louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03338270: Clinical Validation Study of Multi-EPI Mix
Official title: Clinical Validation Study of a Novel Minute MRI Sequence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Diseases
Keywords: MRI
Neuroradiology
minute-MRI
multi EPI-mix
Clinical Validation
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: GE Healthcare
First posted: 2017-11-09
Enrollment: 101
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Neuroradiological indication for brain MRI

Brief summary: This study aims to assess the diagnostic validity of a new minute-MRI sequence for neuroradiological evaluation in comparison to conventional MRI.

Detailed description: The study aims to assess the imaging quality with regards to artefacts and lesion conspicuity as well as its diagnostic potential in rendering a probable diagnosis. The primary study aim is to define the AUC for diagnostic performance of minute MRI compared to conventional MRI.

Included patients are those with suspiscion of cerebral pathology.

Study participancts are investigated at 3T.

Eligibility criteria: Inclusion Criteria:

- Neuroradiological MRI

Exclusion Criteria:

- Aborted exam

Primary outcomes:
measure: Diagnostic potential
timeFrame: At MRI scan. Diagnostic accuracy to categorize scan as normal or abnormal on a five point Likert scale compared to abnormal/normal conventional MRI.
Secondary outcomes:
measure: Lesion location determination
timeFrame: At MRI scan
measure: Lesion classification
timeFrame: At MRI scan
measure: Imaging quality
timeFrame: At MRI scan
measure: Diagnostic imaging quality
timeFrame: At MRI scan
measure: Anatomical conspicuity
timeFrame: At MRI scan
measure: Multifocality
timeFrame: At MRI scan
measure: Ability to rule out diseases
timeFrame: At MRI scan
measure: Lesion description
timeFrame: At MRI scan
measure: Diagnostic confidence
timeFrame: At MRI scan
measure: Brain coverage
timeFrame: At MRI scan
measure: Clinical diagnostic summay report
timeFrame: At MRI scan
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Clinical Neuroscience
name: Anna Falk Delgado, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Delgado AF, Kits A, Bystam J, Kaijser M, Skorpil M, Sprenger T, Skare S. Diagnostic performance of a new multicontrast one-minute full brain exam (EPIMix) in neuroradiology: A prospective study. J Magn Reson Imaging. 2019 Dec;50(6):1824-1833. doi: 10.1002/jmri.26742. Epub 2019 Apr 1.
Clinical trial NCT03676270: Trends in Modern Phase 1 Oncology Trials
Official title: Trends in Modern Phase 1 Oncology Trials
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: Cancer
Phase I trials
Review
Lead sponsor: Institut Bergonié
Sponsor class: OTHER
First posted: 2018-09-18
Enrollment: 6915
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: unit of analysis = trial (analysis of aggregated data only, with the trial as the unit of analysis)

Brief summary: Overview of response rate published in recent oncology phase I trials

Detailed description: Critics have raised a fundamental ethical challenge about phase 1 cancer research. They point to an expected paucity of benefits, since approximately 5% of patients in phase 1 trials are reported to have tumor shrinkage.

Objective was to conduct a search of the literature using PubMed to identify articles about phase 1 trials that were published from January 1, 2014, through June 30, 2015. The primary end point was the response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

Clinically relevant trials' characteristics were investigated as candidate factors associated with the RR: Funding source (Academic / Industrial), First-in man trial (Yes / No), Expansion cohort (Yes / No), Number of targeted organs (Single / Multiple), Therapy (Single / Combination), Treatment (MAB-Immuno / ITK / Chimioth-HT-other), Biological eligibility criterion (Yes / No), as well as the number of assessable patients, which for ease of clinical interpretation was transformed into a qualitative variable (0-25 / 26 - 50 / 51+).

The RR was described according to the individual trials' characteristics. Associations with trials's characteristics were investigated using statistical modeling.

Eligibility criteria: Trials based on the following eligibility criteria:

* cancer phase 1 trials
* published from January 1, 2014, through June 30, 2015

Primary outcomes:
measure: Response Rate
timeFrame: up to 6 months after treatment initiation
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Insitut Bergonié
Study officials:
affiliation: Institut Bergonié
name: Antoine Italiano, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chakiba C, Grellety T, Bellera C, Italiano A. Encouraging Trends in Modern Phase 1 Oncology Trials. N Engl J Med. 2018 Jun 7;378(23):2242-2243. doi: 10.1056/NEJMc1803837. No abstract available.
Clinical trial NCT04048070: The Effect of Enhanced Recovery After Surgery in Endoscopic Sinus Surgery
Official title: Benefits of Enhanced Recovery After Surgery in Patients Undergoing Endoscopic Sinus Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Rhinosinusitis (Diagnosis)
Surgery
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
First posted: 2019-08-07
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients with chronic rhinosinusitis undergoing ESS were prospectively assigned to one of five groups; ERAS groups with postoperative intravenous Flubiprofen Axetil or analgesia pump, traditional care with Flubiprofen Axetil or analgesia pump (NERAS groups), or traditional care without postoperative intravenous analgesia group (control).
Primary purpose: SUPPORTIVE_CARE

Brief summary: Enhanced recovery after surgery (ERAS) protocols have been widely applied during perioperative periods for different diseases, there are few reports of ERAS in patients undergoing endoscopic sinus surgery (ESS). This study therefore aimed to evaluate the benefits of ERAS protocol compared to traditional care following ESS.


Eligibility criteria: Inclusion Criteria:

* The patient has CRSwNP need endoscopic sinus surgery for treatment.

Exclusion Criteria:

* age under 18 years
* pregnant
* ASA grade IV
* received oral or topical steroids within 4 weeks preceding surgery
* had previous ESS history
* intolerant to NSAIDS
* comorbidity of severe mental disease
* not compliant with therapy.

Primary outcomes:
measure: Pain management
timeFrame: at 2 hours after surgery
measure: Pain management
timeFrame: at 6 hours after surgery
measure: Pain management
timeFrame: at 24 hours after surgery
measure: Pain management
timeFrame: at 48 hours after surgery
Secondary outcomes:
measure: Hunger scores
timeFrame: at 5 minutes before surgery start
measure: Self-rating Anxiety Scale
timeFrame: at baseline and 72 hours after surgery
measure: thirst scores
timeFrame: at 5 minutes before surgery start
measure: General comfort scores
timeFrame: at baseline and 72 hours after surgery
measure: quality of sleeping
timeFrame: at baseline and 72 hours after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tongren Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT01778270: Not Invasive Monitoring of Pleural Drainage
Official title: Not Invasive Monitoring of Pleural Drainage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pleural Effusion
Keywords: pleural effusion
pleural drainage
thorax impedance
respiration parameters
heart sounds analysis
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2013-01-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study investigates if data about monitoring the drainage of pleural effusion can be collected by non invasive sensors (feasibility).

Detailed description: 25 patients \> 18 years old with pleura effusion will be examined with regard to the feasibility of non invasive sensor measurements corresponding to the course of thorax impedance and respiration parameters during body fluids loss before and after pleural drainage. The measured data will be compared to standard routine reference measurements (heart rate, medication, brain natriuretic peptide (BNP), heart minute volume). Additionally heart sound analysis via electronic stethoscope will be compared to standard methods.

Also 25 healthy controls will undergo the same measurements to receive standard values.

Eligibility criteria: Inclusion Criteria:

* patients with pleural effusion undergoing pleural drainage
* male and female patients aged at least 18 years

Exclusion Criteria:

* pregnancy or breast feeding
* implanted pacemaker / Cardiac Resynchronization Therapy (CRT) / Implanted Cardioverter Defibrillator (ICD) except Medtronic Device "OptiVol".
* patients not being able to consent

Primary outcomes:
measure: Change of thorax impedance (Ohm)
timeFrame: once during hospital stay at baseline time 0 before pleura drainage and after pleura drainage at time 1 hour.
Secondary outcomes:
measure: Change of Cardiac output ( l/min) via impedance cardiography
timeFrame: once during hospital stay at baseline time 0 before pleura drainage and after pleura drainage at time 1 hour
Other outcomes:
measure: Change of respiratory parameter CO2 in %/ml exhaled air
timeFrame: once during hospital stay at baseline time 0 before pleura drainage and after pleura drainage at time 1 hour
Locations:
city: Aachen
country: Germany
facility: Univeristy Hospital Aachen
state: North Rhine Westfalia
Study officials:
affiliation: Medical Clinic I, University Hospital Aachen
name: Nikolaus Marx, MD
role: STUDY_DIRECTOR
References:
citation: Zink MD, Weyer S, Pauly K, Napp A, Dreher M, Leonhardt S, Marx N, Schauerte P, Mischke K. Feasibility of bioelectrical impedance spectroscopy measurement before and after thoracentesis. Biomed Res Int. 2015;2015:810797. doi: 10.1155/2015/810797. Epub 2015 Mar 11.
Clinical trial NCT00985270: Pregnane X Receptor (PXR) Agonist Rifampicin Effects on Glucose, Lipid and Hormone Homeostasis
Official title: PXR-agonisti Rifampisiinin Vaikutukset Glukoosi-, Lipidi- ja Hormonihomeostaasiin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glucose Tolerance
Lead sponsor: University of Oulu
Sponsor class: OTHER
First posted: 2009-09-28
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This clinical trial is designed to study the effects of rifampicin on the glucose, lipid and hormone homeostasis in healthy volunteers. The main hypothesis is that rifampicin lowers fasting glucose and enhances insulin sensitivity. The study is a randomized, placebo-controlled, open-label cross-over trial. Twelve subjects will be given 600 mg of rifampicin a day for a week compared to a one-week placebo arm. There is at least a 4-week wash-out between the arms. The main outcome measures are the changes in the fasting glucose and HOMA-IR-index (calculated based on fasting glucose and insulin).


Eligibility criteria: Inclusion Criteria:

* Healthy volunteer
* Age 18-40 years

Exclusion Criteria:

* Any continuous medication
* Any significant disease
* Allergy to rifampicin
* Pregnancy and breast feeding
* Fear of needles and previous difficult blood samplings
* Substance abuse
* Participation in another clinical drug trial within 1 month of enrollment
* Use of soft contact lenses

Primary outcomes:
measure: Fasting glucose
Secondary outcomes:
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Oulu University Hospital
Study officials:
affiliation: Oulu University Hospital
name: Janne Hukkanen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rahunen R, Kummu O, Koivukangas V, Hautajarvi H, Hakkola J, Rysa J, Hukkanen J. Pregnane X Receptor-4beta-Hydroxycholesterol Axis in the Regulation of Overweight- and Obesity-Induced Hypertension. J Am Heart Assoc. 2022 Mar 15;11(6):e023492. doi: 10.1161/JAHA.121.023492. Epub 2022 Mar 1.
Clinical trial NCT04985370: PNE Plus Exercise Versus Exercise for Chronic Rotator Cuff Tendinopathy
Official title: Pain Neuroscience Education Plus Exercise Versus Exercise Alone in the Management of Chronic Rotator Cuff Tendinopathy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Rotator Cuff Tendinosis
Lead sponsor: University of Alcala
Sponsor class: OTHER
First posted: 2021-08-02
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this randomized controlled trial is to evaluate the combined effects of pain neuroscience education plus exercise to exercise alone in the management of patients with chronic rotator cuff tendinopathy regarding pain, function, strength, kinesiophobia, and pain catastrophizing.


Eligibility criteria: Inclusion Criteria:

* Shoulder pain due to rotator cuff tendinopathy lasting more than 6 months.
* Internal Rotation Resisted Strength Test positive.
* Test Item Cluster (Hawkins-Kennedy, painful arc, and infraspinatus test) positive.

Exclusion Criteria:

* History of: tumors, metastasis, osteoporosis, shoulder fractures, shoulder luxation and/or instability, previous shoulder surgery, cervical radiculopathy, full-thickness rotator cuff tears, glenohumeral joint degeneration, inflammatory arthropathy, acromioclavicular joint arthrosis, and rotator cuff calcifications.
* Being treated by other physical therapy or medical treatment for their shoulder pain at the time of recruitment.

Primary outcomes:
measure: Change in pain intensity
timeFrame: Baseline, change from baseline at 4-week, and change from baseline at 12-week
Secondary outcomes:
measure: Shoulder disability change
timeFrame: Baseline, change from baseline at 4-week, and change from baseline at 12-week
measure: Kinesiophobia change
timeFrame: Baseline, change from baseline at 4-week, and change from baseline at 12-week
measure: Catastrophism change
timeFrame: Baseline, change from baseline at 4-week, and change from baseline at 12-week
measure: Strength change
timeFrame: Baseline, change from baseline at 4-week, and change from baseline at 12-week
Other outcomes:
Locations:
city: Alcalá De Henares
country: Spain
facility: Rubén Fernández-Matías
state: Madrid
Study officials:
References:
Clinical trial NCT02907970: Perceived Barriers of Cervical Cancer Screening in Reunion Island and Key Levers for Improvment
Official title: Identification Des barrières au dépistage du Cancer du Col utérin à la Réunion et Des Leviers d'amélioration
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Uterine Cervical Neoplasms
Keywords: Cervical cancer
Screening
Barriers
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2016-09-20
Enrollment: 1000
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Telephone survey from a sounding board of women living in Reunion Island

Brief summary: FOSFORE study aims at identifying the barriers of cervical cancer screening in Reunion Island and key levers for improvment.

Detailed description: FOSFORE is a cross sectional KABP (Knowledge, Attitudes, Beliefs and Practices) telephone survey on cervical cancer screening from a sounding board of women aged between 25 and 65 years and living in Reunion Island.

Sample size was estimated from local datas on cervical cancer screening.

Eligibility criteria: Inclusion Criteria:

* Women aged between 25 and 65 yo
* living in Reunion Island
* speaking French, Creole or Shimaore language
* able to answer phone

Exclusion Criteria:

* history of hysterectomy
* history of incomplete or total conisation

Primary outcomes:
measure: Type of barriers in cervical cancer screening
timeFrame: 6 months
measure: Proportion of barriers in cervical cancer screening
timeFrame: 6 months
Secondary outcomes:
measure: Type of levers in cervical cancer screening
timeFrame: 6 months
measure: Proportion of levers in cervical cancer screening
timeFrame: 6 months
Other outcomes:
Locations:
city: Saint Pierre
country: France
facility: Centre Universitaire de La Réunion
Study officials:
References:
Clinical trial NCT00783770: Maternal and Infant Cord Blood Monosaccharide Content
Official title: Comparison of Monosaccharide Content of Maternal and Umbilical Venous Cord Blood in Term and Preterm Pregnancies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Keywords: Breastfeeding
Infant
Preterm
Nutrition
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: United States Department of Agriculture (USDA)
name: University of Arkansas
First posted: 2008-11-02
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Twenty-four generally healthy mother-infant pairs.

Brief summary: Mother's breast milk provides many benefits to babies with regard to development and improved health. We believe the simple sugars which make up these complex sugars in breast milk and are also found in the brain may be critical to normal brain development in term and preterm infants.

Babies are exposed to these sugars by placental transport during pregnancy and through mother's breast milk after they are born. For the preterm infant, we do not know if breast milk gives enough of these sugars compared to what the baby gets during pregnancy.

A maternal blood sample and blood samples from the baby's umbilical cord will provide us with background information for developing a supplement of special sugars that can be added to infant formulas to provide the amount that the baby usually gets during pregnancy and from breast milk.


Eligibility criteria: Inclusion Criteria:

* Healthy mothers with ages ranging from 18 to 35 yrs
* Delivered infants appropriate weight for gestational age (between 10% and 90%)

Exclusion Criteria:

* Maternal history of smoking, alcohol or drug use

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05422170: HEParin Antagonisation in Transcatheter Aortic Valve Implantation
Official title: Heparin Influence on Anticoagulation and Perioperative Hemostasis During Transfemoral Transcatheter Aortic Valve Implantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Valve Stenosis
Transcatheter Aortic Valve Implantation
Protamine Sulfate Overdose
Keywords: Anticoagulation
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
First posted: 2022-06-16
Enrollment: 50
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 with severe aortic valve stenosis undergoing transfemoral TAVI as best option

Brief summary: Unfractioned heparin is usually given in a defined dosage during transfemoral TAVI. Activated Clotting Time (ACT) is usually used to measure the heparin effect. ACT-analysis is easy to perform at the bedside, but susceptible to interference effects. At the end of the procedure, protamine is given to reverse eventual residual heparin effect. An overdose of protamine can impair the coagulation itself. The investigators want to analyse the effect of a partial heparin reversal by ROTEM Analysis.


Eligibility criteria: Inclusion Criteria:

* Severe aortic valve Stenosis
* transfemoral TAVI as best therapy option
* unfractioned heparin for periprocedural anticoagulation

Exclusion Criteria:

* known hypersensitivity /allergy to unfractioned heparin or protamine
* acute systemic infection
* pre procedural started and ongoing intravenous therapy with unfractioned heparin
* severe periprocedural adverse event with the need for emergency surgery (with or with our CPB)
* refusal of the patient to participate

Primary outcomes:
measure: Primary endpoint
timeFrame: Periprocedural
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Deutsches Herzzentrum München des Freistaates Bayern, Technische Universität München
state: Bavaria
Study officials:
affiliation: Deutsches Herzzentrum München
name: Patrick Mayr
role: PRINCIPAL_INVESTIGATOR
affiliation: Deutsches Herzzentrum München
name: Michael Joner
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01917799: Aspirin, Heparin and Miscarriage
Official title: Low Dose Aspirin and Low-molecular-weight Heparin in the Treatment of Pregnant Libyan Women With Recurrent Miscarriage
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pregnancy
Miscarriage
Keywords: Aspirin
Heparin
pregnancy
miscarriage
Lead sponsor: University of Khartoum
Sponsor class: OTHER
First posted: 2013-08-07
Enrollment: 150
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 48
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Efficacy of low dose aspirin (LDA) versus LDA plus low-molecular-weight-heparin (LMWH) in patients with a history of recurrent miscarriages.


Eligibility criteria: Inclusion Criteria:

* Pregnant women
* History of 2 or more of miscarriage

Exclusion Criteria:

* Twins

Primary outcomes:
measure: Number of miscarriages
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Misurata
country: Libyan Arab Jamahiriya
facility: Misurata Teaching Hospital
Study officials:
References:
citation: Elmahashi MO, Elbareg AM, Essadi FM, Ashur BM, Adam I. Low dose aspirin and low-molecular-weight heparin in the treatment of pregnant Libyan women with recurrent miscarriage. BMC Res Notes. 2014 Jan 9;7:23. doi: 10.1186/1756-0500-7-23.