louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03870009: Validation of a Semi-automatized Method to Detect Cyclic Hyperinflation on CT-scan in ARDS
Official title: Validation of a Semi-automatized Method to Detect Cyclic Hyperinflation on CT-scan in ARDS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Respiratory Distress Syndrome (ARDS)
Keywords: ARDS
computed tomography
cyclic hyperinflation
mechanical ventilation
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-03-11
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study aims to validate a semi-automatized method to quantify cyclic hyperinflation on CT-scan of ARDS patients.

The gold standard will be cyclic hyperinflation assessed on the same CT scan, using manual segmentation of the lung.


Eligibility criteria: Inclusion Criteria:

* ARDS patients defined by the Berlin definition
* invasive mechanical ventilation with an arterial oxygen pressure (PaO2)/inspired fraction of oxygen (FiO2) ratio ≤ 200 mm Hg
* Indication of CT scan identified by the clinician in charge
* oesophageal catheter already inserted

Exclusion Criteria:

* requirement of contrast agent for a chest CT-scan
* ARDS criteria present for more than 72 hours
* Chronic Obstructive Pulmonary Disease (COPD) on a previous lung function test
* pneumothorax or bronchopleural fistula
* patient without both sedation and neuromuscular blocking agents
* contra-indication to transport to the imaging facility
* treatment with extracorporeal membrane oxygenation or extracorporeal carbon dioxide (CO2) removal
* Latex or curare allergy
* patient previously included in the study
* pregnancy
* patient under limitation of care
* patient under an exclusion period following inclusion in another clinical trial
* patient under a legal protective measure
* patient unaffiliated with social security
* inform consent not obtained by next of kin

Primary outcomes:
measure: cyclic hyperinflation measured by manual segmentation
timeFrame: 2 hours after inclusion
measure: cyclic hyperinflation measured by semi-automated segmentation
timeFrame: 2 hours after inclusion
Secondary outcomes:
measure: prevalence of cyclic hyperinflation on CT scan
timeFrame: 2 hours after inclusion
measure: area under receiver operating characteristic (ROC) curve of respiratory system driving pressure to detect cyclic hyperinflation assessed by manual segmentation
timeFrame: 2 hours after inclusion
measure: area under ROC curve of transpulmonary driving pressure to detect cyclic hyperinflation assessed by manual segmentation
timeFrame: 2 hours after inclusion
Other outcomes:
Locations:
city: Lyon
country: France
facility: Croix Rousse Hospital
Study officials:
affiliation: Hospices Civils de Lyon
name: Jean Christophe Richard
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04798807: Screening Nutritional Status of Hospitalized Patients
Official title: Screening Nutritional Status of Hospitalized Patients With Nutritional Risk Screening 2002 and Subjective Global Assessment Tools
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malnourishment
Keywords: Nutritional assessment
Nutritional Risk Screening 2002
Subjective Global Assessment.
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2021-03-15
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were hospitalized in the clinics (hematology, neurology, gastroenterology, nephrology, endocrine, pulmonary disease and cardiology) of Malatya Training and Research Hospital between January 1 and August 30, 2016.

Brief summary: This study investigated the results of the nutritional status of hospitalized patients with Nutritional Risk Screening 2002 (NRS-2002) and Subjective Global Assessment (SGA) screening and compared the effects of two screening method in predicting malnutrition.

Detailed description: In the cross-sectional study demographic data, body mass index (BMI), length of hospital stay (LOS), and cause of hospitalization of hospitalized patients were recorded. For the nutritional assessment all patients were screened with NRS 2002 and SGA within the first days of admission to the patients. The primary predictors of interest in our study were the NRS 2002 and SGA results of patients.

Eligibility criteria: Inclusion Criteria:

* ≥18 years old
* non-bed-dependent
* non-critİcal service patients

Exclusion Criteria:

* \< 18 years old,
* hospitalized due to surgical operation,
* pregnant women,
* breastfeeding women,
* bed-dependent,
* suffered an advanced disease that required palliative care.

Primary outcomes:
measure: Identifying malnourishment according to the Nutritional Risk Screening 2002
timeFrame: First 48 hours of hospitalization
measure: Identifying malnourishment according to the Subjective Global Assessment (SGA)
timeFrame: First 48 hours of hospitalization
measure: Compare the results of two screening tools.
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00415207: Pharmacogenomics of Paclitaxel in Ovarian Cancer
Official title: Pharmacogenomics of Paclitaxel in Ovarian Cancer: Predictors of Toxicity and Response
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Neoplasms
Fallopian Tube Neoplasms
Keywords: CYP2C8
MDR1
Pharmacogenetics
Paclitaxel
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Danish Clinical Intervention Research Academy
name: Ministry of the Interior and Health, Denmark
First posted: 2006-12-22
Enrollment: 300
Sex: FEMALE
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: Patients with ovarian cancer

Brief summary: This study will try to determine whether or not certain genes are responsible for the huge variation in toxicity and effect observed between patients treated with paclitaxel (chemotherapeutic drug). Specifically we will study this retrospectively in patients who participated in clinical trials that are now closed. All patients had ovarian cancer and received paclitaxel/carboplatin chemotherapy after primary surgery.

Detailed description: Paclitaxel is an antineoplastic drug used in the treatment of ovarian cancer. The effect and toxicity is unpredictable in the individual patient. Paclitaxel is removed (eliminated) from the organism by oxidation. CYP2C8 is the enzyme mainly responsible. P-glycoprotein (Pgp) is an efflux transport protein natural to the human organism. Pgp is responsible for excretion of drugs via the bile and the kidneys and is thought to play a role in chemotherapy resistance. Paclitaxel is substrate for Pgp. Single nucleotide polymorphisms are possible causes for variation in both CYP2C8 and Pgp expression/function. We will study a possible role of these genetic variations as predictors of paclitaxel toxicity and effect and the possible implications for individual dosing in the future.

We will use tissue from patients who participated in one of two clinical trials that are both closed for inclusion. Genotypic data from this tissue will be correlated with toxicity and survival data drawn from a research database. We expect to be able to find \>300 available cases to study.

Eligibility criteria: Inclusion Criteria:

* Patients enrolled in "TC/TEC" in Denmark, Sweden or Norway
* Patients enrolled in "OVAR-9" in Denmark, Sweden or Norway

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Clinical Pharmacology, University of Southern Denmark
Study officials:
affiliation: University of Southern Denmark
name: Kim Brøsen, phd
role: STUDY_DIRECTOR
References:
citation: Bergmann TK, Green H, Brasch-Andersen C, Mirza MR, Herrstedt J, Holund B, du Bois A, Damkier P, Vach W, Brosen K, Peterson C. Retrospective study of the impact of pharmacogenetic variants on paclitaxel toxicity and survival in patients with ovarian cancer. Eur J Clin Pharmacol. 2011 Jul;67(7):693-700. doi: 10.1007/s00228-011-1007-6. Epub 2011 Feb 16.
Clinical trial NCT00156507: Improving Asthma Care for Very Low Birth Weight Infants
Official title: Improving Asthma Care for Very Low Birth Weight Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Halcyon Hill Foundation
First posted: 2005-09-12
Enrollment: 192
Sex: ALL
Minimum age (years): 30
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Children born less than 1500 grams are being enrolled into a study to test the effectiveness of a parental educational intervention in reducing the risk of future breathing problems. The intervention teaches parents of these children how to reduce the risk of / and recognize breathing problems.


Eligibility criteria: Inclusion Criteria:

* Premature babies weighing less than 1500 grams at birth receiving care at Strong Memorial Hospital Neonatal Intensive Care Unit

Exclusion Criteria:

* Non-English speaking parents

Primary outcomes:
measure: To evaluate whether education about asthma improves parent knowledge about the disease and its management and to evaluate whether education about asthma influences healthy behaviors to reduce breathing problems
timeFrame: 7-9 months post discharge
Secondary outcomes:
measure: To evaluate the feasibility of implementing the intervention in terms of cost and personnel time and to obtain parental feedback about the intervention.
timeFrame: 1-3 years post baseline
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Strong Memorial Hospital - Neonatal Intensive Care Unit
state: New York
Study officials:
affiliation: University of Rochester
name: Jill S Halterman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00490607: A Prospective Study Comparing the Incidence of Infantile Hemangiomas Following Normal Pregnancies Versus Pregnancies Complicated by Placental Abnormalities
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hemangioma
Keywords: Hemagiomas of infancy
Lead sponsor: Rady Children's Hospital, San Diego
Sponsor class: OTHER
First posted: 2007-06-25
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: The purpose of this study is to investigate the pathogenesis of hemangiomas of infancy as they relate to normal pregnancies and those pregnancies complicated by placenta abnormalities. Women of all gestational ages will be enrolled in the study. Maternal serum, placental, and cord blood samples will be obtained for each subject. A medical history will be obtained for each subject. Post-delivery a member of the study team will perform a cutaneous exam of the infant to establish what birthmarks are present at birth. Mother will receive four phone call follow ups to determine if the infant has had any skin changes. If yes, mother will be asked to bring the child in for evaluation. If a hemangioma is diagnosed, a blood draw will be performed.


Eligibility criteria: Inclusion Criteria:

* pregnant women delivering at Sharp Mary Birch Hospital for Women in San Diego, CA

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Sharp Mary Birch Hospital for Women
state: California
Study officials:
affiliation: Rady Children's Hospital, San Diego
name: Sheila F Friedlander, MA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04196907: Rad-67 Repeatability and Reproducibility
Official title: Noninvasive Hemoglobin Spot Check Repeatability and Reproducibility in a Blood Donation Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: Masimo Corporation
Sponsor class: INDUSTRY
First posted: 2019-12-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The primary objective of this clinical investigation is to evaluate the repeatability and reproducibility of using Rad-67 Pulse CO-Oximeter


Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Weight at least 110 pounds
* Subjects with the intention of being screened for eligibility to donate blood
* The subject has given written informed consent to participate in the study

Exclusion Criteria:

* Subjects with skin abnormalities at the planned application sites that may interfere with sensor application, per directions-for-use (DFU) or trans-illumination of the site, such as burns, scar tissue, infections, abnormalities, etc.
* Subjects unwilling to remove nail polish or acrylic nails
* Subjects with blood cancers such as leukemia
* Subjects with hemoglobin disorders such as sickle-cell anemia and thalassemia or with known history of infectious diseases such as HIV/AIDS, syphilis, hepatitis, etc.
* Subjects with self-disclosed/known pregnancy at the time of enrollment
* Subjects deemed not suitable for the study at the discretion of the investigator
* Subjects unlikely to be able to refrain from excessive motion during data collection. Excessive motion includes postural changes, making hand gestures, involuntary muscular movements, etc.

Primary outcomes:
measure: Variation Ratio of Total Repeatability and Reproducibility Hemoglobin Measurements Using Rad-67.
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: San Diego Blood Bank
state: California
Study officials:
References:
Clinical trial NCT03890107: Clinical Evaluation of the OtoSight
Official title: Clinical Evaluation of a New Middle Ear Diagnostic to Support FDA Regulatory Clearance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Otitis Media
Keywords: Ear Infection
Ear tubes
Myringotomy
Otitis Media
Tympanostomy
Lead sponsor: PhotoniCare, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Carle Foundation Hospital
name: Children's National Health System
name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2019-03-26
Enrollment: 110
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children diagnosed with otitis media and scheduled for tympanostomy tube surgery.

Brief summary: The objective of this study is to evaluate the imaging capabilities and image analysis performance of the OtoSight Middle Ear Scope in pediatric patients undergoing tympanostomy tube placement for otitis media. In this observational study, results of OtoSight imaging will not affect patient standard of care.


Eligibility criteria: Inclusion Criteria:

* Children (17 years old or younger) scheduled for tympanostomy tube placement

Exclusion Criteria:

* Otoscopy contra-indicated or not possible per attending physician's decision

Primary outcomes:
measure: OtoSight imaging exam
timeFrame: 1-5 minutes
Secondary outcomes:
measure: Adverse events
timeFrame: Date of recruitment (day of surgery) to post-operative follow-up visit (approx. 1 month, but can be longer)
Other outcomes:
Locations:
city: Washington
country: United States
facility: Children's National Health System
state: District of Columbia
city: Urbana
country: United States
facility: Carle Foundation Hospital
state: Illinois
Study officials:
affiliation: PhotoniCare, Inc.
name: Ryan Shelton, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01136707: Predictors of Adherence to Orencia
Official title: Predictors of Adherence to Orencia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2010-06-03
Enrollment: 422
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: Commercial health plan members

Brief summary: The purpose of this study is to examine the relationship between loading dose and adherence to Orencia.


Eligibility criteria: Inclusion Criteria:

* Patients will be identified based on the presence of first infusion claim during study period for Orencia
* At least 1 medical or facility claim for rheumatoid arthritis at the time of or 6 months prior to index date
* Patients are required to be continuously enrolled for a minimum pre-index and follow-up period as detailed below
* Patients with a minimum of 3 infusion claims for Orencia
* Only those patients will be included whose first 3 infusion claims occur within 84 days

Exclusion Criteria:

* Patients less than 18 years of age at index date.
* One or more diagnoses of regional enteritis (including Crohn's disease), ulcerative colitis, anal or intestinal fistula, ankylosing spondylitis or other inflammatory spondylopathy, psoriatic arthropathy, or psoriasis any time during the 6-month pre-index period
* Patients who switch between biologics within their first three infusion claims
* Restarts, defined as those patients who go back on Orencia after a gap of 42 days
* Patients who are on other biologics at the same time as Orencia

Primary outcomes:
measure: Total number of days on Orencia therapy
timeFrame: 6 months
Secondary outcomes:
measure: Rheumatoid arthritis-related and total healthcare costs
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT04961307: Evaluation of Heart Function in Breast Cancer Patients Using Trastuzumab
Official title: Evaluation of Heart Function in Breast Cancer Patients Using Trastuzumab
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiotoxicity
Antitumor Drugs
Breast Cancer
Trastuzumab
Keywords: Cardiac safety
Antitumor drugs
Breast Cancer
Trastuzumab
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-14
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 30 female breast cancer patients using trastuzumab, collected demographic and clinical information of all patients before chemotherapy, performed echocardiography (conventional echocardiography, three-dimensional spot tracking technology), and collected blood samples to detect plasma biology Markers (TnT, BNP, GDF-15, topoisomerase)

Brief summary: By dynamically observing the changes of echocardiogram and biomarkers in breast cancer patients using trastuzumab, evaluate the effect of trastuzumab on cardiac function; determine the sensitivity of echocardiography and biomarker indicators And specificity, explore effective and specific early warning indicators, and provide technical support for the evaluation of the cardiac safety of anti-tumor drugs.

Detailed description: Thirty female breast cancer patients using trastuzumab, collected demographic and clinical information of all patients before chemotherapy, performed echocardiography (conventional echocardiography, three-dimensional spot tracking technology), and collected blood samples to detect plasma biology Markers (TnT, BNP, GDF-15, topoisomerase), follow-up echocardiography and biomarkers at 1 month, 3 months and 6 months after chemotherapy.

Eligibility criteria: Inclusion Criteria:

* Patients with breast cancer (18-70 years old)
* Patients who are planning to undergo trastuzumab for the first time

Exclusion Criteria:

* Organic heart disease such as coronary heart disease, heart valve disease, cardiomyopathy
* liver and kidney failure
* severe cerebrovascular disease
* chronic obstructive pulmonary disease
* rheumatic immune system disease
* other tumors

Primary outcomes:
measure: Time ending
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Peking
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT06477107: A Study of Cerebral Perfusion with TDCS in Chronic Hypoperfusion
Official title: Augmenting Cerebral Perfusion with Transcranial Direct Current Stimulation (tDCS) in Chronic Hypoperfusion States
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Moyamoya Syndrome
Moyamoya Disease
Atheroscleroses, Cerebral
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-06-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: For the Phase I portion of the study subjects the order of the stimulation (active vs sham stimulation) in a single session will be randomized and counterbalanced across subjects.

For the Phase II portion of the study a cross-over design will be used and the subjects will be randomly assigned either to active or sham tDCS first, then they will cross over to the other treatment arm after 4-week period of washout.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is being done to examine whether transcranial direct current stimulation (tDCS) will increase cerebral blood flow which may provide a clinical benefit such as improving cognitive impairment.


Eligibility criteria: Inclusion Criteria:

* Vasculopathy leading to imaging evidence of hypoperfusion
* Cognitive impairment

Exclusion Criteria:

* Pregnancy
* Contraindication to MRI or tDCS including metallic implanted objects.
* Medical instability or inability to cooperate during the study as assessed by the treating physician to participate in the study.

Primary outcomes:
measure: Changes in cerebral blood flow
timeFrame: Phase 1 Day 0 and Phase 2 Day 0, 14, 44, and 58
Secondary outcomes:
measure: Change in cognitive impairment
timeFrame: Phase 2 Days 0, 14±3, 44±7, and 58±14, 72±14
measure: Change in Fatigue Severity Scale (FFS)
timeFrame: Phase 2 Days 0, 14±3, 44±7, and 58±14, 72±14
measure: Change in Visual Analogue Scale to Evaluate Fatigue Severity (VAS-F)
timeFrame: Phase I Day 0, Phase 2 Days 0, 14±3, 44±7, and 58±14, 72±14
measure: Change in Stroke Specific Quality of Life (SS-QOL)
timeFrame: Phase 2 Days 0, 14±3, 44±7, and 58±14, 72±14
measure: Change in depression severity
timeFrame: Phase 2 Days 0, 14±3, 44±7, and 58±14, 72±14
measure: Change in sleepiness
timeFrame: Phase 2 Days 0, 14±3, 44±7, and 58±14, 72±14
measure: Change in trail making test
timeFrame: Phase 2 Days 0, 14±3, 44±7, and 58±14, 72±14
measure: Change in memory task
timeFrame: Phase 2 Days 0, 14±3, 44±7, and 58±14, 72±14
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Zafer Keser
role: PRINCIPAL_INVESTIGATOR
References: