louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02859272: Vaginal Vault Suspension During Benign Hysterectomy. A Questionnaire and Register-based Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Pelvic Organ Prolapse
Benign Hysterectomy
Suspension
Keywords: Suspension, benign hysterectomy, post operative prolapse
Lead sponsor: Nykøbing Falster County Hospital
Sponsor class: OTHER
Collaborators: name: Zealand University Hospital
name: Copenhagen University Hospital, Denmark
name: University Hospital, Gentofte, Copenhagen
First posted: 2016-08-09
Enrollment: 11000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women operated with a benign hysterectomy from May 2012-June 2014.

Brief summary: Female pelvic organ prolapse (POP) is characterized by lack of vaginal support which enables pelvic organs to bulge into the vaginal walls and sometimes protrude through the genital hiatus. POP is more frequent among women who had their uterus removed.

We would like to investigate whether suspension of the top of the vagina during remowal of the uterus prevents subsequent POP.

The purpose of the PhD project is therefore to describe validity, terminology, and operative performance of used suspension methods during benign hysterectomy in Denmark. Further, to investigate these suspension methods' possible association with pain, life quality, sexuality, pessary use, and POP .

Detailed description: In 2012 the investigators introduced codes of suspension methods to the Danish hysterectomy and hysteroscopy Database's registration chart. Consequently, validity of these codes needs to be ensured to enable their use in further research.

Thereafter, the prevalence of Danish gynecologists' use of the different suspension methods will be investigated. A questionnaire will elucidate a possible relation between the suspension methods and pain, life quality and sexuality. Through a register based study in the National Patient Register the association between suspension methods and post hysterectomy POP and possible confounding will be investigated.

Eligibility criteria: Inclusion Criteria:

* Alive women two years after hysterectomy
* Benign hysterectomy
* Willingness to participate (in the questionnaire)

Exclusion Criteria:

* Death
* Emigration
* Secret address

Primary outcomes:
measure: Through national registries investigate the prevalence of postoperative pelvic organ prolapse among hysterectomized women in relation to performed suspension method.
timeFrame: 6 months
Secondary outcomes:
measure: Through a questionnaire investigate postoperative pain in relation to suspension method.
timeFrame: 2 years
measure: Through a questionnaire investigate life quality in relation to suspension method.
timeFrame: 2 years
measure: Through a questionnaire investigate sexuality in relation to suspension method.
timeFrame: 2 years
measure: Validity of suspension methods
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04157972: Effects of SIMEOX on Static Hyperinflation in Patients With COPD
Official title: Short-term Effects of SIMEOX on Static Hyperinflation in Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2019-11-08
Enrollment: 25
Sex: ALL
Minimum age (years): 45
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The visits include sessions (test 1 and 2) with SIMEOX or a positive expiratory pressure device (PEP) (chosen according to the subject's randomization) lasting 20 minutes, each followed by a rest period of 30 minutes.

Lung function tests will be performed before, after and 30 minutes after performing the devices (SIMEOX and PEP).
Primary purpose: TREATMENT

Brief summary: This study will investigate the effects on the SIMEOX technology on static hyperinflation in patients with chronic obstructive pulmonary disease (COPD).

Detailed description: This is a crossover study assessing the short-term effects of SIMEOX and PEP device on static hyperinflation in patients with COPD.

Patients will perform lung function tests (to assess the residual volume and functional residual capacity) before, after and 30 minutes after a 20-min long session of SIMEOX or PEP (depending of randomization).

Eligibility criteria: Inclusion Criteria:

* Patients with chronic obstructive pulmonary disease,
* Forced expiratory volume in 1s (FEV1) \<80% of predicted value,
* Stable condition (no pulmonary exacerbation for more than 28 days).

Exclusion Criteria:

* Routine use of one of the two treatments - SIMEOX and/or PEP,
* Inability to understand or carry out the instructions,
* Severe cardiac comorbidity, neuromuscular disease,
* Severe scoliosis,
* Patient with a pacemaker.

Primary outcomes:
measure: Change in functional residual capacity (FRC) using body plethysmography
timeFrame: 15 minutes
measure: Change in functional residual capacity (FRC) using helium dilution
timeFrame: 5 minutes
measure: Change in air trapping
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc
state: Brussels Capital
Study officials:
References:
Clinical trial NCT03111368: EUS-FNA of Solid Pancreatic Mass: Comparison Between Negative Pressure and Slow-pull Technique
Official title: Endoscopic Ultrasound-guided Fine Needle Aspiration (EUS-FNA) of Solid Pancreatic Mass: Comparison Between Negative Pressure and Slow-pull Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Neoplasm
Keywords: eus-fna
pancreatic neoplasm
slow-pull
negative pressure
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
name: Medi - Globe
First posted: 2017-04-12
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 50 patients with pancreatic mass will undergo endoscopic ultrasound-guided fine needle aspiration using two techniques: negative pressure and slow-pull. Cytological results will be compared.

Detailed description: The study will analyze the cytological results of endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) of pancreatic mass using two different techniques of needle suction. Negative pressure and slow-pull. 50 patients with pancreatic mass will be submitted to four passes with both techniques. Each patient will be randomized to decide which technique will be first and subsequently on a alternated fashion until four passes are completed. Smear cytology and cell block preparations for each technique were obtained. The pathologist was blinded for the EUS-FNA technique.

Eligibility criteria: Inclusion Criteria:

* pancreatic solid mass

Exclusion Criteria:

* endoscopic ultrasound non accessible lesions

Primary outcomes:
measure: Diagnostic yield
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas da FMUSP
state: SP
Study officials:
affiliation: Hospital das Clinicas Faculdade de Medicina da Universidade de São Paulo
name: Spencer Cheng
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03747068: The Influence of Biologcal Treatment on the Short-Term Complications of Surgery in Patients With Inflematory Bowel Disease.
Official title: Preoperative Use of ANTI-Tumor Necrosis Factor Therapy in Ulcerative Colitis Patients Who Underwent Ileal Pouch-Anal Anastomosis (IPAA) is Not Associated With Histological Fibrosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ulcerative Colitis
Anti TNF Therapy
Ileal Pouch Anal Anastomosis (IPAA)
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
Collaborators: name: Mount Sinai Hospital, Canada
name: University of Toronto
First posted: 2018-11-20
Enrollment: 130
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All individuals with IBD who underwent IPAA from January 2002 to June 2013 were reviewed. Patients with CD and those without adequate clinical records documenting the 30-day postoperative clinical outcomes were excluded

Brief summary: BACKGROUND: Previous studies of short-term surgical outcomes after preoperative exposure to anti-TNF therapy in ulcerative colitis (UC) patients who have undergone IPAA have been conflicting. We sought to determine whether preoperative exposure to anti-TNF therapy affects histological measures of fibrosis in the colorectum, which may be a potential factor in adverse anastomosis complications following IPAA surgery.

METHODS: Individuals who received infliximab as maintenance therapy and who received their last dose within 180 days of the first stage of IPAA were selected. The control group comprised UC patients who were not exposed to anti-TNF therapy, matched by age, sex, BMI, disease duration, albumin levels, and post-operative leak outcome. Hematoxylin and eosin- (H\&E) and trichrome-stained slides from the most distal, well-oriented, full-thickness section of colorectum from each patient's total colectomy specimen were evaluated. Blinded assessment of the degree of fibrosis in the lamina propria, the submucosa, the submucosa immediately adjacent to the muscularis propria, and the subserosa was performed by a single observer using a semi-quantitative pictorial scale.


Eligibility criteria: Inclusion Criteria:

* all individuals with IBD who underwent IPAA from January 2002 to June 2013 were reviewed .

Exclusion Criteria:

* Patients with CD
* Patients without adequate clinical records documenting the 30-day postoperative clinical outcomes .

Primary outcomes:
measure: to determine whether preoperative exposure to anti-TNF therapy affects histological measures of fibrosis in the rectum, as increased rectal fibrosis may be a potential factor in adverse anastomosis complications following IPAA surgery
timeFrame: all individuals with IBD who underwent IPAA from January 2002 to June 2013 were reviewed
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03164668: Menthol Flavored E-cigarette Use During a Simulated Ban of Menthol Cigarettes
Official title: Menthol Flavored E-cigarette Use During a Simulated Ban of Menthol Cigarettes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use Disorder
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2017-05-23
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this formative study is to provide preliminary data regarding how the availability of menthol flavored e-cigarettes affects tobacco use behavior in the context of a ban on menthol flavored cigarettes


Eligibility criteria: Inclusion Criteria:

* Self identify as African American
* smoke primarily menthol cigarettes
* be between the ages of 18 and 64
* smoke a minimum number of cigarettes per day
* agree to abstain from menthol cigarettes for an 8 week period

Exclusion Criteria:

* current unstable medical / psychiatric condition
* regular use any form of nicotine or tobacco other than cigarettes
* are pregnant or breast feeding

The investigators will evaluate if there are other reasons why someone may not be eligible to participate

Primary outcomes:
measure: Number of Cigarettes Smoked Per Day
timeFrame: 1 month
measure: Number of E-cigarette Puffs Used Per Day
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Clinical and Translational Sciences Institute
state: Minnesota
Study officials:
References:
Clinical trial NCT00897468: Developing Mouse Models of Breast Cancer Using Tissue Samples From Women With Breast Cancer
Official title: Developing In-Vivo Models of Human Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: breast cancer
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: breast cancer patients

Brief summary: RATIONALE: Changing the genes in laboratory mice to create a living model of human breast cancer may help doctors learn more about breast cancer.

PURPOSE: This research study is developing mouse models of breast cancer using tissue samples that were previously collected from women with breast cancer.

Detailed description: OBJECTIVES:

* To develop new in vivo models of human breast cancer.
* To correlate response in this model to actual treatment outcome in patients, if the in vivo model is proven feasible.

OUTLINE: Previously collected breast tumor fragments are implanted into the renal capsule site of SCID mouse hosts (mouse with severe combined immune deficiency) to establish metastatic spread patterns, and both histologic and molecular tumor characteristics.

Patients' medical charts are reviewed to obtain relevant information, including general demographics, smoking and alcohol use, as well as outcome data such as survival and response to treatment.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of breast cancer

  * Any stage of disease
  * Primary or metastatic disease
* Human breast tumor tissues available after the diagnoses have been made
* Enrolled on the ongoing Breast Tissue Repository trial VU-VICC-BRE-03103

  * Have consented to the use of their tissues for research purpose
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Menopausal status not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Development of new in vivo models of human breast cancer
timeFrame: 1 year
measure: Correlation of response in this model to actual treatment outcome in patients, if the in vivo model proven feasible
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: A. Bapsi Chakravarthy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05671172: Effect of Adding Hyaluronidase to Bupivacaine in Transversus Abdominis Plane Block for Cesarean Section
Official title: Effect of Adding Two Different Doses of Hyaluronidase to Bupivacaine in Ultrasound-Guided Transversus Abdominis Plane (TAP) Block for Post-cesarean Section Analgesia; A Randomized Controlled Double Blinded Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain, Postoperative
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2023-01-04
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Since TAP block needs to affect several nerves in single tissue plane with a single prick, hyaluronidase is expected to aid greatly in the spread of the LA and help the block. However, there have not been adequate studies to establish the efficacy of adding hyaluronidase in lateral TAP after cesarean section. Hence, the present study was carried out to evaluate the efficacy of hyaluronidase in different concentrations added to bupivacaine in US-guided bilateral lateral TAP block.


Eligibility criteria: Inclusion Criteria:

* parturients who aged between 18-40 years old
* with ASA physical status grade II and
* scheduled for elective CS under spinal anesthesia

Exclusion Criteria:

* patients with ASA grade III or IV,
* refusal to participate,
* emergency CS or complicated pregnancy,
* those with bleeding disorders or on anticoagulants,
* those with severe respiratory and cardiovascular diseases,
* having any local infection at the injection site,
* history of allergy to one of the used drugs,
* obese patients (body mass index ≥ 30 kg/m2).

Primary outcomes:
measure: the duration of analgesia
timeFrame: 24 hours postoperative
Secondary outcomes:
measure: the postoperative pain severity
timeFrame: every 0,2,4,8,12, up to 24 hours postoperative
measure: total morphine consumption
timeFrame: at 24 hours postoperatively
measure: patient satisfaction
timeFrame: at 24 hours postoperatively
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Samar Rafik Amin
state: Qalubia
Study officials:
References:
Clinical trial NCT03054272: Visual Perception Exploration Using Eye-tracking Technology in a Cannot Intubate/Cannot Oxygenate Simulation
Official title: Visual Perception Exploration Using Eye-tracking Technology in a Cannot Intubate/Cannot Oxygenate Simulation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patient Simulation
Perception
Intubation; Difficult or Failed
Keywords: High-fidelity simulation
Eye-tracking
Difficult intubation
Lead sponsor: Université de Montréal
Sponsor class: OTHER
First posted: 2017-02-15
Enrollment: 14
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Residents and attending physicians from University of Montreal Anesthesia Department

Brief summary: Using eye-tracking technology, the aim of this observational study is to compare the visual interests between attending physicians and residents watching a Cannot Intubate/Cannot Oxygenate (CICO) scripted and simulated scenario

Detailed description: Attending physicians and residents, from the department of Anesthesiology at the Université de Montréal were recruited on a voluntary basis. A 13-minute video based on a suggested CICO algorithm from the Difficult Airway Society to manage unanticipated difficult intubation in adults (3) was produced at the University of Montreal Simulation Centre using high-fidelity settings. The scenario was about a patient, with a cervical collar, in the post-anesthesia care unit. Throughout the video, the patient presents increasing respiratory distress worsening to respiratory failure. The anesthesiologist fails to ventilate, intubate and insert a laryngeal mask leading to a cricothyroidotomy. All participants were looking at a screen on which the scenario was broadcast. The screen was equipped with TobiiEyeX®, an eye-tracking system that automatically aggregates gaze data.

Eligibility criteria: Inclusion Criteria:

* Residents and attending physicians from University of Montreal Anesthesia Department

Exclusion Criteria:

* None

Primary outcomes:
measure: Difference between Time to First Fixation and Total View Duration of areas of interests.
timeFrame: The primary endpoint is collected during 15 minutes, throughout the viewing of the video by the participant
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Université de Montreal
name: Issam Tanoubi, Dr
role: STUDY_DIRECTOR
affiliation: Université de Montreal
name: Komi Sodoke, Msc
role: PRINCIPAL_INVESTIGATOR
affiliation: Université de Montreal
name: Mathieu Tourangeau, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04102072: The Consistency of Cardiac Output Measurements by Different Methods in VA-ECMO Patients
Official title: The Consistency of Cardiac Output Measurements by Different Methods in VA-ECMO Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Extracorporeal Membrane Oxygenation
Keywords: pulmonary artery catheter
echocardiography
fluid responsiveness
extracorporeal membrane oxygenation
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2019-09-25
Enrollment: 20
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: Objective：

1. To evaluate the consistency of cardiac output measured by different hemodynamic monitoring methods in patients with VA-ECMO
2. To evaluate whether different hemodynamic monitoring methods can accurately detect the trend of cardiac output changes

Detailed description: Venoarterial extracorporeal membrane oxygenation (VA-ECMO) has been used for profound cardiogenic shock to bridge to decision,ventricular assist devices,or transplant.Close monitoring of cardiac output, especially in patients before and after intervention (such as volume expansion, diuresis, vasoconstriction, vasodilation therapy), can help to adjust the treatment strategy. Hemodynamic monitoring in ECMO patients requires familiarity with the underlying pathophysiology and circulatory mechanics of extracorporeal flow.Limited to the actual clinical situation of patients, one or two hemodynamic monitoring methods may be accepted. Is there consistency between different hemodynamic monitoring results? And whether hemodynamic monitoring can accurately detect the changes of these parameters before and after intervention is an important issue in clinical practice. This study will provide important reference for VA-ECMO patients how to choose appropriate hemodynamic monitoring tools and how to interpret the results of hemodynamic monitoring.

Eligibility criteria: Inclusion Criteria:

1. cardiac surgery
2. treatment with VA-ECMO
3. mechanical ventilation
4. hemodynamic monitoring according to patient's condition (PAC, Flotrac, echocardiography)

Exclusion Criteria:

1. age \< 18
2. cardiac arrhythmia
3. moderate to severe aortic, mitral and tricuspid regurgitation
4. active hemorrhage
5. IABP
6. spontaneous triggering of the ventilator

Primary outcomes:
measure: Baseline Cardiac Output measurement
timeFrame: within1 minute at baseline position
measure: Cardiac Output measurement afterTrendelenburg Maneuver
timeFrame: 1 minute after starting Trendelenburg Maneuver
measure: Cardiac Output measurement after Dobutamine stress test
timeFrame: 5 minutes after dobutamine stress test
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan hospital, Fudan university
Study officials:
affiliation: Fudan University
name: Zhe Luo, Doctor
role: STUDY_CHAIR
References: