louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00216931: Treatment of Elevated Arterial Pulmonary Pressure With Inhaled Iloprost
Official title: Treatment of Elevated Arterial Pulmonary Pressure With Inhaled Iloprost
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Persistent Pulmonary Hypertension
Respiratory Distress Syndrome
Lead sponsor: Lund University Hospital
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2005-09-22
Enrollment: 40
Sex: ALL
Minimum age (years): 24
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if iloprost is effective in the treatment of elevated arterial pulmonary pressure in children with ventilator treated respiratory distress syndrome.


Eligibility criteria: Inclusion Criteria:

* Elevated arterial pulmonary pressure
* GA \> 24 GW
* 24-48 hours of age
* Ventilator treatment

Exclusion Criteria:

* Congenital anomalies
* Severe hypotension

Primary outcomes:
measure: Oxygenation index
measure: Cardiac output
Secondary outcomes:
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: University Hospital in Lund , Department of Pediatrics
Study officials:
affiliation: Lund University Hospital, Department of Pediatrics
name: Vineta Fellman, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02827331: Taking Account of Inobservable Periods in Longitudinal Drug Treatment Follow-up
Official title: Taking Account of Inobservable Periods in Longitudinal Drug Treatment Follow-up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Drug Exposition
Keywords: Benzodiazepines
Fracture
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2016-07-11
Enrollment: 171861
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population studied is from french general sample of beneficiaries. Patients are incident users of benzodiazepines

Brief summary: The question of the inclusion of periods of interruptions and periods unobservable has been studied as part of medico-administrative databases. However, the specificity of the health insurance databases justify the realization of dedicated methodological research. A thorough knowledge of the purpose of these data, how they collect and restitution is an essential prerequisite to carry out this work.

One type of scheme cohort exposed/unexposed led to the formulation of a finding on the basis of the comparison between the exposure groups. However, this traditional approach has the major drawback of neglecting the changing nature of drug exposure, and therefore fails to take into account any changes or interruptions doses. Approaches to take into account the time dependent variables were developed. These allow to take into account any interruptions. However, as part of study on health databases, sometimes we do not have the status in relation to the exhibition on the entire monitoring period. This is for example the case during hospitalization. The bias generated by the failure to take account of these periods ("non measurable time bias") can be problematic when a long exposure and chronic disorders require hospitalization.


Eligibility criteria: General Inclusion Criteria:

* Beneficiaries of all social security regimen with a minimum of one year of data in general sample of beneficiaries

Group expose to benzodiazepine :

* Exposition to at least one benzodiazepine or anxiolytic

Group antidepressants and anxiolytics and hypnotics non benzodiazepines :

* Exposition to at least one antidepressants and anxiolytics and hypnotics non benzodiazepines

Control group :

- Patient having a medical consultation without prescription of interest

Exclusion Criteria:

* Non incident patient : Patient having a prescription of benzodiazepines, clonazepam, tetrazepam, antidepressants, anxiolytics ou hypnotics non benzodiazepine during the last 12 months before index date

Primary outcomes:
measure: Comparison of mortality from all causes in the 3 groups as assessed by clinical data collected
timeFrame: through the end of study (12 months)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital of Toulouse
name: Maryse LAPEYRE-MESTRE
role: STUDY_DIRECTOR
References:
Clinical trial NCT03925831: Trend Analysis of the Service of Pediatric Palliative Care
Official title: The Trend Analysis and Associated Factors of Initiating the Service of Pediatric Palliative Care
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nursing Caries
Palliative Care
Pediatric Population
Pediatric Cancer
Oncology
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2019-04-24
Enrollment: 5000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals died from cancer in the National Health Insurance Database.

Brief summary: Palliative care has received considerable attention in Taiwan in recent years. The relevant research has been widely conducted for palliative care in adult population. However, the research in children population is relatively insufficient. In the limited studies, most of them are the experiences generated from individual institutions. This study is going to retrieve the data from 2008-2017 National Health Insurance Research Database, Cancer Registry Database, Death Registry Database and other relevant materials in order to analyze the trends of using pediatric palliative care service, the types of services, the timing of initiating palliative care, and the preference of using palliative care service among different life span in the past decade. In addition, the study will examine the differences of the timing of initiating of pediatric palliative care service and the types of diseases among different characteristics of children and healthcare providers. And the study will discuss how pediatric palliative care services affect medical costs.


Eligibility criteria: Inclusion Criteria:

Individuals died from cancer between 2008 and 2017.

Exclusion Criteria:

-

Primary outcomes:
measure: Taiwan Health and Welfare Data
timeFrame: 2008-2017
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan Universtiy Hospital
Study officials:
References:
Clinical trial NCT02633631: Contraceptive Choice Center
Official title: The Center for Contraceptive Excellence: an Innovative Health Services Delivery and Payment Model
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Unintended Pregnancy
Contraception
Family Planning
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Centers for Medicare and Medicaid Services
First posted: 2015-12-17
Enrollment: 2664
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We plan to recruit women who are at high risk for unintended pregnancy and birth.

Brief summary: The Contraceptive Choice Center will use an innovative-model of contraceptive care which was developed as a part of the Contraceptive CHOICE Project (CHOICE). This delivery model will deliver high-quality family planning services for women and reduce unintended pregnancies and births. This intervention will result in improved health for women, improved health care, and reduced costs to Medicaid.

The Center will provide care to women ages 14-45 years of age.

Detailed description: The Center will provide high-quality contraceptive care using the innovative model of the Contraceptive CHOICE Project. Specifically, the model will provide the following components: 1) Structured, evidence-based contraceptive counseling; 2) education of providers about long-acting reversible contraceptive (LARC) methods and evidence-based guidelines for contraceptive provision; 3) removal of patient barriers to family planning services; and 4) post-visit contraceptive support. The model addresses the barriers to contraceptive uptake.

Eligibility criteria: Inclusion Criteria:

* Childbearing-age seeking family planning services
* Negative pregnancy test
* Willing and able to undergo informed consent

Exclusion Criteria:

* Current participation in a research study that would interfere with the conduct of this study
* Currently pregnant

Primary outcomes:
measure: Rate of unintended pregnancy
timeFrame: 24 months
Secondary outcomes:
measure: Rate of unintended births
timeFrame: 24 months
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Division of Clinical Research at Washington University
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Tessa Madden, MD,MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00450931: Drug Facts Page or a Short Drug Summary in Helping Patients and Doctors Understand Medical Information
Official title: Helping Patients and Physicians Make Sense of Medical Data
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Health Status Unknown
Keywords: health status unknown
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-03-22
Enrollment: 200
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED

Brief summary: RATIONALE: The way in which information about a drug is provided may affect the ability of patients and doctors to understand how a drug works and the side effects of the drug.

PURPOSE: This randomized trial is studying how well a drug facts page works compared with a standard brief summary in helping patients and doctors understand medical information.

Detailed description: OBJECTIVES:

Primary

* Compare the effect of a prescription drug summary (one-page summary of drug information that includes a table with data on drug benefit and side effects) vs standard brief summary in direct-to-consumer advertisements on the comparisons of two drugs for the same indication, knowledge of drug efficacy and side effects of each drug.

Secondary

* Comprehension of information contained in the drug facts box and rating of the usability of the drug information.

OUTLINE: This is a randomized study. Participants are contacted by phone via random-digit dialing for initial interview using the computer-assisted telephone interviewing (CATI) system. Eligible participants are then randomized to 1 of 4 intervention arms.

* Arm I: Participants receive 2 advertisements for a drug to treat heartburn with a drug facts second page.
* Arm II: Participants receive 2 advertisements as in arm I for drugs to treat heatburn with the standard second page (i.e., brief summary).

Participants in both arms complete the self-reported questionnaire mailed with the advertisement intervention.

PROJECTED ACCRUAL: A total of 200 participants will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* English-speaking adults
* Must be able to be chosen by Random Digit Dialing

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Comparison of two drugs for the same indication
measure: Knowledge of drug efficacy and side effects of each drug
Secondary outcomes:
measure: Comprehension of information contained in the drug facts box and rating of the usability of the drug information
Other outcomes:
Locations:
Study officials:
affiliation: White River Junction Veterans Affairs Medical Center
name: Steven Woloshin, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: White River Junction Veterans Affairs Medical Center
name: Harold Bae
References:
Clinical trial NCT01513031: Determination of Rates and Reasons for Non-Adherence to Anti-Arrhythmic Therapy for Atrial Fibrillation
Official title: Pilot Project to Determine Rates and Reasons for Non-Adherence in Patients Receiving Chronic Oral Antiarrhythmic Therapy for Atrial Fibrillation in the State of Nebraska
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Atrial Fibrillation
Medication Adherence
Keywords: Atrial fibrillation
Anti-arrhythmic medication
Medication adherence
Lead sponsor: Creighton University
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2012-01-20
Enrollment: 9
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to determine if follow-up by a pharmacist over the telephone improves adherence and short term clinical outcomes in the patient with atrial fibrillation prescribed an oral anti-arrhythmic medication. This study will also identify the reasons people stop taking their anti-arrhythmic therapy. A pharmacist will provide medication counseling about their anti-arrhythmic therapy, then will follow-up by telephone on a monthly basis to assess adherence over one year.


Eligibility criteria: Inclusion Criteria:

* Prescribed a new anti-arrhythmic medication for atrial fibrillation

Primary outcomes:
measure: Adherence to anti-arrhythmic medication
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Bryan LGH
state: Nebraska
city: Omaha
country: United States
facility: Alegent Health Bergan Mercy Medical Center
state: Nebraska
city: Omaha
country: United States
facility: Creighton University
state: Nebraska
Study officials:
affiliation: Creighton University
name: Dan Hilleman, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00491231: Is Orthostatic Hypotension Associated With Nondipping Hypertension
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Orthostatic Hypotension
Nondipping Hypertension
Keywords: orthostatic hypotension
ambulatory blood pressure monitoring
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2007-06-26
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 400 subjects who are referred for 24hABPM

Brief summary: The aim of the study is to evaluate whether orthostatic hypotension is associated with nondipping hypertension.

Methods and patients: 400 subjects who are referred for 24hABPM will be filled questioner regarding their medical background and medications. All patients will be subjected to orthostatic test before connection to the 24 ABPM. The orthostatic changes in blood pressure and heart rate will be correlated to the changes in blood pressure and heart rate from day to night as recorded by the 24H ABPM.


Eligibility criteria: Inclusion Criteria:

* All patients who are referred for ABPM

Exclusion Criteria:

* Known secondary hypertension

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tel-Hashomer
country: Israel
facility: The Chaim Sheba Medical center
state: Ramat Gan
Study officials:
affiliation: The Chaim Sheba Medical Center
name: Ehud Grossman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05605431: Predictors of OSA in Patients With COPD
Official title: Predictors of Obstructive Sleep Apnea in Patients With Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: OSA
COPD
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-11-04
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: two groups , COPD with OAS ( OVERLAP SYNDROME) COPD without OSA

Brief summary: Chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea(OSA) are common disorders ,the co-existence of both conditions is called overlap syndrome Smoking , obesity , airway resistance and inflammation are considered risk factors for both conditions ,interestingly either COPD and OSA are associated with increased cardiovascular complications with further increased risk in overlap syndrome Multiple theories could explain that one disorder can predispose or exaggerate the other. For example, in COPD cigarette smoking and inhaled steroids are linked to myopathy of upper airway dilator muscles. Moreover in core-pulmonale redistribution of edema fluid in supine position during sleep can also contribute to or exacerbate OSA .

On the other hand , OSA patients might smoke frequently and more heavily to compensate for excessive daytime sleepiness and to help them to lose weight , which results in exaggerated airway inflammation and exacerbate COPD. Rationale of the study was to assess the prevalence and predictors of OSA among patients with stable COPD.


Eligibility criteria: Inclusion Criteria:

* All stable COPD patients

Exclusion Criteria:

* Patients with end organ failure

Primary outcomes:
measure: screening for OSA among COPD
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr alainy school of medicine
Study officials:
References:
Clinical trial NCT03788031: Perceptual Learning Treatment for Amblyopia
Official title: Towards Developing a Perceptual Learning Treatment for Amblyopia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amblyopia
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2018-12-27
Enrollment: 54
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objectives. To develop a new treatment for amblyopia using a perceptual learning approach.

Hypothesis to be tested. Our proposed experiments are designed to investigate whether practicing a grating detection task can improve vision in patients with amblyopia.

Design and subjects. A total of 36 patients with amblyopia will be randomized allocated into two intervention groups: Group 1, perceptual learning therapy. Group 2, occlusion therapy. A control group comprising of 18 subjects with normal vision will be recruited for comparison. A battery of tests will be used to assess a range of visual functions before and after the treatment intervention.

Study instruments. Grating acuity testing system

Interventions. We have established a clinical protocol for acuity training. On each trial, a properly oriented stimulus will be presented randomly at one of the four locations on a flat monitor screen. The visual task is to indicate the location of the stimulus. Participants will be required to undertake 20 one-hour sessions of training.

Main outcome measures. Resolution acuity, visual acuity, contrast sensitivity function


Eligibility criteria: Inclusion Criteria:

* Visual acuity in the amblyopic eye: 20/25 or worse

Exclusion Criteria:

* Manifest eye disease \& nystagmus

Primary outcomes:
measure: Change of grating acuity
timeFrame: 20 hours
Secondary outcomes:
measure: Change of visual acuity
timeFrame: 20 hours
measure: Change of contrast sensitivity
timeFrame: 20 hours
measure: Change of stereopsis
timeFrame: 20 hours
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Optometry Research Clinic
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Tsz Wing Leung, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Levi DM, Li RW. Improving the performance of the amblyopic visual system. Philos Trans R Soc Lond B Biol Sci. 2009 Feb 12;364(1515):399-407. doi: 10.1098/rstb.2008.0203.
citation: Li RW, Klein SA, Levi DM. Prolonged perceptual learning of positional acuity in adult amblyopia: perceptual template retuning dynamics. J Neurosci. 2008 Dec 24;28(52):14223-9. doi: 10.1523/JNEUROSCI.4271-08.2008.
citation: Li RW, Ngo C, Nguyen J, Levi DM. Video-game play induces plasticity in the visual system of adults with amblyopia. PLoS Biol. 2011 Aug;9(8):e1001135. doi: 10.1371/journal.pbio.1001135. Epub 2011 Aug 30.
Clinical trial NCT06061731: Low-frequency Electrical Stimulation of Acupuncture Points
Official title: Master's Degree Candidate in Acupuncture and Tuina
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Stroke Sequelae
Lead sponsor: Heilongjiang University of Chinese Medicine
Sponsor class: OTHER
First posted: 2023-09-29
Enrollment: 57
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: low-frequency acupoint electrical stimulation
Primary purpose: TREATMENT

Brief summary: Abstract:

Objective: To examine the effect of low-frequency acupoint electrical stimulation (LFES) on the surface electromyographic (sEMG) signals of the thumb-to-finger movement muscles in stroke patients, and to evaluate the clinical efficacy of LFES on hand function recovery after stroke.

Detailed description: Methods: Sixty patients who met the inclusion criteria were randomly assigned to a LFES group or an electroacupuncture (EA) group, with 30 patients in each group. Both groups received conventional treatment, and the EA group was treated with acupoints from the book of Acupuncture and Moxibustion, while the LFES group was treated with acupoints from a previous study. The sEMG characteristic values (MAX and RMS), Chinese Stroke Clinical Neurological Deficit Scale (CSS), Brunnstrom Motor Function Evaluation, Modified Ashworth Scale (MAS), Lindmark Hand Function Score and Lovett Muscle Strength Classification were measured before and after treatment.

Eligibility criteria: Inclusion Criteria:

①Diagnostic criteria for upper extremity motor dysfunction after stroke. ②Age 35-75 years and duration of illness is 2 weeks to 3 months. ③ Impaired hand function with Lovett classification ≥ grade 2 and MAS ≤ grade 2. ④No organ dysfunction such as heart, liver, lung, kidney or blood circulation dysfunction. ⑤Clear consciousness, no major impairment in intelligence, hearing or speech, and stable condition. ⑥Patients voluntarily participated in this subject trial and signed the informed consent form.

Exclusion Criteria:

* Presence of neurological or musculoskeletal disorders affecting functional recovery prior to the onset of the disease. ②Brainstem infarction, bilateral cerebral infarction or transient ischemic attack.

Primary outcomes:
measure: sEMG eigenvalues
timeFrame: Three weeks
Secondary outcomes:
measure: CSS score
timeFrame: Three weeks
measure: Brunnstrom's method of motor function evaluation
timeFrame: Three weeks
measure: Modified Ashworth Scale
timeFrame: Three weeks
measure: Lindmark hand function score
timeFrame: Three weeks
measure: Lovett muscle strength classification
timeFrame: Three weeks
Other outcomes:
measure: Clinical efficacy evaluation
timeFrame: Three weeks
Locations:
city: Harbin
country: China
facility: Low-Frequency Acupoint Electrical Stimulation
state: Heilongjiang
Study officials:
affiliation: Heilongjiang University of Chinese Medicine
name: Xue Xia
role: STUDY_CHAIR
References: