louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01796535: The PerX360º System™ Registry
Official title: An Observational, Multi Center, Non-Randomized (Single Arm) Registration of the PerX360º System™
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: DDD
Lead sponsor: Interventional Spine, Inc.
Sponsor class: INDUSTRY
First posted: 2013-02-21
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult subjects treated with the Optiport™ and Opticage™ products

Brief summary: This is a multi-center, non-randomized post marketing surveillance registry including up to 125 patients treated with the PerX360º System™. Patients will receive a follow-up evaluation at the per physician defined time points: at discharge, an Interim 1 visit (1 month), an Interim 2 visit (3-6 months) and a Final visit (12 months). Imaging obtained at visits should be per standard of care.

Detailed description: For all patients participating in the registry, the following outcomes will be analyzed:

* Change in pain score on the Visual Analog Scale(VAS) from baseline for leg pain
* Change in pain score on the Visual Analog Scale(VAS) from baseline for back pain
* Change in Oswestry Disability Index (ODI) score from baseline
* Proportion of patients with a device related complication
* Proportion of patients with lack of revision, removal, or reoperation
* Proportion of patients with radiographic fusion

Eligibility criteria: Inclusion Criteria:

* Patient understands the nature of the procedure and provides written informed consent
* Patient is willing to return to the treating physician for his/her routine follow-up visits up to 12 months post treatment
* Age \> 18 years
* Patient is treated with the Optiport™ and Opticage™ products

Exclusion Criteria:None

Primary outcomes:
measure: Fusion
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Los Angeles Brain and Spine Institute
state: California
city: St. Augustine
country: United States
facility: Flagler Hospital
state: Florida
Study officials:
References:
Clinical trial NCT04761835: STEP-IT-UP - Peanut Allergy Study for Infants
Official title: Subthreshold Peanut in Infants - Understanding Plasticity
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Peanut Allergy
Food Allergy
Keywords: infant food allergy
treatment study
peanut allergy treatment
increase threshold of peanut intake for peanut allergic children
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Icahn School of Medicine at Mount Sinai
First posted: 2021-02-21
Enrollment: 0
Sex: ALL
Minimum age (years): 4
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Open label, randomized trial (1:1) to either dietary peanut intake or strict avoidance prior to a double blind placebo controlled food challenge 52 weeks later.
Primary purpose: TREATMENT

Brief summary: Multicenter randomized (1:1) trial of strict avoidance versus sub-threshold dietary introduction of peanut in peanut allergic infants 4-14 months of age who react at a minimum cumulative dose of at least 430 mg of peanut protein at initial oral food challenge (OFC) for 12 months, followed by cross-over to sub-threshold dietary introduction of peanut in those randomized initially to avoidance.


Eligibility criteria: Inclusion Criteria:

* Children age 4-14 months suspected to be peanut allergic

Exclusion Criteria:

* Significant medical problems

Primary outcomes:
measure: Oral food challenge threshold to peanut at week 52
timeFrame: 52 weeks
Secondary outcomes:
measure: 1. Oral food challenge threshold to peanut at week 52 for those initially randomized to dietary peanut compared to the oral food challenge threshold at week 104 for those initially randomized to strict avoidance
timeFrame: 104 weeks
measure: Oral food challenge threshold at 1 month avoidance after 12 months in each treatment group
timeFrame: 56 weeks
measure: Oral food challenge threshold at 2 months avoidance after 12 months in each treatment group
timeFrame: 60 weeks
measure: Safety with dietary introduction of peanut or avoidance
timeFrame: 52 weeks
measure: Rate of discontinuation of dietary peanut
timeFrame: 104 weeks
measure: Severity of eczema as assessed by the Scoring Atopic Dermatitis (SCORAD) score
timeFrame: 104 weeks
measure: Peanut skin prick test wheal size
timeFrame: 104 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Johns Hopkins University
name: Corinne Keet
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00964535: Bioequivalence Study of Budesonide/Formoterol Easyhaler and Symbicort Turbohaler in Asthmatics
Official title: Bioequivalence Study Comparing Two Budesonide/Formoterol Fumarate Dihydrate Device-metered Dry Powder Inhalers, Budesonide/Formoterol Easyhaler 200/6 µg/Inhalation and Symbicort Turbohaler 200 µg/6 µg/Inhalation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Asthma
Lead sponsor: Orion Corporation, Orion Pharma
Sponsor class: INDUSTRY
First posted: 2009-08-25
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the test product Budesonide/formoterol Easyhaler with the marketed product Symbicort Turbohaler in terms of the drug absorbed into the bloodstream.


Eligibility criteria: Inclusion Criteria:

* Males or females aged 18-60 years with documented diagnosis of asthma
* Prebronchodilator forced expiratory volume in one second (FEV1) at least 80% of the predicted value
* The asthma should be stable on the same regular treatment for at least 4 weeks before screening.

Exclusion Criteria:

* Use of oral, parenteral or rectal corticosteroids within 4 weeks preceding the screening
* Respiratory infection within 4 weeks preceding the screening
* Any condition requiring regular concomitant treatment or likely to need concomitant treatment during the study with medicinal products which have pharmacokinetic interactions with budesonide
* Any disorder or clinically significant abnormal laboratory value or physical finding that may interfere with the interpretation of test results or cause a health risk for the subject if he/she participates in the study

Primary outcomes:
measure: Pharmacokinetic parameters Cmax and AUCt of plasma budesonide and formoterol concentrations
timeFrame: within 24 h
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Medicines Evaluation Unit
Study officials:
affiliation: Orion Corporation, Orion Pharma
name: Ulla Sairanen, MSc
role: STUDY_DIRECTOR
References:
Clinical trial NCT03457935: Detection of Early Idiopathic Pulmonary Fibrosis
Official title: The Role of the miR200 Family in the Restoration of Normal Lung Homeostasis and Detection of Early IPF
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Idiopathic Pulmonary Fibrosis
Lead sponsor: Temple University
Sponsor class: OTHER
Collaborators: name: Boehringer Ingelheim
First posted: 2018-03-08
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with non-IPF ILD and a new diagnosis of IPF.

Brief summary: The purpose of the study is to determine if miR200 family may serve as a biomarker of IPF.


Eligibility criteria: Inclusion Criteria for IPF Patients:

* Informed consent
* Subjects ≥ 40 y.o.
* Naive patients with no IPF treatment
* IPF diagnosis based on the ATS/ERS/JRS/ALAT criteria

Inclusion Criteria for non-IPF ILD Patients:

* Informed consent
* Subjects ≥ 18 y.o.
* ILD diagnosis

Exclusion Criteria:

* HIV
* Hepatitis B
* Hepatitis C
* Pregnant or lactating women

inclusion criteria for controls: informed consent \>18 years old; no lung diseases

Primary outcomes:
measure: To determine miR200 levels (fold change) in blood samples.
timeFrame: Baseline (one time).
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
Study officials:
References:
Clinical trial NCT04950335: Comparison of AOCT and AOPT for the Treatment of Medial Large Cystic OLT
Official title: Comparison of Autologous Osteoperiosteal and Osteochondral Transplantation for the Treatment of Medial Large Cystic Osteochondral Lesions of the Talus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteochondral Lesions of the Talus
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-06
Enrollment: 46
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with symptomatic OLTs who underwent AOPT or AOCTvat our sports medicine institute between March, 2015 and March, 2018

Brief summary: Autologous osteoperiosteal transplantation using tissue harvested from the iliac crest is used to treat large cystic osteochondral lesions of the talus. This study is to compare clinical and radiological outcomes between patients undergoing AOPT and those undergoing AOCT for large cystic OLTs.

Detailed description: From March 2015 to March 2018, 23 patients who underwent AOPT and 23 patients who underwent AOCT to treat large cystic OLTs (\>10mm) were retrospectively evaluated. For comparability, the two groups were matched based on their demographics, including sex, age, body mass index, side of injury, follow-up period, and the preoperative cyst volume. Clinical outcomes were assessed using the visual analog scale (VAS), the American Orthopaedic Foot \& Ankle Society (AOFAS) score, and the Tegner score. Donor-site morbidity was recorded according to the symptoms, including pain, stiffness, swelling and discomfort. Radiological outcomes were evaluated using the Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score, and the International Cartilage Repair Society (ICRS) score was obtained during second-look surgery.

Eligibility criteria: Inclusion Criteria:

* presence of medial large cystic OLTs (\>10 mm in diameter) confirmed by preoperative magnetic resonance imaging (MRI)
* patients who underwent either primary AOPT or AOCT

Exclusion Criteria:

* small cystic OLTs
* ankle osteoarthritis
* ankle pigmented villonodular synovitis
* prior surgery on the ipsilateral ankle
* injuries or relevant trauma to the affected ankle after surgery

Primary outcomes:
measure: MOCART
timeFrame: two years after sugery
Secondary outcomes:
measure: VAS
timeFrame: pre-surgery, two years after sugery
measure: Tegner
timeFrame: pre-surgery, two years after sugery
measure: AOFAS
timeFrame: pre-surgery, two years after sugery
measure: ICRS
timeFrame: one year after sugery
Other outcomes:
Locations:
Study officials:
affiliation: Peking University Third Hospital
name: Qinwei Guo, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05433935: Exploring Biomarkers of the Carcinogenesis of Intraductal Papillary Mucinous Neoplasm (IPMN) of the Pancreas
Official title: A Prospective, Open Large Cohort Study of Intraductal Papillary Mucinous Neoplasm (IPMN) of the Pancreas
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intraductal Papillary Mucinous Neoplasm
Keywords: intraductal papillary mucinous neoplasm
biomarkers
prospective cohort
Lead sponsor: Zhejiang University
Sponsor class: OTHER
Collaborators: name: The Second Hospital of Hebei Medical University
name: Second Affiliated Hospital of Nanchang University
name: Meng Chao Hepatobiliary Hospital of Fujian Medical University
name: Huizhou Municipal Central Hospital
First posted: 2022-06-27
Enrollment: 5000
Sex: ALL
Minimum age (years): 0
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients ought to meet all inclusion and exclusion criteria. In addition, the patient of the prospective cohort should be thoroughly informed about the study, including the study visit schedule and required evaluations and all regulatory requirements for informed consent. The written informed consent of the prospective cohort should be obtained from the patient prior to enrollment.

Brief summary: This is a prospective, open large cohort study to explore biomarkers for detecting early carcinogenesis of IPMN.

Detailed description: This prospective study was designed to explore biomarkers for detecting early carcinogenesis of IPMN. This study intends to prospectively and continuously enroll IPMN patients, and regularly collect biological samples including blood, urine, feces and saliva. We aimed to detect biomarkers which can predict the carcinogenesis of IPMN by multi-omics. The primary endpoint is the predictive accuracy of biomarkers for IPMN malignant transformation. The probability of IPMN malignant transformation , rates of surgical resection and survival after surgery are secondary endpoints.

Eligibility criteria: Inclusion Criteria:

* clinically diagnosed as IPMN;
* without other malignant tumor;
* agree to sign informed consent.

Exclusion Criteria:

* with mental disorders which can affect cognition and cooperation;
* with serious blood diseases or taking drugs that can affect peripheral blood

Primary outcomes:
measure: The accuracy of IPMN malignant transformation
timeFrame: Up to 10 years
Secondary outcomes:
measure: the probability of IPMN malignant transformation
timeFrame: Up to 10 years
measure: rates of surgical resection
timeFrame: Up to 10 years
measure: survival after surgery
timeFrame: Up to 10-15 years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: the First Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: Zhejiang University
name: Tingbo Liang, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03464435: A Novel Combined Therapy for Refractory Vernal Keratoconjunctivitis
Official title: A Novel Combined Therapy for Refractory Vernal Keratoconjunctivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vernal Keratoconjunctivitis
Keywords: Refractory Vernal Keratoconjunctivitis
0.1% tacrolimus
loteprednol etabonate 0.5%/tobramycin 0.3%
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2018-03-14
Enrollment: 20
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of 0.1% tacrolimus combined with loteprednol etabonate 0.5%/tobramycin 0.3% (LE/T) in vernal keratoconjunctivitis (VKC) patients resistant to conventional treatment. This prospective 6-mouth period study aims to include 20 severe VKC patients who were not responding to conventional treatments. All the patients will be treated with 0.1% tacrolimus suspension two times daily, LE/T eye drops four times daily for 1 month. Additionally, 0.1% olopatadine two times daily and preservative-free artificial tears four times daily will be used. After the first month, LE/T will be stopped, with other treatments continued for the last 5 months. Visual acuity and intraocular pressure (IOP) will be measured at enrollment and 1, 2, 3 and 6 months after treatment. Besides, 6 subjective symptoms and 6 clinical signs will be graded at each visit based on a 4-point scale. The primary endpoints are the change in symptoms and objective signs. Treatment failure will be recorded if extra corticosteroids were required.


Eligibility criteria: Inclusion Criteria:

* vernal keratoconjunctivitis patients resistant to conventional treatments

Exclusion Criteria:

* Patients diagnosed with other coexisting eye disease; with a confirmed or possible pregnancy; younger than 5 years old; had presence of systemic diseases other than coexisting allergic rhinitis, asthma, and atopic dermatitis; reported hypersensitivity to tacrolimus

Primary outcomes:
measure: the change of objective ocular signs
timeFrame: before treatment and 1, 2, 3 and 6 months after treatment
Secondary outcomes:
measure: the change of Best corrected visual acuity
timeFrame: before treatment and 1, 2, 3 and 6 months after treatment
measure: the change of intraocular pressure
timeFrame: before treatment and 1, 2, 3 and 6 months after treatment
measure: the change of subjective ocular symptoms
timeFrame: before treatment and 1, 2, 3 and 6 months after treatment
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05236335: Modulation of Circulating Levels of the Ketone Body 3-hydroxybutyrate in Patients With Type 2 Diabetes and Heart Failure With Preserved Ejection Fraction: Cardiovascular Effects.
Official title: Modulation of Circulating Levels of the Ketone Body 3-hydroxybutyrate in Patients With Type 2 Diabetes and Heart Failure With Preserved Ejection Fraction: Cardiovascular Effects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure With Preserved Ejection Fraction
Diabetes Mellitus, Type 2
Ketonemia
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2022-02-11
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Heart failure (HF) is among the most common causes of death in patients with type 2 diabetes (T2D). Ketones, 3-hydroxybutyrate (3-OHB), have shown to have beneficial hemodynamics effect in patients with hearth failure with reduced ejection fraction. However, this have never been investigated in patients with heart failure with preserved ejection fraction (HFpEF).

In this study we would like to investigate the effect of 14 days modulation of circulating ketone body levels on cardiac function and exercise capacity in patients with HFpEF and T2D.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* LVEF \> 40 %
* a clinical diagnosis of HFpEF and/or left ventricular hypertrophy (posterior wall thickness \> 12 mm) and/or previous myocardial infarction
* age ≥ 18 years old,
* one of the following criteria (a-d) should be fulfilled:

  1. Echocardiographic signs of diastolic dysfunction E/e' \> 8
  2. Septal e ́\< 7 cm/s and/or lateral e ́ \< 10 cm/s
  3. Left atrium volume index ≥34 mL/m2 and/or left atrial diameter \> 4 cm
  4. NT-proBNP \> 125 pg/ml.

Exclusion Criteria:

* Insulin treatment, inability to give informed consent

Primary outcomes:
measure: Cardiac Output (L/min)
timeFrame: 14 days ketone ester treatment
Secondary outcomes:
measure: Pulmonal wedge capillary Pressure (PCWP)
timeFrame: 14 days ketone ester treatment
measure: Exercise capacity (METs)
timeFrame: 14 days ketone ester treatment
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
References:
Clinical trial NCT00163735: Potential Allergens in Wine: Double-blind Placebo-controlled Trial
Official title: Potential Allergens in Wine: Double Blind Placebo-controlled Trial and Basophil Activation Analysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Allergy
Anaphylaxis
Keywords: Food allergy
wine
milk allergy
egg allergy
nut allergy
fish allergy
Lead sponsor: Bayside Health
Sponsor class: OTHER_GOV
Collaborators: name: Australian Wine Research Institute
name: National Health and Medical Research Council, Australia
name: The Alfred
First posted: 2005-09-14
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: This study is designed to identify whether wines which are produced using the common potential food allergens such as proteins derived from fish, milk or egg are likely to contain sufficient food allergens to cause allergic reactions in susceptible individuals.

Detailed description: Recent international legislation requires labelling of wines made using potentially allergenic food proteins "casein", egg white, isinglass ( fish derived), milk or evaporated milk where "there is detectable residual processing aid". However it is not clear whether the final wine contains concentrations of residual added food proteins that can provoke allergic reactions.

Comparison:This study is a double blind, placebo-controlled trial to determine whether adults known to be allergic to eggs, fish, milk and/or nuts exhibit allergic reactions following consumption of Australian commercial wines fined with food allergens.

Eligibility criteria: Inclusion Criteria:

Individuals with IgE-mediated food allergy to milk, fish, egg or nuts Otherwise no major medical problems Able to drink wine -

Exclusion Criteria:

Major asthma or cardiac disease Unwilling or unable to participate

-

Primary outcomes:
measure: Allergic reactions to wine
Secondary outcomes:
measure: Positive basophil activiation test to wines
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: AIR Med, Alfred Hospital
state: Victoria
Study officials:
affiliation: Alfred Hospital and Monash University
name: Robyn E O'Hehir, MBBS PhD FRACP
role: STUDY_DIRECTOR
affiliation: Monash University
name: Jennifer M Rolland, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Australian Wine Research Institute
name: Creina S Stockley, PhD
role: PRINCIPAL_INVESTIGATOR
References: