louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03252834: Genetic Variants and Chemotherapy-induced Abnormal Thermal Sensation
Official title: To Study the Individual Variants of Chemotherapy-induced Abnormal Thermal Sensation in Cancer Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Chemotherapy-induced Abnormal Thermal Sensation
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2017-08-17
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Colorectal, endometrial, or ovarian cancer patients who are scheduled to receive post-operative adjuvant chemotherapy

Brief summary: This is a prospective, single arm, single center study evaluating the use of a 4-gene panel to predict the occurrence of chemotherapy-induced abnormal thermal threshold in endometrial and ovarian cancer patients receiving post-operative chemotherapy with Carboplatin/Paclitaxel, and stage III colorectal cancer patients receiving adjuvant chemotherapy with mFOLFOX6. A total of 100 patients will be enrolled during 2017 July\~ 2019 June. Blood sample will be collected before chemotherapy to analyze the genetic variants of TRPV1, TRPM2, TRPA1 and ORAI1. All patients will receive neurologic examination (Quantitative Sensory Test, QST) and complete the questionnaires for quality of life (EQ5D \& CIPN20). The primary endpoint of this study is to test if the genetic variant of TRPV1, TRPM2, TRPA1, and ORAI1 is a predictive biomarker for the chemotherapy-induced abnormal thermal sensation in cancer patients.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 20 years old
* Pathological stage I\~IV for ovarian cancer, stage II\~IV for endometrial cancer, or stage III for colorectal cancer.
* Scheduled to receive adjuvant Paclitaxel/Carboplatin for ovarian or endometrial cancer, or mFOLFOX6 for colorectal cancer.
* Patient willing to provide blood sample for research purposes.
* Ability of the patient to provide informed consent.

Exclusion Criteria:

* Prior treatment with neurotoxic chemotherapy, such as oxaliplatin, cisplatin, carboplatin, taxanes or vinca alkaloids.
* Receiving chemotherapy within 6 months.
* A family history of a genetic or familial neuropathy
* Poor compliance

Primary outcomes:
measure: The change of thermal pain threshold
timeFrame: before chemotherapy & 3, 6, and 9 months after chemotherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
Study officials:
References:
Clinical trial NCT00797134: Retinal Thickness Analysis Using Optical Coherence Tomography
Official title: Retinal Thickness Analysis Using Optical Coherence Tomography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Retinopathy
Lead sponsor: Association for Innovation and Biomedical Research on Light and Image
Sponsor class: OTHER
First posted: 2008-11-25
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects followed regularly by their ophthalmologist performing, as part of their follow-up, optical coherence tomography with OCT, and fulfilling the inclusion/exclusion criteria will be included.

Brief summary: The main objective of this study is to characterize and correlate diabetic macular edema (DME), i.e. increased retinal thickness, measured by Optical Coherence Tomograph (OCT), and retinal visual function.

The secondary objectives of this study are the analysis and characterization of DME progression over time (between two visits), and the comparison of OCT data obtained with different devices.

The results of this study will be used exclusively for scientific purposes.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of DR
* Females or Males
* Age over 18 years
* Signed Informed Consent Form

Exclusion Criteria:

* Cataract or other eye disease that may interfere with fundus examinations
* Vitreous syneresis or posterior vitreous detachment
* Dilatation of the pupil \< 5 mm

Primary outcomes:
measure: Retinal thickness.
timeFrame: After visit(s)
Secondary outcomes:
measure: Choroidal Thickness
timeFrame: After visit(s)
Other outcomes:
Locations:
city: Coimbra
country: Portugal
facility: AIBILI
Study officials:
affiliation: Association for Innovation and Biomedical Research on Light and Image
name: José Cunha-Vaz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01388634: Prolonged Hospital Stay and Readmission After Elective Ventral Hernia Repair
Official title: Nationwide Analysis of Prolonged Hospital Stay and Readmission After Elective Ventral Hernia Repair
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventral Hernia
Keywords: Length of hospital stay
readmission
ventral hernia
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2011-07-06
Enrollment: 2258
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients registered in The Danish Ventral Hernia Database in 2008

Brief summary: The aim of the present study was to analyse factors associated with prolonged length of hospital stay, readmission and death in a nationwide group of patients undergoing elective ventral hernia repair in search for areas of interest to improve outcome after ventral hernia surgery

Detailed description: Detailed analysis of reasons for prolonged hospital stay and readmission in patients undergoing a ventral hernia repair

Eligibility criteria: Inclusion Criteria:

* patients with elective ventral hernia repair in Denmark 2008

Exclusion Criteria:

* emergency repairs

Primary outcomes:
measure: Length of hospital stay
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 1 week
Secondary outcomes:
measure: Readmission
timeFrame: 30 days
Other outcomes:
Locations:
city: Køge
country: Denmark
facility: Dept. of surgery, Køge Hospital
Study officials:
affiliation: Dept. surgery Køge hospital
name: Frederik Helgstrand, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Helgstrand F, Rosenberg J, Kehlet H, Bisgaard T. Nationwide analysis of prolonged hospital stay and readmission after elective ventral hernia repair. Dan Med Bull. 2011 Oct;58(10):A4322.
Clinical trial NCT00205634: Macrolide Antibiotic Therapy for Patients With Cystic Fibrosis
Official title: Macrolide Antibiotic Therapy for Patients With Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cystic Fibrosis
Keywords: Cystic Fibrosis (CF)
Macrolide antiobiotics
airway inflammation
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2005-09-20
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate whether Biaxin (clarithromycin) improves sputum abnormalities, lung function, and overall feeling of well-being in people with cystic fibrosis (CF). Biaxin is an antibiotic commonly used for the treatment of respiratory infections in people who do not have CF, and is sometimes used in CF patients as well. Studies done in a disease called diffuse panbronchiolitis (which is similar to CF) and some preliminary studies that have been done in CF patients suggest that Biaxin might have a beneficial effect on CF sputum in ways unrelated to its antibiotic activity.


Eligibility criteria: Inclusion Criteria:

* diagnosis of CF
* ability to reliably perform spirometry
* FEV1 of 30% predicted at the time of screening

Exclusion Criteria:

* Mycobacterium in a sputum culture ever recorded
* a respiratory exacerbation requiring IV antibiotics in the 60 days prior
* used a investigational drug or device in the 60 days prior
* significant (\>30ml) of hemoptysis in the past year
* require oxygen or have significant liver or renal disease

Primary outcomes:
measure: Pulmonary Function Testing - FEV1
measure: Quality of Life
Secondary outcomes:
measure: decrease in neutrophil-dominated airway inflammation
measure: decrease in Pseudomonas alginate production in vitro and in the airway
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Bruce K Rubin, MEngr,MD,MBA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02921334: Early Tracheotomy for Switching Between Invasive and Noninvasive Ventilation to Facilitate Weaning
Official title: Efficacy and Safety of Early Tracheotomy for Switching Between Invasive and Noninvasive Ventilation to Facilitate Weaning: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ventilator Weaning
Lead sponsor: Chongqing Medical University
Sponsor class: OTHER
First posted: 2016-10-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is early tracheotomy to facilitate weaning by switching between invasive and noninvasive ventilation.

Detailed description: When a patient is eligible to this study, he or she is randomly assigned to intervention or control group.In intervention group,tracheotomy is performed. And then, patient is switched to noninvasive ventilation by masking the tracheotomy tube. If the patient presents distress in noninvasive ventilation, he or she is switched to invasive ventilation. If the distress relieves, patient is switched to noninvasive ventilation again until the patient successfully weans from ventilator. In control group, the patient is weaned as the conventional methods.

Eligibility criteria: Inclusion Criteria:

* duration of invasive ventilation 5 to 7 days
* anticipation of difficult weaning
* Glasgow Coma Scale ≥13
* no upper airway obstruction
* presence of spontaneous breath

Exclusion Criteria:

* age less than 18 or more than 85 years;
* contraindications for noninvasive ventilation;
* anticipation of survival less than 6 months;
* refusal of tracheotomy

Primary outcomes:
measure: ventilator weaning days
timeFrame: from enrollment to 90 days
Secondary outcomes:
measure: successful weaning rate
timeFrame: from enrollment to 90 days
measure: ICU stay days
timeFrame: from admission to 90 days
measure: hospital stay days
timeFrame: from admission to 90 days
measure: ICU mortality
timeFrame: from admission to 90 days
measure: hospital mortality
timeFrame: from admission to 90 days
Other outcomes:
Locations:
city: ChongQing
country: China
facility: The first affiated hospital, chongqing medical university
state: Chongqing
Study officials:
affiliation: First Affiliated Hospital of Chongqing Medical University
name: Shuliang Guo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02940834: Sodium Imbalance in Traumatic Brain Injury Patients: Prevalence, Predictors and Prognostic Significance in a Tertiary Care Centre
Official title: Sodium Imbalance in Traumatic Brain Injury Patients: Prevalence,Predictors and Prognostic Significance in a Tertiary Care Centre
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sodium Imbalance in Traumatic Brain Injury
Lead sponsor: PGIMER
Sponsor class: UNKNOWN
First posted: 2016-10-21
Enrollment: 55
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult and paediatric patients with isolated traumatic brain injury admitted in ICU in PGIMER

Brief summary: Observational study about prevalence, predictors of sodium imbalance and prognostic significance.


Eligibility criteria: Inclusion Criteria:

* adult and paediatric patients with isolated head injury

Exclusion Criteria:

* age more than 80 years, patient admitted after 24 hours of trauma, chronic kidney disease, chronic liver disease, associated chest trauma, abdominal trauma

Primary outcomes:
measure: correlate prevalence of sodium imbalance with severity of traumatic brain injury by biochemistry lab reports
timeFrame: first 10 days after admission in icu or discharge whichever is earlier
Secondary outcomes:
measure: predisposing factors for development of sodium imbalance in traumatic brain injury patients by logistic regression analysis of data
timeFrame: first 10 days after admission in icu or discharge whichever is earlier
measure: relationship between sodium imbalance and outcome in traumatic brain injury patients by assessing Glasgow outcome score telephonically
timeFrame: 1st and 3rd month after discharge
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: Post Graduate Institute of Medical Education and Research
Study officials:
References:
Clinical trial NCT02420834: Dry Eye Treatment With Artificial Tears
Official title: Dry Eye Treatment With Artificial Tears
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Lead sponsor: Aston University
Sponsor class: OTHER
First posted: 2015-04-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Dry eye is a chronic irritating eye condition that affects many people, caused by poor tear quality and insufficient quantity. Treatments are traditionally in the form of artificial tears applied to the ocular surface. However, there is little evidence in the scientific literature that demonstrates their efficacy relative compared to each other, nor how to decide which one might be most effective for an individual patient. Therefore the investigators aim to examine the efficacy of different classes of artificial tears (those designed to increase viscosity, reduce evaporation or to mimic the component balance of the natural tears). In addition, the investigators also aim to determine how the treatment preferred by an individual could potentially have been predicted from their baseline condition.

Detailed description: The efficacy of different classes of artificial tears (non-pharmaceutical) will be examined in patients that report dry eyes by prescribing each category of treatment \[0.40% Sodium Hyaluronate (Clinitas Soothe), 0.15% Sodium Hyaluronate (Hyabak), 0.25% Carboxymethylcellulose, electrolyte balanced (Theratears), and Phospholipid liposomal spray (Tears Again)\] for a month in turn following a short wash-out period and to examine their tear film and ocular surface after each one.

Eligibility criteria: Inclusion Criteria:

* subjective symptoms indicative of dry eye

Exclusion Criteria:

* Diabetes
* Sjögren's Syndrome
* recent ocular infection
* hay fever
* used any eye drops or ocular medications,
* were currently on medications known to affect the eyes
* wore contact lenses
* were pregnant.

Primary outcomes:
measure: Symptoms
timeFrame: 4 months
Secondary outcomes:
measure: Non-invasive break-up time
timeFrame: 4 months
measure: Tear meniscus height
timeFrame: 4 months
measure: lid parallel conjunctival folds
timeFrame: 4 months
measure: Ocular Surface Staining
timeFrame: 4 months
measure: Phenol Red Test
timeFrame: 4 months
Other outcomes:
Locations:
city: Thornton
country: United Kingdom
facility: Specsavers
state: Cleveleys
Study officials:
affiliation: Aston University
name: James S Wolffsohn, BSc PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06099717: Clinical Performance of Dual-cantilevered Single-implant Bridge
Official title: Clinical Performance of a Novel Implant-supported Fixed Dental Prostheses (iFDP): the Dual-cantilevered Single-implant Bridge (T-bridge)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dental Implant Failed
Keywords: Dental implant
Lead sponsor: University of Bern
Sponsor class: OTHER
Collaborators: name: ITI International Team for Implantology, Switzerland
First posted: 2023-10-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial
Primary purpose: TREATMENT

Brief summary: The study aims to evaluate the clinical performance (implant and prosthetic survival/ success rates) of a novel implant-supported fixed dental prosthesis design: the dual-cantilevered single implant bridge (T-Bridge) made out of monolithic zirconia bonded to a titanium base abutment (Variobase abutments)


Eligibility criteria: Inclusion Criteria:

* Age ≥ 20 years
* Willingness to sign an informed consent and participate in the study
* Three missing adjacent teeth in the posterior site.
* Tooth gap of 21-24 mm.
* Presence of natural or artificial opposing dentition
* Sufficient vertical interocclusal space of an implant restoration (7mm)
* Sufficient ridge height to place an implant of 10mm in length
* Sufficient ridge width for the placement of a 4.1mm diameter implant. Simultaneous GBR to achieve a width of 6.5mm will be included.

Exclusion Criteria:

* Any physical or mental disorder that would interfere with the ability to perform adequate oral hygiene or the capability of providing written informed consent and compliance with the protocol
* Any disorder that would interfere with wound healing or represent a contraindication for implant surgery, such as but not limited to uncontrolled diabetes or conditions resulting in or requiring immunosuppression, radiation, chemotherapy, frequent use of antibiotics or antiresorptive medication such as bisphosphonates.
* Pregnancy or lactation
* Heavy smoking habit with ≥ 10 cig/d
* Severe bruxism or clenching habits, presence of oro-facial pain
* Insufficient ridge width/height for the study implant

Primary outcomes:
measure: Implant and prosthetic success
timeFrame: 10 years
measure: Implant and prosthetic survival
timeFrame: 10 years
Secondary outcomes:
measure: Implant and prosthetic complications
timeFrame: 10 years
Other outcomes:
Locations:
city: Goiania
country: Brazil
facility: Universidade Federal de Goias
state: Goias
Study officials:
affiliation: University of Bern
name: Martin Schimmel, Prof
role: STUDY_CHAIR
References:
Clinical trial NCT05642117: Pediatric Telephone Center Board 15
Official title: Pediatric Telephone Center Board 15 and Adhesion Factors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Emergencies
Pediatric ALL
Response, Acute Phase
Keywords: Urgent Medical Aid Service (SAMU)
Pediatric
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2022-12-08
Enrollment: 785
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all pediatric's emergency call for a child Under 15yo with a medical advice given by the physician.

Brief summary: This study evaluates the follow-up of advices given in a Urgent Medical Aid Service (SAMU 29) for every pediatric's emergency call under 15yo and try to evaluate the adhesion's factors.

Detailed description: Many of pediatric's medical emergency are followed by a medical advice in a Urgent Medical aid Service (SAMU).

This advices could be medications advices, to see a general praticionner the same day or later, or to consult in an emergency department.

But the rate of advices really followed by callers is unknown. This study evaluate by who, when and why this advices are followed or not.

Eligibility criteria: Inclusion Criteria:

* all emergency calls at SAMU 29 for under 15yo childs
* medical advices were given by the physician (medication at home OR consult in an emergency department OR consult the general praticionner the same day or later.

Exclusion Criteria:

* all emergency calls at SAMU 29 for upper 15yo childs
* participation opposition.
* need for an ambulance or an emergency medical team at home

Primary outcomes:
measure: rate of medical advices with follow-up completed in epidemic condition
timeFrame: 10 days
measure: rate of medical advices with follow-up completed in summer
timeFrame: 10 days
Secondary outcomes:
measure: epidemiology of pediatric's emergency calls in Urgent Medical Aid Service (SAMU 29)
timeFrame: 10 days in epidemic condition
measure: epidemiology of pediatric's emergency calls in Urgent Medical Aid Service (SAMU 29)
timeFrame: 10 days in summer
measure: adhesion factors to follow medical advice
timeFrame: 10 days in epidemic condition
measure: adhesion factors to follow medical advice
timeFrame: 10 days in summer
Other outcomes:
Locations:
city: Brest
country: France
facility: CHU de Brest
Study officials:
References: