louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00887523: Trial Comparing Prone and Supine Intensity-modulated Radiotherapy (IMRT) After Breast-conserving Surgery in Patients With Large Breast Volume at High Risk for Skin Toxicity and Fibrosis
Official title: Randomized Controlled Trial Comparing Prone and Supine Intensity-modulated Radiotherapy (IMRT) After Breast-conserving Surgery in Patients With Large Breast Volume at High Risk for Skin Toxicity and Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Carcinoma
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: National Cancer Plan, France
First posted: 2009-04-24
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 84 patients with a cup size C or more will be randomized to receive intensity-modulated radiotherapy in supine or prone position.


Eligibility criteria: Inclusion Criteria:

* female patients
* multidisciplinary decision of adjuvant whole-breast irradiation (WBI) after lumpectomy for breast cancer
* minimum 18 years
* informed consent obtained, signed and dated before specific protocol procedures

Exclusion Criteria:

* mastectomy
* need for axillary irradiation
* bilateral breast irradiation
* previous irradiation at the same time
* mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study
* patient unlikely to comply with the protocol; i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study.

Primary outcomes:
measure: acute moist desquamation
timeFrame: weekly during radiotherapy and 1 month after radiotherapy
Secondary outcomes:
measure: Acute skin toxicity other than moist desquamation
timeFrame: weekly during radiotherapy and 1 month after radiotherapy
measure: Late skin toxicity
timeFrame: at 6, 12, 18 and 24 months after radiotherapy
measure: skin and lung fibrosis assessed with computed tomography
timeFrame: before radiotherapy and 1 month and 1 year after radiotherapy
measure: Quality of life
timeFrame: at 1 year and 2 years after radiotherpay
measure: dose-volume parameters
timeFrame: of planning
measure: time of treatment delivery
timeFrame: daily during radiotherapy
measure: single nucleotide polymorphisms associated with skin toxicity and breast fibrosis
timeFrame: 1 blood sample before radiotherapy
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Wilfried De Neve, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vakaet V, Van Hulle H, Vergotte M, Schoepen M, Deseyne P, Van Greveling A, Post G, Speleers B, Paelinck L, Monten C, De Neve W, Veldeman L. 5-Year Outcomes of a Randomized Trial Comparing Prone and Supine Whole Breast Irradiation in Large-Breasted Women. Int J Radiat Oncol Biol Phys. 2021 Jul 1;110(3):766-771. doi: 10.1016/j.ijrobp.2021.01.026. Epub 2021 Jan 27.
Clinical trial NCT01034423: Omega-3 Fatty Acids and Health Effects
Official title: Omega-3 Fatty Acids and Health Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Focus: health effects from omega-3 fatty acids, from fish oil with different quality
Lead sponsor: Oslo Metropolitan University
Sponsor class: OTHER
First posted: 2009-12-17
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators want to study health effects from omega-3 fatty acids, from fishoil with different quality.


Eligibility criteria: Inclusion Criteria:

* Healthy individuals.

Exclusion Criteria:

* Pregnant women, lactating women, chronic diseases and smoking.

Primary outcomes:
measure: Primary and secondary oxidation products
timeFrame: baseline (0 weeks), 3 weeks and 7 weeks
Secondary outcomes:
measure: inflammatory markers
timeFrame: after 0,3 and 7 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Oslo Metropolitan University
name: Stine M Ulven, PhD
role: STUDY_CHAIR
References:
citation: Myhrstad MC, Ottestad I, Gunther CC, Ryeng E, Holden M, Nilsson A, Bronner KW, Kohler A, Borge GI, Holven KB, Ulven SM. The PBMC transcriptome profile after intake of oxidized versus high-quality fish oil: an explorative study in healthy subjects. Genes Nutr. 2016 May 31;11:16. doi: 10.1186/s12263-016-0530-6. eCollection 2016.
citation: Myhrstad MC, Ulven SM, Gunther CC, Ottestad I, Holden M, Ryeng E, Borge GI, Kohler A, Bronner KW, Thoresen M, Holven KB. Fish oil supplementation induces expression of genes related to cell cycle, endoplasmic reticulum stress and apoptosis in peripheral blood mononuclear cells: a transcriptomic approach. J Intern Med. 2014 Nov;276(5):498-511. doi: 10.1111/joim.12217. Epub 2014 Mar 20.
citation: Ottestad I, Hassani S, Borge GI, Kohler A, Vogt G, Hyotylainen T, Oresic M, Bronner KW, Holven KB, Ulven SM, Myhrstad MC. Fish oil supplementation alters the plasma lipidomic profile and increases long-chain PUFAs of phospholipids and triglycerides in healthy subjects. PLoS One. 2012;7(8):e42550. doi: 10.1371/journal.pone.0042550. Epub 2012 Aug 28.
citation: Ottestad I, Vogt G, Retterstol K, Myhrstad MC, Haugen JE, Nilsson A, Ravn-Haren G, Nordvi B, Bronner KW, Andersen LF, Holven KB, Ulven SM. Oxidised fish oil does not influence established markers of oxidative stress in healthy human subjects: a randomised controlled trial. Br J Nutr. 2012 Jul;108(2):315-26. doi: 10.1017/S0007114511005484. Epub 2011 Dec 5.
Clinical trial NCT02833623: Efficacy of Short-message-based Re-education (SMRE) on Helicobacter Pylori Eradication
Official title: Efficacy of Short-message-based Re-education (SMRE) on Helicobacter Pylori Eradication
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Helicobacter Pylori Eradication Rate
Keywords: Helicobacter Pylori eradication rate
Efficacy of Short-message-based Re-education (SMRE)
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2016-07-14
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Helicobacter pylori (H. pylori) is a pathogen that infects more than 50% of the human population, resulting in high healthcare costs worldwide. However, H. pylori eradication rate is low nowadays and patients's compliance is one of the most important effective factors.


Eligibility criteria: Inclusion Criteria:

* outpatients aged 18-70 years
* confirmed diagnosis of H. pylori infection by at least one of the following methods: 13C-urea breath test, histology, rapid urease test or bacterial culture
* an intention of H. pylori eradication treatment and have written inform consent
* ability to read short messages on the mobile phone

Exclusion Criteria:

* advanced chronic disease that would not allow the patient to complete the treatment or follow-up or attend visits
* allergy to any of the drugs used in this study
* previous Helicobacter Pylori eradication treatment
* pregnancy or breastfeeding (female participants with childbearing potential were required to use medically accepted contraception for the duration of the study)
* taking antibiotics or PPIs or bismuth salts within four weeks
* previous gastrointestinal surgery

Primary outcomes:
measure: The difference of H. pylori eradication rate between two groups
timeFrame: 8 months
Secondary outcomes:
measure: Rate of non-compliance with instructions between 2 groups
timeFrame: 8 months
Other outcomes:
measure: The different rate of adverse events between 2 groups
timeFrame: 8 months
measure: The different rate of symptom remissions after Hp eradication therapy between 2 groups
timeFrame: 8 months
Locations:
city: Jinan
country: China
facility: Department of Gastroenterology, Qilu Hospital, Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Yanqing Li, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04765423: Fluciclovine (Axumin) PET/CT vs. NaF PET/CT in Prostate Cancer Osseous Metastatic Disease
Official title: [F-18] Fluciclovine (Axumin) PET/CT vs. [F-18] NaF PET/CT in the Evaluation of Prostate Cancer Osseous Metastatic Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Malignant Neoplasm of Prostate
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 0
Sex: MALE
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 look at whether F-18 Fluciclovine (i.e. Axumin) is better or as good as F-18 Sodium Fluoride (F-18 NaF) when looking at bone disease from prostate cancer. Axumin is a radioactive agent used on a positron/computed tomography (PET/CT) camera to look for prostate cancer in general.

Detailed description: The study will assess the diagnostic performance of \[F-18\] fluciclovine PET/CT compared to \[F-18\] NaF PET/CT as the reference standard. Each bone lesion identified on \[F-18\] NaF PET/CT will be compared with the level of \[F-18\] fluciclovine uptake

The primary objective is to assess \[F-18\] fluciclovine efficacy in the evaluation of osseous metastatic disease in prostate cancer on a lesion-by-lesion comparison with \[F-18\] NaF as a the reference standard.

Eligibility criteria: Inclusion Criteria:

* Referred for initial staging or restaging of prostate cancers with clinical suspicion of bone metastases.
* Must understand and voluntarily sign an Informed Consent Document

Exclusion Criteria:

-Cannot tolerate imaging up to 60 minutes of total imaging

Primary outcomes:
measure: Number of lesions seen by [F-18] NaF PET/CT which are also seen by [F-18] fluciclovine PET/CT
timeFrame: At time of scan, up to 60 minutes per scan
measure: Sensitivity
timeFrame: At time of scan, up to 60 minutes per scan
measure: Specificity
timeFrame: At time of scan, up to 60 minutes per scan
measure: Positive Predictive Value (PPV)
timeFrame: At time of scan, up to 60 minutes per scan
measure: Negative Predictive Value (NPV)
timeFrame: At time of scan, up to 60 minutes per scan
measure: Area under the curve (AUC)
timeFrame: At time of scan, up to 60 minutes per scan
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
name: Robert Jones, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00773123: Efficacy of Retinal Nerve Fiber Layer (RNFL) / Ganglion Cell Layer Thickness Ratio by RT-View Utilizing Spectral -Domain Technology as a Diagnostic Predictor of Glaucoma.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Primary Open Angle Glaucoma
Keywords: RT-View
Spectral domain OCT
Ganglion cell layer
RNFL
Visual field defect
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2008-10-16
Enrollment: 300
Sex: ALL
Minimum age (years): 10
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: primary open angle glaucoma

Brief summary: RT-View utilizes spectral domain technology to assess both RNFL and ganglion cell layer thickness. This study aims to correlate visual field defects in patients with glaucoma to both RNFL and ganglion cell layer thickness.


Eligibility criteria: Exclusion Criteria:

* Evidence of retinal disease
* Neovascular glaucoma
* Secondary glaucoma due to intraocular inflammation
* Lens induced glaucoma
* Tumor induced glaucoma

Primary outcomes:
measure: Ganglion cell layer thickness
timeFrame: 1 month
Secondary outcomes:
measure: Visual field defect
timeFrame: 1 month
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Institute of Vision Research, Department of Ophthalmology, Severance Hospital, Yonsei University School of Medicine
Study officials:
References:
Clinical trial NCT00375323: Recombinant Factor VIIa (NovoSeven) on Restoring Coagulation Activation
Official title: Effects of Recombinant Factor VIIa (NovoSeven) on Restoring Coagulation Activation in Patients With Hemophilia A and Antibodies to Factor VIII
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hemophilia A
Keywords: factor VIII inhibitor
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2006-09-12
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL

Brief summary: The purpose of the study is to compare the effects of recombinant factor VIIa (NovoSeven) on restoring coagulation activation between patients with hemophilia A and antibodies to factor VIII and normal subjects (controls) by use of an in vivo method.


Eligibility criteria: Inclusion Criteria:

* Adult patients with hemophilia A and current antibodies to factor VIII -

Exclusion Criteria:

* Life-threatening hemorrhage
* Severe liver failure
* Any other severe co-morbidity (including diabetes mellitus, renal failure, cancer, septicemia, disseminated intravascular coagulation, crush injury)
* Exposure to other haemostatic drugs during the previous 7 days
* Hypersensitivity to hamster, mouse or bovine proteins
* Known or suspected allergy to NovoSeven or any of its components

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Sabine Eichinger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01700023: 3-dimensional Sensor Technology to Quantify Leg-edema
Official title: Pilot-study HI-SENS: Innovative Sensor Technology to Quantify Cardiac Control Mechanisms in Heart Failure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ADHF
Keywords: acute heart failure
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
Collaborators: name: AIT Austrian Institute of Technology GmbH
First posted: 2012-10-04
Enrollment: 15
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 hospitalized for decompensated heart failure with leg-edema

Brief summary: The purpose of the study is two-fold:

1. to test 3-dimensional reconstruction of leg-edema in patients hospitalized for acute heart failure with leg-edema.
2. to measure changes in QRS-morphology in a simulation of conventional blood-pressure measurement in patients hospitalized for acute heart failure.

Detailed description: Leg-edema are common in patients with worsening heart failure. Apart from using a measuring tape there is no standardized tool to quantify leg-edema. Consequently, in patents with heart failure early detection of leg-edema is quite difficult.

From earlier pacemaker-studies it has been shown that an increase of afterload changes ECG-signals. Currently it is unknown how simple diagnostic procedures such as measuring blood-pressure affect QRS-morphology in patients with heart failure.

Eligibility criteria: Inclusion Criteria:

* hospitalization for worsening heart failure
* age greater than 18 years
* ability to stand without help from others
* informed consent

Exclusion Criteria:

* leg-edema of non-cardiac origin (venous, lymphatic)
* dialysis shunt

Primary outcomes:
measure: accuracy of 3-dimensional measurements
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University
Study officials:
affiliation: Medical University of Graz
name: Friedrich M Fruhwald, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00780923: Effect of Continuous Positive Airway Pressure Treatment on Inflammation in Patients With Obstructive Sleep Apnea
Official title: A Longitudinal Study of Short-Term Effects of CPAP Treatment on Airway and Systemic Inflammation in Patients With Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Inflammation
Continuous Positive Airway Pressure
Lead sponsor: Kyoto University, Graduate School of Medicine
Sponsor class: OTHER
First posted: 2008-10-28
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effects of CPAP treatment on airway and systemic inflammation in obstructive sleep apnea.

Detailed description: Obstructive sleep apnea (OSA) is characterised by repetitive episodes of upper airway obstruction during sleep. Systemic and airway inflammation has been recently shown to be associated with OSA and is hypothesized to contribute to the clinical manifestation and the complications of OSA patients.

Continuous positive airway pressure (CPAP) is a first-line treatment for OSA and improves diurnal and nocturnal symptoms. However, the effectiveness of CPAP in reversing airway inflammation is less compelling in comparison to systemic inflammation.

This study will assess NO in exhaled breath, inflammatory biomarkers in induced sputum and blood of OSA patients and other clinical measurements before and after 3 months of CPAP treatment.

Eligibility criteria: Inclusion Criteria:

* Subjects on admission for sleep study under the Respiratory Care and Sleep Control Medicine, Kyoto University Hospital.
* Subjects diagnosed with OSA (apnea hypopnea index \>=20/hour) by overnight polysomnography.

Exclusion Criteria:

* Known history of respiratory diseases that will affect airway inflammatory markers like asthma, chronic obstructive pulmonary disease and bronchiectasis.
* Treatments with corticosteroids or other immunosuppressive drugs.

Primary outcomes:
measure: Inflammatory biomarkers in induced sputum and blood. Cell counts in induced sputum.
timeFrame: 3 months
Secondary outcomes:
measure: NO in exhaled breath
timeFrame: 3 months
measure: Airway resistance
timeFrame: 3 months
measure: PSG measurement(AHI,etc.)
timeFrame: 3 months
measure: Quality of Life
timeFrame: 3 months
measure: Psychological status
timeFrame: 3 months
measure: Sleep quality
timeFrame: 3 months
Other outcomes:
Locations:
city: Kyoto
country: Japan
facility: Kyoto University Graduate School of Medicine
Study officials:
affiliation: Kyoto University, Graduate School of Medicine
name: Kazuo Chin, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kyoto University, Graduate School of Medicine
name: Toru Oga, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06231823: Extraction of the Compromised First Permanent Molars
Official title: The Extraction of Compromised First Permanent Molars in a Group of Egyptian Children
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Caries
Caries,Dental
Keywords: first permanent molar
molar incisor hypo mineralization
dental extraction
space closure
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 37
Sex: ALL
Minimum age (years): 8
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Compromised first permanent molars (FPM), whether diagnosed with severe molar incisor hypomineralization (MIH), irreversible pulpities, or necrosis, require frequent re-treatment consequently entering the restorative cycle, which leads to their inevitable extraction and implant placement. Extraction of compromised first permanent molars in 8-10-year-old children allows the mesial migration of the second permanent molars during their eruption, thereby favoring spontaneous space closure as a permanent solution.

Detailed description: Extraction of compromised first permanent molars in children decreases the burden of repeated restorative procedures for theses molars, which will eventually need frequent repair. This will end in their inevitable extraction with its consequences. The extraction of the FPM will be delivered by Nour Wahba, Dina Darwish, and Basma Nagi, lecturers in Pediatric Dentistry and Dental Public Health Department, faculty of Dentistry, Ain Shams University.All patients will be recalled for follow-up yearly for three-years. The first follow-up will be done after 6months to perform the Quality of life questionnaires. The position of the second permanent molar will be checked clinically and radiographically to evaluate the space between second premolar and the second molar.

Eligibility criteria: Inclusion Criteria:

* Healthy patients\&#39; class I according to the American Society of Anesthesiologists (ASA class I)
* Age: 8-10 years
* Angle class I occlusion
* The radiographic presence of the second premolar
* The radiographic stages of development E or F for formation the second permanent molar.
* First permanent molar that is severely affected by MIH, signs of necrosis, signs of irreversible pulpitis or non-restorability.

Exclusion Criteria:

* Refusal of the parents to sign the informed consent.
* Signs of reversible pulpitis of first permanent molar.
* Patients with severe malocclusion.

Primary outcomes:
measure: clinical spontaneous space closure
timeFrame: 3 years
measure: radiographic spontaneous space closure
timeFrame: 3 years
Secondary outcomes:
measure: assessment of the Quality of life
timeFrame: 6 months
measure: Midline shift
timeFrame: 3 years
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
state: El-Willi
Study officials:
affiliation: Ain Shams Univeristy
name: Dina D Abdelmoneim
role: PRINCIPAL_INVESTIGATOR
References: