louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04783870: Effect of Dapagliflozin on LV Remodeling Post AMI
Official title: Effect of Dapagliflozin on Left Ventricular Remodeling in Patients With Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Myocardial Infarction
Lead sponsor: Instituto Mexicano del Seguro Social
Sponsor class: OTHER_GOV
First posted: 2021-03-05
Enrollment: 60
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 overall hypothesis of the study is that Dapagliflozin will reduce left ventricular remodeling in patients who have had a myocardial infarction.

Detailed description: In patients with heart failure, with or without diabetes, SGLT2i have shown to decrease remodeling. However, this has not been tested in patients following an acute myocardial infarction.

Acute myocardial infarction is serious condition with increasing incidence across the world. Following treatment, a reasonable amount of patients develop remodeling of the left ventricle, which is associated with worse prognosis. This occurs despite patients are treated with GDMT.

Dapagliflozin is an SGLT2i with biological plausibility to decrease left ventricular remodeling following acute myocardial infarction. In the present study, researchers will test the hypothesis that Dapagliflozin will reduce left ventricular remodeling in patients who have had a myocardial infarction (less than 7 days). This will be a randomized, single-blind, placebo controlled trial. The primary endpoint will be the change in end-diastolic and end-systolic left ventricular volumes from baseline to the end of the intervention (6 months). We will include patients with acute myocardial infarction who have been treated with primary PCI.

Eligibility criteria: Inclusion Criteria:

* Acute myocardial infarction treated within the 24 hours of beginning of symptoms
* Signed informed consent
* SBP \> 90 mmHg
* Age \>= 18 years

Exclusion Criteria:

* Glomerular Filtration Rate \< 30 ml/min/1.73 m2.
* Pregnant or lactating woman
* Cancer or life-threatening condition
* Use of continuous parental inotropic agents
* Psychiatric disease incompatible with being in study.
* Any contraindication to MRI procedures.
* Any other medical or physical condition considered to be inappropriate by a study physician
* Scheduled for a PCI or CABG within the next 6 months
* Hemodynamic unstability
* Currently on any SGLT2i
* One or more episodes of severe hypoglicemia
* Acute urinary or genital infection

Primary outcomes:
measure: Left ventricular remodeling
timeFrame: 6 months
Secondary outcomes:
measure: Natriuretic peptides
timeFrame: 6 months
measure: Quality of life assessed with KCCQ
timeFrame: 6 months
Other outcomes:
Locations:
city: Ciudad de México
country: Mexico
facility: Hospital de Cardiología, Centro Médico Nacional Siglo XXI
Study officials:
affiliation: Instituto Mexicano del Seguro Social
name: Juan B Ivey-Miranda, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05419570: Short Time Low PEEP Challenge and Mini Fluid Challenge
Official title: Ability of Short Time Low PEEP Challenge and Mini Fluid Challenge to Predict Fluid Responsiveness During Pancreaticoduodenectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intraoperative Care
Fluid Responsiveness
Keywords: Intraoperative monitoring
fluid therapy
Lead sponsor: Istanbul Saglik Bilimleri University
Sponsor class: OTHER
First posted: 2022-06-15
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing pancreaticoduodenectomy

Brief summary: Optimizing fluid therapy is one of the main concerns for anesthesiologists during the intraoperative period. It becomes even more important in high-risk long lasting surgeries as pancreaticoduodenectomy. Therefore evaluating fluid responsiveness prior to fluid loading is highly recommended. To the best of our knowledge there is no study comparing the abilities short time low PEEP challenge and mini fluid challenge in predicting fluid responsiveness.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing pancreaticoduodenectomy

Exclusion Criteria:

* Body mass index (BMI) \> 35 kg / m2
* any ventricular dysfunction
* Crs \< 35 ml / cmH2O
* valvular heart disease
* ASA score \> 3
* cardiac arrhythmia
* history of lung disease

Primary outcomes:
measure: Difference between the abilities of two methods to predict fluid responsiveness defined as an increase in stroke volume index >15% after fluid loading
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Başakşehir Çam adn Sakura City Hospital
city: Istanbul
country: Turkey
facility: Başakşehir Çam and Sakura City Hospital
Study officials:
References:
Clinical trial NCT05496270: Surgery Alone Versus Neoadjuvant Treatment Followed by Surgery For MRI-defined T3 Mid-low Rectal Cancer
Official title: Surgery Alone Versus Neoadjuvant Treatment Followed by Surgery For MRI-defined T3 Mid-low Rectal Cancer: A Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Cancer
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2022-08-11
Enrollment: 1509
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: T3 mid-low rectal cancer patients with clear MRF

Brief summary: Neoadjuvant treatments (nCRT) are becoming the standard treatment for patients with stage II or stage III mid-low rectal cancer. In fact, with the introduction of total mesorectal excision, the local recurrence has been reduced significantly. Recently few studies have shown that surgery alone is enough for patients with T3 rectal cancer. These issues raised the question of whether nCRT is needed for all T3 rectal cancer patients. Therefore, this study was designed to compare the long-term oncological outcomes between surgery and surgery following nCRT among patients with MRI-defined T3, clear MRF mid-low rectal cancer.


Eligibility criteria: Inclusion Criteria:

1. Eighteen- to eighty-year-old patients.
2. T3 rectal cancer with clear mesorectal fascia (MRF),
3. within 12 cm from the anal verge at initial diagnosis by magnetic resonance imaging (MRI)

Exclusion Criteria:

1. emergency surgery due to bleeding, perforation, and bowel obstruction,
2. recurrent rectal cancer,
3. inflammatory bowel disease,
4. Stage IV.

Primary outcomes:
measure: 3-year diseases free survival
timeFrame: 3 years after surgery
Secondary outcomes:
measure: Margin-free （R0）resection rate
timeFrame: Immediately after the surgery
measure: 3-year overall survival rate
timeFrame: 3 years after surgery
measure: Number of participants with surgical complications
timeFrame: 30 days after surgery
measure: Local recurrence rate
timeFrame: 3 years after the surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05307770: Extended-Release Melatonin in Patients With Rapid Eye Movement Sleep Behavior Disorder
Official title: Randomized, Double-Blind, Cross-Over Study Comparing the Efficacy of Immediate and Extended-Release Melatonin as a Supplement Affecting the Sleep Cycle in Patients With Parkinson Disease and Rapid Eye Movement Sleep Behavior Disorder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Rapid Eye Movement Sleep Behavior Disorder
Parkinson Disease
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-04-01
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this research is to compare the efficacy of immediate versus extended-release melatonin as a supplement affecting the sleep cycle in patients with Parkinson disease and Rapid Eye Movement Sleep Behavior Disorder.

Detailed description: Enrolled patients with Parkinson disease and previously diagnosed rapid eye movement sleep behavior disorder, who are being treated at Mayo Clinic in Florida, will be randomized to receive either immediate-release melatonin or extended-release melatonin and then will be crossed over to receive the opposite intervention. The study will consist of two treatment periods of 4 weeks separated by a washout period of 2 weeks.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with Parkinson's disease and rapid eye movement sleep behavior disorder.
* Patient registered to Parkinson's disease database of Mayo Clinic Florida.

Exclusion Criteria:

* Patients who are using other sleep aids or medications (Clonazepam).
* Patients who are not willing to undertake 1 week of washout period.
* Patients who do not sign a consent for research.

Primary outcomes:
measure: Change in sleep cycle
timeFrame: Baseline and 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Emir Festic, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01825070: Montmorency Cherry Juice and Uric Acid Metabolism
Official title: The Influence of Tart Montmorency Cherries on Indices of Uric Acid Metabolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammation
Keywords: Montmorency tart cherries
Inflammation
Uric acid
Lead sponsor: Northumbria University
Sponsor class: OTHER
First posted: 2013-04-05
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Cherries have been show to possess the ability to reduce uric acid concentrations and inflammation. Tart Montmorency cherries possess a higher concentration of the plant compounds than other cherries and hence makes the expectation possible that Montmorency cherries will lower uric acid and inflammation.

Detailed description: Plasma and urinary uric acid concentration, plasma phytochemical content and inflammatory biomarkers will be measured in order to elucidate the effects of an acute dose of tart cherry juice on indices related to the condition of gout.

Participants will be required to attend the laboratory at a range of time points over two periods of 96 hours, separated by a 7 day washout period, to provide blood samples. In order to provide a baseline sample, participants will attend the laboratory in the morning following an overnight fast and voiding of any urine. Following this participants will be given 30mls (30 mls provides 323 mg/380 µmol of anthocyanins) of tart cherry juice or placebo, diluted with 60 mls of water to consume within 10 minutes. Participants will be required to consume identical dosages of the supplement immediately prior to evening meals and breakfasts (or same time each morning following blood sampling if non-breakfast eater) over the next 96 hours. Further blood and urine samples will be collected at 1, 2, 3, 5, 8, 24, 26, 48, 50, 72, 74 and 96 hours and will require participants to return to the laboratory at each of these time points. Following the first period of supplementation participants will complete a 7 day washout period in which they will not be required to attend the laboratory. Following the washout period they will repeat the supplementation period consuming the supplement they did not receive during the first period.

Eligibility criteria: Inclusion Criteria:

* apparently healthy males/females between the ages of 18-40 years

Exclusion Criteria:

* underlying clinical pathology

Primary outcomes:
measure: Change in uric acid
timeFrame: 0, 1, 2, 3, 5, 8, 24, 26, 48 hours
Secondary outcomes:
measure: Change in C-reactive protein
timeFrame: 0,1,2,3,5,8,24,26,48 hours
Other outcomes:
measure: Change in anthocyanins, polyphenolics and creatinine
timeFrame: 0,1,2,3,5,8,24,26,48 hours
Locations:
city: Newcastle upon Tyne
country: United Kingdom
facility: Northumbria University
state: Tyne and Wear
Study officials:
affiliation: Northumbria University
name: Glyn Howatson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06863870: Assessment of Circulating Tumor Cells and microRNAs in Patients With Metastatic Non-cutaneous Melanoma
Official title: Assessment of Circulating Tumor Cells and microRNAs in Patients With Metastatic Non-cutaneous Melanoma
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Melanoma Neoplasms
Keywords: uveal melanoma
mucosal melanoma
melanoma primary unknown
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-03-07
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diagnosis of metastatic UM or MM or MUP will be enrolled

Brief summary: the study aims to implement new approaches for the identification of circulating tumor cells and circulating microRNAs, which aim to silence the expression of genes and thus prevent the production of proteins in patients with advanced melanoma (uval, mucosal, of unknown origin). It also aims to verify whether their expression can be related to the prognosis of the disease and the response to treatments.

Detailed description: Here we propose a study to identify a technique for the isolation of circulating tumor cells (CTCs) from blood samples of patients with diagnosis of metastatic melanoma (uveal, mucosal, from primary unknown) to identify a potential role of CTCs and to study the role for circulating microRNAs (miRNAs) in the management of metastatic UM, MM and MUP.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of UM, MM or MUP
* Diagnosis of metastatic disease
* Age ≥ 18 years, at the time of the tissue collection

Exclusion Criteria:

* Personal medical history of concomitant other cancer

Primary outcomes:
measure: Melanoma circulating tumor cell (CTC) count (number of CTC/ml)
timeFrame: At enrollment and at every scheduled follow-up visits throughtout the study (24 months)
measure: Circulating microRNAs (copies/ml)
timeFrame: At enrollment and at every scheduled follow-up visits throughtout the study (24 months)
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Throughtout the study duration (24 months) for a minumum of 6 months for each patient
measure: To correlate the count of CTC and the expression of circulating microRNAs with patients' prognosis in order to discover liquid biomarkers for prognosis of UM, MM and MUP
timeFrame: Throughtout the study duration (24 months) for a minumum of 6 months for each patient
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Andrea Ardizzoni, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03612206: Effect of Early Enteral Nutrition on Serum Acetylcholine Level and Inflammation in Critically Ill Patients
Official title: Effect of Early Enteral Nutrition on Serum Acetylcholine Level and Inflammation in Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Enteral Nutrition
Inflammation
Lead sponsor: Nanjing PLA General Hospital
Sponsor class: OTHER
First posted: 2018-08-02
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study population mainly includes patients who suffered severe complications after surgery or severe trauma

Brief summary: Early enteral nutrition(EEN) is an important treatment for critical ill patients and attenuate systemic inflammation, but the mechanisms are not clear. Thus the investigator conducted this study to observe if EEN affects systemic inflammation though regulation of blood acetylcholine


Eligibility criteria: Inclusion Criteria:

* initiating enteral nutrition within the first 24-48h after intensive care unit (ICU) admission
* age more than 18 years
* Acute Physiology and Chronic Health Evaluation II (APACHE II) score \>8

Exclusion Criteria:

* not expected to survive 24 hours
* pregnancy
* any terminal stage disease

Primary outcomes:
measure: 28-day mortality
timeFrame: 14 months
measure: Intestinal barrier function within one week
timeFrame: 14 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Tao G, Min-Hua C, Feng-Chan X, Yan C, Ting S, Wei-Qin L, Wen-Kui Y. Changes of plasma acetylcholine and inflammatory markers in critically ill patients during early enteral nutrition: A prospective observational study. J Crit Care. 2019 Aug;52:219-226. doi: 10.1016/j.jcrc.2019.05.008. Epub 2019 May 10.
Clinical trial NCT05355506: The Development and Effectiveness of Heart Failure Self-Health Management Application
Official title: National Taipei University of Nursing and Science
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Heart Failure
Keywords: Heart Failure
Lead sponsor: National Taipei University of Nursing and Health Sciences
Sponsor class: OTHER
First posted: 2022-05-02
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inclusion Criteria:

* Heart failure

Exclusion Criteria:

* Health

Brief summary: Aims: To develop a smartphone application and investigate its effectiveness on patients with heart failure after using the "heart failure self-health management application.".

Detailed description: Abstract Aims: To develop a smartphone application and investigate its effectiveness on patients with heart failure after using the "heart failure self-health management application.".

Design: The single-group pre- and post-test experimental design was adopted. Methods: This study used convenience sampling and the one-group pretest and posttest design as the research methods and developed the "heart failure self-health management application" using the Google cloud database and Web App. The research period was from July 1 to December 31, 2019, a total of 36 patients diagnosed with heart failure during hospitalization completed the pretest and posttest. This App (1) provides text and video heart failure self-care knowledge content; (2) enables users to record and browse blood pressure, heart rate, and weight; and (3) provides the data from the Dutch Heart Failure Knowledge Scale and Technology Acceptance Model.

Keywords: heart failure; self-health management; application

Eligibility criteria: Inclusion Criteria:

* Heart failure

Exclusion Criteria:

* Health

Primary outcomes:
measure: participant's knowledge about heart failure significantly increased after the intervention
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei county
country: Taiwan
facility: Pei-Hung Liao
Study officials:
References:
Clinical trial NCT02871206: Adjuvanted Inactivated Vaccine Versus Inactivated Influenza Vaccine in Hutterite Children
Official title: A Randomized Controlled Trial of Adjuvanted Inactivated Vaccine Versus Inactivated Influenza Vaccine in Hutterite Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: University of Calgary
name: University of Saskatchewan
First posted: 2016-08-18
Enrollment: 3425
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is a randomized controlled trial (RCT) comparing adjuvanted influenza vaccine (AV) to unadjuvanted inactivated influenza vaccine (IIV). Children in Hutterite colonies in Alberta and Saskatchewan will receive AV or IIV. The goal of this study is to determine whether the AV vaccine, can provide increased community-wide protection.


Eligibility criteria: Group A: Receive Intervention

Inclusion Criteria:

-Healthy children aged 6 months to 72 months

Exclusion Criteria:

* Anaphylactic reaction to a previous dose of influenza vaccine or to any of its components
* Known Immunoglobulin E (IgE)-mediated hypersensitivity to eggs manifested as hives, swelling of the mouth and throat, difficulty in breathing, hypotension, or shock
* Guillain- Barré syndrome within eight weeks of a previous influenza vaccine
* Use of aspirin or salicylate- containing products within 30 days before enrollment

Group B:

Inclusion Criteria:

* household and extended family members of children in Group A
* extended family is defined as the household members of the grandparents of the children in Group A

Exclusion Criteria:

* there are no exclusion criteria for this category of participants

Group C:

Inclusion Criteria:

* other Hutterite community members that are not in Group A

Exclusion Criteria:

* there are no exclusion criteria for this category of participants

Primary outcomes:
measure: Laboratory-confirmed influenza infection
timeFrame: Up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: McMaster University
name: Mark Loeb, MD, MSc.
role: PRINCIPAL_INVESTIGATOR
References: