louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01665365: Long-term Clinical Outcome in Patients Undergoing Remote Ischemic Conditioning Before Primary Percutaneous Coronary Intervention for ST-elevation Myocardial Infarction: a Follow-up Study
Official title: Long-term Clinical Outcome in Patients Undergoing Remote Ischemic Conditioning Before Primary Percutaneous Coronary Intervention for ST-elevation Myocardial Infarction: a Follow-up Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: ST-elevation Myocardial Infarction (STEMI)
Keywords: Myocardial infarction
Remote ischemic conditioning
Clinical outcome
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Oxford University Hospitals NHS Trust
name: The Hospital for Sick Children
First posted: 2012-08-15
Enrollment: 251
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 aim of this prospective follow-up study is to investigate 5-year clinical outcome in patients with ST-elevation myocardial infarction undergoing remote ischemic conditioning before primary percutaneous coronary intervention.


Eligibility criteria: Inclusion Criteria:

* Chest pain before admission to hospital within 12 h of onset, ST-segment elevation of \> 0,1 mV in 2 or more contiguous leads, 18 years or older.

Exclusion Criteria:

* left bundle branch block, previous myocardial infarction, fibrinolytic treatment in the previous 30 days, previous coronary bypass surgery, left main stem stenosis requiring coronary bypass surgery, severe heart failure requiring mechanical ventilation or use of an intra-aortic balloon pump.

Primary outcomes:
measure: Major adverse cardiac and cerebrovascular events (MACCE)
timeFrame: 5 years
Secondary outcomes:
measure: LV-function and remodeling
timeFrame: 5 years
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Department of Cardiology, Aarhus University Hospital, Skejby
Study officials:
affiliation: Aarhus University Hospital
name: Astrid D Sloth, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02255266: Long-Term Effectiveness of Liraglutide for Treatment of Type 2 Diabetes in Daily Practice
Official title: Long-Term Effectiveness of Liraglutide for Treatment of Type 2 Diabetes in Daily Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2014-10-02
Enrollment: 1788
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive subjects initiating liraglutide in 2011 according to Victoza® SmPC meeting the inclusion criteria will be enrolled.

Brief summary: This study is conducted in Europe. The aim of this study is to investigate Long-Term Effectiveness of Liraglutide for Treatment of Type 2 Diabetes in daily Practice.


Eligibility criteria: Inclusion Criteria:

* Subjects of age above 18 years as per Victoza® SmPC par.4.2 and 5.1 diagnosed with type 2 diabetes receiving the first prescription of liraglutide in 2011

Exclusion Criteria:

* None. Available data from all eligible patients for each center, will be included

Primary outcomes:
measure: Frequency of patients achieving HbA1c reduction of at least 1%-point
timeFrame: Week 0, week 52
Secondary outcomes:
measure: Change in HbA1c (Glycosylated haemoglobin))
timeFrame: Week 0, week 104
measure: Change in body weight
timeFrame: Week 0, week 104
measure: Frequency of patients achieving HbA1c reduction of at least 1%-point
timeFrame: After 4 and 24 months of treatment
measure: Frequency of patients achieving HbA1c target (<=7%)
timeFrame: After 4, 12 and 24 months
measure: Frequency of patients achieving a body weight reduction of at least 3%
timeFrame: After 4, 12 and 24 months
measure: Frequency of patients achieving the composite endpoint consisting in: HbA1c reduction of at least 1%-point and body weight reduction of at least 3%
timeFrame: After 4, 12 and 24 months
measure: Percentage of treatment discontinuation for any reason
timeFrame: At 4, 12 and 24 months
measure: Changes in blood pressure and lipid profile
timeFrame: Week 0, week 104
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Lapolla A, Berra C, Boemi M, Bossi AC, Candido R, Di Cianni G, Frontoni S, Genovese S, Ponzani P, Provenzano V, Russo GT, Sciangula L, Simioni N, Bette C, Nicolucci A; NN2211-4118 Study Group. Long-Term Effectiveness of Liraglutide for Treatment of Type 2 Diabetes in a Real-Life Setting: A 24-Month, Multicenter, Non-interventional, Retrospective Study. Adv Ther. 2018 Feb;35(2):243-253. doi: 10.1007/s12325-017-0652-2. Epub 2017 Dec 21.
Clinical trial NCT01194466: Transcutaneous Electrical Nerve Stimulation (TENS) and Head and Neck Cancer Pain (HNC) (TENS & HNC)
Official title: The Influence of TENS on Mucositis Pain and Function in Head and Neck Cancer Patients: A Randomized and Placebo-Controlled Double Blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head Cancer
Neck Cancer
Pain
Keywords: Head and Neck Cancer
Oral Cancer
Laryngeal Cancer
Oropharyngeal Cancer
Transcutaneous Electrical Nerve Stimulation (TENS)
Oral Mucositis
Pain
Function
TENS
Functional Pain
Non-pharamcologic
Quality of Life
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2010-09-03
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The overall goal of this study is to examine the effect of a single dose of TENS on mucositis pain and function secondary to head and neck radiation therapies. Oral mucositis is an extremely debilitating, unpreventable condition (inflammation, ulcers, bleeding in the mouth, nose, and throat) that causes significant pain, functional impairment, and diminished quality of life. Head and neck cancers pose specific challenges to effective pain management and past studies suggest the use of effective non-pharmacologic strategies such as TENS may be particularly beneficial for avoiding sources of acute and chronic pain, thereby improving quality of life. The investigators hypothesize that a single dose of TENS will decrease pain and improve function and quality of life in head and neck cancer patients. This project is particularly innovative because it is the first known study to examine the efficacy of TENS, an established safe, inexpensive and easy-to-use non-pharmacologic pain management intervention, for treating acute oral mucositis pain. The investigators research translates bench (animal model) science to human subjects using an interdisciplinary approach to pain management. Establishing whether TENS is effective for reducing mucositis pain is a critical first step toward establishing an effective, non-pharmacologic pain relief intervention for mucositis.


Eligibility criteria: Inclusion Criteria:

* Head and Neck Cancer Diagnosis
* Oral mucositis diagnosis

Exclusion Criteria:

* TENS use ≤ 5 years
* Pacemaker
* Pregnancy

Primary outcomes:
measure: Change in Pain Intensity in Head/Neck Cancer Area: 10cm Visual Analog Scale (VAS)
timeFrame: The change in VAS pain score was assessed within one study visit for each of the 3 study TENS conditions
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
affiliation: University of Iowa
name: Jennifer E Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04635566: Pharmacological Enhancement for Nocturnal Incontinence in Orthotopic Bladder Substitute
Official title: Pharmacological Enhancement for Nocturnal Incontinence in Orthotopic Bladder Substitute. A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Incontinence
Urinary Incontinence
Urinary Bladder Cancer
Keywords: Incontinence
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2020-11-19
Enrollment: 120
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this randomised trial, we hypothesised that mebeverine could enhance nocturnal continenece of Orthotopic Bladder Substitute (OBS) patients by decreasing the frequency and reduce maximum amplitude of uninhibited contractions of OBS ileum, and consequently it would increase the OBS capacity


Eligibility criteria: Inclusion Criteria:

* nocturnal enuresis

Exclusion Criteria:

* daytime incontinence
* Orthotopic Bladder Substitute (OBS) reconstruction surgery ≤2 years
* chronic kidney disease
* local tumor recurrence
* adjuvant chemotherapy and/or radiotherapy
* chronic retention requiring use of clean intermittent catheterization or indwelling urethral catheterization
* suspected or known narrow-angle glaucoma
* sensitivity to mebeverine.

Primary outcomes:
measure: assess the 3-months nocturnal continence rate
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Urology and Nephrology Center
state: Aldakahlia
Study officials:
References:
Clinical trial NCT00844766: Validation of a Home-screening Test for Lactose Intolerance
Official title: A Study to Validate a Home-screening Test for Lactose Intolerant People
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Lactose Intolerance
Keywords: Lactose intolerance
Lactose
Home-screening test
Validate
Lead sponsor: University Hospitals, Leicester
Sponsor class: OTHER
First posted: 2009-02-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with lactose intolerance

Brief summary: The hypothesis underlying this study is that whilst there is no home-screening test for lactose intolerance, this test would have significant value as lactose tolerance tests and breath hydrogen tests are expensive and time consuming. Therefore, it would be highly beneficial to validate a simple home-screening test.

This study will validate a simple home-screening test that uses lactose and not milk.


Eligibility criteria: Inclusion Criteria:

* Diagnosed lactose intolerance as demonstrated by a lactose tolerance test
* Diagnosed as not having lactose intolerance as demonstrated by a lactose tolerance test

Exclusion Criteria:

* Pregnant
* Breastfeeding
* Unwillingness to comply with study outline

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospitals, Leicester
name: John F Mayberry, DSc MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02512666: Non Invasive Optical Imaging of WBC Count
Official title: Non Invasive Optical Imaging of Capillaries Through the Nailfold for White Blood Cell Enumeration in Patients With Hematologic Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematologic Malignancy
Keywords: Hematologic malignancy
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2015-07-31
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This research study is looking at a small device that measures white blood cell (WBC) counts by being placed against the finger nail for participants who are undergoing stem cell transplantation at Massachusetts General Hospital or have a hematologic malignancy and are being seen as an outpatient.

Detailed description: The objective of this study is to obtain data that would support the use of a method to obtain WBC counts from images of small blood vessels called capillaries. These would be obtained by pressing a small device on the surface of participants' finger nails to look through the nail. These images will be obtained using a portable microscope called the Dino-Lite Digital Microscope.

Having a non-invasive way to quickly measure WBC counts could be useful for a variety of healthcare applications.

Eligibility criteria: Inclusion Criteria:

* Patients with lymphoid malignancies or plasma cell dyscrasias who are admitted to the Massachusetts General Hospital to undergo autologous stem cell transplantation or are seen in the outpatient clinic
* Age ≥ 18 years
* Ability to understand and the willingness to sign a written informed consent document.
* Patients must have WBC ≥ 3000 / µl and ANC ≥ 1500 / µl at admission or their last clinical visit to be enrolled.

Exclusion Criteria:

* History of allergic reactions attributed to compounds of similar chemical or biologic composition of baby oil.
* Myelodysplasia
* Skin phototype \< 4 in the Fitzpatrick scale.

Primary outcomes:
measure: Video of nail-fold imaging captured by capillaroscope
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Yi-Bin A Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05394766: Remote Patient Monitoring and Health Coaching vs. Usual Care for the Treatment of Hypertension
Official title: A Pragmatic RCT of Remote Patient Monitoring and Health Coaching vs. Usual Care for the Treatment of Hypertension
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Omada Health, Inc.
First posted: 2022-05-27
Enrollment: 550
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: High blood pressure, also known as hypertension, affects nearly half of all Americans and increases the risk for heart disease and stroke. Only about half of people with high blood pressure have it under control. New methods to control blood pressure are needed to reduce heart attack and stroke rates. The purpose of this study is to test whether a digital program that includes personalized health coaching and remote patient monitoring with a connected blood pressure cuff, all delivered on a smartphone or website, can improve blood pressure control compared with usual care among patients with high blood pressure.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of hypertension
* 18+ years of age
* English-speaking
* Receives primary care at Stanford Primary Care

Exclusion Criteria:

* \<18 years of age
* Primary language not English
* Active or prior enrollment in Omada Program

Primary outcomes:
measure: Mean change from baseline in systolic blood pressure at 1-year
timeFrame: Baseline, 1 year
Secondary outcomes:
measure: Mean change from baseline in A1c at 1-year
timeFrame: Baseline, 1 year
measure: Mean change from baseline in weight at 1-year
timeFrame: Baseline, 1 year
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Steven Lin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06950866: Home-Based Executive Function Training Intervention For Attention-Deficit/ Hyperactivity Disorder-prone Children
Official title: Home-Based Executive Function Training Intervention For Attention-Deficit/ Hyperactivity Disorder-prone Children
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
Keywords: Attention Deficit Hyperactivity Disorder (ADHD)
Executive function training
Lead sponsor: Wuhan Mental Health Centre
Sponsor class: OTHER
First posted: 2025-04-30
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to investigate the effectiveness of a home-based executive function training Intervention on children's ADHD symptoms, executive function and parents' parenting stress.


Eligibility criteria: Inclusion Criteria:

* 1.SNAP-IV scale, inattention or hyperactivity-impulsivity scale score \> 1.2
* 2.Parents who could understand or lacking of access to computers and the Internet
* 3.Parents can commit to ensuring full participation and complete the training and test evaluations in full compliance with the researcher's requirements
* 4.Children and their parents consent to the study

Exclusion Criteria:

* 1.Children or parents with severe organic encephalopathy and other severe mental disorders
* 2.Parents or children are receiving ADHD-related behavioral treatment
* 3.Parents or children who dropped out before the study started or in the middle of the study

Primary outcomes:
measure: 1.Chinese version of Swan-son Nolan and Pelham, Version IV Scale-parent form (SNAP-IV)
timeFrame: Baseline, 1 month after intervention, 2 months after intervention
measure: 2.Behavior Rating Inventory of Executive Function (BRIEF)
timeFrame: Baseline, 1 month after intervention, 2 months after intervention
measure: 3.Parenting Stress Index-Short Form (PSI-SF)
timeFrame: Baseline, 1 month after intervention, 2 months after intervention
Secondary outcomes:
measure: 4.Client Satisfaction Questionnaire (CSQ)
timeFrame: Baseline, 1 month after intervention, 2 months after intervention
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03420066: The NEXUS™ Compassionate Use Data Collection Study
Official title: NEXUS™ Aortic Arch Stent Graft System Data Collection Study for Compassionate-Use Procedures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Arch Aneurysm
Lead sponsor: Endospan Ltd.
Sponsor class: INDUSTRY
First posted: 2018-02-05
Enrollment: 7
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population will include all patients that were implanted with the Nexus device as part of the compassionate use.

Brief summary: A Multicenter, observational Data Collection Study to Evaluate the Safety and Performance of the Nexus™ Aortic Arch Stent Graft System in patients that were implanted with the device as part of Compassionate Use Procedures.

Detailed description: The purpose of the study is to collect and analyze data that is recorded as standard of care for patients that were implanted with the Nexus device as part of Compassionate Use Procedures.The data will be used to obtain additional information on the safety and performance of the Nexus™ Aortic Arch Stent Graft System in patients affected by pathologies involving the aortic arch.

Data will be collected at each time point of patient's follow up conducted according to the standard of care in each site.

Eligibility criteria: Inclusion Criteria:

* Patients for whom the Nexus implantation was initiated as part of a compassionate use procedure.
* A signed and dated Informed Consent document is available that authorizes to collect the patient's personal data following implantation of the Nexus systems and throughout the follow ups visits up to 5 years following implantation.

Exclusion Criteria:

-There are no exclusions. Data will be collected for all implanted population as described in the inclusion section above

Primary outcomes:
measure: Primary Safety Evaluation Criteria
timeFrame: within 30 days post implantation
measure: Performance Evaluation Criteria
timeFrame: within 30 days post implantation
Secondary outcomes:
measure: Secondary Safety Evaluation Criteria
timeFrame: within 1 year post-implantation
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Ospedale San Filippo Neri
state: Lazio
city: Auckland
country: New Zealand
facility: ADHB Charitable Trust
city: Zürich
country: Switzerland
facility: Klinik Hirslanden
city: Zürich
country: Switzerland
facility: Zurich University Hospital
Study officials:
References:
Clinical trial NCT00679666: Corneal Crosslinking in Keratoconus and Corneal Ectasia
Official title: Corneal Collagen Cross-Linking for the Treatment of Progressive Keratoconus and Corneal Ectasia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Progressive Keratoconus
Corneal Ectasia
Keywords: keratoconus
ectasia
cross-linking
riboflavin
UVA light
cornea
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2008-05-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Prospective, randomized, single site to determine the safety and effectiveness of performing corneal collagen cross-linking (CXL) using riboflavin and UVA light in eyes progressive keratoconus or corneal ectasia.

Detailed description: After epithelial surface removal riboflavin drops are applied until there is saturation of the cornea.Then the UVA light is turned on to active the crosslinking process while drops are continued for the 30 minute of lamp use to replenish the riboflavin.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of keratoconus with documented progression over the previous 12 months.
* Diagnosis of corneal ectasia
* Must be able to complete all study visits.

Exclusion Criteria:

* Prior corneal surgery in keratoconus group
* Corneal scarring
* Pregnancy

Primary outcomes:
measure: change in keratometry
timeFrame: 3 months
Secondary outcomes:
measure: best spectacle-corrected visual acuity
timeFrame: 3 months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Medical Center
state: Ohio
city: Dublin
country: United States
facility: OSU Havener Eye Institute
state: Ohio
Study officials:
affiliation: The Ohio State Univesity
name: Richard Keates, MD
role: PRINCIPAL_INVESTIGATOR
References: