louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00823888: Mechanics of Knee Bracing
Official title: Mechanics of Knee Bracing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Knee Osteoarthritis
pneumatic bracing
Lead sponsor: The New England Baptist Hospital
Sponsor class: OTHER
Collaborators: name: Boston University
name: Spaulding Rehabilitation Hospital
First posted: 2009-01-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The overall objective of this project is to determine whether the provision of a pneumatic knee brace in patients with medial knee osteoarthritis (OA) improves knee mechanics. Secondary objectives will be to assess if the brace relieves knee pain and improves function. We will test the hypothesis that compared to the control treatment (see below for the definition) the use of a pneumatic knee brace is effective in medial knee OA.

Detailed description: This study is closed to enrollment and in the data analysis phase

Eligibility criteria: Inclusion Criteria:

* knee pain, aching or stiffness on most of the past 30 days
* x-ray verified predominant medial tibiofemoral osteoarthritis (TFOA)
* overall pain that is due to the medial TFOA (versus being referred from the back, hips, or other pre-existing conditions)
* ambulatory persons

Exclusion Criteria:

* use of a crutch, walker, or wheelchair or cane more than 50% of the time
* history of Deep Vein Thrombosis
* Pain emanating more from back or hip than from knee
* Low pain score on WOMAC
* predominant patellofemoral disease or knee pathology other than medial compartment OA likely to be causing their knee pain.
* Planning to move from area within 1 month of study screening.
* Unable to fit the brace properly
* BMI greater than 35
* corticosteriod injections in the past month
* Bilateral total knee replacements or plan for TKR
* Other types of arthritis including Rheumatoid Arthritis, Systemic Lupus Erythematosus, gout, psoriatic arthritis, pseudogout.
* woman who are pregnant (due to x-rays taken to determine eligibility)

Primary outcomes:
measure: To undertake a clinical trial in patients with medial knee OA to determine whether provision of a pneumatic knee brace leads to a reduced adduction moment during the time of this treatment than during the use of a control treatment.
timeFrame: At study visit
Secondary outcomes:
measure: To undertake a clinical trial in patients with medial knee OA to determine whether provision of a pneumatic knee brace leads to a lower pain score and improved function during the time of this treatment than during the use of a control treatment.
timeFrame: During study visit
Other outcomes:
Locations:
city: Boston
country: United States
facility: New England Baptist Hospital
state: Massachusetts
Study officials:
affiliation: New England Baptist Hospital, Tufts Medical Center
name: William F Harvey, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00923988: Effect of Passive Smoking on Platelet Function and Endothelial Function
Official title: Acute Effects of Short-term Exposure to Secondhand Smoke on Platelet Activation and Endothelial Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endothelial Function
Platelet Aggregation
Keywords: Secondhand smoke
passive smoking
platelet function
endothelial function
Lead sponsor: Kantonsspital Graubünden
Sponsor class: OTHER
First posted: 2009-06-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Passive smoking is associated with an increased risk for cardiovascular events. However, the exact mechanisms by which passive smoking affects cardiovascular health are not entirely understood. In the present study, the researchers investigate the effects of short-term exposure to secondhand smoke on platelet function and peripheral microvascular endothelial function in healthy individuals. For this purpose, platelet function and endothelial function are measured before and after a 1-hour exposure to secondhand smoke in a concentration that is encountered in bars and restaurants without smoke-free policies. The researchers' hypothesis is that short-term exposure leads to platelet activation and impairment of endothelial function.


Eligibility criteria: Inclusion Criteria:

* healthy individuals
* nonsmokers
* no regular medication (in particular no drugs affecting platelet function or vascular function)

Exclusion Criteria:

* exposition to secondhand smoke within 1 week before inclusion
* use of drugs affecting platelet function or vascular function within 1 week before study inclusion

Primary outcomes:
measure: Change in platelet aggregation and/or endothelial function
timeFrame: 12-24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Chur
country: Switzerland
facility: Kantonsspital Graubuenden
Study officials:
affiliation: Division of Cardiology, Department of Internal Medicine, Kantonsspital Graubuenden, Loestrasse 170, CH-7000 Chur, Switzerland
name: Piero O. Bonetti, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01237288: Therapeutic Use of Oral Sodium Phosphate (Z-521) in Primary Hypophosphatemic Rickets
Official title: Therapeutic Use of Oral Sodium Phosphate (Z-521) in Primary Hypophosphatemic Rickets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Primary Hypophosphatemic Rickets
Lead sponsor: Zeria Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2010-11-09
Enrollment: 16
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the efficacy and safety of oral phosphate (Z-521) in subjects with primary hypophosphatemic rickets.


Eligibility criteria: Inclusion Criteria:

* Diagnosed as primary hypophosphatemic rickets based on familial history, genetic test or laboratory test results.

Exclusion Criteria:

* A hyperparathyroidism

Primary outcomes:
measure: Serum ALP level
timeFrame: 6 month
measure: Serum phosphate level
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Chiba
country: Japan
facility: Chiba Children's Hospital
city: Kanagawa
country: Japan
facility: Kanagawa Children's Medical Center
city: Osaka
country: Japan
facility: Osaka University Hospital
city: Tokyo
country: Japan
facility: Tokyo Metropolitan Children's Medical Center
Study officials:
affiliation: Osaka University Hospital
name: Keiichi Ozono, M.D., Ph.D.
role: STUDY_CHAIR
References:
citation: Ozono K, Hasegawa Y, Minagawa M, Adachi M, Namba N, Kazukawa I, Kitaoka T, Asakura Y, Shimura A, Naito Y. Therapeutic use of oral sodium phosphate (phosribbon((R)) combination granules) in hereditary hypophosphatemic rickets. Clin Pediatr Endocrinol. 2014 Jan;23(1):9-15. doi: 10.1292/cpe.23.9. Epub 2014 Feb 3.
Clinical trial NCT02985788: Self Digital Photography for Assessing Elbow Range of Motion
Official title: Validation of Self Digital Photography for Assessing Elbow Range of Motion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contracture of Elbow Joint
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2016-12-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who have an elbow contracture in the sagittal plane

Brief summary: Loss of elbow range of motion can significantly affect activities of daily living. Measuring elbow range of motion is critical for tracking post surgical outcomes. This study seeks to validate the ability to validate self photography as a means of followup through long distance correspondence.

Detailed description: Loss of elbow range of motion is common after trauma and can significantly affect activities of daily living. Patients across the country travel to tertiary referral centers to have this problem addressed. Followup is critical and can often be difficult given distances between patients home and their healthcare provider. Measuring postoperative outcomes requires accurate and reliable documentation of range of motion. Previously, the investigators have validated digital photography as a means of accurately measuring elbow range of motion. In that study, photographs were taken by a non-professional photographer. With the advance in personal technology, patients now have the ability to take photos themselves. This study seeks to validate self photography, which will ultimately improve patient follow up and improve clinical monitoring

Eligibility criteria: Inclusion Criteria:

* Elbow contracture in the sagittal place

Exclusion Criteria:

* Unable to read English
* Unable to forward flex shoulder to 90 degrees or hold their shoulder at 90 degrees for the duration of the examination
* Unable to tolerate the exercise due to pain

Primary outcomes:
measure: Digital photo-based elbow range of motion measurement compared to traditional goniometry
timeFrame: up to 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Shawn O'Driscoll, PhD MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01615588: The Glycaemic Index of Manuka Honey
Official title: The Glycaemic Index of Manuka Honey
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: manuka honey
glycaemic index
blood glucose control
individuals
current disease
medication use
Lead sponsor: Waiariki Institute of Technology
Sponsor class: OTHER
Collaborators: name: Manuka Health New Zealand
First posted: 2012-06-08
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Five high methylglyoxal (460-667 mg/kg) Manuka honey samples were selected from different geographical locales around the North Island of New Zealand and tested for glycaemic index (GI) in 10 healthy volunteers in a single-blinded, randomised study. Participants were fed honey containing 25g of available carbohydrate in 200 ml water and the blood glucose responses measured (area under the curve; AUC) and compared to that of 25 g of available carbohydrate from glucose.


Eligibility criteria: Inclusion Criteria:

* healthy (Body mass index (BMI) 20-25)
* non-smoking
* aged between 18-45 years
* absence of diabetes or chronic illness
* not taking any medications.

Exclusion Criteria:

* currently dieting
* suffering from illness or chronic disease
* currently taking medication
* smokers (including recreational)
* outside healthy BMI range

Primary outcomes:
measure: Determine the Glycaemic index of Manuka honey
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rotorua
country: New Zealand
facility: Waiariki Institute of Technology
state: BOP
Study officials:
References:
Clinical trial NCT02473588: Long Time Interval Analysis for Non Invasive Measurement of Cardiac Output
Official title: Comparison of Retia Medical (Long Time Interval Analysis) to Deltex Esophageal Doppler for Cardiac Output Measurement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypotension
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2015-06-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A group of engineers at Michigan State developed a novel waveform analysis technique ("Long Time Interval Analysis" \[LTIA\]) that attempts to estimate cardiac output non-invasively. Retrospective comparison of LTIA to invasive techniques (e.g. thermodilution) suggest acceptable agreement. Thus, a prospective trial of LTIA is warranted. This study compares LTIA to a validated measure of cardiac output - esophageal Doppler monitoring.


Eligibility criteria: Inclusion Criteria:

* Adult (18 years or older)
* Undergoing hepatobiliary surgery (open or laparoscopic) requiring general anesthesia as part of the patient's clinical care
* Attending anesthesiologist plans to place an intra-arterial catheter for routine care
* Attending anesthesiologist believes that non-invasive cardiac output monitoring would benefit the patient

Exclusion Criteria:

* Minors (17 years or younger)
* Parturient (pregnant women)
* Cognitively impaired
* Unable to sign informed consent form
* Prisoner
* Prior esophageal surgery
* Moderate to severe aortic regurgitation
* Mechanical cardiac support (e.g., intra-aortic balloon pump)
* Severe, persistent arrhythmias

Primary outcomes:
measure: Pearson Correlation Coefficient
timeFrame: Data collected in first 20 minutes of anesthesia/surgery will be recorded; Pearson correlation coefficient will be calculated after all 60 subjects have been enrolled
Secondary outcomes:
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
Study officials:
References:
Clinical trial NCT00171288: Efficacy and Safety Study of Fluvastatin and Ezetimibe Combined Versus Fluvastatin Alone
Official title: Efficacy and Safety Study of Fluvastatin and Ezetimibe Combined Versus Fluvastatin Alone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dyslipidemia
Keywords: Dyslipidemia, ezetimibe, inflammatory markers, fluvastatin
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 83
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: TREATMENT

Brief summary: The objective of this study is to assess the effect of the combination treatment on C-reactive protein and inflammatory markers as well as the safety and tolerability in a Spanish population


Eligibility criteria: Inclusion Criteria:

* Patients aged 18-75 Primary hypercholesterolemia Signed informed consent

Exclusion Criteria:

* Patients involved in clinical trials 3 months prior to inclusion Patients treated with drugs specified in protocol Fertile women not using contraceptive methods

Other protocol defined in and exclusion criteria may apply

Primary outcomes:
measure: Change from baseline in low density lipoprotein cholesterol after 12 weeks
Secondary outcomes:
measure: Change from baseline in total triglyceride, high density lipoprotein cholesterol, and composition of low density lipoprotein cholesterol after 12 weeks
measure: Change from baseline in circulating marker of inflammation after 12 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Novartis
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT06806488: Study to Assess Clinical Characteristics and Outcome of Patients with Marginal Zone Lymphomas
Official title: Retrospective Observational Study to Assess Clinical Characteristics and Outcome of Patients with Marginal Zone Lymphomas
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Marginal Zone B Cell Lymphoma
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-02-04
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Marginal zone lymphoma patients who were diagnosed and treated in our Hospital between December 2012 and December 2018

Brief summary: This is a purely retrospective and observational monocentric study

Detailed description: the study aimed at describing the characteristics and outcome of Marginal zone lymphoma patients who were diagnosed and treated in our Hospital between December 2012 and December 2018

Eligibility criteria: Inclusion Criteria:

1. Marginal zone lymphoma patients who were diagnosed and treated in our Hospital between December 2012 and December 2018.
2. Age ≥ 18 years at enrolment.
3. Written informed consent (if applicable)

Exclusion Criteria:

* none

Primary outcomes:
measure: clinical characteristics of Marginal zone lymphoma patients
timeFrame: through study completion, an average of 1 years
Secondary outcomes:
measure: effectiveness
timeFrame: through study completion, an average of 1 years
measure: safety
timeFrame: through study completion, an average of 1 years
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero - Universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Pier Luigi Zinzani, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00244088: Study Evaluating the Etiology of Intra-Abdominal Infections
Official title: Study of the Etiology of Intra-Abdominal Infections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intra-abdominal Infection
Keywords: Abdominal infection
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-10-25
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Surgery units

Brief summary: The aim of this study is to define the etiology of intra-abdominal infections, to study the role of Enterococcus spp and Pseudomonas aeruginosa in these infections and to clarify the need for specific enterococcal antimicrobial coverage.


Eligibility criteria: Inclusion Criteria:

* A case will be defined as an intra-abdominal abscess or peritoneal fluid culture that will be positive for enterococcus or an enterococcal bacteriemia in association with an intra-abdominal source of infection.
* A control will be defined as a culture-positive intra-abdominal infection or bacteriemia due to an intraabdominal focus where enterococci have not been isolated.

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03135288: Cell-phone Assisted Postpartum Counseling on the Use of Long-acting Reversible Contraceptives
Official title: Effect of Cell-phone Assisted Postpartum Counseling on the Use of Long-acting Reversible Contraceptives: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Family Planning
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-05-01
Enrollment: 1000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Unintended and closely spaced pregnancies are a major public health problem that affects not only the individuals directly involved but also the society indirectly. It increases the risks of infants with adverse outcomes such as preterm, low birth weight and small for gestational age. Pregnancy occurring within six months of the last delivery holds a 7.5-fold increased risk for induced abortion, a 3.3-fold increase in miscarriage and a 1.6-fold increased risk of stillbirth. But, use of contraceptive methods has been shown to reduce unwanted pregnancy, high fertility and maternal mortality rates.


Eligibility criteria: Inclusion Criteria:

* Women who deliver a live birth at greater than 28 week's gestation.
* Women desire birth spacing for more than one year
* Women who were holding and /or one of her family hold a cell-phone and accept to receive messages and phone calls to remind her with her contraceptive program

Exclusion Criteria:

* Women who refuse to participate in the study.
* Women aren't able to respond to the questionnaire due to their health status.
* Anticipation of difficulty of subsequent communication with the women
* Women with contraindications of using long acting reversible contraception ( contraindicated if intrauterine device or implant use)

Primary outcomes:
measure: Initiation of Long acting reversible contraception method
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut Faculty of Medicine
Study officials:
References:
citation: Palmer MJ, Henschke N, Bergman H, Villanueva G, Maayan N, Tamrat T, Mehl GL, Glenton C, Lewin S, Fonhus MS, Free C. Targeted client communication via mobile devices for improving maternal, neonatal, and child health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013679. doi: 10.1002/14651858.CD013679.
citation: Shaaban OM, Saber T, Youness E, Farouk M, Abbas AM. Effect of a mobile phone-assisted postpartum family planning service on the use of long-acting reversible contraception: a randomised controlled trial. Eur J Contracept Reprod Health Care. 2020 Aug;25(4):264-268. doi: 10.1080/13625187.2020.1764528. Epub 2020 May 21.