louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00909701: Metabolic Response Following Intake of 2 Metabolic Preconditioning Drinks
Official title: Investigating the Metabolic Response Following Intake of 2 Metabolic Preconditioning Drinks: a Randomized Double-blind Crossover Healthy Volunteer Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Starvation
Keywords: Dietary supplement
healthy volunteers
Anaesthesia for surgery
Lead sponsor: University of Nottingham
Sponsor class: OTHER
Collaborators: name: Enhanced Recovery After Surgery Group (part of ESPEN)
First posted: 2009-05-28
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Surgical patients are usually starved for 8 to 12 hours before operation in order to reduce the chances of vomiting and other complications during the anaesthetic. Recent studies have suggested that this period of starvation might be harmful as it 'weakens' or 'stresses' the body before the operation. To avoid these harmful effects of starvation, patients are now given carbohydrate drinks (sugar-containing drinks that provide energy for the body) up to 2 hours before the operation. These drinks have been shown to make patients feel better, reduce sickness after the anesthetic/surgery and result in quicker recovery from operation. But the ways in which the sugar drinks have these beneficial effects on the body are unknown. The optimum time of giving these drinks to patients before operation is also unknown. This study will investigate the hormone responses of the body, following intake of 2 different carbohydrate drinks, in order to determine the optimum time of intake of these drinks in order to obtain the maximum benefits for the body.


Eligibility criteria: Inclusion Criteria:

* healthy male Caucasian volunteers aged 18-40 years,
* BMI of 20-25 kg/m2,
* able to give voluntary written informed consent to participate in the study, - able to understand the requirements of the study, including anonymous publications, AND
* agree to co-operate with the study procedure.

Exclusion Criteria:

* any history of acute or chronic illness, smoking, regular medication or substance abuse, OR
* have taken part in any other clinical study within the previous 3 months.

Primary outcomes:
measure: changes in plasma insulin and glucose levels
timeFrame: For 6 hours after intake of drink (blood samples will be taken at 20 min intervals for a total of 6 hours)
Secondary outcomes:
measure: Changes in plasma glucagon, non-esterified fatty acids and beta-hydroxybutyrate concentrations
timeFrame: For 6 hours after intake of drink (blood samples will be taken at 20 min intervals for a total of 6 hours)
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Nottingham Digestive Diseases Centre Biomedical Research Unit
state: Nottinghamshire
Study officials:
affiliation: University of Nottingham
name: Dileep Lobo, FRCS
role: STUDY_CHAIR
References:
Clinical trial NCT02292901: McGrath Mac VideoLaryngoscope vs the Macintosh Laryngoscope
Official title: Randomised Controlled Trial of Intubation With the McGrath Mac VideoLaryngoscope vs the Macintosh Laryngoscope
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Tracheal Intubation
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2014-11-18
Enrollment: 158
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: Videolaryngoscopes become widely used. The aim of this study is to compare McGrath Mac videolaryngoscope to conventional MacIntosh laryngoscope in patients without known risk of difficult of mask ventilation and of tracheal intubation.


Eligibility criteria: Inclusion Criteria:

* patient scheduled for a general anesthesia with orotracheal intubation

Exclusion Criteria:

* predictable risk of difficult mask ventilation or of difficult tracheal intubation
* necessity of a rapid sequence induction
* contra-indication to sufentanil, to propofol, or to atracurium
* ENT, thoracic surgery, or intracranial surgery

Primary outcomes:
measure: Ease of tracheal intubation
timeFrame: 1 hour
Secondary outcomes:
measure: Time to obtain the first capnogram (sec)
timeFrame: one hour
measure: Score of Cormak and Lehane modified by Yentis
timeFrame: one hour
measure: POGO (percentage of glottic opening) score
timeFrame: one hour
measure: Rate of use of alternative techniques for intubation
timeFrame: one hour
measure: Rate of esophageal intubation
timeFrame: one hour
measure: Incidence of arterial oxygen desaturation (SpO2 <92%)
timeFrame: one hour
measure: Rate of failure of tracheal intubation
timeFrame: one hour
measure: Rate of hemodynamic abnormality
timeFrame: one hour
measure: Postoperative throat pain
timeFrame: one day
measure: Postoperative hoarseness
timeFrame: one day
measure: Questionnaire of Salditt-Isabel
timeFrame: one hour
Other outcomes:
Locations:
city: Levallois-Perret
country: France
facility: Institut Hospitalier Franco-Britannique
state: Hauts de Seine
city: Suresnes
country: France
facility: Hopital Foch
state: Hauts de Seine
Study officials:
affiliation: Hopital Foch
name: Michel Chandon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06471101: Applying Artificial Intelligence to Identify Subphenotypes of Acute Kidney Injury in Mexican Patients With Severe COVID-19
Official title: Applying Artificial Intelligence to Identify Subphenotypes of Acute Kidney Injury in Mexican Patients With Severe COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Acute Kidney Injury
Keywords: machine learning
artificial intelligence
Lead sponsor: Instituto Nacional de Enfermedades Respiratorias
Sponsor class: OTHER_GOV
First posted: 2024-06-24
Enrollment: 2934
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute kidney injury and COVID-19

Brief summary: The goal of this observational study was to identify subphenotypes of acute kidney injury patients with COVID-19, and the investigators analyzed their impact on mortality. The study included demographic and clinical variables of the participants. The implementation of Machine Learning algorithms and Artificial Intelligence methods are used, and some specific implementations were designed for the analysis, where each group was characterized by traditional statistical methods.


Eligibility criteria: Inclusion Criteria:

* Patients older than 15 years old, hospitalized, and with severe acute respiratory syndrome (SARS-CoV-2) positive confirmation.

Exclusion Criteria:

* Patients who did not have at least 1 creatinine measurement.

Primary outcomes:
measure: Subphenotypes of acute kidney injury in patients
timeFrame: Through study completion, an average of one month
Secondary outcomes:
measure: Mortality of acute kidney injury patients
timeFrame: Through study completion, an average of one month
measure: Severity of acute kidney injury patients
timeFrame: Through study completion, an average of one month
measure: Non-recovery in acute kidney injury patients
timeFrame: Through study completion, an average of one month
measure: Renal replacement therapy requirement in acute kidney injury patients
timeFrame: Through study completion, an average of one month
measure: Length of stay of acute kidney injury patients
timeFrame: Through study completion, an average of one month
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Instituto Nacional de Enfermedades Respiratorias
Study officials:
References:
Clinical trial NCT05909501: Assessment of Geriatric Evaluations Impact on New AML Guidance
Official title: AGE-ING (Assessment of Geriatric Evaluations Impact on New AML Guidance) Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: AML, Adult
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2023-06-18
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited from the physician practices of Penn Medicine.

Brief summary: The goal of the study is to measure physiologic age (there is no current formal definition but is meant to imply that patients should be evaluated holistically rather than on age alone) at baseline in newly diagnosed AML patients over 50 years receiving either intensive or non-intensive treatment. This information will be used to evaluate toxicity, early mortality, remission rates and long term survival.


Eligibility criteria: Inclusion Criteria:

* AML diagnosis by peripheral flow cytometry and/or bone marrow aspirate and biopsy
* New diagnosis being considered for new line of treatment
* Age ≥ 50 years.
* Performance status 0,1, and 2

Exclusion Criteria:

* Inability to understand or unable to sign a written informed consent
* Unable to fill out questionnaires on their own and/or do not have someone to help complete them

Primary outcomes:
measure: Evaluate physiologic age using baseline measures of physical function, depression, cognition, frailty, and PROs in newly diagnosed AML patients receiving intensive and non-intensive treatment in relation to overall survival at 1 year.
timeFrame: At baseline, 14 days after treatment, 1 month after treatment
measure: Evaluate baseline measures of physiologic age in relation to short term mortality
timeFrame: At 30 days and 60 days
measure: Evaluate baseline measures of physiologic age in relation to grade 3, 4, and 5 toxicities from treatment
timeFrame: At baseline, 14 days after treatment, 1 month after treatment
measure: Evaluate baseline measures of physiologic age in relation to complete remission
timeFrame: At baseline, 14 days after treatment, 1 month after treatment
measure: Compare baseline measurements to serial measurements to understand how physical function changes over time with treatment
timeFrame: At baseline, 14 days after treatment, 1 month after treatment
measure: Evaluate albumin as a biomarker predictor of clinical outcomes of short term mortality, 1 year OS and toxicity
timeFrame: At 30 days and 60 days
measure: Create a predictive pre-treatment screening tool
timeFrame: At baseline, 14 days after treatment, 1 month after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center at University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Catherine Lai, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00911001: SALTO - Epidemiological Study on Compliance and Treatment Satisfaction
Official title: Compliance and Treatment Satisfaction in Prophylaxis of Postsurgical Thromboembolism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thromboembolism
Keywords: Arthroplasty
Antithrombotic prophylaxis treatment
Replacement
Knee
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-06-01
Enrollment: 480
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: Patients in antithrombotic prophylaxis treatment after total knee/hip replacement

Brief summary: Patients that are on total knee/hip replacement initiate prophylaxis treatment on the hospital ground. Once they leave the hospital, as outpatients they continue with the treatment at least during two consecutive weeks. Patients will be instructed to follow treatment recommendations (either LMWH or oral treatment, at physician discretion) and to come back to the surgeon after that period. At that visit, the Treatment Satisfaction Questionaire with Medication (TSQM) test as well as the Moriski-Green Questionaire (measures compliance with medication) will be answer by the patient. TSQM is an self administered validated scale (validated also in spanish) that measures in a generic way the treatment satisfaction to a treatment. Morinski-Green test will be used to measure the compliance degree on medication.


Eligibility criteria: Inclusion Criteria:

* Patients in antithrombotic prophylaxis treatment after total knee/hip replacement. This is an epidemiological study where the patients to be included will be those that are treated with antithrombotics as out-patients in real life conditions.

Exclusion Criteria:

* Patients who has been previously treated with injectable antithrombotic treatments.
* Diabetic patients treated with insulin.
* Patients who do not sign Informed Consent Form.

Primary outcomes:
measure: To measure the Treatment Satisfaction with medication through the self administered scale TSQM.
timeFrame: 2 weeks
Secondary outcomes:
measure: To measure compliance with medication and the relationship with satisfaction through the Moriski-Green Questionaire
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Many Locations
country: Spain
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06710301: Cortical Correlates of Spatial Navigation Skills in an Immersive Virtual Reality Environment
Official title: Study of the Cortical Correlates of Spatial Navigation Skills in an Immersive Virtual Reality Environment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Palsy (CP)
Keywords: Navigation skills
EEG
Virtual Reality
Cerebral Palsy
Lead sponsor: IRCCS Eugenio Medea
Sponsor class: OTHER
First posted: 2024-11-29
Enrollment: 70
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this study is to investigate the neural mechanisms that undergoes spatial navigation skills in children/adolescents aged between 8 and 17 years. These skills play an important role in daily life, as they allow us to orient ourselves in familiar and unfamiliar environments, locate objects, interact with them and memorize their position. Navigation abilities vary widely between individuals, change with age and might be affected by diseases, such as the cerebral palsy (CP). Previous studies have, in fact, demonstrated differences in the learning and adaptation methods of spatial navigation skills in children affected by CP compared to typically developing (TD) peers. Through the use of the electroencephalogram (EEG) we want to shed light on the mechanisms that govern this ability with the aim of:

1. better characterize spatial navigation skills in children/adolescents, both TD and affected by CP;
2. investigate the origin of the differences found between the spatial navigation skills of TD children and those affected by CP, improving knowledge of the pathology and thus allowing, in the future, to identify more adequate rehabilitation interventions.


Eligibility criteria: Inclusion Criteria:

* typically developing subjects aged between 8 and 17 years;
* subjects with CP aged between 8 and 17 years;

Exclusion Criteria:

* subjects aged under 8 or over 17 years;
* subjects with epileptic problems;
* subjects with poor head control;
* subjects with visual problems that can not be corrected with prescription lens;

Primary outcomes:
measure: Power Spectral Density (PSD)
timeFrame: Once
measure: Navigation performance
timeFrame: Once
Secondary outcomes:
Other outcomes:
Locations:
city: Bosisio Parini
country: Italy
facility: IRCCS Scientific Institute E. Medea
state: LC
city: Conegliano
country: Italy
facility: IRCCS Scientific Institute E. Medea
state: TV
Study officials:
References:
Clinical trial NCT03305601: Information During Maternity
Official title: Information During Maternity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2017-10-10
Enrollment: 104
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: During the pregnancy , it's now compulsary for the doctors to inform pregnant women and the couple about the medical, non medical informations and explain the physiological changes . As usual, medical staff and doctors explain and inform by oral and with a booklet patient.

In order to cluster and make more accessible these informations, the maternity team of GHPSJ has developed an application on smartphone . If this application has been evaluated on his contents and accordance to recommendations, there is no evaluation about the satisfaction of patient.

The aim is to study the impact of this kind of application on pregnant women satisfaction.


Eligibility criteria: Inclusion Criteria:

* single pregnancy
* delivery at 37 weeks of amenhorrhea
* age \> 18
* with an email address

Exclusion Criteria:

* refusing participation
* foetal pathology

Primary outcomes:
measure: satisfaction score
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile-de-France
Study officials:
References:
Clinical trial NCT01554501: The Role of Stress in Self-Control, Coping, and Emotion Regulation
Official title: The Role of Stress in Self-Control, Coping and Emotion Regulation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stress
Keywords: stress
self-control
emotion regulation
health
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Drug Abuse (NIDA)
First posted: 2012-03-15
Enrollment: 855
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample

Brief summary: The purpose of this study is to examine the effects of stress on mental and physical health and behavior.


Eligibility criteria: Inclusion Criteria:

* ages 18-50
* able to read and write

Exclusion Criteria:

* Any psychotic disorder or current psychiatric symptoms requiring specific attention, including active symptoms of psychosis or suicidal/homicidal ideation
* Pregnant women
* Inability to give informed consent
* Traumatic brain injury or loss of consciousness

Primary outcomes:
measure: Stress response and lifestyle behaviors
timeFrame: Baseline
Secondary outcomes:
measure: Biological stress responses
timeFrame: Baseline
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Stress Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Rajita Sinha, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02108301: Hepatitis C in Renal Transplant Recipients
Official title: Hepatitis C in Renal Transplant Recipients - Safety and Efficacy of a Conversion of Immunosuppression to High-dose Cyclosporine A and Its Impact on Hepatitis C Virus-replication, Parameters of Liver Function and Glucose Tolerance. An Open Label Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Hepatitis C-virus Infection
Renal Transplantation
Keywords: chronic hepatitis C-virus infection
renal transplantation
glucose tolerance
immunosuppression
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2014-04-09
Enrollment: 30
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 aim of the present trial is to evaluate whether the conversion of immunosuppression from tacrolimus to cyclosporine A induces changes in (i) hepatitis C-virus load, (ii) parameters of hepatic function and (iii) parameters of glucose tolerance in hepatitis C-positive renal transplant recipients.


Eligibility criteria: Inclusion Criteria:

* written informed consent
* prior renal transplantation
* current tacrolimus-based immunosuppressive regimen
* hepatitis C-infection
* age 18-70 years

Exclusion Criteria:

* current hemodialysis or peritoneal dialysis
* pregnancy or breastfeeding
* known contraindication for cyclosporine A-treatment

Primary outcomes:
measure: change in Hepatitis C-virus load at 12 weeks
timeFrame: one day before and 4, 8 and 12 weeks after the conversion
Secondary outcomes:
measure: change in oral glucose insulin sensitivity (OGIS) index at 12 weeks
timeFrame: one day before and 12 weeks after the conversion
measure: change in serum hepcidin levels at 12 weeks
timeFrame: one day before and 12 weeks after the conversion
Other outcomes:
measure: serum creatinine levels
timeFrame: 12 weeks
measure: serum glutamic-pyruvic transaminase concentrations
timeFrame: 12 weeks
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna, Department of Internal Medicine III, Division of Nephrology and Dialysis
Study officials:
References:
citation: Handisurya A, Kerscher C, Tura A, Herkner H, Payer BA, Mandorfer M, Werzowa J, Winnicki W, Reiberger T, Kautzky-Willer A, Pacini G, Saemann M, Schmidt A. Conversion from Tacrolimus to Cyclosporine A Improves Glucose Tolerance in HCV-Positive Renal Transplant Recipients. PLoS One. 2016 Jan 6;11(1):e0145319. doi: 10.1371/journal.pone.0145319. eCollection 2016.