louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01589042: Chocolate Balloon Angioplasty Registry
Official title: Chocolate Balloon Angioplasty Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Arterial Disease
Lead sponsor: TriReme Medical, LLC
Sponsor class: INDUSTRY
First posted: 2012-05-01
Enrollment: 490
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: Patients with Peripheral Arterial Disease appropriate for treatment with balloon angioplasty

Brief summary: To collect data from real-world use with the Chocolate PTA Balloon Catheter to support the effectiveness of the device for use during percutaneous transluminal angioplasty (PTA) procedures.


Eligibility criteria: Inclusion Criteria:

1. \>18 years of age
2. Lesion successfully crossed with a guide-wire
3. Reference Vessel Diameter (RVD) within the treatment range of the Chocolate PTA Catheter used at the target lesion appropriate for 1:1 dilatation
4. Patient has given consent for their information to be submitted to this registry

Exclusion Criteria:

1. Lesion required stenting as the primary treatment approach
2. Life expectancy \<12 months
3. Patient is enrolled in another clinical study that may impact the results of this registry

Primary outcomes:
measure: Achievement of Optimal PTA
timeFrame: average of 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Heart Institute
state: Arizona
city: Rancho Mirage
country: United States
facility: Desert Cardiology
state: California
city: Gainesville
country: United States
facility: Cardiovascular Research of North Florida
state: Florida
city: Miami
country: United States
facility: Mount Sinai Medical Center
state: Florida
city: Elk Grove Village
country: United States
facility: Alexian Brothers Heart and Vascular
state: Illinois
city: Boston
country: United States
facility: St. Elizabeth's Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: St. John's Hospital
state: Michigan
city: Wyoming
country: United States
facility: Metro Health Hospital
state: Michigan
city: Jackson
country: United States
facility: Jackson Heart Clinic
state: Mississippi
city: Raleigh
country: United States
facility: Rex Health
state: North Carolina
city: Dallas
country: United States
facility: Cardiovascular Research of Dallas
state: Texas
city: Dallas
country: United States
facility: VA North Texas
state: Texas
city: Racine
country: United States
facility: Wheaton Franciscan Healthcare
state: Wisconsin
Study officials:
affiliation: Metro Health Hospital
name: Jihad Mustapha, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St Elizabeth's Med Center / Tufts Univ School of Medicine
name: Lawrence Garcia, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00727142: Conservative Versus Surgical Management of Idiopathic Normal Pressure Hydrocephalus (INPH)
Official title: Conservative Versus Surgical Management of Idiopathic Normal Pressure Hydrocephalus
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Normal Pressure Hydrocephalus
Keywords: NPH
Hydrocephalus
Shunt
Lead sponsor: University College London Hospitals
Sponsor class: OTHER
First posted: 2008-08-01
Enrollment: 14
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to provide class 1 evidence supporting or refuting the existence of normal pressure hydrocephalus.

Detailed description: By comparing one group with active CSF shunting with another with non .

Eligibility criteria: Inclusion Criteria:

* Idiopathic Normal pressure Hydrocephalus

Exclusion Criteria:

* Alzheimer disease
* Vascular dementia

Primary outcomes:
measure: improvement in walking speed
timeFrame: 3 months
Secondary outcomes:
measure: improved cognition or continence
timeFrame: 3 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: National Hospital for Neurology and Neurosurgery
Study officials:
affiliation: NHNN
name: Laurence Watkins, FRCS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03724942: Brexpiprazole for the Long-term Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type
Official title: A Multicenter, Uncontrolled, Open-label Trial to Evaluate the Safety of Extended Treatment With Brexpiprazole (OPC-34712) to Patients With Agitation Associated With Dementia of the Alzheimer's Type
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Agitation Associated With Dementia of the Alzheimer's Type
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-10-30
Enrollment: 164
Sex: ALL
Minimum age (years): 55
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the safety of brexpiprazole 1 mg or 2 mg after a 14 week treatment regimen for agitation associated with dementia of the Alzheimer's type patients who completed in a double-blind trial, and to investigate the efficacy of brexpiprazole.


Eligibility criteria: Inclusion Criteria:

* Patients who completed the double-blind treatment period for 10 weeks and all observation, examination and evaluation at Week 10 of the double-blind trial.
* Patients whose caregiver can properly collect the necessary information.

Exclusion Criteria:

* Patients who had a serious adverse event which the principal investigator or sub-investigator assessed as related to the investigator product during the double-blind trial.
* Patients who had delirium during the double-blind trial.

Primary outcomes:
measure: The Frequency of Subjects With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: From baseline to week 14
Secondary outcomes:
measure: Mean Change From Baseline in Cohen-Mansfield Agitation Inventory (CMAI) Score at 14 Weeks After Dosing
timeFrame: Baseline and 14 weeks after dosing
measure: Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at 14 Weeks After Dosing.
timeFrame: Baseline and 14 weeks after dosing.
measure: Clinical Global Impression of Improvement (CGI-I) Score at 14 Weeks After Dosing
timeFrame: 14 weeks after dosing.
Other outcomes:
Locations:
city: Shirakawa
country: Japan
facility: Jisenkai Nanko Psychiatric Institute
Study officials:
affiliation: Otsuka Pharmaceutical Co., Ltd.
name: Osamu Sato
role: STUDY_DIRECTOR
References:
Clinical trial NCT05323942: The Effect of Sleep Hygiene and Exercise Therapy in Children With Sleep Bruxism
Official title: The Effect of Sleep Hygiene and Exercise Therapy on Bruxism, Sleep Habits, and Oral Habits in Children With Sleep Bruxism.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Bruxism, Childhood
Keywords: Bruxism
Sleep Habits
Oral Habits
Children
Lead sponsor: Hasan Kalyoncu University
Sponsor class: OTHER
First posted: 2022-04-12
Enrollment: 37
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aims of this study were to determine the relationship between sleep bruxism, oral habits, and sleep habits and establish treatment approaches in children.

Detailed description: This cross-sectional study was conducted on children aged between 6-and 13 years, diagnosed with sleep bruxism (SB). Initially, 82 children with a diagnosis of SB were evaluated. Among those, 37 children volunteered were followed for 8 weeks to investigate the effects of the education, sleep hygiene and therapeutic exercise program.

Sleep hygiene education includes routines about bedtime, sleeping room environment, and timing for exercise.

Therapeutic exercises program 5x5 included breathing exercises, head-neck, and scapular posture exercises which included jaw muscle and neck muscle stretching and strengthening exercises. They were asked to repeat each exercise 5 times and 5 times a day for 8 weeks.

Eligibility criteria: Inclusion Criteria:

* Children between the ages of 6 - 13,
* Having a diagnosis of sleep bruxism,,
* And a parent signing informed consent for participation in the study.

Exclusion Criteria:

* Children who received orthodontic treatment,
* Children with the dentofacial anomaly, a history of TMJ surgery, having a medical history of neurological or psychiatric disease
* and those who could not cooperate were excluded from the study.

Primary outcomes:
measure: Change from Baseline in Pain at 8 weeks
timeFrame: Baseline, 8 weeks
measure: Change from Baseline in Children's Sleep Habits Questionnaire (CSHQ) at 8 weeks
timeFrame: Baseline, 8 weeks
measure: Change from Baseline in Oral Habits at 8 weeks
timeFrame: Baseline, 8 weeks
Secondary outcomes:
measure: Change from Baseline in Temporomandibular Joint (TMJ) Range of Motion (ROM) at 8 weeks
timeFrame: Baseline, 8 weeks
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Hasan Kalyoncu University
Study officials:
affiliation: Hasan Kalyoncu University
name: Aysenur Tuncer, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06090942: Cognitive Training for Digital Biomarkers
Official title: The Effectiveness of Cognitive Training for Digital Biomarkers: Evidence From the Urban and Rural Area
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cognitive Decline
Healthy Aging
Keywords: digital biomarker
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2023-10-19
Enrollment: 90
Sex: ALL
Minimum age (years): 60
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study aims to conduct cognitive training for digital biomarkers among older adults.

Detailed description: The prevalence of dementia in rural areas is higher than in urban areas. However, the resource and research input on cognitive training for rural older adults still needs improvement. There is also no solution for preventing or early detection of dementia in rural areas. Unlike biomarkers that require invasive detection, digital biomarkers have been advocated in recent years for early disease prediction. However, there are still few studies on the effectiveness of digital biomarkers in evaluating cognitive function in the elderly. In addition, although previous studies have confirmed that cognitive training can be effective for older adults, it is difficult for the elderly in rural areas to obtain these cognitive-promoting resources due to distance. Moreover, the autonomy and right of choice of older adults are the keys to the success of their health behavior change.

Eligibility criteria: Inclusion Criteria:

1. At least 60 years of age, Can communicate in Chinese (Taiwanese)
2. Bring your own mobile device with Internet access.
3. Can act alone without physical impairment；full score of basic activities of daily living scale and instrumental activities of daily living scale.

Exclusion Criteria:

1. Dementia diagnosed by a physician and in compliance with ICD-10
2. Physician diagnosed with significant mental illness or communication impairment
3. Participated in other cognitive training studies within the past year
4. Medical conditions associated with rapid functional and cognitive decline
5. Severe visual impairment

Primary outcomes:
measure: digital biomarker
timeFrame: pretest, immediate post test, 3 month follow-up, 6 month follow-up
Secondary outcomes:
measure: Montreal Cognitive Assessment(MoCA)
timeFrame: pretest, immediate post test, 3 month follow-up, 6 month follow-up
measure: Digit Span(DS)
timeFrame: pretest, immediate post test, 3 month follow-up, 6 month follow-up
measure: Digit Vigilance Test(DVT)
timeFrame: pretest, immediate post test, 3 month follow-up, 6 month follow-up
measure: Computerized version of Wisconsin Card Sort Test (WCST)
timeFrame: pretest, immediate post test, 3 month follow-up, 6 month follow-up
measure: Stroop color-word test (SCWT)
timeFrame: pretest, immediate post test, 3 month follow-up, 6 month follow-up
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00896142: Optima Coronary Artery Disease (CAD) (Optimal Mechanical Evaluation)
Official title: Optima CAD (Optimal Mechanical Evaluation)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Ischemic Cardiomyopathy
Keywords: ischemic cardiomyopathy
cardiac resynchronization therapy
LV structure and function
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2009-05-11
Enrollment: 50
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: 18+ years of age must be patients of UPMC Cardiovascular Institute

Brief summary: To evaluate the impact of left ventricular (LV) lead location on LV mechanical function.


Eligibility criteria: Inclusion Criteria

1. Ischemic Cardiomyopathy
2. Left ventricular ejection fraction less than 40%
3. Clinical indication for invasive electrophysiology testing
4. Patient is at least 18 years of age

Exclusion Criteria

1. Unstable angina, acute myocardial infarction and/or revascularization procedure within 3 months
2. CVA or TIA within the past 6 months
3. Prosthetic heart valve
4. Patient is status post heart transplant
5. Women who are pregnant or with child -bearing potential and who are not on a reliable form of birth control. Women of child-bearing potential are routinely tested for pregnancy as part of the standard of care prior to EPS procedures being performed.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Presybterian
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: David S. Schwartzman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03307642: Evaluation of the School Kids Influenza Prevention Project
Official title: Evaluation of a Text Based Reminder Recall System to Increase Utilization of the School Kids Influenza Prevention Project and Increase Influenza Vaccination Rates in Monroe County, NY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Influenza Vaccination
School-located Influenza Vaccination
Keywords: Influenza vaccination rates
Respiratory Tract Diseases
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
First posted: 2017-10-12
Enrollment: 18540
Sex: ALL
Minimum age (years): 4
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: SLIV will be offered at all schools in an urban school district. Students will be randomized into either SLIV + standard communication about SLIV or SLIV + standard communication + text message reminders.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Children whose parents receive text reminders are more likely to be consented to participate in the school located influenza vaccination clinic than children whose parents do not receive text reminders.


Eligibility criteria: Inclusion Criteria:

- Enrolled in the urban school district

Exclusion Criteria:

- Attends a school in the urban district containing a school-based health center

Primary outcomes:
measure: Influenza vaccination status
timeFrame: Through January, 2018
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
affiliation: University of Rochester
name: Stanley Schaffer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01811342: Continuous Hemoglobin Evaluation
Official title: Evaluation of the Masimo Continuous Hemoglobin Monitor With Polar Plot Methodology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia
Keywords: Hemoglobin
Patient Monitoring
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2013-03-14
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing elective surgery.

Brief summary: Evaluate potential sources of error that affect the accuracy of continuous hemoglobin monitoring.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective surgery.

Exclusion Criteria:

* 0

Primary outcomes:
measure: Evaluation of the Masimo Continuous Hemoglobin Monitor with Polar Plot Methodology
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
Study officials:
References:
Clinical trial NCT05499442: EEG Motor Movement and Imagery Dataset for Stroke
Official title: Construction of Non-invasive EEG Motor Movement and Imagery Dataset for Stroke
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Stroke
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2022-08-12
Enrollment: 120
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: Patients with motor dyfunction in Xuanwu Hospital of Capital Medical University were admitted from January 1, 2022 to December 31, 2023

Brief summary: The investigators collect and analyze the alpha and beta wave of EEG activity at the motor cortices of the participants, When the motor task is being performed. The Brodmann area 10-20 method and portable EEG equipment was used in the single-center study.

Detailed description: To understand the motor mechanism of stroke patients with motor dysfunction, an EEG motor movement and imagery dataset for Stroke will be created. 120 subjects will be enrolled in the single-center study. The investigators collect and analyze the EEG activity at the motor cortices of the participants, When the motor movement or imagery task is being performed. The alpha and beta wave of EEGs were recorded from 32 electrodes as per the international 10-20 system with portable EEG equipment.

Eligibility criteria: Inclusion Criteria:

1. The diagnosis of cerebral infarction conforms to the diagnostic criteria of Chinese guidelines for the diagnosis and treatment of acute ischemic stroke 2018, and the diagnosis of intracerebral hemorrhage conforms to the diagnostic criteria of Chinese guidelines for the diagnosis and treatment of intracerebral hemorrhage 2019.
2. First onset.
3. Age ≥ 18 years old.
4. Motor dysfunction of upper and / or lower limbs: muscle strength decreased by 0 to 5-grade and / or ataxia.
5. Informed consent has been signed.

Exclusion Criteria:

1. Vital signs are unstable.
2. Serious circulatory system, respiratory system, motor system and other diseases, such as atrial fibrillation, heart failure, pulmonary infection, severe liver and kidney insufficiency, lower extremity venous thrombosis and other serious diseases.
3. Functional impairment of upper or lower limbs caused by other diseases of nervous system or other reasons, such as fracture, deformity, etc.
4. Unable to cooperate to complete the examination, such as mental disorder, cognitive impairment, visual impairment, sitting balance disorder, etc
5. Other reasons: alcoholism; Skull defect; Head skin defect, etc.

Primary outcomes:
measure: EEG characteristics of motor
timeFrame: 1-7day
measure: Action Research Arm Test
timeFrame: 1-7days
measure: Fugl-meyer Assessment
timeFrame: 1-7days
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Beijing
state: Beijing
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Junwei Hao
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06608342: Autologous Hematopoietic Stem Cell Transplantation Combined With CD19-CART Treatment of Adult High-risk Acute Lymphoblastic Leukemia
Official title: Clinical Study of Autologous Hematopoietic Stem Cell Transplantation Combined With CD19-CART Treatment for Adult High-risk Acute Lymphoblastic Leukemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Acute Lymphoblastic Leukemia ALL
Keywords: inaticabtagene autoleucel
auto-HSCT
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sponsor class: OTHER
Collaborators: name: Juventas Cell Therapy Ltd.
First posted: 2024-09-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To observe the efficacy and side effects of autologous hematopoietic stem cell transplantation combined with CD19-CART for adult acute lymphoblastic leukemia, and to evaluate the safety and efficacy of this regimen in the treatment of acute lymphoblastic leukemia.

Detailed description: To observe the efficacy and side effects of autologous hematopoietic stem cell transplantation combined with CD19-CART for adult acute lymphoblastic leukemia, and to evaluate the safety and efficacy of this regimen in the treatment of acute lymphoblastic leukemia.

Eligibility criteria: Inclusion Criteria:

* Adult patients with high-risk acute B-lymphoblastic leukemia
* Complete remission was achieved after induction chemotherapy, and autologous CD19-CAR-T was successfully prepared
* Eligible for autologous hematopoietic stem cell transplantation
* No major organ dysfunction

Exclusion Criteria:

* Combined with malignant tumors of other organs
* With a serious infection that is not under control
* Syphilis, AIDS, hepatitis B, hepatitis C, any one of them positive
* Patients who have had an allergic reaction to the drugs used in this study or similar drugs
* Other patients deemed unsuitable for inclusion by the investigators

Primary outcomes:
measure: Relapse rate within 2 years
timeFrame: Time Frame: From autologous hematopoietic stem cell transplantation to 2 years after transplantation
Secondary outcomes:
measure: Non-relapse mortality
timeFrame: Time Frame: From autologous hematopoietic stem cell transplantation to 2 years after transplantation
measure: Progression-free survival
timeFrame: Time Frame: From autologous hematopoietic stem cell transplantation to 2 years after transplantation
measure: Overall survival rate
timeFrame: Time Frame: From autologous hematopoietic stem cell transplantation to 2 years after transplantation
measure: Incidence of infection
timeFrame: Time Frame: From autologous hematopoietic stem cell transplantation to 2 years after transplantation
Other outcomes:
Locations:
city: Tianjin
country: China
facility: NO.288 Nanjing Road，Heping District，Tianjin, Tianjin,
state: Tianjin
Study officials:
References: