louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02971553: PEEP Resuscitation Trial
Official title: A Randomised Controlled Trial on Positive End-expiratory Pressure (PEEP) During Resuscitation of Non-breathing Neonates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Newborn Resuscitation
Lead sponsor: Helse Stavanger HF
Sponsor class: OTHER_GOV
Collaborators: name: Haydom Lutheran Hospital
First posted: 2016-11-23
Enrollment: 330
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Each year, almost 3 million newborn babies die within their first month of life, often as a consequence of labour complications. Approximately 5% of newborns will not start breathing at birth and need immediate help. The optimal ventilation strategy with liquid-filled lungs has not been determined. Animal studies suggest that assisted ventilation with positive end expiratory pressure (PEEP) improves the aeration of liquid-filled lungs leading to more rapid recovery. However, no large human clinical studies have investigated the clinical responses to assisted ventilation with PEEP in asphyxiated newborns.

Detailed description: Laerdal Global Health has developed a PEEP valve which has been tested and shown to provide reliable end-expiratory pressures in a manikin model, even with a high mask leak. Whether this PEEP valve provides reliable PEEP in vivo and whether this translates to clinical beneficial outcomes remains to be proven.

The aim is to study whether lung aeration can be improved by adding a device for positive end expiratory pressure (PEEP) to better distend the airways in neonates more than 28 weeks gestation.

Eligibility criteria: Inclusion Criteria:

* Neonates who need assisted bag/mask ventilation after birth due to failure to initiate breathing the first 60 seconds after birth.

Exclusion Criteria:

* Babies with major deformities not deemed to be viable.
* Missing parental consent

Primary outcomes:
measure: Delta heart rate (beats/minute) during each ventilation sequence
timeFrame: 10 minutes
Secondary outcomes:
measure: Neonatal outcome dead versus alive
timeFrame: Up to 24 hours
measure: Time to cessation of ventilation
timeFrame: Up to 1 hour
measure: Time to heart rate above 140 beats/minute
timeFrame: Up to 1 hour
measure: Mean ariway pressures given
timeFrame: Up to 1 hour
measure: Time to detection of exhaled CO2 above 1% and 4%
timeFrame: Up to 1 hour
Other outcomes:
Locations:
city: Haydom
country: Tanzania
facility: Haydom Lutheran Hospital, Research Institute
state: Manyara
Study officials:
affiliation: Muhimibili National Hospital
name: Hussein Kidanto, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Holte K, Ersdal H, Eilevstjonn J, Gomo O, Klingenberg C, Thallinger M, Linde J, Stigum H, Yeconia A, Kidanto H, Stordal K. Positive End-Expiratory Pressure in Newborn Resuscitation Around Term: A Randomized Controlled Trial. Pediatrics. 2020 Oct;146(4):e20200494. doi: 10.1542/peds.2020-0494. Epub 2020 Sep 11.
Clinical trial NCT00127153: A Study of V110 a Pneumococcal Vaccine in Healthy Adults (V110-013)
Official title: A Comparative Study in Healthy Adults of the Safety, Tolerability, and Immunogenicity of V110 Formulated With Either All New Process Polysaccharides or All Current Process Polysaccharides
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy
Pneumococcal Infections
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2005-08-05
Enrollment: 130
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to evaluate the safety, tolerability, and immunogenicity of an investigational pneumococcal vaccine in healthy adults.


Eligibility criteria: Inclusion Criteria:

* Males and females in good health, ages 20-40, with no history of pneumococcal vaccination

Exclusion Criteria:

* Subjects with a recent febrile illness
* Known or suspected immune dysfunction, conditions associated with immunosuppression, and receipt of immunosuppressive chemotherapy, including long-term corticosteroid therapy

Primary outcomes:
measure: Immunogenicity
Secondary outcomes:
measure: Safety
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03914053: Balancing of Patients Treated by Vitamin K Antagonists (VKAS) in General Medicine
Official title: Balancing of Patients Treated by Vitamin K Antagonists (VKAS) in General Medicine : Study ok Variables Influencing the Time Paid in the Therapeutic Target
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thromboembolism
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2019-04-12
Enrollment: 3387
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient treated with VKA

Brief summary: Despite the rise in prescriptions for direct oral anticoagulants,Vitamin K antagonists(VKA) remains the most prescribed treatment for treating and preventing long-term thromboembolic events. They remain the most important drugs of iatrogenic accidents despite the means deployed by the health authorities. The balance of the patients under VKA can be appreciated thanks to the time spent in the therapeutic zone or TTR which is correlated with the risk of occurrence of haemorrhagic or thrombotic events.

Detailed description: Despite the rise in prescriptions for direct oral anticoagulants, Vitamin K antagonists (VKA) remains the most prescribed treatment for treating and preventing long-term thromboembolic events. They remain the most important drugs of iatrogenic accidents despite the means deployed by the health authorities. The balance of the patients under VKA can be appreciated thanks to the time spent in the therapeutic zone or TTR which is correlated with the risk of occurrence of haemorrhagic or thrombotic events.

The management of VKA in France seems hardly comparable to that of the neighboring countries in front of:

* A TTR estimated at 60%.
* Majority management of anticoagulant treatments by general practitioners.
* The weak development of clinics anticoagulants.
* The takeoff of direct oral anticoagulant prescriptions.
* Preponderance of fluindione prescriptions among the various oral anticoagulants.

It therefore seems interesting to study a cohort of French patients under VKA. Through the calculation of the TTR, the investigators will be able to draw a picture of the balance of the anticoagulant treatment and try to identify factors that can influence it.

Eligibility criteria: Inclusion Criteria:

* Patient treated with VKA.
* Realization of INR in one of the labs of the territory of LaboSud Oc biology between 1 September 2015 and 13 January 2016.

Exclusion Criteria:

* Less than 3 INR during the data collection period (TTR calculation not possible).
* Time greater than 56 days between two INRs (calculation of the invalid TTR).
* Interrupted treatment (calculation of invalid TTR).
* Lack of information about the patient

Primary outcomes:
measure: time spent in the therapeutic range (TTR)
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Emile Emile
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05479253: AI-assisted Endoscopy Report System In Improving Reporting Quality
Official title: A Single-center Study of an AI-assisted Endoscopy Report System In Improving Reporting Quality
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Artificial Intelligence
Endoscopy
Lead sponsor: Renmin Hospital of Wuhan University
Sponsor class: OTHER
First posted: 2022-07-29
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DEVICE_FEASIBILITY

Brief summary: In this study, we proposed a prospective study about the effectiveness of artificial intelligence system for endoscopy report quality in endoscopists. The subjects would be divided into two groups. For the collected endoscopic videos, group A would complete the endoscopy report with the assistance of the artificial intelligence system. The artificial intelligence assistant system can automatically capture images, prompt abnormal lesions and the parts covered by the examination (the upper gastrointestinal tract is divided into 26 parts). Group B would complete the endoscopy report without special prompts. After a period of forgetting, the two groups switched, that is, group A without AI assistance and group B with AI assistance to complete the endoscopy report. Then, the completeness of the report lesion, the accuracy of the lesion location, the completeness of the lesion and the standard part in the captured images, and so on were compared with or without AI assistance.


Eligibility criteria: Inclusion Criteria:

1. Males or females who are over 18 years old;
2. After qualified medical education and obtained the Certificate of Chinese medical practitioner;

Exclusion Criteria:

1. Doctors without qualified medical education and didn't obtaine the Certificate of Chinese medical practitioner;
2. The researcher believes that the subjects are not suitable for participating in clinical trials.

Primary outcomes:
measure: Integrity of report lesion
timeFrame: one month
measure: Accuracy of lesion location
timeFrame: one month
measure: Integrity of lesion in captured images
timeFrame: one month
measure: Integrity of standard part in captured images
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
Study officials:
References:
Clinical trial NCT03128853: Spot-Check Noninvasive Hemoglobin (SpHb) Repeatability and Reproducibility
Official title: Spot-Check Noninvasive Hemoglobin (SpHb) Repeatability and Reproducibility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anemia
Healthy
Lead sponsor: Masimo Corporation
Sponsor class: INDUSTRY
First posted: 2017-04-25
Enrollment: 57
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Single-arm study to investigate the repeatability and reproducibility of SpHb measurements from the Rad-67 and DCI Mini sensor.

Detailed description: This study aims to evaluate the repeatability and reproducibility of Masimo's pulse CO-Oximeter and sensor to determine the device and sensor's precision in SpHb measurements.

Eligibility criteria: Inclusion Criteria:

* Age one month and older
* Weight greater than or equal to 3 kg
* The subject or the subject's legally authorized representative has given written informed consent/assent to participate in the study

Exclusion Criteria:

* Decision-impaired adult and pediatric patients who are unable to give informed consent/assent
* Decision-impaired adult on behalf of a pediatric patient who is unable to assent
* 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, nail polish, acrylic nails, infections, abnormalities, etc.
* 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: Repeatability and reproducibility of CO-oximeter and sensor
timeFrame: 120 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Masimo Clinical Laboratory
state: California
city: Charlotte
country: United States
facility: Site 1
state: North Carolina
Study officials:
References:
Clinical trial NCT05310253: Stress & Social Cognition in BPD (part 2)
Official title: "Fight-or-flight" Versus "tend-and-befriend" Response to Behavioral and Pharmacological Interventions in Patients with Borderline Personality Disorder (Part II)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Borderline Personality Disorder
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2022-04-04
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: FACTORIAL
Primary purpose: OTHER

Brief summary: The investigators will examine how a combination of pharmacological mineralocorticoid receptor (MR) stimulation and psychosocial stress will influence prosocial behavior in patients with Borderline Personality Disorder (BPD) compared to healthy controls (HC).

Detailed description: The investigators will examine whether MR stimulation enhances prosocial behavior in BPD patients under additional psychosocial stress. Participants will be randomly assigned to receive either fludrocortisone as an MR stimulant or placebo. Afterwards, participants will either undergo the stress or placebo condition of the Trier Social Stress Test ((P-)TSST). Subsequently, cognitive and emotional empathy, as well as sharing and punishment behavior will be measured.

Eligibility criteria: Inclusion Criteria "BPD group":

* clinical diagnosis of borderline personality disorder
* female
* BMI between 17.5-30

Inclusion Criteria "control group":

* female
* BMI between 17.5-30
* no clinical diagnosis of any mental disorder

Exclusion Criteria:

* acute depressive episode,
* acute or lifetime psychotic symptoms
* acute substance abuse
* physical illness

Primary outcomes:
measure: Empathy: Multifaceted Empathy Test
timeFrame: 15 minutes after (P-)TSST
Secondary outcomes:
measure: Sharing behavior
timeFrame: 10 minutes after (P-)TSST
measure: Punishment behavior
timeFrame: 10 minutes after (P-)TSST
Other outcomes:
measure: salivary cortisol
timeFrame: 3 hours
measure: salivary alpha amylase
timeFrame: 3 hours
measure: sex hormones
timeFrame: 3 hours
Locations:
city: Berlin
country: Germany
facility: Charite University
Study officials:
References:
Clinical trial NCT02903953: Clinical Research Outside of Teaching Hospitals (RECHNONU)
Official title: Clinical Research Outside of Teaching Hospitals : Current Situation in North-eastern France
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Medical Staff, Hospital
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2016-09-16
Enrollment: 129
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Non-teaching hospitals of North-eastern France

Brief summary: The very most part of clinical research in France takes place in teaching hospitals. Advantages to develop it in others hospitals are numerous: access to innovative treatments, improvement of healthcare quality, hospitals' attractiveness, increased inclusion rates and reduced selection bias. The objectives of the study are to report the current situation of clinical research outside of teaching hospitals in France.

Detailed description: The very most part of clinical research in France takes place in teaching hospitals. Advantages to develop it in others hospitals are numerous: access to innovative treatments, improvement of healthcare quality, hospitals' attractiveness, increased inclusion rates and reduced selection bias. The objective the study is report the current situation of clinical research outside of teaching hospitals in France.

A three-stage survey was conducted between January and October 2012 in non-teaching hospitals of North-eastern France. First questionnaires were sent to administrative and medical boards of all hospitals with more than 100 beds, then to head doctors of every department in hospitals with more than 300 beds and finally meetings were organized with clinical research actors of 20 selected hospitals.

Eligibility criteria: Inclusion Criteria:

* non-teaching hospitals
* established in north-eastern France

Exclusion Criteria:

* more than 100 beds
* for the second stage only:
* less than 300 beds

Primary outcomes:
measure: Description of the clinical research in non-teaching hospitals of north-eastern France
timeFrame: 1 year
Secondary outcomes:
measure: Specificities of each centers in clinical research
timeFrame: 1 year
measure: Problems to solve for developing clinical research
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: CHR Metz-Thionville
name: Christophe GOETZ, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02543853: The Effect of Two Different Endoscopic Entry Techniques on Postoperative Gastrointestinal Function
Official title: The Effect of Two Different Endoscopic Entry Techniques on Postoperative Gastrointestinal Function
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastrointestinal Disorder Postoperative
Lead sponsor: Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Sponsor class: OTHER
First posted: 2015-09-07
Enrollment: 140
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine effect of veres needle entry and direct trocar entry on postoperative gastrointestinal functions.

Detailed description: Women planned to have laparoscopic surgery will be randomized into two groups, in first group pneumoperitoneum will be provided by veres needle, in other group direct trocar entry will be used to provide pneumoperitoneum. After surgery gastrointesitinal functions, shoulder pain, blood loss will be compared between groups.

Eligibility criteria: Inclusion Criteria:

* Laparoscopic surgery for benign or malignant disease

Exclusion Criteria:

* Patients with gastrointestinal intervention
* Patients who had undergone previous operations
* Patients with gastrointestinal intervention dysfunction

Primary outcomes:
measure: Bowel sound (first bowel sound)
timeFrame: Postoperative first 72 hours
Secondary outcomes:
measure: Gas discharge
timeFrame: Postoperative first 72 hours
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Zeynep Kamil
Study officials:
References:
citation: Compeau C, McLeod NT, Ternamian A. Laparoscopic entry: a review of Canadian general surgical practice. Can J Surg. 2011 Oct;54(5):315-20. doi: 10.1503/cjs.011210.
citation: Daskalakis M, Scheffel O, Weiner RA. High flow insufflation for the maintenance of the pneumoperitoneum during bariatric surgery. Obes Facts. 2009;2 Suppl 1(Suppl 1):37-40. doi: 10.1159/000198252. Epub 2009 Mar 18.
citation: Ahmad G, O'Flynn H, Duffy JM, Phillips K, Watson A. Laparoscopic entry techniques. Cochrane Database Syst Rev. 2012 Feb 15;(2):CD006583. doi: 10.1002/14651858.CD006583.pub3.
Clinical trial NCT00738153: An Observational Study on Efficacy and Safety in Subjects Using Levemir® for the Treatment of Insulin Dependent Type 1 or Type 2 Diabetes
Official title: Efficacy and Safety Study of Levemir® (Insulin Detemir) to Treat Type 1 and 2 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-08-20
Enrollment: 798
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any subject with type 1 or type 2 diabetes is eligible for the study, including newly-diagnosed subjects who have never received insulin or an insulin analogue before

Brief summary: This observational study is conducted in Africa. The aim of this observational study is to evaluate the efficacy and the incidence of serious adverse drug reactions while using insulin Levemir® under normal clinical practice conditions.


Eligibility criteria: Inclusion Criteria:

* Any subject with Type 1 or Type 2 diabetes mellitus is eligible for the study, including newly-diagnosed subjects who have never received insulin or an insulin analogue before. The selection of the subjects will be at the discretion of the individual physician

Exclusion Criteria:

* Subjects who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit
* Currently being treated with insulin detemir
* Previously enrolled in this study
* Hypersensitivity to insulin detemir or to any of the excipients
* Pregnancy, breast-feeding, the intention to become pregnant or judged not to be using adequate contraceptive measures.

Primary outcomes:
measure: The incidence of serious adverse drug reactions, including major hypoglycaemic events
timeFrame: From baseline to 12 and 24 weeks of Levemir® therapy, respectively
Secondary outcomes:
measure: Number of serious adverse events
timeFrame: From baseline to 12 and 24 weeks of Levemir® therapy, respectively
measure: Number of all adverse events
timeFrame: From baseline to 12 and 24 weeks of Levemir® therapy, respectively
measure: Number of all hypoglycaemic events
timeFrame: in the 4 weeks preceding the visits at 12 weeks and 24 weeks.
measure: Weight changes
timeFrame: at the end of study
measure: HbA1c
timeFrame: at the end of study
measure: Sub -group analysis of hypo risk
timeFrame: From baseline to 12 and 24 weeks of Levemir® therapy, respectively
Other outcomes:
Locations:
city: Casablanca
country: Morocco
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT01160653: Cognitive & Motor Training After Stroke For Everyday Walking Restoration
Official title: Cognitive and Motor Training After Stroke for Everyday Walking Restoration
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Stroke
Keywords: stroke
Gait training
Cognitive Training
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2010-07-12
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test a unique, combined cognitive and motor intervention designed to restore safe, more normal coordinated gait components into the real world environment for individuals with stroke.


Eligibility criteria: Inclusion Criteria:

* greater than or equal to 6 months post stroke
* ability to give informed consent
* impaired gait
* medically stable

Exclusion Criteria:

* pacemaker
* unstable/uncontrolled medical condition(s)

Primary outcomes:
measure: Coordinated Components of gait using the Gait Assessment and Intervention Tool (G.A.I.T.)
timeFrame: post treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: VA Medical Center, Cleveland
state: Ohio
Study officials:
affiliation: VA Medical Center-Cleveland
name: Janis Daly, PhD MS
role: PRINCIPAL_INVESTIGATOR
References: