louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02803671: Analysis of the Impact of Patent Ductus Arteriosus on Brain Function in Preterm Neonates: Multimodal Approach Integrating EEG-NIRS, Ultrasound and Clinical Data
Official title: Analysis of the Impact of Patent Ductus Arteriosus on Brain Function in Preterm Neonates: Multimodal Approach Integrating EEG-NIRS, Ultrasound and Clinical Data
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ductus Arteriosus, Patent
Keywords: preterm neonates
EEG-NIRS
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2016-06-17
Enrollment: 51
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This project corresponds to the main field of research of the investigators's laboratory concerning analysis of cerebral electrometabolic and haemodynamic activity in neonates. In this context, the investigators have developed know-how and specific acquisition and analysis tools (2 patents and several publications), allowing them to apply this know-how in children with patent ductus arteriosus.

Patent ductus arteriosus after birth is characterized by shunting of a variable proportion of cardiac output towards the pulmonary circulation. The direct consequences of this shunting are: (i) overload of the pulmonary vasculature and left heart chambers, increasing the risk of left heart failure, haemorrhagic pulmonary oedema and late respiratory complications such as bronchopulmonary dysplasia; (ii) in contrast with the pulmonary circulation, other systemic organs are deprived of part of their normal perfusion and are subject to ischaemic hypoxia; the resulting neuronal hypoxia rapidly leads to metabolic and electrical dysfunction, the analysis of which constitutes one of the objectives of this project.


Eligibility criteria: Inclusion Criteria:

1. Group of children :

   * meeting the age criteria
   * having a ductus arteriosus persistence.
2. Group of children :

   * meeting the age criteria
   * with persistent ductus arteriosus in the ultrasound examination
   * for which a cardiac or respiratory treatment has already been put in place.
3. normal group of children :

   * meeting the age criteria
   * without ductus arteriosus persistence ultrasound or detectable neurological disorders after clinical, neurophysiological and radiological (ETF , Scanner, MRI).

Exclusion Criteria:

-

Primary outcomes:
measure: change in cerebral tissue oxygenation
timeFrame: Day 3, Day 5 , Day 12, week 5
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
affiliation: CHU Amiens
name: Guy KONGOLO, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04487171: Screening for Postpartum Depression and Associated Risk Factors Among Women Who Deliver in Four Hospital in France During the COVID-19 Epidemic
Official title: Screening for Postpartum Depression and Associated Risk Factors Among Women Who Deliver in Four Hospital in France During the COVID-19 Epidemic
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postpartum Depression
Covid19
Prevalence
Social Distance
Keywords: Postpartum Depression
Covid19
Prevalence
Social Distance
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier de Beauvais
name: Central Hospital Saint Quentin
name: Centre Hospitalier Compiègne
First posted: 2020-07-27
Enrollment: 248
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Postpartum depression (PPD) represent around 15% of birth in developed countries. The context of the COVID-19 epidemy represents a possible source of additional emotional distress. The objective of this study is to determine the screening prevalence and risk factors of postpartum depression, among women who deliver in fourth hospital in the North of France in the context of the COVID epidemy.


Eligibility criteria: Inclusion Criteria:

* Single baby delivery
* alive new born child without admission in neonatal intensive care unit
* French-speaking mother
* mother older than 18 years old

Exclusion Criteria:

* Patients who refuses the inclusion

Primary outcomes:
measure: Variation of prevalence of clinically-significant post-partum depressive symptoms
timeFrame: up to 35 days after delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
affiliation: CHU Amiens
name: Arthur FOULON, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03419078: Nutrition and Outcomes of Hematopoietic Cell Transplantation (HCT)
Official title: Route and Adequacy of Nutrition and Outcomes of Haematopoietic Cell Transplantation in Patients With Haematological Neoplasms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Allogeneic Stem Cell Transplant
Graft Versus Host Disease
Hematologic Malignancy
Stem Cell Transplant Complications
Keywords: enteral nutrition
parenteral nutrition
artificial nutrition support
non-relapse mortality
survival
Lead sponsor: Imperial College Healthcare NHS Trust
Sponsor class: OTHER
First posted: 2018-02-01
Enrollment: 484
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients aged 17 or above who underwent their first HCT for hematologic malignancy at Hammersmith Hospital, using a sibling or unrelated donor between January 2000 and December 2014

Brief summary: Retrospective case-note review to determine if nutrition via the enteral compared to the parenteral route results in better outcomes after haematopoietic cell transplantation.

Detailed description: This is a retrospective case-note review of adults undergoing haematopoietic cell transplantation to treat a haematological malignancy who have been admitted to Hammersmith Hospital from 2000 to 2014. All patients receiving an allogeneic haematopoietic cell transplant from a matched sibling or identically matched unrelated donor will be included. We will record the route and assess the broad adequacy of nutritional intakes to determine if nutrition via the enteral compared to the parenteral route results in better outcomes after haematopoietic cell transplantation. Our outcomes are graft versus host disease incidence and severity, transplant related (early) mortality and overall survival.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing their first HCT for a hematologic malignancy
* Undergoing HCT using a sibling or unrelated donor
* Undergoing HCT infusion between January 2000 and December 2014

Exclusion Criteria:

* HCT using umbilical cord blood donors
* HCT using haploidentical donors

Primary outcomes:
measure: Number of Participants With Acute Graft Versus Host Disease (GvHD) at Any Site (Grade II or Above) and Acute GvHD of the Gut of Any Grade
timeFrame: 100 days after the date of hematopoietic cell infusion
measure: Non Relapse Mortality
timeFrame: 100 days after the date of hematopoietic cell infusion
Secondary outcomes:
measure: Graft Versus Host Disease-free and Relapse-free Survival
timeFrame: 5 years after the date of hematopoietic cell infusion
measure: 5 Year Survival
timeFrame: 5 years after the date of hematopoietic cell infusion
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04602871: Early Detection of COVID-19 Using Breath Analysis - Feasibility Study
Official title: Early Detection of the 2019 Novel Coronavirus (SARS-CoV-2) Using Breath Analysis - Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Lead sponsor: Scentech Medical Technologies Ltd
Sponsor class: INDUSTRY
First posted: 2020-10-26
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Early Detection of COVID-19 Using Breath Analysis -Feasibility Study.

Detailed description: An interventional diagnostic prospective study study with risks and minimal constraints.

Eligibility criteria: Inclusion Criteria:

Hospitalized group:

* Age 18 to 75 years at the time of consent
* Positive results for SARS-CoV-2
* Capable of understanding written and/or spoken language
* Able to provide informed consent
* Was not treated with Anti-viral drugs
* Not a pregnant woman

Healthy group:

* Healthy volunteers
* Age 18 to 75 years at the time of consent
* No history of COVID-19
* Capable of understanding written and/or spoken language
* Able to provide informed consent
* Was not treated with Anti-viral drugs
* Not a pregnant woman

Sexes Eligible for Study: All

Exclusion Criteria:

Hospitalized group:

* Age under 18 years old
* (Anticipated) inability to complete breath sampling procedure due to e.g. hyper- or hypoventilation, respiratory failure or claustrophobia when wearing the sampling mask
* Persons under guardianship or deprived of liberty
* Patients with the following diseases: Cancer, Asthma, Chronic Respiratory Disease

Healthy group:

* Age under 18 years old
* History of COVID-19
* Persons under guardianship or deprived of liberty
* Subjects with the following diseases: Cancer, Asthma, Chronic Respiratory Disease

Primary outcomes:
measure: Correlation between Volatile Organic Compounds pattern in-breath biopsy and COVID-19 detection.
timeFrame: Through the study completion, up to 3 months.
Secondary outcomes:
measure: Correlation between Volatile Organic Compounds pattern and the course of the disease
timeFrame: Through the study completion, up to 3 months.
Other outcomes:
Locations:
city: Be'er Sheva
country: Israel
facility: Soroka Medical Center
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
affiliation: Meir Medical Center, Kfar Saba, Israel
name: David Shitrit, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05462171: The Prevalence of Erectile Dysfunction (ED) and Premature Ejaculation (PE) in Poland
Official title: The Prevalence of Erectile Dysfunction (ED) and Premature Ejaculation (PE) in Poland
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Erectile Dysfunction
Premature Ejaculation
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2022-07-18
Enrollment: 3000
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: A representative group of male Polish population (n=3000).

Brief summary: The first large population-based study to evaluate erectile dysfunction (ED) and premature ejaculation (PE) in Poland. The study objective is to assess the prevalence and bother of ED and PE in the representative group of male population of Poland.


Eligibility criteria: Inclusion Criteria:

* Age ≥18
* A sufficient level of education to understand study procedures and be able to communicate with site personnel

Exclusion Criteria:

• Age \<18

Primary outcomes:
measure: Prevalence of ED in Poland
timeFrame: Through study completion, an average of 3 months
measure: Prevalence of PE in Poland
timeFrame: Through study completion, an average of 3 months
Secondary outcomes:
measure: Bother of ED and PE in Poland
timeFrame: Through study completion, an average of 3 months
measure: Prevalence of lower urinary tract symptoms in patients with PE and ED in Poland
timeFrame: Through study completion, an average of 3 months
measure: Prevalence of overactive bladder in patients with PE and ED in Poland
timeFrame: Through study completion, an average of 3 months
measure: Prevalence of depressive symptoms in patients with PE and ED in Poland
timeFrame: Through study completion, an average of 3 months
measure: Prevalence of insomnia in patients with PE and ED in Poland
timeFrame: Through study completion, an average of 3 months
Other outcomes:
Locations:
city: Krakow
country: Poland
facility: Department of Urology, Jagiellonian University
state: Malopolskie
Study officials:
References:
Clinical trial NCT00939978: Effect of Preoperative Recombinant Human Erythropoietin on Transfusion Risk in Valvular Heart Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Surgery
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2009-07-15
Enrollment: 74
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The administration of rhEPO on the one day before cardiac surgery will be effective to decrease the bleeding due to the surgery.


Eligibility criteria: Inclusion Criteria:

* The 90 patients who are planned to have the heart surgery during this study period.(minimum age 20)

Exclusion Criteria:

* Uncontrolled hypertension(diastolic blood pressure(DBP)\>100 mmHg), Hct \> 45%, Plt. count)\>450,000
* There are no history of seizure, thrombus, cancer, acute hepatitis, alcoholism, peripheral blood vessel disease, pure red blood cell dysfunction, liver function failure, chronic multiple arthritis.
* No pregnancy, acute hyper parathyroidism.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance hospital
Study officials:
References:
Clinical trial NCT02650778: Automated Breast Ultrasound Screening
Official title: Automated Breast Ultrasound Screening in Women With Dense Breasts (BIRADS 3 or 4) and BIRADS Category 1 or 2 Mammogram Assigning BIRADS 3 Lesions to Yearly Follow-up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Breast Cancer
Automated whole breast ultrasound
BI-RADS category 3 lesions
Lead sponsor: Northeastern Ohio Radiology Research and Education Fund
Sponsor class: OTHER
First posted: 2016-01-08
Enrollment: 2257
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women age \>18 scheduled for routine screening mammogram. Women with Density 3 or 4 and BIRADS category 1 or mammogram are asked to participate in study

Brief summary: Women with dense breasts (BIRADS 3 or 4) with a BIRADS category 1 or 2 mammogram are asked to participate in a automated volume breast ultrasound scanner. The study evaluates prospectively the changes in recall rate, positive biopsy rate, cancer detection rate when BIRADS category 3 lesions are given a 1 year follow-up recommendation.

Detailed description: Women with dense breasts (BIRADS 3 or 4) with a BIRADS category 1 or 2 mammogram are asked to participate in a automated volume breast ultrasound scanner. If the women agrees to participate and sign informed consent she undergoes an automated whole breast scan. The scan is interpreted independent of the mammogram. Scans are assigned a BIRADS category score of 1, 2, 3,or 0. BIRADS category 3 lesions are reported as no evidence of malignancy and a 1 year follow-up is recommended. BIRADS category 0 lesions are requested to have a hand held ultrasound including elastography. Follow up is then determined by BIRADS score and elastography results of hand held ultrasound.

The study evaluates prospectively the changes in recall rate, positive biopsy rate, cancer detection rate when BIRADS category 3 lesions are given a 1 year follow-up recommendation.

Eligibility criteria: Inclusion Criteria:

* Women age \>18 scheduled for routine screening mammogram. Women with Density 3 or 4 and BIRADS category 1 or mammogram are asked to participate in study

Exclusion Criteria:

* Inability to give informed consent

Primary outcomes:
measure: Decreased recall rate for screening breast ultrasound while maintaining cancer detection rate
timeFrame: 3 years
Secondary outcomes:
measure: Increased positive biopsy rate
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
References:
citation: Barr RG, DeSivestri A, Golatta M. Outcomes of Return to Routine Screening for BI-RADS 3 Lesions Detected at Supplemental Automated Whole-Breast Ultrasound in Women With Dense Breasts: A Prospective Study. AJR Am J Roentgenol. 2021 Dec;217(6):1313-1321. doi: 10.2214/AJR.21.26180. Epub 2021 Jul 14.
Clinical trial NCT02077478: Total Intravenous Anesthesia: TCI Versus MCI
Official title: Total Intravenous Anesthesia: TCI Versus MCI, Unresolved Question
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Test the Differences Between Schinder's TCI Model and MCI
Lead sponsor: Università degli Studi di Ferrara
Sponsor class: OTHER
First posted: 2014-03-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: test the following differences between Schinder's Target Controlled Infusion (TCI ) model and manually controlled infusion (MCI) :

* remifentanil and propofol total dose given
* incidence of awareness or inadequate anesthesia
* number of rescue dose given


Eligibility criteria: Inclusion Criteria:

* patients undergoing breast or thyroid surgery

Exclusion Criteria:

* BMI \> 35
* Surgery shorter than 30 minutes
* Patients with history of: alcol or drug abuse, kidney or liver failure, cardiovascular disease

Primary outcomes:
measure: incidence of awareness or inadequate anesthesia
timeFrame: every 3 minutes till the end of surgery
Secondary outcomes:
measure: remifentanil and propofol total dose given
timeFrame: every 30 minutes till the end of surgery
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: 0532206570
Study officials:
References:
citation: Russell D. Intravenous anaesthesia: manual infusion schemes versus TCI systems. Anaesthesia. 1998 Apr;53 Suppl 1:42-5. doi: 10.1111/j.1365-2044.1998.53s113.x.
Clinical trial NCT00967278: Hemodynamic Changes in Off-pump Coronary Artery Bypass Grafting
Official title: Hemodynamic Changes in Off-pump Coronary Artery Bypass Grafting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: OPCAB
pulmonary artery catheter
esophageal doppler
hemodynamics
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2009-08-27
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with coronary artery disease indicated to elective surgical treatment

Brief summary: The purpose of this study is to study the positioning and stabilization of different cardiac walls performed during off-pump coronary artery bypass grafting (CABG) may have dissimilar impact on hemodynamics.

The objective is to evaluate hemodynamics during distal coronary anastomoses in different cardiac walls.

Detailed description: * Twenty patients undergoing off-pump CABG monitored with pulmonary artery catheter and esophageal doppler will be enrolled.
* Patients with a left ventricular ejection fraction \<50%, age \>80 yr, creatinine \>1.4 mg/dl, reoperation, valvular heart disease or chronic obstructive pulmonary disease were excluded
* Data will be collected after volemic and hemodynamic adjustments, after heart positioning and establishment of a suction stabilizer and before its removal in anterior, lateral or posterior wall artery anastomosis.
* Data was compared by means of two-way repeated measures ANOVA.

Eligibility criteria: Inclusion Criteria:

* Normal left ventricular function
* Minimal to moderate surgical risk according to criteria proposed by Higgins et al. (JAMA. 1992 May 6;267(17):2344-8)

Exclusion Criteria:

* Patients with a left ventricular ejection fraction \<50%,
* Age \>80 yr
* Creatinine \>1.4 mg/dl
* Reoperation
* Valvular heart disease
* Chronic obstructive pulmonary disease
* High surgical risk according to criteria proposed by Higgins et al. (JAMA. 1992 May 6;267(17):2344-8)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Study officials:
References:
Clinical trial NCT03013478: Computer Based Training in CBT in Primary Care
Official title: Computer Based Training in CBT in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Abuse
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2017-01-06
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To conduct an 8-week randomized trial evaluating the feasibility and efficacy of adding CBT4CBT to treatment as usual in a community based primary care program in a population of 60 individuals who meet current DSM criteria for substance use disorder other than nicotine.

Detailed description: The investigators will conduct an initial evaluation of the computer program as an enhancement of treatment as usual in a community-based primary care clinic. Sixty individuals with a current DSM-IV alcohol or substance use disorder will be randomly assigned to either (1) treatment as usual, or (2) treatment as usual plus exposure to the 'CBT for CBT' program over a period of 8 weeks. Primary outcomes will be retention in treatment and reduction in drug use over 8 weeks. Secondary outcomes include treatment utilization

Eligibility criteria: Inclusion Criteria:

* Are 18 years of age or older.
* Are applying for outpatient substance abuse treatment
* Meet current DSM-IV criteria for cocaine, marijuana, opioid, alcohol or other stimulant use disorder
* Are sufficiently stable for 8 weeks of outpatient treatment
* Can commit to 8 weeks of treatment and are willing to be randomized to treatment
* Are willing to provide locator information.

Exclusion Criteria:

* Have an untreated bipolar or schizophrenic disorder
* Have a current legal case pending such that incarceration during the 8 week protocol is likely
* Are in need of detoxification from alcohol, opioids or benzodiazepines

Primary outcomes:
measure: retention in treatment
timeFrame: 0 - 8 weeks
measure: reduction in drug use
timeFrame: 0 - 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital St Raphael's Campus
state: Connecticut
Study officials:
affiliation: Yale University
name: Kathleen M Carroll, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tetrault JM, Holt SR, Cavallo DA, O'Connor PG, Gordon MA, Corvino JK, Nich C, Carroll KM. Computerized Cognitive Behavioral Therapy for Substance Use Disorders in a Specialized Primary Care Practice: A Randomized Feasibility Trial to Address the RT Component of SBIRT. J Addict Med. 2020 Dec;14(6):e303-e309. doi: 10.1097/ADM.0000000000000663.