louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02121275: Lung Ultrasound for the Detection of Pulmonary Atelectasis in the Perioperative Period
Official title: Lung Ultrasound for the Detection of Pulmonary Atelectasis in the Perioperative Period
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Pulmonary Atelectases
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2014-04-23
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing elective laparoscopic surgery at the Medical University of Vienna

Brief summary: Atelectases (collapsed lung areas) of 15-20% of total lung occur in up to 90% of patients who are anaesthetized and intubated. The goal of the present prospective study is to detect atelectatic areas in the perioperative period in the lungs of patients undergoing elective laparoscopic surgery non-invasively and without x-ray exposure. Results of lung ultrasound (LUS) as the experimental method will be compared to the results of Electrical Impedance Tomography (EIT) as the reference technique for the detection of atelectasis. A device for peripheral Oxygen saturation measurement (MASIMO Radical-8) will detect changes in ventilation. The investigators want to confirm or disprove former findings of the appearance of intraoperative atelectases and to prove that ultrasound is a valid tool for detection of atelectases.


Eligibility criteria: Inclusion Criteria:

* Male or female,
* age 18 - 75
* BMI \< 30
* Laparoscopic operation

Exclusion Criteria:

* Pregnancy
* Pulmonary infection
* Chronic pulmonary diseases
* Morbid Obesity

Primary outcomes:
measure: Correlation between evidence of atelectasis in lung ultrasound and evidence of atelectasis in electric impedance tomography
timeFrame: on the day of laparoscopic surgery, expected average 2 hours in total
Secondary outcomes:
measure: respiratory variability of oxygen saturation
timeFrame: on the day of laparoscopic surgery, expected average 2 hours in total
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna, Dept. of Anesthesiology and General Intensive Care
Study officials:
affiliation: Medical University of Vienna
name: Roman Ullrich, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04808375: Risk Factors for Pregnancy-induced Hypertension in Pregnant Patients Undergoing Cesarean Section
Official title: Risk Factors for Pregnancy-induced Hypertension in Pregnant Patients Undergoing Cesarean Section: a Retrospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Adverse Maternal and Neonatal Outcomes
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2021-03-22
Enrollment: 1200
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all women presenting for pregnancy-induced hypertension in Renji Hospital Affiliated to Shanghai Jiaotong University from January 2013 to January 2020 cesarean section operation

Brief summary: After Institutional Review Board approval, we performed a retrospective cohort study among all women presenting for pregnancy-induced hypertension under Cesarean section in Renji Hospital Affiliated to Shanghai Jiaotong University from January 2013 to January 2020.Perioperative data were collected, including preoperative general condition, laboratory examination, auxiliary examination (blood routine, blood coagulation, liver and kidney function, electrocardiogram, cardiac ultrasound, etc.), perioperative indicators, postoperative laboratory examination (blood routine, blood coagulation, liver and kidney function, etc.), postoperative follow-up and satisfaction survey of patients.


Eligibility criteria: Inclusion Criteria:

* all women presenting for pregnancy-induced hypertension in Renji Hospital Affiliated to Shanghai Jiaotong University from January 2013 to January 2020 cesarean section operation

Exclusion Criteria:

* no

Primary outcomes:
measure: Adverse maternal outcomes
timeFrame: 42 days after delivery
measure: Adverse neonatal outcomes
timeFrame: 42 days after delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital, Shanghai Jiao Tong University, School of Medicine
state: Shanghai
Study officials:
References:
Clinical trial NCT05597475: GLP1R-imaging in Post-RYGB Hypoglycemia
Official title: Visualizing Beta Cells in Patients With Hyperinsulinemic Hypoglycemia After Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Hypoglycemia Post Gastric Bypass Surgery
Hyperinsulinemic Hypoglycemia
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
First posted: 2022-10-28
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: In order to evaluate the difference in beta cell mass in patients with and without hyperinsulinemic hypoglycemia after Roux en Y gastric bypass (RYGB) investigators aim to compare quantitative PET imaging of the pancreas between these patient groups.

These highly relevant data will provide investigators with more information on the possible role of beta cell mass in the mechanisms of hyperinsulinemic hypoglycemia bariatric surgery.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent

Patients:

- Persisting hyperinsulinemic hypoglycemia after a low-carbohydrate diet and/or insulin suppressive medication for one year.

Controls:

* RYGB at least 2 years ago
* Normal glucose levels before and after RYGB (fasting glucose between 4 and 6 mmol/l or HbA1c between 20 and 42 mmol/mol)
* Score ≤ 7 on Sigstad's scoring system (Table 1)
* Hypoglycemia excluded by 14-day continuous glucose monitoring
* Individual matched to HH group on age (± 5 years), sex and BMI at time of inclusion (± 2 kg/m2)

Exclusion Criteria:

* Anti-diabetic medication in the past 6 months
* Treatment with synthetic Exendin (Exenatide, Byetta®) or Dipeptidyl-Peptidase IV inhibitors in the past six months.
* Known liver failure or serum liver values over 2 times normal value at the time of standard laboratory assessment. Normal values of total bilirubin, γ-GT, ASAT and albumin are \<21 μmol, \<40 U/l, \<30 U/l and 35-50 g/l respectively
* Pregnancy or the wish to become pregnant within 6 months
* Breast feeding
* Kidney failure, i.e. calculated creatinine clearance below 40 ml/min
* Age \< 18 years
* No signed informed consent

Primary outcomes:
measure: Pancreatic uptake of 68Ga-NODAGA-exendin-4
timeFrame: baseline
Secondary outcomes:
measure: Beta cell function
timeFrame: baseline
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate hospital
Study officials:
References:
Clinical trial NCT01026675: Early Screening for Gestational Diabetes Mellitus
Official title: Early Screening for Gestational Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gestational Diabetes Mellitus
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: Canadian Diabetes Association
First posted: 2009-12-04
Enrollment: 1442
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant Women

Brief summary: The working hypothesis of this proposal is that screening for gestational diabetes mellitus as early as the 1st trimester is efficient for detecting the forthcoming presence or absence of gestational diabetes mellitus. The investigators long-term goal is the prevention of gestational diabetes mellitus onset i.e. the prevention of progression to gestational diabetes mellitus, in order to enable delivery of appropriate counselling, diagnostics and treatment for pregnant women, as well as to improve pregnancy outcomes. Therefore, robust 1st trimester screening criteria is needed.

The overall objective of this proposal is to determine an accurate and valid 1st trimester 1h post 50g oral glucose challenge test plasma glucose cut-off value that is predictive of gestational diabetes mellitus onset.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 yrs
* Gestational age between 6 and 13 weeks from last menstrual period,
* Alcohol \< 2 drinks/day
* Not involved in regular high intensity physical activity
* Singleton pregnancy
* Otherwise good health status.

Exclusion Criteria:

* Type 1 or type 2 diabetes
* Taking drugs interfering with glucose metabolism

Primary outcomes:
measure: oral glucose challenge test plasma glucose value
timeFrame: 6-13 weeks
Secondary outcomes:
measure: oral glucose challenge test plasma glucose cut-off value
timeFrame: 6-13 weeks
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Centre de recherche clinique Étienne-Le Bel du CHUS
state: Quebec
Study officials:
affiliation: Université de Sherbrooke
name: Jean-Luc Ardilouze, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01255475: Blood Pressure Reduction in Heart Failure
Official title: Effect of Blood Pressure Reduction in Patients With Chronic Heart Failure - Randomized, Double-blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Heart Failure
Cardiac Failure
Congestive Heart Failure
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2010-12-07
Enrollment: 21
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: Previous studies have demonstrated a direct association between blood pressure level and cardiovascular risk. However in patients with heart failure this association is considered controversial. The aim of this study is to evaluate the effect of the reduction of blood pressure in patients with heart failure. The investigators will examine the effects of this intervention over mortality, quality of life, and cardiac function.


Eligibility criteria: Inclusion Criteria:

* stable chronic heart failure for at least 6 months
* ejection fraction of 40% or less, as measured by transthoracic echocardiography
* optimal clinical treatment for chronic heart failure according to current international guidelines.

Exclusion Criteria:

* patient refusal
* rheumatic or degenerative valvular disease
* restrictive cardiomyopathy
* evidence of myocardial ischemia
* alcohol or drug use
* malignant neoplasm
* active infection
* surgical intervention in the 3 previous months
* lactation, childbearing or childbearing potential.
* pulmonary embolism in the 6 previous months

Primary outcomes:
measure: Any cause mortality
timeFrame: 12 months after randomization
measure: Unplanned hospital admission from any cause
timeFrame: 12 months after randomization
Secondary outcomes:
measure: Cardiovascular death
timeFrame: 12 months after randomization
measure: Acute myocardial ischemia
timeFrame: 12 months after randomization
measure: Stroke
timeFrame: 12 months after randomization
measure: Symptomatic hypotension
timeFrame: 12 months after randomization
measure: Renal function
timeFrame: 12 months after randomization
measure: Peak exercise oxygen consumption
timeFrame: 12 months after randomization
measure: Quality of life
timeFrame: 12 months after randomization
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Heart Institute (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
state: SP
Study officials:
affiliation: Heart Institute (InCor) HC FMUSP
name: Edimar A Bocchi, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00848575: A Preliminary Study Utilizing a Flexible Endoscope for Pelvic Culdoscopy
Official title: A Preliminary Study Utilizing a Flexible Endoscope for Pelvic Culdoscopy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Diagnostic or Therapeutic Laparoscopy
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2009-02-20
Enrollment: 2
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Sampling method: PROBABILITY_SAMPLE
Study population: Participants will be selected from among women attending the gynecologic clinics or gynecologic oncology clinic of UAMS. Subjects from all races and ethnicities may participate. No children (aged \<18 years) are to be enrolled.

Brief summary: The culdoscopic approach will allow for equal or better visualization of female pelvic structures


Eligibility criteria: Inclusion Criteria:

* Female
* Ages 18 to 70 years old
* Ability to understand and give informed consent
* Scheduled for diagnostic or therapeutic laparoscopy for a clinical indication
* Presence of a uterus and at least one ovary at the initiation of the procedure

Exclusion Criteria:

* Documented culdesac mass
* Inability to tolerate anesthesia
* Documentation of positive urine pregnancy test
* History of prior pelvic radiation
* Scheduled for emergency laparoscopy
* Any other medical or psychiatric condition that, in the opinion of the investigative team, will interfere with the ability of the participant to safely complete the study
* History of significant non-compliance with previous therapy or unwillingness to return for follow up visits
* Prior hysterectomy and/or bilateral salpingo-oophorectomy

Primary outcomes:
measure: Visualization of female pelvic structures using a flexible endoscope and a standard laparoscope will be compared.
timeFrame: 02/2010
Secondary outcomes:
measure: Complications related to the procedures will be recorded and, if possible, attributed to one of the two techniques. If feasible, a comparison will be made between complications attributable to each approach.
timeFrame: 02/2010
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: UAMS
name: Alexander Burnett, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01978275: Stimulating Catheter for Lumbar Plexus
Official title: Are Stimulating Catheters More Efficacy for Lumbar Plexus Block Compared With Traditional Non-stimulating Ones? A Randomized, Prospective, Blinded, up and Down Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Knee Arthritis Disease
Keywords: total knee arthroplasty
lumbar plexus block
stimulating catheters
peripheral nerve blocks
Lead sponsor: ASST Gaetano Pini-CTO
Sponsor class: OTHER
First posted: 2013-11-07
Enrollment: 58
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: Stimulating catheters have been introduced to reduce the incidence of secondary failure after continuous peripheral nerve blocks, but they effectiveness over traditional nonstimulating catheters is still controversial. Furthermore no volume-response study has compared the success rates of the two techniques for continuous lumbar plexus block. The aim of this prospective, randomized, blinded study is to detect if stimulating catheters decrease the minimal effective volume (MEAV) of 1.5% mepivacaine required for successful lumbar plexus block (LPB) in 50% of patients compared with conventional non-stimulating catheters.


Eligibility criteria: Inclusion Criteria:

* patients undergoing total knee arthroplasty

Exclusion Criteria:

* diabetes
* coagulation disorders
* allergy to local anesthetic

Primary outcomes:
measure: minimum effective anesthetic volume in 50% of patients
timeFrame: thirty minutes after local anesthetic injection
Secondary outcomes:
measure: morphine requirement
timeFrame: intraoperatively
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Istituto Ortopedico G. Pini
state: Milano
Study officials:
References:
Clinical trial NCT00860275: Drug-Drug Interaction (DDI) w/Ketoconazole or Fluconazole
Official title: A Study of the Effect of Concomitant Administration of Ketoconazole or Fluconazole on the Pharmacokinetics of BMS-708163 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer Disease
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2009-03-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to determine if the concomitant administration of either ketoconazole or fluconazole with BMS-708163 will affect the PK of BMS-708163 and to assess safety and tolerability of BMS-708163


Eligibility criteria: Inclusion Criteria:

* Healthy male and postmenopausal female subjects 18-55 yrs old inclusive

Exclusion:

* Premenopausal women

Primary outcomes:
measure: PK profile of BMS-708163
timeFrame: Within 14 days after dose
Secondary outcomes:
measure: Safety and tolerability of BMS-708163 when administered alone and with either ketoconazole or fluconazole
timeFrame: During the entire study period
Other outcomes:
Locations:
city: Austin
country: United States
facility: Ppd Development, Lp
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT03938675: Early Use of Raw Milk and Breastfeeding Continuation
Official title: Early Use of Mother's Own Raw Milk, Maternal Satisfaction, and Breastfeeding Continuation in Hospitalised Neonates: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breastfeeding Continuation
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-05-06
Enrollment: 516
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Neonates male or female admitted between April 2012 andJune 2013, who were intended to be breastfed and remained hospitalized for 7 days or more.

Brief summary: BACKGROUND:

Despite the critical importance of breast milk for preterm and sick neonates, there is no consensus regarding the use of raw mother's own milk (MOM) in neonatal units.

OBJECTIVES:

This study aimed to describe the use of raw MOM in hospitalised neonates before day 7 (early use), and to investigate: (i) related factors, (ii) maternal satisfaction, and (iii) the association with breastfeeding continuation.

METHODS:

This prospective cohort included 516 neonates intended to be breastfed in 2 French neonatal units. Neonates receiving raw MOM before day 7 were compared to those who did not. The association between early use of MOM and breastfeeding continuation at hospital discharge, and up to 6 months later, was measured by logistic regression.


Eligibility criteria: Inclusion Criteria:

* Eligible neonates were those admitted between April 2012 and June 2013, who were intended to be breastfed and remained hospitalized for 7 days or more.

Exclusion Criteria:

* Neonates with parents not fluent in French were excluded.

Primary outcomes:
measure: Change in breastfeeding after hospital discharge
timeFrame: On Day 60 and Day 180 after hospital discharge
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hospices Civils de Lyon
name: Sophie Laborie, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00799175: Local Infiltration Analgesia Following Total Knee Arthroplasty
Official title: Local Infiltration Analgesia With Ropivacaine, Ketorolac and Epinephrine Intra- and Postoperatively in Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: Postoperative pain
Local infiltration analgesia
Knee arthroplasty
Lead sponsor: Region Örebro County
Sponsor class: OTHER
First posted: 2008-11-27
Enrollment: 48
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary aim of this study is to evaluate if intra- and postoperative administration of ropivacaine, ketorolac and epinephrine into the operating field would affect morphine consumption. Secondary end-points are hospital stay, pain intensity and side effects. In an attempt to assess the safety of this technique, knee function and patient satisfaction scores are assessed up to 3 months after surgery.

Detailed description: Postoperative pain is often severe following knee arthroplasty. Recently, a local infiltration analgesia (LIA) technique was developed by Drs Kerr and Kohan in Sydney, Australia. With this LIA-technique, a long-acting local anesthetic (ropivacaine), a nonsteroidal anti-inflammatory drug (ketorolac), and epinephrine are infiltrated intraoperatively and via an intraarticular catheter postoperatively. We ahve completed a study on unicompartmental knee arthroplasty and the present study is investigating total knee arthroplasties.

The primary aim of this study is to evaluate if intra- and postoperative administration of ropivacaine, ketorolac and epinephrine into the operating field would affect morphine consumption. Secondary end-points are hospital stay, pain intensity and side effects. In an attempt to assess the safety of this technique, knee function and patient satisfaction scores are assessed up to 3 months after surgery.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for total knee arthroplasty
* Aged 20-85 yrs
* ASA physical status I-III and mobility indicating normal postoperative mobilization

Exclusion Criteria:

* Known allergy or intolerance to one of the study drugs
* Serious liver-, heart- or renal decease
* Rheumatoid arthritis
* Chronic pain or bleeding disorder

Primary outcomes:
measure: Morphine consumption
timeFrame: 0-48 hours
Secondary outcomes:
measure: hospital stay, pain intensity, side effects, knee function and patient satisfaction scores
timeFrame: 0-3 months
Other outcomes:
Locations:
city: Orebro
country: Sweden
facility: University Hospital Orebro
city: Orebro
country: Sweden
facility: University Hospital Orebro
Study officials:
affiliation: University Hospital Orebro, Sweden
name: Kjell Axelsson, Prof
role: PRINCIPAL_INVESTIGATOR
References: