louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01144325: Minimally Invasive Esophagectomy (MIE) in Prone Versus Left Decubitus Position
Official title: Minimally Invasive Esophagectomy in Prone or Left Decubitus Position: A Prospective Randomized Clinical Trial From A Single Institution
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Esophageal Cancer
Esophagectomy
Keywords: Minimally Invasive Esophagectomy
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2010-06-15
Enrollment: 2
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this prospective randomized study is to compare clinical outcomes from two different patient position(prone vs left decubitus)with thoracoscopic esophageal mobilization in the procedure of Minimally Invasive Esophagectomy (MIE).

* Comparing morbidities from the two groups
* Comparing short-term quality of life from the two groups
* Comparing oncological results (3,5 year survival) from the two groups

Detailed description: Thoracoscopic esophagectomy is routinely performed in two positions. The left decubitus position is the most commonly used position at most centers. However prone position is another alternative.

The left decubitus position is advocated for its the same position as the open procedure and easy to learn, as well as easy to emergent conversion to open thoracotomy .However, the disadvantage of this position is the need of lung retraction for better exposure and definitely one lung ventilation. They are regarded as potential causes leading lung injury.

Prone thoracoscopic esophageal mobilization has been advocated for its potential benefits of increased operative exposure, no lung retraction, avoid one lung ventilation, improved surgeon ergonomics. But it is difficult to make emergent conversion under this positon and not familiar with most thoracic or digestive surgeons. A longer learning curve may be needed.

A few publications have compared the two position with thoracoscopic mobilization of the esophagus in retrospective study of a small cohort. Until now, no prospective randomized study has been carried out in this field.

Eligibility criteria: Inclusion Criteria:

* clinical stage I/II esophageal cancer
* normal blood test of basic metabolism panel
* pulmonary function: FEV1 \> 1.2L, FEV1% \> 50%, DLCO \> 50%
* heart function: NY grade I and grade II
* sign informed consent

Exclusion Criteria:

* Patients who received neoadjuvant therapy
* Mental disorders

Primary outcomes:
measure: Perioperative morbidity and mortality from the two groups
timeFrame: 1 -5 years after surgery
Secondary outcomes:
measure: short-term quality of life(postoperative 6 months and 1 year) between the two groups
timeFrame: 1 year
measure: 3-and 5-year survival rate between the two groups
timeFrame: 1 - 5 years after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhong Shan Hospital, Fu Dan University
Study officials:
References:
Clinical trial NCT02105025: A Novel Clinically Usable Point Score To Prejudge The Complexity Of Colonoscopy
Official title: A Novel Clinically Usable Point Score To Prejudge The Complexity Of Colonoscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Insertion Time
Keywords: insertion time
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2014-04-07
Enrollment: 612
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a prospective study involving only one tertiary center in China. The patients were enrolled from the Endoscopy Center of Xi jing Hospital of Digestive Diseases in China.

Brief summary: Colonoscopy is the current common method for management of colorectal diseases, and effectiveness of colonoscopy associate with complication rate. A lot of patients were failed because of technical difficulty, those required more than 10 min to intubate the cecum are consider as difficult colonoscopy, in such condition, specialized equipment or maneuvers may be required for a successful colonoscopy. Thus, it is important to set up a clinical model to predict the technical difficulty of the examination in preoperational stage.


Eligibility criteria: Inclusion Criteria:

* patients aged 18-90 years old who undergoing colonoscopy without sedation

Exclusion Criteria:

* no bowel preparation or colon cleansing by enema only
* no need to reach cecum
* prior finding of severe colon stenosis or obstructing tumour
* history of colectomy
* unstable hemodynamics
* pregnant
* unable to give informed consent

Primary outcomes:
measure: Cecal intubation time
timeFrame: up to 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Endoscopic center, Xi jing Hospital of Digestive
state: Shanxi
Study officials:
References:
citation: Jia H, Wang L, Luo H, Yao S, Wang X, Zhang L, Huang R, Liu Z, Kang X, Pan Y, Guo X. Difficult colonoscopy score identifies the difficult patients undergoing unsedated colonoscopy. BMC Gastroenterol. 2015 Apr 9;15:46. doi: 10.1186/s12876-015-0273-7.
Clinical trial NCT02040025: Evaluating the Effects of EECP on Circulation, Blood Glucose Level and Blood Pressure in Type 2 Diabetes Mellitus
Official title: Evaluating the Effects of EECP on Circulation, Blood Glucose Level and Blood Pressure in Type 2 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Diabetes Mellitus
Keywords: hypertension
diabetes mellitus
hemoglobin A1C
peripheral vascular resistance
EECP
Blood pressure
angiogenesis
Coronary Artery Disease
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Lead sponsor: David Grant U.S. Air Force Medical Center
Sponsor class: FED
First posted: 2014-01-20
Enrollment: 2
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: Department of Defense type 2 diabetic patients enrolled in the Travis AFB, CA EECP clinic.

Brief summary: The purpose of this proposed Department of Defense study is to evaluate the effect of Enhanced External Counterpulsation (EECP) on circulation, blood glucose control and blood pressure of type 2 diabetic patients receiving EECP therapy.


Eligibility criteria: Inclusion Criteria:

1. Age equal to or greater than 18
2. Diagnosis of Type 1 or Type 2 diabetes mellitus
3. Prescribed EECP therapy in the DGMC EECP clinic
4. Medically cleared for EECP therapy
5. TRICARE beneficiary

Exclusion Criteria:

1. DGMC EECP clinic patient withou a diagnosis of Type 1 or Type 2 diabetes mellitus

Primary outcomes:
measure: Change from baseline in TCOM (Transcutaneous oximetry measurement) values
timeFrame: At baseline & post intervention, expected to be on average 30 minutes
Secondary outcomes:
measure: Change from baseline in hemoglobin A1C laboratory values
timeFrame: At baseline & post intervention, expected to be on average 30 minutes
Other outcomes:
Locations:
city: Travis Air Force Base
country: United States
facility: David Grant USAF Medical Center
state: California
Study officials:
affiliation: David Grant U.S. Air Force Medical Center
name: Bradley Williams, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Martin JS, Beck DT, Aranda JM Jr, Braith RW. Enhanced external counterpulsation improves peripheral artery function and glucose tolerance in subjects with abnormal glucose tolerance. J Appl Physiol (1985). 2012 Mar;112(5):868-76. doi: 10.1152/japplphysiol.01336.2011. Epub 2011 Dec 22.
citation: Bondesson SM, Edvinsson ML, Pettersson T, Edvinsson L. Reduced peripheral vascular reactivity in refractory angina pectoris: Effect of enhanced external counterpulsation. J Geriatr Cardiol. 2011 Dec;8(4):215-23. doi: 10.3724/SP.J.1263.2011.00215.
citation: Braith RW, Conti CR, Nichols WW, Choi CY, Khuddus MA, Beck DT, Casey DP. Enhanced external counterpulsation improves peripheral artery flow-mediated dilation in patients with chronic angina: a randomized sham-controlled study. Circulation. 2010 Oct 19;122(16):1612-20. doi: 10.1161/CIRCULATIONAHA.109.923482. Epub 2010 Oct 4.
Clinical trial NCT01744925: Icotinib at Different Doses in Second-line Treatment for Non-small Cell Lung Cancer Patients With Wild Type EGFR
Official title: An Open-label,Randomized,Controlled Study to Evaluate the Safety and Efficacy for Icotinib at Different Doses in Second-line Treatment for Non-small Cell Lung Cancer Patients With Wild Type EGFR
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2012-12-07
Enrollment: 60
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: This study is designed to evaluate the safety and efficacy of icotinib at routine dose and higher dose as second-line treatment in non-small cell lung cancer patients with epidermal growth factor receptor of wild type.


Eligibility criteria: Inclusion Criteria:

* Recurrent or progressive Non-Small Cell Lung Cancer stage IV or IIIB patients with Histologic or cytologic confirmation.
* Wild type epidermal growth factor receptor status.
* Progressed after first-line chemotherapy.
* No previous systemic anticancer therapy.
* Measurable lesion according to response evaluation criteria in solid tumors with at least one measurable lesion not previously irradiated.
* Provision of written informed consent.

Exclusion Criteria:

* Evidence of clinically active Interstitial Lung Diseases (Patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded).
* Positive epidermal growth factor receptor mutation.
* Known severe hypersensitivity to icotinib or any of the excipients of this product.
* Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study.

Primary outcomes:
measure: Objective Response Rate
timeFrame: 4 weeks
Secondary outcomes:
measure: Progression free survival
timeFrame: 3 months
measure: Overall survival
timeFrame: 14 months
measure: Number of Participants with Adverse Events
timeFrame: 18 months
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Medical University Cancer Institute and Hospital
name: Changli Wang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01691625: Concurrent Chemoradiation With or Without DC-CIK Immunotherapy in Treating Locally Advanced Esophageal Cancer
Official title: Concurrent Chemoradiation With or Without DC-CIK Immunotherapy in Treating Locally Advanced Esophageal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Esophageal Carcinoma
Keywords: Locally advanced esophageal carcinoma
DC-CIK
Immunotherapy
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2012-09-25
Enrollment: 50
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 purpose of this study is to show if the adoptive cellular therapy with autologous dendritic cells and cytokine-induced killer cells (CIK) combined with concurrent chemoradiation could improve the quality of life of the patients with locally advanced esophageal cancer, compared with concurrent chemoradiation only.


Eligibility criteria: Inclusion Criteria:

* cytologically or histologically confirmed locally advanced esophageal carcinoma
* Age: \> 18
* Karnofsky performance status ≥ 70
* At least one measurable tumor lesions according to the RECIST criteria.
* Normal functions of heart, lung, liver, kidney and bone marrow
* Blood exams qualified for chemotherapy, which included hemoglobulin ≥9 g/dl, neutrophil ≥1.5×109/L and platelet (PLT) ≥100×109/L, creatinine ≤1.5 UNL
* Informed consent signed

Exclusion Criteria:

* Patients with metastatic disease in the central nervous system (CNS).
* Patients who are pregnant or nursing.
* Patients with poor bone marrow, liver and kidney functions, which would make chemotherapy intolerable
* Patients with contraindication for irradiation: complete obstruction of esophagus, deep esophageal ulcer, fistula to mediastinum, or haematemesis
* coexisted morbidities that investigators believed not suitable for chemoradiation

Primary outcomes:
measure: the quality of life
timeFrame: initial assessment, months 1, 3, 6 and 12
Secondary outcomes:
measure: progression-free survival
timeFrame: 1 year
Other outcomes:
measure: Immunological assessment
timeFrame: baseline, months 1, 3, 6 and 12
Locations:
city: Beijing
country: China
facility: Capital Medical University Cancer Center
state: Beijing
Study officials:
References:
Clinical trial NCT00457925: Absorption, Distribution, Metabolism And Excretion Study For GSK221149A
Official title: An Open-label, Two Period Study to Determine the Excretion Balance and Pharmacokinetics of [14C]-GSK221149A, Administered as Single Doses of an Oral Solution and an Intravenous Infusion to Healthy Female Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obstetric Labour, Premature
Premature Labor
Keywords: absorption,
metabolism,
excretion
distribution,
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-04-09
Enrollment: 6
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a phase one study investigating the absorption, distribution, metabolism and excretion of GSK221149A in six healthy women of non-child bearing potential.


Eligibility criteria: Inclusion criteria:

* Healthy adult, non-smoking females
* Aged between 30 - 55 years old, and BMI of between 19 and 32
* Not of child-bearing potential

Exclusion criteria:

* No clinically significant findings on clinical examination, medical examination and blood tests.
* Radiation exposure over previous 3 years is greater than 10mSv
* History of bleeding or gastric problems

Primary outcomes:
measure: Urinary and fecal cumulative excretion as a percentage of the total radioactive dose administered over time. Collection of plasma, urine and fecal samples for assessment of metabolites. Samples are collected for approximately 7 days (or longer).
Secondary outcomes:
measure: Clinical Safety data. PK parameters of GSK221149A and drug-related material (radioactivity) in plasma following oral and intravenous dosing. Samples are collected for approximately seven days (or longer) following dosing.
Other outcomes:
Locations:
city: Madison
country: United States
facility: GSK Investigational Site
state: Wisconsin
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT03979625: Prognosis Related to Induced Thrombopenia With Heparin Under Venoarterial ECMO in Reanimation
Official title: Prognosis Related to Induced Thrombopenia With Heparin Under Venoarterial ECMO in Reanimation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heparin-induced Thrombocytopenia
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2019-06-07
Enrollment: 39
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 hospitalized in intensive care for cardiogenic shock requiring cardiac assisting with ECMO-VA.

Brief summary: Thrombocytopenia is a frequent and serious adverse event in patients treated with veno-arterial extracorporeal membrane oxygenation (VA-ECMO) for refractory cardiogenic shock. Similarly to postcardiac surgery patients, heparin-induced thrombocytopenia (HIT) could represent the causative underlying mechanism. However, the epidemiology as well as related mortality regarding HIT and VA-ECMO remains largely unknown. The investigators aimed to define the prevalence and associated 90-day mortality of HIT diagnosed under VA-ECMO.This retrospective study included patients under VA-ECMO from 20 French centers between 2012 and 2016.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Patient hospitalized in intensive care for a cardiovascular failure requiring the setting up of an ECMO-VA
* ECMO-VA duration ≥ 3 days
* HIT confirmed by immunological tests
* Patient affiliated to a Social Security scheme

Exclusion Criteria:

* Known antecedent of TIH prior to cannulation
* Pregnant woman
* ECMO-VA following cardiopulmonary arrest or septic shock

Primary outcomes:
measure: Death
timeFrame: 90 days after inclusion
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02755025: Clinical Score Usefulness and EHR Integration
Official title: Evaluation of Clinical Score Usefulness and Feasibility of Integration Into Electronic Health Record Interfaces
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Keywords: Sepsis
SOFA score
Automated calculation
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2016-04-28
Enrollment: 215
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: Adult patients admitted to the medical intensive care unit during the 2 month time period after the automated SOFA scoring module is activated within the electronic dashboard.

Brief summary: The SOFA score is a severity of illness and prognostic score used in the ICU. It has also recently been adopted as part of the definition of sepsis. This study will prospectively evaluate the usability of automated SOFA scoring for ICU patients within an electronic patient monitoring dashboard. It will also assess for changes in physician ordering (volume and types of orders) after automatic scoring is implemented.


Eligibility criteria: Inclusion Criteria:

* Patients admitted to the medical intensive care unit within 2 months of automated SOFA scoring module activation.

Exclusion Criteria:

* Refusal to allow medical records to be used for clinical research.

Primary outcomes:
measure: SOFA related laboratory order volume
timeFrame: 2 months
Secondary outcomes:
measure: Module usability
timeFrame: 2 months
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Christopher A Aakre, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01352325: Efficacy of System Constellations in a General Population
Official title: Randomized Controlled Trial on the Efficacy of System Constellations on Psychological Well-being in a General Population Based Sample
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Psychological Well-being
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2011-05-11
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the efficacy of system constellations in a monocentric, single-masked randomized controlled trial.

The method of system constellations refers to an approach which integrates ideas from family systems therapy with elements from psychodrama. The constellations are conducted in a group based seminar-setting, each seminar lasting three days.

Based on the model of a general psychotherapy and the consistency theory, the effects of system constellations on psychological functioning are explored.

It is predicted that participation in a system constellation seminar changes the level of psychological functioning at 4 months.


Eligibility criteria: Inclusion Criteria:

* agreement to participate in a 3-day system constellations seminar
* agreement to be randomized into treatment group or control group (waiting condition)
* agreement not to participate in another system constellation seminar until completion of study

Exclusion Criteria:

* acute suicidal tendency
* acute psychotic episode
* acute drug or alcohol intoxication

Primary outcomes:
measure: Change from Baseline in psychological well-being at 2 weeks and four months
timeFrame: Baseline, day of treatment, 2 weeks after treatment, 4 months after treatment
Secondary outcomes:
measure: Change from Baseline in Psychological distress after 2 weeks and 4 months
timeFrame: Baseline, day of treatment, 2 weeks after treatment, 4 months after treatment
measure: Change from Baseline in Incongruence at 2 weeks and 4 months
timeFrame: Baseline, day of treatment, 2 weeks after treatment, 4 months after treatment
measure: Goal achievement at 2 weeks and 4 months
timeFrame: day of treatment, 2 weeks after treatment, 4 months after treatment
measure: Change from Baseline in 'Experiences in family and organisational systems' at 2 weeks and 4 months
timeFrame: day of treatment, 2 weeks after treatment, 4 months after treatment
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Institute of Medical Psychology, University Hospital Heidelberg
state: Baden-Württemberg
Study officials:
affiliation: Institute of Medical Psychology, University Hospital Heidelberg/Germany
name: Jochen Schweitzer-Rothers, Professor
role: STUDY_DIRECTOR
References:
citation: Hunger C, Bornhauser A, Link L, Schweitzer J, Weinhold J. Improving experience in personal social systems through family constellation seminars: results of a randomized controlled trial. Fam Process. 2014 Jun;53(2):288-306. doi: 10.1111/famp.12051. Epub 2013 Nov 19.