louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04362579: Advanced Multi-Modal Wearable Sensing for the Prediction of Pre-Term Labor
Official title: Advanced Multi-Modal Wearable Sensing for the Prediction of Pre-Term Labor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy Preterm
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2020-04-27
Enrollment: 91
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women

Brief summary: Percent agreement of vital signs monitoring between the experimental sensor and standard of care monitoring

Detailed description: The primary objective of the Prentice study is to assess and validate EMG performance of the new home-use sensor with extended battery life in detecting continuous EHG in a range of uterine contraction intensities, frequencies, and durations compared to gold-standard FDA-cleared tocodynamometer (GE Corometrics 250cx) in non-stress testing for antepartum surveillance.

An "at-home" study will validate the developed modifications to the wearable sensors system that provides a continuous electrohysterography (EHG) along with other additional physiological parameters (e.g. heart rate, heart rate variability, sleep quality, physical activity, and continuous blood pressure) for longitudinal monitoring in the home setting.

Eligibility criteria: * Maternal age \>18 years old
* Pregnant mothers \>13 weeks (home study only)
* Pregnant mothers \>26 weeks undergoing nonstress testing or delivering
* Singleton pregnancy (inpatient or clinic visit patients only)
* History of preterm labor or premature birth, active smoker, chronic condition (ex: HTN or DM), or an interval of less than 6 months between the prior pregnancy
* Singleton pregnancy (home study only)
* No fetal abnormality or chromosomal abnormality
* Subjects willing and able to comply with requirements of the protocol

Exclusion Criteria

* Women who refuse to signed the informed consent form
* Maternal age under 18 years old
* Multiple pregnancy
* Known major fetal malformation or chromosomal abnormality
* Medical or obstetric problem that would preclude the use of abdominal electrodes
* Inability to consent to this study due to medical illness, diminished intellectual capacity, or language barrier
* Women using pacemakers

Primary outcomes:
measure: Device comparison to standard monitoring
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Shuai Xu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05276479: Dietary Plant Hormone and Mental Health
Official title: Association Between Dietary Plant Hormone Intake and Mental Health
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dietary Behavior
Stress
Sleep
Depression, Anxiety
Lead sponsor: University of Bern
Sponsor class: OTHER
First posted: 2022-03-11
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy subjects

Brief summary: The aim of this cross-sectional online study is to investigate the association between regular feeding behavior and stress, sleep as well as anxiety and depressive symptoms in healthy subjects.

Detailed description: The gut-microbiota-brain (GMB) axis has a multidirectional communication between the intestine, the microbiota, and the central nervous system (CNS). Over the past decade, there has been extensive research showing that the GMB axis has a profound influence not only on neurological disorders but also on neural development, activation of the neuroendocrine axis and neurotransmission, as well as modulation of complex human behaviors. Thus, the GBM-axis is involved in the regulation of stress, emotions, behaviour, and higher cognitive functions. As the GMB plays an essential role in human psychological functioning and mental health, the dietary manipulation of the microbiome may have direct effects on mental well-being, sleep, anxiety and depressive symptoms.

Eligibility criteria: Inclusion Criteria:

* Age 18 to 30

Exclusion Criteria:

* None

Primary outcomes:
measure: Quality of life
timeFrame: At baseline
measure: Depression
timeFrame: At baseline
measure: Sleep
timeFrame: At baseline
Secondary outcomes:
measure: Anxiety
timeFrame: At baseline
measure: Stress and Coping
timeFrame: At baseline
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: University Hospital of Psychiatry, University of Bern
Study officials:
affiliation: University Hospital of Psychiatry, University of Bern
name: Leila M Soravia, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01522079: Spinal Muscular Atrophy and Cardiac Autonomic Function
Official title: Spinal Muscular Atrophy and Cardiac Autonomic Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Muscular Atrophy
Keywords: spinal muscular atrophy
heart rate variability
posture
air stacking
Lead sponsor: Centro Universitário Augusto Motta
Sponsor class: OTHER
First posted: 2012-01-31
Enrollment: 9
Sex: ALL
Minimum age (years): 5
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Respiratory dysfunction is the major cause of morbidity and mortality in patients with spinal muscular atrophy (SMA). Air stacking is a clearance airway technique frequently used but its effects on cardiac autonomic function in patients with spinal muscle atrophy is not clear.

Objective: To evaluate the acute effect of air stacking and posture on cardiac autonomic function in patients with spinal muscular atrophy types II and III.

Methods: Patients with spinal muscle atrophy type II and III will be recruited. Electrocardiogram signals will be recorded for analyses of heart rate variability during air stacking in supine and sitting position.

Detailed description: Background: Respiratory dysfunction is the major cause of morbidity and mortality in patients with spinal muscular atrophy. Air stacking is a clearance airway technique frequently used but its effects on cardiac autonomic function in patients with spinal muscle atrophy is not clear.

Objective: To evaluate the acute effect of air stacking and posture on cardiac autonomic function in patients with spinal muscular atrophy types II and III.

Methods: Patients with spinal muscle atrophy type II and III will be recruited. Electrocardiogram signals will be recorded for analyses of heart rate variability during air stacking in supine and sitting position. Data will collected before, during and after air stacking and will be compared using Anova Repeated Measures or Kruskal-Wallis Anova on Ranks, followed by Tukey test. The relationship between heart rate variability indexes and age will be evaluated by Pearson correlation. Significant level will be set at 5%.

Eligibility criteria: Inclusion Criteria:

* diagnosis of SMA types II and III,
* absence of acute respiratory disease in the last two weeks,
* agreement to participate in the study,
* according written informed consent and
* at least 5 years old.

Exclusion Criteria:

* respiratory disease in the last two weeks

Primary outcomes:
measure: Cardiac autonomic function
timeFrame: Thirty minutes during air stacking manuever
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Centro Universitário Augusto Motta
name: Cristina M Dias, PT - PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02952079: Comparison of BlephEx to MiBoflo as Treatment Options for Blepharitis
Official title: Comparison of BlephEx to MiBoflo as Treatment Options for Blepharitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Meibomian Gland Dysfunction
Dry Eye
Posterior Blepharitis
Lead sponsor: University of the Incarnate Word
Sponsor class: OTHER
First posted: 2016-11-02
Enrollment: 11
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 goal of this study is to compare which treatment - BlephEx or MiBoFlo - will be a better option for patients suffering from dry eye secondary to Meibomian Gland dysfunction.

Detailed description: The investigators have previously studied the effect of the BlephEx instrument (debridement of lid debris) in relieving signs and symptoms of blepharitis (Connor CG et al, ARVO 2014). This previous study demonstrated positive results from the BlephEx treatment. Warming the eyelids (e.g., using warm wash cloths) still remains a viable treatment option for this disease. However, patients are often non-compliant with warm compress therapy due to the requirement of performing it at least twice per day. The MiBoflo delivers uniform and consistent amounts of heat to the eyelid. It is suggested that two treatments over 30 days is adequate to relieve signs and symptoms of Meibomian gland dysfunction. This equipment is currently used in optometric practices in this country.

There are no clinical studies comparing BlephEx and MiBoflo as treatment options for blepharitis. Hence, the current study will provide new and useful information on which treatment option may be better for treating blepharitis and Meibomian gland dysfunction. Part of this study will also investigate if a combination of BlephEx and MiBoflo treatments is more beneficial to the patient. The data generated will directly benefit clinical practice and impact several millions of patients who suffer from this Blepharitis and / or Meibomian gland dysfunction.

Eligibility criteria: Inclusion Criteria:

* Must have dry eye secondary to Meibomian gland dysfunction (posterior blepharitis)

Exclusion Criteria:

* Must not have active ocular surface infections. Must not be currently using steroids or immunosuppression eye drops.

Primary outcomes:
measure: Ocular irritation symptoms (OSDI Questionnaire score)
timeFrame: one month
Secondary outcomes:
measure: Tear break-up
timeFrame: one month
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Rosenberg School of Optometry
state: Texas
Study officials:
affiliation: University of the Incarnate Word
name: Srihari Narayanan, OD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02135679: The Detection Of Circulating Tumor Cells (CTC) In Patients With NSCLC Undergoing Definitive Radiotherapy Or Chemoradiotherapy
Official title: The Detection Of Circulating Tumor Cells (CTC) In Patients With Non-small Cell Lung Cancer (NSCLC) Undergoing Definitive Radiotherapy Or Chemoradiotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2014-05-12
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: NSCLC patients

Brief summary: CTC levels collected pre-surgery will be correlated with pathological samples.

Detailed description: Patients with NSCLC who undergo radiation as part of a definitive course of treatment will be enrolled. Blood collections will be obtained before, during, and after radiotherapy. We will collect demographic and treatment data and explore \& describe the pattern of CTC detection in all patients

Eligibility criteria: Inclusion Criteria:

* Patients with biopsy-proven NSCLC who are undergoing definitive radiotherapy as a part of their treatment regimen.
* Age 18 or older
* Signed informed consent
* Patients who are incapable of providing informed consent are excluded from participating in this study.

Primary outcomes:
measure: To Describe the Pattern of CTCs Before and After Definitive Radiotherapy for Each Treatment Stratum
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Steven Feigenberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04938479: D-dimer Prognostic Marker of Cerebral Infarction After Revascularization Procedure
Official title: D-dimer Prognostic Marker of Cerebral Infarction After Revascularization Procedure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebral Infarction
Cerebral Infarction Recovery
Keywords: Cerebral Infarction
cerebral infarction recovery
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2021-06-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients under 65 years of age who have presented a heart attack brain and undergoing a revascularization procedure

Brief summary: Cerebral infarction is the leading cause of acquired disability in adults. Absence of biological marker used in current practice and identified as a prognostic factor for recovery. D-dimers are degradation products of stabilized fibrin translating an activation of coagulation whatever the cause. Studies have shown that increased D-dimer levels in patients with MI is associated with a higher mortality rate, the link with post-intervention non-revascularization has been demonstrate.

The purpose of this project is to search for a correlation between the level of D-dimer and the degree of recovery evaluated by the NIHSS score


Eligibility criteria: Inclusion Criteria:

* Patients aged 18 to 65
* Cerebral infarctions undergoing a revascularization procedure by thrombolysis and / or thrombectomy, at the Amiens University Hospital between January 2015 and December 2020.
* Patients having benefited from a D-dimer assay (during their stay)

Exclusion Criteria:

-

Primary outcomes:
measure: Correlation between D-dimer concentration and NIHSS score
timeFrame: 3 months
measure: Correlation between D-dimer concentration and NIHSS score
timeFrame: 6 months
measure: Correlation between D-dimer concentration and the Rankin score
timeFrame: 3 months
measure: Correlation between D-dimer concentration and the Rankin score
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References:
Clinical trial NCT03273179: Cerebral Venous Sinus Thrombosis: Re-exploration of Clinical Assessment Scales
Official title: Cerebral Venous Sinus Thrombosis: Re-exploration of Clinical Assessment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebral Venous Sinus Thrombosis
CSF Pressure Increased
Papilledema
Keywords: cerebral venous sinus thrombosis
CSF pressure
modified Rankin Scale
papilledema
NIHSS
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2017-09-06
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All individual with confirmed diagnosis of CVST are eligible for this research

Brief summary: This is a single-center, retrospective, open-label study. This study is planned to investigate the accuracy of mRS and NIHSS, comparing with the accuracy of CSF pressure and papilledema grade in assessing cerebral venous sinus thrombosis.


Eligibility criteria: Inclusion Criteria:

* confirmed diagnosis of CVST by head MRI, DSA or MRV onset of CVST within one month

Exclusion Criteria:

* unable to complete examinations unable to complete follow-ups

Primary outcomes:
measure: baseline CSF pressure
timeFrame: baseline
measure: baseline mRS
timeFrame: baseline
measure: baseline papilledema grade
timeFrame: baseline
Secondary outcomes:
measure: baseline NIHSS
timeFrame: baseline
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital Capital Medical University
Study officials:
References:
Clinical trial NCT04703179: Rare and Undiagnosed Disease Research Biorepository
Official title: Rare and Undiagnosed Disease Research Biorepository
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Undiagnosed Disease
Rare Diseases
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-01-11
Enrollment: 5000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with any rare and undiagnosed disease. Both affected and unaffected family members may also be invited for participation as part of the genetic evaluation.

Brief summary: This research study is being done to find markers and identify causes of rare and undiagnosed diseases by analyzing patient's DNA (i.e., genetic material), RNA, plasma, urine, tissues, or other samples that could be informative of symptoms. Researchers are creating a biobank (library) of samples and information to learn more about treating rare and undiagnosed diseases.


Eligibility criteria: Inclusion Criteria:

* Has Mayo Clinic or other medical health system ID, or another unique identifier
* Able to provide informed consent

Must meet one of the following:

* Individual must have evidence of a rare disease or a suspected genetic disorder as determined by a provider or genetic counselor
* Biological family member of an enrolled individual

Exclusion Criteria:

* Individuals who have situations that would limit compliance with the study requirements
* Institutionalized (i.e. Federal Medical Prison)

Primary outcomes:
measure: Enrollment of Study Participants
timeFrame: 5 years
Secondary outcomes:
measure: Body-of-Knowledge
timeFrame: 5 years
measure: Discovery of Disease Mechanisms and Therapeutic Approaches
timeFrame: 5 years
measure: Diagnostic Yield
timeFrame: 5 years
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Filippo Pinto e Vairo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04220879: Study on Intraocular Structural Parameters and Surgical Effect Before and After the Onset of Malignant Glaucoma
Official title: Study on Intraocular Structural Parameters and Surgical Effect Before and After the Onset of Malignant Glaucoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glaucoma
Malignant Glaucoma
Keywords: Malignant Glaucoma
Biometric Measurements
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2020-01-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Outpatients \>=18 years old with or without malignant glaucoma

Brief summary: In this retrospective observational study, we collected intraocular structure parameters of malignant glaucoma and primary angle closure glaucoma. Anterior chamber depth (ACD) and width (ACW), lens vault (LV), ciliary process-ciliary process distance(CCD), trabecular-ciliary processes distance (TCPD), ciliary body max thickness (CBMT), peripheral iris thickness (PIT), trabecular ciliary process angle (TCPA), and anterior vault (AV), were measured by ultrasound biomicroscopy. Other parameters measured by A-scan ultrasonography and optical coherence tomography. To analyze the high risk factors and the possible pathogenesis of the disease and discuss the long-term effect of different treatment methods.

Detailed description: Outcome Measures:

Anterior chamber depth (ACD) and width (ACW), lens vault (LV), ciliary process-ciliary process distance(CCD), trabecular-ciliary processes distance (TCPD), ciliary body max thickness (CBMT), peripheral iris thickness (PIT), trabecular ciliary process angle (TCPA), and anterior vault (AV), were measured by ultrasound biomicroscopy. Other parameters measured by A-scan ultrasonography and optical coherence tomography.

Eligibility criteria: Inclusion Criteria: (1) history of operation, (2) diagnosis of MG, and (3) eyes with clear optical media.

Exclusion Criteria:(1)hypertension or diabetes and (2) diagnosis of ocular fundus diseases.

Primary outcomes:
measure: Trabecular ciliary process angle
timeFrame: baseline
measure: Choroidal vascularity parameter
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhognshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Zhognshan Ophthalmic Center, Sun Yat-sen University
name: Chengguo O Zuo
role: STUDY_DIRECTOR
References:
Clinical trial NCT00196079: The ASPECT Study - Asian Paclitaxel-Eluting Stent Clinical Trial
Official title: The ASPECT Study - Asian Paclitaxel-Eluting Stent Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: coronary artery
stenosis
drug eluting stent
stent
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 177
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 ASPECT study is an Asian multicenter, randomized, controlled, triple-blinded study designed to evaluate the ability of the Cook Incorporated Paclitaxel Eluting Supra G Coronary Stent to reduce restenosis in the coronary artery.


Eligibility criteria: Inclusion Criteria:

* Patient must be eligible to undergo planned treatment of a single de novo lesion in a native coronary artery.
* Patient must be an acceptable candidate for coronary artery bypass surgery.
* Patient must have given signed informed consent.
* Patient agrees to return at one month for an office visit to assess cardiovascular status and at 4-6 months for an office visit to assess cardiovascular status and for a diagnostic angiogram.

Exclusion Criteria:

* Patient is less than 18 years old.
* Patient has history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
* The patient is simultaneously participating in another investigative interventional cardiovascular device or drug study.
* Patient has known hypersensitivity or contraindication to aspirin, Clopidogrel, or stainless steel, or a sensitivity to contrast dye that.
* Patient is pregnant.
* Patient has other medical condition that may cause the patient to be non-compliant with the protocol, confound the results or is associated with limited life expectancy.

Primary outcomes:
measure: Angiographic in-stent % diameter at follow-up.
Secondary outcomes:
measure: Major adverse events
measure: Total lesion revascularization
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: Contact Sponsor
state: Indiana
Study officials:
affiliation: Asan Medical Center
name: Seung Jung Park, MD
role: PRINCIPAL_INVESTIGATOR
References: