louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03323307: Low Cost OCT for Point of Care
Official title: Low Cost Optical Coherence Tomography for Point of Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Optical Coherence Tomography (OCT) of the Retina
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: University of North Carolina, Chapel Hill
name: Wallace H. Coulter Foundation
First posted: 2017-10-27
Enrollment: 70
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: The purpose of this study is to compare the performance of a prototype optical coherence tomography (OCT) machine with currently available high resolution OCT machines.


Eligibility criteria: Inclusion Criteria:

* patients scheduled to receive standard OCT testing as part of their clinical visit

Exclusion Criteria:

* none

Primary outcomes:
measure: Number of Participants With Acceptable OCT Image Quality
timeFrame: day 1
Secondary outcomes:
measure: Central Macular Thickness
timeFrame: day 1
measure: Total Macular Volume
timeFrame: day 1
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina Kittner Eye Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Adam Wax, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01645007: Prevalence of Hepatitis B Infection in the Galilee Region, Israel
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Hepatitis B
Keywords: Hepatitis B
Prevalence
HBsAg
Vaccination
Galilee
Lead sponsor: Western Galilee Hospital-Nahariya
Sponsor class: OTHER_GOV
First posted: 2012-07-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Native Israeli Druze

Brief summary: Primary Aims:

1. Evaluate HBV (Hepatitis B Virus) infection prevalence among Druze in the Galilee.
2. Educate the population in order to reduce transmission
3. Increase awareness among primary care providers

Secondary Aims:

1. Identify chronic HBV infected patients who need to be followed and treated,
2. Identify HBV infected women in a childbearing age
3. Identify non immunized individuals and recommend vaccination
4. Identify previously vaccinated individuals who are not immunized
5. Identify previously vaccinated individuals who became infected

Study Design:

Study population is targeted to native Israeli Druze. We aim for evaluating up to 20,000 people from Druze communities in the Galilee area

This work will be divided into three sections:

1. Increasing awareness: lectures and local events will be taken place in the communities. Written information will be given and primary care-providers mainly family doctors, nurses and obstetric surgeons will be involved.
2. All participants, upon signing a consent will:

   * Fill up a questioner
   * Checked for weight, height and waist circumflex
   * Have a blood sample taken
3. Results and recommendations will be forwarded to all participants


Eligibility criteria: Inclusion Criteria:

* All consent adults who are 18 year old or older

Exclusion Criteria:

* Individuals younger than 18 year old
* Individuals who cannot or will not sign consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05702307: Determining the Glycemic Effects of Sunflower Pasta
Official title: Determining the Effects of Sunflower Pasta on Glycemic Responses in Healthy Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Potential Abnormality of Glucose Tolerance
Appetitive Behavior
Keywords: blood glucose
pasta
glycemic index
glycemic load
Lead sponsor: Agricultural University of Athens
Sponsor class: OTHER
Collaborators: name: Institute of Technology and Agricultural Products
First posted: 2023-01-27
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover assignment
Primary purpose: OTHER

Brief summary: This study investigated the effects of five types of pasta on the glycemic responses

Detailed description: This study aimed to 1.determine the glycemic index and glycemic load of five types of pasta (tagliatella control, 5% sunflower tagliatella, 16% sunflower tagliatella, 16% sunflower penne and 16% sunflower fusilli) and 2. investigate the effects of these pasta types on postprandial glycemic responses in healthy subjects

Eligibility criteria: Inclusion Criteria:

* healthy
* non-smoking
* non-diabetic men and women
* body mass index between 18 and 25 kg/m2

Exclusion Criteria:

* severe chronic disease (e.g. cardiovascular diseases, diabetes mellitus, kidney or liver conditions, endocrine conditions)
* gastrointestinal disorders
* pregnancy
* lactation
* competitive sports
* alcohol abuse
* drug dependency

Primary outcomes:
measure: Capillary blood glucose responses
timeFrame: 2hr
Secondary outcomes:
measure: Subjective appetite ratings
timeFrame: 2 hours
measure: Blood pressure
timeFrame: 2 hours
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Agricultural University of Athens
state: Attica
Study officials:
affiliation: Agricultural University of Athens
name: Emilia Papakonstantinou, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06133907: Investigation of the Frequency of Hereditary Hyper Alpha-tryptasemia in Patients With Elevated Basal Tryptasemia
Official title: Investigation of the Frequency of Hereditary Hyper Alpha-tryptasemia in Patients With Elevated Basal Tryptasemia (Protocol HaT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Allergic Bronchiolitis
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The aim of the study is to assess the number of patients with elevated blood tryptase for whom this elevation could be linked to a hereditary alpha-tryptase secretion abnormality or hyper-alpha-tryptasemia. This information will enable to better optimize the management and follow-up of patients who have experienced hypersensitivity reactions and have elevated basal blood tryptase levels. The patients will be offered the opportunity to take part in the study. If they consent to participate, they will be tested for hereditary hyper-alpha-tryptasemia. A blood sampling will be performed in the center. A few weeks after, the patient will be informed about the blood sample result during a medical consultation organized in the center.


Eligibility criteria: Inclusion Criteria:

* Patients who came in the pneumoallergology department of the CHU de Nice since January 2014 for an allergological workup
* Patients who have received at least one basal tryptase assay, according to recommendations
* informed consent signature

Exclusion Criteria:

* High tryptasemia (≥ 8ng/ml) synchronous with anaphylactic reaction and unconfirmed basally
* Known diagnosis of systemic mastocytosis

Primary outcomes:
measure: Prevalence of hereditary hyper alpha-tryptasemia
timeFrame: at inclusion
Secondary outcomes:
measure: Phenotyping our patient cohort
timeFrame: at 36 months
measure: Set up a serotheque to support scientific and medical projects in this field
timeFrame: At inclusion
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice - Hôpital de Pasteur
state: Alpes-Maritimes
Study officials:
affiliation: CHU de Nice, Service de Pneumologie
name: Leroy Sylvie, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00005307: Etiology of Blood Dyscrasias: Analysis of the International Agranulocytosis and Aplastic Anemia Study Data
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia, Aplastic
Blood Disease
Agranulocytosis
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To quantify the role of drugs and other factors in the etiology of agranulocytosis and aplastic anemia.

Detailed description: BACKGROUND:

Agranulocytosis and aplastic anemia are rare but serious blood diseases that can be caused by drugs and other environmental factors. In 1980, there were only limited quantitative estimates of the risk between various exposures, particularly drugs, and the two dyscrasias. The data were collected in the IAAAS, a multicenter population-based case-control study conducted from 1980 to 1986 in eight regions. The study was funded by a pharmaceutical company to investigate a single hypothesis, but information was obtained on all drugs and on other factors, enabling a general investigation of the dyscrasias.

DESIGN NARRATIVE:

The study was for retrospective data analysis only. Standard case-control methods were used. In most instances, multivariate analysis was used to control confounding, especially by simultaneous use of other causal drugs. Adverse effects and the relative safety of drugs in relation to the two dyscrasias were documented. Because the IAAAS was population-based, incidence rates were provided directly, and excess risks were estimated for associated drugs. Such quantitative measures of association were generally unavailable. Among the drugs that were analyzed were various categories such as psychotropics, antihistamines, and cardiovascular drugs, and individual drugs such as allopurinol. Factors other than drugs were also evaluated, including exposure to radiation and chemicals such as benzene and insecticides, history of viral infection, and history of allergy and other conditions.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Kelly JP, Kaufman DW, Shapiro S. Risks of agranulocytosis and aplastic anemia in relation to the use of cardiovascular drugs: The International Agranulocytosis and Aplastic Anemia Study. Clin Pharmacol Ther. 1991 Mar;49(3):330-41. doi: 10.1038/clpt.1991.37.
Clinical trial NCT02129907: The Purpose of the Study is to Examine Whether Iron Deficiency Anemia is Associated With Increased Production of Thrombin and Whether Correction of Anemia by Providing Iron Intravenously Causes a Significant Reduction in Production of Thrombin.
Official title: The Purpose of the Study is to Examine Whether Iron Deficiency Anemia is Associated With Increased Production of Thrombin and Whether Correction of Anemia by Providing Iron Intravenously Causes a Significant Reduction in Production of Thrombin.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Iron Deficiency Anemias
Keywords: Anemias
Iron-Deficiency
thrombin
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2014-05-02
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: men and women over age 18 suffering from iron deficiency anemia that wasnt responded to oral iron treatment or there is contraindication for oral iron therapy.

Brief summary: In total 50 subjects with iron deficiency anemia treated with intravenous iron are planned for inclusion in this trial. After signing an informed consent a blood sample will be obtained from each participant before iron treatment. The investigators will measure the thrombin generation in plasma assessed by the calibrated automated thrombogram (CAT). patient will go face to face interview and will be asked to answer structured questionnaire which will include information on demographics, clinical data ( fever, allergies , etc.) and comorbidities

Two weeks after completing intravenous iron administration additional blood samples will be taken: thrombin generation will be measured


Eligibility criteria: Inclusion Criteria:

* age \>18 years
* Iron deficiency anemia that did not response to oral iron treatment and is planned to receive iron supplement intravenously.
* Signing the informed consent

exclusion criteria:

* chronic inflammatory disease
* renal failure
* Malignancy
* Infectious disease
* Other reason for anemia except iron deficiency anemia.
* Pregnant women
* Use of anti aggregating agents or anticoagulants

Primary outcomes:
measure: thrombin generation levels
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Haemek medical center
Study officials:
References:
Clinical trial NCT02952807: Vaginal Misoprostol and Foley Catheter for Induction of Labor
Official title: Sequential Versus Concurrent Use of Vaginal Misoprostol Plus Foley Catheter for Induction of Labor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Induction of Labor Affected Fetus / Newborn
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2016-11-02
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: to compare between sequential and concurrent use of vaginal misopristol plus foleys catheter for induction of labor

Detailed description: two groups of patients who are eligible for labor induction were randomized to either sequential use of vaginal misopristol plus foleys catheter or concurrent use of vaginal misopristol plus foleys catheter.

Eligibility criteria: Inclusion Criteria:

* Indication for labour induction Term pregnancy with alive fetus Bishop score less than five

Exclusion Criteria:

* Age less than 18 years Previous uterine scar Nonvertex presentation Non-reassuring fetal status Fetal anomalies Fetal growth restriction Genital bleeding Tumors, malformations and/or ulcers of vulva, perineum or vagina

Primary outcomes:
measure: induction delivery interval (time from starting induction to delivery)
timeFrame: 48hours
Secondary outcomes:
measure: Need of oxytocin for augmentation of labour
timeFrame: 48h
measure: Number of doses needed to bring on labour
timeFrame: 48h
measure: Failed induction (failure to elicit contraction after 72 hours)
timeFrame: 72h
measure: Hyperstimulation syndrome
timeFrame: 24h
measure: Cesarean section
timeFrame: 72h
measure: Severe neonatal morbidity or perinatal death
timeFrame: 28 days
measure: Serious maternal morbidity or maternal death
timeFrame: 42 days
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University
Study officials:
affiliation: FACULTY OF MEDICINE ,ZAGAZIG UNIVERSITY
name: ibrahim A el sharkwy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00885807: A Prospective Chart Review to Validate the WFIRS (Weiss Functional Impairment Rating Scale)
Official title: Psychometric Validation of the Weiss Functional Impairment Rating Scale and the Weiss Symptom Record in Patients With Attention-Deficit Hyperactivity Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Attention-Deficit/Hyperactivity Disorder
Keywords: ADHD
WFIRS
WSR
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
name: Purdue Pharma LP
name: Shire
First posted: 2009-04-22
Enrollment: 220
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: People with ADHD from 7 years of age

Brief summary: The purpose of the study is to evaluate the psychometric validation of the Weiss Functional Impairment Rating Scale and the Weiss Symptom Record. It is hypothesized that the Weiss Functional Impairment Rating Scale has strong psychometric properties and good convergent validity with other measures of functioning and discriminant validity from symptoms and quality of life.

Detailed description: The measures for this rating scale were developed at the request of the Canadian Attention Deficit Disorder Resource Alliance to provide clinician friendly tools free of charge as a way of improving screening for ADHD and comorbidity.

Patients are consented during clinic visits and agree to allow use of clinic data for the purpose of this research. They complete additional measure(s) for the purpose of the study. The data is then entered.

Internal consistency will be measured using Cronbach's alpha. Convergent, concurrent and discriminant validity will be measured using Pearson correlations. Domain reliability is determined with factor analysis. Up to 220 patients will be enrolled in the study.

Eligibility criteria: Inclusion Criteria:

* Compliance to complete the WFIRS is key to inclusion.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Provincial ADHD Program, BC Children's & Women's Health Centre
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Margaret D. Weiss, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: BC Children's & Women's Hospital, Vancouver
name: Chistopher Gibbins, MD
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: Grant Iverson, MD
role: STUDY_DIRECTOR
affiliation: BC Children's & Women's Hospital, Vancouver
name: Brian Brooks, MD
role: STUDY_DIRECTOR
affiliation: BC Children's & Women's Hospital, Vancouver
name: Li Ying Lu, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00868907: Study Assessing Dosing Time and Calcium and Vitamin D on the Relative BA of 35 mg DR Risedronate Dosed With Food
Official title: A Crossover Study to Assess the Relative BA of Delayed-release Risedronate Compared When Dosed With Either Dinner, Breakfast or Breakfast Plus a Calcium/Vitamin D Tablet
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Warner Chilcott
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2009-03-25
Enrollment: 101
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Randomized, open-label, single dose, 3-treatment, 3-period crossover study, with a 14- to 17-day washout period between doses. The study will consist of a screening visit, study center admission (preceding Treatment Periods 1, 2 and 3), 3 treatment periods (4 days each), 1 washout period (14 to 17 days separating periods 1, 2 and 3), and exit procedures.


Eligibility criteria: Inclusion Criteria:

* female, 40 to 70 years of age
* non-lactating and either surgically sterile or postmenopausal
* body mass index less than or equal to 32 kg/m2 at screening

Exclusion Criteria:

* no use of a bisphosphonate within 1 month
* no history of GI disease
* no use of any medications within 7-14 days prior to scheduled dosing day

Primary outcomes:
measure: Relative BA of DR Risedronate dosed: After breakfast and with calcium/vitamin D tablet, compared to DR Risedronate dosed after breakfast After dinner compared to DR Risedronate administered after breakfast.
timeFrame: 72 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Honolulu
country: United States
facility: Research Site
state: Hawaii
city: Evansville
country: United States
facility: Research Site
state: Indiana
Study officials:
affiliation: Procter and Gamble
name: Chantell Wilson, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01717807: C11-Erlotinib PET/CT as a Tool for Identification and Characterization of Tumor With High Expression of Epidermal Growth Factor Receptor(EGFR).
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer
Pancreatic Cancer
Keywords: epithelial growth factor receptors
lung cancer
advanced tumor of pancrease
erlotinib
C11-Erlotinib PET/CT
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2012-10-30
Enrollment: 30
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: oncological patients with NSC type of lung cancer and with advanced pacreatic cancer.

Brief summary: The EGFR is one of the most frequently overexpressed proteins in various cancers including lung cancer, and is related to tumor progression and resistance to most treatments.

New treatment strategies targeting EGFR have been developed: "although much work remains to be done, erlotinib has already established itself as part of the therapeutic armamentarium against cancer"(A review of erlotinib and its clinical use. Tang PA, Tsao MS, Moore MJ. Expert Opin Pharmacotherapy. 2006 Feb;7(2):177-93.)

Noninvasive PET/CT imaging of EGFR expression activity and mutation status in NSCLC could aid in the selection of patients for individualized therapy with EGFR kinase inhibitors.

Whole-body noninvasive PET/CT imaging could estimate treatment-responsive vs. -resistant tumor burden before the initiation of therapy with EGFR inhibitors.

The purposes of the study are:

1. To adjust an optimal treatment for patients with tumors that have high expression of EGFR by identification of this type of cancer using C11-Erlotinib PET/CT during pretreatment work-up; as well as to follow up after treatment response.
2. To recognize patients with advanced pancreatic cancer responding to treatment with erlotinib and to distinguish them from non-responders.


Eligibility criteria: Inclusion Criteria:

* patients with NSC type of lung cancer with high expression of EGFR who are candidates for erlotinib as second / third line of treatment;
* patients with advanced pancreatic tumor who are candidates for complex gemcitabine and erlotinib treatment.

Exclusion Criteria:

* lack of histological diagnosis;
* not a candidate for erlotinib;
* pregnancy.

Primary outcomes:
measure: Measure of extent and intensity ( by standardized uptake value - SUV) of C11-Erlotinib accumulation by tumors and metastasis before and after treatment
Secondary outcomes:
measure: size of tumor and metastasis (mm)
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Hebrew University Medical Center
Study officials:
References: