louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00529776: Prophylaxis of Ventilator Associated Pneumonia by Continuous Lateral Rotation Therapy
Official title: Prophylaxis of Ventilator Associated Pneumonia by Continuous Lateral Rotation Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumonia, Ventilator-Associated
Keywords: Prevention of ventilator associated pneumonia
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2007-09-14
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Hypothesis: Ventilator associated pneumonia (VAP) in critically ill patients may be prevented by continuous lateral rotation therapy (CLRT) using specially designed, motor driven beds.

Patients are randomized to CLRT or supine position if mechanically ventilated and not suffering from pneumonia or ARDS within 48 hours after intubation. Prophylaxis of VAP is standardized in both groups. Primary endpoint is incidence of VAP, secondary endpoints are length of ventilation, length of stay and mortality.


Eligibility criteria: Inclusion Criteria:

* Mechanically ventilated
* Intubated not longer than 48 h
* Medical cause for ICU admission
* Expected to be ventilated for \> 48 hours

Exclusion Criteria:

* Pneumonia or ARDS present
* Postoperative patient

Primary outcomes:
measure: Ventilator associated pneumonia
Secondary outcomes:
measure: Length of hospital stay
measure: Length of mechanical ventilation
measure: ICU and hospital Mortality
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Vienna General Hospital, Medical University of Vienna
Study officials:
affiliation: Department of Internal Medicine I, Medical University of Vienna, Austria
name: Thomas Staudinger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept. of Internal Medicine I, Medical University of Vienna
name: Thomas Staudinger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04601376: Testing of Mobile Monitoring System
Official title: To Implement and Test the Mobile Monitoring Tool to Identify SSI (R33 Phase)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Orthopedic Disorder
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2020-10-23
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: We will complete a prospective, observational study comparing the accuracy of the mobile monitoring tool on identifying SSI compared to manual review.


Eligibility criteria: Inclusion Criteria:

* Orthopaedic surgery patient at hospital 175

Exclusion Criteria:

* no access to mobile phone

Primary outcomes:
measure: Promis PF Short form (change in self reported capability)
timeFrame: 1 day, 1 week, 2 week, 4 week, 12 weeks after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02560376: 68Ga-NOTA-exendin-4 PET/CT for the Localization of Insulinoma and Diagnosis of Nesidioblastosis
Official title: 68Ga-NOTA-exendin-4 PET/CT for the Localization of Insulinoma and Diagnosis of Nesidioblastosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Insulinoma
Nesidioblastosis
Keywords: PET/CT
glucagon-like peptide-1 receptor (GLP-1R) imaging
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: National Institute for Biomedical Imaging and Bioengineering (NIBIB)
First posted: 2015-09-25
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the diagnostic performance and evaluation efficacy of 68Ga-NOTA-exendin-4 in insulinoma and nesidioblastosis patients. A single dose of 55.5-111 Mega-Becquerel (MBq) 68Ga-NOTA-exendin-4 will be injected intravenously. Visual and semiquantitative method will be used to assess the PET/CT images.

Detailed description: 68Ga-NOTA-exendin-4 is an optimal probe targeting GLP-1R. The investigators will determine the use of 68Ga-NOTA-exendin-4 PET/CT in the detection of insulinomas, and to compare its diagnostic value with conventional imaging. GLP-1R imaging, specifically expressed on pancreatic beta cell surface, might help with diagnosis of different types of nesidioblastosis (ie. focal or diffuse type), and may improve the treatment strategy of nesidioblastosis. The investigator will determine the use of 68Ga-NOTA-exendin-4 PET/CT in differentiating nesidioblastosis.

Eligibility criteria: Inclusion Criteria:

* Patients with hypoglycaemia in the presence of neuroglycopenic symptoms and documented Whipple's triad.
* Biochemically proven endogenous hyperinsulinemic hypoglycaemia (plasma glucose concentration \<3.0 mM, insulin \>3 µU/ml, and C-peptide \>0.6 ng/ml).
* Conventional imaging within 1 month
* Signed written consent
* Age above 6 years (congenital hyperinsulinemic with the symptoms onset in school age is also the subject of this study)

Exclusion Criteria:

* Pregnancy
* Breastfeeding
* Renal function: serum creatinine \> 3.0 mg/dl
* Known allergy against exendin-4
* Any medical condition that, in the opinion of the investigator, may significantly interfere with study compliance.

Primary outcomes:
measure: Standardized uptake value of 68Ga-NOTA-exendin-4 PET/CT in Diagnosis of Insulinoma and Nesidioblastosis
timeFrame: 1 year
Secondary outcomes:
measure: Adverse events collection
timeFrame: 1 week
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College
name: Fang Li, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01876576: The Impact of Diet Liberalization on Bowel Preparation for Colonoscopy
Official title: The Impact of Diet Liberalization on Bowel Preparation for Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonic Diseases
Keywords: colonoscopy
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2013-06-12
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study will evaluate the expansion of dietary options from clear liquids the entire day to a low reside breakfast and lunch for patients prior to undergoing bowel preparation with MoviPrep® and its effect on preparation quality for colonoscopy.

Detailed description: This study will evaluate the expansion of dietary options from clear liquids the entire day to a low reside breakfast and lunch for patients prior to undergoing bowel preparation with MoviPrep® and its effect on preparation quality for colonoscopy. MoviPrep® is a commercially available 2 liter bowel purgative for use before colonoscopy in adults 18 years of age or older that is comprised of polyethylene glycol-electrolyte solution (PEG-ELS) plus sodium sulfate, sodium ascorbate, and ascorbic acid.

Eligibility criteria: Inclusion Criteria:

* Elective outpatients \> 18 yrs undergoing colonoscopy

Exclusion Criteria:

* Unable or unwilling to give informed consent
* Age \< 18 years
* Pregnant
* Breast feeding
* Gastroparesis - established or suspected
* Pseudo-obstruction - established or suspected
* Severe constipation (\< 1 BM a week)
* Bowel obstruction
* Colon resection
* Chronic nausea or vomiting
* Known Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency
* PEG allergy
* Significant psychiatric illness

Primary outcomes:
measure: Efficacy - Overall bowel cleansing based on Boston Bowel Preparation Scale score BBPS score of 2-3 for each segment AND total score
timeFrame: 1 day (At colonoscopy)
Secondary outcomes:
measure: Efficacy - Individual colon segment cleansing Successful cleansing defined as BBPS score of 2 - 3 for a segment
timeFrame: 1 day (At colonoscopy)
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: David Kastenberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05835076: Helicobacter Pylori Screening at Sohag University
Official title: Helicobacter Pylori Screening in Hyperemesis Gravidarum in Early Pregnancy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: In Early Pregnancy
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-04-28
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Cross sectional study to screen Helicobacter pylori in hyperemesis gravidarum

Brief summary: Screen of Helicobacter pylori in hyperemesis gravidarum in early pregnancy to detect the impact of the severity of the disease on pregnant women


Eligibility criteria: Inclusion Criteria:

* pregnant woman \<16wk

Exclusion Criteria:

* pregnant woman \>16wks

Primary outcomes:
measure: Positive
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06693076: Benchmarks in Acute Laparoscopic Cholecystectomy
Official title: Benchmarks in Acute Laparoscopic Cholecystectomy - a National Registry Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gallbladder
Gall Stones (&Amp; [Calculus - Gall Bladder])
Gall Stone
Gallbladder Inflammation
Keywords: laparoscopic cholecystectomy
benchmarking
surgical outcomes
reference values
quality improvement
Lead sponsor: Region Östergötland
Sponsor class: OTHER
First posted: 2024-11-18
Enrollment: 40000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with gallbladder inflammation.

Brief summary: The aim of this observational cohort study is to define peri- and postoperative reference values for acute laparoscopic cholecystectomy, using the achievable benchmarks of care methodology (ABC™). Another aim is to develop adjusted reference values for groups with a risk factor of severe postoperative complications. The goal is to spur quality improvement initiatives.

Detailed description: The data source is the Swedish patient registry GallRiks, a prospective quality registry for gallbladder surgery and endoscopic retrograde cholangio-pancreatography (ERCP). The time frame will be 2015-2023. Register variables related to surgical quality will be analyzed, such as postoperative complications, perioperative adverse events, surgical duration and length of stay. The study will analyze data for the time of surgery and up to 30 days afterwards. As the researchers do not yet have the data available, the exact number of enrolled participants can not yet be given.

Eligibility criteria: Inclusion Criteria:

* adults ≥ 18 years of age
* laparoscopic acute cholecystectomy

Exclusion Criteria:

* other indications than acute cholecystitis will be excluded
* cholecystectomy due to malignancy
* other organ surgery performed at the same occasion
* previous upper gastrointestinal surgery
* single port access
* robotic surgery
* no data concerning surgical intervention

Primary outcomes:
measure: Benchmark values of acute laparoscopic cholecystectomy
timeFrame: Day of surgery
measure: Postoperative benchmark values of acute laparoscopic cholecystectomy
timeFrame: 0-30 days after surgery
Secondary outcomes:
measure: Adjusted benchmarks for severe complications
timeFrame: 0-30 days after surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00917176: Occipital Nerve Stimulation in Fibromyalgia
Official title: Subcutaneous C2 Stimulation: Treatment of Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fibromyalgia
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2009-06-10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate whether greater occipital nerve stimulation is effective in the treatment of fibromyalgia related pain. The study uses sub sensory threshold stimulation and placebo stimulation in order to investigate whether sub-threshold stimulation is feasible in a placebo controlled study.


Eligibility criteria: Inclusion Criteria:

* Diagnosed according to the criteria of the American College of Rheumatology (ACR-90)
* Minimally treated with adequate trials during 3 months
* Insight of the patient in her disease and capable of understanding and signing an informed consent

Exclusion Criteria:

* History of severe illness or suffering from severe chronic disease
* History of substance abuse, unless treated and in remission during 6 months
* Cardiac disease
* History of epileptic insults
* Psychiatric disorders with psychotic symptoms
* Pace maker / defibrillator
* Pregnancy

Primary outcomes:
measure: Pain scores on Visual Analogue Scale (VAS), pain Catastrophizing Scale (PCS), pain vigilance and awareness questionnaire (PVAQ)
timeFrame: at a weekly base during 10 weeks
Secondary outcomes:
measure: Scores on Fatigue and Mood
timeFrame: at a weekly base, during 10 weeks
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: University Hospital Antwerp
Study officials:
affiliation: University Hospital, Antwerp
name: Dirk De Ridder, M.D., PhD.
role: STUDY_CHAIR
affiliation: University Hospital, Antwerp
name: Mark Plazier, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ahmed S, Plazier M, Ost J, Stassijns G, Deleye S, Ceyssens S, Dupont P, Stroobants S, Staelens S, De Ridder D, Vanneste S. The effect of occipital nerve field stimulation on the descending pain pathway in patients with fibromyalgia: a water PET and EEG imaging study. BMC Neurol. 2018 Nov 12;18(1):191. doi: 10.1186/s12883-018-1190-5.
Clinical trial NCT05662176: The Effect of Trauma Informed Care in Childbirth
Official title: The Effect of Supportive Care Based on Trauma Informed Care at Childbirth on Perinatal Mental Health Outcomes: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychological Well-being
Childbirth
Care Pattern, Maternal
Keywords: Intrapartum supportive care
Trauma Informed Care
birth trauma
fear of childbirth
perinatal well-being
Lead sponsor: Mersin University
Sponsor class: OTHER
First posted: 2022-12-22
Enrollment: 91
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to determine the effect of supportive care based on trauma informed care during childbirth on perinatal mental health outcomes.

Detailed description: This is a randomized control experimental study. Data were collected from 100 women who attended supportive care based on trauma informed care or standart care from Turkey between July 2022 and September 2022. Participants who met the inclusion criteria were informed about the purpose of the study and the procedures to be performed, informed consent was obtained from those who agreed to participate, and women were assigned to the groups in line with a computer-based randomization program with an allocation ratio of 1:1. Block randomization could not be performed because of the different and long delivery processes. Data were collected in both groups at birth (latent phase, active phase, and transitional phase), within 24 hours of birth, and 6th-8th postpartum days after hospital admission and at least one hour of care. collected by the first author. The CONSORT directive was followed in the planning, implementation and writing of the research.

Eligibility criteria: Inclusion Criteria:

* The ages of 18-40 women,
* At least primary school graduate,
* Mother tongue Turkish,
* Single fetus,
* Term,
* Spontaneous birth,
* Cervical dilatation between 0-5 cm (latent phase) and without a condition that could prevent vaginal delivery.
* Primiparous women
* Not have any disease or complication and agreed to participate in the study were included.

Exclusion Criteria:

* Women who developed a complication with the fetus or themselves during delivery,
* Not be reached during follow-ups by telephone,
* Wanted to withdraw from the study

Primary outcomes:
measure: Labor pain
timeFrame: through delivery, an average of 24th hours
measure: Fear of Childbirth (DFS)
timeFrame: through delivery, an average of 24th hours
measure: Perceived control and support in birth (SCIB)
timeFrame: Postpartum 24th hours
measure: Birth Trauma (City BITS)
timeFrame: Postpartum 8 th week
Secondary outcomes:
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Gozde Gokce Isbir
Study officials:
References:
Clinical trial NCT01932476: Gluten Immunity and Islet Autoimmunity in Type-1 Diabetes
Official title: Randomized Double-Masked Gluten Challenge to Evaluate Markers of Autoimmunity in Patients With Type-1 Diabetes and Celiac Disease After Oral Gluten Challenge
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Celiac Disease
Lead sponsor: Joslin Diabetes Center
Sponsor class: OTHER
Collaborators: name: ImmusanT, Inc.
First posted: 2013-08-30
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine whether the immune response causing celiac disease is related to the autoimmune response causing type-1 diabetes.

Detailed description: Participants meeting eligibility criteria will have blood collected before and after a three-day oral gluten challenge. This blood will be tested for biomarkers associated with islet autoimmunity and gluten-specific cellular immunity.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Celiac Disease by histology and serology
* For those with Type-1 Diabetes, at least one anti-islet antibody
* HLA-DQ2.5 genotype

Exclusion Criteria:

* Not following a gluten free diet for at least 12 months
* Known gluten exposure within the prior 2 months
* Treatment with systemic immune modifying biological agents (adalimumab, etanercept, infliximab, certolizumab pegol) in prior 6 months
* Treatment with systemic immunomodulatory agents in prior 30 days
* Human immunodeficiency virus infection, untreated hepatitis B virus, or hepatitis C virus infection
* Nut allergy
* Hemoglobin level below normal range
* History of angina
* Pregnant or lactating
* Severe symptoms to gluten challenge in the past
* Elevation in transglutaminase-IgA or deamidated gliadin peptide IgA or IgG greater than or equal to 50% above upper limit of normal
* Uncontrolled complications of type-1 diabetes or celiac disease which pose a risk to participation

Primary outcomes:
measure: Change in Markers of Autoimmunity
timeFrame: Baseline and day 3 post challenge
Secondary outcomes:
measure: Gastrointestinal Symptoms
timeFrame: Baseline and 6 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
Study officials:
affiliation: Joslin Diabetes Center
name: Jason Gaglia, MD, MMSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04210076: Mindfulness Training for Small Teams
Official title: Mindfulness Training for Small Teams
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Change
Keywords: attentional performance
psychological well-being
operational performance
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2019-12-24
Enrollment: 356
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to look at how mindfulness training may influence how the participant thinks, feels, and acts.


Eligibility criteria: Inclusion Criteria:

* Individuals who are between 18 and 65 years of age
* Individuals who are fluent English speakers
* Individuals who are active-duty service members
* Men and women of all races and ethnicities

Exclusion Criteria:

* Individuals who have a medical or neurological condition that might interfere with performance on the task in the study (e.g., epilepsy)
* Individuals with a history of hospitalization for psychological/mental health issues within the last 6 months.

Primary outcomes:
measure: Change in Attentional Performance
timeFrame: Baseline (testing session 1) to week 5 (testing session 2)
measure: Change in Working Memory Performance
timeFrame: Baseline (testing session 1) to week 5 (testing session 2)
Secondary outcomes:
measure: Change in Cohesion
timeFrame: Baseline (testing session 1) to week 5 (testing session 2)
measure: Change in Team Situation Monitoring
timeFrame: Baseline (testing session 1) to week 5 (testing session 2)
measure: Change in Workgroup Emotional Intelligence
timeFrame: Baseline (testing session 1) to week 5 (testing session 2)
measure: Change in Team Mindfulness
timeFrame: Baseline (testing session 1) to week 5 (testing session 2)
measure: Change in Mindfulness
timeFrame: Baseline (testing session 1) to week 5 (testing session 2)
measure: Change in Decentering
timeFrame: Baseline (testing session 1) to week 5 (testing session 2)
measure: Change in Psychological Health
timeFrame: Baseline (testing session 1) to week 5 (testing session 2)
measure: Change in Positive Affect
timeFrame: Baseline (testing session 1) to week 5 (testing session 2)
measure: Change in Negative Affect
timeFrame: Baseline (testing session 1) to week 5 (testing session 2)
measure: Change in Perceived Stress
timeFrame: Baseline (testing session 1) to week 5 (testing session 2)
Other outcomes:
measure: Change in Accuracy on Cognitive and Marksmanship Drills
timeFrame: Baseline (testing session 1) to week 5 (testing session 2)
measure: Change in Reaction Time on Cognitive and Marksmanship Drills
timeFrame: Baseline (testing session 1) to week 5 (testing session 2)
Locations:
city: Coral Gables
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Amishi P Jha, PhD
role: PRINCIPAL_INVESTIGATOR
References: