louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01141127: Tranexamic Acid (TXA) in Pediatric Cardiac Surgery
Official title: Tranexamic Acid (TXA) During Pediatric Cardiac Surgery: A Prospective Randomised Study Comparing Two Dosing Regimens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bleeding
Keywords: tranexamic acid in pediatric surgery
fibrinolysis and paediatric cardiac surgery
Lead sponsor: Centre Chirurgical Marie Lannelongue
Sponsor class: OTHER
First posted: 2010-06-10
Enrollment: 18
Sex: ALL
Minimum age (years): 12
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine tranexamic acid plasma levels in children undergoing cardiac surgery at risk of bleeding and to compare two dosing regimens.

Detailed description: Tranexamic acid (TXA) is administered intravenously to prevent bleeding associated with cardiac surgery and by pass in adult and children. The pharmacokinetic of this product is unknown in the pediatric population. Only a few studies report a clinical efficacy with different dosages. The purpose of this study is to determine the plasma level of TXA using two different administrations methods: continuous versus intermittent. The second objective is to determine whether fibrinolysis decreased. The population consists in children weighting 10 to 30 Kilos, undergoing cardiac surgery and at high risk of bleeding.

Eligibility criteria: Inclusion Criteria:

* children weighing between 10 and 30kg surgery with cardiopulmonary bypass for congenital heart disease deemed hemorrhagic

Exclusion Criteria:

* the patients undergoing a surgical procedure short and simple
* patients with past history of convulsions neurologiques especially allergies to the TA
* patients with renal insufficiency

Primary outcomes:
measure: Preoperative plasma tranexamic acid concentration is measured using high performance liquid chromatography
timeFrame: Blood samples are collected during the operative period within 24 hours
Secondary outcomes:
measure: preoperative plasma tranexamic acid concentration is measured using high performance liquid chromatography
timeFrame: blood samples collected during the operative period within the first 24 hours
Other outcomes:
Locations:
city: Plessis-Robinson
country: France
facility: Centre Chirurgical Marie Lannelongue
Study officials:
affiliation: CCML
name: Roland COUTURIER, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Couturier R, Rubatti M, Credico C, Louvain-Quintard V, Anerkian V, Doubine S, Vasse M, Grassin-Delyle S. Continuous or discontinuous tranexamic acid effectively inhibits fibrinolysis in children undergoing cardiac surgery with cardiopulmonary bypass. Blood Coagul Fibrinolysis. 2014 Apr;25(3):259-65. doi: 10.1097/MBC.0000000000000051.
Clinical trial NCT00285727: Ropinirole Controlled Release (CR) as an Adjunctive Agent in the Treatment of Major Depression
Official title: Ropinirole Controlled Release (CR) as an Adjunctive Agent in the Treatment of Major Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Disorder, Major
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Duke University
name: GlaxoSmithKline
First posted: 2006-02-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an 8 week study for patients who are currently taking antidepressant medication but not fully responding. Ropinirole CR would be taken in conjunction with current antidepressant medication. Patients come into the clinic once a week when starting on the medication and then once every other week for the remainder of the 8 weeks.

Detailed description: We hope to learn whether ropinirole CR (controlled release formulation) is safe and effective when taken with an antidepressant to reduce the symptoms of depression. Adults who have a diagnosis of major depression and are currently taking an adequate dose of antidepressant medication will be sought for participation. They will continue to take the antidepressant medication and will receive ropinirole CR, an investigational medication, for eight weeks during which information will be collected about mood and cognitive functioning.

Eligibility criteria: Inclusion Criteria:

* Age 18 to 65 years old
* Currently experiencing major depression
* On at least an adequate dose of fluoxetine, paroxetine, sertraline, citalopram, escitalopram, venlafaxine, bupropion, mirtazapine or duloxetine for at least 6 weeks (monotherapy). Exclusion Criteria:1. Pregnant females or females of child bearing years not using adequate birth control in the opinion of the investigators
* Known sensitivity to ropinirole
* Significant medical conditions that would preclude safe participation in the study in the opinion of the investigators.
* Significant abnormalities observed in screening laboratory evaluation

Primary outcomes:
measure: HamD
Secondary outcomes:
measure: MADRS
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: Stanford
country: United States
facility: Depression Research Clinic, Psychiatry Department, Stanford School of Medicine
state: California
Study officials:
affiliation: Depression Research Clinic, Psychiatry Department, Stanford School of Medicine
name: Charles Debattista
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02542527: Evaluation of the Functionality of a Fluid Filled Single Breast Pump
Official title: C88- Pilot Study A Prospective Case Series for Evaluation of the Functionality of a Fluid Filled Single Breast Pump Applied on a Lactating Breast
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lactation
Lead sponsor: Medela AG
Sponsor class: INDUSTRY
First posted: 2015-09-07
Enrollment: 4
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study is an early (during the product development process) feasibility study. It shall evaluate the device design concept with respect to device functionality of a new fluid filled breast pump in a small number of subjects.


Eligibility criteria: Inclusion criteria:

* Female over 18 years
* Participant has an established milk flow, general rule: approx. 50 ml per breast per pumping session
* The participant is pumping at least 2 times a week
* The participant is 1-6 months after giving birth (postpartum) at the day of data assessment
* The participant agrees to pump or feed the last time a minimum of 3 hours before the start of the pumping sessions
* The participant agrees that the pumped breast milk cannot be fed to her infant (will be disposed)
* The participant agrees to photograph and video record the breast and upper body (no face)
* The participant agrees to the presence of up to 3 men in the room during the pumping session

Exclusion criteria:

* Participant or their baby is dependent on life-sustaining electric devices (e.g. heart pacemaker, insulin pump, etc.)
* Participant has an medical condition of the breast
* Participant is allergic to plastics or silicone

Primary outcomes:
measure: Breast pump vacuum (mmHg)
timeFrame: Measured during a single 25 minute pumping session
Secondary outcomes:
Other outcomes:
Locations:
city: Baar
country: Switzerland
facility: Medela AG
state: Zug
Study officials:
affiliation: Medela Switzerland
name: Danielle Prime, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06679127: Validity and Feasibility of Newborn Bed Monitoring Device - a Clinical Pilot Study
Official title: Validity and Feasibility of Newborn Bed Monitoring Device - a Clinical Pilot Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Validation
Lead sponsor: University of Turku
Sponsor class: OTHER
First posted: 2024-11-07
Enrollment: 315
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All parents will be informed about the study when moving from labour ward to postnatal ward. Newborns participating in the study will be approximately 1-3 days old. Parents of the participating newborns will be informed about the study and invited to participate to the study part for parents.

All healthcare professionals working in the study unit during the newborn data collection are able to participate in the study part for healthcare professionals.

Brief summary: The aim of this clinical pilot study is to evaluate the validity, acceptability and usability of the newborn bed monitoring device among newborns, parents and healthcare professionals in hospital environment. The specific aims for the study are to:

1. validate the following infant parameters collected with the bed monitoring device: heart rate, breathing rate, movements.
2. evaluate the feasibility on detecting awake, REM and non-REM sleep stages
3. collect data on environmental factors from the infant sleep environment
4. explore how parents and healthcare professionals perceive the acceptability and usability of the bed monitoring device
5. describe the key requirements for the bed monitoring device to be implemented in the newborn care path

The participating newborns will be sleeping on the bed monitoring device for two hours and the measurements of the device will be compared with the reference device (golden standard). The acceptability and usability will be assessed by parents and healthcare professionals by fulfilling a questionnaire and participating in interviews.


Eligibility criteria: Inclusion Criteria for newborns:

* received informed consent from both parents/guardians
* newborn is treated in the Ward of families and newborns
* newborn is having normal health status without ongoing additional treatments. No exclusion criteria

Inclusion criteria for parents:

* being a parent of newborn participating in the study with bed monitoring device
* being able to participate in Finnish. No exclusion criteria

Inclusion criteria for healthcare professionals:

* being a healthcare professional working with newborns
* being able to participate in Finnish. No exclusion criteria

Primary outcomes:
measure: Heart rate
timeFrame: Two hours from the beginning of the data collection
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00365027: Transfer of Fresh Versus Frozen/Thawed Embryos in IVF Cycles Where GnRH Agonist is Utilized for Oocyte Maturation.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Ovarian Hyperstimulation Syndrome
Infertility Drugs
Female
Keywords: GNRH agonist
ovarian hyperstimulation syndrome
Embryo cryopreservation
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2006-08-16
Enrollment: 0
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: It has been suggested that in IVF cycles where GNRH agonist is utilized for final oocyte maturation in patients at risk of ovarian hyperstimulation, pregnancy rates are reduced. We hypothesize that the use of GNRH antagonist reduces pregnancy rates through an effect on the endometrium and not oocyte quality, therefore better results may be obtained by not returning these embryos in a fresh cycle but rather cryopreserving them and returning them to the uterus and a later stage.


Eligibility criteria: Inclusion Criteria:

* Woman at risk of ovarian hyperstimulation syndrome in IVF cycles for whom GNRH agonist was utilized for final oocyte maturation

Exclusion Criteria:

* Patient's refusal to participate

Primary outcomes:
measure: Implantation rate per transfer
measure: Pregnancy rate per embryo transfer
measure: Implantation rate per IVF cycle
measure: Pregnancy rate per IVF cycle
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: HaE'mek medical center
name: Eliezer Shalev
role: STUDY_CHAIR
References:
Clinical trial NCT01679327: Study of Bevacizumab Plus Chemotherapy in Patients With Metastatic Colorectal Cancer
Official title: Study of Bevacizumab Plus Chemotherapy in Patients With Metastatic Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Colorectal Cancer
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2012-09-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluates the relationship of biomarker expression and efficacy of bevacizumab plus chemotherapy in patients with unresectable/metastatic colorectal cancer. Before the treatment, the investigators detect the VEGF-A,VEGF-C,VEGF-D,VEGFR-1,VEGFR-2,VEGFR-3 expression in tumor tissue by IHC and detect those protein expression level in plasma by ELISA. After at least 6 weeks treatment, the investigators detect again VEGF-A,VEGF-C,VEGF-D expression level in plasma by ELISA. The aim of the study is to identify whether those biomarkers could predict Bevacizumab efficacy.


Eligibility criteria: Inclusion Criteria:

* More than 18-years old,male or female
* Pathologically approved as unresectable/metastatic colorectal cancer
* KPS \> 70% or ECOG 0-2
* HGB \> 80 g/L, NEUT ≥ 1.5x109 /L, PLT ≥ 80x109 /L; CR \< 1.5 x Upper normality，
* TB \< 1.5 X Upper normality，AST or ALT \< 2.5 x Upper normality.
* Signed consent

Exclusion Criteria:

* Other malignancies simultaneously except in situ cervix or nonmelanoma skin cancer
* Pregnancy or in lactation
* HGB \< 80 g/L, NEUT \< 1.5x109 /L, PLT \< 80x109 /L; CR ≥ 1.5 x Upper normality， TB ≥ 2.5 X Upper normality，AST or ALT ≥2.5 x Upper normality，AKP ≥ 2.5 X Upper normality

Primary outcomes:
measure: Overall response rate
timeFrame: 36 months
Secondary outcomes:
measure: progression free survival
timeFrame: 36 months
measure: overall survival
timeFrame: 36 months
measure: Number of Participants with Adverse Events
timeFrame: 36 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Institute&Hospital Chinese Academy of Medical Sciences
Study officials:
affiliation: Chinese Academy of Medical Sciences
name: Yihebali Chi, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Chinese Academy of Medical Sciences
name: Jinwan WANG
role: STUDY_DIRECTOR
References:
Clinical trial NCT01862627: Macular Retinoschisis and Detachment Associated With Glaucomatous Optic Neuropathy
Official title: Macular Retinoschisis and Detachment Associated With Glaucomatous Optic Neuropathy But Without Optic Disc Pit Nor High Myopia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Macular Retinoschisis
Macular Detachment
Normal Tension Glaucoma
Keywords: Macular retinoschisis
Macular detachment
vitrectomy
Lead sponsor: Kyorin University
Sponsor class: OTHER
First posted: 2013-05-24
Enrollment: 11
Sex: ALL
Minimum age (years): 10
Maximum age (years): 95
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients with macular retinoschisis and detachment associated with normal tension glaucoma

Brief summary: Clinical features, optical coherence tomography findings and surgical outcome in eyes with macular retinoschisis and detachment with normal tension glaucoma but without optic disc pit or high myopia were evaluated.


Eligibility criteria: Inclusion Criteria:

* The patients with macular retinoschisis and detachment associated with normal tension glaucoma

Exclusion Criteria:

* Optic pit maculopathy, high myopia

Primary outcomes:
measure: Optical coherence tomography
timeFrame: One year
Secondary outcomes:
measure: Visual recovery
timeFrame: One year
Other outcomes:
Locations:
city: Mitaka
country: Japan
facility: Kyorin Eye Center
state: Tokyo
Study officials:
affiliation: Kyorin Eye Center
name: Makoto Inoue, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04202991: The Relationship Between Pain, Balance and Gait in People With Chronic Obstructive Pulmonary Disease
Official title: An Investigation of the Relationship of Pain With Balance and Gait Impairment in People With Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Balance Impairment
Gait Impairment
Pain
Keywords: COPD, balance, gait, pain
Lead sponsor: Teesside University
Sponsor class: OTHER
Collaborators: name: South Tees Hospitals NHS Foundation Trust
name: North Tees and Hartlepool NHS Foundation Trust
First posted: 2019-12-18
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: People with COPD referred to, or attending, Pulmonary Rehabilitation at local National Health Service Hospitals/Clinics

Brief summary: The balance, gait and pain in Chronic Obstructive Pulmonary Disease (COPD) study will aim to investigate the link between balance and gait impairment, and high rates of pain in people with COPD. This cross-sectional observational study will compare balance and gait outcomes for people with COPD who have pain, to those who are pain free.


Eligibility criteria: Inclusion Criteria:

* Have a spirometry confirmed diagnosis of COPD as per Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines
* Be 18 years or over at the point of recruitment
* Be able to communicate with good verbal English or use adaptive equipment to communicate.
* Be able to complete test procedures
* Stable COPD (six weeks clear of exacerbation)
* No uncorrected visual or somatosensory disturbance

Exclusion Criteria:

* No other conditions that may affect balance or gait e.g. neurological or vestibular conditions
* Recent exacerbation of COPD (within the last six weeks)
* Unable to provide written informed consent
* Unable to speak English or no translation options available
* Any other acute health conditions that would make activity unsafe e.g. acute infection, unstable cardiac disease.

Primary outcomes:
measure: Balance Evaluations Systems Test (BESTest)
timeFrame: 20-30 minutes
Secondary outcomes:
measure: Berg Balance Scale
timeFrame: 5 minutes (for additional items not featured within the BESTest
measure: Gait analysis
timeFrame: 10 minutes
Other outcomes:
measure: 30 second sit to stand test
timeFrame: 30 seconds
measure: Peak muscle torque (quadriceps, hamstrings, hip abductors and adductors, ankle plantar flexors and dorsiflexors).
timeFrame: 30 minutes
measure: PiMax
timeFrame: 5 minutes
measure: Brief Pain Inventory Short Form
timeFrame: 5 minutes
measure: Physical Activity Scale for the Elderly
timeFrame: 5 minutes
Locations:
city: Middlesbrough
country: United Kingdom
facility: South Tees Hospitals NHS Trust
city: Stockton-on-Tees
country: United Kingdom
facility: North Tees Hospitals NHS Trust
Study officials:
affiliation: Teesside University
name: Samantha L Harrison, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01709591: Effect of Prenatal Education on Perceptions of Epidural Acceptance
Official title: Effect of Targeted Prenatal Education on Perceptions of Epidural on Acceptance of Epidural Analgesia: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Pain
Keywords: intrapartum pain management, epidural
Lead sponsor: Santa Clara Valley Health & Hospital System
Sponsor class: OTHER
First posted: 2012-10-18
Enrollment: 111
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine if targeted prenatal educational program on womens' perceptions of epidural increases the acceptance of intrapartum epidural analgesia relative to the control group.

Detailed description: Racial/ethnic disparities exist in the proportion of patients receiving epidural analgesia. The purpose of our study is to determine if culturally-sensitive educational program targeting womens' perceptions of epidural increases the acceptance of intrapartum epidural use.

Eligibility criteria: Inclusion Criteria:

1. Women with viable intrauterine gestation seeking prenatal care
2. Candidates for Intrapartum epidural analgesia

Exclusion Criteria:

1. Intrapartum epidural analgesia is contraindicated
2. Trial of labor is contraindicated.
3. Patients planning an elective cesarean

Primary outcomes:
measure: pre and post intervention PEQ survey results to elucidate the changes in perceptions of epiduralepidural based on the PEQ survey
timeFrame: One year time period
Secondary outcomes:
Other outcomes:
Locations:
city: San Jose
country: United States
facility: Santa Clara Valley Health and Hospital System
state: California
Study officials:
affiliation: Santa Clara Valley Health and Hospital System
name: Anita Sit, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04962191: Idylla EGFR Lung Trial
Official title: Technology Study: Measuring Potential Impact of Research Use Only Rapid EGFR Testing on Standard of Care
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer
Technology
Oncology
Keywords: Protean BioDiagnostics
Lead sponsor: Protean BioDiagnostics
Sponsor class: INDUSTRY
First posted: 2021-07-14
Enrollment: 150
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: Target population is patients diagnosed with primary lung cancer and potentially have known EGFR mutation status.

Brief summary: This retrospective, observational study will compare the results of a BioCartis' EGFR mutation test on the Idylla platform with test results from SoC pathology results from tissue biopsies in the same setting. A comparable rapid testing platform for EGFR may serve as a more accessible means to diagnose, and overall, more patients treated successfully with targeted therapies. Up to 150 samples will be tested and compared with existing results.

Detailed description: This study will compare the results of a BioCartis' EGFR mutation test on theIdylla platform with test results from standard of care (SoC) pathology results from tissue biopsies. The Idylla™ EGFR Mutation Test, performed on the BioCartis Idylla™ System, is an in vitro diagnostic test for the qualitative detection of exon 18, exon 20, and exon 21 mutations. Additionally, exon 19 deletions and exon 20 insertions in the EGFR oncogene. A rapid testing platform for EGFR may serve as a more accessible means to diagnose, and overall, more patients treated successfully with targeted therapies.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with primary lung cancer
* Data from primary diagnosis must be included in pathology report or data entry.
* Detailed pathology report included for all samples

Exclusion Criteria:

* Limited or no tissue available
* Only tissue available is from fine needle aspiration
* Tissue blocks older than 5 years old

Primary outcomes:
measure: Idylla EGFR Mutation Test
timeFrame: Retrospective tissue samples no longer than 5 years old
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: 6555 Sanger Rd, Suite 260
state: Florida
Study officials:
affiliation: CEO and Founder
name: Anthony Magliocco, MD
role: PRINCIPAL_INVESTIGATOR
References: