louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03883971: Third Trimester 3D Printed Models Versus 3D Ultrasound Effects on Maternal-Fetal Attachment
Official title: Effects of 3D Printing Technology on Maternal Fetal Bonding Compared to 2D/3D Ultrasounds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maternal-Fetal Relations
Lead sponsor: Creighton University
Sponsor class: OTHER
Collaborators: name: John Cote
First posted: 2019-03-21
Enrollment: 96
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 3D ultrasound only or 3D ultrasound and printed model of fetal face
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will invite healthy women with singleton pregnancies and normal 20 week ultrasounds to participate in the study that will involve completing a demographic questionnaire and measure of attachment, a 3D ultrasound, being randomized to receive a 3D printed model of the fetal face or not, and completing the attachment measure again.


Eligibility criteria: Inclusion Criteria:

* women
* between19-45 years of age
* singleton pregnancy
* no less than 26-weeks pregnant and no more than 31-weeks pregnant at randomization
* normal fetal anatomic survey (fas) ultrasound
* fluent in English

Exclusion Criteria:

* additional medical or entertainment ultrasounds after the 20 week anatomic ultrasound

Primary outcomes:
measure: Maternal Antenatal Attachment Scale (MAAS)
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Creighton Univeristy
state: Nebraska
Study officials:
References:
Clinical trial NCT05102071: Clinical Outcomes and Healthcare Cost and Resource Utilization (HCRU) in Patients With Type 2 Diabetes and Cardiovascular Disease on 2nd Line Empagliflozin Versus 2nd Line Sulfonylureas
Official title: Clinical and Economic Impact of 2nd Line Initiation of Empagliflozin After Metformin, as Compared to 2nd Line Initiation of Sulfonylurea After Metformin in Patients With Type 2 Diabetes and Cardiovascular Disease
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Diabetes Mellitus, Type 2
Cardiovascular Diseases
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2021-11-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Type 2 Diabetes (T2D) and Cardiovascular Disease (CVD).

Brief summary: Evaluation of clinical outcomes (specifically cardiovascular outcomes like hospitalization for heart failure), and healthcare cost, and resource utilization, among patients on empagliflozin as an add-on therapy to metformin versus patients on sulfonylureas as an add-on therapy to metformin in patients with Type 2 Diabetes (T2D) and Cardiovascular Disease (CVD).


Eligibility criteria: Inclusion criteria:

* Prevalent metformin use + initiation of empagliflozin OR prevalent metformin use + initiation of sulfonylurea
* ≥18 years of age at index date during study observation
* ≥1 inpatient and/or ≥ 2 outpatient claims denoting T2D diagnosis (in any position) in the 12 months prior to index date
* ≥1 inpatient and/or ≥2 outpatient claims denoting CVD (in any position) diagnosis in the 12 months prior to index date
* ≥2 months post-index date
* ≥12 months of no exposure to T2D medications in the pre-index period (excluding metformin in both arms)
* ≥12 months of continuous enrolment prior to index date

Exclusion criteria:

* Diagnosis of Type 1 Diabetes, secondary, or gestational diabetes in the 12 months prior to index date
* Diagnosis of severe comorbidities including malignancy, end-stage renal disease, human immunodeficiency virus, Hepatitis C infection, or organ transplant in the 12 months prior to index date
* Admission to nursing home in the 12 months prior to index date

Primary outcomes:
measure: Occurrence of first hospitalization for congestive heart failure (HHF)
timeFrame: up to 5 years and 3 months
Secondary outcomes:
measure: Hospitalizations
timeFrame: up to 5 years and 3 months
measure: Emergency department (ED) visits
timeFrame: up to 5 years and 3 months
measure: Length of stay
timeFrame: up to 5 years and 3 months
measure: Number of filled drugs
timeFrame: up to 5 years and 3 months
measure: Outpatient visits
timeFrame: up to 5 years and 3 months
measure: All cause cost
timeFrame: up to 5 years and 3 months
Other outcomes:
Locations:
city: Ridgefield
country: United States
facility: Boehringer Ingelheim Pharmaceuticals Inc
state: Connecticut
Study officials:
References:
Clinical trial NCT01676571: Pharmacokinetic Properties of Lu AA21004 (Vortioxetine) in Healthy Young Chinese Men and Women
Official title: A Single-centre, Open-label, Single-dose Interventional Study Investigating the Pharmacokinetic Properties of Lu AA21004 in Healthy Young Chinese Men and Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2012-08-31
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The rationale for this pharmacokinetic (PK) study is to determine the PK parameters for Lu AA21004 (Vortioxetine) in the Chinese population.


Eligibility criteria: Inclusion Criteria:

* The subject is a Chinese man or woman
* The subject is, in the opinion of the investigator, generally healthy
* If female, the subject must have a negative pregnancy test at screening and baseline, and agree not to try to become pregnant from Screening until after the Follow-up Visit

Exclusion Criteria:

* The subject is, in the opinion of the investigator, unlikely to comply with the clinical study protocol or is unsuitable for any other reason.

Other inclusion and exclusion criteria may apply.

Primary outcomes:
measure: PK AUC determination of Lu AA21004 (Vortioxetine)
timeFrame: 11 days
measure: PK Cmax determination of Lu AA21004 (Vortioxetine)
timeFrame: 11 days
Secondary outcomes:
Other outcomes:
measure: PK MR determination of metabolites Lu AA34443 and Lu AA39835
timeFrame: 11 days
measure: Number of patients with adverse events as a measure of safety and tolerability
timeFrame: 11 days
Locations:
city: Tianjin
country: China
facility: CN001
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
citation: Miao J, Wang G, Hou J, Areberg J, Zhao Y, Hojer AM, Ettrup A. Pharmacokinetics and Safety of Vortioxetine in the Chinese Population. Adv Ther. 2019 Nov;36(11):3134-3146. doi: 10.1007/s12325-019-01092-4. Epub 2019 Sep 24.
Clinical trial NCT00568971: Study of Weekly DCF to Treat Advanced Gastric Cancer
Official title: Phase II Study of Weekly Docetaxol Combined With Cisplatin and 5-Fu in Patients With Advanced Gastric Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Gastric Cancer
Keywords: DCF
Advanced gastric cancer
Phase II study
Efficacy
Toxicity
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2007-12-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of weekly docetaxol combined with cisplatin and 5-Fu in patients with AGC.

Detailed description: Recently,in a multi-center, open-label randomized phase III study (V325), compared to the control arm of CF regimen, DCF showed higher efficacy in terms of response rate, time to progression and overall survival. But the regimen had increased grade 3-4 neutropenia (82% vs 57%) and febrile neutropenia infection (29% vs 12%). We began to study on weekly DCF in the patients with advanced gastric cancer to evaluate the efficacy no less than that of 3-week' regimen.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 70 years
* Patients with histologically confirmed, unresectable, recurrent and/or metastatic gastric adenocarcinoma
* ECOG performance status ≤1,life expectancy more than 3 months,
* Normal laboratory findings:absolute neutrophil count and platelet count ≥ 2.0×109/L and 80×109/L, respectively, hepatic function (total serum bilirubin ≤ UNL, transaminases ≤ 1.5 times upper normal limit) and renal function (calculated creatinine clearance ≥ 60 ml/min).
* Measurable disease according to the RECIST.

Exclusion Criteria:

* Pregnant or lactating women
* Serious uncontrolled diseases and intercurrent infection
* The evidence of CNS metastasis
* History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
* Received other chemotherapy regimen after metastasis
* Used taxane in adjuvant settings
* Participated in other clinical trials.

Primary outcomes:
measure: Response rate, overall survival
timeFrame: 2-6 months
Secondary outcomes:
measure: Side effects
timeFrame: 2-6 month
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Cancer Hospital
state: Shanghai
Study officials:
affiliation: Fudan University
name: Jin Li, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04953871: Enthesitis Assessment Before and After Anti-Tumor Necrosis Factor Treatment in Spondyloarthritis
Official title: Clinical and Ultrasonographic Enthesitis Assessment Before and After Anti-Tumor Necrosis Factor Treatment in Patients With Spondyloarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Spondyloarthritis
Enthesitis
Anti-Tumor Necrosis Factor Drugs
Lead sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Sponsor class: OTHER
First posted: 2021-07-08
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Biological therapies should be considered in patients with high disease activity despite nonsteroid antiinflammatory drug treatment. The first option among biological therapies is anti-Tumor Necrosis Factor (anti-TNF) drugs. In recent years, anti-TNF treatments have shown that clinical and ultrasonographic enthesitis may improve as well as disease activity, quality of life and acute phase reactants. In this prospective study, we aimed to evaluate the clinical and ultrasonographic evaluation of enthesitis and to determine its response to anti-TNF treatment in patients with SpA.In this prospective study, we aimed to evaluate the clinical and ultrasonographic evaluation of enthesitis and to determine its response to anti-TNF treatment in patients with SpA.


Eligibility criteria: Inclusion Criteria:

* Spondyloarthritis patients were diagnosed according to 2009 Assessment of Spondyloarthritis International Society (ASAS) criteria

Exclusion Criteria:

* Severe cardiovascular and respiratory diseases,
* Severe liver and kidney failure,
* Pregnancy and lactation,
* Active infection,
* Malignancy,
* Demyelinating diseases,
* Systemic lupus erythematosus,
* History of knee, elbow, foot and ankle surgery,
* Fluoroquinolone, retinoid and fluoride use,
* Local corticosteroid injection at the examination sites within the six weeks before evaluation
* Peripheral neuropathy

Primary outcomes:
measure: change from ultrasonographic entesitis score at 3 months
timeFrame: before and 3 months after anti-TNF treatment
Secondary outcomes:
measure: Change from disease activity
timeFrame: before and 3 months after anti-TNF treatment
measure: Change from disease activity
timeFrame: before and 3 months after anti-TNF treatment
measure: Change from quality of life
timeFrame: before and 3 months after anti-TNF treatment
measure: Change from Functionality
timeFrame: before and 3 months after anti-TNF treatment
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06032871: Comparisons of Two Airway Clearance Techniques
Official title: Comparison of Two Airway Clearance Techniques by Electrical Impedance Tomography- a Parallel Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Airway Clearance Impairment
Keywords: Airway clearance technique
Ventilator associated pneumonia
Electrical impedance tomography
High frequency chest wall oscillation
Chest physiotherapy
Lead sponsor: Chang Gung University
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to compare the effectiveness of two airway clearance techniques for patients with ventilator associated pneumonia. The main questions it aim to answer are:

* effect of the therapies on volume changes
* outcome on sputum clearance Participants will receive airway clearance techniques of
* chest physiotherapy
* high frequency chest wall oscillation.

Detailed description: Sputum can be accumulated in the airways of intubated patients, resulting in recurrent pneumonia. The airway clearance therapy is often utilized with chest physiotherapy or high frequency chest wall oscillation which has become popular for its easy of use and less time consuming to the healthcare workers. The main questions it aim to answer are on effectiveness of the therapies on lung volume changes and sputum clearance by two airway clearance techniques. With the oscillation of entire chest wall, the investigators hypothesize that the high frequency chest wall oscillation is more effectively clear sputum in the distal airways.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with chronic pulmonary disease
* Diagnosed with ventilator associated pneumonia
* Receive airway clearance therapy

Exclusion Criteria:

* Head injury, spinal injury
* Instable hemodynamics
* Intercranial pressure \> 20 cmH2O
* Active hemoptysis
* Empyema
* Eye surgery
* Abdominal distension
* Chest tube insertion
* Active tuberculosis

Primary outcomes:
measure: end-expiratory lung impedance
timeFrame: Measurement before intervention, 30 after, 1 hour and 2 hours after intervention
Secondary outcomes:
measure: Weight of secretions
timeFrame: Sputum is collected before intervention, 30 after, 1 hour and 2 hours after intervention
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung University
name: Hui-Ling Lin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rowley DD, Malinowski TP, Di Peppe JL, Sharkey RM, Gochenour DU, Enfield KB. A Randomized Controlled Trial Comparing Two Lung Expansion Therapies After Upper Abdominal Surgery. Respir Care. 2019 Oct;64(10):1181-1192. doi: 10.4187/respcare.06812. Epub 2019 May 21.
Clinical trial NCT05464771: The Impact of Patient Safety Incidents on Patients' Quality of Life
Official title: The Impact of Patient Safety Incidents on Patients' Quality of Life
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip Fractures
Knee Fracture
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2022-07-19
Enrollment: 395346
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The data available for our study was collected between 2013 and 2017. The patient safety incidents studied are relatively rare, and in order to yield enough observations to reliably estimate the impact of different incidents, the sample is limited to patients undergoing hip or knee replacements because these have more observations than do varicose veins and groin hernia. There are 267,477 and 288,967 observations for patients undergoing hip replacement and knee replacement respectively. Furthermore, the sample is limited to patients with observations of health status both before and after surgery.

Brief summary: This study estimates the impact of patient safety events on QoL in elective surgery patients using a secondary data set

Detailed description: Background: The burden of patient safety incidents (PSIs) is often characterised by their impact on mortality, morbidity and treatment costs. Few studies have attempted to estimate the impact of PSIs on patients' health-related quality of life (HRQoL) and the studies that have made such estimates primarily focus on a narrow set of incidents. The aim of this paper is to estimate the impact of PSIs on HRQoL of patients undergoing elective surgery in England.

Materials and Methods: A unique linked longitudinal data set consisting of Patient Reported Outcome Measures (PROMS) for patients with hip and knee replacements linked to Hospital Episode Statistics (HES) collected between 2013/14 and 2016/17 is examined. Patients with any of nine US Agency for Healthcare Research and Quality (AHRQ) PSI indicators are identified. HRQoL is measured using the general EuroQol five dimensions questionnaire (EQ-5D) before and after surgery. Exploiting the longitudinal structure of the data, exact matching combined with difference in differences to estimate the impact of experiencing a PSI on HRQoL and its individual dimensions, comparing HRQoL improvements after surgery in similar patients with and without a PSI.

Eligibility criteria: Inclusion Criteria:

* no

Exclusion Criteria:

* Patients for which health related quality of life is not observed both before and after surgery.

Primary outcomes:
measure: EuroQual - 5 Dimensions (EQ5D)
timeFrame: 2013-17
Secondary outcomes:
Other outcomes:
Locations:
city: Multiple Locations
country: United Kingdom
facility: Acute Trusts in England
Study officials:
References:
Clinical trial NCT01567371: LiDCO Monitor Study
Official title: Use of the LiDCORapid Monitor in Patients During Graded Phlebotomy and the Removal of Autologous Blood
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Surgery
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2012-03-30
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a study to validate the utility and accuracy of the non-invasive device (LiDCOrapid monitor) during a period of phlebotomy and graded blood loss in patients who are having cardiac surgery.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for intraoperative phlebotomy following anesthetic induction to obtain autologous blood for use following cardiopulmonary bypass and cardiac surgery.

Primary outcomes:
measure: Difference in Pulse Pressure Variability From Baseline to Post-ANH
timeFrame: 1 Day
Secondary outcomes:
measure: Difference in Stroke Volume Variability From Baseline to Post ANH.
timeFrame: 1 Day
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT04753671: QUANTRA® References Range Protocol in Pregnancy and Postpartum
Official title: Normal Pregnancy and Postpartum Reference Ranges Intervals for QUANTRA® (STAGO BIOCARE) Hemostasis Point of Care Device
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy Postpartum
Keywords: Hemostasis
pregnancy
postpartum
point of care
coagulopathy
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2021-02-15
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: a cohort of Healthy pregnant woman (indemne of any chronic pathology neither obstetrical pathology)

Brief summary: Postpartum hemorrhage (PPH) remains the leading cause of maternal death. PPH associated coagulopathy varies and their treatments (tranexamic acid, fibrinogen concentrates,plasma, platelets need to be targeted and administrated early. Point of care hemostasis devices are helpful to develop this strategy. Quantra® (STAGO BIOCARE) use an innovative method to detect the clot formation. Pregnancy and non-hemorrhagic postpartum reference ranges are missing. The objective of this study is to establish these norms needed to elaborate thereafter the thresholds to be targeted in PPH conditions.


Eligibility criteria: Inclusion Criteria:

* Healthy pregnant woman (indemne of any chronic pathology neither obstetrical pathology)
* Delivering vaginally without postpartum hemorrhage for 60 patients
* Delivering through a programmed C-section for 20 patients
* Having given a non-opposition agreement to participate in the study.
* Major patient with social insurance

Exclusion Criteria:

* Any acute or chronic hemostasis pathology before pregnancy or during pregnancy instrumental delivery or cesarean section Postpartum bleeding.

Primary outcomes:
measure: Description of the QUANTRA® parameters range intervals before and after vaginal delivery
timeFrame: At admission (= before delivery )
measure: Description of the QUANTRA® parameters range intervals before and after vaginal delivery
timeFrame: At 30 minutes +/- 10 minutes after delivery
Secondary outcomes:
measure: Description of the QUANTRA® parameters range intervals before and after vaginal delivery
timeFrame: At 30 up to 60 minutes after birth and placental removal.
measure: Comparison between end of pregnancy and immediate postpartum reference values (both vaginal and caesarean deliveries)
timeFrame: At 30 up to 60 minutes after birth
Other outcomes:
Locations:
city: Lille
country: France
facility: Hop Jeanne de Flandre Chu Lille
Study officials:
affiliation: University Hospital, Lille
name: Anne-Sophie DUCLOY-BOUTHORS, MD
role: PRINCIPAL_INVESTIGATOR
References: