louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03895606: Prediction of Kidney Injury After Hyperthermic Intraperitoneal Chemotherapy (HIPEC)* With Machine Learning
Official title: Application of Machine Learning to Predict Postoperative Acute Kidney Injury in Patients Undergoing Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy Using High-resolution, Time-synchronized Physiological Data From Vital Recorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Chemotherapy
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2019-03-29
Enrollment: 57
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing cytoreductive surgery with hyperthermic intraoperative chemotherapy

Brief summary: Patients undergoing cytoreductive surgery with hyperthermic intraoperative chemotherapy (CRS with HIPEC) are prone to postoperative kidney dysfunction. Previous models predicting kidney injury after CRS with HIPEC did not include intraoperative physiologic data. This study is designed to include not only mean arterial pressure but other parameters such as systolic, diastolic arterial pressure, heart rate, oxygen saturation, body temperature, cardiac index, stroke volume variation and many other physical parameters using a data collection system that can record them every 1-7 seconds. The data will be analyzed using machine learning algorithms.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing cytoreductive surgery with hyperthermic intraoperative chemotherapy

Exclusion Criteria:

* patients under 19

Primary outcomes:
measure: number of patients with postoperative acute kidney injury staged by Kidney Disease: Improving Global Outcomes (KDIGO)
timeFrame: during postoperative day 7
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam Severeance Hospital
Study officials:
References:
Clinical trial NCT01328899: Feasibility Study of PneumRx's Lung Volume Reduction Coil (LVRC)
Official title: Feasibility Study of the PneumRx, Inc. Lung Volume Reduction Coil for the Treatment of Emphysema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Emphysema
Keywords: Emphysema
COPD
RePneu
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
Collaborators: name: PneumRx, Inc.
First posted: 2011-04-05
Enrollment: 60
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multicenter single arm open label study. The primary objective is to evaluate the safety and effectiveness of the Lung Volume Reduction Coil (LVRC) for the treatment of patients with emphysema in multiple centers.


Eligibility criteria: Inclusion Criteria:

* Greater than or equal to 35 years of age
* bilateral heterogenous emphysema
* Patient has stopped smoking for a minimum of 8 weeks
* Read, understood and signed the Informed consent form

Exclusion Criteria:

* Patient has a history of recurrent significant respirator infection
* Patient has an inability to walk \> 140 meters
* Patient has evidence of other disease that may compromise survival such as lung cancer, renal failure, etc
* Patient is pregnant or lactating
* Patient has clinical significant bronchiectasis
* Patient has had previous LVR surgery, lung transplant or lobectomy
* Patient has been involved in other pulmonary drug studies within 30 days prior to this study

Primary outcomes:
measure: St. George's Respiratory Questionnaire
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice - Hospital Pasteur
city: Reims
country: France
facility: Gaetan Deslee
city: Strasbourg
country: France
facility: CHRU de Strasbourg-NHC
city: Berlin
country: Germany
facility: Campus Charite Mitte
city: Donaustauf
country: Germany
facility: Klinikum Donaustauf
city: Gauting
country: Germany
facility: Asklepios
city: Heidelberg
country: Germany
facility: Thoraxklinik
city: Hemer
country: Germany
facility: Lungenklinik
city: Stuttgart
country: Germany
facility: Krankenhaus von Roten Kreuz
city: Teubingen
country: Germany
facility: UKT University Hospital
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
References:
citation: Hartman JE, Klooster K, Gortzak K, ten Hacken NH, Slebos DJ. Long-term follow-up after bronchoscopic lung volume reduction treatment with coils in patients with severe emphysema. Respirology. 2015 Feb;20(2):319-26. doi: 10.1111/resp.12435. Epub 2014 Nov 23.
citation: Deslee G, Klooster K, Hetzel M, Stanzel F, Kessler R, Marquette CH, Witt C, Blaas S, Gesierich W, Herth FJ, Hetzel J, van Rikxoort EM, Slebos DJ. Lung volume reduction coil treatment for patients with severe emphysema: a European multicentre trial. Thorax. 2014 Nov;69(11):980-6. doi: 10.1136/thoraxjnl-2014-205221. Epub 2014 Jun 2.
Clinical trial NCT02550899: Polyacrylamide Hydrogel Injection Treatment for Anal Incontinence
Official title: Polyacrylamide Hydrogel Injection Treatment for Anal Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anal Incontinence
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2015-09-16
Enrollment: 30
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: A randomized study to evaluate the safety and effects of transanal submucosal polyacrylamide hydrogel injection therapy for anal incontinence.

Detailed description: A prospective randomized study to assess the use of Bulkamid for anal incontinence using three different transanal injection techniques .

Patients with anal incontinence severity Wexner score \>7. Standardised injection treatment at baseline. Clinical status and subjective symptom evaluation (Wexner score and FIQL) at baseline, 2 months, 6 months and 1 year.

Eligibility criteria: Inclusion Criteria:

* informed consent, anal incontinence with Wexner score \>10

Exclusion Criteria:

* ino additional pregnancies, schedule for pelvic organ surgery within 1 year of treatment, current or previous pelvic organ cancer, insulin treated diabetes, inflammatory bowel disease

Primary outcomes:
measure: Wexner overall score
timeFrame: 1 year
Secondary outcomes:
measure: FIQL overall score
timeFrame: 1 year
measure: Adverse events
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Karolinska Institutet Danderyd Hospital
name: Daniel Altman, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01835899: Safety, Tolerability and Pharmacokinetics of Multiple Rising Oral Doses of BI 1015550 Powder for Oral Solution
Official title: Safety, Tolerability and Pharmacokinetics of Multiple Rising Oral Doses of BI 1015550 Powder for Oral Solution in Healthy Male Volunteers q.d. or b.i.d.for 14 Days (a Randomised, Double-blind, Placebo-controlled Within Dose Groups Phase I Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2013-04-19
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate safety, tolerability, and pharmacokinetics of multiple rising oral doses of BI 1015550 in healthy male volunteers


Eligibility criteria: Inclusion criteria:

1. Healthy male subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions
2. Subjects unable to understand or to comply with study requirements

Primary outcomes:
measure: Percentage of Subjects With Drug-related Adverse Events
timeFrame: From first drug administration until last drug administration, upto 18 days.
Secondary outcomes:
measure: Cmax
timeFrame: 0:15h(hours); 0:30h; 0:45h; 1h;1:15h;1:30h; 2h;3h; 4h; 6h; 8h;10h; 12h; 24h; 34h and 47:55h after first drug administration.
measure: AUCt,1
timeFrame: 0:15h(hours); 0:30h; 0:45h; 1h;1:15h;1:30h; 2h;3h; 4h; 6h; 8h;10h and 12h after first drug administration
measure: AUC0-infinity
timeFrame: 0:15h(hours); 0:30h; 0:45h; 1h;1:15h;1:30h; 2h;3h; 4h; 6h; 8h;10h; 12h; 24h; 34h and 47:55h after first drug administration.
measure: Cmax,ss
timeFrame: 311:55h (hours); 312:15h; 312:30h; 312:45; 313h; 313:15h; 313:30h; 314h; 315h; 316h; 318h; 320h; 322h; 324h; 336h; 346h; 360h; 384h & 408h after first drug administration; last drug administration was at 312 h.
measure: AUCt,ss
timeFrame: 311:55h; 312:15h; 312:30h; 312:45; 313h; 313:15h; 313:30h; 314h; 315h; 316h; 318h; 320h; 322h and 324h after first drug administration; last drug administration was at 312 h.
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: 1305.2.1 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT03515499: Incentives for Adherence in Adolescent Asthma
Official title: Incentives for Medication Adherence in Adolescents With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Asthma in Children
Keywords: Adherence
Incentives
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2018-05-03
Enrollment: 52
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Financial incentives have been suggested as a possible means for increasing adherence to asthma medications. This study will evaluate an incentive strategy (daily small reward for adherence) in maintaining high levels of adherence as tracked by adherence sensors in adolescents with asthma.

Detailed description: Two groups will be enrolled. The control group will have mediation monitoring sensors placed on their controller inhalers. The treatment group will also have the monitoring sensors placed on their medications, however they will be paid up to $1 per day for perfect adherence for 3 months. Both groups will be monitored for 4 months. 10 subjects will be chosen from each group to complete semi-structured phone interviews

Eligibility criteria: Inclusion Criteria:

* physician diagnosed asthma
* on at least one inhaled controller medication

Exclusion Criteria:

* language other than English or Spanish (these are the only languages supported by the adherence monitoring application)
* other severe chronic lung disease including tracheostomy/ventilator dependence, interstitial lung disease or cystic fibrosis, or significant developmental delay.

Primary outcomes:
measure: Change in adherence rates
timeFrame: Daily for 12 weeks
Secondary outcomes:
measure: Changes in Qualitative outcomes - Barriers
timeFrame: After 3 months of monitoring
measure: Changes in Qualitative outcomes - Facilitators
timeFrame: After 3 months of monitoring
measure: Changes in Qualitative outcomes - Incentives
timeFrame: After 3 months of monitoring
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Childrens Hospital Colorado
state: Colorado
Study officials:
affiliation: Assistant Professor
name: Heather Hoch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01542099: The EC50 of Remifentanil Blunting Hemodynamic Response to Double Lumen Tube Intubation
Official title: The Effect Site Concentration of Remifentanil Blunting Hemodynamic Responses to Tracheal Intubation: Single Versus Double Lumen Tube
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodynamic Responses During Tracheal Intubation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2012-03-02
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the effect site concentration of remifentanil blunting hemodynamic changes to tracheal intubation of single or double lumen tubes.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing thoracic surgery that require one lung ventilation

Exclusion Criteria:

* patient who does not agree with this study
* BMI \< 16.0 or BMI \> 30
* cardiovascular disease, pulmonary disease, renal disease
* alcoholic abuser or drug abuser
* patient who takes any drug to influence cardiovascular system or sympathetic nervous system
* any use of local anesthetics or drugs to influence cardiovascular system during tracheal intubation

Primary outcomes:
measure: Changes from baseline in heart rate and mean arterial pressure after intubation
timeFrame: intubation period
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
citation: Kim TK, Hong DM, Lee SH, Paik H, Min SH, Seo JH, Jung CW, Bahk JH. Effect-site concentration of remifentanil required to blunt haemodynamic responses during tracheal intubation: A randomized comparison between single- and double-lumen tubes. J Int Med Res. 2018 Jan;46(1):430-439. doi: 10.1177/0300060517721072. Epub 2017 Jul 21.
Clinical trial NCT02350699: Control Study of Nautilus BrainPulse for the Detection of Concussion
Official title: Non Blinded Control Study of High School Athletes in Non Contact Sports
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Concussion
Lead sponsor: Jan Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2015-01-30
Enrollment: 22
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who are healthy controls and participate in a non-contact sport at the high school level.

Brief summary: To use the Nautilus BrainPulse to compare and contrast the signal patterns from this cohort's signal patterns with those of concussed high school athletes.

Detailed description: This study is a non-blinded study in high school athletes who will be presumed to no be suffering from a concussion. Healthy controls will be recruited from high school sports that are not associated with physical contact, which could generate concussions.

The primary objective of this study is to improve Jan Medical's signal analysis. Jan Medical will perform analysis.

Eligibility criteria: Inclusion Criteria:

* Male and female between 14 and 19 years of age
* Participating in non-contact sport at the Freshman, JV, and varsity level in a Bay Area High School
* Able to provide signed informed consent or have a legally authorized representative willing to provide informed consent on the subject's behalf

Exclusion Criteria:

* History, if any, of concussion or stroke
* History, if any, of alcohol or drug abuse
* History, if any, of mental disorder or cerebrovascular disorder
* Pregnant women
* Failure to comply with recording schedule
* Not suitable for participation in the study in the opinion of the PI
* Have suffered a concussion during the study
* Plays a contact sport (ex- football, lacrosse, basketball, soccer, ice hockey, cross-country)
* Related to a Jan Medical employee

Primary outcomes:
measure: To collect non-blinded Nautilus BrainPulseTM recordings from high school athletes who do not participate in a contact sport
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mountain View
country: United States
facility: Jan Medical, Inc.
state: California
Study officials:
affiliation: Jan Medical, Inc.
name: Paul Lovoi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02238899: Multicenter Register for Children and Young Adults With Intracranial Localized Medulloblastoma, CNS-PNET or Ependymoma
Official title: Multicenter Register for Children and Young Adults With Intracranial Localized Medulloblastoma, Central Nervous System (CNS)- Primitive Neuroectodermal Tumour (PNET), or Ependymoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Medulloblastoma, Childhood
Cerebral Primitive Neuroectodermal Tumor
Ependymoma
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2014-09-12
Enrollment: 354
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with medulloblastoma, CNS-PNET (incl. pineoblastoma, ependymoblastoma, CNS-neuroblastoma), or ependymoma (WHO II/ III) and age at diagnosis 0-21 years

Brief summary: The Register is based on the study HIT 2000 that recruited patients until 31.12.2011. All german patients with intracranial medulloblastoma, CNS-PNET, ependymoma can be included in the register. Object of the register is to maintain the quality of diagnostic standard by using of central review (Neuroradiology, Pathology, and cranio spinal fluid (CSF) cytology).

Furthermore, the register should enable to continue the collection of epidemiologic data and biological material (tumor material, CSF, and blood) for associated studies.

Detailed description: The Register is based on the study HIT 2000 that recruited patients until 31.12.2011. All german patients with intracranial medulloblastoma, CNS-PNET, ependymoma can be included in the register. Object of the register is to maintain the quality of diagnostic standard by using of central review (Neuroradiology, Pathology, and cranio spinal fluid (CSF) cytology).

Furthermore, the register should enable to continue the collection of epidemiologic data and biological material (tumor material, CSF, and blood) for associated studies.

The register gives recommendations for the therapy of the patients, but these are not mandatory.

Eligibility criteria: Inclusion Criteria:

* age at diagnosis 0-21 years
* histologically proven medulloblastoma, CNS-PNET (incl. pineoblastoma, ependymoblastoma, CNS-neuroblastoma), or ependymoma (WHO II/ III)

Exclusion Criteria:

* none

Primary outcomes:
measure: Event free survival (EFS)
timeFrame: up to 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Hospital
Study officials:
affiliation: University Hospital Hamburg
name: Stefan Rutkowski, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01726699: Scripps Tumorgraft Study
Official title: Scripps Tumorgraft Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Solid Tumor Malignancy or Hematologic Malignancy
Lead sponsor: Scripps Translational Science Institute
Sponsor class: OTHER
First posted: 2012-11-15
Enrollment: 11
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults with a solid tumor malignancy or a hematologic malignancy

Brief summary: Study the genetic traits of cancerous tissues and to help improve cancer treatment by developing tumor models for studying new cancer drugs.


Eligibility criteria: Inclusion Criteria:

* Age 21 or over
* diagnosis of a solid tumor malignancy, either resectable or metastatic or a hematologic malignancy
* cognitively and emotionally able to give informed consent

Exclusion Criteria:

* Under age 21
* Not cognitively or emotionally able to give informed consent

Primary outcomes:
measure: Facilitate the development of individualized tumorgraft models for many different types of cancer.
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Translational Science Institute
state: California
Study officials:
affiliation: Director, Applied Genetic Epidemiology
name: Laura Goetz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04489199: Dijon Stroke Cohort
Official title: Dijon Stroke Cohort
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: CVA, Dijon Registry
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2020-07-28
Enrollment: 4000
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 included in the Dijon Stroke Registry

Brief summary: The Dijon Stroke Registry, accredited by the Registry Evaluation Committee, INSERM and Public Health France, has been studying the epidemiology of cerebrovascular accidents (cerebral infarction, intracerebral haemorrhages, meningeal haemorrhages) and transient ischaemic attacks (TIAs) within the city of Dijon since 1985.

As a result of the development of therapies for acute disease, the prognosis of patients has improved over time. Thus, the number of stroke survivors has increased by 90% between the 1980s and today. This raises new issues: risk of vascular recurrence, drug iatrogeny, and functional impact of stroke for motor, cognitive or thymic function. In the absence of available data in France, the investigators wish to set up an extended cohort follow-up of patients in order to study their long-term prognosis and to study the impact of future therapies on the evolutionary course of the disease.


Eligibility criteria: Inclusion Criteria:

* patients included in the Dijon Stroke Registry and not opposed to participating

Exclusion Criteria:

* minor patients; opposition to participation

Primary outcomes:
measure: Death rate
timeFrame: Trough study completion, an average of 10 years
measure: Disability rate
timeFrame: Trough study completion, an average of 10 years
measure: Quality of Life Questionnaire
timeFrame: Trough study completion, an average of 10 years
measure: Neuropsychological questionnaire
timeFrame: Trough study completion, an average of 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourgogne
Study officials:
References: