louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03905174: Massive Implants the Next Generation
Official title: A Randomised, Single Blind Study Assessing Radiological Outcomes for Massive Segmental Femoral Replacements Using Either Porous Collar or Porous Collar With HA or Porous Collar With HA and Autologous Stem Cells
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bone Cancer
Bone Diseases
Keywords: revision surgery
Lead sponsor: Royal National Orthopaedic Hospital NHS Trust
Sponsor class: OTHER
Collaborators: name: Adler Ortho
First posted: 2019-04-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study will review the use of massive segmental replacements in the femur, which have a porous collar with and without HA, and autologous stem cell augment. This is a randomised controlled trial.

Detailed description: The current surgical treatment of bone cancer patients and revision limb salvage requires usage of massive endoprosthetic bone implants. The incidence of aseptic loosening is a major cause of prosthesis failure in these patients, exploring ways to reduce such failures would allow extending longevity of massive implants in a relatively young population.

Current published literature stipulates that osteointegration could improve longevity of massive implants. Evidence suggests that usage of osteointegrated hydroxyapatite (HA) coated collar would reduce the incidence of aseptic loosening around the cemented intramedullary stem in distal femoral bone prosthesis

Eligibility criteria: Inclusion Criteria:

* Bone cancer patients requiring primary or revision femoral segmental replacements and non-cancer patients requiring revision femoral segment replacement for aseptic loosening
* Male or female, aged 18 years or above
* Able to provide consent

Exclusion Criteria:

* unable/unwilling to consent
* revisions surgery due to infection
* bone cancer patients excluded from stem cell arm
* bone cancer patients with pathological fractures

Primary outcomes:
measure: Radiological outcomes (X-ray, CT)
timeFrame: at 26 weeks (+/- 2 weeks)
measure: Radiological outcomes (X-ray, CT)
timeFrame: at 1 year (+/- 2 weeks)
measure: Radiological outcomes (X-ray, CT)
timeFrame: at 2 years (+/- 2 weeks)
Secondary outcomes:
measure: Visual Analogue Score (VAS) pain score
timeFrame: up to 2 years (+/- 2 weeks)
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal National Orthopaedic Hospital NHS Trust
state: Middx
Study officials:
affiliation: Royal National Orthopaedic Hospital NHS Trust
name: Panos Gikas, PhD FRCS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00876174: Effects of Genotypes on Interferon Signaling in Chronic Hepatitis C
Official title: Effects of Genotypes on Interferon Signaling in Chronic Hepatitis C
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Chronic Hepatitis C
Keywords: Chronic hepatitis C
Genotype 1
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2009-04-06
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with genotype 1, chronic hepatitis C who are to undergo antiviral therapy and their healthy family member or significant other

Brief summary: The objective of this pilot project is to investigate the prognostic criteria for sensitivity of Chronic Hepatitis C (CHC) Genotype 1, patients to IFNa treatment. Signal transduction in peripheral blood mononuclear cell (PBMC) of control groups will be compared with that of CHC patients. For this study, 20 patients with Hepatitis C virus (HCV) infection who are to undergo standard antiviral therapy and 10 healthy donors (significant others of the HCV subject) will be enrolled. Signal transduction will be studied in peripheral blood of CHC subjects before the treatment, after 1 and 3 months of treatment, and 4-6 months following the completion of treatment.

Detailed description: In addition, the mechanism of non-responsiveness of HCV patients to IFNa will be studied. For this purpose, formation of complexes between STAT1 and its negative regulator, PIAS1 (immunoprecipitation, Western blot) will be examined. In comparing subjects on standard therapy vs the addition of betaine, (under separate studies) we will assess whether the formation of STAT1-PIAS1 complexes is due to impaired methylation on STAT1 on arginine residues which may be over come by the addition of betaine.

Eligibility criteria: Inclusion Criteria

* 19 years of age or older, of either gender
* History of chronic hepatitis C documented by HCVRNA or healthy family member/significant other
* Documented genotype 1 for hepatitis participants or no hepatitis infection for healthy control
* Subject prescribed antiviral therapy for hepatitis participants or none for healthy control
* Able to give informed consent

Exclusion Criteria

* Under 19 years of age
* Unable to give informed consent

Primary outcomes:
measure: Prognostic criteria for sensitivity of Chronic Hepatitis C patients to interferon alpha treatment
timeFrame: 3 years
Secondary outcomes:
measure: Effects of antiviral treatment on interferon gene signaling in peripheral blood mononuclear cells
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
affiliation: University of Nebraska
name: Mark E Mailliard, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00666874: Effect of Weight Loss and Lifestyle Changes on Vascular Inflammatory Markers in Obese Women
Official title: Effect of Weight Loss and Lifestyle Changes on Vascular Inflammatory Markers in Obese Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity, lifestyle, vascular inflammation
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2008-04-25
Enrollment: 120
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 46
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Obesity is an independent risk factor for cardiovascular disease, which may be mediated by increased secretion of proinflammatory cytokines by adipose tissue.

To determine the effect of a program of changes in lifestyle designed to obtain a sustained reduction of body weight on markers of systemic vascular inflammation and insulin resistance.

Randomized single-blind trial conducted from February 1999 to February 2002 at a university hospital in Italy.

One hundred twenty premenopausal obese women (body mass index 30) aged 20 to 46 years without diabetes, hypertension, or hyperlipidemia.

The 60 women randomly assigned to the intervention group received detailed advice about how to achieve a reduction of weight of 10% or more through a low-energy Mediterranean-style diet and increased physical activity. The control group (n = 60) was given general information about healthy food choices and exercise.


Eligibility criteria: Inclusion Criteria:

* obese premenopausal women,
* aged 20 to 46 years
* sedentary (\<1 h/wk of physical activity)
* with no evidence of participation in diet reduction programs within the last 6 months.

Exclusion Criteria:

* type 2 diabetes mellitus or impaired glucose tolerance (plasma glucose levels of 140-200 mg/dL \[7.8-11.1 mmol/L\] 2 hours after a 75-g oral glucose load)
* hypertension (blood pressure \>140/90 mm Hg)
* cardiovascular disease, psychiatric problems
* history of alcohol abuse (intake of 500 g/wk in the last year)
* current smoking
* any medication use.

Primary outcomes:
measure: Vascular inflammatory markers (IL-6, IL-18, CRP, Adiponectin)
timeFrame: 24 months
Secondary outcomes:
measure: Insulin resistance (HOMA)
timeFrame: 24 months
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Department of Geriatrics and Metabolic Diseases
Study officials:
affiliation: Department of Geriatrics and metabolic Diseases
name: Dario Giugliano, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Esposito K, Pontillo A, Di Palo C, Giugliano G, Masella M, Marfella R, Giugliano D. Effect of weight loss and lifestyle changes on vascular inflammatory markers in obese women: a randomized trial. JAMA. 2003 Apr 9;289(14):1799-804. doi: 10.1001/jama.289.14.1799.
Clinical trial NCT01548274: Impact of Sarpogrelate in the Function of Endothelial Progenitor Cells
Official title: Impact of Sarpogrelate in the Function of Endothelial Progenitor Cells
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atherosclerosis
Keywords: endothelial progenitor cells
Lead sponsor: Aichi Gakuin University
Sponsor class: OTHER
First posted: 2012-03-08
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effects of Sarpogrelate in endothelial progenitor cells of patients with atherosclerosis.

Detailed description: Endothelial progenitor cells play an important role in vasculogenesis and vascular repair. Sarpogrelate, a inhibitor of HT2A, is used an an anti-platelet drug, however, a direct effect in vascular cells is supposed.

Eligibility criteria: Inclusion Criteria:

* Patients with atherosclerosis

Exclusion Criteria:

* Patients with high risk of bleeding
* Patients with pregnancy
* Patients with allergic reaction of Salpogrelate

Primary outcomes:
measure: The number and function of endothelial progenitor cells
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Aichi-Gakuin University
state: Aichi
Study officials:
References:
Clinical trial NCT03899974: Metabolic Effects of High-amylose Wheat-based Breads
Official title: Metabolic Effects of High-amylose Wheat-based Breads in Overweight Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postprandial Hyperglycemia
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2019-04-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The amylose-amylopectin ratio influences starch properties. A higher amylose content is associated with slower starch digestion thus reducing the postprandial plasma glucose response and improving the overall postprandial metabolism. So far, limited evidence is available on the metabolic effect of wheat-based foods rich in amylose. This randomised controlled study investigated the acute metabolic effects of amylose-rich wheat-based breads in overweight subjects focusing on potential mechanisms.


Eligibility criteria: Inclusion Criteria:

* Overweight/obese
* 18-70 years

Exclusion Criteria:

* age \<18 and \>70 years;
* fasting triglycerides ≥400 mg/dl;
* fasting cholesterol \>270 mg/dl;
* cardiovascular events (myocardial infarction or stroke) during the 6 months prior to the study
* established diabetes mellitus or any chronic disease
* renal and liver failure (creatinine \>1.7 mg/dl and transaminases \>2 times than normal values, respectively)
* anaemia (Hb \<12 g /dl)

Primary outcomes:
measure: 2-hours blood glucose response
timeFrame: over 2 hours after the test meal
Secondary outcomes:
measure: 2-hours blood insulin response
timeFrame: over 2 hours after the test meal
measure: 4-hours blood glucose response
timeFrame: over 4 hours after the test meal
measure: 4-hours blood insulin response
timeFrame: over 4 hours after the test meal
measure: intestinal fermentation
timeFrame: over 4 hours after the test meal
measure: glucose response
timeFrame: over 2 hours after the standard meal
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Federico II University
state: Naples
Study officials:
References:
Clinical trial NCT03775174: Expanded Access to Mepsevii
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: MPS VII
Mucopolysaccharidosis VII
Sly Syndrome
Keywords: Expanded Access
Compassionate Use
Lead sponsor: Ultragenyx Pharmaceutical Inc
Sponsor class: INDUSTRY
First posted: 2018-12-13
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: Individual patient expanded access requests may be considered for patients who have no other treatment options

Detailed description: Expanded access may be available outside of the US in countries prior to approval by the local regulatory agencies. For full details, please visit the links provided below.

Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04923074: the Application of Diffusion Tensor Imaging in the Evaluation of Peripheral Neuropathy in ANCA Associated Vasculitis
Official title: the Application of Diffusion Tensor Imaging(DTI) in the Evaluation of Peripheral Neuropathy in Anti-neutrophil Cytoplasmic Antibodies Associated Vasculitis(AAV)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ANCA Associated Vasculitis
Keywords: peripheral neuropathy
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-06-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult AAV patients with peripheral neuropathy

Brief summary: 1. Include qualified 50 ANCA-associated vasculitis(AAV) patients; and the first 27 patients will be divided into 3 groups with different diffused tension image (DTI) parameters and to choose the best strategy；
2. On baseline, 6 months after treatment and 24 months after treatment, the AAV patients will accomplish the Birming-ham vasculitis activity score(BVAS) besides DTI；
3. The new serum biomarkers of AAV associated peripheral neuropathy will be measured by ELISA； (4) Another cohort with 50 patients with AAV associated peripheral neuropathy who were evaluated by traditional methods (electromyogram) and compared to the patients cohort that evaluated using DTI by cost-benefit analysis


Eligibility criteria: Inclusion Criteria:

* age between 18-80 years old；
* must fulfill 2012 criteria of ANCA associated vasculitis
* presented with peripheral neuropathy diagnosed by specialists

Exclusion Criteria:

* the ANCA associated vasculitis is already in the stable stage after treatments
* any vital organ dysfunction
* active infection or cancer
* can not finish DTI scan

Primary outcomes:
measure: To assess the optimal b-value (a key parameter) for DTI in AAV associated peripheral neuropathy
timeFrame: 2 years
Secondary outcomes:
measure: the association between normative diffusion value of DTI (FA and ADC value) and disease activity activity score of AAV (BVAS).
timeFrame: 2 years
measure: the association between normative diffusion value of DTI (FA and ADC value) and serum biomarkers of AAV associated neuropathy
timeFrame: 2 years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 2nd affiliated hospital of Zhejiang University, School of Medicine
state: Zhejiang
Study officials:
affiliation: 2nd affiliated hospital of Zhejiang University, School of Medicine
name: Jing Xue
role: STUDY_CHAIR
References:
Clinical trial NCT01553474: Blood and Saliva Sample Collection for AREDS 2
Official title: Blood and Saliva Sample Collection and Submission to the Age-Related Eye Disease Study 2 (AREDS2) Genetic Repository
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Age-Related Macular Degeneration
Eye Diseases
Keywords: Age-Related Macular Degeneration (AMD)
Eye Diseases
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2012-03-14
Enrollment: 56
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: Background:

- The Age-Related Eye Disease Study 2 (AREDS 2) is looking at different eye diseases. Study participants will provide blood and saliva samples. The samples will be stored for research on eye diseases.

Objectives:

- To collect blood and saliva samples for AREDS 2 research.

Eligibility:

- AREDS 2 research study participants.

Design:

* Participants will provide blood and saliva samples.
* The samples will be submitted with personal and medical information. This information will be collected during the AREDS 2 procedures.

Detailed description: AREDS2 is a multi-center, Phase III, randomized clinical trial designed to assess the effects of oral supplementation of high doses of macular xanthophylls (lutein and zeaxanthin) and/or omega-3 long-chain polyunsaturated fatty acids (LCPUFAs) as a treatment for age-related macular degeneration (AMD), cataract and moderate vision loss. In addition to this objective, the AREDS2 study will provide information on the clinical course, prognosis, and risk factors for development and progression of both AMD and cataract. Other study goals include the evaluation of eliminating beta-carotene and/or reducing zinc in the original AREDS formulation on the progression and development of AMD. AREDS2 will also seek to validate the fundus photographic AMD scale developed from AREDS.

The objective of this protocol is to have AREDS2 participants submit blood and saliva samples to the AREDS2 Genetic Repository (Fisher BioServices, Rockville, MD) in order to provide further materials for the study of the genetic and biochemical bases for eye disease and possibly other diseases.

Eligibility criteria: * INCLUSION CRITERIA:

Participants will be eligible if they were enrolled in the AREDS2 protocol and willing to have their blood drawn and saliva collected.

EXCLUSION CRITERIA:

Participants will not be eligible if they were not enrolled in AREDS2 and are not willing to have their blood drawn and saliva collected.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center, 9000 Rockville Pike
state: Maryland
Study officials:
affiliation: National Eye Institute (NEI)
name: Wai T Wong, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01740765: Energy Expenditure and Substrate Utilization During Acute Under- and Over-feeding
Official title: Energy Expenditure and Substrate Utilization During Acute Under- and Over-feeding
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2012-12-04
Enrollment: 7
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study will determine the impact of 24, 48 and 72 hours of over and underfeeding on energy expenditure as measured in the metabolic chamber at the UNC Chapel Hill Nutrition Research Institute (UNC NRI).

Detailed description: Subjects will complete a baseline eucaloric study day. Following this, subjects will be randomized to complete 3 days of overfeeding (150% of baseline eucaloric energy requirements) or 3 days of underfeeding (50% of baseline eucaloric energy requirements). After completing one of these study arms, subjects will cross-over and complete the second arm. All study arms will be separated by two weeks. 24-hour energy expenditure will be measured 3 times during each of 3 day periods. We hypothesize that the impact of over or underfeeding on EE will be evident after 24-hours and will be comparable to 72 hour EE.

Eligibility criteria: Inclusion Criteria:

* Woman
* Postmenopausal
* Aged 50-65 years
* BMI 25-35kg/m2
* Not taking blood pressure or anti-inflammatory medications or any other medications that may impact the results
* Thyroid hormone profile within the normal reference range
* No medical condition which may impact the results (e.g. diabetes)
* Accustomed to eating regular meals including breakfast

Exclusion Criteria:

* Smoker
* Heavy exerciser (defined as \>150 minutes/week for more than 3 months)
* Abuses alcohol or drugs
* Vegetarian

Primary outcomes:
measure: Energy Expenditure
timeFrame: 24-hour energy expenditure will be assessed
Secondary outcomes:
measure: Whole blood transcriptomics
timeFrame: Fasting a.m. sample, before lunch, and at 0.5, 2, and 4.5 hours post lunch
measure: Plasma metabolomics
timeFrame: Fasting a.m. sample, before lunch, and at 0.5, 2, and 4.5 hours post lunch
Other outcomes:
Locations:
city: Kannapolis
country: United States
facility: UNC Chapel Hill Nutrition Research Institute
state: North Carolina
Study officials:
affiliation: UNC Chapel Hill Nutrition Research Institute
name: Andrew G Swick, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02375165: Biomarkers for the Detection of Lymphatic Insufficiency
Official title: Biomarkers for the Detection of Lymphatic Insufficiency
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Lymphedema
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2015-03-02
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who receive their care within Dr. Rockson's clinic in the Stanford Center for Lymphatic and Venous Disorders may be spoken to about voluntary participation in this study.

Brief summary: Acquired lymphedema is a disease that causes chronic swelling of the limb(s). It is frequently under-recognized or misdiagnosed. This study is designed to lead to the development of an accurate, noninvasive, blood test to allow testing for lymphedema. This approach is particularly useful to investigate relative responses to treatment interventions.

Detailed description: The validation of a sensitive and specific biomarker assay for human acquired lymphatic vascular insufficiency would represent a highly significant development for the patient community. Accurate bioassay for the presence of lymphatic vascular insufficiency should help to pave the road for future human clinical trials of experimental drugs and therapies designed to treat human lymphatic diseases. Molecular profiling will be performed in human tissues (skin) obtained by biopsy. The insights gained from these initial analyses will determine the targets for assay in human body fluids (blood).

Eligibility criteria: Inclusion Criteria

For lymphedema participants:

* clinical diagnosis of lymphedema of at least 6 months' duration

Control participants:

* no evidence of lymphedema

Exclusion Criteria

For lymphedema participants:

* active cancer
* infection
* bleeding tendency
* active coronary artery disease
* congestive heart failure
* history of stroke or transient ischemic attack (TIA)
* uncontrolled hypertension
* renal insufficiency (serum creatinine \> 1.1)
* active inflammatory or autoimmune disease (other than lymphedema)

For control participants:

* lymph node dissection
* radiation therapy
* active inflammatory disease

Primary outcomes:
measure: Biomarkers for the Detection of Lymphatic Vascular Insufficiency
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Stanford University
name: Stanley G Rockson, MD
role: PRINCIPAL_INVESTIGATOR
References: