name: Susan Zbikowski, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of New Mexico
name: Katie Witkiewitz, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kaiser Permanente
name: Jeffery Fellows, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McDaniel AM, Vickerman KA, Stump TE, Monahan PO, Fellows JL, Weaver MT, Carlini BH, Champion VL, Zbikowski SM. A randomised controlled trial to prevent smoking relapse among recently quit smokers enrolled in employer and health plan sponsored quitlines. BMJ Open. 2015 Jun 29;5(6):e007260. doi: 10.1136/bmjopen-2014-007260.
Clinical trial NCT05713292: Pirfenidone in Adult Hospitalized Patients With COVID-19
Official title: A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pirfenidone in Adult Hospitalized Patients With COVID-19.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: COVID-19 Pneumonia
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2023-02-06
Enrollment: 168
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: This center intends to conduct a multicenter, randomized, placebo-controlled study to evaluate the effectiveness and safety of Nintedanib ethanesulfonate soft capsule in the treatment of pulmonary fibrosis in patients with moderate to severe COVID-19.


Eligibility criteria: Inclusion Criteria:

* Subjects Age ≥ 18 Willing and able to provide written informed consent
* SARS-CoV-2 infection confirmed by PCR test/antigen dectection or positive serologies
* Time of illness onset ≥8 days
* Have findings consistent with interstitial lung disease found on CT scan
* Willing not use other investigational agents of anti-fibrosis

Exclusion Criteria:

* Pre-existing severe liver disease
* Pre-existing severe chronic kidney disease
* Pre-existing interstitial lung disease
* Pre-existing severe COPD or other structural lung disease
* Receiving invasive mechanical ventilation
* Currently Pregnant or Breast Feeding
* Poor baseline health conditoin
* Disability to complete lung function test
* Receiving pirfenidone wthin half-year

Primary outcomes:
measure: To investigate the effect of pirfenidone on fibrotic signs induced by COVID19 infection
timeFrame: 1 month
Secondary outcomes:
measure: distance walked in 6 Minutes (6MWD)
timeFrame: at the 1 month and 3 months follow-up vist
measure: the EuroQol five-dimension five-level (EQ-5D-5L)
timeFrame: at the 1 month and 3 months follow-up vist
measure: Medical Research Council (mMRC) dyspnoea scale
timeFrame: at the 1 month and 3 months follow-up vist
measure: difference of forced vital capacity (FVC) between two groups
timeFrame: at the 1 month and 3 months follow-up vist
measure: difference of total lung capacity (TLC) between two groups
timeFrame: at the 1 month and 3 months follow-up vist
measure: difference of DLCO between two groups
timeFrame: at the 3 months follow-up vist
measure: incidence of adverse event
timeFrame: within 2 months after enrollment
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT02616692: HCC Patient Preferences in Japan
Official title: Patient Preferences for Treatments for Hepatocellular Cancer (HCC) in Japan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Cancer
Keywords: HCC
Patient preferences
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2015-11-30
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with hepatocellular cancer (HCC)

Brief summary: This non-interventional cross-sectional online survey will evaluate preferences among patients with self-reported HCC. The survey will ask patients to express their preferences regarding descriptions of HCC treatments, which will include sorafenib (which will be described as 'oral anti-cancer therapy'), repeated transarterial chemoembolization (TACE), and hepatic arterial infusion chemotherapy (HAIC). Please note that all interventions that patients may have received before completing this online survey were given regardless of their participation in this survey. Questions also include asking patients to rank various treatment characteristics (e.g., mechanism of action, risk of adverse effects, etc.) relative to each other. The ultimate goal is to better understand patient perceptions of these treatments and to provide evidence to help in patients' and physicians' treatment decision-making in HCC.


Eligibility criteria: Inclusion Criteria:

The following eligibility criteria will be used:

* Have a diagnosis of HCC
* Are \> 20 years of age
* Reside in Japan
* Are able to read and understand Japanese to provide informed consent and complete the survey instrument

Exclusion Criteria:

None are currently considered

Primary outcomes:
measure: Preference weight scores for 13 selected HCC treatment attributes associated with Sorafenib, repeated TACE, and HAIC
timeFrame: up to 8 weeks
Secondary outcomes:
measure: Response to the direct preference elicitation item asking which is most preferred: oral anti-cancer therapy (Sorafenib), repeated TACE, and HAIC
timeFrame: up to 8 weeks
measure: Like/dislike ratings of each treatment attribute (Extent of patients like or dislike of different treatment attributes)
timeFrame: up to 8 weeks
measure: Willingness to try oral anti-cancer therapy (Sorafenib), TACE, and HAIC
timeFrame: up to 8 weeks
measure: Maximum acceptable risk of hand-foot skin reaction willing to take for oral anti-cancer therapy (Sorafenib) therapy that will stop cancer from getting worse for a specified period of time
timeFrame: up to 8 weeks
measure: Maximum acceptable risk of life-threatening side effect willing to take for oral anti-cancer therapy (Sorafenib) therapy that will stop cancer from getting worse for a specified period of time
timeFrame: up to 8 weeks
Other outcomes:
Locations:
city: Many Locations
country: Japan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04842292: Nebulized Heparin for COVID19-associated Acute Respiratory Failure
Official title: Utilization of Nebulized Heparin for Patients Receiving Mechanical Ventilation for COVID19-associated Acute Respiratory Failure
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Covid19
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2021-04-13
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of the current study is to investigate the utilization of nebulized heparin to circumvent pathologic changes in COVID-19 and prevent harmful effects possible with systemic anticoagulation.


Eligibility criteria: Inclusion Criteria:

Patients admitted with confirmed COVID-19 receiving mechanical ventilation for ARDS (paO2/FiO2 ratio =300) within 48 hours

Exclusion Criteria:

* Allergy to heparin
* Any history of heparin-induced thrombocytopenia
* High risk of bleeding (platelet count \< 50,000/µL or international normalized ratio \> 1.5)
* Patients with known bleeding disorders (i.e. hemophilia or von Willebrand Disease)
* Active bleeding
* Pulmonary bleeding during this hospital admission (Pulmonary bleeding is frank bleeding in the lungs, trachea or bronchi with repeated hemoptysis, or requiring repeated suctioning, and temporally associated with acute deterioration in respiratory status)
* Neurosurgical procedures during this hospital admission or such procedures are planned
* Epidural catheter in place
* Any history of intracranial, spinal or epidural hemorrhage
* Tracheostomy in place
* Cervical spinal cord injury associated with reduced long-term ability to breathe independently
* Spinal or peripheral nerve disease with a likely prolonged reduction in the ability to breathe independently
* Receiving extra-corporeal membrane oxygenation or continuous renal replacement therapy
* Usually treated with hemodialysis or peritoneal dialysis for end-stage renal failure
* Death is deemed imminent or inevitable or there is an underlying disease with a life expectancy of fewer than 90 days
* Pregnant or might be pregnant.
* Objection from the treating clinician
* Consent refused by the patient or substitute decision maker.
* History of thrombosis (VTE or cardiovascular event)

Primary outcomes:
measure: Mean PaO2/FiO2 Ratio
timeFrame: Within the first 10 days of ICU stay or up until ICU discharge, whichever occurs first
Secondary outcomes:
measure: Clinically Significant Bleeding
timeFrame: Up to discharge or 3 months following enrollment, whichever occurs first
measure: Incidence of Venous Thromboembolism
timeFrame: Up to discharge or 3 months following enrollment, whichever occurs first
Other outcomes:
Locations:
city: Lexington
country: United States
facility: UK Healthcare
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Brittany D Bissell
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06372392: Universal Fixed Meal Boluses Usage in Patients With Medtronic Minimed 780G Pumps
Official title: Randomized Controlled Study of the Usage of Universal Fixed Meal Bolus Coefficients for the Control of Postprandial Hyperglycemia in the Users of Medtronic Minimed 780G Pumps
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type1diabetes
Lead sponsor: Tartu University Hospital
Sponsor class: OTHER
Collaborators: name: Estonia Research Council
First posted: 2024-04-18
Enrollment: 20
Sex: ALL
Minimum age (years): 7
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Cross-over study of 20 pediatric patients (age 7-19) randomized to the group receiving universal fixed meal boluses coefficients (300/TDD for breakfast and 400/TDD other meal) or to the group with individualized coefficients for the period of 14 days with consecutive analysis of the results from Carelink Raport.


Eligibility criteria: Inclusion Criteria:

* age 7-19
* type 1 diabetes diagnosed at least 1 year ago
* insulin in the dose 0,5-1,0 units/day/kg
* MiniMed 780G pump usage at least 1 month.

Exclusion Criteria:

* Active coeliac disease
* Chronic disease possible to influence diabetes treatment
* Acute disease at the moment of recruitment

Primary outcomes:
measure: Time in range (TIR)
timeFrame: 4 weeks
Secondary outcomes:
measure: TBR
timeFrame: 4 weeks
measure: TAR
timeFrame: 4 weeks
measure: auto-corrections %
timeFrame: 4 weeks
measure: coefficient of variability
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Tartu
country: Estonia
facility: TartuUH
state: Tartumaa
Study officials:
affiliation: Tartu University Hospital
name: Aleksandr Peet
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05247892: Effectiveness of Ultrasound Versus Fluoroscopy Guided S1 Injections and Radiofrequency
Official title: Effectiveness of Ultrasound Versus Fluoroscopy Guided S1 Injections and Radiofrequency for the Management of Radicular Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Chronic
Lead sponsor: Diskapi Teaching and Research Hospital
Sponsor class: OTHER
First posted: 2022-02-21
Enrollment: 60
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 investigators aim to compare the effect of ultrasound versus floroscopy guided pulsed radiofrequency treatment of the lumbar dorsal root ganglion (DRG) of S1 in patients with a chronic lumbosacral radicular pain.


Eligibility criteria: Inclusion Criteria:

* Persistent pain score ≥ 4 on VAS, not responding to traditional treatments
* Radicular pain in lumbar region for 3 months or more,
* Pattern of radiation suggestive for S1 pathology

Exclusion Criteria:

* Patient refusal
* Coagulopathy
* Uncooperative patients
* Malignant disorder or currently under treatment for a malignant disorder
* Pregnancy
* Leg pain due to localized hip or knee pathology

Primary outcomes:
measure: Pain scores
timeFrame: baseline to 6 months post-procedure
Secondary outcomes:
measure: Oswestry Disability Index (ODI)
timeFrame: baseline to 6 months post-procedure
measure: Patient satisfaction Questionnaire
timeFrame: baseline to 6 months post-procedure
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Diskapi Yildirim Beyazit Training and Research Hospital
Study officials:
References: