louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02293642: Bone Pain Score Validation Initiative
Official title: Prospective Epidemiology Study to Validate the BOMET-QoL-10 in Patients With Bone Metastasis in Germany
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone Metastasis
Keywords: primary cancers of the breast
primary cancers of the kidney
primary cancers of the lung
primary cancers of the prostate
Lead sponsor: iOMEDICO AG
Sponsor class: INDUSTRY
First posted: 2014-11-18
Enrollment: 370
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 diagnosed with bone metastases from primary cancers of the breast, kidney, lung or prostate

Brief summary: Translation and validation of the BOMET-QoL-10 questionnaire in Germany and assessment of its validity and responsiveness.

Detailed description: Aim of this study is to translate the questionnaire and to examine the psychometric properties of BOMET-QoL-10 in a German population. Correlations with the EORTC QLQ-C30/BM22 at the time of enrolment and throughout the study aim to verify that the BOMET-QoL-10 is reliable, valid and able to detect stabilization or changes in quality of life.

Eligibility criteria: Inclusion Criteria:

* Male or female adults patients (≥ 18 years)
* Diagnosed cancer of the breast, kidney, lung or prostate
* Bone metastases
* Estimated life expectancy of at least 6 months
* Fluent German speaking, reading and writing
* Informed written consent

Exclusion Criteria:

* Patients without bone metastases
* Participation in another study involving questionnaires
* Patients not able to comply with the assessments specified in the protocol

Primary outcomes:
measure: QoL
timeFrame: 6 months
Secondary outcomes:
measure: Impact of characteristics on questionnaire scores
timeFrame: 6 months
measure: Sensitivity of questionnaire
timeFrame: 6 months
measure: Sequence effects of questionnaires
timeFrame: 6 months
Other outcomes:
Locations:
city: Multiple Locations
country: Germany
facility: Multiple Sites All Over Germany
Study officials:
affiliation: Outpatient Centre for Interdisciplinary Oncology and Haematology, D-Freiburg
name: Norbert Marschner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marschner N, Wilke J, Reschke D, Kaiser F, Schmoor C, Grugel R, Boller E. A brief instrument to measure health-related quality-of-life in patients with bone metastasis: validation of the German version of Bone Metastases Quality-of-Life-10 (BOMET-QoL-10). J Med Econ. 2018 Sep;21(9):920-929. doi: 10.1080/13696998.2018.1484750. Epub 2018 Jun 18.
Clinical trial NCT03771742: Modified Paramedic Sagittal vs. Transverse TMQLB
Official title: Randomized Prospective Study to Evaluate Cranial Dermatomal Spread of Modified Paramedic Sagittal Versus Transverse Approach TMQLB for Adrenal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nerve Block
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2018-12-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The classical transmuscular qudratus lumborum block(TMQLB) described by Borglum aims to provide lower thoracic paravertebral space(PVS) and sympathetic blockade by injecting local anesthetics between QL and PM muscle at the L3-L4 vertebral level using a transverse scan, posterior-anterior, in-plane approach. Recently, a paramedian sagittal oblique(TMQLB) approach has been introduced to facilitate cranial spread by injecting the local in a caudal to cranial direction. Currently, there are no data comparing the two techniques mentioned above with regards to extent of spread for PVS. Our objective is to investigate the extent of cranial dermatomal spread of TMQLB when equal dosage(ml/kg) of local anesthetic are injected with the transverse versus an modified paramedian sagittal approach for patients undergoing laparoscopic adrenalectomy. In addition, the investigators wish to compare the performance time, caudal dermatomal spread of TMQLB and postoperative analgesia effect.


Eligibility criteria: Inclusion Criteria:

* Age 18-70 yrs
* American Society of Anesthesiologists physical statusⅠ-Ⅲ
* Undergo laparoscopic adrenalectomy
* Informed consent
* Able to cooperate with study process

Exclusion Criteria:

* Allergy to local anesthetic and other medications used in the study
* Patient refusal or lack of informed consent
* Coexisting hematological disorder or with deranged coagulation parameters
* Pre-existing major organ dysfunction such as hepatic and renal failure
* History of previous renal surgery.

Primary outcomes:
measure: Cephalic sensory dermatomal spread
timeFrame: 20 minutes after block performance
Secondary outcomes:
measure: Time to performance of procedure
timeFrame: Duration of procedure
measure: Total sensory dermatomal spread
timeFrame: 20 minutes after block performance
measure: Incidence of complication
timeFrame: Within 48hours after surgery
measure: Caudal sensory dermatomal spread
timeFrame: 20 minutes after block performance
measure: cumulative rate of rescue analgesics usage
timeFrame: At 0,2,4,8,12,24,48 hours after surgery
measure: NRS pain scores
timeFrame: At 0,2,4,8,12,24,48hours after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
affiliation: Peking Union Medical College Hospital
name: Xulei CUI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00438542: HMW-Adiponectin is Raised in Newborns
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pre-Eclampsia
Keywords: Adiponectin, cord blood, pre-eclampsia
Lead sponsor: University of Oslo
Sponsor class: OTHER
First posted: 2007-02-22
Sex: ALL
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER

Brief summary: Cross sectional, hospital-based study dealing with adiponectin levels in newborns to mothers with pre-eclampsia. Venus cord blood samples were collected immediately after birth; 30 cases and 62 controls were enrolled into the study. The study was approved by the local ethics committee and all participants gave written consent.


Eligibility criteria: Inclusion Criteria:

* Pre-eclampsia

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Institute of Clinical Chemistry, Medical Faculty, University of Oslo, Norway
name: Lars Morkrid, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00220142: Molecular Markers of Prognosis in Colorectal Cancer Patients
Official title: Molecular Markers of Prognosis in Colorectal Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The GI unit Royal Marsden Hospital NHS trust (RMHNHST) has co-ordinated and published results from a large multicentre randomised clinical trial of patients with locally advanced CRC (Saini et al. 2003). A total of 716 patients Dukes' B and C CRC operated with curative intent were randomised to receive either bolus or infusional 5FU regimes. Patients treated at the RMHNHST made up the majority of the total sample cohort (n=550). Analysis of results after a median of 19.8 months follow-up showed that infused 5-FU given over 12 weeks resulted in similar survival to bolus 5-FU and FA over a six-month period (log rank p=0.764). There was, however, significantly less toxicity associated with the infusional regime.

Brief summary: To correlate the molecular profile of a series of defined CRCs with prognosis and toxicity.


Eligibility criteria: Inclusion Criteria:

* All patients participating in the RMHNHST study of infusional versus bolus 5FU (Saini et al. 2003).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital
state: Surrey
Study officials:
affiliation: Royal Marsden NHS Foundation Trust
name: David Cunningham
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03260842: Bio-Repository of High Risk Cohorts for the Early Detection of Pancreas Cancer
Official title: Bio-Repository of High Risk Cohorts for the Early Detection of Pancreas Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreatic Cyst
Pancreas Disease
Keywords: early detection
biomarkers
pancreas cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2017-08-24
Enrollment: 500
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 at high risk for developing pancreas cancer defined by the presence of a pancreatic cyst and/or family history or genetic mutation for pancreas cancer.

Brief summary: Bio-repository to collect bio-specimens from patients with 1) pancreatic cysts and 2) patients at high risk, defined by family history and/or genetic mutations, for pancreatic cancer.

Detailed description: Observational study to collect bio-specimens from 2 separate patient cohorts identified to be at high risk for subsequent development of pancreas cancer.

1. Patients diagnosed with a pancreatic cyst undergoing either endoscopic ultrasound or surgery. Bio-specimens collected include pancreatic cyst fluid and blood. These will be collected using a standard operating protocol.
2. Patients defined as a high risk individual for pancreas cancer by family history and/or known genetic mutations. Bio-specimens collected include blood. This will be collected using a standard operating protocol.

Eligibility criteria: Inclusion Criteria:

* Older than 18 with pancreas cyst
* Older than 18 at high risk for Pancreas cancer

Exclusion Criteria:

* Unable to provide consent
* Not willing to provide bio-specimens

Primary outcomes:
measure: Pancreas Cancer
timeFrame: 5-10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Faculty
name: Walter Park, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04355442: Evolution of Facial Trauma During COVID Containment Measures
Official title: Evolution of Maxillofacial Trauma Activity During COVID-19 Containment Measures: a French Multicentric Comparative Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Maxillofacial Injuries
Skull Fractures
COVID-19
Keywords: Pandemics
Maxillofacial fractures
Facial trauma
Containment
Quarenteen
Outbreak
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Unités de CMF des CHU de Paris (Dr Davrou - Pitié salpetrière)
name: Amiens (Dr Dapke)
name: Nantes (Pr Corre)
name: Toulouse (Pr Lauwers - Purpan)
name: Marseille (Dr Foletti - La conception)
name: Nice (Dr Savoldelli)
name: Clermont Ferrand (Dr Sesque)
name: Perpignan (Dr Llobet)
name: Lyon (Dr Bourlet - Croix Rousse)
First posted: 2020-04-21
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with facial trauma requiring surgery

Brief summary: The COVID-19 global pandemic has led to a major professional and social national reorganization: professional because it involves a redeployment of medical staff and material resources, and social because it imposes prolonged containment measures on an entire population.

The maxillofacial trauma activity is mainly linked to sports or leisure accidents, fights and road accidents.

It seems to appear since the beginning of containment measures a significant drop in maxillofacial trauma activity at the national level, which, if it is demonstrated in a significant way in several French hospital centers, would allow to redeploy the material and human resources related to this activity on sectors in tension due to the pandemic.

Detailed description: This study will compare maxillo-facial activity during the first month of COVID-19 containment measures in France with a comparable period in 2018 and 2019. This comparison will be made in 10 major French hospital centers.

Eligibility criteria: Inclusion criteria:

* Maxillo-facial fracture
* Requiring
* Trauma that occured between March 16 and April 15, 2020 or 2018 or 2019
* All ages

Exclusion criteria:

* Patients who refused the collection of their data

Primary outcomes:
measure: evolution of number of maxillofacial trauma
timeFrame: 1 year
Secondary outcomes:
measure: variability in terms of type of trauma
timeFrame: 1 year
measure: Comparative assessment of types of trauma by the inter-regional variability
timeFrame: 1 year
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uh Montpellier
Study officials:
affiliation: UH MONTPELLIER
name: Marie de BOUTRAY, PH
role: STUDY_DIRECTOR
References:
Clinical trial NCT04074642: OCT-angiography as a Pronostic Marker for Visual Impairment in Patients Undergoing Neurosurgery for Compressive Macroadenoma : a Prospective Study.
Official title: OCT-angiography as a Pronostic Marker for Visual Impairment in Patients Undergoing Neurosurgery for Compressive Macroadenoma : a Prospective Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pituitary Adenoma
Keywords: macroadenoma
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2019-08-30
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the study is to assess accurancy of OCT angiography as a pronostic marker for patients undergoing neurosurgery for compressiver macroadenoma as compared with visual acuity, visual field and OCT.


Eligibility criteria: Inclusion Criteria:

* pituitary compressive adenoma (for experimental group)
* pituitary non compressive adenoma

Exclusion Criteria:

* retinian disease
* amblyopia
* parkinson disease
* pregnant woman

Primary outcomes:
measure: change of middle deviation
timeFrame: before surgery (= inclusion), 4 months after surgery and 10 months after surgery
measure: Change of visual function index
timeFrame: before surgery (= inclusion), 4 months after surgery and 10 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de NICE
city: Nice
country: France
facility: Hôpital Pasteur 2 - Service d'Ophtalmologie
Study officials:
affiliation: ophtalmology department, Nice University Hospital
name: ARNAUD MARTEL
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03480542: Central Venous Access Study
Official title: The CentrAl VenouS Catheter Access DocumEntation (CASCADE) Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Central Line Catheters
Lead sponsor: Hackensack Meridian Health
Sponsor class: OTHER
First posted: 2018-03-29
Enrollment: 217
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Three hundred patient electronic medical records will be reviewed from the Critical Care Units (Medical Intensive Care Unit, Coronary Care Unit, Cardiac Surgical Intensive Care Unit, Surgical Intensive Care Unit).

Brief summary: The aim of this study is to document clinicians variation in practice in comparison to standard guidelines by the Medical Center's approved Evidence-based Practice (EBP) guidelines, policies, and procedures for Central Venous Catheter(CVC), Peripherally Inserted Central Catheter (PICC), and Hemodialysis (HD catheters by way of a structured retrospective review of the Electronic Medical Record (EMR) system.

Detailed description: This will be a single site retrospective (non-experimental) study utilizing the electronic medical record, both descriptive and correlational methods.

There will be two outcomes:

1. The outcomes associated with the management of Central Venous Catheter(CVC), Peripherally Inserted Central Catheter (PICC), and Hemodialysis (HD) Catheter in adherence with hospital approved Evidence-based Practice guidelines for Central Venous Catheter(CVC), Peripherally Inserted Central Catheter (PICC), and Hemodialysis (HD) Catheter.
2. The mechanical/technical, thrombotic, and other adverse outcomes (Heparin induced coagulopathy) associated with central venous catheters due to variation in insertion and management practices of Central Venous Catheter(CVC), Peripherally Inserted Central Catheter (PICC), and Hemodialysis (HD) Catheter.

Eligibility criteria: Inclusion Criteria:

• Adult patients in Medical Intensive Care Unit (MICU), Coronary Care Unit (CCU), Cardiac Surgical Intensive Care Unit (CSICU), Surgical Intensive Care Unit (SICU) with either CVCs, PICCs, or HD catheters.

Exclusion Criteria:

• Pediatric (including neonates), obstetric and gynecology, medical-surgical, and oncology patients.

Primary outcomes:
measure: Adherence to Clinical Guidelines for Catheter Interventions and Management
timeFrame: 1 year
Secondary outcomes:
measure: Number of Documented Catheter Complications
timeFrame: 1 year
Other outcomes:
Locations:
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
Study officials:
affiliation: Hackensack Meridian Health
name: Claudia Douglas, DNP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00666042: Bioequivalence of Eye Drops and Spray Administration of Vigamox
Official title: Laboratory-masked, Randomized Parallel, Comparative, Pilot Study on the Bioavailability of Vigamox in the Aqueous Humor When Administered Either as Commercially Available Eye Drops or in a Spray Form
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Lead sponsor: Advanced Ophthalmic Pharma
Sponsor class: INDUSTRY
First posted: 2008-04-24
Enrollment: 16
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The study compares the amounts of Vigamox absorbed when administered as eye drops or in a spray form. Both administrations will be prior to patients undergoing elective cataract surgery and the aqueous samples will be analyzed by a laboratory in a masked fashion. The hypothesis is that there will be no difference between the 2 modes of administration.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for elective cataract surgery

Exclusion Criteria:

* Allergy to Vigamox

Primary outcomes:
measure: Bioequivalency between the 2 ways of administration
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Dept. of Ophthalmology, TAMC
Study officials:
affiliation: TAMC, Tel Aviv, Israel
name: Adi Michaeli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03216642: The Study of Bacteriology and Pathogen Drug Sensitivity of Chronic Dacryocystitis
Official title: The Study of Bacteriology and Pathogen Drug Sensitivity of Chronic Dacryocystitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dacryocystitis
Bacteriology
Keywords: Dacryocystitis
Bacteriology
Microbial Sensitivity Tests
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2017-07-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will be conducted among patients with chronic dacryocystitis attending Zhongshan Ophthalmic Center.

Brief summary: An observational study was designed to research the bacteriology and pathogen drug sensitivity of chronic dacryocystitis in China and optimize antibiotic therapy.

Detailed description: For patients diagnosed with chronic dacryocystitis，we will collect the secretions after lacrimal passage irrigation, note the characters of the secretions and send the secretions for bacteria culture, analysis and pathogen drug sensitivity.

Eligibility criteria: Inclusion Criteria:

1. Diagnosed with chronic dacryocystitis
2. No involvement in other drug experiment in the past 1 week

Exclusion Criteria:

1. Can not cooperate the specimen collection
2. With any other eye disease

Primary outcomes:
measure: Bacterial agents
timeFrame: 2 weeks
Secondary outcomes:
measure: Sensitivity test
timeFrame: 2 weeks
measure: The colour of lacrimal sac secretion
timeFrame: 2 weeks
measure: The character of lacrimal sac secretion
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Clinical Research Center
state: Guangdong
Study officials:
References:
Clinical trial NCT00378170: Laryngoscope Prototype Tested Against the Traditional Macintosh Blade
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia, Intravenous
Keywords: intubation
difficulty
Macintosh
dental damage
complications
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2006-09-19
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary objective is to evaluate a knewly developed blade (for intubating patients about to undergo surgery) and compare it to the traditional Macintosh blade

Detailed description: Intubation of patiens can be difficult, even impossible. It can result in different complications as damage to the teeth, lacerations of the mucosa, bleeding, fractures/luxations, hypoxia, hypercapnia, reflex bradycardia and in worst case braindamage and death.

The more difficult the intubation is the more frequent complicationrate. We believe to have developed a laryngoscopeblade that hopefully eases the intubationproces and thereby reduces the complicationrisk.

The patients included in this study is patients who are undergoing elective surgery requering intubation.

Eligibility criteria: Inclusion Criteria:

* age over 18
* ASA 1-III
* Patients undergoing elective surgery requering intubation at KAS Herlev

Exclusion Criteria:

* Prior difficult intubation indicating awake fiberoptic intubation
* pathology in the airways predicting difficult intubation
* columna cervicalis fractures
* pregnancy
* Requirement for Rapid sequence induction

Primary outcomes:
measure: succes rate - immediate evaluation
measure: difficulty - immediate evaluation
Secondary outcomes:
measure: Cormack & Lehane grading
measure: Time to intubate
measure: Interincissor gap
measure: vissible complication
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: KAS Herlev university Hospital
Study officials:
name: Ann Møller, consultant
role: STUDY_DIRECTOR
References: