louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01126762: Trial of Fish Intake Advice in Pregnancy
Official title: A Pilot Randomized Controlled Trial to Promote Healthful Fish Consumption in Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutrition
Keywords: Docosahexaenoic acid
fish
pregnancy
methylmercury
n-3 polyunsaturated fatty acid
Lead sponsor: Harvard Pilgrim Health Care
Sponsor class: OTHER
Collaborators: name: Harvard School of Public Health (HSPH)
name: Harvard University
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: National Institute of Environmental Health Sciences (NIEHS)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2010-05-20
Enrollment: 61
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The overall goal of this project is to establish a pilot study to develop and refine an intervention to promote consumption of fish low in mercury and high in n-3 PUFA among pregnant women. The investigators will demonstrate our ability to recruit pregnant women, influence their fish consumption, and measure changes in nutrient and toxicant biomarkers.


Eligibility criteria: Inclusion Criteria:

* age 18 years or older
* Currently pregnant 12-22 weeks
* Singleton pregnancy
* Consuming fish \<=2 times per month

Exclusion Criteria:

* Inability to answer questionnaires in English
* Plans to leave study area prior to delivery
* Would never eat fish (e.g. vegan, allergy to fish)

Primary outcomes:
measure: Plasma elongated n-3 PUFA levels
timeFrame: 12 weeks
Secondary outcomes:
measure: Whole blood mercury
timeFrame: 12 weeks
measure: Fish consumption
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Harvard Pilgrim Health Care
state: Massachusetts
Study officials:
affiliation: Harvard Pilgrim Health Care Institute
name: Emily Oken, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Oken E, Guthrie LB, Bloomingdale A, Gillman MW, Olsen SF, Amarasiriwardena CJ, Platek DN, Bellinger DC, Wright RO. Assessment of dietary fish consumption in pregnancy: comparing one-, four- and thirty-six-item questionnaires. Public Health Nutr. 2014 Sep;17(9):1949-59. doi: 10.1017/S1368980013001985. Epub 2013 Jul 24.
citation: Oken E, Guthrie LB, Bloomingdale A, Platek DN, Price S, Haines J, Gillman MW, Olsen SF, Bellinger DC, Wright RO. A pilot randomized controlled trial to promote healthful fish consumption during pregnancy: the Food for Thought Study. Nutr J. 2013 Mar 15;12:33. doi: 10.1186/1475-2891-12-33.
Clinical trial NCT05278962: HF Patients With LVADs Being Treated With SGLT2i
Official title: Heart Failure Patients With Left Ventricular Assist Devices Being Treated With Sodium-Glucose Co-Transporter 2 Inhibitors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Heart Failure With Reduced Ejection Fraction
Keywords: left ventricular assist device
SGLT2i
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2022-03-15
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to observe outcomes of sodium-glucose co-transporter 2 inhibitors (SGLT2i) in heart failure (HF) patients with left ventricular assist devices (LVAD).

Detailed description: The exact mechanism of cardiovascular benefit from SGLT2i continues to be the source of further research. The investigators hypothesize that heart failure patients with LVADs will similarly benefit from the SGLT2i-associated natriuresis and diuresis, which in turn reduces preload. This is further associated with reduced heart failure readmissions and right ventricular failure. Additionally, the animal models indicating reduced cardiac work and remodeling in this population may benefit these patients as one of the goals of LVAD implantation is to reduce cardiac energy expenditure and promote remodeling and recovery in these patients.

This is a prospective, randomized controlled study to assess cardiac benefit of SGLT2i in 40 consecutive patients with heart failure undergoing LVAD implantation. After routine LVAD implantation, patients will be randomized 1:1 to one of two routine care arms: management with an SGLT2i \[empagliflozin 10 milligram (mg) daily or dapagliflozin 10 mg daily, based on formulary coverage\] or no SGLT2i. The patient's treating physician will be able to override randomization assignment if they determine that the assignment is not in the patient's best interest. SGLT2i management (if applicable) and follow-up care will be dictated by routine care. Data will be collected from the subject's medical record for 6 months.

Eligibility criteria: Inclusion Criteria:

1. LVAD implantation
2. Have not already been prescribed management with an SGLT2i
3. Estimated glomerular filtration rate (eGFR) ≥ 30 milliliters(ml)/minute(min)/1.73 meter(m)2
4. Age ≥ 18 years-old
5. Able to provide informed consent

Exclusion Criteria:

1. Diagnosis of Type 1 diabetes mellitus
2. eGFR \< 30 ml/min/1.73 m2
3. Age \< 18 years-old

Primary outcomes:
measure: Change in number of ramp stages needed to achieve hemodynamic optimization
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Mark Belkin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02966262: Korea University Anam Hospital Optical Coherence Tomography Registry
Official title: Optical Coherence Tomography Registry of Korea University Anam Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Optical Coherence Tomography
Lead sponsor: Korea University Anam Hospital
Sponsor class: OTHER
First posted: 2016-11-17
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All comer registry with patients who had undergone coronary intervention and optical coherence tomography

Brief summary: All comer registry who had undergone intravascular optical coherence tomography during and/or after coronary intervention.

Detailed description: Optical coherence tomography registry is composed with before coronary stenting, immediate after coronary stenting and follow-up study.

Eligibility criteria: Inclusion Criteria:

* patients who had undergone coronary intervention and optical coherence tomography

Exclusion Criteria:

* none

Primary outcomes:
measure: Incidence of participants with Major Adverse Cardiovascular Events (MACE)
timeFrame: Up to 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
Study officials:
affiliation: Korea University Anam Hospital
name: Do-Sun Lim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02348762: Energetics and Function in Older Humans
Official title: Energetics and Function in Older Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Aging
Erythrocyte Glutathione Deficiency
Muscle Weakness
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2015-01-28
Enrollment: 16
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators have previously reported that older patients with HIV are deficient in glutathione (GSH) due to decreased availability of cysteine and glycine, and that oral supplementation with cysteine (as n-acetylcysteine) and glycine for 2-weeks corrects their own levels, and improves concentrations of red-cell GSH. The investigators also found that when GSH deficient, subjects had impaired mitochondrial energetics and this improved with an increase in intracellular GSH concentrations. The current proposal will investigate if cysteine and glycine supplementation for a duration of 24 weeks will result in changes in : (a) GSH levels; (b) body composition/anthropometry; (c) strength and function; (d) quality of life; (e) mitochondrial energetics; (f) biochemistry (including dyslipidemia and oxidative stress); (g) protein and glucose metabolism; (h) cognition and memory. 3 months after completing supplementation, measurement of GSH concentrations, strength, function, mitochondrial energetics and neurocognitive tests will be done to determine the effects of washout.

Detailed description: Data not available at present

Eligibility criteria: Inclusion Criteria:

Older subjects:

* age 70-80 years;

Younger subjects:

* age 21-30 years

Exclusion Criteria:

1. No known diabetes, liver disease, kidney disease, coronary heart disease, stroke, or cancer;
2. Any limitations in ability to walk;
3. Triglyceride concentrations greater than 500 mg/dl (if lipid lowering medications are stopped);
4. BMI less than 20.

Primary outcomes:
measure: Red blood cell concentrations of Glutathione measured by HPLC
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor Metabolic Research Unit (MRU)
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: R V Sekhar, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02708862: Four Methods of Pre-oxygenation
Official title: Comparison of Emergency Department Preoxygenation Techniques in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Failure
Lead sponsor: Hennepin Healthcare Research Institute
Sponsor class: OTHER
First posted: 2016-03-15
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Four methods of preoxygenation will be compared in healthy volunteers

Detailed description: After informed consent, each volunteer will undergo the following techniques:

Simple mask at "flush" flow (40-60 L/min) Non-rebreather mask at 15 L/min Non-rebreather mask at 60 L/min Bag valve mask with one way exhalation valve at 15 L/min

After 3 minutes, the exhaled oxygen will be measured with an oxygen sensor

Eligibility criteria: Inclusion Criteria:

* Over 18 years old

Exclusion Criteria:

* Any active respiratory pathology (asthma, chronic obstructive pulmonary disease, other lung disease, smoking history more than 5 years)
* pregnant

Primary outcomes:
measure: Exhaled Oxygen Concentration
timeFrame: Immediately after 3 minutes of oxygen supplementation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Driver BE, Prekker ME, Kornas RL, Cales EK, Reardon RF. Flush Rate Oxygen for Emergency Airway Preoxygenation. Ann Emerg Med. 2017 Jan;69(1):1-6. doi: 10.1016/j.annemergmed.2016.06.018. Epub 2016 Aug 10.
Clinical trial NCT05150262: Urinary Procedures Performed by Gynecologists, Results and Learning Curves.
Official title: Urinary Procedures Performed by Gynecologists, Results and Learning Curves.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gynecologic Cancer
Endometriosis
Keywords: Gynecologic Cancer
Endometriosis
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2021-12-09
Enrollment: 96
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult woman with gynecological cancer or endometriosis, having undergone surgery between 01/01/2010 and 04/30/2021 at Strasbourg University Hospital

Brief summary: Urinary procedures such as placing a JJ catheter, performing a psoic bladder, a Bricker technique or even a partial cystectomy are relatively frequent procedures in the context of the surgical management of gynecological cancer or endometriosis in order to obtain maximum reduction in oncology, or to overcome all endometriotic lesions when they affect the urinary tract. However, gynecological surgeons are not always trained in these specific procedures, the learning of which is crucial in the optimal management of these patients.

The aim of the research is to describe the surgical experience in terms of urinary actions (JJ catheter placement, psoic bladder, Bricker technique, cystectomy) over the past 10 years and determine a learning curve for a surgical team made up of only gynecological surgeons


Eligibility criteria: Inclusion criteria:

* Adult woman (≥18 years old)
* Woman with gynecological cancer or endometriosis, having undergone surgery between 01/01/2010 and 04/30/2021 at Strasbourg University Hospital
* With the performance of urological procedures during the operation performed by a surgical team composed of a gynecological surgeon
* Woman who did not express her opposition to the reuse of her data for the purposes of this research.

Exclusion criteria:

* Woman who expressed her opposition to participating in the study
* Surgery performed by a team of surgeons not composed exclusively of gynecologists

Primary outcomes:
measure: Describe the surgical experience in terms of urinary procedures (JJ catheter placement, psoic bladder, Bricker's technique, cystectomy) over the past 10 years
timeFrame: Files analysed retrospectively from January 01, 2010 to April 30, 2021 will be examined]
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de gynécologie Obstétrique - Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Service de gynécologie Obstétrique - Hôpitaux Universitaires de Strasbourg
name: Lise LECOINTRE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06597162: The Effect of Patient Safety Education Using Problem-Based Learning Approach on Nurses Patient Safety Knowledge Levels and Patient Safety Attitudes
Official title: The Effect of Patient Safety Education Using Problem-Based Learning Approach on Nurses Patient Safety Knowledge Levels and Patient Safety Attitudes
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Problem-Based Learning
Nursing
Patient Safety
Keywords: patient safety,
problem based learning
nursing
Lead sponsor: Kıbrıs İlim Üniversitesi
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 80
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This research was planned to reveal and evaluate the effects of the problems experienced in the Turkish Republic of Northern Cyprus Health System, which takes the Republic of Turkey Health System as an example, on patient safety for nurses and to determine the goals that will lead to a solution. As it is known, there are deficiencies in the patient safety training program and legal regulations covering patient safety in healthcare institutions in TRNC. The training program in this research forms the basis for disseminating such training programs in all health institutions operating in TRNC, ensuring patient safety and providing higher quality and safer care.

Detailed description: This research aims to shed light on the literature and the TRNC Health System. It is envisaged that developing and improving patient safety programs in healthcare institutions, supporting the infrastructure system for the use and development of scientific knowledge focused on patient safety, creating appropriate working environments, and correcting the incorrect behavior of healthcare professionals regarding patient safety will contribute to the development of patient safety and facilitate the delivery of quality patient care. This research was planned to determine the effect of the patient safety training program given using the problem-based learning approach on nurses\&#39; patient safety knowledge levels and patient safety attitudes.

Eligibility criteria: Inclusion Criteria:

Nurse

* Must work as a nurse
* Must not have received this patient safety training before

Exclusion Criteria:

Nurse

* Should not accept to participate in the research voluntarily
* The data collection form must be filled incompletely

Primary outcomes:
measure: Patient Safety Information Form
timeFrame: 10 week
Secondary outcomes:
measure: Patient Safety Attitude Scale
timeFrame: 10 week
Other outcomes:
Locations:
city: Kyrenia
country: Cyprus
facility: Cyprus Science Univercity
Study officials:
References:
Clinical trial NCT05771662: Multimodal Brain Monitoring as a Prognostic Tool for Intracerebral Hemorrhage
Official title: Multimodal Brain Monitoring as a Prognostic Tool for Intracerebral Hemorrhage - A Prospective Observational Cohort Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intracerebral Hemorrhage
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
First posted: 2023-03-16
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically Ill, Spontaneous Intracerebral Hemorrhage Adult Patients.

Brief summary: To verify if there is an association between advanced multimodal brain monitoring parameters in the first 48h and fist 7 days of admission with intrahospital and six-months functional outcome, even when controlled to other factors that may influence the outcome. Secondary Goals: To describe multimodal neuromonitoring parameters variation in the first seven days of ICH and identify any trends.


Eligibility criteria: Inclusion Criteria:

* Spontaneous Intracerebral Hemorrhage
* ICU admission in the first 24hours
* Need for intraparenchymal Neuromonitoring
* Over 18 years old

Exclusion Criteria:

* Tumour, Trauma or known Vascular Lesion
* Pregnancy

Primary outcomes:
measure: Relation between multimodal brain monitoring parameters and outcome.
timeFrame: 6 months
Secondary outcomes:
measure: ICH Neuromonitoring Pattern.
timeFrame: 7 days
measure: ICH Neuromonitoring and Short Term Outcome
timeFrame: 28 days
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Centro Hospitalar São João
Study officials:
References:
Clinical trial NCT05086562: Prevalence of Chronic Abdominal Pain in Migraneurs
Official title: Prevalence of Chronic Abdominal Pain in Migraneurs
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Migraine
IBD
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2021-10-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Migraneurs with Chronic Abdominal Pain

Brief summary: To collect data on the prevalence of Chronic Abdominal Pain in Migraneurs in Germany


Eligibility criteria: Inclusion Criteria:

* chronic abdominal pain
* migraine

Exclusion Criteria:

* not able to sign written informed consent

Primary outcomes:
measure: Visual analog scale (VAS) for pain
timeFrame: observational, through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite University Medicine
Study officials:
References:
Clinical trial NCT00420862: The DANTE Trial. A Randomized Study on Lung Cancer Screening With Low-Dose Spiral Computed Tomography
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Lung Cancer
Keywords: Lung neoplasms
Early diagnosis
Screening
Spiral Computed Tomography
Randomized Controlled Trial
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
Collaborators: name: Lega Italiana per la Lotta contro i Tumori
First posted: 2007-01-11
Enrollment: 2400
Sex: MALE
Minimum age (years): 60
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: High survival rates have been reported for screen-detected Stage I lung cancer patients, but there are concerns about the potential biases of uncontrolled studies. DANTE is a prospective randomized controlled trial exploring the effects of screening with LDCT on lung-cancer-specific mortality, and on the prevalence and incidence rates of lung cancer, stage distribution and resectability rates in a selected high-risk population. The prevalence of a set of biomarkers in sputum and blood samples is also being determined.


Eligibility criteria: Inclusion Criteria:

* Male sex
* Age 60-74 years
* smokers of more than 20 cigarettes/day for at least 20 years (actual smokers or ex-smokers from no more than 10 years)

Exclusion Criteria:

* severe cardiopathy
* advanced BPCO with chronic hypoxaemia (rest SatO2 \< 94%)
* chronic severe renal insufficiency
* hypertension not controlled with drugs
* type 2 diabetes or other severe systemic disease
* severe previous cerebrovascular lesions with permanent invalidity (not self-sufficient).
* severe vascular lesions with repeated ictus, trophic lesions, or limb loss, if actual smoker
* Dementia, psychosis, severe depression or maniac-depressive syndrome
* actual or precedent neoplasia, excepted skin tumor not-melanoma or scaly cells laryngeal and buccal cavity tumor, N0, recovered from more than 10 years or other tumors recovered from more than 10 years
* transplantation less than 5 years or with rejection episodes in the last 2 years
* unable subjects

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: MI
Study officials:
affiliation: Istituto Clinico Humanitas
name: Gianni Ravasi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Infante M, Lutman FR, Cavuto S, Brambilla G, Chiesa G, Passera E, Angeli E, Chiarenza M, Aranzulla G, Cariboni U, Alloisio M, Incarbone M, Testori A, Destro A, Cappuzzo F, Roncalli M, Santoro A, Ravasi G; DANTE Study Group. Lung cancer screening with spiral CT: baseline results of the randomized DANTE trial. Lung Cancer. 2008 Mar;59(3):355-63. doi: 10.1016/j.lungcan.2007.08.040. Epub 2007 Oct 23.