louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05091762: Effect of Physiological Ischemic Training on Patients With Atherosclerosis
Official title: Effect of Physiological Ischemic Training on Patients With Atherosclerosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atherosclerosis
Keywords: resistance training
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2021-10-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To study whether the resistance training with blood flow obstruction in patients in early atherosclerosis period can produce a beneficial effect on preventing atherosclerosis.


Eligibility criteria: Inclusion Criteria:

1. LDL \> 3.11mmol/l and less than 5.63mmol/l;
2. No serious heart, blood vessel and other related diseases;
3. There were no skeletal and muscular diseases affecting sports training;
4. No regular exercise in the past half year (no more than 2 times a week, no more than 30 minutes each time);
5. Smoking less than 1 pack / year, no history of drinking.

Exclusion Criteria:

1. Haven't other serious heart and vascular diseases other than hyperlipidemia and / or bones and muscles that affect sports training Diseases;
2. Pregnant women and people with disabilities;
3. Other circumstances determined by the researcher not suitable for the study.

Primary outcomes:
measure: Endothelium dependent vasodilation
timeFrame: 8 weeks
measure: Blood lipid analysis results
timeFrame: 8 weeks
Secondary outcomes:
measure: The inflammatory state
timeFrame: 8 weeks
measure: Endothelial repair function
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
Study officials:
affiliation: Nanjing First Hospital, Nanjing Medical University
name: Aicui Lin, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01999062: Automated Breast Radiation Therapy Using an MR-Guided Process
Official title: Automated Breast Radiation Therapy Using an MR-Guided Process
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Breast RT
Breast radiation therapy
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Princess Margaret Hospital, Canada
First posted: 2013-12-03
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In the proposed research study, we are investigating the feasibility of integrating automated planning tools to MR images acquired using a novel MR-guided linac, for on-line adaptive radiation treatment. However, these on-line automation tools require further technical refinement and clinical validation. The goal of this research proposal is to develop an on-line MR-guided radiation therapy process for adapting breast IMRT treatment. Such an approach will provide early stage breast cancer patients timely access to high-quality adaptive treatments without exposure to additional ionizing radiation.


Eligibility criteria: Inclusion Criteria:

* Patients who will receive standard two-field tangential whole breast radiation therapy with dose prescription of 4240 cGy in 16 fractions, 5000 cGy in 25 fractions or 4000 cGy in 16 fractions.
* Female patients with any stage of breast cancer.
* Patients with prior treatment such as surgery or chemotherapy for any type of cancer.
* Able to provide a written informed consent.
* ≥ 18 years of age.

Exclusion Criteria:

* Patients who will not receive 4240 cGy in 16 fractions, 5000 cGy in 25 fractions, or 4000 cGy in 16 fractions
* Males.
* Patients who received partial breast radiation and not the standard dose.
* Patients who are unable to provide informed consent.
* \< 18 years of age.

Primary outcomes:
measure: Time between planning of Radiation treatment and the start of radiotherapy
timeFrame: 3 years
measure: The effect of breathing on the position of the heart and lung in treatment plans
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
affiliation: Princess Margaret Cancer Centre
name: Robert Dinniwell, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Princess Margaret Cancer Centre
name: Tom Purdie, Physicist
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02132962: Sarcopenia and Cirrhosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cirrhosis
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Hvidovre University Hospital
First posted: 2014-05-07
Enrollment: 17
Sex: MALE
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The study investigates the effect of aminoacid infusion on proteinturnover in muscle from cirrhosis subjects, compared to healthy controls.

The hypothesis is that aminoacid infusion can attenuate the increase in proteindegradation that follows cirrhosis.


Eligibility criteria: Inclusion Criteria:

* Male subjects
* Diagnosis of cirrhosis, Child-Pugh A, B, C.

Exclusion Criteria:

* Acute illness within 3 weeks
* Ascites collections within 10 days
* Heart-, kidney, pulmonary disease. Cancer. Type 1 diabetes.
* Active alkoholdrinking

Primary outcomes:
measure: Turnover of phenylalanine and tyrosine in skeletal muscle tissue during amino acid infusion. Inflammatory markers. Protein signaling cascade.
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
References:
Clinical trial NCT01183962: Vitamin D and T-Regulatory Cells in Coronary Artery Disease
Official title: Vitamin D and T-Regulatory Cells in Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Coronary Artery Disease
Cardiovascular Disease
Keywords: CAD
Vitamin D
CVD
Lead sponsor: Creighton University
Sponsor class: OTHER
First posted: 2010-08-18
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the effect of Vitamin D supplementation on cardiovascular disease and certain cells (T-regulatory cells) in the body that play a role in plaque formation in arteries. This study will determine the levels of Vitamin D and T-regulatory cells in subjects with coronary artery disease and if Vitamin D supplementation will affect future events such as heart attach and stroke.


Eligibility criteria: Inclusion Criteria:

* between the ages of 30 and 80 years
* have a history of medically treated coronary artery disease

Exclusion Criteria:

* history of smoking in the past 2 years
* history of diabetes mellitus

Primary outcomes:
measure: increase in T-regulatory Cells
timeFrame: 1 year
Secondary outcomes:
measure: decrease pro-inflammatory cytokines & sTNFR1 and increase serum IL-10
timeFrame: 1 year
Other outcomes:
Locations:
city: Omaha
country: United States
facility: The Cardiac Center at Creighton University
state: Nebraska
Study officials:
affiliation: Creighton University
name: Michael DelCore, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01900262: Exercise Interventions, Running Biomechanics and Injury in Novice Runners
Official title: The Effects of Isolated Strengthening and Functional Training on Strength, Running Mechanics, Postural Control and Injury Prevention in Novice Runners
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Running
Leg Injuries
Keywords: Biomechanics
Ankle Strength
Postural Control
Running Mechanics
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Biomechanigg Research Ltd.
name: Canadian Institutes of Health Research (CIHR)
First posted: 2013-07-16
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to understand the effects of muscle strengthening and balance exercise interventions on muscle strength, running mechanics and postural control in novice recreational runners. Participants will be assessed before and after they engage in an 8-week exercise intervention program.


Eligibility criteria: Inclusion Criteria:

* Novice recreational runners
* Less than one year of running experience
* Run at least twice a week for a total weekly distance between 5 and 15 km as your main form of physical activity
* 18-50 years of age

Exclusion Criteria:

* Neurological abnormalities or lower extremity injury or pain within three months of enrollment.
* No extensive history with balance training or isolated ankle strengthening within the last year.

Primary outcomes:
measure: Change in Strength
timeFrame: Week 0, Week 8
measure: Change in Running Mechanics
timeFrame: Week 0, Week 8
measure: Change in Postural Control
timeFrame: Week 0, Week 8
Secondary outcomes:
measure: Cumulative Running Related Injuries
timeFrame: Week 0 through Week 24
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
References:
citation: Baltich J, Emery CA, Whittaker JL, Nigg BM. Running injuries in novice runners enrolled in different training interventions: a pilot randomized controlled trial. Scand J Med Sci Sports. 2017 Nov;27(11):1372-1383. doi: 10.1111/sms.12743. Epub 2016 Aug 3.
citation: Baltich J, Emery CA, Stefanyshyn D, Nigg BM. The effects of isolated ankle strengthening and functional balance training on strength, running mechanics, postural control and injury prevention in novice runners: design of a randomized controlled trial. BMC Musculoskelet Disord. 2014 Dec 4;15:407. doi: 10.1186/1471-2474-15-407.
Clinical trial NCT00348062: A Multicenter Evaluation of Methods to Reduce Hyperemia Associated With Bimatoprost Therapy for Glaucoma or Ocular Hypertension
Official title: A Multicenter Evaluation of Methods to Reduce Hyperemia Associated With Bimatoprost Therapy for Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma
Lead sponsor: Innovative Medical
Sponsor class: INDUSTRY
First posted: 2006-07-04
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Evaluate the incidence of hyperemia in patients using bimatoprost and to determine if simple interventions reduce its incidence and to assess the value of detailed instruction in increasing patient compliance and willingness to continue bimatoprost therapy, despite the occurrence of hyperemia.


Eligibility criteria: Inclusion Criteria:

* · Male or female \> 18 years of age

  * No prior use of bimatoprost
  * Diagnosis of open-angle glaucoma or ocular hypertension
  * Ability to provide informed consent and likely to complete all study visits

Exclusion Criteria:

* · Known contraindication to bimatoprost

  * Uncontrolled systemic disease
  * Active ocular disease other than glaucoma or ocular hypertension
  * Required use of ocular medications other than the study medications during the study (intermittent use of artificial tear solutions will be permitted)
  * History of intraocular surgery within the last 3 months

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Dr. Noecker
state: Pennsylvania
Study officials:
affiliation: UPMC Eye Center
name: Robert Noecker, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01404962: Safety of Haemophilus Influenza Type b Vaccine When Administered to Korean Children
Official title: A Post Marketing Surveillance Study to Monitor the Reactogenicity and Safety of Vaxem™Hib When Administered According to the Prescribing Information in Korea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Haemophilus Influenzae Type B Infection
Keywords: Haemophilus influenza type b
children
Korea
vaccine
Prevention of haemophilus influenza type b
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-07-28
Enrollment: 764
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This is a multicenter, post marketing surveillance study which aims to evaluate the safety profile of haemophilus influenza type b vaccine when administered to Korean children according to the product insert.


Eligibility criteria: Inclusion Criteria:

* Male and female children 2 months to 5 years of age scheduled to receive vaccination

Exclusion Criteria:

* Contraindications to Vaxem™Hib Korean Prescribing information

Primary outcomes:
measure: Number of participants with Adverse Events 28 days following vaccination
timeFrame: 29 days to 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Gyeonggi-do
country: Korea, Republic of
facility: Moon's Pediatrics Clinic
city: Incheon
country: Korea, Republic of
facility: Wooriai Pediatrics clinic
city: Seoul
country: Korea, Republic of
facility: KyungHee University Hospital
city: Seoul
country: Korea, Republic of
facility: Hanil General Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei Pediatrics Clinic
Study officials:
References:
Clinical trial NCT05020262: Incisive CT Clinica Trial Protocol
Official title: A Retrospective, Single-center, Readerblind, Nonrandomized Clinical Trial Was Conducted to Evaluate the Function of Incisive CT Precise Image and Precise Cardiac Function
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: CT Images
Lead sponsor: Philips Healthcare (Suzhou) Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: The Second Hospital of Nanjing Medical University
First posted: 2021-08-25
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The original data of the images are from the patient base in the age range of 18 to 75 years (18≤ age ≤75 years)

Brief summary: The purpose of this study was to evaluate whether the new features of Incisive CT: Precise Image, (PI) and Precise Cardiac (PC) had the expected effectiveness


Eligibility criteria: Inclusion Criteria:

* The original data of the images are from the patient base in the age range of 18 to 75 years (18≤ age ≤75 years)
* Original image data are collected in Incisive CT (version 4.5) and traceable;
* Time range for inclusion of original image data: from the start of the clinical trial to the completion of collection in compliance with this protocol;

Exclusion Criteria:

- The investigator deemed it inappropriate to include the original image data for this clinical trial

Primary outcomes:
measure: The quality of PI/PC and iDose4/ cardiac imaging reconstructed images was basically equal or above 3 score
timeFrame: through study completion, an average of 2months
Secondary outcomes:
measure: Imaging reconstruction enhancement condition using PI/PC compared with using iDose4/ cardiac basically equivalence to or above 3 score
timeFrame: through study completion, an average of 2months
measure: Imaging reconstruction diagnostic confidence using PI/PC compared with using iDose4/ cardiac basically equivalence to or above 3 score
timeFrame: through study completion, an average of 2months
measure: Imaging reconstruction clarity using PI/PC compared with using iDose4/ cardiac basically equivalence to or above 3 score
timeFrame: through study completion, an average of 2months
measure: Imaging reconstruction Noise level using PI/PC compared with using iDose4/ cardiac basically equivalence to or above 3 score
timeFrame: through study completion, an average of 2months
measure: Imaging reconstruction Image texture using PI/PC compared with using iDose4/ cardiac basically equivalence to or above 3 score
timeFrame: through study completion, an average of 2months
measure: Imaging reconstruction Image artifacts using PI/PC compared with using iDose4/ cardiac basically equivalence to or above 3 score
timeFrame: through study completion, an average of 2months
Other outcomes:
Locations:
Study officials:
affiliation: The Second Hospital of Nanjing Medical University
name: Chao Du, Deputy Director
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01486862: Efficacy of Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes Failing on OADs
Official title: NovoMix® 30 (Biphasic Insulin Aspart 70/30) Titrate-to-target: An Observational Study of the Efficacy of NovoMix® 30 in Subjects With Type 2 Diabetes Mellitus Not Achieving Glycaemic Targets on OADs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-12-07
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial is conducted in North America. The aim of this trial is to investigate the efficacy of biphasic insulin aspart 30 in subjects with type 2 diabetes not achieving glycaemic targets on OADs (oral anti-diabetic drugs).


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus for at least 12 months
* HbA1c between 7.5-14.5% (inclusive) at screening
* Insulin naïve
* An antidiabetic regimen that has been stable for at least 3 months prior to screening
* An antidiabetic regimen that includes a minimum of 2 OADs

Exclusion Criteria:

* Use of any insulin preparations within the past 6 months
* Active proliferative retinopathy or maculopathy requiring treatment within 6 months prior to screening

Primary outcomes:
measure: Percentage of subjects achieving HbA1c (glycosylated haemoglobin A1c) below 7.0%
Secondary outcomes:
measure: Change in HbA1c
measure: Total number of hypoglycemic events
measure: Adverse events
Other outcomes:
Locations:
city: Pachuca
country: Mexico
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT05745662: Accuracy of Pulse Oximeters With Profound Hypoxia At Rest (NIHO17)
Official title: Determination of SpO2 and PR Accuracy Specifications at Rest / Accuracy of Pulse Oximeters With Profound Hypoxia / Pulse Oximeter Accuracy Evaluation Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypoxia
Lead sponsor: Nihon Kohden
Sponsor class: INDUSTRY
Collaborators: name: University of California, San Francisco
First posted: 2023-02-27
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adult volunteers. At least 10 subjects will be recruited to complete the study. Of these 2 will be dark pigmented. If the number of samples is less than the required 200 or if less than 2 of dark pigment subjects successfully complete the study, subjects will be added to include 2 of dark pigmented subjects and at least 200 data points.

Brief summary: The aim of this study is to determine the accuracy of devices called pulse oximeters, which measure blood oxygen by shining light through fingers, ears or other skin, without requiring blood sampling. Study will be used with patients at rest.

Detailed description: This study is intended to evaluate performance of a new design pulse oximeter (test device) manufactured by Nihon Kohden Corporation sufficiently to support performance claims for an FDA 510K submission or ISO technical file. Specifically, SpO2 and pulse rate accuracy will be assessed for a Nihon Kohden OLV-4202 pulse oximeter with adult patients under a controlled setting of varying levels of inhaled oxygen concentration levels for patients at rest.

Eligibility criteria: Inclusion Criteria:

* Both male and female subjects who can give written informed consent
* Healthy subjects capable of undergoing controlled hypoxemia to the levels outlined in the desaturation profile
* Meeting the demographic requirements

Exclusion Criteria:

* Age below 18 or over 50
* Pregnant women
* Significant arrhythmia
* Blood pressure above 150 systolic or 90 diastolic
* Carboxyhemoglobin levels over 3%
* Subjects whom the investigator consider ineligible for the study

Primary outcomes:
measure: Accuracy of Sensor Oxygen Saturation by Arms Calculation
timeFrame: 30 seconds
Secondary outcomes:
measure: Accuracy of Sensor Pulse Rate by Arms Calculation
timeFrame: 30 seconds
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Hypoxia Research Laboratory
state: California
Study officials:
affiliation: UCSF Hypoxia Research Laboratory
name: Philip Bickler, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04782362: Validity and Reliability of the Turkish Version of the Pectus Carinatum Body Image Quality of Life Questionnaire for Patients With Pectus Carinatum
Official title: Validity and Reliability of the Turkish Version of the Pectus Carinatum Body Image Quality of Life Questionnaire for Patients With Pectus Carinatum
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pectus Carinatum
Quality of Life
Body Image
Brace
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2021-03-04
Enrollment: 60
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Pectus Carinatum

Brief summary: In children with severe pectus carinatum, a significant loss of self-esteem, impairment in social behavior due to a decrease in quality of life associated with physical appearance and mental health has been reported. However, a questionnaire measuring these problems specific to this disease is not available in Turkish. Therefore, in our study, we aimed to investigate the validity and reliability of the Pectus Carinatum Body Image Quality of Life Questionnaire (PeCBI-QOL) in patients with Pectus Carinatum.


Eligibility criteria: Inclusion Criteria:

1. Patients who have been diagnosed with Pectus Carinatum by a doctor (2 cm above the protrusion level)
2. Between the ages of 10-18,
3. Having dissatisfaction with this defect

Exclusion Criteria:

1. Having severe scoliosis (Cobb angle over 20 degrees)
2. Having chronic systemic disease
3. Having a serious psychiatric illness
4. Having complex mixed type pectus deformity

Primary outcomes:
measure: Pectus Carinatum Body Image Quality of Life Questionnaire
timeFrame: 15-21 days
Secondary outcomes:
measure: The Pectus Excavatum Evaluation Questionnaire
timeFrame: 15-21 days
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Acibadem University
Study officials:
References: