louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03654365: Advanced Electronic Population Health and Personal Health Record Tools to Improve Once Lifetime Hepatitis C Screening
Official title: Once Lifetime Hepatitis C (HCV) Screening Among Adults Using Advanced Electronic Population Health Tools and Personal Health Record Tools Tied to an Advanced Electronic Health Record (EHR).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis C
Keywords: preventative screening
electronic health records
personal health records
population health tools
Lead sponsor: MetroHealth Medical Center
Sponsor class: OTHER
First posted: 2018-08-31
Enrollment: 1024
Sex: ALL
Minimum age (years): 51
Maximum age (years): 71
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This study involves randomizing patients due for once in a lifetime Hepatitis C screening based on Center for Disease Control and Prevention and United States Preventative Services Task Force guidelines in one of three primary care clinics within the MetroHealth System to bulk messaging and bulk ordering for HCV antibody vs usual care (routine alerting).

Detailed description: All patients had to have an active personal health record account at the time of being randomized.

Patients had to have been seen by their primary care provider in the last 6 months to be eligible and therefore had a "missed opportunity" for Hepatitis C screening.

Control group received "usual care" which in our system included alert (health maintenance reminder) to the primary care provider at the time of the visit and passive alert in their personal health record (i.e. an alert if they log into their personal health record and look for reminders for preventative care that it due/overdue).

Intervention group received same care as control group plus automatic ordering of the hepatitis C screening test and active electronic letter their personal health record that they were due for hepatitis C screening, what hepatitis C is, what the testing and if positive, treatment could involve, and instruction to go to one of the laboratories in the healthcare system to have their blood drawn if they were interested in the testing.

Eligibility criteria: Inclusion Criteria:

* seen recently in one of the three primary care study sites and have an active person health record at the time of randomization; and meet Centers for Disease Control and Prevention/United States Preventative Services Task Force guidelines for once in a lifetime hepatitis C screening

Exclusion Criteria:

* already had once in a lifetime screen for hepatitis C or positive for hepatitis C (by lab test or International Classification of Disease code)

Primary outcomes:
measure: Impact on hepatitis C antibody testing rates at 12 weeks post direct patient messaging
timeFrame: 12 weeks post-intervention
Secondary outcomes:
measure: Impact of bulk ordering vs bulk messaging and bulk ordering on HCV antibody testing rates
timeFrame: 12 weeks post-intervention
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01281566: A Study of Cisapride in Premature Infants With Feeding Problems
Official title: Double-blind, Randomized, Placebo-controlled Clinical Trial to Assess the Efficacy and Safety of R051619 (Cisapride Oral Suspension 0.2mg/kg q.i.d) for the Treatment of Feeding Intolerance in Premature Infants
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Infant, Premature
Infant, Newborn
Keywords: Cisapride (Prepulsid)
Feeding intolerance
Enteral feeding
Nasogastric tube
Neonate
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
First posted: 2011-01-24
Enrollment: 8
Sex: ALL
Minimum age (years): 36
Maximum age (years): 99
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness of Cisapride in improving feeding problems in premature newborn infants.

Detailed description: This is a double-blind study where the identity of the treatment assigned (Cisapride or placebo) will not be known to the patient's legal guardian or any study staff involved with the study. Patients will be randomized (assigned by chance) to receive either the drug Cisapride or a placebo (a placebo is identical in appearance to Cisapride but does not contain Cisapride or any active drug) to see if Cisapride is effective in improving feeding problems (referred to as feeding intolerance) in premature newborn infants who cannot tolerate oral feeding by mouth or through a tube going directly to the stomach or intestine. Patients will be given either cisapride at a dose of 0.2 mg/kg or placebo as a liquid suspension through a tube from the nose to the stomach (referred to as a nasogastric tube) 15 minutes before feeding once every 6 hours (or 4 times a day referred to as a q.i.d. schedule).

Eligibility criteria: Inclusion Criteria:

* Must be hospitalized and on continuous cardiac monitoring for the duration of the study
* Patient has demonstrated feeding intolerance as defined by the protocol
* Patient's parent or legal guardian must sign the informed consent form

Exclusion Criteria:

* Currently active significant cardiovascular disease, as determined by the neonatologist/physician, including congenital heart disease and heart block (patent ductus arteriosus without cardiac compromise at the time of randomization is acceptable)

Primary outcomes:
measure: Time from start of study medication to full enteral feeding
timeFrame: Up to 42 days
Secondary outcomes:
measure: Number and type of adverse events
timeFrame: Up to 42 days
Other outcomes:
Locations:
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT02600065: Analysis of CMV Infections in Patients With Brain Tumors or Brain Metastases During and After Radio(Chemo)Therapy
Official title: Analysis of CMV Infections in Patients Suffering From Brain Tumors and Brain Metastases During and After Radio(Chemo)Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cytomegalovirus Infections
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2015-11-09
Enrollment: 350
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 with brain tumours (glioblastoma or anaplastic astrocytoma Patients with brain metastases from diagnosed primary tumours

Brief summary: Radio(chemo)therapy is the standard therapy for both, brain tumors and brain metastases. Neurological decline is observed in these patients and tumor progression or radiotherapy side effects have been made responsible for this. However CMV encephalitis may also be a reason. Therefore the investigators aim to analyze the CMV status in patients during and after radio(chemo)therapy. It will be checked by CMV-DNA (PCR analysis) and CMV antibodies (IgG and IgM ELISA) in the blood of the patients. These findings will be correlated with changes in the brain, visualized by MRI. In addition a detailed immunophenotyping in the peripheral blood will be performed.


Eligibility criteria: Inclusion Criteria:

* brain tumours (glioblastoma or anaplastic astrocytoma)
* brain metastases from diagnosed primary tumours
* legal age
* planned chemoradiation and adjuvant chemotherapy \[metastases\]
* planned chemoradiation and adjuvant chemotherapy with temodal (according to Stupp et. al.) \[brain tumors\]

Exclusion Criteria:

* fertile patients who refuse effective contraception during study treatment
* persistent drug and/or alcohol abuse
* patients not able or willing to behave according to study protocol
* patients in care
* patients that are not able to speak German
* patients with claustrophobia
* patients with artificial joint or any metal parts in the body
* patients with pacemakers

Primary outcomes:
measure: Change of CMV status during radio(chemo)therapy (RCT)
timeFrame: up to day 45 after start of Radiotherapy
Secondary outcomes:
measure: Change of circulating immune cells of treated patients by deep immunophenotyping.
timeFrame: up to month 6 after the start of Radiotherapy
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Departement of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität erlangen-Nürnberg
state: Bavaria
Study officials:
affiliation: Department of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg
name: Rainer Fietkau, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01362465: Characterization of Interventricular Conduction Measurements
Official title: Characterization of Interventricular Conduction Measurements
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Heart Failure
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
First posted: 2011-05-30
Enrollment: 25
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: This study is an effort to use left ventricular (LV) lead based measurements to identify late electrical activation and avoid scar.

Detailed description: The aim of this study is to characterize how right ventricular (RV) to left ventricular (LV) conduction delays are altered by pacing site in patients with a cardiac resynchronization therapy (CRT) system. The study will be performed in conjunction with a CRT implant.

Eligibility criteria: Inclusion Criteria:

* Patient is greater than 18 years of age.
* The patient or the patient's legally authorized representative is willing to give informed consent.
* CRT indicated guidelines.
* Patient is receiving a Medtronic IPG or ICD.

Exclusion Criteria:

* Patients who are pregnant.
* Patient is in AF.
* Patient with 3rd degree AV block.

Primary outcomes:
measure: Measure how RV to LV conduction times are altered by pacing site in patients with a CRT system.
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Durham VA
name: Brett Atwater, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Catholic Health Initiative Iowa Corp
name: Robert Hoyt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sterns Cardiovascular Foundation
name: Eric E Johnson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chicago
name: John F Beshai, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00846066: Oral Health Training Program for Pediatric Residents
Official title: Effective Educational Instruction in Preventive Oral Health: Hands On Training (HOT)Versus Web Based Training (WBT): A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preventive Oral Health
Keywords: educational research,
instructional methods,
Hands on training,
Web based training,
pediatric residents
preventive oral health,
dental caries,
Instructional strategies in Preventive Oral health
Web-based training on Preventive Oral Health
Hands on Training on Preventive Oral Health
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
First posted: 2009-02-18
Enrollment: 56
Sex: ALL
Minimum age (years): 22
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study was to compare the effect of the addition of hands on training by a pediatric dentist on the pediatric residents skills, confidence, opinions and practice related to preventive oral health.

Detailed description: Objectives:

To compare the addition of Hands on Training (HOT) to Web Based Training (WBT)on residents' skills, confidence, opinions and practice .

Methods: Pediatric residents participated in WBT on preventive oral health. Then the WBT subjects were randomly assigned to receive HOT by a dentist, or WBT alone. All subjects were assessed on skills in the performance of an oral exam, by direct observation. Residents' confidence regarding oral health counseling, and their opinions about the importance of the incorporation of oral health into the well child visit, was measured by surveys utilizing a Likert scale. Residents' change in practice was assessed by a retrospective chart audit.

Eligibility criteria: Inclusion Criteria:

Pediatric Residents in the Continuity Care Clinics at Children's Mercy Hospital during the months of January and February 2007

Exclusion Criteria:

1. Residents on leave of absence
2. Residents who have their Continuity Care Clinics off site
3. Residents refusing consent for inclusion of results in study

Primary outcomes:
measure: Mean Percentage of Correct Skills
timeFrame: 3 months after Hands-on Training (HOT)
measure: Percent Change From Baseline in Confidence at 4 Months
timeFrame: Baseline and 4 months
measure: Percent Change From Baseline in Opinions Regarding Incorporating Oral Health Into a Well Child Visit at 4 Months
timeFrame: Baseline and 4 months
measure: Percent Change From Baseline in Practice of Oral Health Based on Pre and Post Study Chart Audit at 6 Months
timeFrame: At baseline and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Childrens Mercy Hospital
state: Missouri
Study officials:
affiliation: Children's Mercy Hospital Kansas City
name: Nasreen J Talib, MD,MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03277066: A 4-week Study to Evaluate the Efficacy and Safety of HP-5000 in Subjects With Knee Osteoarthritis
Official title: A 4-week, Randomized, Double-blind, Multicenter, Placebo-controlled Phase 2 Study to Evaluate the Efficacy and Safety of HP-5000 in Subjects With Osteoarthritis (OA) of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis of the Knee
Lead sponsor: Noven Therapeutics
Sponsor class: INDUSTRY
First posted: 2017-09-08
Enrollment: 289
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A 4-week, Randomized, Double-blind, Multicenter, Placebo-controlled Phase 2 Study to Evaluate the Efficacy and Safety of HP-5000 in Subjects with Osteoarthritis (OA) of the Knee

Detailed description: This is a multicenter, randomized, double-blind, and placebo-controlled phase 2 study evaluating 2 formulations of HP-5000 in subjects with OA of the knee. The study will consist of up to 28-day Screening Phase that will include a Washout Period of current prescription and over the counter (OTC) analgesics, a 4-week double-blind Treatment Phase, and a 1-week safety Follow-up Period.

Eligibility criteria: Inclusion Criteria:

* Male or female aged 40 to 85 years with a clinical diagnosis of OA of the target knee according to the American College of Rheumatology (ACR) criteria, including:
* Symptoms for at least 6 months prior to screening, AND
* Knee pain in the target knee for 30 days of the preceding month (periarticular knee pain due to OA and not due to other conditions such as bursitis, tendonitis, etc.) AND
* The pain in the target knee required the use of nonsteroidal anti-inflammatory drugs (NSAIDs) either over the counter (OTC) per recommendation of a physician or prescribed.

Exclusion Criteria:

* Body mass index (BMI) \> 40
* Any subject who disobeyed the restriction of prohibited therapies (i.e., use rescue medication) during Screening Washout Period.
* Secondary OA of the knee (rheumatoid arthritis, gout, psoriasis, syphilitic neuropathy, ochronosis, metabolic or other primary bone disease or acute trauma).

Primary outcomes:
measure: Evaluate Efficacy & Safety of HP-5000 Topical Patches in Subjects With Osteoarthritis of the Knee: Change in Osteoarthritis Pain Score
timeFrame: Baseline and 4 weeks
Secondary outcomes:
measure: WOMAC Pain Score Week 2 Change From Baseline
timeFrame: Baseline and 2 weeks
measure: WOMAC Stiffness Score Change From Baseline
timeFrame: Baseline and 4 weeks
measure: WOMAC Physical Function Score
timeFrame: Baseline and 4 weeks
Other outcomes:
Locations:
city: Jersey City
country: United States
facility: Noven Pharmaceuticals, Inc.
state: New Jersey
Study officials:
affiliation: Noven Pharmaceuticals, Inc.
name: Gunnar Klauss, MD, MSc
role: STUDY_DIRECTOR
References:
Clinical trial NCT03763266: Low Residue Diet During 3 Days vs 1 Day Prior Colonoscopy
Official title: Low Residue Diet 3 Days Versus 1 Day as Preparation for Colonoscopy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonoscopy
Colon Adenoma
Colorectal Neoplasms
Inflammatory Bowel Diseases
Colon Disease
Keywords: bowel preparation
low residue diet
colonoscopy
Lead sponsor: Parc Taulí Hospital Universitari
Sponsor class: OTHER
First posted: 2018-12-04
Enrollment: 858
Sex: ALL
Minimum age (years): 50
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Colonoscopy is the gold-standard for the evaluation of the colorectal mucosa. Colonoscopy quality indicators are the adenoma detection rate, the rate of cecal intubation and the bowel preparation.

The role of diet in preparing for colonoscopy is not fully established. Currently there is not enough evidence available to choice between 3 days of low residue diet versus 1 day.

The research hypothesis is that the low residue diet offers a non-inferior bowel preparation and an improved tolerance.


Eligibility criteria: Inclusion Criteria:

* Participants in the colorectal cancer screening program that give consent

Exclusion Criteria:

* Contraindication for colonoscopy

Primary outcomes:
measure: Bowel preparation
timeFrame: During the colonoscopy
Secondary outcomes:
measure: Diet tolerance
timeFrame: It is reported before entering the endoscopy room. Regarding the 3 or 1 days on low fiber diet depending on which study group is the participant.
measure: Preparation tolerance
timeFrame: It is reported before entering the endoscopy room. Regarding the 3 or 1 day on bowel preparation depending on which study group is the participant.
measure: Adenoma detection rate
timeFrame: up to 2 weeks after colonoscopy depending on pathology department workload.
measure: Endoscopic diagnosis
timeFrame: It is assessed during the colonoscopy and will be reported the same day.
measure: Cecum intubation rate
timeFrame: It will be calculated through study completion, approximately 1 year, for all the study period using all participants having the colonoscopy done
measure: Intubation time
timeFrame: it is assessed from the start of the colonoscopy until cecum is reached (1 day)
measure: Withdrawal time
timeFrame: it is assessed from at the beginning of the withdrawal of the colonoscope until the colonoscopy is finished. (procedure)
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Hospital Parc Taulí
state: Barcelona
Study officials:
affiliation: Corporació Sanitaria Parc Taulí
name: Eva Martínez, PhD
role: STUDY_DIRECTOR
affiliation: Corporació Sanitaria Parc Taulí
name: Salvador Machlab, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Corporació Sanitaria Parc Taulí
name: Rafel Campo, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05964166: Tetragraph® Monitor: Tolerance of Preoperative Placement
Official title: Tetragraph® Monitor: Tolerance of Preoperative Placement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, non-blinded, single arm study. The primary objective of this study is to evaluate the tolerance to preoperative placement of the adhesive sensor for the Tetragraph® Neuromuscular Transmission Monitor in pediatric-sized patients ≤ 12 years of age.


Eligibility criteria: Inclusion Criteria:

1. Patients requiring anesthetic care and use of neuromuscular blockade
2. Age ≤ 12 years
3. ASA 1-4

Exclusion Criteria:

1. History of a peripheral neurologic or neuropathic disorder
2. Upper extremity cannot be used for TOF monitoring
3. Undergoing a surgical procedure in which neuromuscular blockade is not required
4. Patient is edematous
5. Patients with significant behavioral or neurocognitive issues which affect behavior and impact the ability to place the sensor

Primary outcomes:
measure: Tolerance to Preop Placement as Assessed by Likert Scale
timeFrame: 30 mins. prior to surgery
Secondary outcomes:
measure: Application Ease
timeFrame: 30 minutes prior to surgery
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT01311466: Liver Transplantation and Uveal Malignant Melanoma
Official title: Open Non-randomized Study to Assess the Benefit of Liver Transplantation in Patients With Liver Metastasis After Ocular Malignant Melanoma (Uveal Melanoma)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uveal Malignant Melanoma
Keywords: Liver transplantation
Overall survival
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2011-03-09
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with uveal malignant melanoma with liver metastases have median survival of less than 12 months. There is no established treatment showing increased overall survival. The study will determine if liver transplantation will result in long term survival in patients with liver metastases from uveal malignant melanoma.


Eligibility criteria: Inclusion Criteria:

* Uveal malignant melanoma
* Liver metastases
* ECOG 0-1

Exclusion Criteria:

* Extra hepatic disease
* Previous other malignancy
* Previous organ transplantation

Primary outcomes:
measure: Over all survival
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital, Radium hospitalet
name: Svein Dueland, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: