louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03908723: Treatment of Macular Edema Caused by Leber's Miliary Aneurysms Using Intravitreal Aflibercept and Peripheral Laser Photocoagulation
Official title: Treatment of Macular Edema Caused by Leber's Miliary Aneurysms Using Intravitreal Aflibercept and Peripheral Laser Photocoagulation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Macular Edema Caused by Leber's Miliary Aneurysms
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2019-04-09
Enrollment: 6
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluates the effectiveness of intravitreal Aflibercept (IVA) injection therapy, combined with peripheral laser photocoagulation, in the treatment of macular edema caused by Leber's miliary aneurysm. We believe that our study makes a significant contribution to the literature because to our knowledge, it is the first to report cases, in which IVA injection therapy was used to treat this condition.


Eligibility criteria: Inclusion Criteria:

* FA revealed many aneurysms with leakage in the temporal mid-peripheral retina and near the macula. Optical coherence tomography (OCT) showed moderate to marked cystoid macular edema and subretinal fluid. There were no abnormal findings in the cornea, anterior chamber, or lens. No particular lesions were found in the opposite eye of each subject. Based on these findings, the patients were diagnosed with Leber's miliary aneurysm.

Exclusion Criteria:

-

Primary outcomes:
measure: Visual acuity improvement
timeFrame: 6 months after 3 consequative injections
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria university
Study officials:
References:
Clinical trial NCT01945723: Tissue Characterization From Various Parts of the Gastrointestinal Tract in Healthy Volunteers
Official title: Tissue Characterization From Various Parts of the Gastrointestinal Tract in Healthy Volunteers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy
Keywords: Endoscopy
Gastrointestinal tract
Bacterial markers
volunteers
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-09-18
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 10 healthy volunteers

Brief summary: Tissue characterization will be performed, from different regions of the gastrointestinal tract in healthy volunteers.

Detailed description: During an endoscopic examination tissue samples will be taken from different regions of the gastrointestinal mucosa. The tissue samples will be used to characterize bacterial markers in the various intestinal segments.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers,
* Age: 20-60 years,
* Consent to perform endoscopic examination.

Exclusion Criteria:

* Antibiotics - a month prior to participation in the study,
* A chronic health condition.

Primary outcomes:
measure: Bacterial markers in different intestinal segments.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Department of Gastroentherology
Study officials:
References:
Clinical trial NCT01215123: An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Breast Cancer
Official title: Avastin in First Line Metastatic or Recurrent Breast Cancer. Retrospective Phase IV Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-10-06
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Breast cancer patients with first line treatment with Avastin

Brief summary: This observational study will assess the median time of treatment duration and the safety of Avastin (bevacizumab) as first line treatment in patients with metastatic breast cancer. Data will be collected for approximately 24 months.


Eligibility criteria: Inclusion Criteria:

* Patients with metastatic breast cancer in first line treatment who have completed treatment with Avastin

Exclusion Criteria:

* Patients not willing or unable to signed written consent form

Primary outcomes:
measure: Time to Disease Progression (TDP)
timeFrame: Up to a maximum of 36.4 months
Secondary outcomes:
measure: Treatment Duration: Number of Bevacizumab Cycles
timeFrame: Up to a maximum of 36.4 months
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Buenos aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Capital Federal
country: Argentina
city: La Pampa
country: Argentina
city: Mar Del Plata
country: Argentina
city: Rosario
country: Argentina
city: San Miguel de Tucuman
country: Argentina
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01220323: Transcranial Direct Current Stimulation for Chronic Pain Relief
Official title: Transcranial Direct Current Stimulation for Chronic Pain Relief
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chrronic Pain Patients
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-10-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In the present study, the investigators intend to investigate whether anodal transcranial direct current stimulation (tDCS) may be effective in reducing pain in chronic pain patients.

Detailed description: tDCS is a noninvasive brain stimulation technique that utilizes low amplitude direct currents applied via scalp electrodes to modulate the level of cortical excitability.Several studies have demonstrated that tDCS applied over the sensory-motor cortex has been able to decrease pain sensation and to increase pain threshold in healthy subjects and in chronic pain patients.

The aim of this study was to test whether daily sessions of anodal tDCS repeated for 5 consecutive days may be effective in reducing pain in a large number of chronic pain patients.

Patients will receive sham tDCS or real tDCS in a 5-day period of treatment in a randomized, sham controlled study. The participants will be divided to 2 groups of 50 each. One group will receive 5 days period of 20 min 2mA tDCS over the lt M1 and the other will receive sham stimulation. X week later the groups will switch to the other arm.

Pain will be measured using visual analog scale (VAS) for pain and the short form McGill questionnaire (SF-MPQ). Disability will be measured using the ( Pain Disability Index (PDI) of Life-54 scale (MSQoL-54). Depressive symptoms and anxiety will also be evaluated using the Center for Epidemiological Studies-Depression Scale and the State-trait Anxiety Inventory (STAI). Cognitive function will be mesured using minimental test. Evaluations will be performed at baseline, immediately after the end of treatment, and once a week during a 3-week follow-up period.

Eligibility criteria: Inclusion Criteria:

* over 18
* chronic pain patients VAS \> 4

Exclusion Criteria:

* pregnancy
* scalp lacerations
* History of seizures
* metal implants in the head
* heart pace maker

Primary outcomes:
measure: Pain relief
timeFrame: 5 days
Secondary outcomes:
measure: Avaluation of tDCS treatment for chronic pain on disability, depression, anxiety, and cognition of treated patients.
timeFrame: 5 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02651623: Study to Evaluate The Effect Of Sertraline on the Cardiac Repolarization in Healthy Subjects
Official title: A Phase 1, Single Center Randomized, Three-way Crossover, Double-blinded, Placebo- And Moxifloxacin-controlled Thorough Qt (Tqt) Study To Determine The Effects Of Sertraline (Zoloft (Registered)) On The Cardiac Repolarization In Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2016-01-11
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to demonstrate a lack of effect of sertraline on QTc intervals relative to time-matched placebo in healthy subjects

Detailed description: Evaluate multiple doses of 400 mg per day of sertraline on QTc, and evaluate the safety and tolerability of sertraline in healthy subjects.

Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).

Risk factors for QT prolongation or torsades de pointes

Primary outcomes:
measure: Postdose QTcF (Fridericia's correction) intervals
timeFrame: 0 to 72 hours
Secondary outcomes:
measure: Averse events, vital signs, physical examinations and abnormal laboratory for safety assessments (safety and tolerability)
timeFrame: Through study completion, an average of 3 months
measure: Relationship between QTc prolongation and measured sertraline/metabolite plasma concentrations
timeFrame: 0 to 72 hours
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Pfizer Clinical Research Unit
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00926523: Biomarkers in the Evaluation of Chronic Lung Disease
Official title: Biomarkers in the Evaluation of Chronic Lung Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Hypertension
Pulmonary Arterial Hypertension
Interstitial Lung Disease
Keywords: Pulmonary Hypertension
Pulmonary Arterial Hypertension
Interstitial Lung Disease
MIF
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2009-06-23
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects are either a healthy volunteer, or someone who has confirmed Pulmonary Hypertension and Interstitial Lung Disease

Brief summary: We hypothesize that hypoxia-induced pulmonary vascular remodeling is mediated by macrophage migration inhibitory factor (MIF), that remodeling is in fact the reflection of a chronic inflammatory process, and that MIF may be a useful biomarker of the severity and progression of both ILD and PH.

Detailed description: We hypothesize that hypoxia-induced pulmonary vascular remodeling is mediated by macrophage migration inhibitory factor (MIF), that remodeling is in fact the reflection of a chronic inflammatory process, and that MIF may be a useful biomarker of the severity and progression of both ILD and PH.

To study this hypothesis, we have two specific aims:

1. To evaluate plasma MIF concentration as a marker of severity in ILD and PH and
2. To determine the utility of breathe condensate analysis in the evaluation of ILD and PH. If we are successful in identifying MIF as a biomarker, it may identify MIF as a useful therapeutic target, as we have shown in other inflammatory disorders.

Eligibility criteria: Inclusion Criteria:

* Subject are at least 18 years of age
* Subject has confirmed Pulmonary Hypertension and Interstitial Lung Disease
* Subject are able to complete study procedures, such as spirometry, and Pulmonary Exercise test.

Exclusion Criteria:

* Subject are pregnant
* Subject is unable to perform tasks associated with study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New Hyde Park
country: United States
facility: Interstitial Lung Disease and Pulmonary Hypertension Programs
state: New York
Study officials:
affiliation: Northwell Health
name: Arunabh Talwar, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: North Shore Long Island Jewish Healthy System
name: Ed Miller, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00921323: The Use of Pedometers as an Adjunctive Tool in a School-based Pediatric Weight Management Program
Official title: The Use of Pedometers as an Adjunctive Tool in a School-based Pediatric Weight Management Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Physical activity
pedometers
children
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: Children's Miracle Network
First posted: 2009-06-16
Enrollment: 50
Sex: ALL
Minimum age (years): 12
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is:

* To validate the use of pedometers in assessing the level of physical activity in middle school children.
* To evaluate whether setting a step goal through the use of pedometers could increase physical activity and prevent weight gain in middle school children.


Eligibility criteria: Inclusion Criteria:

* All healthy 8th grade students at the Springboard Academy of the Milton Hershey School willing to participate in the study and whose parents give consent.

Exclusion Criteria:

* Any medical condition that prevents the child from walking during the 12 week study period.
* Non-English speaking student.

Primary outcomes:
measure: Body mass index
timeFrame: 3 months
Secondary outcomes:
measure: Daily step counts
timeFrame: 3 months
measure: Survey questionnaire
timeFrame: 3 months
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State College of Medicine / Penn State Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
References:
Clinical trial NCT02155023: Feasibility Study to Determine the Optimal Calibration Method for Glucose Sensors
Official title: An Open, Single-centre, Non-controlled Feasibility Study to Determine the Optimal Calibration Method for Glucose Sensors Used for Continuous Glucose Monitoring in Patients With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
Collaborators: name: European Commission
First posted: 2014-06-04
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Two new glucose sensors (IR-Glucose Reader (Joanneum Research, Austria), IR-CGM (IMM, Germany)) will be investigated to determine the optimal calibration method in patients with type 1 diabetes

Detailed description: The subjects (Type 1 diabetes) will stay at the Clinical Research Centre for the whole period of the investigation (12 hours).

Continuous blood glucose monitoring will be performed using the IR-Glucose Reader system and/or the IR-CGM system based on microdialysis. In parallel blood glucose measurements will be performed every 15 min as reference. The measurements of the sensors will be calibrated with different schemes and the difference between the calibrated glucose readings and the reference blood glucose values will be determined.

Eligibility criteria: Inclusion Criteria:

* Informed consent obtained after being advised of the nature of the study
* Male or female aged 18 to 75 years (both inclusive)
* The subject has Type 1 diabetes (as defined by WHO) for at least 24 months
* Body Mass Index (BMI) \<= 35 kg/m2

Exclusion Criteria:

* Subject is actively enrolled in another clinical trial or took part in a study within 30 days
* Experienced recurrent severe hypoglycaemic unawareness (as judged by the investigator)
* A history of drug or alcohol dependence
* Positive result for HIV antibodies
* Positive result for Hepatitis B antigen or Hepatitis C antibodies
* Any other significant concomitant disease such as endocrine, cardiac, neurological, malignant, other pancreatic disease or uncontrolled hypertension as judged by the investigator
* Patient is pregnant, or breast feeding during the period of the study
* Patient donated blood in the last 3 months

Primary outcomes:
measure: difference between calibrated measurements and reference
timeFrame: 12 hours
Secondary outcomes:
measure: evaluate necessary run-in procedures by assessment of error over time
timeFrame: 12 hours
Other outcomes:
measure: Distribution of the glucose values
timeFrame: 12 hours
measure: Malfunction of the systems
timeFrame: 12 hours
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
state: Styria
Study officials:
affiliation: Medical University of Graz
name: Thomas R Pieber, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02221323: A Trial to Compare the PK and PD of Insulin Lispro Administered Into Different Tissues in Subjects With Diabetes Mellitus Type 1
Official title: A Trial to Compare the Pharmacokinetics and Pharmacodynamics of Insulin Lispro Administered s.c. Into Lipohypertrophic or Normal Abdominal Adipose Tissue in Subjects With Diabetes Mellitus Type 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus
Lead sponsor: Profil Institut für Stoffwechselforschung GmbH
Sponsor class: INDUSTRY
First posted: 2014-08-20
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this trial is to compare the pharmacokinetics and pharmacodynamics of insulin lispro injection into either lipohypertrophic lesions or normal tissue, utilizing both state-of-the-art euglycaemic clamp and mixed meal tolerance testing. The magnitude of insulin efficacy after injection into these different areas is still unclear. The results from this study may expand the knowledge on the severity of this issue and may provide evidence for future treatment recommendations regarding injection sites for insulin administration.


Eligibility criteria: Inclusion Criteria:

* AUCINS.0-4h and AUCGIR.0-4h during treatment period 1

Exclusion Criteria:

* AUCINS.0-4h and AUCBG.0-4h during treatment period 2, intra-subject variability of AUCINS.0-4h and AUCGIR.0-4h during treatment period 1

Primary outcomes:
measure: AUCINS.0-4h and AUCGIR.0-4h
timeFrame: up to 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Profil Institut für Stoffwechselforschung GmbH
state: NRW
Study officials:
affiliation: Profil Institut für Stoffwechselforschung GmbH
name: Ulrike Hövelmann
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04561323: Diagnosing Acute Onset Insufficient Intestinal Blood Flow (Bowel Ischemia) With a Novel CT Technique Called Dual-energy CT (DECT). This Observational Study Seeks to Evaluate Whether DECT Can Improve the Diagnosis of Bowel Ischemia and How the DECT Findings Correlate With Intraoperative Findings
Official title: Dual-energy CT in the Diagnosis of All-Cause Acute Bowel Ischemia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bowel Ischemia
Acute Bowel Ischemia / Infarction
Keywords: Dual-energy CT
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2020-09-23
Enrollment: 44
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population consists of admitted patients at Rigshospitalet, Denmark.

Brief summary: The aim of this study is to evaluate the performance of dual-energy CT (DECT) in the diagnosis of acute bowel ischemia (ABI). ABI is a condition characterised by inadequate blood supply to portions of the intestine. ABI is a relatively rare condition, but is associated with a high mortality rate.

DECT is an emerging field within radiology. Few reports have reported an increased conspicuity for ABI using DECT compared with conventional CT, which is the current preoperative golden standard.

The investigators hypothesize that DECT increases conspicuity of ABI compared with conventional CT and that DECT image findings correlate with the intraoperative findings.


Eligibility criteria: Inclusion Criteria:

* Referred on the suspicion of acute bowel ischemia

Exclusion Criteria:

* Patient not scanned with DECT
* Patient does not undergo abdominal surgery

Primary outcomes:
measure: Adding DECT information increases assessor confidence without lowering the specificity compared with standard CT in the diagnosis and/or exclusion of ABI.
timeFrame: 10 minutes
Secondary outcomes:
measure: Intraoperative ICG fluorescence angiogram perfusion assessment and its correlation to DECT image evaluation.
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Diagnostic Radiology, Rigshospitalet
Study officials:
References: