louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00443144: D3-GHR Polymorphism and Turner Syndrome
Official title: D3-Growth Hormone Receptor Polymorphism and Total Effect of Recombinant Human Growth Hormone on Growth in Girls With Turner Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Turner Syndrome
Short Stature
Keywords: growth hormone receptor polymorphism
pharmacogenomics
growth promoting therapy
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2007-03-05
Sex: FEMALE
Minimum age (years): 38
Maximum age (years): 14
Standard ages: CHILD

Brief summary: The protein polymorphism of the growth hormone receptor characterized by the genomic deletion of exon 3 has been linked to the magnitude of the first-year-growth response to growth hormone (GH) in girls with Turner syndrome.

Objective: to study the long-term effect of GH therapy in Turner syndrome in correlation to this GHR polymorphism in a mainly retrospective design (chart-review).


Eligibility criteria: Inclusion Criteria:

* Turner syndrome defined by a structural aberration or lack of the X chromosome.
* Growth velocity less than 2 cm/year at the time of final analysis (= final height).

Exclusion Criteria:

* Age \<3.5 or \>14 years at start of GH therapy,
* GH peak serum levels \< 8 ng/ml in two independent tests,
* Thelarche at start or during the first year of treatment,
* Oxandrolone therapy for any time and a duration of GH therapy less than 2 years.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: University-Children's Hospital
Study officials:
affiliation: University-Children's Hospital Tübingen
name: Gerhard Binder, M.D. PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dos Santos C, Essioux L, Teinturier C, Tauber M, Goffin V, Bougneres P. A common polymorphism of the growth hormone receptor is associated with increased responsiveness to growth hormone. Nat Genet. 2004 Jul;36(7):720-4. doi: 10.1038/ng1379. Epub 2004 Jun 20.
Clinical trial NCT01136044: Clinical Experience With a Tensor Fasciae Latae Perforator Flap Based on Septocutaneous Perforators
Official title: Clinical Experience With a Tensor Fasciae Latae Perforator Flap Based on Septocutaneous Perforators
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Soft Tissue Defect
Keywords: tensor fasciae latae
septocutaneous perforators
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2010-06-03
Enrollment: 14
Sex: ALL
Minimum age (years): 16
Maximum age (years): 71
Standard ages: CHILD
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 possible harvest of a tensor fasciae latae flap based on septocutaneous perforators.This study should further confirm our data from an anatomical study concerning location, distribution, diameter and differentiation of the perforators.


Eligibility criteria: Inclusion Criteria:

* soft tissue defect
* no previous operations in the thigh region

Exclusion Criteria:

* obese patients

Primary outcomes:
measure: Confirmation of the anatomical data in the clinical trial
timeFrame: January 2008 till may 2010
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Department of Surgery, Division of Plastic Surgery
Study officials:
affiliation: Medical University of Graz
name: Martin Hubmer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hubmer MG, Schwaiger N, Windisch G, Feigl G, Koch H, Haas FM, Justich I, Scharnagl E. The vascular anatomy of the tensor fasciae latae perforator flap. Plast Reconstr Surg. 2009 Jul;124(1):181-189. doi: 10.1097/PRS.0b013e3181ab114c.
Clinical trial NCT04371744: QT-Logs : Artificial Intelligence for QT Interval Analysis of ECG From Smartwatches in Patient Receiving Treatment for Covid-19
Official title: QT-Logs : a Clinical Study to Monitor Cardiac Safety, With Artificial Intelligence for QT Interval Analysis of ECG Data From Smartwatches, in Patients Receiving Hydroxychloroquine Treatment for COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2020-05-01
Enrollment: 100
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: 100 consecutives patients ambulatory treated with the Hydroxychloroquine and Azythromycine combination, at the early stage of COVID-19 infection for 10 days, at the university hospital of La Timone, in Marseille

Brief summary: This observational pilot prospective study will evaluate a new method for remote monitoring of corrected QT measurement using an artificial intelligence (AI)-based solution and ECG data collected via smartwatches (AI-QTc), in patients ambulatory treated with the HC-AZ combination, at the early stage of COVID-19 infection, at a tertiary hospital center. Daily ECGs will be performed via the smartwatches. AI-QTc will be compared to standard manual QTc reviewed by cardiologist. Correlation and agreement between measures will be assessed.


Eligibility criteria: Inclusion Criteria:

* Patient over 18 years old
* SARS-COV-2 confirmed infection by positive nasopharyngual PCR
* Prescription of association hydroxychloroquine and azythromycine for COVI-19 therapy
* Patient's smartphone able to download the smartwatches application

Exclusion Criteria:

* Presence of a pacemaker
* Pregnant or breastfeeding females
* Refusal to participate
* Incapacity
* Adult under legal protection (trusteeship, guardianship)

Primary outcomes:
measure: Corrected QT (QTc) interval measurement
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille
Study officials:
References:
citation: Maille B, Wilkin M, Million M, Resseguier N, Franceschi F, Koutbi-Franceschi L, Hourdain J, Martinez E, Zabern M, Gardella C, Tissot-Dupont H, Singh JP, Deharo JC, Fiorina L. Smartwatch Electrocardiogram and Artificial Intelligence for Assessing Cardiac-Rhythm Safety of Drug Therapy in the COVID-19 Pandemic. The QT-logs study. Int J Cardiol. 2021 May 15;331:333-339. doi: 10.1016/j.ijcard.2021.01.002. Epub 2021 Jan 29.
Clinical trial NCT04198844: The Effectiveness and Safety of Apixaban in NVAF Patients With History of Osteoporosis and/or Fracture: A Nation-wide Population Based Study
Official title: The Effectiveness and Safety of Apixaban Versus Warfarin in Non-valvular Atrial Fibrillation (NVAF) Patients With the History of Osteoporosis and/or Fracture: A Nation-wide Population Based Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Atrial Fibrillation
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2019-12-13
Enrollment: 0
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: Non-valvular atrial fibrillation patients with warfarin or apixaban user

Brief summary: Old age, less body weight and deteriorated renal function are significant clinical factors for the outcomes of atrial fibrillation- so called 'fragile'- and these are common risk factors in osteoporosis and fracture. Therefore, in real world, these risk factors and co-morbidities are commonly considered when it comes to prescribe anticoagulant in atrial fibrillation patients. Recent study even reported that comorbid atrial fibrillation in patients with osteoporosis might be associated with an increased risk of bone fracture and death after fracture. Because there have been very few data about the effectiveness/safety of anticoagulant among non-valvular atrial fibrillation with prior osteoporosis/fracture, this study is planned to provide real-world evidences for this specific type of non-valvular atrial fibrillation patients.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years or older on the index date
* Patients had ≥1 medical claim for atrial fibrillation with at least one hospitalization or at least two outpatient visits during the reference period

Exclusion Criteria:

* Patients with valvular atrial fibrillation or transient atrial fibrillation
* Having ≥ 2 types of oral anticoagulant on the index date
* who have contraindications to oral anticoagulant
* confounder factors related to the outcome (osteoporotic fractures)

Primary outcomes:
measure: Composite of ischemic stroke, hemorrhagic stroke and and systemic embolism
timeFrame: from index date (1st prescription date for oral anticoagulants during the intake period) to follow up period(the index date- Nov 30, 2016 or outcomes whichever comes first)
Secondary outcomes:
measure: Major bleeding including gastrointestinal bleeding, intracranial bleeding, and other bleeding
timeFrame: from index date (1st prescription date for oral anticoagulants during the intake period) to follow up period (the index date- Nov 30, 2016 or outcomes whichever comes first)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00534144: Comparison Between Effects of Two Iron Preparations on Protein in the Urine
Official title: A Randomized Controlled Trial of the Effect of IV Iron on Proteinuria in Non-Dialysis Chronic Kidney Disease Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Kidney Failure, Chronic
Anemia, Iron-Deficiency
Lead sponsor: Watson Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-09-24
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study will compare the effects of sodium ferric gluconate complex and iron sucrose on urine concentrations of various chemicals including protein


Eligibility criteria: Inclusion Criteria:

* Moderate to severe anemia
* Iron deficiency
* Moderate to severe chronic kidney disease, not receiving dialysis
* Age ≥ 18 or greater and able to give informed consent

Exclusion Criteria:

* Known sensitivity to Sodium Ferric Gluconate Complex in Sucrose Injection, Iron sucrose USP, or any of their components
* Clinically unstable
* Indication of iron sufficiency
* Bladder obstruction conditions that would not allow for good urine output

Primary outcomes:
measure: Change in urine protein
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Alhambra
country: United States
state: California
city: Bell Gardens
country: United States
state: California
city: Exeter
country: United States
state: California
city: Glendale
country: United States
state: California
city: Visalia
country: United States
state: California
city: Ft Lauderdale
country: United States
state: Florida
city: Hines
country: United States
state: Illinois
city: Shreveport
country: United States
state: Louisiana
city: Boston
country: United States
state: Massachusetts
city: Houston
country: United States
state: Texas
city: Fairfax
country: United States
state: Virginia
city: San Juan
country: Puerto Rico
Study officials:
affiliation: Watson Laboratories, Inc.
name: Naomi V. Dahl, Pharm.D.
role: STUDY_DIRECTOR
References:
citation: Agarwal R, Leehey DJ, Olsen SM, Dahl NV. Proteinuria induced by parenteral iron in chronic kidney disease--a comparative randomized controlled trial. Clin J Am Soc Nephrol. 2011 Jan;6(1):114-21. doi: 10.2215/CJN.06020710. Epub 2010 Sep 28.
Clinical trial NCT03102944: Determining Normal Values of BNP Levels for the Minicare BNP IVD Assay.
Official title: Minicare BNP Normal Value Study - MI-BNP-CE02-NV2016
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: Philips Handheld Diagnostics
Sponsor class: INDUSTRY
First posted: 2017-04-06
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy volunteers

Brief summary: Main objective is to determine normal values for Brain Natriuretic Peptide (BNP) levels for the Minicare BNP using K2-EDTA (ethylenediaminetetraacetic acid ) venous whole blood and K2-EDTA plasma samples from healthy subjects.

K2-EDTA whole blood and K2-EDTA plasma samples from approximately 150 normal healthy volunteer, preferably 50% men and 50% women, will be analysed using the Minicare BNP system. This will be a single-center study. The study will consist of a 1-day visit for each study subject on which screening based on a questionnaire, blood draw and discharge will occur. For each eligible subject, K2-EDTA whole blood will be collected and both K2-EDTA whole blood and K2-EDTA plasma will be analyzed using the Minicare BNP. Blood donors, presenting voluntarily at one of the Sanquin posts in, the Netherlands (e.g Eindhoven) will be checked on health status and selected based on 2 questionnaires. The collected K2-EDTA whole blood tubes from eligible subjects will be transferred from the Sanquin posts to Philips Eindhoven for Minicare BNP testing. From one subject, both K2-EDTA whole blood and K2-EDTA plasma will be measured in singleton. K2-EDTA whole blood and plasma will be measured within 6 hours after blood collection. The data obtained will be used for determination of normal values of BNP in a healthy population. Leftover plasma samples (without cells/ RNA/DNA) will be aliquoted and stored at Philips for potential future analysis/ projects). Testing will be done according to a DRAFT Instructions for use (IFU) of the Minicare BNP.


Eligibility criteria: Inclusion Criteria:

* ≥18 years old
* Willing and able to sign the informed consent form (ICF)

Exclusion Criteria:

* Subjects suffering from cardiac and/or vascular disease, renal dysfunction, hypertension, cancer, Chronic Obstructive Pulmonary Disease (COPD), instable diabetes, pregnancy and extreme overweight are not allowed to donate blood.
* Subjects with a history of cardiac and/or vascular disease, renal dysfunction, cancer, COPD or instable diabetes are not allowed to donate blood.

Primary outcomes:
measure: Normal values for BNP for the Minicare BNP
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Eindhoven
country: Netherlands
facility: Philips EB Handheld Diagnostics
Study officials:
affiliation: Clinical Affairs Manager
name: Diederick Keizer
role: STUDY_CHAIR
References:
Clinical trial NCT02789644: Clinical Trial to Investigate Pharmacokinetics, Metabolomics and Biomarker in Elderly After UDCA Administration
Official title: A Randomized, Open-label Clinical Trial to Investigate Pharmacokinetics, Metabolomics and Biomarker in Healthy Elderly Subjects After Ursodeoxycholic Acid Administration
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Aged
Keywords: Ursodeoxycholic acid
Metabolomics/biomarker
Pharmacokinetics
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-06-03
Enrollment: 16
Sex: ALL
Minimum age (years): 70
Maximum age (years): 84
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A clinical study to investigate pharmacokinetics, metabolomics and biomarker in healthy elderly subject after ursodeoxycholic acid administration

Detailed description: This study has a randomized, open-label, two-treatment, one-sequence, multiple drug administration design. The purpose of this study is as follows; To investigate pharmacokinetics, metabolomics and biomarker in healthy elderly subject after ursodeoxycholic acid administration

Eligibility criteria: Inclusion Criteria:

* Healthy Subjects aged 70 - 84 years
* A body mass index (BMI) in the range of 18.5 kg/m2 - 29.9 kg/m2.
* Good health based on complete medical history, physical examinations, vital signs, electrocardiography (ECG), and clinical laboratory evaluations.

Exclusion Criteria:

* Subjects who have clinically significant disease of cardiovascular, respiratory, renal, endocrinological, hematological, gastrointestinal, neurological(central nervous system), psychiatric disorders or malignant tumor
* Subject judged not eligible for study participation by investigator

Primary outcomes:
measure: Area under the plasma concentration-time curve (AUC) of ursodeoxycholic acid
timeFrame: predose and 2, 4, 5, 7, 9, 10, 12, 24h postdose
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
affiliation: Department of Clinical Pharmacology and Therapeutics, Seoul National University Bundang hospital
name: Jae-Yong Chung, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03047044: The Comparison of Postoperative Pain After Lumbar Fusion Surgery in Intravenous Patient-controlled Analgesia Between Conventional Mode and Optimizing B.I Mode With 'PAINSTOP' Equipment
Official title: The Comparison of Postoperative Pain After Lumbar Fusion Surgery in Intravenous Patient-controlled Analgesia Between Conventional Mode and Optimizing B.I Mode With 'PAINSTOP' Equipment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Back Pain
Fusion of Spine, Lumbar Region
Spinal Stenosis
Keywords: lumbar fusion surgery
Patient Controlled Analgesia
Optimizing Basal Infusion Mode
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2017-02-08
Enrollment: 58
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The postoperative pain of lumbar fusion surgery is very severe that it is necessary to use additional analgesics as well as a patient controlled analgesia (PCA). The most common pain control method of this surgery is the intravenous (IV) PCA. but, if it is relatively insufficient amount of narcotic analgesics ,in the case of IV PCA, may be failed to reduce the pain intensity effectively. Consequently, it may result in the a lot of rescue analgesics requirement, which leads to the adverse effects in patients who are very sensitive to narcotic analgesics. In addition, the patient's satisfaction to the PCA may be low compared with that of expected. For the recently released PCA instrument 'PAINSTOP', the investigators can specify the mode setting including total volume, flow rate (basal rate) per hour, bolus dose, and lock out time (LOT). Furthermore, this device can be set to optimize basal infusion (B.I), which is a new mode, so that the administered rate and amount of drug can be increased or decreased according to the patient's use of bolus button. Therefore, this PCA device can be implemented to the conventional mode, and added the function of automatically controlling the basal rate and administered amount of drug according to the use demand of the patient. However, since there are few studies related to this new mode of PCA, more research is needed in patients with postoperative pain.


Eligibility criteria: Inclusion Criteria:

1. The subjects who undergoing lumbar fusion surgery
2. ASA class Ⅰ-Ⅲ
3. Written consents obtained to participate voluntarily in this clinical trial

Exclusion Criteria:

1. Sudden change of surgical plan
2. Patients who have the hypersensitivity to the pain killers including narcotics
3. Patients who are unable to express the degree of pain

Primary outcomes:
measure: the pain numeric rating scale
timeFrame: At postoperative 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT04362644: Molecular Imaging Probes to Inform Heterogeneity in Idiopathic Pulmonary Fibrosis
Official title: Molecular Imaging Probes to Inform Heterogeneity in Idiopathic Pulmonary Fibrosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Idiopathic Pulmonary Fibrosis
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2020-04-27
Enrollment: 10
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the study is to see if imaging with fluorine-18 Fluorodeoxyglucose (\[18F\] FDG) and fluorine-18 Displacement Per Atom (\[18F\]DPA-714) using positron emission tomography and computed tomography (PET/CT) will show lung inflammation and fibrosis in patients diagnosed with idiopathic pulmonary fibrosis (IPF). This study may help physicians and researchers better understand how best to treat patients with IPF in the future.


Eligibility criteria: Inclusion Criteria:

1. Age between 40-85 years old.
2. A diagnosis of IPF that fulfills American Thoracic Society (ATS) / European Respiratory Society (ERS) 2018 consensus criteria within 5 years.
3. Ability and willingness to give informed consent and adhere to study requirements.
4. Ratio of forced expiratory volume in 1 second to forced vital capacity (FEV1/FVC) \>0.70.
5. High or mixed affinity binder for TSPO ligands based on genotyping for single-nucleotide polymorphism (SNP)rs6971.

Exclusion Criteria:

1. Acute exacerbation of IPF within \<30 days
2. Diagnosis of Diabetes Mellitus (Type 1 or Type 2).
3. Diagnoses of current infection by clinical or microbial assessments.
4. Treatment for \>14 days within the preceding month with \>20 mg. prednisone (or equivalent) or any treatment during the last month with a cellular immunosuppressant.
5. Subjects with prior radiation therapy to the thorax.
6. Women who are pregnant, or who are breastfeeding. IPF is a disease of older adults, and male predominant, so this will not be a frequent consideration.
7. Severe cardiovascular disease, defined as any of the following within the preceding 12 weeks: acute myocardial infarction or unstable angina, a coronary revascularization procedure, or stroke.
8. Subjects with known liver disease.
9. Diagnosis of any active cancer with the exception of basal cell carcinoma of skin.
10. Low affinity binder for TSPO ligands based on genotyping for SNP rs6971.
11. Active cigarette smoking or vaping

Primary outcomes:
measure: Correlate quantitative PET measures of lung inflammation with [F-18]FDG and [F-18]DPA-714 to pulmonary function tests.
timeFrame: screening to 48 hours post 2nd imaging visit.
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The University of Alabama at Birmingham
state: Alabama
Study officials:
References: