louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01523717: Procalcitonin Monitoring Sepsis Study
Official title: Procalcitonin Decrease Over 72 Hours and Outcome in Patients With Severe Sepsis or Septic Shock
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Sepsis
Septic Shock
Keywords: procalcitonin
decrease over 72 hours
severe sepsis
septic shock
Lead sponsor: Brahms AG
Sponsor class: INDUSTRY
First posted: 2012-02-01
Enrollment: 858
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adult patients with severe sepsis or septic shock in the emergency department, medical floor, ICU

Brief summary: The purpose of this study is to investigate the relationship between a procalcitonin decrease over 72 hours and outcome in patients who have severe sepsis or septic shock.


Eligibility criteria: Inclusion Criteria:

* Adult patients (i.e. \>18 years of age) diagnosed with severe sepsis or septic shock as defined in Appendix 1, who are already in the ICU or come from the ED, other wards or directly from out of hospital
* Blood sample collection within 12 hours after diagnosis "severe sepsis or septic shock"No prior enrollment into this study
* Written informed consent

Primary outcomes:
measure: 28 day all cause mortality
timeFrame: within 28 day safter inlclusion
Secondary outcomes:
measure: all-cause in-hospital mortality
timeFrame: mortality during hospital stay
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California Davis Health System
state: California
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Worcester
country: United States
facility: Saint Vincent Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Detroit Receiving Hospital
state: Michigan
city: Detroit
country: United States
facility: Sinai Grace Hospital
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: New York
country: United States
facility: New York Methodist Hospital
state: New York
city: New York
country: United States
facility: Stony Brook University
state: New York
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Nathan Shapiro, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05896917: Comparison of 3D Printed Foot Orthoses With Prefabricated Foot Orthoses
Official title: Do 3D Printed Foot Orthoses Reduce Self-reported Pain?-a Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Flexible Flatfoot
Lead sponsor: Taibah University
Sponsor class: OTHER
First posted: 2023-06-09
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare the effects of 3D printed insoles versus prefabricated insoles in otherwise healthy subjects with flatfoot condition.

The main question it aims to answer is:

* If 3D printed insoles are better in terms of fit, weight, durability, comfort, and effectiveness compared to prefabricated insoles.
* If 3D printed insoles are better in terms of reducing pain compared to prefabricated insoles.

Participants will be divided in two groups. One group will receive 3D printed insoles and other group will wear prefabricated insoles for four weeks. After four weeks, researchers will record their feedback about their insoles which will help them to compare the two insoles.

Detailed description: The purpose of this research is to compare the effects of 3D printed insoles versus prefabricated insoles in flatfoot subjects. This study will recruit healthy adult subjects with flexible flat feet but otherwise good physical and mental health. They will be divided into groups of an equal number of people. Prefabricated insoles will be given to one group, while 3D printed insoles will be given to the other. Subjective feedback will be collected at week zero, when the subjects will be given the insoles to wear, and again at the end of fourth week. Statistical analysis will be used to determine whether or not there is a significant difference in the responses of the two groups. The results will help us in identifying which insoles are better than the other in terms of parameters described above.

Eligibility criteria: Inclusion Criteria:

* Age of 18 years or above
* Flatfoot symptoms such as foot/calf pain and fatigue after prolonged walking
* Foot postural index ranging from 6 to 12
* No neurological or physical disabilities

Exclusion Criteria:

* Below 18 years of age
* Inability to understand or answer questions
* Any lower limb surgery within the past two years
* Any lower limb injury within the past six months
* Any neurological disorder affecting gait

Primary outcomes:
measure: Visual Analog Scale
timeFrame: Will be measured at Week 0
measure: Visual Analog Scale
timeFrame: Will be measured at Week 4
measure: Quebec User Evaluation of Satisfaction with Assistive Technology questionnaire.
timeFrame: Will be measured at 4th week
Secondary outcomes:
Other outcomes:
Locations:
city: Medina
country: Saudi Arabia
facility: Medical Rehabilitation Hospital
state: Al Madinah
Study officials:
affiliation: Taibah University
name: Abu Z Bari, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01293617: Blackberry Intake and Biomarkers of Cancer Risk
Official title: Blackberry Intake and Biomarkers of Cancer Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: USDA Beltsville Human Nutrition Research Center
Sponsor class: FED
First posted: 2011-02-10
Enrollment: 52
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Berry components have been shown to influence cancer processes in cell culture studies. The investigators will conduct a study to investigate if blackberries influence the same cancer processes in a human feeding study.


Eligibility criteria: Inclusion Criteria:

* Non-smoking men and women
* Aged 40-75
* BMI 19-38 kg/m2

Exclusion Criteria:

* Younger then 40 ears old or older than 75 years old
* BMI less than 19 or greater than 38
* Use of blood-thinning medications such as warfarin, dicumarol, or anisinidione
* Presence of kidney disease, liver disease, gout, certain cancers, untreated thyroid, gastrointestinal, other metabolic diseases or malabsorption syndromes
* Type 2 diabetes requiring the use of oral antidiabetic agents or insulin
* Fasting triglycerides greater than 300 mg/dL
* Fasting glucose greater than 126 mg/dL
* History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g. vegetarians, very low fat diets, high protein diets)
* Use of prescription of over-the-counter antiobesity medications or supplements during and for at least 6 months prior to the start of the study or a history of a surgical intervention for obesity
* Active cardiovascular disease
* Use of any tobacco products in the past 6 months
* Use of oral or IV antibiotics during the month preceding the study or during the study
* Unwillingness to abstain from vitamin, mineral, and herbal supplements for two weeks prior to the start of the study
* Known (self-reported) allergy or adverse reaction to blackberries or gelatin
* Unable or unwilling to give informed consent or communicate with study staff
* Self-report of alcohol or substance abuse within the past 12 months and/or current acute treatment or rehabilitation program for these problems (long-term participation in Alcoholics Anonymous is not an exclusion)
* Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol

Primary outcomes:
measure: Change from baseline in 8-oxo-dG levels after 5 days
timeFrame: Day 5
Secondary outcomes:
Other outcomes:
Locations:
city: Beltsville
country: United States
facility: Beltsville Human Nutrition Research Center
state: Maryland
Study officials:
affiliation: Beltsville Human Nutrition Research Center, USDA
name: Janet A Novotny, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00444717: Impact of Pitavastatin in Hypercholesterolemic Patients With Metabolic Syndrome
Official title: Multicenter Study for Anti-oxidative and Anti-inflammatory Effects of Pitavastatin in Hypercholesterolemic Patients With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Metabolic Syndrome
Oxidative Stress
Inflammation
Keywords: statin
metabolic syndrome
oxidative stress
inflammation
Lead sponsor: Aichi Gakuin University
Sponsor class: OTHER
First posted: 2007-03-08
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate anti-oxidative and anti-inflammatory effects of pitavastatin in hypercholesterolemic patients with the metabolic syndrome.

Detailed description: The metabolic syndrome is defined as a cluster of cardiovascular risk factors including visceral obesity, dyslipidemia, elevated blood pressure and impaired glucose tolerance. Recently, it has been described that oxidative stress and inflammatory reaction, which are important in progression of atherosclerosis, increases in individuals with the metabolic syndrome. Statins might have beneficial effects such as anti-oxidative and anti-inflammatory actions that are independent from their cholesterol-lowering effects. Pitavastatin, a chemically synthesized statin, has potent LDL-cholesterol lowering and also anti-oxidative and anti-inflammatory effects in animal studies. However, the effects of pitavastatin on oxidative stress and inflammatory action in patients with the metabolic syndrome have not been reported.

Eligibility criteria: Inclusion Criteria:

* Hypercholesterolemic patients

Exclusion Criteria:

* Patients receiving lipid-lowering agents
* Familial hypercholesterolemia
* Renal disease
* Diseases of liver, gallbladder and bile ducts
* Pregnant women

Primary outcomes:
measure: Thiobarbituric acid reactive substance; high sensitive C-reactive protein
timeFrame: 12 weeks
Secondary outcomes:
measure: Total cholesterol; LDL-cholesterol; HDL-cholesterol; triglyceride;
timeFrame: 12 weeks
measure: Homeostasis model assessment for insulin resistance; adiponectin;
timeFrame: 12 weeks
measure: Soluble intercellular adhesion molecule-1
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Tatsuaki Matsubara
state: Aichi
Study officials:
affiliation: Department of Internal Medicine, School of Dentistry, Aichi Gakuin University
name: Tatsuaki Matsubara, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Matsubara T, Naruse K, Arakawa T, Nakao M, Yokoi K, Oguri M, Marui N, Amano T, Ichimiya S, Ohashi T, Imai K, Sakai S, Sugiyama S, Ishii H, Murohara T. Impact of pitavastatin on high-sensitivity C-reactive protein and adiponectin in hypercholesterolemic patients with the metabolic syndrome: the PREMIUM Study. J Cardiol. 2012 Nov;60(5):389-94. doi: 10.1016/j.jjcc.2012.07.012. Epub 2012 Aug 11.
Clinical trial NCT02887417: Glioblastoma Platelet Activation Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glioblastoma
Circulating Platelet-monocyte Conjugates
Keywords: platelet activation
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
First posted: 2016-09-02
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: consecutive patients with suspicious for glioblastoma

Brief summary: Glioblastoma face an increased risk of venous or arterial thromboembolism. Furthermore, the most frequent immune cells in glioblastoma are tumor associated macrophages, which find theirself in an anti-inflammatory (M2) phenotype.

Increased conjugates between circulating platelets and monocytes reflect an pro-inflammatory status.

Detailed description: Glioblastoma face an increased risk of venous or arterial thromboembolism. Furthermore, the most frequent immune cells in glioblastoma are tumor associated macrophages, which find theirself in an anti-inflammatory (M2) phenotype.

Increased conjugates between circulating platelets and monocytes reflect an pro-inflammatory status.

Eligibility criteria: Inclusion Criteria:

* MR-morphological suspicion for glioblastoma
* informed consent

Exclusion Criteria:

* no informed consent

Primary outcomes:
measure: Mean P-selectine expression in all platelets
timeFrame: 01/ 2016 - 10/ 2016
measure: Mean CD63 expression in all platelets
timeFrame: 01/ 2016 - 10/ 2016
measure: Mean CD40 Expression in all platelets
timeFrame: 01/ 2016 - 10/ 2016
measure: Mean platelet-monocyte-conjugate formation in the monocyte population
timeFrame: 01/ 2016 - 10/ 2016
Secondary outcomes:
Other outcomes:
Locations:
city: Greifswald
country: Germany
facility: Department of Neurosurgery
Study officials:
References:
Clinical trial NCT00709917: Observational Study of the Switch of Metformin Alone to Metformin Combined With Repaglinide in Type 2 Diabetes
Official title: Observational Study Investigating the Efficacy of Switching From Metformin Monotherapy to a Dual Therapy of Metformin and Repaglinide on Glycaemic Control in Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-07-03
Enrollment: 2171
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type 2 diabetic patients having failed on metformin monotherapy

Brief summary: This study is conducted in Europe.

The aim of this observational study is to investigate the switch from metformin alone to metformin combined with repaglinide in type 2 diabetic patients not achieving adequate glycaemic control on maximal dose of metformin given alone and to analyse different epidemiological parameters.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetic patients with inadequate glycaemic control when received metformin alone on maximal dose
* Signed informed consent
* Treatment in accordance with the summary of product characterisation

Exclusion Criteria:

* Any contraindication to metformin or repaglinide

Primary outcomes:
measure: Safety (number of hypoglycaemic incidents)
timeFrame: After 10-20 weeks
measure: HbA1C
timeFrame: After 10-20 weeks
Secondary outcomes:
measure: safety
timeFrame: After 10-20 weeks
measure: posology
timeFrame: After 10-20 weeks
measure: lifestyle
timeFrame: After 10-20 weeks
measure: FBG
timeFrame: After 10-20 weeks
Other outcomes:
Locations:
city: Brussels
country: Belgium
city: Luxembourg
country: Luxembourg
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT01866917: Study of TAP and Laparoscopic and Robotic Gynecologic Procedures and Obese Women
Official title: Effectiveness of Transversus Abdominis Plane Block in Reducing Immediate Postoperative Pain in Obese Women After Laparoscopic or Robotic Gynecologic Procedures
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Pain
Keywords: Transversis Abdominis Plane Block
obese
robotic surgery
laparoscopic surgery
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2013-06-03
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study the effect of the Transversis Abdominis Plane (TAP) block on pain after surgery for obese women undergoing laparoscopic or robotic gynecologic procedures.


Eligibility criteria: Inclusion Criteria:

* BMI greater than or equal to 30, women undergoing laparoscopic or robotic in-patient procedures

Exclusion Criteria:

* Conversions, non-obese women

Primary outcomes:
measure: Postoperative Numeric Pain Rating Score (NPRS) 0-10 Scale; (0 is Equivalent to no Pain; 10 is Equivalent to the Worst Pain Imaginable)
timeFrame: 0, 1, and 2 hours
measure: Postoperative Numeric Pain Score (NPS) 0-10 Scale; (0 is Equivalent to no Pain; 10 is Equivalent to the Worst Pain Imaginable)
timeFrame: 4hrs, 8hrs, 12hrs, and 24hrs.
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Moses Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Ja Hyun Shin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02724241: E-Cigarettes and SNA
Official title: The Effects of Electronic Cigarettes on Sympathetic Nerve Activity and Oxidative Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nicotine Dependence
Keywords: nicotine
autonomic tone
oxidative stress
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2016-03-31
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Randomized controlled trial of electronic cigarettes with nicotine, without nicotine, and sham control, on sympathetic nerve activity and markers of oxidative stress.

Detailed description: Participants will use an electronic cigarette on 3 occasions: 1) with nicotine, 2) without nicotine, 3) sham control, and measures of autonomic tone, including heart rate variability (HRV) and sympathetic nerve activity (MSNA: microneurography), and oxidative stress will be measured pre and post exposure.

Eligibility criteria: Inclusion Criteria:

Healthy

Exclusion Criteria:

* Cardiac disease
* Respiratory disease
* Diabetes mellitus

Primary outcomes:
measure: Heart Rate variability
timeFrame: 10 minutes after exposure
measure: Paraoxonase
timeFrame: less than 1 hour after exposure
Secondary outcomes:
measure: muscle sympathetic nerve activity
timeFrame: 10 minutes after exposure
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCaliforniaLA
state: California
Study officials:
References:
Clinical trial NCT03466541: Workplace Interventions Preventing Risky Use of Alcohol and Sick Leave
Official title: Workplace Interventions Preventing Risky Use of Alcohol and Sick Leave
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Alcohol Consumption
Sick Leave
Workplace Interventions
Presenteeism
Keywords: Alcohol consumption
Sick leave
Workplace interventions
Presenteeism
Lead sponsor: University of Stavanger
Sponsor class: OTHER
Collaborators: name: Kompetansesenter rus - region vest Stavanger (KoRus)
name: Stamina Helse
name: Presenter
name: University of Oslo
name: Oslo Metropolitan University
name: Alcohol and Drug Research Western Norway (KoRFor)
name: Norwegian Institute of Public Health
First posted: 2018-03-15
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to investigate the effectiveness of two workplace interventions (the Riskbruk model and Balance) in reducing risky alcohol consumption, sickness absence and presenteeism. The purpose is to assess whether the Riskbruk model should be implemented in the Norwegian workforce in its entirety, whether the less extensive and costly alternative Balance is sufficient, or if neither one of them show effectiveness compared to usual care.


Eligibility criteria: Inclusion Criteria:

* Employees screening positive for at-risk drinking (8+ on the AUDIT)

Exclusion Criteria:

-

Primary outcomes:
measure: Change in alcohol consumption
timeFrame: Baseline and 6 months
measure: Change in sickness absence
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Change in presenteeism
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Stavanger
country: Norway
facility: University of Stavanger
state: Rogaland
Study officials:
References: