louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03573635: Continuous Supraglottic Aspiration in Intubated and Mechanically Ventilated Patients: the "SUPRAtube" Device
Official title: Evaluation of the Effectiveness and Safety of an Own-invention System for Continuous Supraglottic Aspiration in Intubated and Mechanically Ventilated Patients: the "SUPRAtube" Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aspiration Pneumonias
Lead sponsor: Fundación Cardiovascular de Colombia
Sponsor class: OTHER
First posted: 2018-06-29
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Purpose of the trial: Evaluate the efficacy and safety of the device of self-invention of continuous oropharyngeal aspiration denominated "SUPRAtube" in patients with orotracheal intubation and mechanical ventilation.


Eligibility criteria: Inclusion Criteria:

• Endotracheal intubation and invasive mechanical ventilation,

Exclusion Criteria:

* Immediate postoperative oral cavity.
* Traumatic oral cavity injury.
* Platelet count less than 50000.

Primary outcomes:
measure: aspirated secretions
timeFrame: 24 hours after intubation
Secondary outcomes:
measure: Adverse events
timeFrame: 24 hours after intubation
Other outcomes:
Locations:
city: Piedecuesta
country: Colombia
facility: Fundación Cardiovascular de Colombia
state: Santander
Study officials:
References:
Clinical trial NCT06103435: Multivisceral Resections for Locally Advanced Gastric Cancer
Official title: Multivisceral Resections for Locally Advanced Gastric Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
Keywords: gastric cancer
locally advanced cancers
multivisceral resections
splenectomy
pancreatectomy
colectomy
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2023-10-26
Enrollment: 1476
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with resectable gastric cancer treated between January 1996 and December 2020 in the First Department of Surgery, Jagiellonian University Medical College

Brief summary: The goal of this observational study is to assess whether the postoperative course and survival of patients subject to multivisceral resections for locally advanced gastric cancer (cT4b) were affected by the extent of surgery. An electronic database of 1476 patients with non-metastatic gastric cancer treated between January 1996 and December 2020 will be reviewed. The main questions it aims to answer are:

* Does splenectomy, distal pancreatectomy or partial colectomy affect postoperative complications
* What factors affect prognosis of patients with locally advanced gastric cancer


Eligibility criteria: Inclusion Criteria:

* gastric adenocarcinoma
* intraoperatively suspected infiltration of surrounding organs (stage cT4bN0-3bM0)
* partial or total gastrectomy

Exclusion Criteria:

* distant metastases (M1)
* gastrectomy combined with resection of organs other than spleen, pancreas, or colon

Primary outcomes:
measure: Complications
timeFrame: up to 90 days
measure: Survival
timeFrame: Overall survival from surgery to death or last follow up, whichever came first, assessed up to 60 months
Secondary outcomes:
measure: Rate of reoperations
timeFrame: up to 90 days
measure: Length of postoperative hospital stay
timeFrame: Up to 6 months
measure: Rate of readmissions
timeFrame: One year from surgery
Other outcomes:
Locations:
city: Kraków
country: Poland
facility: First Department of Surgery, Jagiellonian University Medical College
state: Małopolska
Study officials:
affiliation: Jagiellonian University
name: Marek Sierżęga, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02923635: A Prospective Comparative Study Between Oncoplastic Breast Surgery and Standard Wide Local Excision
Official title: A Prospective Comparative Study Between Oncoplastic Breast Surgery and Standard Wide Local Excision:Margin Length and Patient Satisfaction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Oncoplastic breast surgery
Standard Wide Local Excision
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2016-10-04
Enrollment: 70
Sex: FEMALE
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to asses the oncological safety of oncoplastic breast surgery, and its impact on patient satisfaction.

Detailed description: This non-randomized prospective trial was conducted on70 female patients presented to tertiary breast unit-Ain Shams University hospitals with breast cancer during the period from September 2012 to February 2013. All patients sharing in the study signed an informed consent that was approved in the ethical committee held on April 2012. Patients were classified in two groups each one 35 patients: group (A) standard wide local excision and group (B) oncoplastic group. Standard wide local excision done by general breast surgeons while oncoplastic surgeries done by breast surgeon assisted by plastic surgeon. The following data were recorded: Age, family history, margin length, weight and volume of the specimen, margin status and patient satisfaction.

Eligibility criteria: Inclusion Criteria:

* Patients with macromastia in oncoplastic group.
* Tumors \>20% of breast volume in oncoplastic group.
* Young patients in oncoplastic group
* Tumors in medial or central quadrants in oncoplastic group

Exclusion Criteria:

* Patients \>60 years.
* Patients with co-morbidities in oncoplastic group.
* Tumors \>20% of breast volume in standard group.
* Tumors in medial or central quadrants in standard group

Primary outcomes:
measure: Margins in all specimens measured in millimeters
timeFrame: Two years
Secondary outcomes:
measure: Patient satisfaction assessed using questionnaire
timeFrame: two years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03400735: Comparison of Cefdinir and Cefdinir/Clavulanic Acid Combination in Adults
Official title: Comparison of Cefdinir and Cefdinir/Clavulanic Acid Combination in Treatment of Acute Exacerbation of Chronic Bronchitis (AECB) and Community-acquired Pneumonia (CAP) in Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Exacerbation of Chronic Bronchitis
Community-Acquired Pneumoniae
Lead sponsor: Neutec Ar-Ge San ve Tic A.Ş
Sponsor class: INDUSTRY
First posted: 2018-01-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is planned to compare the efficacy and safety of cefdinir and cefdinir/clavulanic acide treatments in acute exacerbation of chronic bronchitis (AECB) and community-acquired pneumoniae (CAP) patients.


Eligibility criteria: Inclusion Criteria:

* The diagnosis of chronic bronchitis
* The diagnosis of community-acquired pneumoniae
* FEV1 value = 30-80%
* The diagnosis of mild-severe acute exacerbation of chronic bronchitis (AECB)
* Oxygen saturation \< 90%

Exclusion Criteria:

* Pregnancy or breastfeeding
* Allergy against to penicillin or cephalosporins
* Renal impairment
* Active hepatic disease
* Antibiotic use except study drugs
* Immunosuppressive therapy before 6 months of study initiation
* Use of probenecid like drugs

Primary outcomes:
measure: The comparison of clinical success rates according to laboratory parameters
timeFrame: 7-10 days
Secondary outcomes:
measure: The comparison of remission or relief of inflammation according to laboratory parameters
timeFrame: 7-10 days
measure: The comparison of patient satisfaction according to satisfaction questionnaire
timeFrame: 7-10 days
measure: The comparison of adverse events
timeFrame: 7-10 days
Other outcomes:
Locations:
city: Erzincan
country: Turkey
facility: Erzincan University Mengücek Gazi Training and Research Hospital
city: İstanbul
country: Turkey
facility: Yedikule Chest Diseases Training and Research Hospital
Study officials:
References:
Clinical trial NCT02087735: Measurement of Urinary Catabolites of PACs as Biomarkers of Consumption of Cranberry Extracts
Official title: Measurement of Urinary Catabolites of the Proanthocyanidines (PACs) in Healthy Young Women as Biomarkers of Consumption of Cranberry Extracts.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Urinary Tract Infections
Keywords: Cranberry
Proanthocyanidins
Urinary catabolites
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2014-03-14
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this cross over pilot study is to investigate the urinary catabolites of Proanthocyanidines (PACs) as biomarkers of cranberry extracts in healthy young women.


Eligibility criteria: Inclusion Criteria:

* Healthy women.
* 18 to 40 years.

Exclusion Criteria:

* No internet access.
* No refrigerator access during the 9 hours of sample collection.
* Women who had or expect to take antibiotic.
* Women who had or expect to take cranberries, blueberries or bilberries in the form of berries, juice or extracts.
* Women who had or expect to take dark chocolate.
* Women who had personal history of acute or chronic renal failure.

Primary outcomes:
measure: Urinary catabolites of PACs
timeFrame: within 9 hours following the intake of cranberry extracts
Secondary outcomes:
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Laval University, Department of Medecine, Institut sur la nutrition et les aliments fonctionnels (INAF).
state: Quebec
Study officials:
affiliation: Laval University
name: Sylvie Dodin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00644735: Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Comparison of the Remission Rates of Once Daily Treatment With Esomeprazole 20mg and Lansoprazole 15mg for 6 Months in Patients Whose EE Has Been Healed
Official title: Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Comparison of the Remission Rates of Once Daily Treatment With Esomeprazole 20mg and Lansoprazole 15mg for 6 Months in Patients Whose EE Has Been Healed.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Erosive Esophagitis
Keywords: Erosive Esophagitis
Nexium
Esomeprazole
Lansoprazole
Heartburn
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-03-27
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study to look at the rates of remission (non re-appearance of erosive esomeprazole) when treated with esomeprazole or lansoprazole; in patients in with erosive esomeprazole (EE) that is in remission (i.e. previously healed EE).


Eligibility criteria: Inclusion Criteria:

* Episodes of heartburn (described as a burning feeling rising from the stomach or lower part of the chest up towards the neck) for 2 days or more during the last 7 days prior to baseline
* Confirmed diagnosis of Erosive Esophagus, patients must undergo an endoscopy before entering the study.

Exclusion Criteria:

* Any signs of gastrointestinal bleeding at the time of the starting the study.
* Any previous gastric or esophageal surgery.
* Various gastrointestinal diseases as listed in the protocol.

Primary outcomes:
measure: To compare rates of remission (non re-appearance of erosive esomeprazole) when treated with esomeprazole or lansoprazole; in patients in with erosive esomeprazole (EE) that is in remission (i.e. previously healed EE).
timeFrame: Symptoms will be assessed by the investigator at each visit and the patients will undergo an endoscopy at Months 3 and 6
Secondary outcomes:
measure: To compare endoscopic remission rates through 6 months of treatment with E20 and L15, after initial healing of EE.
timeFrame: Symptoms will be assessed by the investigator at each visit and the patients will undergo an endoscopy at Months 3 and 6
measure: The assessment of symptoms in the two treatment groups after 1, 3 and 6 months.
timeFrame: patients will undergo an endoscopy at Months 3 and 6
measure: To assess the safety and tolerability of up to 6 months of treatment with E20 and L15 after initial healing of EE.
timeFrame: Symptoms will be assessed by the investigator at each visit and the patients will undergo an endoscopy at Months 3 and 6
Other outcomes:
Locations:
Study officials:
affiliation: Nexium Global Product Director, AstraZeneca
name: Paula Fernstrom
role: STUDY_DIRECTOR
References:
Clinical trial NCT00172835: Use of Procalcitonin in the Diagnosis of Pleural Effusion
Official title: Evaluation of Procalcitonin as a Diagnostic Tool for Patients With Pleural Effusion
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pleural Effusion
Keywords: pleural effusion
procalcitonin
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: NATURAL_HISTORY
Time perspective: OTHER

Brief summary: Among several markers of inflammation and sepsis, procalcitonin (PCT) markers is being studied to investigate their accuracy for the diagnosis of bacterial infections. PCT is the prehormone of calcitonin, which is normally secreted by the C cells of the thyroid in response to hypercalcemia; under these normal conditions, negligible serumPCT concentrations are detected. The mechanism proposed for PCT production after inflammation and its role are still not completely known. It is believed that PCT is produced by the liver and peripheral blood mononuclear cells, modulated by lipopolysaccharides and sepsis-related cytokines. It binds to polysaccharides in pathogens, activating the classical complement pathway. The reported diagnostic accuracy of PCT for the diagnosis of bacterial infections has varied across studies.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of pleural effusion
* Pleural effusion proved by chest sonography

Exclusion Criteria:

* Conditions for which thoracentesis are contraindicated
* Pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Department of Laboratory Medicine, National Taiwan University Hospital
name: Po-Ren Hsueh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02178735: Clinical Outcomes and Urodynamic Effects After Vaginal Tailored Mesh Surgery for Pelvic Organ Prolapse
Official title: Clinical Outcomes and Urodynamic Effects After Vaginal Tailored Mesh Surgery for Pelvic Organ Prolapse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pelvic Organ Prolapse
Keywords: pelvic organ prolapse, vaginal mesh, urodynamic studies
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2014-07-01
Enrollment: 104
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the clinical outcome and urodynamic effect of two novel vaginal tailored mesh surgeries.

Detailed description: We will review the medical records (including medical data, urodynamic data, pad weight data, etc) of women who underwent either anterior or posterior novel vaginal tailored mesh surgeries at National Taiwan University Hospital between November 2011 and November 2013.

Eligibility criteria: Inclusion Criteria:

* All women with pelvic organ prolapse who underwent either anterior or/and posterior vaginal tailored mesh surgeries in National Taiwan University Hospital between November 2011 and November 2013

Exclusion Criteria: nil

Primary outcomes:
measure: Recurrence of pelvic organ prolapse
timeFrame: 1 year
Secondary outcomes:
measure: The change of pad weight
timeFrame: 3 months
measure: The change of maximum urethral closure pressure
timeFrame: 3 months
measure: Vaginal mesh erosion
timeFrame: 1 year
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Obstetrics & Gynecology, National Taiwan University Hospital
Study officials:
affiliation: Department of Obstetrics & Gynecology, National Taiwan University Hospital
name: Ho-Hsiung Lin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chang TC, Hsiao SM, Chen CH, Wu WY, Lin HH. Clinical Outcomes and Urodynamic Effects of Tailored Transvaginal Mesh Surgery for Pelvic Organ Prolapse. Biomed Res Int. 2015;2015:191258. doi: 10.1155/2015/191258. Epub 2015 Nov 8.
Clinical trial NCT03212235: Hypofractionated Radiation Therapy for Glioblastoma
Official title: Hypofractionated Radiation Therapy Plus Concomitant and Adjuvant Temozolomide for Glioblastoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Glioblastoma Multiforme
Lead sponsor: Instituto do Cancer do Estado de São Paulo
Sponsor class: OTHER
First posted: 2017-07-11
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Notwithstanding major improvements in treatment modalities, the prognosis of patients with glioblastoma is poor. Hypofractionated radiation therapy as an alternative of the standard 6-week regimen could be an attractive approach as an effort to prevent tumor cell repopulation and reduction the total treatment period promoting patient comfort and convenience.


Eligibility criteria: Inclusion Criteria:

* Patients 18 to 70 years of age with newly diagnosed and histologically confirmed glioblastoma.
* WHO performance status of 2 or less and adequate hematologic, renal, and hepatic function.

Exclusion Criteria:

* Prior diagnosis of cancer, unless disease free for \> 3 years
* Previous history of radiotherapy in the head and neck region (except initial larynx tumor - T1, T2 / N0M0).
* Specific severe, active co-morbidities
* Tumor located in the brainstem
* Presence of leptomeningeal carcinomatosis
* Multicentric tumor

Primary outcomes:
measure: Overall survival
timeFrame: 24 months
Secondary outcomes:
measure: Progression-free survival
timeFrame: 24 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto do Cancer do Estado de São Paulo (ICESP) - FMUSP
state: Sao Paulo
Study officials:
References:
Clinical trial NCT01150435: Driving Ability of Drug Dependant Patients in Maintenance Therapy
Official title: Driving Ability of Drug Dependant Patients in Maintenance Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Driving Ability
Lead sponsor: Hummel, Christiane
Sponsor class: INDIV
Collaborators: name: Ludwig-Maximilians - University of Munich
First posted: 2010-06-25
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: drug dependent patients in stable maintenance therapy

Brief summary: "Mobility" is a contributing factor in today's society. Drug dependence displays not only a medical but also an economic problem: Especially for an intended reintegration of a drug dependant patient in maintenance therapy the possession of a driving licence could be decisive for a job allocation and therefore the intended reintegration to society.

Subject of this study was to verify if patients under substitution therapy with R, S- Methadone, S- Methadone, Buprenorphine and Buprenorphine plus Naloxone are just as fit to drive a car as a non drug dependent person.

For this investigation we compared 121 drug dependent patients in stable maintenance therapy for a minimum of two years without consumption of any other psychotropic substances than their maintenance drug (including THC) with non- drug dependant subjects of the same gender, age and level of education.

This is the largest study on this topic worldwide. The neuro- cognitive working order was tested by means of the "Vienna Test System" an objective, reliable and valid test quantifying reaction time, attention efficiency, concentration, maximum resilience and orientation. Current use of any other psychotropic substance or alcohol just as any serious illness (including psychiatric diseases, except for an effectively treated depression) lead to exclusion from this study.


Eligibility criteria: Inclusion Criteria:

* Drug dependent patients in stable maintenance therapy for a minimum of two years without consumption of any other psychotropic substances than their maintenance drug (including THC)
* Written agreement on attending this study after full clarification
* majority

Exclusion Criteria:

* Patients, who do not approve or are not able to approve, to this study
* Patients, who are not legally competent
* Patients in emergency situations
* Patients under age
* Consumption of any other psychotropic substances than the maintenance drug
* Severe illnesses p.e. malignant diseases, serious psychiatric illness

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Institut für Rechtsmedizin
state: Baveria
Study officials:
affiliation: Institut für Rechtsmedizin München
name: Thomas Gilg, Proffessor
role: STUDY_DIRECTOR
References: