louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00267176: Safety and Efficacy of Lumiracoxib in Patients With Osteoarthritis and With Controlled Hypertension
Official title: A 4-week, Multicentre, Randomized, Double-blind, Double-dummy, Parallel Group Ambulatory Blood Pressure Monitoring Study to Investigate Whether Treatment With Lumiracoxib 100 mg Once Daily Results in an Improved 24-hour Blood Pressure Profile Compared to Ibuprofen 600 mg Three Times a Day in Osteoarthritis Patients With Controlled Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis
Controlled Hypertension
Keywords: Osteoarthritis,
hypertension,
lumiracoxib,
ibuprofen,
24-hour blood pressure profile
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-12-20
Enrollment: 1020
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will investigate the effect on ambulatory blood pressure of lumiracoxib 100 mg once daily versus ibuprofen 600 mg three times a day in osteoarthritis patients with controlled hypertension.


Eligibility criteria: Inclusion Criteria:

* Osteoarthritis of the hand, hip, knee or spine
* High blood pressure (\<140/ 90 mmHg) which is controlled by antihypertensive medication(s).

Exclusion criteria

• Evidence or history of any cardiac and cerebral thrombotic/ ischemic diseases and/ or events

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Assessment of the 24-hour systolic BP profile of lumiracoxib 100 mg o.d. in comparison to ibuprofen 600 mg t.i.d. after 4 weeks of treatment.
Secondary outcomes:
measure: Assessment of the effect of lumiracoxib 100 mg o.d. on diastolic BP derived from ABPM after 4 weeks of treatment in comparison to ibuprofen 600 mg t.i.d.
measure: Assessment of the effect of lumiracoxib 100 mg o.d. on daytime and nighttime BP (systolic and diastolic) derived from ABPM after 4 weeks of treatment in comparison to ibuprofen 600 mg t.i.d.
measure: Assessment of the effect of lumiracoxib 100 mg o.d. on the incidence of significant increases in ABP in comparison to ibuprofen 600 mg t.i.d.
measure: Exploratory analysis of the effect of lumiracoxib 100 mg o.d. on the incidence of uncontrolled hypertension in comparison to ibuprofen 600 mg t.i.d.
measure: Exploratory analysis of the effect of lumiracoxib 100 mg o.d. on the ABPM profile between 0 and 4 hours after morning dose in comparison to ibuprofen 600 mg t.i.d.
Other outcomes:
Locations:
city: O'Fallon
country: United States
facility: Southern Illinois Clinical Research
state: Illinois
city: Nuernberg
country: Germany
facility: Novartis
Study officials:
affiliation: Southern Illinois Clinical Research
name: Bradkey Sakran, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: MacDonald TM, Reginster JY, Littlejohn TW, Richard D, Lheritier K, Krammer G, Rebuli R. Effect on blood pressure of lumiracoxib versus ibuprofen in patients with osteoarthritis and controlled hypertension: a randomized trial. J Hypertens. 2008 Aug;26(8):1695-702. doi: 10.1097/HJH.0b013e328302c9fe.
Clinical trial NCT05864976: Neurosurgical Neuronavigation Using Resting State MRI and Machine Learning
Official title: Advancing Neurosurgical Neuronavigation Using Resting State MRI and Machine Learning - a Prospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Glioblastoma Multiforme
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-05-18
Enrollment: 100
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: Participants being seen at Washington University School of Medicine.

Brief summary: This study is investigating the use of a computer algorithm to analyze scans of the brain before surgery to predict how a person's tumor will respond to treatment.


Eligibility criteria: Inclusion Criteria:

* Must have a radiological diagnosis of a lesion in the brain with characteristics consistent with glioblastoma multiforme.
* Must be planning to undergo a pre-operative MRI.
* Must be at least 18 years old.
* Must be able to understand and willing to sign an IRB approved written informed consent document.

Exclusion Criteria:

* Contraindication to MRI.
* Inability to have clinical follow-up (e.g., patient is out of town and will do follow-up elsewhere).

Primary outcomes:
measure: Number of participants who are deemed as short-term survivor or a long-term survivor
timeFrame: Through completion of follow-up (estimated to be 2 years)
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Dimitrios Mathios, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04072276: Long-Term Immunogenicity Study of Inactivated EV71 Vaccine in Children
Official title: Long-Term Immunogenicity Study of Inactivated EV71 Vaccine Produced in Vero Cells With Adjuvant AlPO4 in Children: Extension Study of Protocol CT-EV-21
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Enterovirus 71 Human
Keywords: EV71 Vaccine
Lead sponsor: Medigen Vaccine Biologics Corp.
Sponsor class: INDUSTRY
First posted: 2019-08-28
Enrollment: 227
Sex: ALL
Minimum age (years): 2
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who have completed participation in study CT-EV-21

Brief summary: This study is designed to evaluate the long-term antibody titers of EV71 vaccine 4 and 5 years after first dose vaccination for subjects at the age of 2 to \< 6 years , and 3 to 5 years after first dose vaccination for subjects at the age of 2 months to \< 2 years

Detailed description: This is an extension study of protocol CT-EV-21, to evaluate the long-term immunogenicity of EV71vaccine.

The first study visit will be approximately 3 or 4 years after the administration of first vaccination of EV71 vaccine or placebo in CT-EV-21 study; 4 years after the first vaccination for subjects 2 to \< 6 years of age (2b), and 3 years after first dose for subjects 2 months to \< 2 years of age (2c and 2d).

Subjects of 2b will remain in the study for approximately 12 months and will have 2 clinic visits; subjects of 2c and 2d will remain in the study for approximately 24 months and will have 3 clinic visits. Immunogenicity response against EV71 virus antigen at each visit will be assessed.

Eligibility criteria: Inclusion Criteria:

* Subjects who have completed participation in study CT-EV-21 part 2b, 2c, and 2d, and have received protocol specified doses of EV71 vaccine or Placebo (total of 2 doses in part 2b, and 3 doses for part 2c and 2d).
* The subjects' guardians are able to understand and sign the informed consent form.

Exclusion Criteria:

* Subjects and/or guardians who refuse to comply with the study procedures

Primary outcomes:
measure: Serum neutralizing antibody titer
timeFrame: Up to 5 years after first dose of EV71 vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Hsinchu
country: Taiwan
facility: Mackay Memorial Hospital, HsincChu
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital, Taipei
city: Taipei
country: Taiwan
facility: National Taiwan University Hosptial
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital, LinKou
Study officials:
affiliation: National Taiwan University Hospital
name: Li-Min Huang, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chang Gang Memorial Hospital, LinKou
name: Cheng-Hsun Chiu, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Mackay Memorial Hospital, HsinChu
name: Chien-Yu Lin, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Mackay Memorial Hospital
name: Nan-Chang Chiu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01080976: Comparing Google With A Focused Diabetes Search Engine
Official title: Comparing Google With A Focused Diabetes Search Engine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2010-03-05
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary Care Physicians, Informaticians, Diabetologists

Brief summary: Abstract Diabetes behavior can be influenced by patients exploring diabetes topics that may lack scientific credibility. The question this study examines is whether a Google or Health on the Net (HON) internet search, presents websites that would incline a more or less likely recommendation to patients ? A preliminary trial suggests that referrers recommend websites based on rules that may prioritize website source over content. This study will qualitatively assess the rules that participants use in deciding which websites are more suitable than others.

Method The investigators will inject a diabetes related search term into a HON and a Google search engine. The top 5 mutually exclusive websites from each search engine will be presented to 5 people from three groups stratified across endocrinologists, informaticians and PCPs. Participants will rank the websites and then identify the rules that they applied to reach their decision.


Eligibility criteria: Inclusion Criteria:

* physician, informatician, diabetologist

Exclusion Criteria:

-

Primary outcomes:
measure: Website Ranking
timeFrame: Immediate
measure: Search Engine Preference
timeFrame: Immediate
Secondary outcomes:
Other outcomes:
Locations:
city: Brookline
country: United States
facility: Charles Safran
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Charles Safran, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01346176: The Influence of Default Options in Advance Directives
Official title: The Influence of Default Options in Advance Directives for Older Patients: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advance Care Planning
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh
First posted: 2011-05-02
Enrollment: 132
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The investigators aim to assess the influence of default options in advance directives on older patients selections of life- extending therapies and to determine whether alerting patients to the spectrum of possible default options in advance directives influences their selections of life-extending therapies by manipulating the default options of advance directives given to patients in with severe respiratory disease

Detailed description: The project is designed to document that default options influence terminally ill patients end-of-life decisions (in this case, adults with advance forms of lung disease) and that our team can recruit and retain patients in a study of advance care planning. In addition, because a larger-scale randomized clinical trial will require that the investigators alert participants to the range of possible default options, the investigators must also determine the effects that this alerting will have on their selections of life-extending therapies. Therefore, the investigators seek to achieve three aims: (1) assess the influence of default options in advance directives on patients selections of life-extending therapies; (2) determine whether alerting patients to the spectrum of possible default options in advance directives influences their selections of life extending therapies; and (3) document the feasibility of recruiting and retaining patients with advanced lung diseases from university-based clinical settings into a randomized trial of default options in advance directives.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of chronic obstructive pulmonary disease (COPD), idiopathic pulmonary fibrosis (IPF), non-small-cell lung cancer, or other interstitial or fibrotic lung disease
* Neither listed for nor considering solid organ transplantation
* Anticipated survival of less than 2 years
* Must be fluent and literate in English

Exclusion Criteria:

* Diagnosis of small-cell lung cancer or other respiratory diseases for which life extending medical therapies may be available

Primary outcomes:
measure: Proportion of Subjects Who Select Palliative Care Options
timeFrame: 6 months
Secondary outcomes:
measure: Patient Satisfaction With Advance Care Planning.
timeFrame: Two months after AD completion
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania School of Medicine
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Scott D. Halpern, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02442076: Skin and Acupuncture Needle Vibration Behaviors Through Observation
Official title: Skin and Acupuncture Needle Vibration Behaviors Through Observation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Skin Vibration
Acupuncture
Keywords: Skin vibration
Acupuncture needle vibration
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: National Central University,Taiwan(R.O.C)
First posted: 2015-05-13
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers who is

1. Aged 20\~65
2. Without chronic disease
3. Didn't receive surgery in the past 12 months

Brief summary: Skin tremor induced by artery pulses are usually sensed by doctor's fingers in Traditional Chinese Medicine(TCM). On the other hand, vibration of acupuncture needle was also stated by Huang Di Nei Jing (Yellow Emperor). However; the characteristics of skin tremor and its correlation with vibrating acupuncture needles, how the skin tremor and vibration of needles varies from area to area, are not yet clarified.In this study, the abovementioned issues will be investigated experimentally through non-invasive method.

About 10 healthy volunteers, aged 20\~65, will be recruited. The investigators will measure the needle and the skin tremor by video optical microscopy. The variation of skin tremor and needle vibration and their spectra will be analyzed digitally. The model correlating skin tremor, needle vibration and basic physiological parameters will be constructed.The fact that the skin tremor and the needle vibration come from the same origin is expected.

However; due to the leverage effects and different dynamical responses to the source vibrations at different frequencies, needle vibration might exhibit some difference from skin vibration in their power spectra. This study should be able to construct a clear model of the possible vibration sources such as heartbeat and breathing, the area dependence of vibrations, the correlation between the skin and the needle vibrations, and the correlation with other physiological parameters.


Eligibility criteria: Inclusion Criteria:

* Healthy employees or students of National Central University aged between twenty to sixty-five.

Exclusion Criteria:

* With chronic diseases, severe psychological disorder or injury, or been in a surgery in the past twelve months.

Primary outcomes:
measure: The frequency and spectra of the vibrating acupuncture needle ,by video optical microscopy
timeFrame: 30 minutes
measure: The frequency and spectra of tremor of the skin surrounding the acupunctured point ,by video optical microscopy
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan City
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital
Study officials:
References:
Clinical trial NCT01629576: Obesity and Financial Incentives
Official title: Finanzielle Anreize Zur Reduktion Von Übergewicht
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Obesity
Lead sponsor: Rhine-Westphalia Institute for Economic Research
Sponsor class: OTHER
First posted: 2012-06-27
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Investigate whether economic incentives help obese individuals to lose weight.


Eligibility criteria: Inclusion Criteria:

* BMI above 30
* age between 18 anf 75
* registered residence in the German federal state of Baden-Württemberg

Exclusion Criteria:

* considerable language barriers
* pregnancy
* psychological disorders
* eating disorders
* tumor disease within last five years
* abuse of alcohol
* abuse of drugs
* serious general diseases

Primary outcomes:
measure: bodyweight
timeFrame: 22 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bad Kissingen
country: Germany
state: Baden-Würrttemberg
Study officials:
References:
Clinical trial NCT05387876: Vitamin D Intervention and Associated Changes in the Gut Microbiome and Vitamin D Levels in Healthy Adults
Official title: Association of Vitamin D Supplementation and Normal Dietary Intake of Vitamin D With Changes in the Gut Microbiome and Markers of Colorectal Cancer Risk
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer
Lead sponsor: Baylor University
Sponsor class: OTHER
First posted: 2022-05-24
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blind placebo controlled randomized intervention of vitamin supplementation
Primary purpose: BASIC_SCIENCE

Brief summary: Although dietary vitamin D supplementation has been used in the clinical setting for decades, the effect of supplementary vitamin D consumption on the structure of the microbiome has not been studied in humans in fine scale or with concomitant adjustment for dietary intake. Understanding the interaction of vitamin D with the microbiome in humans could lead to important advancements in the understanding of how vitamin D together with diet impacts the microbiome composition, and ultimately, risk of EOCRC. This study has the potential to lay the ground work for an adjunctive therapy to manipulate the microbiome to reduce risk of EOCRC. This proposed study is designed to evaluate the effect of vitamin D supplementation on the normal structure of the microbiome and data will not be used to diagnose, prevent, cure or treat disease.


Eligibility criteria: Inclusion Criteria:

* Adult 18 years or older

Exclusion Criteria:

* Women who are currently pregnant or breastfeeding
* Use of antibiotics within the last 2 weeks
* Use of supplementary vitamin D within the last month
* Self-reported, pre-existing history of inflammatory bowel disease, heart disease or diabetes
* Students under 18
* Tanning/sun exposure \> 60 min at a time in last 4 weeks
* No phenobarbital, carbamazepine, spironolactone chronic therapy; or steroid use within the last 2 weeks
* Severe allergy to ingredients found in supplements

Primary outcomes:
measure: Microbiome alterations
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Waco
country: United States
facility: Baylor University
state: Texas
Study officials:
affiliation: Baylor University
name: Kristen L Greathouse, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01253876: Effect of Soymilk Replacement on Anthropometric and Blood Pressure Value
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Weight
Waist
Systolic Blood Pressure
Diastolic Blood Pressure
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2010-12-03
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: yes

Brief summary: Soymilk components such as isoflavones, essential fatty acids, phytoesterols, good fats, inositols might have beneficial effects on weight control and blood pressure management. Most studies in this regard have been conducted on postmenopausal or premenopausal women and there are few studies on female youths. Therefore, we are going to determine the effects of soy consumption on the weight, waist circumference and blood pressure in overweight and obese female youths. This was a cross-over randomized clinical trial which was conducted in 2010 in Isfahan on overweight or obese young female youths. After three weeks run-in, females were randomly assigned to consume a diet containing caw's milk or a diet in which only one glass of soy milk was substituted; each one for six weeks. Random sequencing generated in SPSS was used for allocating females in different group randomly. Patients were not blinded because they had to use soy milk in one period of trial and use caw's milk in another period.


Eligibility criteria: Inclusion Criteria:Being in the age range of 18 to 30 and having body mass index more than 30 kg/m2 were the inclusion criteria.

-

Exclusion Criteria:Having allergy to soy product or caw's milk and not consuming the soy milk or caw's milk, incidence of chronic or acute diseases which make patients not to follow the research protocol or beginning to consume the medications were the exclusion criteria.

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Isfahan University of Medical Sciences
Study officials:
References: