louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01510275: Combined Use of Respiratory Devices After Thoracic Surgery
Official title: Efficacy on Combined Use of Respiratory Devices RESPILIFT® and RESPIVOL® in Adult Cardio-thoracic Surgery Patients. Randomized-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dyspnea
Well Being
Keywords: cardio-thoracic surgery
patients
pulmonary volume
respiratory muscle performance
Lead sponsor: Villa Pineta Hospital
Sponsor class: OTHER
First posted: 2012-01-16
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In a rehabilitation setting, respiratory muscle training with re-expansion techniques in patients following cardio-thoracic surgery represents a consolidated intervention. New devices called RESPILIFT® and RESPIVOl® improve deep inspiration and pulmonary volume with an effect on respiratory muscle performance and perceived dispnoea. The aim of the investigators study is to test the clinical efficacy of RESPILIFT® and RESPIVOl® in patients with a recent history of cardio-thoracic surgery.


Eligibility criteria: Inclusion Criteria:

* \> 18 years old
* recent cardio-thoracic surgery (\< 30 days of admission)
* compliance to pulmonary rehabilitation program

Exclusion Criteria:

* clinical instability
* concomitant severe co-morbidities
* inability to use respiratory devices

Primary outcomes:
measure: Respiratory muscle performance
timeFrame: Change from Baseline in MEP at 6 months
Secondary outcomes:
measure: Respiratory muscle performance
timeFrame: Enrollment (T0), Day 8 (T8), at the end (T14) and after 6 months (T6m)
measure: Pulmonary volumes
timeFrame: Enrollment (T0), Day 8 (T8), at the end (T14) and after 6 months (T6m)
measure: Pulmonary gas exchange
timeFrame: Enrollment (T0), at the end (T14) and after 6 months (T6m)
measure: Perceived dispnoea, well being and thoracic pain
timeFrame: At enrollment (T0), every day during the treatment (T2,T4, T6, T8, T10, T12), at the end (T14) and after 6 months (T6m)
measure: Perceived quality of life
timeFrame: Enrollment (T0), at the end (T14) and after 6 months (T6m)
Other outcomes:
Locations:
city: Modena
country: Italy
facility: Villa Pineta Hospital
city: Modena
country: Italy
facility: Villa Pineta Hospital
Study officials:
affiliation: University of Modena - Ospedale Villa Pineta
name: Enrico E Clini, MD
role: STUDY_DIRECTOR
References:
citation: Crisafulli E, Venturelli E, Siscaro G, Florini F, Papetti A, Lugli D, Cerulli M, Clini E. Respiratory muscle training in patients recovering recent open cardiothoracic surgery: a randomized-controlled trial. Biomed Res Int. 2013;2013:354276. doi: 10.1155/2013/354276. Epub 2013 Jul 30.
Clinical trial NCT01891175: Prevention of Maternal Hypotension During Elective Caesarean Section Performed With Spinal Anaesthesia, Through Intermittent Pneumatic Compression System in the Lower Extremities
Official title: Prevention of Maternal Hypotension During Elective Caesarean Section Performed With Spinal Anaesthesia, Through Intermittent Pneumatic Compression System in the Lower Extremities.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypotension
Keywords: Caesarean
hypotension
Spinal Anaesthesia
intermittent pneumatic compression
lower extremities
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
First posted: 2013-07-03
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The hypotension defined as 20 % less than the basal SBP (systolic blood pressure)and / or an absolute value \<90-100 mmHg, he presents an incident of 80-85% after an anesthesia intradural in the pregnant women, fact that worries for provoking undesirable effects so much in the mother and as in the fetus /newborn baby.

The purpose of this study is to determine the effectiveness of intermittent pneumatic compression system in the lower extremities in order to reduce the vasopressors drugs requirements to maintain hemodynamic stability in pregnant women undergoing elective caesarean sections with an spinal anaesthesia.


Eligibility criteria: Inclusion Criteria:

* Pregnant women over 18 years scheduled for elective caesarean section in the third quarter of the pregnancy. Inform Consent signed.

Exclusion Criteria:

* Caesarean section urgent / emergent
* Caesarean section with epidural anaesthesia
* Caesarean section of multiple pregnancies
* Obstetric Pathology: Preeclampsia, Eclampsia, HELLP syndrome (Hemolysis Elevated Liver enzymes Low Platelet count), Small for gestational age (SGA), preterm (\<32 weeks)
* Valvular heart disease and / or ischemic
* High blood pressure diagnosed and in treatment.
* Sepsis
* Morbid obesity (BMI\> 40)
* Insulin-dependent diabetes
* Block level achieved with spinal anaesthesia\> T5
* Patients that can not meet the study protocol

Primary outcomes:
measure: The dose of needed vasopressor (phenylephrine).
timeFrame: From the beginning of caesaria section (usually from 32 to 42 weeks of pregnancy) until the end of the surgery.
Secondary outcomes:
measure: Effectiveness of Intermittent pneumatic compression system in order to decrease requirements of vasopressors (Phenylephrine).
timeFrame: From the beginning of caesaria section untill discharge of the recovery room ( a maximum of 4 hours).
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron Hospital
Study officials:
References:
Clinical trial NCT02595775: A Trial of an Audit and Feedback Report to Improve Colonoscopy Performance
Official title: A Randomized Controlled Trial of an Audit and Feedback Report to Improve Colonoscopy Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Polyps
Keywords: endoscopy measures
audit and feedback
quality improvement
randomized controlled trial
Colonoscopy
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Cancer Care Ontario
First posted: 2015-11-03
Enrollment: 833
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This project aims to measure the impact of a physician report card (also called an audit \& feedback report) on colonoscopy performance. Endoscopists in Ontario will be randomly assigned to either receive the endoscopist report card or to no feedback. Using Ontario health administrative data, the quality of colonoscopy will be compared between those who received the report card and those who do not. The investigators will also measure the effect of receiving endoscopist report card on colonoscopy performance amongst endoscopists who perform poorly at baseline compared to those who do not. Further, the acceptability of two educational interventions that aim to improve the quality of colonoscopy will be evaluated by conducting one-on-one interviews with select participants. This study is critical to ensure that Canadians have access to the highest quality colonoscopy possible.


Eligibility criteria: Inclusion Criteria:

* All practising endoscopists in Ontario who performed at least 5 colonoscopies in 2014

Exclusion Criteria:

-

Primary outcomes:
measure: Change in polypectomy rate from baseline
timeFrame: At month 12
Secondary outcomes:
measure: Additional outcome 1- Change in cecal intubation rate
timeFrame: At month 12
measure: Additional outcome 2 - Change in annual colonoscopy volume
timeFrame: At month 12
measure: Additional outcome 3 - Change in poor bowel preparation rate
timeFrame: At month 12
Other outcomes:
Locations:
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Jill Tinmouth, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tinmouth J, Sutradhar R, Li Q, Patel J, Baxter NN, Llovet D, Paszat LF, Rabeneck L. A Pragmatic Randomized Controlled Trial of an Endoscopist Audit and Feedback Report for Colonoscopy. Am J Gastroenterol. 2021 Oct 1;116(10):2042-2051. doi: 10.14309/ajg.0000000000001498.
Clinical trial NCT02087475: Perioperative FOLFIRI VS Adjuvant FOLFIRI in Resectable Advanced CRC Failed to Oxaliplatin
Official title: Randomized Open-label Phase III Study Comparing Perioperative FOLFIRI Versus Adjuvant FOLFIRI in Resectable Advanced Colorectal Cancer Failed to Oxaliplatin-containing Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Colorectal Neoplasms
Effects of Chemotherapy
Surgery
Metastasis
Local Neoplasm Recurrence
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2014-03-14
Enrollment: 360
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: Colorectal cancer (CRC) is one of the most leading causes of cancer death in China. Although multiple treatment modalities including surgery, radiotherapy and chemotherapy have been developed, the prognosis of advanced CRC still remains poor. While around 30% of resectable advanced CRC could be cured. This study is designed to compare perioperative FOLFIRI versus adjuvant FOLFIRI in resectable advanced CRC who exposed to oxaliplatin in open-label, phase III mode.


Eligibility criteria: Inclusion Criteria:

* Age:18-80
* ECOG score: 0 or 1
* Histological confirmed of Colorectal Adenocarcinoma
* History of exposure to oxaliplatin
* With local recurrent or metastatic focus
* Tumor resectable confirmed by at less 3 hepatobiliary surgeon
* Informed content acquired

Exclusion Criteria:

* History of Exposure to Irinotecan
* Received surgery in recently 4 weeks or did not recover from surgery
* Other history of cancer in recent 5 years
* Fluorouracil allergy or dihydropyrimidine dehydrogenase defect
* Women with potential pregnancy.

Primary outcomes:
measure: Progress Free Survival
timeFrame: 3 years
Secondary outcomes:
measure: Overall Survival
timeFrame: 3 Years
measure: R0 Resection Rate
timeFrame: 6 Month
measure: Treatment RelatedToxicity
timeFrame: 3 Year
measure: Life Quality
timeFrame: 3 Years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The 6th Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sixth Affiliated Hospital, Sun Yat-sen University
name: Ping Lan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04916275: Post-traumatic Stress, Signs of Depression and Burnout Syndrome Among Nursing Home Staff in Occitanie During the COVID-19 Pandemic
Official title: Stress Post Traumatique, Signes de dépression et Syndrome d'épuisement Professionnel Chez le Personnel Des EHPAD en Occitanie Pendant la pandémie COVID-19 : étude Prospective
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Post Traumatic Stress Disorder
Anxiety
Depressive Disorder
Substance Use Disorders
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2021-06-07
Enrollment: 501
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Professionasl working in a nursing home in Occitanie

Brief summary: Nursing home staff face multiple stresses during the Covid-19 pandemic including personal risk of infection, risk of transmission of the virus to residents and relatives, and risk of witnessing end-of-life scenarios under difficult contexts (absence of families). The hypothesis of this study is that the Covid-19 period is associated with an incidence of more than 30% of post-traumatic stress in nursing home staff.


Eligibility criteria: Inclusion Criteria:

* Professional working in a nursing home in Occitanie
* Professional agreeing to participate
* Professional in a nursing home for at least 3 months
* Professional able to read French
* Profession with an internet connection

Exclusion Criteria:

* The subject is in a period of exclusion determined by a previous study
* The subject refuses to participate
* The subject has already been included into the study
* It is impossible to give the subject informed information
* The subject is under safeguard of justice or state guardianship
* The subject is unable to express consent

Primary outcomes:
measure: To assess the prevalence of post-traumatic stress disorder (PTSD) in the context of the COVID-19 health crisis
timeFrame: Day 0
Secondary outcomes:
measure: Prevalence of depression in the context of the COVID-19 health crisis
timeFrame: Day 0
measure: Prevalence of burn out in the context of the COVID-19 health crisis
timeFrame: Day 0
Other outcomes:
measure: Optional assessment of work memory abnormalities associated with symptoms of post-traumatic stress disorder, anxiety and depression
timeFrame: Day 0
measure: Optional assessment of cognitive flexibility abnormalities associated with symptoms of post-traumatic stress disorder, anxiety and depression
timeFrame: Day 0
measure: Optional assessment of decision-making abnormalities associated with symptoms of post-traumatic stress disorder, anxiety and depression
timeFrame: Day 0
Locations:
city: Montpellier
country: France
facility: CHU de Montpellier
city: Nimes
country: France
facility: CHU de Nîmes, Hôpital Universitaire Carémeau
city: Toulouse
country: France
facility: CHU de Toulouse
Study officials:
affiliation: CHU de Nimes
name: Ismaël Conejero
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01537575: Intravenous Immunoglobulins for Post-Polio Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Post-polio Syndrome
Lead sponsor: Azienda Ospedaliera Universitaria Integrata Verona
Sponsor class: OTHER
First posted: 2012-02-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Postpolio syndrome is a condition that affects many polio survivors years after the acute infection and causes symptoms to increase or new symptoms to develop. Proinflammatory cytokine production within the central nervous system (CNS) indicates an underlying inflammatory process, amenable to immunomodulatory therapy. In this study the investigators sought to confirm that antiinflammatory treatment with intravenous immunoglobulin improves the disease.


Eligibility criteria: Inclusion Criteria:

* a history of acute poliomyelitis
* increased muscle weakness, muscle fatigue and pain in muscle groups previously affected by poliomyelitis
* a diagnosis of postpolio syndrome according to the criteria of Halstead and Rossi

Exclusion Criteria:

* clinically relevant systemic disease
* malignancy
* hypothyroidism
* diabetes mellitus not fully controlled by medical therapy
* medical or orthopedic disorders that could give rise to symptoms mimicking post-polio syndrome
* conditions associated with prolonged coagulation time
* serum IgA deficiency
* previous allergic reaction to IVIG
* body-mass index greater than 30
* immune-modulating treatments other than IVIG within the preceding 6 months

Primary outcomes:
measure: SF-36 physical component
timeFrame: Baseline; 2 and 4 months after treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03465475: Anesthetic Cost Analysis With Desflurane in Automated Gas Control Mode
Official title: Anesthetic Cost Analysis With Desflurane in Automated Gas Control Mode With Maquet Flow-i Anaesthesia Machine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Safety Issues
Keywords: Low flow anesthesia
Desflurane
Cost analysis
Automated gas control
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2018-03-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing hepatectomy operation

Brief summary: Inhalation agents constitute the major part of anesthetic drug costs (20% - 25%) and a significant portion of the applied inhalation agents are thrown into the atmosphere through the waste gas system without being absorbed by the patient. The amount of waste gas is directly correlated to the fresh gas flow (FGF). Reducing the TGA during general anesthesia reduces the consumption of inhalant agents and contributes to the reduction of greenhouse gas pollution. Risks such as hypoxia, hypercapnia, inadequate depth of anesthesia and potential toxic gas accumulation were associated with low flow anesthesia, but the patient was provided with adequate safety by following pulse oximetry, capnography, FiO2 and anesthetic gas analysis. We aimed to perform anesthetic cost analysis and patient security in automated gas control mode (AGC).

Detailed description: After the ethical approvel 60 adult patients scheduled for hepatectomy will be taken to study. Patients will be monitored after they are taken to the operating room (ECG, NIBP, SpO2, Body Temp, BIS, NIRS, PVI, PI, ORI). After the anesthesia induction and tarakeal entubation, first twenty patient will take 300 mL fresh gas flow with AGC mode (group 1), Second twenty patient will take 600 mL fresh gas flow with AGC mode (group 2), third twenty patient will take 600 mL fresh gas flow with manually. Hemodynamic and gas consumption data will be recorded. An operating room will be reserved for this study.

Eligibility criteria: Inclusion Criteria:

* Adult patients undergoing hepatectomy with general anesthesia

Exclusion Criteria:

* Essential data missing
* Patient participating in other research projects
* Drug allergy
* Anesthetic complication story

Primary outcomes:
measure: Amount of used anesthetic gas (desflurane)
timeFrame: Through study completion, an average of 2 month
Secondary outcomes:
measure: Heart rate
timeFrame: Through study completion, an average of 2 month
measure: Mean arterial pressure
timeFrame: Through study completion, an average of 2 month
measure: Peripheral oxygen saturation
timeFrame: Through study completion, an average of 2 month
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Inonu Univercity
Study officials:
affiliation: Investigator
name: Yusuf Z Çolak, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05303259: Effect of Bevacizumab on Asymptomatic Radiotherapy-induced Brain Injury
Official title: Effect of Bevacizumab on Asymptomatic Radiotherapy-induced Brain Injury in Patients With Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Brain Injuries
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the effect of Bevacizumab on asymptomatic radiotherapy-induced brain injury patients with head and neck cancer.

Detailed description: Radiotherapy-induced brain injury (RI) is a serious complication of radiotherapy in head and neck cancer (HNC) patients. Previous studies have confirmed that Bevacizumab has a good effect on patients with symptomatic RI .However, patients with RI maybe do not show clinical symptoms in the early stage. The clinical symptoms will appear with the progression of the RI lesion. There has been no relevant research on whether early intervention is necessary for asymptomatic RI. The investigators conduct this multicenter, randomized clinical research to explore the efficacy and safety of Bevacizumab in asymptomatic RI.

Eligibility criteria: Inclusion Criteria:

Head MRI confirmed RI lesions. Sign the informed consent.

Exclusion Criteria:

With clinical symptoms of RI lesions. Head MRI showed bleeding lesions Contraindications of Bevacizumab. Pregnant women and parturient women.

Primary outcomes:
measure: The incidence and duration of onset of clinical symptoms.
timeFrame: Change form baseline to evaluation at 1 year.
Secondary outcomes:
measure: change of RI volume.
timeFrame: Change form baseline to evaluation at 1 year.
measure: change of cognitive function.
timeFrame: Change form baseline to evaluation at 1 year.
measure: overall survival
timeFrame: Change form baseline to evaluation at 1 year.
measure: change of quality of life.
timeFrame: Change form baseline to evaluation at 1 year.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital
state: Guangdong
Study officials:
affiliation: sun yat-sen memorial hospital,sun yat-sen universicy
name: Yamei Tang, Ph.D
role: STUDY_CHAIR
References: