louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01507844: Continuous Positive Airway Pressure Effect on Air Trapping in Chronic Obstructive Pulmonary Disease Patients
Official title: Continuous Positive Airway Pressure Effect on Air Trapping, Endurance Time in Chronic Obstructive Pulmonary Disease Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
CPAP
Sham
FEV1
IC
RV/TLC
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2012-01-11
Enrollment: 24
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Chronic obstructive pulmonary disease is a disease characterized by small airways inflammation and obstruction. The small airways disease produces hyperinflation (air trapping), which increases with exercise. Continuous positive airways pressure may reduce small airways obstruction and therefore air trapping. Pulmonary function tests including lung volumes at rest and and after exercise will be measured. In addition, exercise endurance time before treatment and after treatment will be measured.

Detailed description: Continuous positive airways pressure which prevent small air ways collapse and may also clear secretions. At first stage the optimal pressure for reducing air trapping will be determined. In addition, all patients will undergo a maximal exercise test. A baseline complete pulmonary function test is performed followed by continuous positive air way pressure at the pre-determined pressure. This will be followed by exercise at 60% of maximal obtained previously.

Eligibility criteria: Inclusion Criteria:

* chronic obstructive lung disease stage 2-3 GOLD
* FRC \> 120%

Exclusion Criteria:

* active ischemic heart disease
* heart failure
* peripheral vascular disease

Primary outcomes:
measure: improved small airways obstruction
timeFrame: 2-3 hrs
Secondary outcomes:
measure: improved respiratory symptoms
timeFrame: 2-3 hrs
Other outcomes:
Locations:
city: Beer Yaakov
country: Israel
facility: Pulmonary Institute
Study officials:
affiliation: Assaf-Harofeh Medical Center
name: David stav, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05297344: Clinical Study of the Direct Pulp Capping in Primary Teeth
Official title: Clinical Study of the Direct Pulp Capping in Primary Teeth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Direct Pulp Capping
Pulpotomy
Primary Teeth
Lead sponsor: The Dental Hospital of Zhejiang University School of Medicine
Sponsor class: OTHER
First posted: 2022-03-28
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Research content: select the patients with accidental pulp exposure or decayed pulp exposure in the pediatric dentistry department of The Affiliated Stomatology Hospital of Zhejiang University School of Medicine from February 2022 to October 2022.

1. Strictly implement the case selection criteria to reduce the deviation. 2. Conduct uniform training and assessment for doctors. 3. Record in detail: the age, gender, tooth position, cavity type, x-Ray examination, size and reason of pulp exposure, time of hemostasis, filling material, signs and symptoms of initial consultation and follow-up, etc. 4. Analyze the clinical data to study the success rate of direct pulp capping of primary teeth; analyze the influence of various factors to study how to improve the success rate of direct pulp capping of primary teeth.


Eligibility criteria: Inclusion Criteria:

* No irreversible signs or symptoms of pulpitis in the affected tooth.
* Mechanical pulp exposure caused by cavity preparation or trauma, or pulp exposure after decayed tissue removal, with healthy dentin around the pulp exposure.
* The size of the exposed pulp\<1 mm.
* The morphology of pulp tissue at the pulp exposure is normal, and the bleeding should be able to be controlled within 5 minutes.
* X-ray showed that there was no abnormal resorption or fracture of the root and no lesions around the root.

Exclusion Criteria:

* The child is unable to cooperate with the treatment.
* Pulp exposure \> 1 mm.
* Irreversible signs or symptoms of pulpitis in the affected tooth.
* Abnormal morphology of the pulp tissue at the pulp exposure, much bleeding and inability to stop bleeding.
* X-ray shows: abnormal resorption or fracture of the tooth root and lesions around the root.
* The parents or the child refused to participate in the experiment.

Primary outcomes:
measure: Success rate of the direct pulp capping
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Affiliated Hospital of Stomatology, Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References:
Clinical trial NCT00584792: Diet, Genetic Variation and Prostate Cancer Among African Americans
Official title: Diet, Genetic Variation and Prostate Cancer Among African Americans
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2008-01-02
Enrollment: 102
Sex: MALE
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: African American males between the ages of 35 and 75.

Brief summary: This is a single center pilot study to asses the feasibility of conducting a larger population-based study. It is an investigator-initiated study funded yb the UC Davis Cancer Center's Development Award Program. The hypothesis is that the percent african ancestry in an individual may determine their prognosis if diagnosed with prostate cancer.


Eligibility criteria: Inclusion Criteria:

Self-identification as a male with African ancestry Between ages of 35-75

Exclusion Criteria:

No African ancestry Not between ages of 35-75

-

Primary outcomes:
measure: Is there a difference in ancestry percentage between the controls (no cancer) and the cases (prostate cancer)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of California, Davis
name: Lesley Butler, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00046592: Mechanisms of Disability in Peripheral Arterial Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Arterial Occlusive Diseases
Peripheral Vascular Diseases
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2002-10-01
Sex: ALL
Minimum age (years): 59
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To determine the mechanisms by which atherosclerotic peripheral artery disease (PAD) causes functional impairment and to define the degree to which peripheral artery disease associated pathophysiologic findings change over time.

Detailed description: BACKGROUND:

Research demonstrates that men and women with lower extremity peripheral arterial disease (PAD) have poorer functioning than men and women without PAD. Preliminary data also indicate that more severe PAD at baseline, as measured by the ankle brachial index (ABI), is associated with a greater incidence of functional loss. However, the pathophysiologic mechanisms in the lower extremities responsible for PAD-related functional impairment and functional loss are not well defined.

DESIGN NARRATIVE:

The study cohort will consist of 790 individuals identified from three Chicago-area medical centers, of whom 500 will have PAD. Participants will undergo a baseline and two annual follow-up visits. Pathophysiologic findings in the lower extremities refer to reduced muscle mass, reduced muscle quality, and reduced peripheral sensory and motor function. Quality of muscle tissue is defined as the ratio of muscle force to muscle mass. Muscle mass will be measured with Computed Tomography (CT). Peripheral nerve function will be determined using surface electroneurography (ENG). Lower extremity functional measures will consist of measures pertinent to functioning during daily living and include six minute walk distance, seven-day physical activity level (assessed by accelerometer), walking speed, balance tests, and lower extremity muscle power.

The cross-sectional study will test the hypotheses that a) chronic lower extremity arterial ischemia is associated with specific pathophysiologic findings in lower extremity muscle and nerve and that b) these ischemia-related pathophysiologic findings are associated with lower extremity functional limitation.The longitudinal study will test the hypotheses that a) greater baseline lower extremity arterial ischemia as measured by ABI is associated with greater progression of pathophysiologic findings over two year follow-up and that b) greater ischemia-related pathophysiologic findings in the legs at baseline is associated with greater functional decline over two year follow up. Results will be used to develop interventions designed to improve lower extremity functioning and prevent functional decline in persons with PAD.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Northwestern University Feinberg School of Medicine
name: Mary McDermott
References:
Clinical trial NCT00202592: S90652 in Paediatric Hypertension
Official title: Safety and Effects on Blood Pressure of Daily Dose 0.025 to 0.135 Milligram Per Kilogram of S90625 a Paediatric Formulation of Perindopril, in Hypertensive Children - 24 Months
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertension
Lead sponsor: Servier
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The aim of the study is to assess the long-term safety and effects on blood pressure of a paediatric formulation of perindopril in hypertensive children


Eligibility criteria: Inclusion Criteria:

* Hypertensive children, who have been treated for four months at least with S90652, with safety and efficacy

Exclusion Criteria:

* Poorly controlled hypertension
* Girls with signs of pubescence

Primary outcomes:
measure: Clinical safety assessed from the patient's (parents) complaints and clinical follow-up
Secondary outcomes:
measure: Blood pressure
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Necker Enfants Malades
Study officials:
affiliation: Hôpital Necker-Enfants Malades, Paris, France
name: Patrick Niaudet, Pr
role: STUDY_CHAIR
References:
Clinical trial NCT02987192: Minimally Invasive Lumbar Aneasthesia Used for Cesarean Section
Official title: Comparison of the Impact Between Minimally Invasive and Traditional Spinal Anesthesia for Cesarean Section in Maternal Anticoagulation Therapy:Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anticoagulation
Minimally Invasive
Spinal Anesthesia
Keywords: spinal anesthesia
anticoagulation
minimally invasive
Cesarean Section
Maternal
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2016-12-08
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Spinal canal anesthesia is marked the most commonly used method of cesarean section. Traditional spinal anesthesia may cause post-dural puncture headache and low back pain.Plenty of parturients are undergoing anticoagulation therapy.They may be forced to accept general anesthesia in order to avoid epidural hematoma.Therefore, we propose minimally invasive spinal anesthesia.

Detailed description: Traditional group patients will receive cutting type 22 gauge needles, while minimally invasive group patients will receive pen type 27 gauge needles.Patients will be blinded to the intervention allocations. Spinal anesthesia will be performed with a standardized technique. Lumbar puncture will be performed through an interspace (L3-4 or L2-3) with patients in a lateral decubitus position. After free flow of cerebrospinal fluid through the needle tip be verified, 2ml ropivacaine will be injected. We will record puncture situation, anesthesia plane and measure post-dural puncture headache, post-operative back pain and epidural hematoma.

Eligibility criteria: Inclusion Criteria:

1. puerpera accept anticoagulation therapy
2. American society of anesthesiologists(ASA) classification I to II level
3. Willing to participate in this study and signed an informed consent
4. pregnancy at least 37 weeks

Exclusion Criteria:

1. platelet count less than 50\*100000000
2. International Normalized Ratio more than 1.5
3. site of puncture with infection
4. with intracranial hypertension
5. with lumbar spine or spinal cord disorders

Primary outcomes:
measure: Visual analogue score of post-dural puncture headache
timeFrame: 1 to 7 days after operation
Secondary outcomes:
measure: Visual analogue score of low back pain
timeFrame: 1 to 7 days after operation
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital, Shanghai Jiao Tong University, School of Medicine
state: Shanghai
Study officials:
affiliation: Anesthesiology Department Renji Hospital, Shanghai Jiao Tong University, School of Medicine
name: WEIFENG YU, MD
role: STUDY_CHAIR
References:
citation: Huang D, Zhu L, Chen J, Zhou J. Minimally invasive spinal anesthesia for cesarean section in maternal anticoagulation therapy: a randomized controlled trial. BMC Anesthesiol. 2019 Jan 12;19(1):11. doi: 10.1186/s12871-018-0679-1.
Clinical trial NCT02932592: evAluation of Glycemic RangE During acutE Coronary syndroME in Nondiabetic paTients (AGREEMENT)
Official title: evAluation of Glycemic RangE During acutE Coronary syndroME in Nondiabetic paTients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Coronary Syndrome
Lead sponsor: University of Pavia
Sponsor class: OTHER
First posted: 2016-10-13
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: CGMS
Primary purpose: DIAGNOSTIC

Brief summary: To evaluate the glycemic variations during acute coronary syndrome in non-diabetic patients (euglycemic, or with impaired fasting glucose, or with impaired glucose tolerance)

Detailed description: All nondiabetic patients with dysglycemia (fasting plasma glucose between 100 and 125 mg/dl) will be monitored with a device (Continuous Glucose Monitoring System) and all these patients will be undergone an oral glucose tolerance test after the discharge from this Unit.

Eligibility criteria: Inclusion Criteria:

* nondiabetic patients
* acute coronary syndrome

Exclusion Criteria:

* diabetic patients

Primary outcomes:
measure: Glycemic status
timeFrame: 15 days
Secondary outcomes:
measure: Lipid profile
timeFrame: 15 days
measure: Lipid profile
timeFrame: 15 days
measure: Lipid profile
timeFrame: 15 days
measure: Lipid profile
timeFrame: 15 days
measure: Endothelial damage
timeFrame: 15 days
measure: Endothelial damage
timeFrame: 15 days
measure: Inflammation parameters
timeFrame: 15 days
measure: Inflammation parameters
timeFrame: 15 days
measure: Inflammation parameters
timeFrame: 15 days
measure: Inflammation parameters
timeFrame: 15 days
measure: Inflammation parameters
timeFrame: 15 days
measure: Inflammation parameters
timeFrame: 15 days
measure: Heart damage
timeFrame: 15 days
measure: Heart damage
timeFrame: 15 days
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Giuseppe Derosa
Study officials:
affiliation: University of Pavia
name: Giuseppe Derosa, MD, PhD, FESC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05631392: Study to Evaluate the Clinical and Radiographic Outcomes of the BEE® HA Cage for Anterior Cervical Discectomy and Fusion
Official title: A Prospective, Non-randomised, Multi-centre, Post-market Clinical Follow-up Observational Study to Evaluate the Clinical and Radiographic Outcomes of the BEE® HA Cage for Anterior Cervical Discectomy and Fusion.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cervical Disc Degeneration
Lead sponsor: Invibio Ltd
Sponsor class: INDUSTRY
Collaborators: name: NGMedical GmbH
First posted: 2022-11-30
Enrollment: 51
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prospective study so patient population taken from those undergoing cervical spine fusion surgery.

Brief summary: Observational data collection of information after undergoing standard Cervical spine fusion surgery.


Eligibility criteria: Inclusion Criteria:

1. Subjects aged 18 years of age or older (≥ 18 years) and are skeletally mature.
2. Subjects with discopathy, disc hernia with radiculopathy and/or myelopathy, or stenosis of the foramen and spinal canal with or without cervical radiculopathy/myelopathy, at one or two contiguous levels from C3 to C7, and confirmed by imaging studies (CT and/or MRI will be taken according to standard local procedures and confirmed by the Investigator that imaging represents the indication for surgery).
3. Subjects with a documented individual history of neck and/or upper extremity pain and/or functional/neurological deficit associated with the cervical level to be treated.
4. Subjects who are indicated for surgical treatment with the BEE® HA Cage with RESORBA® Synthetic Bone injectable bone substitute (RESORBA Medical GmbH).
5. Subjects who have completed at least 6 weeks of conservative non-operative treatment without obtaining adequate symptomatic relief.

Exclusion Criteria:

1. Subjects who have undergone previous spinal surgery either anterior or posterior.
2. Subjects with evidence of tumour and/or malignant disease with resultant life expectancy of less than two years.
3. Subjects with a known allergy to the material used in the instrumentation.
4. Subjects with evidence of an active infection and/or with any condition that would compromise their participation and follow-up in this clinical study.
5. Subjects who have known osteoporosis or severe osteopenia as determined by the Investigator.
6. Subjects who have any conditions outlined as contraindicated in the Instructions for Use.

Primary outcomes:
measure: Neck Disability Index (NDI) Questionnaire
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Halle
country: Germany
facility: Bg Klinikum Bergmannstrost Halle
Study officials:
References:
Clinical trial NCT03332992: Comparative Tests of Flu Vaccination Phone Messages
Official title: Comparative Tests of Flu Vaccination Phone Messages
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influenza, Human
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Emmi Solutions
name: University of Iowa
name: University of Utah
First posted: 2017-11-06
Enrollment: 7206
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This project is a partnership between Emmi Solutions, a private company that delivers health promotion messages to employees of client organizations, and the University of Michigan and affiliated academic investigators. In particular, Emmi sends out pre-recorded and interactive telephone calls on behalf of their healthcare clients to promote influenza vaccination each Fall. The collaboration will design various scripts (based on established risk communication, behavior change, and behavioral economic principles) to be pre-recorded and sent out on these calls on a randomized basis (with approval by client organizations), with the number of arms to vary based on the size of each client's participant list (to ensure sufficient statistical power within each client's sample). Emmi will deliver the calls and track individual responses to questions posed during the call. Emmi will then provide a de-identified dataset to the academic research team for analysis to determine whether any scripts provided greater or lesser effects to people's their motivations to get a flu vaccination.


Eligibility criteria: Inclusion Criteria:

* Patient of client organizations of Emmi Solutions
* Provided a phone number to their care team

Exclusion Criteria:

-

Primary outcomes:
measure: Vaccination intentions (Time 1)
timeFrame: Day 1 (Assessed during the intervention telephone call)
Secondary outcomes:
measure: Documented influenza vaccination
timeFrame: Within 6 months / during 2017-2018 influenza season
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Emmi Solutions
state: Illinois
Study officials:
affiliation: University of Michigan
name: Brian J Zikmund-Fisher, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05566392: Longterm Influence of Pediatric Long COVID Syndrome
Official title: Longterm Influence of Pediatric Long COVID Syndrome on the Neuropsychiatric Function, Social Function, Neuroimage, and Gut Microbiota
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COVID-19-Associated Encephalitis
Long COVID
Keywords: pediatric neurology
psychiatric evaluation
Long COVID syndrome
magnetic resonance image
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2022-10-04
Enrollment: 500
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Aged between 6-18 years old pediatric patient diagnosed as COVID would be enrolled. The patient who had neuropsychiatric disorders would be excluded. We also enroll age- and gender-matched healthy participants for cross-over comparison

Brief summary: We enroll pediatric patients who were diagnosed COVID-19 for main observation target. We will perform brain MRI and neuropsychiatric evaluation 4-6 months after COVID-19 diagnosed. We also enroll healthy age- and gender-matched participant for cross-over comparison. We will perform same evaluation process one year later for longitudinal evaluation


Eligibility criteria: Inclusion Criteria:

* Age 6-18 years old
* Has been diagnosed COVID-19 before

Exclusion Criteria:

* History of neuropsychiatric disorders
* Have some device not allowed for MRI

Primary outcomes:
measure: Difference between COVID and healthy group
timeFrame: 1 years after enrollment for primary evaluation
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Children Hospital Pediatric Neurology Department
Study officials:
affiliation: National Taiwan University Children Hospital Pediatric neurology department
name: Wang-Tso Lee, PHD
role: PRINCIPAL_INVESTIGATOR
References: