louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01666587: Ischemia Reperfusion: Prostaglandins and Antioxidants
Official title: The Role of Prostaglandin and Anti-oxidant Availability on Recovery From Forearm Ischemia-reperfusion Injury in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Reperfusion Injury
Lead sponsor: University of Essex
Sponsor class: OTHER
First posted: 2012-08-16
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purposes of this study are two-fold. The first purpose is to determine the effect of taking vitamins on the recovery of an artery (blood vessel) following an induced temporary injury. The second purpose is to determine whether a specific vasodilator is less abundant after the injury and whether this contributes to increased constriction or after the injury. Finally, does vitamin consumption have an effect on the recovery from the injury if one of the substances in the blood that causes vessels to enlarge (dilate) is stopped?


Eligibility criteria: Inclusion Criteria:

* Healthy males
* Healthy females

Exclusion Criteria:

* Smokers
* Cardiovascular disease
* Peripheral vascular disease
* Neurological deficits
* Diabetes Type I or II
* Pregnant women
* Adverse reactions to Ibuprofen

Primary outcomes:
measure: Change in flow mediated dilation
timeFrame: Change from baseline at 15 minutes after ischemia-reperfusion injury
Secondary outcomes:
measure: Change in low flow mediated constriction
timeFrame: Change from baseline at 15 minutes after ischemia-reperfusion injury
Other outcomes:
Locations:
city: Colchester
country: United Kingdom
facility: University of Essex
state: Essex
Study officials:
affiliation: Thompson Rivers University
name: Mark Rakobowchuk, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02494687: Domperidone Expanded Access Program for Oncology Patients With Gastroparesis Who Have Failed Standard Therapy
Official title: Domperidone Expanded Access Program for Oncology Patients With Gastroparesis Who Have Failed Standard Therapy
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Oncology Patients With Gastroparesis
Lead sponsor: Eastern Regional Medical Center
Sponsor class: OTHER
First posted: 2015-07-10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: Gastroparesis is a digestive disorder in which motility of the stomach is either slowed or absent. The gastroparesis prevents normal digestion from occurring. The purpose of this study is to provide oral Domperidone offered under the U.S. Food and Drug Administration (FDA) expanded access program, to patients that, based on the treating doctor's assessment, could benefit from , a prokinetic effect for the relief of refractory gastroesophageal reflux disease with upper gastrointestinal (GI) symptoms, gastroparesis, and chronic constipation.

Detailed description: At the discretion of the Investigator, 10-30 mg of oral domperidone is administered QID (four times a day). The Investigator will be starting patients on 10 mg four times a day for 2 weeks, then increase to 20 mg four times a day for 2 weeks. The participant will be evaluated at each time point. If the participant still is not having relief of symptoms the investigator may increase their dose to 30mg four times a day.

Eligibility criteria: Inclusion Criteria:

1. Male or female
2. Age 18 and older
3. Symptoms or manifestations secondary to GERD (e.g., persistent esophagitis, heartburn, upper airway signs or symptoms or respiratory symptoms), gastrointestinal motility disorders such as nausea, vomiting, severe dyspepsia or severe chronic constipation refractory to standard therapy.
4. Patients must have a comprehensive evaluation (physical exam and also may include EGD, gastric emptying study, as clinically necessary) to eliminate other causes of their symptoms.
5. Patient has signed informed consent for the administration of domperidone that informs the patient of potential adverse events including:

   * increased prolactin levels
   * extrapyramidal side-effects
   * breast changes
   * cardiac arrhythmias including QT prolongation and death

Exclusion Criteria:

History of, or current, arrhythmias including ventricular tachycardia, ventricular fibrillation and Torsade des Pointes. Patients with minor forms of ectopy (PACs) are not necessarily excluded.

1. Clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged QTc (QTc\> 450 milliseconds for males, QTc\>470 milliseconds for females).
2. Clinically significant electrolyte disorders.
3. Gastrointestinal hemorrhage or obstruction
4. Presence of a prolactinoma (prolactin-releasing pituitary tumor).
5. Pregnant or breast feeding female
6. Known allergy to domperidone

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Eastern Regional Medical Center, Inc.
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01943747: International Multicentre Prevalence Study on Sepsis
Official title: Surviving Sepsis Campaign. International Multicentre Prevalence Study on Sepsis.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Sepsis
Septic Shock
Keywords: sepsis
severe sepsis
septic shock
infection
organ dysfunction
quality improvement
Lead sponsor: European Society of Intensive Care Medicine
Sponsor class: OTHER
Collaborators: name: Society of Critical Care Medicine (SCCM)
First posted: 2013-09-17
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients presenting with either severe sepsis or septic shock

Brief summary: To mark 10 years of the Surviving Sepsis Campaign (SSC), and timed to coincide with World Sepsis Day, on September 13, 2013, the SSC, ESICM and SCCM will be conducting an international point prevalence study of severe sepsis and septic shock. The goal of this project is to determine the world wide burden of severe sepsis and define current practices of sepsis care internationally. The study is a simple data collection exercise for patients presenting with either severe sepsis or septic shock on World Sepsis Day.

Detailed description: De---identified patient---level data will be collected on patients presenting to a participating intensive care unit or emergency department with severe sepsis or septic shock over a 24 hour period from 00:00 to 24:00 November 07, 2013. De---identified data that is already collected as part of routine clinical care will be collected for this study. Data to be collected includes hospital and ICU characteristics, patient characteristics, severity of illness, and adherence to SSC bundle elements and mortality. It will take between 30---60 minutes to collect and enter data for each patient admitted with severe sepsis or septic shock over the 24 hours study period.

Eligibility criteria: Inclusion Criteria:

To be eligible patients must have all of the following:

* Must be admitted or transferred to either the ED or an Intensive Care Unit.
* Have a high clinical suspicion of an infection
* Have sepsis as defined by an infection together with two or more SIRS criteria
* Evidence of acute organ dysfunction and/or Shock.

Exclusion Criteria:

* Patients less than 18 years of age
* Patients in whom the sepsis has been present from before the beginning of the study period
* Any patients previously included in the study during the same study period

Primary outcomes:
measure: 28-Day Mortality
timeFrame: one week
Secondary outcomes:
measure: Organ Failure
timeFrame: one week
Other outcomes:
measure: Length of Stay in the Hospital
timeFrame: one week
Locations:
city: Brussels
country: Belgium
facility: All centres willing to contribute are welcome.
Study officials:
affiliation: European Society of Intensive Care Medicine
name: Andrew RHODES, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05422547: Role of Immunoscore® in Stage II-III Colorectal Cancer
Official title: Role of Immunoscore® in Stage II-III Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colon Adenocarcinoma
Keywords: colorectal cancer
colon carcinoma
immunoscore
immune response
predictive markers
prognostic markers
tumour microenvironment
Lead sponsor: D'Or Institute for Research and Education
Sponsor class: OTHER
Collaborators: name: HalioDx
name: Diagnosticos da America SA
First posted: 2022-06-16
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with stage II - III colorectal cancer undergoing oncological surgery.

Brief summary: The proposed study is a bidirectional analytical study, composed of a retrospective and a prospective cohorts. Patients with stage II - III colorectal cancer undergoing oncological surgery will be analyzed. The study will include a convenience sample of 100 individuals. Fifty cases will be included retrospectively and fifty prospectively.

The study aims to evaluate the benefit of using the Immunoscore test as a predictor of recurrence in patients with operated stage II-III colon tumors. It will also be evaluated the impact on oncologic decision and costs.


Eligibility criteria: Inclusion Criteria:

1. Anatomopathological diagnosis of colorectal adenocarcinoma
2. Stage II - III (AJCC 8th edition)
3. Patient undergoing surgery with curative intent

Exclusion Criteria:

1. Current or previous diagnosis (within the last 5 years) of another invasive primary malignant neoplasm, with the exception of non-melanoma skin neoplasm
2. Presence of distant metastatic disease evidenced in imaging tests

Primary outcomes:
measure: Tumour recurrence
timeFrame: 2 years
Secondary outcomes:
measure: Disease-free survival (DFS)
timeFrame: 5 years
measure: Overall survival (OS)
timeFrame: 5 years
measure: DFS acoording tumor side
timeFrame: 3 years
measure: OS acoording tumor side
timeFrame: 3 years
measure: Indication of adjuvant therapy
timeFrame: 6 months
measure: Biomarker measurements
timeFrame: 6 months
measure: Possible economic impact
timeFrame: 5 years
Other outcomes:
Locations:
city: Brasília
country: Brazil
facility: Instituto D'Or de Pesquisa e Ensino - Brasília
state: Distrito Federal
city: Rio De Janeiro
country: Brazil
facility: Instituto D'Or de Pesquisa e Ensino - Rio de Janeiro
Study officials:
affiliation: Instituto D'Or de Pesquisa e Ensino
name: Paulo M Hoff, PhD
role: STUDY_CHAIR
affiliation: Instituto D'Or de Pesquisa e Ensino
name: Fernando A Soares, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06252077: Very Low Ketogenic Diet and Energy Expenditure
Official title: Effect of Very Low Ketogenic Diet on Energy Metabolism in Women With Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Energy Metabolism
Lead sponsor: University of Pisa
Sponsor class: OTHER
First posted: 2024-02-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: body weight loss
Primary purpose: TREATMENT

Brief summary: This study aimed at evaluating the effectiveness of the active phase of a very low-calorie ketogenic diet in females with obesity lasting 28 days on body weight, body composition and energy metabolism using a metabolic chamber.

Detailed description: Patients were recruited at the Obesity and Lipodystrophy Center, University Hospital of Pisa. Enrolled subjects underwent active phase of very low-calorie ketogenic diet within the metabolic chamber from day 0 for a duration of 4 weeks (day 0-28). On days 0, 7, and 28, patients underwent a 24-hour measurement of energy metabolism using the metabolic chamber. On the day of exit from the chamber measurement of body composition was conducted using total-body densitometry (Lunar iDXA; GE Healthcare).

Eligibility criteria: Inclusion Criteria:

* overweight and obesity

Exclusion Criteria:

* Type 1 and type 2 diabetes mellitus
* endocrine disorders
* asthma or pulmonary conditions
* cardiovascular disease
* gastrointestinal disease
* liver disease
* kidney diseases
* anemia (hemoglobin \< 11 g/dL)
* leucopenia (white blood cells \< 4,000/mcL)
* thrombocytopenia (platelets \< 150,000/mcL)
* central nervous system disorders
* neurodegenerative diseases
* psychiatric disorders
* eating disorders
* alcohol abuse and substance dependence
* pregnancy
* lactation.

Primary outcomes:
measure: measure of energy expenditure
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: University Hospital of Pisa, Endocrinology Unit
Study officials:
affiliation: University of Pisa
name: Ferruccio Santini, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06116877: Effect of Adding Zirconium Oxide Nanoparticles to Printable Implant Overdenture
Official title: Effect of Adding Zirconium Oxide Nanoparticles to Printable Implant Overdenture Acrylic Resin Base Material. Clinical Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prosthesis Durability
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2023-11-03
Enrollment: 20
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical study will be conducted to evaluate and compare non-modified printable acrylic resin base material and modified printable acrylic resin base material with zirconia oxide nanoparticles for a 2-implant retained complete overdenture regarding:Surface roughness; microbiological assessment of denture base microbiological analysis peri-implant soft tissue health around used implants


Eligibility criteria: Inclusion Criteria:

* 1. Patients are healthy, free from any systemic diseases relating to bone resorption such as uncontrolled diabetics or osteoporosis. This will be achieved through medical history and clinical examination by physician.

  2. They will have completely edentulous jaws for at least 1 year. 3. They will be of angle's class I maxillo-mandibular relationship and have upper and lower completely edentulous arches.

  4. Residual alveolar ridges covered with healthy firm mucosa. 5. All included patients will have sufficient available length and width of mandibular bone to accommodate conventional implant. (At least 5 mm buccolingual width and 12 mm vertical height of bone.

Exclusion Criteria:

* Patients with chronic systemic diseases that affect bone metabolism
* Uncontrolled diabetic patients
* Patients with TMJ dysfunction
* Smokers

Primary outcomes:
measure: Surface roughness
timeFrame: one year
measure: Microbiological assessment
timeFrame: one year
measure: Peri-implant soft tissue health
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University ,Faculty of dentistry
Study officials:
References:
Clinical trial NCT02276677: Oxytocin Effects on Food Motivation Pathways
Official title: Oxytocin Effects on Food Motivation Pathways
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Overweight and Obesity
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2014-10-28
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Oxytocin is a peptide hormone produced in the brain that regulates food intake. However, the mechanisms for this effect in humans is not yet clear.

In this study, the investigators will therefore examine the effect of a single dose of intranasal oxytocin (compared to placebo) on levels of appetite-regulating hormones and functional magnetic resonance imaging activation of areas of the brain involved in food motivation.


Eligibility criteria: Inclusion Criteria:

* Age 18-45 years old
* BMI 25-40
* Regular breakfast eater (at least 4 times per week)
* Stable weight within the past three months

Exclusion Criteria:

* Psychiatric disease, use of psychotropic medications
* History of eating disorder
* History of excessive exercise within the last three months (having run more that 25 miles in any one week or having exercised more than ten hours in any one week)
* History of diabetes mellitus
* Active substance abuse
* Hematocrit lower than the normal range
* Gastrointestinal tract surgery (including gastrectomy, gastric bypass surgery, and small or large bowel resection)
* History of cardiovascular disease (such as hypertrophic cardiomyopathy, valvular heart disease, coronary heart disease, or coronary artery spasms)
* Untreated thyroid disease
* Tobacco use
* Cardiac pacemaker, surgical aneurysm clips, neurostimulator, implanted pumps, metal fragments in body/eyes, nitroglycerin patch, severe claustrophobia

Primary outcomes:
measure: Change in functional magnetic resonance imaging activation of food motivation brain regions
timeFrame: Functional magnetic resonance imaging at T60 min after oxytocin/placebo
Secondary outcomes:
measure: Change in hormone levels (cholecystokinin, glucagon-like peptide-1)
timeFrame: Blood draws at T0, T30, T60, T120 min after oxytocin/placebo
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Elizabeth A Lawson, MD, MMSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02042677: Assessment of a Skin Barrier
Official title: User Assessment of a One-Piece Skin Barrier
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Ileostomy
Keywords: ileostomy
1-piece
assessment
Nova
NovaLife
Dansac
Lead sponsor: Hollister Incorporated
Sponsor class: INDUSTRY
Collaborators: name: St George's Healthcare NHS Trust
name: London North West Healthcare NHS Trust
First posted: 2014-01-23
Enrollment: 18
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: Current users of either Dansac flat Nova or NovaLife skin barriers with drainable pouches who have an ileostomy.

Brief summary: This evaluation is being conducted to determine user perception of a new flat one-piece skin barrier compared to their normal barrier.

Detailed description: Design:

This is a multi-site, unblinded, historically controlled assessment of a one-piece flat skin barrier. Study barriers are CE-marked. Approximately 30 subjects are enrolled in the UK.

Eligibility criteria: Inclusion Criteria:

1. is at least 18 years of age.
2. has an ileostomy.
3. is at least six weeks postoperative.
4. lives and cares for their stoma independently in the community.
5. currently uses a Dansac Nova or NovaLife 1-piece flat skin barrier.
6. currently uses a drainable pouch.
7. is able to wear a 1-piece flat cut-to-fit 10-55 mm.
8. Has a peristomal skin irritation score of 2 or less.
9. is willing to follow the protocol as demonstrated by signing the informed consent and who in the opinion of the investigator is qualified to participate.

Exclusion Criteria:

1. has a fistula on or near the stoma.
2. has been involved in a study involving stoma care with in the last 30 days.
3. is pregnant or lactating, as determined by interview only.
4. is undergoing chemotherapy, radiation or steroid therapy.
5. has an existing medical condition that would compromise their participation in the study.

Primary outcomes:
measure: barrier adhesion
timeFrame: 10 days
measure: barrier tack
timeFrame: 10 days
measure: comfort
timeFrame: 10 days
measure: leakage
timeFrame: 10 days
measure: ease of barrier removal
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Harrow
country: United Kingdom
facility: St. Mark's Hospital
city: London
country: United Kingdom
facility: St. George's Hospital
Study officials:
affiliation: St. George's Hospital
name: Heather Dennis
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Mark's Hospital
name: Sarah Varma, Stoma Nurse
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01976377: Mucin Glycosylating Enzymes in Head and Neck Cancers
Official title: Expression of Mucin Glycosylating Enzymes in Head and Neck Cancers and Its Correlation With Clinico-pathological Parameters.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glycosyltion Enzymes and Function Abnormalities
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2013-11-05
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Head and neck cancer patients receiving operation in National Taiwan University Hospital

Brief summary: Head and neck squamous cell carcinoma(HNSCC) is the fourth common malignancy in Taiwan. It accounts for 5.8% of all cancers and causes 2,463 deaths per year. Aberrant glycosylation is the hallmark of most human cancers, including HNSCC, and affects many cellular properties. This study is aimed at exploring the role of mucin glycosylating enzymes in HNSCC.

Detailed description: Glycosylation is the most common post-translational modification of proteins. Aberrant glycosylation is the hallmark of most human cancers and affect many cellular properties, including cell proliferation, apoptosis, differentiation, transformation, migration and immune response.

Though widely explored in various human cancers, the role of mucin glycosylating enzymes in HNSCC has not been elucidated. Our aims is to analyze the expression patterns of mucin glycosylating enzymes in HNSCC tissues. Furthermore, we will correlate the expression levels of mucin glycosylating enzymes with clinical characteristics of HNSCC patients.

Eligibility criteria: Inclusion Criteria:

* Head and neck cancer patients receiving operation in National Taiwan University Hospital

Exclusion Criteria:

* Recurrence or non-operable patients

Primary outcomes:
measure: Measure the expression of mucin glycosylating in head and neck cancer
timeFrame: 1~5 years after patient received surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University
Study officials:
affiliation: National Taiwan University Hospital
name: Pei-Jen Lou, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: