louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02685540: Death Rate in Anesthesia: A Study in a Tertiary Hospital
Official title: Death Rate in Anesthesia: A Retrospective Study of Five Years Period From a Tertiary Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sudden Death
Keywords: Anesthesia
mortality
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2016-02-18
Enrollment: 792
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent anesthesia and surgery and died inside the hospital

Brief summary: Death rate in anesthesia is one of the most valuable methods to assess the safety of anesthesia practice among different types of patients.

In the investigators study, the investigator will review the death rate in anesthesia whether regional or general over the past five years from 2010 to 2014, by examining the patients records from the hospital database.

Detailed description: Death rate in anesthesia is one of the most valuable methods to assess the safety of anesthesia practice among different types of patients. Most of the studies of death rate in anesthesia are retrospective. Although retrospective studies suffer many draw backs in their design and results, but they are still common method to evaluate the safety of anesthesia practice for surgical patients.

In the investigators study, the investigators will review the death rate in anesthesia whether regional or general over the past five years from 2010 to 2014, by examining the patients records from the hospital database.

The cause of death will be grouped into: totally anesthesia related, partially anesthesia related, surgery related or patient condition related.

The records and files of dead patients will be examined by committee from the researchers to estimate the cause of death.

The end point of the investigators study will be anesthesia death rate inside the hospital.

Eligibility criteria: Inclusion Criteria:

* Patients who underwent anesthesia and surgery.
* Patients who died inside the hospital.

Exclusion Criteria:

* Patient who underwent anesthesia and surgery and do not died and discharged home.
* Patients who died outside the hospital.

Primary outcomes:
measure: number of anesthetized patients who died in the perioperative period inside the hospital
timeFrame: 30 days post-operative
Secondary outcomes:
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: University of Jordan
Study officials:
affiliation: University of Jordan
name: Subhi M Alghanem, FFARCS
role: STUDY_CHAIR
References:
citation: Watters DA, Hollands MJ, Gruen RL, Maoate K, Perndt H, McDougall RJ, Morriss WW, Tangi V, Casey KM, McQueen KA. Perioperative mortality rate (POMR): a global indicator of access to safe surgery and anaesthesia. World J Surg. 2015 Apr;39(4):856-64. doi: 10.1007/s00268-014-2638-4.
Clinical trial NCT03780140: Expanded Access to Cefiderocol for the Intravenous Treatment of Severe Gram Negative Bacterial Infections
Official title: Expanded Access to Cefiderocol for the Intravenous Treatment of Severe Gram Negative Bacterial Infections
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Bacterial Infections
Keywords: S-649266
cefiderocol
Gram-negative
Lead sponsor: Shionogi Inc.
Sponsor class: INDUSTRY
First posted: 2018-12-19
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: Expanded access may be provided for cefiderocol for qualified patients who have limited treatment options and are not eligible for a clinical trial.


Eligibility criteria: Hospitalized patients with serious Gram-negative bacterial infections and who have limited treatment options and are not eligible for a clinical trial.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Shionogi
name: Shionogi Clinical Trials Administrator Clinical Support Help Line
role: STUDY_DIRECTOR
References:
Clinical trial NCT00813540: The Effects of Exercise Training on the Health-related Fitness of Colon Cancer Survivors
Official title: The Effects of Exercise Training on the Health-related Fitness of Colon Cancer Survivors: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Colonic Neoplasms
Keywords: Colonic Neoplasms
Aerobic Exercise
Weight Lifting
Body Composition
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
First posted: 2008-12-23
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Recent studies have suggested that individuals diagnosed with colon cancer who are inactive and/or overweight, may have poorer survival outcomes. Exercise training has been shown to improve fitness and body composition in other cancer survivor groups. The investigators hypothesize that an exercise training program will be a safe, feasible, and effective intervention to improve the fitness and body composition of a group of colon cancer survivors.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed Stage II or III colon cancer diagnosis
* Less than or equal to 1 year since the completion of all adjuvant treatment
* Negative Physical Activity Readiness Questionnaire (PAR-Q) or completed Physical Activity Readiness Medical Examination (PARmed-X) form
* 18 years of age or older
* Ability to understand and provide written informed consent in English
* Willingness to be randomized
* Willingness to complete outcome measures at each assessment time point
* Available for the duration of study intervention period
* Able to travel to our fitness centre 3/week for the study period

Exclusion Criteria:

* Any absolute contraindication to to exercise testing or training
* Evidence of active disease (metastatic, recurrent, or unresectable colon cancer)
* Any uncontrolled medical condition or psychiatric illness that would prevent completion of the exercise program or interfere with the study assessments

Primary outcomes:
measure: Safety (Monitoring for Adverse Events)
timeFrame: 12 Weeks
Secondary outcomes:
measure: Change in Aerobic Capacity
timeFrame: Baseline and 12 Weeks
measure: Change in body composition
timeFrame: Baseline and 12 Weeks
measure: Feasibility (Adherence to the exercise training program)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Cross Cancer Institue
state: Alberta
Study officials:
affiliation: AHS Cancer Control Alberta
name: Kerry Courneya, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00367640: Safety and Efficacy of Sublingual Immunotherapy (SLIT) Tablets in Grass Pollen Rhinoconjunctivitis
Official title: Randomised,Double-blind,Placebo-controlled,Multinational,Multi-centre,Phase IIb/III Study of the Efficacy and Safety of Three Doses of Sublingual Immunotherapy (SLIT) Administered as Tablets Once Daily to Patients Suffering From Grass Pollen Rhinoconjunctivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Allergy
Keywords: Sublingual immunotherapy
Grass pollen tablet
Allergic rhinoconjunctivitis
Lead sponsor: Stallergenes Greer
Sponsor class: INDUSTRY
First posted: 2006-08-23
Enrollment: 628
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and efficacy of SLIT compared with placebo for reduction of symptoms and rescue medication usage


Eligibility criteria: Inclusion Criteria:

* Written consent
* Grass-pollen related allergic rhinoconjunctivitis for at least the last 2 pollen seasons.
* Sensitised to grass pollen (positive SPT and RAST level of at least class 2).
* Total symptom score of the RRTSS during the previous pollen season greater than or equal to 12.
* Safety laboratory resuts within the references ranges

Exclusion Criteria:

* Pregnancy, breast-feeding/lactation
* Had received desensitisation treatment for grass pollen
* Treatment by immunotherapy with another allergen within the previous 5 years
* Usual contraindications of immunotherapy such as serious immunopathologic conditions or malignancies
* Treated with beta-blockers or under continuous corticotherapy

Primary outcomes:
measure: Average Rhinoconjunctivitis Total Symptom Score
timeFrame: Pollen period (average of 32 days in the ITT set)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hôpital Rangueil-Larrey, Toulouse, France
name: Alain DIDIER, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Didier A, Malling HJ, Worm M, Horak F, Jager S, Montagut A, Andre C, de Beaumont O, Melac M. Optimal dose, efficacy, and safety of once-daily sublingual immunotherapy with a 5-grass pollen tablet for seasonal allergic rhinitis. J Allergy Clin Immunol. 2007 Dec;120(6):1338-45. doi: 10.1016/j.jaci.2007.07.046. Epub 2007 Nov 1.
Clinical trial NCT04214340: Appendicitis in Adults and Children in France-A Prospective Study by the French Surgical Association Multicenter Cohort
Official title: Current Management of Appendicitis in Adults and Children in France-A Prospective Study by the French Surgical Association Multicenter Cohort (APPEA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Appendicitis Acute
Peritonitis
Keywords: laparoscopic surgery
Lead sponsor: Association Francaise de Chirurgie
Sponsor class: OTHER
First posted: 2020-01-02
Enrollment: 2285
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: Patients admited in participating centers for acute appendicitis between 2016/03/01 and 2016/06/30

Brief summary: Acute appendicitis still represents a surgical challenge, despite profound changes in practice in recent decades. The objective of this study was comprehensively document current surgical practices aimed at improving the management and follow-up of pediatrics and adults patients presenting with appendicitis in France.

Detailed description: The APPEA series is a national multicentric prospective cohort that included children and adults in France with acute appendicitis presenting between March 1st and June 30th, 2016. Data included demographic characteristics, medical history, symptoms, biology, radiology, treatments given during hospitalization, the modalities of the intervention, and any complications during a follow-up period of 6 months.

Eligibility criteria: Inclusion Criteria:

* patients admitted for appendicitis in participating centers
* informed

Exclusion Criteria:

* patient's (or parent's for children) opposition

Primary outcomes:
measure: Surgical practices in the management of adults and pediatrics patients with appendicitis
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: CHU Grenoble Alpes
name: catherine ARVIEUX, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bhangu A, Soreide K, Di Saverio S, Assarsson JH, Drake FT. Acute appendicitis: modern understanding of pathogenesis, diagnosis, and management. Lancet. 2015 Sep 26;386(10000):1278-1287. doi: 10.1016/S0140-6736(15)00275-5.
citation: Mak GZ, Loeff DS. Paradigm Shifts in the Treatment of Appendicitis. Pediatr Ann. 2016 Jul 1;45(7):e235-40. doi: 10.3928/00904481-20160525-01.
citation: Teixeira FJR Jr, Couto Netto SDD, Akaishi EH, Utiyama EM, Menegozzo CAM, Rocha MC. Acute appendicitis, inflammatory appendiceal mass and the risk of a hidden malignant tumor: a systematic review of the literature. World J Emerg Surg. 2017 Mar 9;12:12. doi: 10.1186/s13017-017-0122-9. eCollection 2017.
citation: Wagner M, Tubre DJ, Asensio JA. Evolution and Current Trends in the Management of Acute Appendicitis. Surg Clin North Am. 2018 Oct;98(5):1005-1023. doi: 10.1016/j.suc.2018.05.006. Epub 2018 Jul 13.
Clinical trial NCT02559440: Mometasone Furoate and Oxymetazoline in the Treatment of Adenoid Hypertrophy
Official title: Combination Therapy With Mometasone Furoate and Oxymetazoline in the Treatment of Adenoid Hypertrophy Concomitant With Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Adenoidal Hypertrophy
Lead sponsor: Guangzhou Women and Children's Medical Center
Sponsor class: OTHER
First posted: 2015-09-24
Enrollment: 240
Sex: ALL
Minimum age (years): 5
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effect of MF/OXY in the treatment of adenoid hypertrophy children with severe allergic rhinitis.

Detailed description: The investigators performed a two stages, parallel, randomized, double-blind, double-dummy, clinical trial in 240 AH children concomitant with perennial allergic rhinitis. In the first treatment stage, the 240 children were assigned to MF (50μg, 1 puff in each nostril every evening) or control group (normal saline) after two week's run-in period. After 6 week's treatment, the children in MF group were evaluated and grouped as responders and non-responders according to subjective symptoms and objective performance.

Responders were followed up for six months and reassessed. Non-responders underwent 2-week washout period and were randomly assigned to 4 groups receiving the following treatments: placebo, OXY (0.05%, 1 puff in each nostril every evening) or MF (50μg, 1 puff in each nostril every evening). All participants received 8 weeks' MF or its placebo plus one week's OXY or its placebo for every second week. After that, the patients were followed for six months and the evaluation was done at different time points.

Eligibility criteria: Inclusion Criteria:

* adenoid occluding at least 75% of the nasopharynx at nasal endoscopy
* age between 5 and 11 years
* chronic obstructive nasal symptoms no less than 12 months
* moderate-to-severe AR

Exclusion Criteria:

* tonsillar hypertrophy
* upper respiratory infection within the last 2 weeks
* sinonasal anatomic anomalies or diseases
* craniofacial malformations
* genetic diseases (i.e., Down's syndrome)
* neurologic or cardiovascular diseases
* immunodeficiency
* history of epistaxis
* asthma
* hypersensitivity to MF or OXY
* undergoing intranasal, topical, or systemic steroid or antibiotic treatment within the past 4 weeks

Primary outcomes:
measure: symptom score assessed by TNSS scopring system
timeFrame: six months
Secondary outcomes:
measure: adenoid size assessed by nasopharyngoscope （calculated the adenoid area in relation to the nasopharyngeal area）
timeFrame: six months
measure: nasal volume assessd by Acoustic rhinometry
timeFrame: six months
Other outcomes:
Locations:
Study officials:
affiliation: Guangzhou Women and Children's Medical Center
name: renzhong Luo
role: STUDY_CHAIR
References:
Clinical trial NCT00363740: Study of GW685698X In Patients With Seasonal Allergic Rhinitis
Official title: Clinical Evaluation of GW685698 for Seasonal Allergic Rhinitis -A Placebo-controlled Study to Determine the Non-inferiority of GW685698 Over Fluticasone Propionate Using a Double-blind Manner-
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rhinitis, Allergic, Seasonal
Keywords: GW685698X
allergic rhinitis
Seasonal Allergic Rhinitis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-08-15
Enrollment: 38
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was designed to compare the efficacy and safety of an investigational nasal spray compared with placebo nasal spray and commonly used drug in the treatment of seasonal allergic rhinitis. Allergic rhinitis is an inflammatory disorder of the upper airway that occurs following allergen exposure. The focus of this study, seasonal allergic rhinitis (SAR), is one type of allergic rhinitis that is triggered by the pollen from trees, grasses, and weeds. Typical symptoms are sneezing, nasal congestion and pruritus, rhinorrhea, and pruritic, watery, red eyes.


Eligibility criteria: Inclusion criteria:

* Informed consent
* Outpatient
* Diagnosis of seasonal allergic rhinitis with symptoms
* Able to comply with study procedures

Exclusion Criteria:

* Significant concomitant medical condition
* Use of corticosteroids/allergy medications
* Laboratory abnormality
* Positive pregnancy test
* Allergy to any component of investigational product

Primary outcomes:
measure: Mean change from baseline over the entire treatment period in three total nasal symptom scores.
Secondary outcomes:
measure: Mean change from baseline over the entire treatment period in four total nasal symptom scores.
measure: Mean change from baseline over the entire treatment period in individual total nasal symptom scores.
Other outcomes:
Locations:
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT03147040: AssessinG Efficacy of Carboplatin and ATezOlizumab in Metastatic Lobular Breast Cancer
Official title: AssessinG Efficacy of Carboplatin and ATezOlizumab in Metastatic Lobular Breast Cancer: GELATO-trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Lobular
Metastatic or incurable locally advanced cancer
Disease progression on endocrine therapy in advanced setting
Lead sponsor: The Netherlands Cancer Institute
Sponsor class: OTHER
Collaborators: name: Roche Pharma AG
First posted: 2017-05-10
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single arm multicenter non-randomized phase II trial testing the efficacy of the combination of carboplatin plus atezolizumab in metastatic ILC


Eligibility criteria: Inclusion Criteria:

* Signed and written informed consent
* Age 18 year or older
* Metastatic or incurable locally advanced lobular breast cancer with confirmation of the lobular histology and E-cadherin loss on a biopsy of a metastatic lesion.
* Metastatic lesion accessible for histological biopsies
* Evidence of progression of disease
* A maximum of two lines of palliative chemotherapy
* WHO performance status of 0 or 1
* Evaluable disease or measurable according to RECIST 1.1

Exclusion Criteria:

* Leptomeningeal disease localization
* History of having received other anticancer therapies within 2 weeks of start of the study drug
* History of immunodeficiency, autoimmune disease, conditions requiring immunosuppression
* Prior treatment with immune checkpoint blockade
* Live vaccine within 2 weeks prior to start of study
* Active other cancer
* Active hepatitis B

Primary outcomes:
measure: Number of patients free of progression at 6 months
timeFrame: At 6 months
Secondary outcomes:
measure: Number of patients free of progression at 6 months in the IR profile subgroup
timeFrame: At 6 months
measure: Number of patients free of progression at 6 months in the non- IR profile subgroup
timeFrame: At 6 months
measure: Number of patients free of progression at 12 months
timeFrame: At 12 months
measure: Objective Response Rate
timeFrame: Assessed up to 60 months
measure: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
timeFrame: Assessed up to one month after end of treatment
measure: Overall Survival
timeFrame: Assessed up to 60 months
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Antoni van Leeuwenhoek
city: Groningen
country: Netherlands
facility: UMCG
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center Cancer Institute
Study officials:
affiliation: NKI-AvL
name: Marleen Kok, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01837940: Efficacy of a Dietary Supplementation With Lactobacillus Reuteri for Digestive Health in an Elderly Population
Official title: Efficacy of a Dietary Supplementation With Lactobacillus Reuteri DSM 17938 for Digestive Health in an Elderly Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Constipation
Diarrhea
Indigestion
Reflux
Abdominal Pain
Lead sponsor: Örebro University, Sweden
Sponsor class: OTHER
Collaborators: name: BioGaia AB
First posted: 2013-04-23
Enrollment: 290
Sex: ALL
Minimum age (years): 65
Standard ages: 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 effect of a daily supplement consisting of the probiotic bacteria, Lactobacillus reuteri, on the digestive health among persons 65 years and older.

Detailed description: The overall purpose of the study is to investigate the effect of daily supplementation, during a three months period, of L. reuteri on digestive health in an elderly Swedish population, residing in the municipality of Örebro. In addition an extensive screening of the study population in regard of overall health status, functionality and well-being as well as the composition of the gut microbiome will be assessed prior study start through the collection of baseline data

Eligibility criteria: Inclusion Criteria:

* Age ≥ 65 years
* Informed consent signed by study participant or legal guardian

Exclusion Criteria:

* Known gastrointestinal disease, with strictures, malignance's and ischemia.
* Inflammatory bowel diseases (IBD)
* Participation in other clinical trials in the past three months.

Primary outcomes:
measure: Change from baseline Gastrointestinal symptoms to 3months
timeFrame: Baseline, at 2 months and at 3months/study end
Secondary outcomes:
measure: Change in use of intestinal motility regulating substances during the 3-month intervention period
timeFrame: at baseline and end of study ( 3months)
Other outcomes:
measure: Change in mood during the 3month intervention period
timeFrame: at baseline, 2months and 3monts/study end
measure: Change in quality of life during the 3-month intervention period
timeFrame: at baseline, at baseline, 2months and 3monts/study end
Locations:
city: Örebro
country: Sweden
facility: Örebro University
state: Närke
Study officials:
affiliation: Örebro Universitet
name: Robert Jan Brummer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ostlund-Lagerstrom L, Kihlgren A, Repsilber D, Bjorksten B, Brummer RJ, Schoultz I. Probiotic administration among free-living older adults: a double blinded, randomized, placebo-controlled clinical trial. Nutr J. 2016 Sep 10;15(1):80. doi: 10.1186/s12937-016-0198-1.