louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04354506: Smart Phone Atrial Fibrillation Application
Official title: Assessing Management of Patients With Atrial Fibrillation Through a Smart Phone Application
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
mobile technology
Lead sponsor: Institute of Longevity
Sponsor class: OTHER
First posted: 2020-04-21
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All eligible patients downloading specific AF mobile technology application

Brief summary: Patients with atrial fibrillation will have the chance to assess their disease management through an application available for free in Android and IOS smart devices


Eligibility criteria: Inclusion Criteria:

Paroxysmal or persistent atrial fibrillation

Exclusion Criteria:

unable to provide informed consent unable to have 1 year of follow-up for any reason

Primary outcomes:
measure: Atrial fibrillation recurrence
timeFrame: 1 year
Secondary outcomes:
measure: Stroke incidence
timeFrame: 1 year
measure: Major bleeding incidence
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Institute of Longevity
name: Dimitris Tsiachris, MD, PHD
role: STUDY_CHAIR
References:
Clinical trial NCT03729206: Microcirculation in Patients With Leukemic Hyperleukocytosis
Official title: Visualization of Microcirculation in Patients With Leukemic Hyperleukocytosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperleukocytic Syndrome
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
First posted: 2018-11-02
Enrollment: 29
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: Hyperleukocytosis in patients with acute leukemia impacts rheology and microvascularization, leading to severe symptoms or even death. The investigators investigated whether blood stream alterations induced by hyperleukocytosis can be detected by sidestream dark-field imaging and whether they correlate with the grade of symptoms.


Eligibility criteria: Inclusion Criteria:

* acute leukemia
* de-novo or relapsed stage
* able to give consent

Exclusion Criteria:

* severe oral mucositis
* unable to give consent
* pregnant women
* patients hospitalized for psychiatric disease

Primary outcomes:
measure: microvascular flow index (MFI) of sublingual microcirculation
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Münster
country: Germany
facility: Universitätsklinikum Münster
Study officials:
affiliation: University Hospital Muenster
name: Christoph Schliemann, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02712606: Accuracy of Pulse Oximeter With Hypoxemic Measurements
Official title: A Study About Accuracy of Pulse Oximeter With Hypoxemic Measurements (Blue Sensor) in Children With Cyanotic Congenital Heart Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cyanotic Congenital Heart Disease
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-03-18
Enrollment: 280
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: tertiary care university children's hospital

Brief summary: A study about accuracy of pulse oximeter with hypoxemic measurements (Blue sensor, Masimo, Irvine, CA, USA) in children with cyanotic congenital heart disease


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of cyanotic congenital heart disease
* weight 2.5kg to 30kg
* undergoing general anesthesia
* preoperative SpO2\<97%

Exclusion Criteria:

* none

Primary outcomes:
measure: accuracy of pulse oximetry using blue sensor
timeFrame: From the start of anesthetic induction until discharge from hospital, assessed up to 1 week.
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT00063206: Study Evaluating DVS-233 in Adult Outpatients With Major Depressive Disorder
Official title: A Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Study of a Flexible Dose of DVS-233 SR in Adult Outpatients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Keywords: Depressive Disorder, Major
Depression, Involutional
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2003-06-25
Enrollment: 247
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: Primary: To compare the antidepressant efficacy and safety of subjects receiving DVS-233 SR versus subjects receiving placebo.

Secondary: To assess the response of subjects receiving DVS-233 SR for the clinical global evaluation, functionality, general well-being, pain, and remission (Hamilton Psychiatric Rating Scale for Depression, 17-item \[HAM-D\<sub\>17\</sub\>\] \< 7) versus those subjects receiving placebo.


Eligibility criteria: Inclusion Criteria:

* Subjects must have a primary diagnosis of major depressive disorder (MDD)
* Depressive symptoms for at least 30 days prior to the screening visit
* Minimum screening and study day -1 (baseline) scores of 20 on the Hamilton Psychiatric Rating Scale for Depression (HAM D\<sub\>17\</sub\>)

Exclusion Criteria:

* Treatment with DVS-233 SR at any time in the past
* Treatment with venlafaxine (immediate release \[IR\] or extended release \[ER\]) within 90 days of study day 1
* Known hypersensitivity to venlafaxine (IR or ER)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor, MD
role: STUDY_DIRECTOR
References:
citation: Liebowitz MR, Yeung PP, Entsuah R. A randomized, double-blind, placebo-controlled trial of desvenlafaxine succinate in adult outpatients with major depressive disorder. J Clin Psychiatry. 2007 Nov;68(11):1663-72. doi: 10.4088/jcp.v68n1105.
Clinical trial NCT03048006: Post-marketing Surveillance Study for Evaluation of Dotarem Safety
Official title: Evaluation of Dotarem Safety
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contrast-enhanced MRI With Dotarem
Lead sponsor: Guerbet
Sponsor class: INDUSTRY
First posted: 2017-02-09
Enrollment: 44456
Sex: ALL
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult and pediatric patients undergoing routine MRI using the MRI contrast medium Dotarem

Brief summary: Guerbet conducted a non-interventional post-marketing surveillance study on its Magnetic Resonance Imaging (MRI) contrast agent Dotarem (gadoteric acid/gadoterate meglumine). The aim of this study, which was conducted in accordance with section 67, paragraph 6 of the German drug regulation, Arzneimittelgesetz, was to gain additional insights into the diagnostic efficacy, reliability and safety of Dotarem in routine practice using the most up-to-date MRI techniques and application methods.

Detailed description: Diagnostic efficacy was assessed by the following endpoints: diagnostic value ("yes"/"no") and imaging quality (5-step scale from "excellent" to "very poor"). Safety was evaluated on the basis of the frequency and seriousness of adverse events that occurred following Dotarem injection.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing routine MRI using the MRI contrast medium Dotarem

Exclusion Criteria:

-

Primary outcomes:
measure: Frequency of Adverse Events
timeFrame: From the beginning of the MRI procedure to 30-60 min after
Secondary outcomes:
measure: Diagnostic Value
timeFrame: During MRI procedure
measure: Image Quality
timeFrame: During MRI procedure
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05627206: The Impact of PM+For Moms Intervention on Improving Mother's Mental Health in Zambia (PM+FM)
Official title: The Impact of PM+For Moms Intervention on Improving Mother's Mental Health in Zambia (PM+FM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
Anxiety
Trauma, Psychological
Keywords: women
low-resourced settings
psychosocial intervention
Lead sponsor: Swiss Tropical & Public Health Institute
Sponsor class: OTHER
Collaborators: name: Innovations for Poverty Action
First posted: 2022-11-25
Enrollment: 270
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: CMHD are particularly prevalent among women, posing a major threat to their own and their children's wellbeing.

Despite the high prevalence of CMHD and the existence of effective treatments, interventions supporting women living in low-resourced settings remain limited.

This study builds on a parent study (Zamcharts NCT03991182), which identified a high prevalence of women with anxiety and/or depression. We propose to design, test, and validate a community-based intervention nested within the public primary health system in Zambia, to identify and treat women with mild-to-severe CMHDs.


Eligibility criteria: Inclusion Criteria:

* Women participating in ZamCharts parent study
* SRQ-20 \>7 (clinically significant symptoms of depression or/anxiety),
* not planning to move within the next 6 months,
* with capacity to consent
* not receiving current mental health care.

Exclusion Criteria:

* Women with active suicidal ideation (determined by Paykel=4 OR 5),
* severe substance use (ACOK-SUD \>4),
* mania or psychotic symptoms

Primary outcomes:
measure: Change in Mental health symptoms. SRQ-20
timeFrame: Change between Baseline (at enrollment) and 6 months after enrollment
measure: Feasibility of the study
timeFrame: Assessed 4 months after enrollment
measure: Acceptability
timeFrame: Assessed 4 months after enrollment
Secondary outcomes:
measure: Change in Mental health symptoms. PSYCHLOPS
timeFrame: Used for the pre-post treatment analysis. Change between Baseline (at enrollment) and 4 months after enrollment
measure: Functionality
timeFrame: Used for the pre-post treatment analysis. Change between Baseline (at enrollment) and 4 months after enrollment
measure: World Bank's Toolkit and Inventory
timeFrame: Used for the pre-post treatment analysis. Change between Baseline (at enrollment) and 4 months after enrollment
measure: Change in Anxiety and Depression symptoms.
timeFrame: Used for the pre-post treatment analysis. Change between Baseline (at enrollment) and 4 months after enrollment
Other outcomes:
Locations:
city: Lusaka
country: Zambia
facility: Innovatations for Poverty Action
Study officials:
References:
Clinical trial NCT04829006: Intelligibility Assessment for Parkinson's Disease
Official title: Automatic Assessment of Intelligibility in Individuals With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: intelligibility
voice disorders
dysarthria
Lead sponsor: Long Island University
Sponsor class: OTHER
First posted: 2021-04-02
Enrollment: 70
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators aim at testing the efficacy of an app to measure sentence intelligibility in noise in speakers with Parkinson's disease and in healthy controls.

Detailed description: Close to 90% of people with Parkinson's disease develop voice problems during the course of the disease. These problems lead to reduced intelligibility, which entails a subsequent reduction in social participation and overall quality of life. The current study will focus on developing and pilot-testing an app to measure the intelligibility of people with PD and of healthy controls. In order to test the app's efficacy, speakers will read a set of 50 sentences that will be embedded in noise for measurement purposes. A group of listeners will also transcribe the spoken sentences to correlate their performance to that of the app. The ultimate purpose of this investigation is to improve self-monitoring and self-sufficiency in people with PD. The study is expected to last 12 months.

Eligibility criteria: Speakers with PD:

Inclusion Criteria:

* Have a medical diagnosis of Parkinson's disease
* Have experienced changes in your voice (e.g., your voice has "lost its strength") and your voice is a current concern
* Have not received individual speech therapy for the past 2 years (group therapy is ok)
* Have a stable medication schedule
* Have not received DBS (Deep Brain Stimulation)
* Are a native speaker of American English

Exclusion Criteria:

* If criteria above are not met

Healthy controls:

Inclusion Criteria:

* Be a native speaker of American English
* Have no history of neurological impairment
* Have no history of speech or language problems

Exclusion Criteria:

* If criteria above are not met

Listeners:

Inclusion Criteria:

* Be a native speaker of American English
* Be between 18-55 years old
* Have no history of speech-language-hearing problems
* Pass a free hearing screening
* Have received the Covid19 vaccine

Exclusion Criteria:

* If criteria above are not met

Primary outcomes:
measure: Transcription scores
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: Long Island University
state: New York
Study officials:
affiliation: Long Island University
name: Gemma Moya Gale, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05103306: Empagliflozin-based Quadruple Therapy vs Basal Insulin-based Therapy
Official title: Long-term Effectiveness and Safety of Empagliflozin-based Quadruple Oral Antidiabetic Agents Therapy Compared to Basal Insulin-based Combination Therapy in Patients With Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 diabetes mellitus
Sodium-glucose co-transporter 2 inhibitor
Empagliflozin
Insulin glargine
Insulin degludec
Lead sponsor: Chungbuk National University Hospital
Sponsor class: OTHER
First posted: 2021-11-02
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Type 2 diabetes, uncontrolled with triple OADs

Brief summary: This study aimed to evaluate the long-term effectiveness and safety of the empagliflozin as add-on thearpy compared to basal insulin-based antidiabetic agents (OADs) combination therapy in patients with type 2 diabetes inadequately controlled on triple OADs in a real clinical practice.

Detailed description: This study aimed to evaluate the long-term effectiveness and safety of the empagliflozin as add-on thearpy compared to basal insulin-based antidiabetic agents (OADs) combination therapy in patients with type 2 diabetes inadequately controlled on triple OADs in a real clinical practice.

Eligibility criteria: Inclusion Criteria:

* Inadequately controlled with triple OADs (metformin, glimepiride, dipeptidyl peptidase-4 inhibitor) showing HbA1c 7.5-12.0%

Exclusion Criteria:

* Type 1 diabetes
* Gestional diabetes
* Diabetes due to secondary causes
* Receiving anticancer treatment
* Receiving glucocorticoids or immune-suppressants
* Have been treated with sodium glucose co-transporter 2 inhibitors for more than 7 consecutive days within 3 months before entering the study
* Have been treated with any type of insulin for more than 7 consecutive days within 3 months before entering the study

Primary outcomes:
measure: Changes in HbA1c From Baseline to months 36
timeFrame: Baseline, month 36 (3-year)
Secondary outcomes:
measure: Achievement of target HbA1c
timeFrame: Baseline, month 36
measure: Changes in HbA1c
timeFrame: Baseline, month 3, 6, 12, 18, 24, 30
measure: Changes in FPG
timeFrame: Baseline, month 3, 6, 12, 18, 24, 30, 36
measure: Changes in lipid profiles
timeFrame: Baseline, month 36
measure: Changes in body weight
timeFrame: Baseline, month 36
measure: Changes in blood pressure
timeFrame: Baseline, month 36
measure: Percentage of patients with hypoglycemic episodes
timeFrame: Baseline, month 36
measure: Percentage of patients with at least 1 episode of genitourinary tract infections
timeFrame: Baseline, month 36
Other outcomes:
Locations:
Study officials:
affiliation: Chungbuk National University Hospital
name: Eu Jeong Ku, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00507806: Microbubble-Enhanced Clotbust Treatment of Acute Ischemic Stroke
Official title: Microbubble-Enhanced Clotbust Treatment of Acute Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Acute Ischemic Stroke
Keywords: Acute Ischemic Stroke
Microbubbles
Transcranial Doppler ultrasound
TIBI
Symptomatic Intracranial Hemorrhage
modified Rankin Scale
Recanalization
Perflutren
Lead sponsor: ImaRx Therapeutics
Sponsor class: INDUSTRY
First posted: 2007-07-27
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 study is designed to examine the safety, tolerability, and activity of a combination of microbubbles (perflutren lipid microsphere \[Definity®\]) and continuous monitoring with 2 MHz transcranial Doppler ultrasound (TCD) as an adjunctive therapy to tissue plasminogen activator (tPA) treatment in subjects with acute ischemic stroke.


Eligibility criteria: Inclusion Criteria:

* Measurable focal neurological deficit (National Institutes of Health Stroke Scale \[NIHSS\] score \> 4 points)
* tPA eligible
* Occlusion of the middle cerebral artery

Exclusion Criteria:

* Right to left cardiac shunt
* Uncontrolled hypertension
* Absent temporal windows

Primary outcomes:
measure: Incidence of symptomatic intracranial hemorrhage
timeFrame: 72 hours
Secondary outcomes:
measure: Complete recanalization of the occluded artery (TIBI 4-5)
timeFrame: End of treatment
measure: NIHSS score of 0-2
timeFrame: 24 hours
measure: Favorable outcome (modified Rankin Scale or NIHSS 0-1)
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Andrei Alexandrov, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alexandrov AV, Molina CA, Grotta JC, Garami Z, Ford SR, Alvarez-Sabin J, Montaner J, Saqqur M, Demchuk AM, Moye LA, Hill MD, Wojner AW; CLOTBUST Investigators. Ultrasound-enhanced systemic thrombolysis for acute ischemic stroke. N Engl J Med. 2004 Nov 18;351(21):2170-8. doi: 10.1056/NEJMoa041175.
Clinical trial NCT05577806: DYG Versus Cetrorelix in Oocyte Donation
Official title: Comparison of Reproductive Outcomes After Progestin-primed Ovarian Stimulation With Dydrogesterone Versus Cetrorelix to Inhibit Spontaneous Ovulation in Oocyte Donation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility, Female
Fertility Disorders
Keywords: Gonadotrophin-releasing hormone (GnRH) analogues
Ovarian stimulation
Oocyte donation
Progestin-primed ovarian stimulation
Dydrogesterone
Lead sponsor: Clinica de la Mujer Medicina Reproductiva, Chile
Sponsor class: OTHER
First posted: 2022-10-13
Enrollment: 202
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 30
Standard ages: ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Oocyte donors undergoing controlled ovarian stimulation

Brief summary: Prospective controlled study to assess the reproductive outcomes of OD recipients in which the donors were subjected to the DYG protocol (20mg/day) compared with those subjected to the short protocol with cetrorelix (0.25 mg/day) from Day 7 or since a leading follicle reached 14 mm. The OD cycles were triggered with triptoreline acetate and the trigger criterion was ≥3 follicles of diameter \>18mm.


Eligibility criteria: Inclusion Criteria:

* Oocyte donors between 21 and 30 years old, with regular menstrual cycles (24-35 d) and a body mass index (BMI) between 18 and 28 kg/m2 without any relevant personal or family history

Exclusion Criteria:

* AMH less than 3 ng/dL
* A positive screening for sexually transmitted diseases

Primary outcomes:
measure: Live Birth Rate per transfer
timeFrame: 40 weeks after ET
measure: Clinical pregnancy per transfer
timeFrame: 12 weeks after ET
measure: Miscarriage rate
timeFrame: 12 weeks after ET
Secondary outcomes:
measure: Number of oocytes retrieved
timeFrame: at time of oocyte retrieval
measure: Number of mature oocytes
timeFrame: 1 day after IVF
measure: Number of fertilized oocytes
timeFrame: 1 day after IVF
measure: Number of blastocists
timeFrame: 5-6 days after OPU
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02747706: Childhood Asthma Mentoring Program for Parents
Official title: Peer Mentor Training to Reduce Hospitalizations for Children With Asthma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asthma
Keywords: peer mentor
health coach
parent support
parent mentor
Lead sponsor: InquisitHealth, Inc.
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Montefiore Medical Center
name: University of North Carolina, Chapel Hill
name: Washington University School of Medicine
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2016-04-22
Enrollment: 240
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: There are 7.1 million children with asthma. Asthma is the cause of 10.5 million missed days of school, 7.5 million outpatient visits, 640,000 ED visits, and 157,000 hospitalization visits in 2008. Recent work has demonstrated that trained peer mentors (individuals from the community) can be effective in reducing hospitalizations for asthmatic children.

This study will evaluate the efficacy of technology-driven parent-to-parent mentoring to reduce asthma-related pediatric hospitalizations and emergency department visits.


Eligibility criteria: Inclusion Criteria:

* Parent of child with persistent asthma, prescription of controller medications, and at least one asthma exacerbation in the past year

Exclusion Criteria:

* Parent has no access to smartphone

Primary outcomes:
measure: Number of hospital admissions
timeFrame: 1-year
measure: Number of emergency department visits
timeFrame: 1-year
Secondary outcomes:
Other outcomes:
Locations:
city: River Edge
country: United States
facility: InquisitHealth
state: New Jersey
Study officials:
affiliation: Chief Medical Officer
name: Ashwin Patel, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: