louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02749916: Contrast Enhanced SWI for Carotid Plaque Imaging
Official title: Contrast Enhanced Susceptibility Weighted Imaging (SWI) for Characterization of Carotid Plaque
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Carotid Plaque Imaging
Keywords: SWI
MP-RAGE
DANTE T1-SPACE
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
First posted: 2016-04-25
Enrollment: 25
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute or recent (within 3months) stroke or TIA (transient ischaemic attack)

Brief summary: This study aims to compare image-based characteristics of carotid walls between symptomatic side and the opposite side. The design of this study is phase IV, prospective observational study.

Detailed description: Atherosclerosis of craniocervical arteries are one of most important causes of stroke. Carotid artery is the most frequent site of atherosclerosis. Recent research in carotid artery covers not only morphology of lumen but also direct visualization of carotid plaque or vessel wall. Vulnerable carotid plaques share pathologic features of intra-plaque inflammation and hemorrhage. There have been reports about post-contrast SWI in the field of vascular imaging. We hypothesized SWI is so sensitive to gadolinium based contrast agent and hemorrhage that contrast-enhanced SWI can visualize vulnerable carotid plaque. The purpose of this study is to investigate gadolinium-enhanced SWI in detection of vulnerable carotid plaque and compare it with MP-RAGE and DANTE T1-SPACE. This can be used to guide proper treatment for stroke.

Eligibility criteria: Inclusion Criteria:

* Patients with acute or recent (within 3months) stroke or TIA
* 50-99% stenosis of internal carotid artery by NASCET criteria
* Written informed consent, prior to registration

Exclusion Criteria:

* Hemorrhagic stroke
* Previous history of carotid endarterectomy (CEA), angioplasty, or stenting
* Contraindication for MR imaging
* Hypersensitivity to gadolinium based contrast media
* Pregnant or lactating women
* Patients under age of 19-year-old
* Renal condition : eGFR \< 60
* Patients unable and/or unwilling to comply with treatment or study instructions.

Primary outcomes:
measure: Detection rate of findings of vulnerable carotid plaque
timeFrame: within 3 days after enrollment
Secondary outcomes:
measure: Accuracy in delinating geometry of carotid inner lumen and outer wall
timeFrame: within 3 days after enrollment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
Study officials:
References:
Clinical trial NCT00724516: Evaluation Of A Novel Breast Compression Paddle For Wire Localization In Mammography
Official title: Evaluation Of A Novel Breast Compression Paddle For Wire Localization In Mammography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mammography
Biopsy, Needle
Keywords: Mammogram
Biopsy
Needle
Wire
Localization
Compression
Paddle
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2008-07-29
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The purpose of this study is to evaluate the functionality of a new breast compression paddle used in mammography for wire localization.

Detailed description: Presently, the breast compression paddles that are used in mammography for wire localization are made of plastic and contain a relatively small rectangular shaped opening through which the wire is placed in the breast. When technologists use this paddle, they must carefully position the breast such that the rectangular opening is above the region for wire localization. A novel paddle has been developed which increases the wire localization access area tremendously and should therefore make it easier to perform the procedure. The purpose of this study is to evaluate the functionality of this new compression paddle. The new compression paddle was developed by Biomedical Engineering students in conjunction with Radiologists and a Medical Physicist at the University of Michigan. It was designed and manufactured for a student project in the Mechanical Engineering 450/599 course at the University of Michigan.

Eligibility criteria: Inclusion Criteria:

* Women who are scheduled to undergo a wire localization procedure on the digital mammography unit at the University of Michigan Cancer Center

Exclusion Criteria:

* Men
* Pregnant Women
* Lactating Women
* Prisoners
* Children under the age of 18
* Mentally impaired individuals

Primary outcomes:
measure: Evaluate the newly designed breast compression paddle.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
Study officials:
affiliation: University of Michigan Hospital
name: Caroline Blane, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04264416: Effects of Whole-Body Electromyostimulation on Golf Performance
Official title: Effects of 16 Weeks of Whole-Body Electromyostimulation on Stability, Strength and Golf Performance in Amateur Golfers - A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Golf Specific Performance
Muscle Strength
Trunk Stability
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2020-02-11
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Golf is becoming increasingly popular in Germany. However, the biomechanical and motor challenge of golf should not be underestimated. Nevertheless, only very few amateur golfers carry out serious preparation and conditioning as part of a strength/stabilization program. The main argument for this limitation is the aspect of "limited time resources". A solution to this problem could therefore be the time-effective and highly individualizable whole-body electromyostimulation (WB-EMS) technology. The aim of the present study is to evaluate the effectiveness of 16 weeks of WB-EMSapplication on maximum strength of the lower extremities, trunk stability and (golf) handicap in male amateur golfers in a (randomized) controlled setting.


Eligibility criteria: Inclusion Criteria:

* golf amateurs with a history if golf \> 2 years
* no WB-EMS application during the last 12 months

Exclusion Criteria:

* contraindications for WB-EMS (in doubt assessment by study physician)
* contraindications for MRI (in doubt assessment by study physician)
* resistance exercise training for more one 60 min/week during the last 12 months
* expected absence of more than one week during the intervention period (WB-EMS)

Primary outcomes:
measure: 18 hole golf score
timeFrame: through study completion, on average 4 months
Secondary outcomes:
measure: Hip-/leg extensor strength
timeFrame: At baseline and after 16 weeks
measure: Trunk strength
timeFrame: At baseline and after 16 weeks
measure: Muscle density at the mid-thigh
timeFrame: At baseline and after 16 weeks
measure: Muscle density at lumbar spine
timeFrame: At baseline and after 16 weeks
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Institute of Medical Physics, Friedrich Alexander University Erlangen-Nürnberg
state: Bavaria
Study officials:
affiliation: Institute of Medical Physics, FAU, Germany
name: Carina Zink-Rückel, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carina Zink-Rückel, Florian Rückel, Simon von Stengel, Wolfgang Kemmler. The Use of Whole Body Electromyostimulation (WB-EMS) as a Golf Warm-Up - A Randomized Controlled Cross-Over Study. Archives of Physical Health and Sports Medicine Volume 2 (2019)1: 04-12
Clinical trial NCT04001816: A Randomized Clinical Trial to Investigate Whether Self Ligating Brackets or Conventional Brackets Are Better for Treating Bimaxillary Proclination
Official title: A Randomized Clinical Trial to Investigate Whether Self Ligating Brackets or Conventional Brackets Are Better for Treating Bimaxillary Proclination
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bimaxillary Proclination
Lead sponsor: The University of The West Indies
Sponsor class: OTHER
Collaborators: name: University of Dundee
First posted: 2019-06-28
Enrollment: 100
Sex: ALL
Minimum age (years): 11
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is a single blind randomised control trial.The patients will be randomly assigned to have conventional brackets placed or self ligating brackets placed.

All patients will undergo full Orthodontic records. This will include an Orthodontic assesment, study models relevant xrays (orthopantogram and a cephalomgram) and clinical photos. After records analysis, patients will be given a prophylaxis and oral hygiene instructions.

Either 3m Victory Series™ Metal Braces or 3m SmartClip™ SL3 Self-Ligating Braces both bracket types will carry the MBT prescription 0.022 slot height, will be bonded using Transbond™ XT (3M Unitek, Monrovia, California, USA) composite resin according to the manufactuer's instruction.

These patients will be recalled at monthly intervals for the duration of treatment time which will be 3 years. A cephalogram will be taken at the end of treatment


Eligibility criteria: Inclusion Criteria:

* Bimaxillary Proclination
* Class I or Class II division 1 incisor relationship with an overjet less than or equal to 6.0 mm
* The cases can be extraction or non extraction cases
* Extraction cases must be of at least both upper first premolars to relieve moderate to severe crowding and/or to reduce the overjet
* No previous orthodontic treatment
* No systemic illness
* No use of anti inflammatory drugs prior to placement of the fixed appliance
* Good oral hygiene and periodontal health with periodontal pockets of less than or equal to 4 mm, full-mouth plaque score less than or equal to 20 per cent
* Cooperative and motivated
* In the permanent dentition with all teeth present at least to the first molars
* No radiographic bone loss was observed on the dental pantomographic image.

Exclusion criteria:

* Patients who required surgery to correct skeletal discrepancies.
* Patients with hyperdontia, hypodontia, or syndromic diseases (e.g. cleft lip and palate).
* Uncooperative patients

Primary outcomes:
measure: Treatment time
timeFrame: 18-24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Augustine
country: Trinidad and Tobago
facility: UWI Dental School
Study officials:
affiliation: The University of The West Indies
name: Trudee Hoyte
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00846716: Shiga Progression of Diabetes, Nephropathy and Retinopathy
Official title: Exploratory Study to Investigate the Suppressive Effect of Oral Anti-Diabetic Drug (TZD) on Progression of Diabetic Nephropathy on
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus
Diabetic Nephropathy
Diabetic Retinopathy
pioglitazone
Lead sponsor: Shiga University
Sponsor class: OTHER
Collaborators: name: Kanazawa Medical University
name: Nagahama Red Cross Hospital
name: Nagahama City Hospital
name: Kohka Public Hospital
name: Second Okamoto General Hospital
name: Omihachiman COmmunity Medical Center
name: Yasu Hospital
name: Toyosato Hospital
name: Ako City Hospital
name: Horide Clinic
name: Kawabata Clinic
name: Seta Clinic
name: Shiga Clinic
name: Osaka University
name: NTT West Osaka Hospital
name: Hyogo prefectural Amagasaki Hospital
name: Tomita Clinic
name: Sawada Clinic
name: Social Insurance Shiga Hospital
First posted: 2009-02-19
Enrollment: 400
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate whether the oral anti-diabetic drug, Thiazolidine (TZD) is effective in suppression of onset or progressin of diabetic nephropathy in Japanese type 2 diabetic patients.

Detailed description: 2. Outcome measures:

1. Primary endpoint Onset or progression of diabetic nephropathy
2. Secondary endpoints (1)Progression of diabetes mellitus (2)Change in HbA1c (3)Change in albumin-creatinine ratio (4)Change in GFR (5)CHange in cystatin C

Eligibility criteria: Inclusion Criteria:

* Type 2 Diabetes Mellitus
* Less than 8.0% in HbA1c
* Less than 300 mg/g Cr of urinary albumine level
* Concomitant therapy with SU and/or Biguanide
* Untreated hypertension and hypertension treated with ARB or ACEI

Exclusion Criteria:

* History of heart failure and concomitant heart failure
* History of administration of TZD agent
* Severe hepatic dysfunction with more than 3 times higher than upper limit of normal range of GOT, GPT or rGPT
* Severe renal dysfunction with more than 2.5 of Cr
* History of AE with TZD agent
* Insulin treatment
* Concomitant urinary track infection

Primary outcomes:
measure: Onset and progression of diabetic nephropathy
timeFrame: 2 years
Secondary outcomes:
measure: Progression of diabetes mellitus change from the baseline in HbA1c change from the baseline in albumine/creatinine ratio change from the baseline in cystatin C onset and progression of diabetic retinopathy safety assessment
timeFrame: 2 years
Other outcomes:
Locations:
city: Otsu
country: Japan
facility: Shiga University of Medical Science
state: Shiga
Study officials:
affiliation: Tsukiwa-machi, Seta, Otsu, Shiga, Japan
name: Atsunori Kashiwagi, PhD.
role: STUDY_CHAIR
References:
Clinical trial NCT05908916: Atezolizumab and Bevacizumab With Combined Radiotherapy for Advanced Hepatocellular Carcinoma
Official title: A Single-arm Phase II Trial of Atezolizumab and Bevacizumab With Combined Radiotherapy in Advanced Hepatocellular Carcinoma With Portal Vein Invasion
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 51
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Atezolizumab plus Bevacizumab combination therapy (AtezoBev) is well-known 1st-line therapy for advanced hepatocellular carcinoma (HCC). However, there are unmet needs for patients with advanced HCC who do not respond to AtezoBev. External beam radiotherapy (RT) is another well-known locoregional therapy for HCC that induces inflammatory cascade and abscopal effect as a systemic anticancer effect and enhances the effect of AtezoBev. Therefore, the investigators aim to verify the effect of AtezoBev plus RT for advanced HCC through this single-center, prospective phase II one-armed cohort study over three years. This study recruits 51 patients to verify the effect of the intervention. Atezolizumab (1200mg) and Bevacizumab (15mg/kg) are administered to patients once for each cycle at 3-week intervals, and additional radiotherapy for the mass or portal vein tumor thrombosis is performed before second cycle of AtezoBev. The primary endpoint is progression-free survival by using response evaluation with modified RECIST.


Eligibility criteria: Inclusion Criteria:

1. age ≥19;
2. clinically or histologically diagnosed HCC;
3. HCC with Vp2-Vp4 portal vein invasion;
4. intact liver function with Child-Pugh class A;
5. adequate size of RT field;
6. intact performance with ECOG below 2;
7. non-pregnant with acceptable contraception in premenopausal women);
8. without other life-threatening diseases;
9. ability to provide written informed consent and to comply with all study conditions.

Exclusion Criteria:

1. Active uncontrolled infection;
2. Current or history (\< or = 5 years) of advanced malignancies in the other organs;
3. History of liver transplantation;
4. miliary HCC which incompatible external beam RT

Primary outcomes:
measure: Progression-free survival
timeFrame: 2 years (per 9 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance hospital
Study officials:
affiliation: Severance Hospital
name: Do Young Kim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00520416: Prospective, Non-Randomized Evaluation of Carbon Dioxide Gas as a Contrast Agent in Comparison With Iodinated Contrast in Endovascular Aneurysm Repair
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carbon Dioxide
Endovascular Abdominal Aortic Aneurym Repair
Prospective
Angiogram
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2007-08-24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: Endovascular repair of infrarenal abdominal aortic aneurysms (AAA) requires a contrast agent to identify the vascular anatomy and placement of the stent graft. Iodine contrast has traditionally been used, but has the potential to harm the kidneys. Another contrast agent is carbon dioxide gas. It has been proven safe to use, but the quality of the images it creates needs to be compared to iodine contrast. Patients in this study undergo the endovascular AAA repair as they normally, with the iodine contrast. At the end of surgery carbon dioxide gas contrast is given as an extra step. The images will be later evaluated.


Eligibility criteria: Inclusion Criteria:

* Infrarenal abdominal aortic aneurysm amendable to endovascular repair

Exclusion Criteria:

* renal failure or contraindication to receiving iodine contrast.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC University Hospital
state: California
Study officials:
affiliation: University of Southern California
name: Fred A Weaver, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00422916: Treatment of Overweight Children and Adolescents
Official title: Evaluation of the Intervention Program "Obeldicks Light" for Overweight Children and Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Lead sponsor: University of Witten/Herdecke
Sponsor class: OTHER
Collaborators: name: University of Bremen
First posted: 2007-01-17
Enrollment: 66
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The intervention program "Obeldicks light" is developed for overweight children aged 8-16 years. This intervention is gender - and age specific.

The 6-month intervention is based on nutrition course, behaviour therapy and exercise therapy. The evaluation compromised quality of structure, process and results of the intervention. 300 participants in a randomised controlled group design will be evaluated at 4 time points: baseline, end of intervention, 6 months after end of intervention and 12 months after end of intervention.Primary outcome measure is change of weight status as standard deviation score of BMI. Drop-outs will be interviewed to improve the intervention.


Eligibility criteria: Inclusion Criteria:

* overweight children

Exclusion Criteria:

* primary disease

Primary outcomes:
measure: change of weight status
timeFrame: 6 months
Secondary outcomes:
measure: Change of eating and exercise behaviour
timeFrame: 6 months
measure: change of quality of life
timeFrame: 6 months
Other outcomes:
Locations:
city: Datteln
country: Germany
facility: Vestische Youth Hospital
Study officials:
affiliation: University of Bremen, Germany
name: Petra Kolip, Prof
role: STUDY_CHAIR
References:
citation: Reinehr T, Bucksch J, Muller A, Finne E, Kolip P. 7-Year follow-up of a lifestyle intervention in overweight children: Comparison to an untreated control group. Clin Nutr. 2018 Oct;37(5):1558-1562. doi: 10.1016/j.clnu.2017.08.017. Epub 2017 Aug 24.
citation: Finne E, Reinehr T, Schaefer A, Winkel K, Kolip P. Health-related quality of life in overweight German children and adolescents: do treatment-seeking youth have lower quality of life levels? Comparison of a clinical sample with the general population using a multilevel model approach. BMC Public Health. 2013 Jun 8;13:561. doi: 10.1186/1471-2458-13-561.
citation: Finne E, Reinehr T, Schaefer A, Winkel K, Kolip P. Changes in self-reported and parent-reported health-related quality of life in overweight children and adolescents participating in an outpatient training: findings from a 12-month follow-up study. Health Qual Life Outcomes. 2013 Jan 2;11:1. doi: 10.1186/1477-7525-11-1.
citation: Reinehr T, Schaefer A, Winkel K, Finne E, Toschke AM, Kolip P. An effective lifestyle intervention in overweight children: findings from a randomized controlled trial on "Obeldicks light". Clin Nutr. 2010 Jun;29(3):331-6. doi: 10.1016/j.clnu.2009.12.010. Epub 2010 Jan 27.
Clinical trial NCT06152016: BE FAST vs. FAST: A Study in the General Public.
Official title: BE FAST vs. FAST: A Randomized Trial Comparing Retention of Stroke Symptoms Between Two Mnemonics in the General Public.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: BE-FAST
FAST
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: BayCare Health System
name: Aurora BayCare Medical Center
First posted: 2023-11-30
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: A randomized, blinded prospective study assessing retention of two stroke mnemonics (BE FAST and FAST) in the general public after receiving brief stroke education. Participants were randomized to one of two education arms and retention was tested at 3 different time intervals.


Eligibility criteria: Inclusion Criteria:

1. Subject 18 years of age or older
2. Subject speaks English (Does not need interpreter)
3. Subject able to read English
4. Subject willing to provide a phone number for future follow up
5. Subject willing and agreeable to up to 2 phone follow up calls
6. Subject willing to provide verbal consent to participate

Exclusion Criteria:

1. Subject non-English speaking (needs interpreter)
2. Subject has visual or hearing impairment
3. Subject has history of Dementia or a learning disability
4. Subject had stroke education within the past year
5. Subject had a previous stroke

Primary outcomes:
measure: Recall Visit 1
timeFrame: 60 minutes
Secondary outcomes:
measure: Retention Rate Symptom
timeFrame: 30 days
measure: Recall Rate Symptom
timeFrame: 30 days
measure: Recall Participant Percentage
timeFrame: 30 days
measure: Patrial Recall Participant Percentage
timeFrame: 30 days
measure: Common Recall Participant Percentage
timeFrame: 30 days
measure: Retention per Professional Background
timeFrame: 30 days
Other outcomes:
Locations:
city: Green Bay
country: United States
facility: Aurora BayCare Medical Center
state: Wisconsin
Study officials:
affiliation: Aurora Baycare
name: Ziad Darkhabani, MD
role: PRINCIPAL_INVESTIGATOR
References: