louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05526937: The Effect of Sprouting of Wheat on Postprandial Glycemic and Satiety Responses of Wheat Bread Products
Official title: The Effect of Sprouting of Wheat on Postprandial Glycemic and Satiety Responses of Wheat Bread Products
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Sugar
Lead sponsor: University of Guelph
Sponsor class: OTHER
First posted: 2022-09-02
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The objective of this study is to investigate the effect of inclusion of 50% sprouted wheat wholemeal in a bread recipe on the postprandial glycemic and satiety responses, as well as on appetite-related sensations and acceptability of the developed products relative to a product made with a similar unsprouted wheat recipe.

Detailed description: This study is a randomized crossover trial involving three different bread products. At each study visit, capillary blood glucose will be measured at fasting, and then 15, 30, 45, 60, 90, and 120 minutes following the start of ingestion of the study food. Visual analogue scales will be used to assess appetite and fullness sensations at fasting, and then 30, 60, 90 and 120 minutes.

Eligibility criteria: Inclusion Criteria:

* Healthy adults
* Age 18-40 years
* Normal non-fasting plasma glucose (\<7.9 mmol/L but not below 3.3 mmol/L)
* BMI ranging from 18.5 to 27.9 kg/m2
* Regular consumer of wheat-based bread products (\>1x per week).

Exclusion Criteria:

* Smoking or regular use of recreational drugs (marijuana, ecstasy, LSD, magic mushrooms etc.)
* Heavy alcohol use (defined as typically \>14 drinks per week or \>4 drinks on one occasion)
* Restrained eater (\>16) as defined by the questionnaire at screening (Appendix E: Three Factor Eating Questionnaire, Stunkard et al.,1985)
* Unusual sleep patterns (Shift-worker, or sleeps 4 hours or less regularly) or irregular breakfast consumption.
* Recent (i.e. \>4 kg in previous 3 months) or intended weight loss or gain
* Food allergies or any life-threatening allergy (food or otherwise)
* Gluten intolerance or sensitivity
* Medications known to affect glucose tolerance (excluding oral contraceptives)
* Presence of disease or drug(s) which influence digestion and absorption of nutrients; including steroids, protease inhibitors or antipsychotics.
* Inability to adhere to Study Protocols

Primary outcomes:
measure: Postprandial glycemic response
timeFrame: 2 hours
Secondary outcomes:
measure: Postprandial satiety response
timeFrame: 2 hours
Other outcomes:
Locations:
city: Guelph
country: Canada
facility: Human Nutraceutical Research Unit
state: Ontario
Study officials:
References:
Clinical trial NCT05092737: Physiological Response to Prone Position in COVID-19 Associated Acute Respiratory Distress Syndrome (ARDS)
Official title: Physiological Response to Prone Position in Intubated Adults With COVID-19 Associated Acute Respiratory Distress Syndrome (ARDS): a Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ARDS
Sars-CoV-2 Infection
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
First posted: 2021-10-25
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: COVID-19 moderate to severe ARDS patients who sustained prone positioning

Brief summary: Retrospective study in COVID-19 ARDS patients hospitalised in the ICU. Investigators aim to explore the effects of prone positioning on oxygenation, dead space ventilation and mortality.


Eligibility criteria: Inclusion Criteria:

* COVID-19 associated moderate to severe ARDS
* Invasive mechanical ventilation
* Prone positioning
* admitted to ICU

Exclusion Criteria:

* already sustained prone positioning in referring hospital
* pronation during ECMO only
* denied consent for data analysis

Primary outcomes:
measure: PaO2/FiO2
timeFrame: Within 2 hours before pronation and 2 hours before supination
Secondary outcomes:
measure: Alveolo-arterial oxygen gradient change
timeFrame: Within 2 hours before pronation and 2 hours before supination
measure: Ventilatory Ratio
timeFrame: Within 2 hours before pronation and 2 hours before supination
measure: Mortality or Extracorporeal membrane oxygenation (ECMO) support
timeFrame: Once between ICU admission and extubation
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Lausanne University Hospitals
state: Vaud
Study officials:
References:
Clinical trial NCT01236937: Respiration Gated Laser Guided CT Lung Nodule Biopsy
Official title: Respiration Gated Laser Guided CT Lung Nodule Biopsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Cancer
Keywords: CT, lung nodule biopsy, Respiration Gated, Lung Cancer
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
First posted: 2010-11-09
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The primary outcome of this study is to investigate the accuracy of respiration gated laser guided CT lung nodule biopsy through a prospective randomized trial using a bellows-based breath hold monitoring system. Secondary outcome is the rate of complications using laser guided CT biopsy in general and with bellows-based breath hold monitoring system. The study has approval from the The Danish National Committee on Biomedical Research Ethics (ref no: H-4-2010-fsp 1).


Eligibility criteria: Inclusion Criteria:

Patients with indeterminate lung nodules referred from the department of pulmonary medicine at Gentofte Hospital, Denmark for a CT guided biopsy are considered for inclusion in this study. The biopsy was preformed as part of regular clinical work up of the patient at the department of Radiology Gentofte Hospital, Denmark. Both men and women were included and no age restrictions were applied.

Exclusion Criteria:

Excluded from biopsy were those with poor pulmonary function test with a forced expired volume in the first second (FEV1) \< 0.5 L, INR\>1.2, blood cloth level under 200\* and ECG with sign of ischemic heart disease. The trial is planned to begin 1.March 2010 and run for 2 years ending at 29 February 2012. During this time approx. 400 participants planned for biopsy are accepted to be included in the trial.

Primary outcomes:
measure: Accuracy of respiration gated laser guided CT lung nodule biopsy
timeFrame: After 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Gentofte University Hospital, Department of Radiology
state: Copenhagen
Study officials:
affiliation: Gentofte University Hospital, Department of Radiology
name: Haseem Ashraf, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gentofte University Hospital, Department of Pulmonology
name: Paul Clementsen, MD, PhD
role: STUDY_CHAIR
affiliation: Gentofte University Hospital, Department of Pulmonology
name: Annete Nørgaard, MD, PhD
role: STUDY_CHAIR
affiliation: Gentofte University Hospital, Department of Radiology
name: Peter S. Myschetzky, MD
role: STUDY_CHAIR
affiliation: Gentofte University Hospital, Department of Pulmonology
name: Asger Dirksen, MD, PhD
role: STUDY_CHAIR
affiliation: Gentofte University Hospital, Department of Pulmonology
name: Zaigham Saghir, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03159637: Pneumoperitoneum and Gynecological Laparoscopic Surgery: An Observational Clinical Study
Official title: Impact Of Posture and Prolonged Pneumoperitoneum on Intra-Operative and Postoperative Outcomes During Gynecological Laparoscopic Surgery: An Observational Clinical Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Laparoscopy
Keywords: Pneumoperitoneum
Trendelenburg position
intra-abdominal pressure
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-05-19
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: female patients only

Brief summary: Laparoscopic surgery is now widely established.Laparoscopic surgery involves insufflation of a gas (usually carbon dioxide) into the peritoneal cavity producing a pneumoperitoneum. The raised intra-abdominal pressure of the pneumoperitoneum, alteration in the patient's position and effects of carbon dioxide absorption cause changes in physiology, especially within the cardiovascular and respiratory systems.

Detailed description: The study will be carried out after approval of the ethical committee of Faculty of Medicine, Assiut University. A full preoperative anesthetic assessment will be carried out. Particular attention to the cardiovascular and respiratory systems is essential because of potential effects of the pneumoperitoneum and patient position.

Eligibility criteria: Inclusion Criteria:

1. Age range 18-50
2. ASA 1
3. Elective gynecological laparoscopic surgery

Exclusion Criteria:

1. Severe ischemic or valvular heart disease
2. Increased intracranial pressure (e.g. Hydrocephalus, Cerebral tumor, Head injury)
3. Hepatic or renal impairment
4. Emergency surgery
5. Open surgery
6. Previous abdominal surgery

Primary outcomes:
measure: mean arterial blood pressure
timeFrame: within the duration of the operation
measure: Pulmonary function tests
timeFrame: within the first 24 hours
Secondary outcomes:
measure: PaO2
timeFrame: within the first 24 hours
measure: Arterial to end-tidal PaCO2- difference
timeFrame: within the first 24 hours
measure: Intra-abdominal pressure
timeFrame: within the first 24 hours
measure: Postoperative nausea and vomiting
timeFrame: within the first 24 hours
measure: Analgesic requirement
timeFrame: within the first 24 hours
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of Medicine
Study officials:
affiliation: Associate Profossor
name: Sayed K Abd-Elshafy, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01277237: The Effect Of Omega-3 Fatty Acids on Non-alcoholic Fatty Liver Disease
Official title: The Effect Of Omega-3 Fatty Acids on Non-alcoholic Fatty Liver Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non Alcoholic Fatty Liver Disease
Keywords: Non alcoholic fatty liver disease
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: NHS Lothian
First posted: 2011-01-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: There is preliminary evidence that Omega 3, a compound naturally found in fish oil, reduces the amount of fat stored in the liver and improves liver function. The purpose of this study is to see whether this observation is correct.


Eligibility criteria: Inclusion Criteria:

* a diagnosis of non-alcoholic fatty liver disease
* fatty infiltration on ultrasound
* abnormal serum liver function tests.

Exclusion Criteria:

* any other identified cause of chronic liver disease
* the prescription of medication which would cause non-alcoholic fatty liver - disease (e.g. tamoxifen)
* already taking supplementary fish oil
* alcohol intake of \>20g/day for women, \>40g/ day for men
* known allergy to fish oil
* on anticoagulants (antiplatelets are permitted)
* severe heart failure (NYHA class IV)
* pregnancy/ lactation
* age under 18 years.

Primary outcomes:
measure: Liver appearance on ultrasound
timeFrame: 6 months
Secondary outcomes:
measure: Liver function tests
timeFrame: 6 months
measure: hepatocyte mitochondrial function
timeFrame: 6 months
measure: Health-related Quality of Life
timeFrame: 6 months
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
state: Lothian
Study officials:
affiliation: Royal Infirmary of Edinburgh
name: Peter C Hayes, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03545737: Compare a New Method and Formula as a Guide for the Intubation of a Left-sided Double-lumen Tube
Official title: Compare the Accuracy of the Distances Between the Midpoint of the Thyroid Cartilage to Suprasternal Notch Base on Body Surface Measurement Add the Distance Between Suprasternal Notch to Carina of Trachea According to Chest CT and Formula Base on Patient's Height as a Guide for the Intubation of a Left-sided Double-lumen Tube
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Therapeutic Procedural Complication
Lead sponsor: The First Hospital of Qinhuangdao
Sponsor class: OTHER_GOV
First posted: 2018-06-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 1. Age\<18 or \>70 years
2. ASA\>III; BMI\>35kg/m2
3. Without suspected tuberculosis or systemic infection
4. Without severe cardiopulmonary disease, preoperative hoarseness and anticipated difficult airway

Brief summary: One-lung ventilation (OLV) is required for the most of thoracic surgery to facilitate surgical visualization by collapsing the lung. The double-lumen tube (DLT) is the commonly used device for OLV. The objective of this study was to compare the accuracy of the distances between vocal cords to carina of trachea and formula base on patient's height as a guide for the intubation of a Left-sided Double-lumen tube

Detailed description: In previous study, investigators found that the distances between vocal cords to carina of trachea was a useful predictive method for the intubation of a Left-sided Double-lumen tube. However in some hospitals preoperative chest CT scans not contain the vocal cords slice. So in this study investigators will compare the accuracy of the distances between the midpoint of the thyroid cartilage to suprasternal notch base on body surface measurement add the distance between suprasternal notch to carina of trachea according to chest CT and formula base on patient's height as a guide for the intubation of a Left-sided Double-lumen tube.

Eligibility criteria: Inclusion Criteria:

1. Adult patients undergoing elective left side thoracic surgery
2. Requiring a Uniblocker or DLT for one-lung ventilation

Primary outcomes:
measure: The incidence of the injuries of bronchi and carina
timeFrame: 1-3days
Secondary outcomes:
measure: The incidence of dislodgement
timeFrame: 1 day
measure: The intubation time
timeFrame: 1-5min
Other outcomes:
Locations:
city: Qinhuangdao
country: China
facility: 中国
state: Hebei
Study officials:
References:
Clinical trial NCT02738437: Kryptonite - a Novel Osteosynthesis Method for Median Sternotomy
Official title: Kryptonite - a Novel Osteosynthesis Method for Median Sternotomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: osteogenesis
Positron-Emission Tomography
Radiostereometric analysis
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
First posted: 2016-04-14
Enrollment: 8
Sex: MALE
Minimum age (years): 60
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study was to investigate the beneficial effect of bone cement in combination with wire cerclage on the stability of the sternum following median sternotomy.

One half of the patients received only wire cerclage the other both bone cement and wire cerclage.

Detailed description: The aim of this study was to investigate the beneficial effect of bone cement in combination with wire cerclage on the stability of the sternum following median sternotomy.

It has been shown previously that wire cerclage alone does not provide a stabile osteosynthesis following median sternotomy. The hypothesis is that if a stabile osteosynthesis can be achieved patient recovery can be hastened and patient discomfort and pain reduced.

One half of the patients received only wire cerclage the other both bone cement and wire cerclage.

The stability of the sternum was evaluated using radiostereometric analysis, PET-CT and patient reported outcomes in the form of SF-36 and VAS.

Eligibility criteria: Inclusion Criteria:

* undergoing elective Heart surgery

Exclusion Criteria:

* none

Primary outcomes:
measure: Radiostereometric analysis
timeFrame: 6 weeks, 3 and 6 months
measure: Evaluation of sternal healing using PET-scan
timeFrame: 3 and 6 months
Secondary outcomes:
measure: Pain
timeFrame: 3 weeks, 3 and 6 months
measure: General well-being
timeFrame: 3 weeks, 3 and 6 months
measure: sternal discomfort
timeFrame: 3 weeks, 3 and 6 months
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital, Skejby, Dept. of Cardiothoracic surgery
Study officials:
References:
citation: Vestergaard RF, Soballe K, Hasenkam JM, Stilling M. Sternal instability measured with radiostereometric analysis. A study of method feasibility, accuracy and precision. J Cardiothorac Surg. 2018 May 18;13(1):41. doi: 10.1186/s13019-018-0735-4.
Clinical trial NCT04717037: Olive Oil Massage Effect for Reduction of Preterm Sepsis (OMEPS)
Official title: Olive Oil Massage Effect for Reduction of Preterm Sepsis (OMEPS), Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Sepsis
Pre-Term
Late-Onset Neonatal Sepsis
Keywords: Olive oil
Massage
Preterm
Late-Onset sepsis
Lead sponsor: King Abdullah International Medical Research Center
Sponsor class: OTHER
Collaborators: name: King Abdulaziz University
First posted: 2021-01-20
Enrollment: 300
Sex: ALL
Minimum age (years): 24
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The OMEPS trial is a randomized clinical trial in the western region of Saudi Arabia. Conducted to assess the safety and feasibility of olive oil as massage for preterm infants and if associated with reduced risk of Late-Onset sepsis.


Eligibility criteria: Inclusion Criteria:

1. Preterm infants born at one of the participated centers.
2. Preterm Infants born at ≥24weeks gestation and ≤32weeks gestation
3. Birth weight ≥ 500gm up to 2000 gm.

Exclusion Criteria:

1. Outborn Infants.
2. Preterm infants \< 24wk or \> 32 wk
3. Preterm infants \< 500 gm or \> 2000gm
4. Critically ill patients, e.g., Hemodynamic unstable, culture-confirmed neonatal sepsis, Hydrops fetalis, Life-threatening congenital anomalies.
5. Congenital skin anomalies or infection
6. Major surgical procedure
7. Any patient whose parents refuse consent.
8. Death within 48 hours of life.

Primary outcomes:
measure: Rate of culture-proven sepsis in the blood or CSF
timeFrame: 72 hours from birth till 28 days of life
Secondary outcomes:
measure: Neonatal Skin Condition score
timeFrame: 72 hours from birth till 28 days of life
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: King Abdulaziz Medical City
state: WR
city: Jeddah
country: Saudi Arabia
facility: King Abdulaziz University Hospital
Study officials:
affiliation: King Abdulaziz Medical city , WR
name: Jubara Alallah
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03215537: Development of Patient Tailored Guideline of Physical Activity for Lung Cancer
Official title: Development of Patient Tailored Guideline of Physical Activity for Lung Cancer Survivor After Surgery; to Improve the Symptoms, Complications and Quality of Life
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Cancer
Keywords: physical activity
cardiopulmonary function
quality of life
Perioperative management
comprehensive intervention
health behavior model
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2017-07-12
Enrollment: 176
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This study aims to propose a perioperative comprehensive intervention based on health behavior model to improve cardiopulmonary function and quality of life among lung cancer patients following

Detailed description: This study aims to propose a perioperative comprehensive intervention based on health behavior model to improve cardiopulmonary function and quality of life among lung cancer patients following:

1. understanding multi-dimensional factors affecting cardiopulmonary function and quality of life
2. development of multidisciplinary comprehensive intervention
3. evaluation the effects of comprehensive intervention using cluster design

Eligibility criteria: Inclusion Criteria:

* lung cancer patients before surgery

Exclusion Criteria:

* Eastern Cooperative Oncology Group Performance Status \<1
* Neoadjuvant therapy
* Multiple cancer
* Recurrent lung cancer.

Primary outcomes:
measure: Changes of cardiopulmonary function
timeFrame: Baseline, 1 month after surgery, 6 months after surgery, 1year after surgery
Secondary outcomes:
measure: complication
timeFrame: 1 month after surgery, 6 months after surgery, 1year after surgery
measure: Changes of pulmonary function
timeFrame: Baseline, 1 month after surgery, 6 months after surgery, 1year after surgery
measure: Changes of physical activity
timeFrame: Baseline, 1 month after surgery, 6 months after surgery, 1year after surgery
measure: Changes of physical fitness
timeFrame: Baseline, 1 month after surgery, 6 months after surgery, 1year after surgery
measure: Changes of quality of life
timeFrame: Baseline, 1 month after surgery, 6 months after surgery, 1year after surgery
measure: Changes of Fatigue
timeFrame: Baseline, 1 month after surgery, 6 months after surgery, 1year after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Jae Ill Zo
role: PRINCIPAL_INVESTIGATOR
References: