louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02202239: Effect of Induction and Maintenance of Anesthesia With Etomidate on Hemodynamics and Oxidative Stress in Diabetic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hemodynamics
Oxidative Stress
Anesthesia
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2014-07-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To explore the effect of induction and maintenance of anesthesia with etomidate on hemodynamics and oxidative stress in diabetic patients.


Eligibility criteria: Inclusion Criteria:

* Aged between 18 and 65 years;
* Diabetic patients preparing for elective surgery;
* Body mass index is between 16 and 30 kg/m2;
* Blood glucose is under 8.3 mmol/kg by oral antidiabetic agents or diet control;
* American Society of Anesthesiology (ASA) Physical Status: Ⅰ or Ⅱ;
* Expected operation duration is between 2 and 8 h;
* Signed informed consent form.

Exclusion Criteria:

* Severe cardiac, cerebral, liver, kidney, lung, endocrine disease or infectious disease;
* Chemotherapy or immunotherapy before the surgery;
* Allergy to trial drug or other contraindication;
* Expected or history of difficult airway;
* Suspected abuse of narcotic analgesia;
* Diseases of neuromuscular system;
* Mentally unstable or has a mental illness;
* Trend of malignant hyperthermia;
* Pregnant or breast-feeding women;
* Attendance of other trial past 30 days.

Primary outcomes:
measure: Mean arterial pressure
timeFrame: from 10 minutes before induction to 1 h after the surgery
measure: Central venous pressure
timeFrame: from 10 minutes before induction to 1 h after the surgery
measure: Heart rate
timeFrame: from 10 minutes before induction to 1 h after the surgery
measure: Respiratory rate
timeFrame: from 10 minutes before induction to 1 h after the surgery
measure: Oxygen saturation
timeFrame: from 10 minutes before induction to 1 h after the surgery
measure: Blood glucose
timeFrame: from 10 minutes before induction to 1 h after the surgery
measure: Insulin
timeFrame: from 10 minutes before induction to 1 h after the surgery
Secondary outcomes:
measure: Super oxide dismutase
timeFrame: from 10 minutes before induction to 1 h after the surgery
measure: Glutathione
timeFrame: from 10 minutes before induction to 1 h after the surgery
measure: Xanthine oxidase
timeFrame: from 10 minutes before induction to 1 h after the surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03872739: To Compare Intravenous and Oral Hydration of the Prevention for CIN in Elderly Patients Undergoing Intravenous CECT
Official title: To Compare Intravenous and Oral Hydration of the Prevention for Contrast-induced Nephropathy in Elderly Patients Undergoing Intravenous Contrast-enhanced Computed Tomography： A Multi-center Randomized Control Trail
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: CIN
Keywords: CIN
Hydration
enhanced computed tomography
Lead sponsor: Guangdong Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2019-03-13
Enrollment: 1368
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To Compare Intravenous and Oral Hydration of the Prevention for Contrast-induced Nephropathy in Elderly Patients Undergoing Intravenous Contrast-enhanced Computed Tomography.

Detailed description: The prospective multicenter randomized controlled clinical research discusses the comparison of oral and intravenous hydration for prevention of contrast-induced nephropathy in elderly patients with enhanced computed tomography, establishing a simple hydration proposal.

Eligibility criteria: Inclusion Criteria:

* Age\>21
* informed consent
* Undergoing Intravenous Contrast-enhanced Computed Tomography

Exclusion Criteria:

* CT enhancement was not performed;
* Dialysis treatment of patients with end-stage renal failure or heart, kidney transplantation;
* Exposure to radioactive contrast medium within 48 hours prior to or within 72 hours of examination;
* Acute decompensated heart failure;
* Allergic to radioactive contrast agent;
* Be subjected to life - threatening trauma;
* Severe infection;
* Surgery was performed within 2 days of CT examination.
* Combined with multiple myeloma, urinary obstruction, aortic dissection
* Can cause acute kidney injury disease;
* Use of aminoglycosides and other nephrotoxic drugs 2 weeks before.

Primary outcomes:
measure: CIN
timeFrame: 72hours
Secondary outcomes:
Other outcomes:
Locations:
city: Guanzhou
country: China
facility: Guangdong provincial people's hospital
state: Guangdong
Study officials:
affiliation: Guangdong Cardiovascular Institute
name: Danqing Yu, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01426139: BIOFLOW-INDIA Safety and Clinical PerFormance of the Drug Eluting ORSIRO Stent in Single de Novo Coronary Artery Lesions
Official title: BIOTRONIK-Safety and Clinical PerFormance of the Drug Eluting ORSIRO Stent in the Treatment of Patients With Single de Novo Coronary Artery Lesions in an Indian Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Biotronik AG
Sponsor class: INDUSTRY
First posted: 2011-08-31
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this clinical investigation is to assess the safety and clinical performance of the Orsiro Limus Eluting Stent System in Indian subjects with single de-novo coronary artery lesions.


Eligibility criteria: Main Inclusion Criteria:

* Subject has provided a written informed consent
* Single de novo lesion with ≥ 50% and \<100% stenosis in up to 2 coronary arteries
* The target lesion length is ≤ 26 mm
* The target reference vessel diameter is ≥ 2.0 mm and ≤ 4.0 mm

Main Exclusion Criteria:

* Evidence of myocardial infarction within 72 hours prior to index procedure
* Unprotected left main coronary artery disease (stenosis \>50%)
* Three-vessel coronary artery disease at time of procedure Thrombus in target vessel
* Target lesion involves a side branch \> 2.0 mm in diameter
* Heavily calcified lesion
* Target lesion is located in or supplied by an arterial or venous bypass graft

Primary outcomes:
measure: In-Stent Late Lumen Loss
timeFrame: 9 months post index procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Chennai
country: India
facility: Madras Medical Mission
city: Gurgaon
country: India
facility: Medanta The Medicity Hospital
city: New Delhi
country: India
facility: Max Super Speciality Hospital
city: New Delhi
country: India
facility: Fortis Escorts Heart Institute and Research Centre
Study officials:
References:
Clinical trial NCT02750839: Influence of Osteoporosis on Clinical Outcomes of Mini-invasive Surgical Treatment of Proximal Humerus Fractures
Official title: Influence of Osteoporosis on Clinical Outcomes of Mini-invasive Surgical Treatment of Proximal Humerus Fractures
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoporosis
Humerus Fracture
Lead sponsor: Azienda Ospedaliera Bolognini di Seriate Bergamo
Sponsor class: OTHER
First posted: 2016-04-26
Enrollment: 65
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with proximal humerus fracture, treated with a mini-invasive technique plate.

Brief summary: Aim of the study is to analyze results of treatment of proximal humerus fractures with mini-invasive technique and plate fixation.

In all the patients a analysis of presence of osteoporosis will be done, clinical and x-ray results will be statistically analyzed to evidence any connection between clinical outcomes and osteoporosis.


Eligibility criteria: Inclusion Criteria:

* Proximal humerus fracture

Exclusion Criteria:

* High risk to surgery (ASA 4 - 5)

Primary outcomes:
measure: correlate osteoporosis (Cortical index) with clinical (Constant score) and radiological (X-ray) results of the procedure
timeFrame: 30 months average
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Azienda Ospedaliera Bolognini di Seriate Bergamo
name: Carlo Trevisan, Chief
role: STUDY_CHAIR
References:
Clinical trial NCT04867239: A Two-day Education Program for Metabolic Syndrome Patients
Official title: Temporal Changes of Metabolic Indicators and Quality of Life by a Two-day Patient Education Program for Metabolic Syndrome Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Keywords: Metabolic Syndrome
Motivation
Patient Education
Quality of Life
Lead sponsor: Pusan National University Yangsan Hospital
Sponsor class: OTHER
First posted: 2021-04-30
Enrollment: 29
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was to evaluate the temporal change of metabolic indicators and quality of life by a two-day patient education program.

Detailed description: This study aimed to evaluate whether a two-day multidisciplinary education camp comprising doctors, nurses, exercise instructors, dietitians, social workers, and health administrators could initiate healthy lifestyle habits, improve health markers though lifestyle modification, increase knowledge and understanding of the disease, and have a profitable effect on mental health in relation to depression and quality of life for patients with metabolic syndrome.

Eligibility criteria: Inclusion Criteria:

* people satisfied with metabolic syndrome criteria

Exclusion Criteria:

* None

Primary outcomes:
measure: Waist circumference (cm)
timeFrame: Change from pre-camp at 3-month and 6-month after camp
measure: Blood pressure (mmHg)
timeFrame: Change from pre-camp at 3-month and 6-month after camp
measure: Korean version of EuroQol-5D (the minimum-maximum value, 0-1)
timeFrame: Change from pre-camp at 3-month and 6-month after camp
measure: Korean version of Beck depression inventory-II (the minimum-maximum value, 0-63)
timeFrame: Change from pre-camp at 3-month and 6-month after camp
measure: Korean version of Beck anxiety inventory (the minimum-maximum value, 0-63)
timeFrame: Change from pre-camp at 3-month and 6-month after camp
measure: Nutritional knowledge score (the minimum-maximum value, 0-20)
timeFrame: Change from pre-camp at 3-month and 6-month after camp
measure: Total cholesterol (mg/dL)
timeFrame: Change from pre-camp at 3-month and 6-month after camp
measure: Triglyceride (mg/dL)
timeFrame: Change from pre-camp at 3-month and 6-month after camp
measure: HDL cholesterol (mg/dL)
timeFrame: Change from pre-camp at 3-month and 6-month after camp
measure: LDL cholesterol (mg/dL)
timeFrame: Change from pre-camp at 3-month and 6-month after camp
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pusan National University Yangsan Hospital
name: Sang Yeoup Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00708539: A Prospective Randomized Multicentre Study to Compare Crinone 8% Once Daily Versus Other Vaginal Progesterone.
Official title: A Prospective Randomized Multicentre Study to Compare Crinone 8% Once Daily Versus Other Vaginal Progesterone.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: IVF - Luteal Phase Support After Embryo Transfer
Lead sponsor: Nordica Fertility Clinic
Sponsor class: OTHER
Collaborators: name: Merck Serono International SA
First posted: 2008-07-02
Enrollment: 2686
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the effect of Crinone 8% administered once daily versus other vaginal progesterone in terms of ongoing pregnancy rate 5 weeks after embryo transfer as well as patient convenience.


Eligibility criteria: Inclusion Criteria:

* 18-40 years
* Regular menstrual cyclus 25-35 days
* both ovaries present
* No more than 2 previous IVF attempts
* Have given written informed consent

Exclusion Criteria:

* More than 2 previous attempts
* Known drug abuse
* Known allergies to the study medication
* No embryo transfer performed in the study cycle
* Previous participating in the study

Primary outcomes:
measure: Equivalence in ongoing pregnancy per embryo transfer between the two groups
timeFrame: week 5 after embryo tranfer
Secondary outcomes:
measure: Convenience for the patient
timeFrame: the treatment period (from the day of embryo transfer and 19 days ahead)
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Faurskov fertility clinic
city: Brædstrup
country: Denmark
facility: Brædstrup Sygehus
city: Dronninglund
country: Denmark
facility: Dronninglund sygehus
city: Frederiksberg
country: Denmark
facility: Dansk Fertilitetsklinik
city: Herlev
country: Denmark
facility: Herlev Hospital
city: Holbæk
country: Denmark
facility: Holbæk Sygehus
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
city: København Ø
country: Denmark
facility: Rigshospitalet
city: Odense
country: Denmark
facility: Odense IVF
city: Odense
country: Denmark
facility: Odense OUH
city: Roskilde
country: Denmark
facility: Roskilde Sygehus
city: Skive
country: Denmark
facility: Skive sygehus
city: Göteborg
country: Sweden
facility: Reproduktionscentrum, Sahlgrenska
city: Huddinge
country: Sweden
facility: Karolinska
city: Malmö
country: Sweden
facility: RMC
city: Stockholm
country: Sweden
facility: Reproduktionscentrum
city: Umeå
country: Sweden
facility: Norrlandsuniversitets sjukhus
Study officials:
affiliation: Nordica Fertilityclinic
name: Svend Lindenberg
role: PRINCIPAL_INVESTIGATOR
affiliation: Nordica Fertility Clinic
name: Svend Lindenberg
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00877539: A Study To Assess The Effect Of PF-03526299 On Lung Function Following An Allergen Challenge In Asthmatic Subjects
Official title: A Randomized, Double-Blind, Double-Dummy, Placebo Controlled, 3-Way Crossover Study To Determine The Effects Of Inhaled Doses Of PF-03526299 On Allergen-Induced Airway Responses In Mild Asthmatic Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma
Keywords: Asthma Allergen Challenge
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-04-07
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: PF-03526299, a novel anti-inflammatory agent should attenuate the effect of a bronchial allergen challenge on lung function and hence provide proof of mechanism for this agent.


Eligibility criteria: Inclusion Criteria:

* Males and females 18-60 years
* Mild asthma
* Atopic to allergens

Exclusion Criteria:

* Unstable asthma
* Smokers or recent ex-smokers
* Recent allergen challenge

Primary outcomes:
measure: Spirometry pre- and post- bronchial allergen challenge
timeFrame: 2 months
Secondary outcomes:
measure: Laboratory safety tests
timeFrame: 2 months
measure: 12-lead ECGs
timeFrame: 2 months
measure: Adverse Event reporting
timeFrame: 2 months
measure: Blood samples for pharmacokinetic measurement
timeFrame: 2 months
measure: Sputum for pharmacodynamic measurement
timeFrame: 2 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: Manchester
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01974739: Hydrochloorthiazide and Hypernatriaemie
Official title: Hypernatraemia and Diuretics in Intensive Care Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypernatraemia
Keywords: intensive care
diuretics
Lead sponsor: Frisius Medisch Centrum
Sponsor class: OTHER
First posted: 2013-11-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Acquired hypernatremia appears to be associated with mortallity in ICU. To reduce hypernatremia and shorten the time of hypernatremia, we investigate the effect of hydrochloorthiazide compared to a placebo


Eligibility criteria: Inclusion Criteria:

* sodium \> 142

Exclusion Criteria:

* no informed consent

Primary outcomes:
measure: sodium level
timeFrame: 7 days
Secondary outcomes:
measure: time hypernatraemia
timeFrame: 7 days
Other outcomes:
Locations:
city: Leeuwarden
country: Netherlands
facility: Medical Centre Leeuwarden
state: Friesland
Study officials:
affiliation: Frisius Medisch Centrum
name: Christiaan Boerma, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02670239: Pharmacokinetics of Imipenem During Ex Vivo Lung Perfusion (EVLP)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Transplantation
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2016-02-01
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: lungs from brain dead donors that were considered at high-risk for transplantation and underwent EVLP

Brief summary: Ex vivo lung perfusion (EVLP) is an established strategy to evaluate and optimize high-risk donor lungs that would otherwise be rejected for transplantation mainly due to the presence of edema or infection. Extracorporeal circuits may negatively affects pharmacokinetic (PK) of several drugs including antibiotics, thus exposing patients to risk of therapeutic failure or drug toxicity. The investigators set out to examine the concentration of imipenem in lung perfusate and in lung biopsy during EVLP, and its clinical impact.


Eligibility criteria: Inclusion Criteria:

1. Best PaO2/FiO2 \< 300 mmHg;
2. Pulmonary edema on chest X-Ray;
3. Poor inflation or deflation at visual inspection;
4. Need for blood transfusion of more than 10U;
5. Maastricht category III/IV

Exclusion Criteria:

1. Diagnosis of pneumonia;
2. severe mechanical injury;
3. gross gastric aspiration

Primary outcomes:
measure: imipenem concentration
timeFrame: change from baseline in imipenem concentration at 6 hours
Secondary outcomes:
measure: pathogens isolated from donors
timeFrame: 48 hours before lung procurement
measure: pathogens isolated from recipients
timeFrame: 48 hours after lung transplantation
measure: Clinical Pulmonary Infection Score
timeFrame: at 72 hours after lung transplantation
measure: Primary graft dysfunction
timeFrame: at 72 hours after lung transplantation
measure: Days of mechanical ventilation
timeFrame: at 28 days
measure: Intensive Care Unit length of stay
timeFrame: at day 28
Other outcomes:
Locations:
city: Turin
country: Italy
facility: University of Turin - Azienda Ospedaliera Città della Salute e della Scienza di Torino
Study officials:
References:
Clinical trial NCT04217239: A Comparison Between Ivor-Lewis and McKeown Minimally Invasive Esophagectomy
Official title: A Comparison of Short-term and Long- Term Outcomes Between Ivor-Lewis and McKeown Minimally Invasive Esophagectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Esophageal Cancer
Keywords: Thoracoscopic
laparoscopic
esophagectomy
Lead sponsor: The Second Hospital of Shandong University
Sponsor class: OTHER
First posted: 2020-01-03
Enrollment: 200
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Surgery is still the main treatment for esophageal cancer, however, the complication and mortality rate of open esophagectomy is high. As a result, the thoracoscopic- laparoscopic minimally invasive esophagectomy (MIE) was developed. The MIE mainly comprised two surgical approaches:

MIE McKeown approach (cervical anastomosis) and MIE Ivor-Lewis approach (intrathoracicanastomosis). The MIE with intrathoracic anastomosis (Ivor-Lewis) is increasingly used for the treatment of mid and lower esophageal cancers. Our study is trying to compare the safety, feasibility, and short-term and long- term outcomes between MIE Ivor-Lewis approach and MIE McKeown approach for the treatment of lower thoracic esophageal cancer and esophageal- gastric junction.


Eligibility criteria: Inclusion Criteria:

(I) Patients with clinically staged T1-3N0-2M0 tumors; good cardiopulmonary function;

(II) Patients with lower thoracic esophageal tumors and esophageal- gastric junction tumor;

(III) Patients without a previous history of cancer;

(IV) Patients without a previous history of neck or chest surgery;

Exclusion Criteria:

(I) cardiopulmonary function not good enough for surgery;

(II) Patients with hybrid MIE

Primary outcomes:
measure: Operating time
timeFrame: 1 day
measure: Blood loss
timeFrame: 1 day
measure: Lymph nodes harvested
timeFrame: 1 day
measure: Pulmonary complication
timeFrame: 1 month
measure: Anastomotic leakage
timeFrame: within one month
measure: Anastomotic stenosis
timeFrame: within three months
measure: recurrent laryngeal nerve injury
timeFrame: within three months
measure: Chylothorax
timeFrame: within one month
measure: Cardiac arrhythmia
timeFrame: within one month
measure: Hospital stay
timeFrame: within 60 days
measure: mortality
timeFrame: within 90 days
Secondary outcomes:
measure: progression-free survival
timeFrame: within 5 years
measure: overall survival
timeFrame: within 5 years
Other outcomes:
Locations:
city: Jinan
country: China
facility: Yunpeng Zhao
state: Shandong
Study officials:
References:
citation: Zhao Y, Shan L, Peng C, Cong B, Zhao X. Learning curve for minimally invasive oesophagectomy of oesophageal cancer and survival analysis. J Cardiothorac Surg. 2021 Nov 10;16(1):328. doi: 10.1186/s13019-021-01712-7.