louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02916602: A Study to Evaluate Efficacy and Safety of HCP1401 for Stage 2 Hypertension Patients Not Controlled by HCP0605
Official title: A Randomized, Double-blind, Multicenter, Phase 3 Study to Evaluate Efficacy and Safety of HCP1401 for Stage 2 Hypertension Patients Not Controlled by HCP0605
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2016-09-27
Enrollment: 340
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A phase 3 study to evaluate efficacy and safety of HCP1401

Detailed description: A randomized, double-blind, multicenter, phase 3 study to evaluate efficacy and safety of HCP1401 for stage 2 hypertension patients not controlled by HCP0605

Eligibility criteria: Inclusion Criteria:

* Hypertension patient who satisfied below condition at Visit 1.

  * patient who takes antihypertensive drug

    * 140mmHg \<= sitSBP \<= 200mmHg
  * patient who doesn't take antihypertensive drug

    * 160mmHg \<= sitSBP \<= 200mmHg
    * 140mmHg \<= sitSBP \<= 200mmHg at Visit 2

Exclusion Criteria:

* Patient who have received 4 or more antihypertensive drug
* Patient with 20mmHg of difference in sitSBP or 10mmHg of difference in sitDBP between 3 times of BP measuring at Visit 1
* Patient with sitDBP \>= 120mmHg at Visit 2
* Patient with secondary hypertension

Primary outcomes:
measure: Change from baseline in sitting systolic blood pressure at week 8
timeFrame: 8 weeks
Secondary outcomes:
measure: Change from baseline in sitting diastolic blood pressure at week 2 and week 8
timeFrame: 2 weeks and 8 weeks
measure: Change from baseline in sitting systolic blood pressure at week 2
timeFrame: 2 weeks
measure: Proportion of subjects achieving Blood Pressure control
timeFrame: 2 weeks and 8 weeks
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-Do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Cheulho Kim, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hong SJ, Jeong HS, Han SH, Chang KY, Hong BK, Lee BK, Chae SC, Kim WS, Park CG, Heo JH, Lee SU, Kim YD, Kim KS, Choi JH, Kang HJ, Kim JJ, Kang SM, Choi YJ, Shin JH, Chun KJ, Shin DG, Park SH, Kwan J, Choi YJ, Jeong MH, Chae JK, Kim DW, Cho JR, Han KR, Won KH, Park SH, Lee SK, Kim SH, Jung J, Kim CH. Comparison of Fixed-dose Combinations of Amlodipine/Losartan Potassium/Chlorthalidone and Amlodipine/Losartan Potassium in Patients With Stage 2 Hypertension Inadequately Controlled With Amlodipine/Losartan Potassium: A Randomized, Double-blind, Multicenter, Phase III Study. Clin Ther. 2017 Oct;39(10):2049-2060. doi: 10.1016/j.clinthera.2017.08.013. Epub 2017 Sep 19.
Clinical trial NCT04393402: Lung Ultrasound Score in Covid 19 Infectious Disease in Critical Care (LUS-COVID19)
Official title: Lung Ultrasound Score in Covid 19 Infectious Disease in Critical Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2020-05-19
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with diagnose of Covid 19 by usully method, and admitted in critical care unit for oxygen-therapy or ventilatory support.

Brief summary: It might be necessary with Sars-Cov2 pneumopathy patient to repeat thoracic images, the tomodensitometry ones in particular. This task is difficult and nearly impossible for several reasons: respiratory and hemodynamic unstable patient, prone position and due to the high contagious nature of the disease.

The lung ultrasound is an easy tool, fast (between 5 and 10 minutes) and as a limited training.

In the context of the Sars-Cov2 epidemic, Buonsenso and al case report depict the first lung ultrasound for a Covid 19 patient.

Peng and al in Intensive Care Medicine accentuate the usefulness of this particular technic.

In the American Journal of Respiratory and Critical Care Medicine, a study has been published as a point-of-care, in which the doctors reported using the lung ultrasound with intensive and critical care patient.

In Critical Care 2016, it has been showed that ultrasound allowed with neat precisions, to predict severe ARDS patient response to the prone position, all-cause.

Another researchers team found a good correlation between lung ultrasound, the SOFA, APACHE II, CPIS score, and patient mortality.

And a new applicability in the pulmonary recruitment by PEEP titration has been presented.

The aim of this study is to evaluate the lung ultrasound in Covid19 ARDS.


Eligibility criteria: Inclusion Criteria:

* Diagnosed Sars-Cov2 patient, with PCR method qualitative or quantitative as usual.
* Intensive or critical care admission
* ARDS with PaO2/FiO2 \<300 at the admission
* Ventilatory support or oxygen-therapy

Exclusion Criteria:

* Age \< 18 years-old
* Pregnancy
* Patient with tutor- or curatorship or in prison

Primary outcomes:
measure: LUS applicability with COVID 19
timeFrame: 10 months
Secondary outcomes:
measure: Radiographic correlation (chest Xray and tomodensitometry)
timeFrame: 10 months
measure: LUS Mortality prediction
timeFrame: 10 months
measure: Prediction of Prone position response
timeFrame: 10 months
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
Study officials:
References:
Clinical trial NCT02043002: Early Changes in Positron Emissions Tomography (PET/CT) Scan as Predictors of Clinical Outcome in NSCLC Treated With EGFR Tyrosin Kinase Inhibitors (TKI)
Official title: Early Changes in 18F-fluorodeoxyglucose Positron Emissions Tomography (18F-FDG-PET/CT) Scan as Predictors of Clinical Outcome in NSCLC Treated With EGFR Tyrosin Kinase Inhibitors (TKI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-small Cell Lung Cancer Patients
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2014-01-23
Enrollment: 67
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: Erlotinib, an anti-cancer agent targeting the epidermal growth factor receptor (EGFR), is an active treatment of patients with non-small cell lung cancer (NSCLC). Effect of treatment is primary seen in patients harboring a mutation in the EGFR. However, 10-15% of patients does not harbor a mutation but respond as well. Identifying these patients is a problem and methods are lacking.

Studies have shown that an early 18F FDG-PET might can predict response and outcome in these patients, but further studies are needed to confirm these findings.


Eligibility criteria: Inclusion Criteria:

* Lung Cancer patients with non-small cell histology and stage IV disease
* candidate for erlotinib treatment as first/ second/ third line of treatment

Exclusion Criteria:

* pregnancy
* severe dyspnoea

Primary outcomes:
measure: 18F-FDG-PET evaluation
timeFrame: Time to progression and latest april 2015 (up to 2 years)
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
state: Jylland
Study officials:
References:
Clinical trial NCT00696202: Mirena Efficiency and Tolerability During the First Year of Use
Official title: A Multicentre, Open Label, Uncontrolled Study of the Tolerance, Acceptability and Contraceptive Efficacy of Mirena 52 mg®, an Intra-uterine Levonorgestrel Device, During the First Year After Insertion Post-partum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Medicated Intrauterine Devices
Contraception
Keywords: Mirena
Levonorgestrel
Intrauterine device
Efficacy
Tolerability
First year of use
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-06-12
Enrollment: 199
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this trial the efficacy and safety of Mirena was investigated during the first year of use


Eligibility criteria: Inclusion Criteria:

* Women aged 25 to 39 years who sought effective contraception during the post-partum period (i.e. insertion of the device between 6 and 12 weeks after parturition).

Exclusion Criteria:

* Standard exclusion criteria for use of intrauterine hormone devices

Primary outcomes:
measure: Adverse event related to the product causing a subject to withdraw, or be withdrawn, from the study at any time up to 12 months from the insertion of Mirena
timeFrame: within 12 months after randomization
Secondary outcomes:
measure: General safety assessment
timeFrame: within 12 months after randomization
Other outcomes:
Locations:
city: Amiens Cedex 01
country: France
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01130402: A Real-time and Computerized Sonographic Reporting System in Predicting Malignant Cervical Lymphadenopathy
Official title: A Real-time and Computerized Sonographic Scoring System for Predicting Malignant Cervical Lymphadenopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphadenopathy
Keywords: age
lymphadenopathy
fine needle aspiration
sonography
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2010-05-26
Enrollment: 189
Sex: ALL
Minimum age (years): 10
Maximum age (years): 83
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with previously untreated neck masses were referred for sonographic evaluation and subsequent US-FNA after informed consent was obtained. Demographic data, including age and sex, side, site, and number of lymphadenopathy was collected as well.

Brief summary: The investigaotors want to establish a real-time and computerized score reporting system based on the significant predictors of the measured sonographic parameters and demographic data.

Detailed description: One hundred eight patients with neck lymphadenopathy, receiving ultrasonography and ultrasound-guided fine-needle aspiration (US-FNA), were used to construct a predictive model. This model was validated by another independent patient cohort.

Eligibility criteria: Inclusion Criteria:

* Patients with previously untreated neck masses underwent neck US

Exclusion Criteria:

* The neck mass was not lymph node
* No US-FNA cytology result

Primary outcomes:
measure: The final diagnoses of lymph nodes were made by US-FNA cytological studies, pathologic results of the biopsy specimens, or at least 3 months of negative follow-up observations.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Far Eastern Memorial Hospital
Study officials:
affiliation: Department of Otolaryngology, Far Eastern Memorial Hospital, Taipei, Taiwan
name: Li-Jen Liao, MD
role: STUDY_DIRECTOR
References:
citation: Liao LJ, Wang CT, Young YH, Cheng PW. Real-time and computerized sonographic scoring system for predicting malignant cervical lymphadenopathy. Head Neck. 2010 May;32(5):594-8. doi: 10.1002/hed.21225.
Clinical trial NCT06595602: Intelligent Lung Support in the Intensive Care Unit
Official title: Intelligent Lung Support in the Intensive Care Unit (IntelliLung): An Observational, Prospective, Multicentre Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Mechanical Ventilation
Intensive Care Medicine
Keywords: Invasive mechanical ventilation
Intensive care medicine
critical care medicine
artificial intelligence
decision support
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 560
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: Invasively mechanically ventilated, adult, acute respiratory distress syndrome (ARDS) and non-ARDS patients expected to stay intubated and ventilated for more than 24 hours.

Brief summary: The aim of this observational study is to test the IntelliLung decision support system based on artificial intelligence. This system is intended to help to set the ventilator. The study includes patients with and without ARDS (acute respiratory distress syndrome) who are receiving invasive mechanical ventilation, as well as patients with additional extracorporeal lung support. The study will be conducted in several centers.

The main question of the study:

How well do the mechanical ventilation settings of healthcare staff match the recommendations of the IntelliLung system?


Eligibility criteria: Inclusion Criteria:

1. Male and female patients, age ⪰18 years
2. Written informed consent
3. Invasively mechanically ventilated patients expected to be intubated for more than 24 hours.

Exclusion Criteria:

1. Expected to die within ≤48 hours
2. Participation in an interventional mechanical ventilation trial
3. Mechanical Ventilation with a closed-loop ventilation mode
4. Persons dependent on the sponsor and/or investigator
5. Subjects who are currently imprisoned or otherwise in confinement ordered by law or other official authorities

Primary outcomes:
measure: Relative time of same device settings of healthcare provider and IntelliLung AI-DSS related to the total IntelliLung AI-DSS running time
timeFrame: From enrollment to discharge from the intensive care unit or successful weaning from the ventilator, assessed up to 180 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: epartment of Anesthesiology and Intensive Care Medicine, Pulmonary Engineering Group, Faculty of Medicine and University Hospital Carl Gustav Carus, TUD Dresden University of Technology, Dresden, Germany
name: Jakob Wittenstein
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04687202: The Clinical Characteristics, Management and Prognosis of Patients Developing Intraoperative Cardiac Arrest During Transcatheter Aortic Valve Implantation
Official title: The Clinical Characteristics, Management and Prognosis of Patients Developing Intraoperative Cardiac Arrest During Transcatheter Aortic Valve Implantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiac Arrest, Transcatheter Aortic Valve Implantation
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2020-12-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who developed intraoperative cardiac arrest during transcatheter aortic valve implantation from January 2014 to May 2019

Brief summary: This study was aimed to investigate the clinical characteristics, management and prognosis of patients developing intraoperative cardiac arrest during transcatheter aortic valve implantation


Eligibility criteria: Inclusion Criteria: patients who developed intraoperative cardiac arrest during transcatheter aortic valve implantation from January 2014 to May 2019 -

Exclusion Criteria: None.

-

Primary outcomes:
measure: Mortality
timeFrame: 1month
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital of Zhejiang University, School of Medicine
state: Zhejiang
Study officials:
References:
Clinical trial NCT05766202: The MOTIVE (Multiparas Overcoming Childbirth Fear Through Intervention and Empowerement) Feasibility Trial
Official title: The Development and Feasibility of Fear of Childbirth Intervention Aiming to Reduce Fear in Pregnant Multiparas: a Mixed Methods Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fear of Childbirth
Anxiety
Depression
Keywords: Multipara
Psychoeducation
Prenatal class
Midwife
Psychiatric nurse
Lead sponsor: Tampere University
Sponsor class: OTHER
Collaborators: name: Finnish Institute for Health and Welfare
name: Metropolia University of Applied Sciences
name: Kanta-Häme Central Hospital
First posted: 2023-03-13
Enrollment: 19
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to develop and pilot an intervention for the treatment of fear of childbirth for multiparas and to evaluate the feasibility of the intervention in the treatment of fear of childbirth in multiparas.


Eligibility criteria: Inclusion Criteria:

* over 18 years of age
* understands finnish language
* has self reported fear of childbirth
* is a multipara
* under 35 weeks pregnant
* willingness to participate in the study

Exclusion Criteria:

* openly psychotic
* at risk of suicide
* serious substance abuse problems

Primary outcomes:
measure: Change of Fear of Childbirth from baseline to pregnancy week 36 to 8 weeks after birth
timeFrame: Baseline, week 36 of pregnancy and 8 weeks after birth
Secondary outcomes:
measure: Depression
timeFrame: Baseline, week 36 of pregnancy and 8 weeks after birth
measure: Anxiety
timeFrame: Baseline, week 36 of pregnancy and 8 weeks after birth
measure: Childbirth experience
timeFrame: Only one measurement point, at 8-weeks after birth.
measure: Pregnancy related anxiety
timeFrame: Baseline and week 36 of pregnancy
measure: Maternal childbirth experience
timeFrame: Only one measurement point, at 8-weeks after birth.
Other outcomes:
Locations:
city: Hämeenlinna
country: Finland
facility: Kanta-Hämeen Keskussairaala
Study officials:
affiliation: Tampere University
name: Laura Sandström, MHSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01057602: Further Validation of the Memory Orientation Screening Test (MOST):A 5-minute Screening Test for Dementia in Primary Care Practice
Official title: Further Validation of the Memory Orientation Screening Test (MOST): A 5-minute Screening Test for Dementia in Primary Care Practice
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dementia
Keywords: Dementia
Screening Tests
Cognition
Memory
MOST
Lead sponsor: Clionsky, Mitchell, Ph.D., ABPP(CN)
Sponsor class: INDIV
First posted: 2010-01-27
Enrollment: 300
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample and primary care clinic

Brief summary: The purpose of this study is to apply a recently developed screening test for dementia, the Memory Orientation Screening Test (MOST) to two additional groups. Group one is composed of 150 elders who do not have dementia and are residing in the community so that we can determine what is a "normal" MOST score. These subjects will also be individually administered a one-hour battery composed of other commonly used tests of memory and information processing. Group two is composed of 150 elders who are administered the MOST by a nurse as part of their regular visit to the primary care doctor's office, and their scores will be compared against a rating of their cognitive ability made independently by the doctor or another nurse. Their scores will also be compared with a list of their medical problems and medications. Our hypothesis for the first group is that the MOST scores will be higher in the normal group than in the previous clinical groups and that MOST scores will correlate significantly with other neurocognitive tests. Our hypothesis for the second group is that the MOST can be administered quickly and easily by briefly trained nurses, that it will compare highly with doctor opinions, and that patients with known medical conditions related to dementia, such as hypertension or diabetes, will have lower MOST scores than patients in better health.


Eligibility criteria: Inclusion Criteria:

* Age 65 or older

Exclusion Criteria:

* Younger than 65,
* diagnosed with dementia,
* blind,
* non-English speaking

Primary outcomes:
measure: Memory Orientation Screening Test score
timeFrame: Day 1
Secondary outcomes:
measure: Other neuropsychological test scores and doctor ratings
timeFrame: Day 1
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Clionsky Neuro Systems, LLC
state: Massachusetts
Study officials:
affiliation: Clionsky Neuro Systems
name: Mitchell I Clionsky, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04756102: Glucose Levels in Early Pregnancy and Feto-maternal Outcome
Official title: Early Pregnancy Glycemic Levels in Non-diabetic Primigravid Women and Pregnancy Outcome; Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Maternal Diabetes
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2021-02-16
Enrollment: 218
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women in their first pregnancy

Brief summary: to find out whether variations in the fasting blood glucose in early pregnancy affect the fetomaternal outcome

Detailed description: Retrospective study conducted on the records of patients who were seen at Jordan University hospital in the period January 2016 to December 2020. All primigravid women with FBS that were done in early pregnancy before completed 20 weeks of gestation were included. Exclusion criteria were known diabetics, multiple pregnancies, thyroid dysfunction, patients taking steroids or any other medications for chronic illness (s) and those with missing data. Patients were divided into 2 groups; group had a FBS 80-120 mg/dl and group 2 with FBS less than 80 mg/dl. Pregnancy outcomes were then compared between the 2 groups.

Gestational age was confirmed by early ultra-sound (US) scan before 16 weeks gestation. All FBS samples were measured at our laboratory. Investigators collected data regarding patients' age, body mass index (BMI), FBS early in pregnancy, any complication in the pregnancy or the pregnancy outcome including miscarriage (defined as pregnancy loss before completed 24 weeks gestation), preterm delivery (defined as spontaneous vaginal delivery before completed 37 weeks gestation), gestational age at delivery, polyhydramnios, congenital abnormality (minor or major), stillbirth, intra-uterine fetal death (IUFD), neonatal death and mode of delivery. For those who underwent cesarean section, the indications were also identified. Fetal outcome included birth weight; APGAR score at 1 minute and APGAR score at 5 minutes. The APGAR score was determined by the neonatologists who routinely attend deliveries at our hospital.

Investigators also identified those who were diagnosed to have GDM with any intervention (metformin or insulin and their dosages). Diagnosis of GDM was based on a standard 75 gm glucose tolerance test (GTT) at 26-28 weeks gestation. A normal FBS level is lower than 95 mg/dL, one hour lower than 180 mg/dL, two hours lower than 155 mg/dL Three hours after drinking the glucose solution, a normal blood glucose level is lower than 140 mg/dL.

Eligibility criteria: Inclusion Criteria:

* Pregnant

Exclusion Criteria:

* Thyroid disorder
* Diabetes mellitus
* Taking Steroids

Primary outcomes:
measure: diagnosis of gestational diabetes
timeFrame: During her pregnancy; an average 20 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Al-Husban University Naser
Study officials:
References: