louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03606629: SOLARIS Endoprosthesis in Iliac Occlusive Disease
Official title: Solaris Endoprosthesis Performance in Treatment of Patients With Peripheral Occlusive Arterial Disease in the Iliac Territory - Post-Marketing Solaris I Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Arterial Disease
Lead sponsor: Scitech Produtos Medicos Ltda
Sponsor class: INDUSTRY
First posted: 2018-07-31
Enrollment: 5
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: Patients with POAD presenting limitant intermitent claudication after 6 months of clinical treatment and patients with rest ischemia, Rutherford class 2 to 5.

Brief summary: Fifty patients will be treated with Solaris Endoprosthesis and followed up to 2 years with Walking Impairment Questionnaire and Doppler Ultrasound evaluation in 30 days, 6 months and 12 months.


Eligibility criteria: Inclusion Criteria:

* Rutherford Class 2 to 5;
* Tasc II Class A, B, C or D;
* Unilateral or bilateral lesion, de novo or restenotic but not in-stent;
* Target lesion of 3 to 10 cm length;
* ≥ 50% stenosis or common iliac or external iliac artery;
* Reference vessel diameter ≥ 5 and ≤ 9 mm;
* Deep femoral artery patent and at least one infrapopliteal artery patent;
* Informed Consent provided.

Exclusion Criteria:

* Thrombocytopenia induced by heparina or tPA intravenous, clopidogrel, ticlopidine or aspirin sensitivity;
* Target lesion near to aneurysm, highly calcified or excessively tortuous;
* Previous stent on target vessel;
* Presence of other lesions that need treatment within 30 days;
* Rutherford Class 6;
* Acute thrombotic occlusion;
* History on amputation on the target limb.

Primary outcomes:
measure: Major Adverse Events
timeFrame: 1 day
measure: Target Lesion Patency
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Passo Fundo
country: Brazil
facility: Hospital de Clínicas de Passo Fundo
state: RS
Study officials:
affiliation: Santa Casa de Misericórdia de Santo Amaro
name: Luiz Furuya, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01199029: Single Dose Study Of PF-04308515 And Prednisone On Carbohydrate
Official title: An Open Label Study Evaluating The Effect Of Single Doses Of Pf-04308515 And Prednisone On Carbohydrate Metabolism Utilizing An Oral Glucose Tolerance Test In Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy People
Glucocorticoids
Prednisone
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-09-10
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will investigate the effect of a single dose of PF-04308515 or prednisone on calculated measures of glucose tolerance and insulin resistance by using a modified oral glucose tolerance test.


Eligibility criteria: Inclusion Criteria:

* BMI 17.5 to 30.5 kg/m2 and total body weight \>50 kg

Exclusion Criteria:

* Fasting glucose above the limits of the reference range for healthy individuals
* "No treatment" OGTT indicative of impaired fasting glucose or impaired glucose tolerance
* Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation

Primary outcomes:
measure: Fold change in AUC (0-4hr) relative to no treatment baseline for plasma glucose, plasma insulin and plasma C-peptide
timeFrame: 4 hours
Secondary outcomes:
measure: Pharmacodynamic effects on plasma glucose, plasma insulin, and plasma C-peptide
timeFrame: 3 days
measure: Safety: adverse events, vital sign measurements, physical examination
timeFrame: 3 days
measure: Pharmacokinetics: sparse PF-04308515 plasma samples will be collected
timeFrame: 3 days
Other outcomes:
Locations:
city: Kalamazoo
country: United States
facility: Pfizer Investigational Site
state: Michigan
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01141829: NADPH Oxidase Polymorphisms in Obstructive Sleep Apnea Syndrome (OSAS)
Official title: NADPH Oxidase p22phox Polymorphisms and Oxidative Stress in Patients With Obstructive Sleep Apnea
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sleep Apnea Syndrome
Oxidative Stress
Single Nucleotide Polymorphism
Keywords: NADPH oxidase
Lead sponsor: Sociedad Española de Neumología y Cirugía Torácica
Sponsor class: OTHER
Collaborators: name: Spanish Research Center for Respiratory Diseases
First posted: 2010-06-11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with OSAS defined by an apnea hypopnea index (AHI)\>10 h-1 will be included in the study along with control subjects without OSAS. Participants were consequently studied at the sleep unit of Hospital Universitario Son Dureta, (Palma de Mallorca, Spain).

Brief summary: Obstructive Sleep Apnea (OSA) is associated with increased oxidative stress. The major sources of Reactive Oxygen Species (ROS) in the vasculature are the NADPH oxidases. Several polymorphisms related to NADPH oxidase expression or NADPH oxidase activity has been identified. The investigators are going to compare the distribution of the allelic frequencies of A-930G and C242T polymorphisms and their possible relationship with the levels of 8-isoprostanes as a marker of oxidative stress in patients with OSA and in a control group without OSA.

Detailed description: DESIGN: CASE-CONTROL STUDY METHODS: We are going to determine the A-930G and C242T p22phox genotypes in patients with OSA and healthy subjects recruited from sleep unit of Son Dureta University Hospital, (Palma de Mallorca, Spain). 8-Isoprostane is going to be measured as an oxidative stress marker with an 8-isoprostane EIA kit (Cayman Chemicals Company, USA) in plasma samples.

Eligibility criteria: Inclusion Criteria:Polyysomnografic study with Apnoea/Hypoapnoea Index higher to 10 in patients and lower in controls.

Exclusion Criteria:

* chronic obstructive pulmonary disease, liver cirrhosis, thyroid dysfunction, rheumatoid arthritis, chronic renal failure and/or psychiatric disorders.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Palma de Mallorca
country: Spain
facility: Hospital Universitario Son Dureta
state: Baleares
Study officials:
References:
Clinical trial NCT04069429: Radiation Dose in Humans From Orally Administered Tc99m-Heparin
Official title: Radiation Dose in Humans From Orally Administered Tc99m-Heparin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Eosinophilic Esophagitis
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: dose assessment of orally administration of Tc99m-Heparin in healthy control and Eosinophilic Esophagitis patients
Primary purpose: BASIC_SCIENCE

Brief summary: This is a research study of a new agent used for evaluation of inflammation in the GI tract. This agent is investigational and thus is being studied to determine appropriate dosing and administration in both normal controls (i.e. people without gastrointestinal complaints) and patients with eosinophilic disease (i.e. those with an immune reaction and inflammation in their bodies with a certain cell called an eosinophil).

The study will test whether the radiolabeled agent will bind to the inflammation of eosinophilic esophagitis patients because an animal model of eosinophilic esophagitis which shows the striking deposition of eosinophil granule proteins is not available.


Eligibility criteria: Inclusion Criteria:

* 10 patients with diagnosed EoE (greater than 20 eosinophils per HPF) on esophageal biopsy will be included as the diseased population
* 7 controls (subjects without GI symptoms and known GI disease)

Exclusion Criteria:

* bleeding diathesis or contraindication to esophageal biopsies
* severe sleep apnea
* incarceration
* pregnancy
* inability to lie flat for 2 hours
* history of bleeding disorder
* Use of steroids
* Breast feeding
* Allergy to heparin or history of severe reaction to heparin
* allergy to mucomyst or severe asthma

Primary outcomes:
measure: Biodistribution of Tc99m-heparin
timeFrame: over approximately 24-26 hours
measure: Calculation of organ doses
timeFrame: over approximately 24-26 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Gerald Gleich, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01626729: Facts-Up-Front Versus Traffic-Light Food Labels
Official title: Facts-Up-Front Versus Traffic-Light Food Labels: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Labeling
Keywords: Food Labeling
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Robert Wood Johnson Foundation
First posted: 2012-06-25
Enrollment: 703
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 U.S. food and beverage industry recently released a new front-of-package nutrition labeling system called Facts Up Front that will be used on thousands of food products. The purpose of this study was to test consumer understanding of the Facts Up Front nutrition labeling system compared to the Multiple Traffic Light system (Traffic Light). Facts Up Front displays grams/milligrams and % daily value information for various nutrients; Traffic Light uses an interpretive color-coded scheme to alert consumers to low, medium or high levels of certain nutrients. Participants in an Internet-based study were randomized to one of five front-of-package label conditions: 1) No Label; 2) Traffic Light; 3) Traffic Light plus information about protein and fiber (Traffic Light+); 4) Facts Up Front; or 5) Facts Up Front plus information about "nutrients to encourage" (Facts Up Front+). Total percentage correct quiz scores were generated reflecting participants' ability to compare two foods on nutrient levels, based on their labels, and to estimate amounts of saturated fat, sugar, sodium, fiber and protein in foods. 703 adult participants recruited through an online database in May 2011 participated in this Internet-based study and data were analyzed in June 2011. The investigators hypothesized that the Traffic Light label groups would perform better than the Facts Up Front groups on all outcomes.


Eligibility criteria: Inclusion Criteria:

* Participants in Survey Sampling International Panels

Exclusion Criteria:

* Younger than 18 years old

Primary outcomes:
measure: Nutrient Comparison and Nutrient Level Estimation Accuracy
timeFrame: Baseline
measure: Perceptions of Health, Taste and Purchase Intent
timeFrame: Baseline
Secondary outcomes:
measure: Consumer Label Preferences
timeFrame: Baseline
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Survey Sampling International & Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Christina A Roberto, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roberto CA, Bragg MA, Schwartz MB, Seamans MJ, Musicus A, Novak N, Brownell KD. Facts up front versus traffic light food labels: a randomized controlled trial. Am J Prev Med. 2012 Aug;43(2):134-41. doi: 10.1016/j.amepre.2012.04.022.
Clinical trial NCT01018329: Magnetic Resonance Imaging in Evaluating Response to RadiationTherapy in Patients With High Grade Glioma
Official title: Multimodality Statistical Model of Early Response of High Grade Glioma to Radiation Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Tumor
Keywords: Adult Brain Tumor
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2009-11-23
Enrollment: 10
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: RATIONALE: Diagnostic procedures, such as magnetic resonance imaging, may help doctors predict a patient's response to treatment and help plan the best treatment. PURPOSE: This clinical trial is studying magnetic resonance imaging in response to radiation therapy in patients with high grade glioma.

Detailed description: Detailed DescriptionOBJECTIVES:

I. To develop a multimodality statistical model to act as a surrogate marker scheme of early changes in high grade glioma patients undergoing radiation therapy, using conventional MRI, MR diffusion tensor imaging, perfusion, permeability, and spectroscopic imaging while incorporating the radiation dose calculations delivered locally and the results of a clinical questionnaire into the model.

II. To assess treatment response to tumor and normal tissue changes. OUTLINE: Patients undergo multimodality MRI imaging at baseline, weeks 1, 2, 3, 5, and 6, and then 4-6 weeks after completion of radiation therapy.

Eligibility criteria: Inclusion Criteria:

* Patients being treated for diagnosed with high grade glioma (WHO grade III or IV) at the University of Pennsylvania Medical Center who will be undergoing radiation therapy to the brain
* Patient or legal representative able to provide written informed consent
* Adult males and nonpregnant females

Exclusion Criteria:

* Vulnerable populations as specified (including pregnant patients, prisoners, patients with pacemakers or metallic implants)
* Patients with renal failure
* Patients with any condition considered a contraindication to MRI

Primary outcomes:
measure: Early brain tumor response
Secondary outcomes:
measure: Early therapeutic-induced changes in normal surrounding brain
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
References:
Clinical trial NCT03609229: Outcomes After Sacrocolpopexy With and Without Burch to Prevent Stress Urinary Incontinence in 3rd and 4th Degree Apical Uterine Prolapse
Official title: Outcomes After Sacrocolpopexy With and Without Burch to Prevent Stress Urinary Incontinence in 3rd and 4th Degree Apical Uterine Prolapse. Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prolapse
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-08-01
Enrollment: 60
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Urinary incontinence will develop after prolapse repair in approximately one quarter of patients with advanced pelvic organ prolapse who remain continent despite significant loss of anterior vaginal and pelvic organ support. Many women with advanced pelvic organ prolapse who choose to undergo surgical management also choose to undergo continence surgery in order to prevent new onset urinary incontinence.


Eligibility criteria: Inclusion Criteria:

- Women with 3rd and 4th degree Apical prolapse

Exclusion Criteria:

* Patients with previous failed surgical intervention
* Patients with medical disorders that may interfere with surgical interventions .
* Patients with apical prolapsed complaining of stress urinary incontinence

Primary outcomes:
measure: the percentage of stress incontinence post operative
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Ahmed Abbas
state: Cairo
Study officials:
References:
Clinical trial NCT00040729: Genetic Study of Patients Previously Treated With Flavopiridol on Clinical Trial NCI-97-C-0171C
Official title: Retrospective Analysis Of Promoter Polymorphism Of UGT1A1 Gene In Cancer Patients Enrolled On Clinical Trials With Flavopiridol At National Cancer Institute To Assess The Pharmacokinetics And Pharmacodynamics Of Flavopiridol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Keywords: unspecified adult solid tumor, protocol specific
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-06-26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: RATIONALE: Genetic testing for a specific enzyme may help doctors determine whether side effects from or response to chemotherapy are related to a person's genetic makeup.

PURPOSE: Genetic trial to determine whether different forms of the UGT1A1 gene are related to the body's ability to break down drugs and to the gastrointestinal side effects seen in patients previously treated with flavopiridol.

Detailed description: OBJECTIVES:

* Determine the relationship between UGT1A1 genotypes and drug pharmacokinetics and occurrence of gastrointestinal toxicity in cancer patients previously treated with flavopiridol on protocol NCI-97-C-0171C.

OUTLINE: Genomic DNA from pre-existing samples of serum or plasma from each patient is analyzed for UGT1A1 gene by polymerase chain reaction and DNA sequencing. Results are then analyzed for a possible association between UGT1A1 genotypic variation and susceptibility to flavopiridol.

Patients do not receive the results of the genetic testing, and the results do not influence the type or duration of treatment.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Cancer patients previously treated with flavopiridol on protocol NCI-97-C-0171C

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* See Disease Characteristics

Endocrine therapy:

* Not specified

Radiotherapy:

* Not specified

Surgery:

* Not specified

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
state: Maryland
Study officials:
affiliation: National Cancer Institute (NCI)
name: William D. Figg, PharmD
role: STUDY_CHAIR
References:
Clinical trial NCT04880980: Comparison of Efficacy of Double Dose Oral Terbinafine Vs Itraconazole in Treatment of Dermatophyte Infections of Skin.
Official title: Comparison of Efficacy of Double Dose Oral Terbinafine Versus Itraconazole in Treatment of Dermatophyte Infections of Skin - A Prospective, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dermatophyte Infection
Terbinafine Adverse Reaction
Itraconazole Adverse Reaction
Keywords: double dose
oral terbinafine
oral itraconazole
dermatophyte skin infection
randomized controlled trial
Lead sponsor: Pak Emirates Military Hospital
Sponsor class: OTHER
First posted: 2021-05-11
Enrollment: 120
Sex: ALL
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief summary: Study would be conducted to compare the efficacy and safety of double than usual dose oral terbinafine versus itraconazole in treatment of dermatophyte infections of skin in patient presenting at dermatology department of Pak Emirates Military Hospital, Rawalpindi, Pakistan.

Detailed description: * Study would be a randomized controlled trial, in which 120 subjects would be randomly divided into two equal groups of 60 each.
* Each group would be prescribed double than usual dose of terbinafine(250 mg twice daily) or itraconazole(100mg twice daily) for 2 weeks initially. Treatment may be extended to 4 weeks if cure has not been achieved.

Patients will be diagnosed and followed on the basis of classical clinical features of dermatophyte infections and microscopic potassium hydro-oxide slide preparation for fungal hyphae and spores.

Liver function tests will be checked on day 0, 14 and 28. Individuals aged 15-50 years with one or no co-morbidity will be included in the study.

Study will be conducted over a period of 6-8 months.

Eligibility criteria: Inclusion Criteria:

* individuals with dermatophyte skin infection, aged 15-50 years with one or no co-morbidities.

Exclusion Criteria:

* individuals with two or more co-morbidities or known cases of chronic liver disease.

Primary outcomes:
measure: Percentage of patients cured by using double dose of oral terbinafine Vs itraconazole in the treatment of resistant dermatophyte skin infections as assessed by measuring pruritis, erythema and scaling .
timeFrame: 2-4 weeks
measure: Adverse effects including effects on liver function tests of double dose oral terbinafine Vs itraconazole in the treatment of resistant dermatophyte skin infections.
timeFrame: 2-4 weeks
Secondary outcomes:
measure: Duration of treatment required to achieve cure from resistant dermatophyte infections.
timeFrame: 2-4 weeks
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Pak Emirates Military Hospital
state: Punjab
Study officials:
affiliation: Pak Emirates Military Hospital
name: Dr. Umar Abdul Ali Qureshi, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00000280: Glutaminergic Agents for Cocaine Abuse - 5
Official title: Glutaminergic Agents for Cocaine Abuse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cocaine-Related Disorders
Keywords: cocaine
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: VA Connecticut Healthcare System
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate glutaminergic agents for cocaine abuse.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Cocaine effects
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: VA Connecticut Healthcare System
state: Connecticut
Study officials:
affiliation: VA Connecticut Healthcare System
name: Thomas R Kosten, M.D.
role: PRINCIPAL_INVESTIGATOR
References: