louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05914285: Assessment of Salbutamol Effect on Arterial Oxygenation in COPD Patients During One-lung Ventilation
Official title: Assessment of Salbutamol Effect on Arterial Oxygenation in COPD Patients During One-lung Ventilation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: One-lung Ventilation
Chronic Obstructive Pulmonary Disease
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 90
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: One-lung ventilation (OLV) is essential part of anesthesia during thoracic procedures. However, OLV induces a drastic increase of intrapulmonary shunt due to maintained pulmonary perfusion through the nonventilated lung, which may result in severe hypoxemia. Although the protective mechanisms of hypoxic pulmonary vasoconstriction favorably modulate pulmonary perfusion to the ventilated lung, the effect is attenuated in patients with history of chronic obstructive pulmonary disease (COPD), which alters compliance of the pulmonary artery.

Salbutamol is a selective short-acting beta2-agonist and when inhaled during OLV, it acts selectively on the pulmonary vasculature reducing pulmonary vascular resistance of well-ventilated lung. We hypothesized that inhaled salbutamol would alleviate ventilation-perfusion mismatch during OLV of COPD patients, and aimed to assess the effects of salbutamol on oxygenation in these patients.


Eligibility criteria: Inclusion Criteria:

* Patient age 40\~80yrs, scheduled for videoscope-assisted pulmonary lobectomy
* American Society of Anesthesiologists Class III 또는 IV
* Moderate or more severe COPD according to GOLD criteria (FEV1/FVC\<70%, FEV1\<80%)

Exclusion Criteria:

* New York Heart Association class \>II
* AST level ≥100 IU/mL or ALT ≥ level 50 IU/L
* Creatinine clearance \< 30mL/min
* History of severe coronary artery occlusive disease, unstable angina, or recent myocardial infarction within 6 months
* History of pulmonary hypertension or pulmonary edema
* History of cerebrovascular accident within 3 months

Primary outcomes:
measure: PaO2 (partial pressure of arterial oxygen) to FiO2 (fraction of inspired oxygen) ratio (P/F ratio)
timeFrame: Thirty minutes after the completion of drug inhalation
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
Study officials:
affiliation: Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University Health System, Seoul, Korea
name: Young Jun Oh
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00976885: Oxygen Consumption Required by Stroke Patients During Completion of the Modified Rivermead Mobility Index (MRMI)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2009-09-15
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: stroke unit of local hospital and community groups

Brief summary: The aim of this study was to measure the oxygen consumption and peak heart rate achieved during Modified Rivermead Mobility Index (MRMI) assessment in age-matched, healthy and stroke patients, and assess the efficacy of the MRMI tasks for aerobic training in patients with stroke.


Eligibility criteria: Inclusion Criteria:

* diagnosis of hemisphere stroke
* aged fifty or above
* ambulatory with/ without walking aid
* had ability to provide informed consent and understand the evaluation procedures

Exclusion Criteria:

* brainstem and cerebellar lesion
* unconscious or drowsy
* musculoskeletal, respiratory or other disease that may limit activity of daily livings
* serious cardiovascular disease

Primary outcomes:
measure: Oxygen consumption
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Cardiopulmonary and exercise physiology laboratory, The Hong Kong Polytechnic University
Study officials:
References:
Clinical trial NCT03097185: Analysis of Graft Function Following Autologous Islet Transplantation
Official title: Analysis of Graft Function Following Autologous Islet Transplantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Pancreatitis
Keywords: pancreatitis
islet cell
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2017-03-31
Enrollment: 100
Sex: ALL
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: The study plans to enroll a total of 100 patients for this study; 85 patients who will undergo with TP-AIT and 15 patients with TP alone.

Brief summary: Analyze inflammatory markers and islet graft function through blood samples collected from subjects with chronic pancreatitis who undergo total pancreatectomy with auto islet transplantation.

Detailed description: A total of 100 subjects will be enrolled in this study; 85 subjects will be enrolled from patients who are scheduled for TP-AIT and 15 subjects will be for TP alone at Baylor University Medical Center at Dallas or Baylor All Saints Medical Center at Fort Worth. The patients who are enrolled in a clinical study, named 'A phase 2/3, multicenter, randomized, double-blind, placebo-controlled, parallel assignment study to assess the efficacy and safety of reparixin in pancreatic islet auto-transplantation (REP0112, IND# 117390)', can be enrolled in this study.

Eligibility criteria: Inclusion Criteria:

1. Patients with chronic pancreatitis and who are scheduled for TP alone or TP-AIT
2. Patients aged 18 or older
3. Patients are able and willing to attend required follow-up visits at Baylor

Exclusion Criteria:

1. Patients who are unable/unwilling to attend follow-up visits at Baylor
2. For TP-AIT subjects: Patients who have advanced stage of chronic pancreatitis. The principal investigator or co-investigators carefully review the medical charts, laboratory results and radiology department reports and determine the suitability for this study.

Primary outcomes:
measure: Analysis of graft function following autologous islet transplantation
timeFrame: One year after transplant of islet cells.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sammons Cancer Center, Baylor University Medical Center
name: Ernest E Beecherl, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00696085: Fetal Alcohol Damage Prevention Study
Official title: Prevention of Fetal Alcohol Damage Using Maternal Blood Markers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fetal Alcohol Syndrome
Substance Abuse
Keywords: fetal alcohol exposure
blood markers of alcohol use
brief intervention
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2008-06-12
Enrollment: 612
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The goal of this study was to determine whether a series of blood markers of alcohol use obtained from alcohol using pregnant women could help them to change their behavior.

Detailed description: This study involved screening pregnant women with an alcoholism screening questionnaire and obtaining blood from those women who screened positive and a subset of women who screened negative. Each woman who had blood drawn were informed of their results, educated about alcohol use in pregnancy and had a brief intervention about their alcohol use, if appropriate. They were monitored throughout the pregnancy with additional blood tests obtained, depending upon their stage in pregnancy. After birth the babies were examined for any signs of alcohol exposure.

Eligibility criteria: Inclusion Criteria:

* Pregnant women seen at one of the obstetric clinics in the study and willing to give a blood sample

Exclusion Criteria:

* over 36 week gestation

Primary outcomes:
measure: Decrease in drinking
timeFrame: during the pregnancy
Secondary outcomes:
measure: improved infant size
timeFrame: after pregnancy finished
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Lewis B Holmes, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01474785: RYGB and the Gastric Adipose Axis
Official title: RYGB Improves Metabolism by Interrupting the Gastric Adipose Tissue Axis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Keywords: Obesity
Bariatric surgery
Nashville, Tennessee
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2011-11-18
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine if interruption in gastric-adipose tissue axis signaling contributes to early improvements in oxidative stress, insulin sensitivity, and inflammation, and to determine if interruption of the stomach in RYGB results in reduction of plasma acylated ghrelin (AG) and in an altered acylated ghrelin:unacylated ghrelin (AG:UAG) ratio which may contribute to decreased oxidative stress and improved insulin sensitivity.


Eligibility criteria: PROTOCOL I

Inclusion Criteria:

* Age 18-65 years
* BMI ≥ 35 kg/m\^2
* Scheduled for bariatric surgery
* Considering bariatric surgery
* Waiting for insurance approval for bariatric surgery
* Currently not considering bariatric surgery, but otherwise eligible
* Enrollment in medical weight loss program

Exclusion Criteria:

* Smoking \>7 cigarettes per day
* Precious malabsorptive or restrictive intestinal surgery
* Pregnant or breastfeeding
* Recent history of neoplasia (5\<years ago)
* Malabsorptive syndromes
* Inflammatory intestinal disease
* Established organ disfunction
* Allergy to acetaminophen

Primary outcomes:
measure: change in glucose disposal rate
timeFrame: baseline and 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Naji Abumrad, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Flynn CR, Tamboli RA, Antoun J, Sidani RM, Williams B, Spann MD, English WJ, Welch EB, Sundaresan S, Abumrad NN. Caloric Restriction and Weight Loss Are Primary Factors in the Early Tissue-Specific Metabolic Changes After Bariatric Surgery. Diabetes Care. 2022 Aug 1;45(8):1914-1916. doi: 10.2337/dc22-0069.
Clinical trial NCT00852085: Reducing Youthful Dangerous Driving
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Injuries
Keywords: Counseling
Crime
Adolescent
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
First posted: 2009-02-26
Enrollment: 482
Sex: ALL
Minimum age (years): 16
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To examine the effectiveness of four motivational counseling groups and a directed observational experience in the emergency room in comparison to education and community volunteering only, in reducing high risk driving behaviors


Eligibility criteria: Inclusion Criteria:

* Age 16-20 years
* Court referred for driving offense
* Speak English

Exclusion Criteria:

* Age over 20 years
* Not court referred
* Not English speaking

Primary outcomes:
measure: Rates of traffic offenses
timeFrame: 12 months post intervention completion
Secondary outcomes:
measure: Self-reported high risk driving behaviors
timeFrame: 12 months post intervention completion
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04289285: Safety and Efficacy of IBI306 in Chinese Subjects With Non-familial Hypercholesterolemia
Official title: Safety and Efficacy of IBI306 in Chinese Non-familial Hypercholesterolemia Subjects at Very High or High Cardiovascular Risk: a Randomized, Double-blind and Placebo-controlled Phase III Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2020-02-28
Enrollment: 804
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: IBI306 is a fully human monoclonal antibody that binds proprotein convertase substilisin/kexin type 9 (PCSK-9), preventing its interaction with the low-density lipoprotein cholesterol receptor (LDL-R) and thereby restoring LDL-R recycling and low-density lipoprotein cholesterol(LDL-C) uptake. This study is being done to investigate the effects of IBI306 in Chinese people with non-familial hypercholesterolemia with very high or high cardiovascular risk. This study will see if IBI306 will reduce low density lipoprotein cholesterol (LDL-C) in Chinese people who are taking a certain type of lipid-lowering medication (statins with or without ezetimibe) and whether it causes any side effects

Detailed description: This is a phase 3, multicenter, double-blind, randomized, placebo-controlled study of IBI306 in Chinese non-familial hypercholesterolemia Subjects with very high or high cardiovascular risk. A total of around 600 subjects who meet admission criteria will be randomized and receive one of the two dose levels of IBI306 or matching placebo: 450mg Q4W, or 600mg Q6W. The double blind period for both groups will be 48 weeks. The study will last 52 weeks

Eligibility criteria: Inclusion criteria:

1. Males and females ≥ 18 to ≤ 75 years of age
2. Diagnosis of hypercholesterolemia
3. LDL cholesterol ≥ 70 mg/dl (1.8mmol/L)
4. Very high or high cardiovascular risk
5. TG≤500 mg/dL(5.64 mmol/L)

Exclusion criteria:

1. Diagnosis of HoFH or HeFH
2. Uncontrolled hypertension
3. Uncontrolled hyperthyroidism or hypothyroidism
4. Severe renal dysfunction
5. Known sensitivity to any of the products to be administered during dosing

Primary outcomes:
measure: Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at week 48
timeFrame: Week 48
Secondary outcomes:
measure: The percent of subjects with LDL-C reduction no less than 50% from baseline
timeFrame: Week 48
measure: The percent of subjects with LDL-C<70mg/dL(1.8 mmol/L)
timeFrame: Week 48
measure: The percent change in Lp(a),ApoB, non-HDL-c, ApoB/ApoA1 from baseline
timeFrame: Week 48
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
Study officials:
References:
Clinical trial NCT02132585: Cross-sectional Study of Use of Speckle Method in Early Diagnosis of Cardiovascular Dysfunction
Official title: Cross Sectional Study of Use of Speckle Tracking Echocardiography in the Early Diagnosis of Cardiovascular Dysfunction and Performance in Sjogren Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sjogren Syndrome
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2014-05-07
Enrollment: 700
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients enrolled from cardiovascular clinic

Brief summary: Speckle tracking (STE) is a novel echocardiographic technique which permits calculation of myocardial velocities and deformation parameters such as strain and strain rate (SR). It is demonstrated that these parameters provide important insights into systolic and diastolic function, ischaemia, myocardial mechanics and many other pathophysiological processes of the heart. In this preliminary study, we investigated the role of STE in detection of early ventricular dysfunction in patients with Sjogren Syndrome, focusing on cardiorespiratory fitness.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Sjogren Syndrome

Exclusion Criteria:

* previous cardiovascular events
* unstable angina
* stroke
* diagnosis of heart failure
* incapacity to provide an informed consent

Primary outcomes:
measure: Longitudinal Myocardial Strain reduction in Sjogren Patients
timeFrame: Baseline, 24 weeks
Secondary outcomes:
measure: Association between 6minute-walking-test and Longitudinal strain reduction
timeFrame: baseline, 24 weeks
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Galeazzi IRCCS of Milan
city: Rome
country: Italy
facility: Sapienza University
Study officials:
References:
Clinical trial NCT01552785: A Comparison of Measurements of Peripheral Tissue Oxygenation by NONIN EQUANOX 7600, INVOS 5100c, and FORE-SIGHT
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Near Infrared Spectroscopy
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2012-03-13
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Citizens of Copenhagen

Brief summary: A comparison of three different devices using near infrared spectroscopy to measure the regional oxygenation. Both absolute values, reproducibility of measurements and sensitivity to changes will be estimated. The study hypothesis is that NONIN EQUANOX 7600 with sensor Model 8004CA, INVOS 5100c with sensor SAFB-SM and FORE-SIGHT with medium sensor have similar characteristics.


Eligibility criteria: Inclusion Criteria:

* Adult
* Double skin fold less than 1 cm on the lower arm

Exclusion Criteria:

* Chronic diseases

Primary outcomes:
measure: Absolute mean value of peripheral regional tissue oxygenation (rStO2) in percent
timeFrame: 3 hours
Secondary outcomes:
measure: Reproducibility of measurement of peripheral regional tissue oxygenation (rStO2) in percent
timeFrame: 3 hours
measure: Sensitivity to changes in peripheral regional tissue oxygenation (rStO2) in percent
timeFrame: 3 hours
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
References:
Clinical trial NCT04726085: Ibuprofen Versus Indomethacin Following Emergent Cerclage Placement
Official title: Efficacy of Ibuprofen Versus Indomethacin as Perioperative Prophylactic Treatment Following Emergent Cerclage Placement for Pregnancy Prolongation: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Preterm Labor
Keywords: cerclage
Lead sponsor: Woman's
Sponsor class: OTHER
First posted: 2021-01-27
Enrollment: 100
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: Cervical insufficiency is defined as painless cervical dilation in the second trimester. Cervical insufficiency can ultimately lead to second trimester loss of pregnancy. Cerclages are utilized in pregnancies affected by cervical insufficiency in order to prolong gestational latency. There have been several studies investigating the efficacy of perioperative medications for cerclage placement and the effects they have on gestational latency. Some such studies have found that perioperative indomethacin in combination with antibiotics have significantly increased gestational latency when compared to placebo. Indomethacin has traditionally been the tocolytic of choice with cerclage placement. At our hospital, ibuprofen has been the tocolytic of choice for cerclage placement secondary to pharmacy availability. Our study aims to evaluate whether gestational latency differs among patients undergoing emergent cerclage whether they receive perioperative ibuprofen or indomethacin.


Eligibility criteria: Inclusion Criteria:

* Viable, singleton pregnancy
* ≥ 18 years old
* Gestational age 16 weeks 0/7 days - 23 week 6/7 days (inclusive)
* Intact membranes at time of enrollment
* Planning to deliver at Woman's Hospital
* Exam or ultrasound indicated cerclage placement

Exclusion Criteria:

* Contraindication to treatments (i.e. ibuprofen or indomethacin)
* Unwilling to be randomized to treatment
* Prophylactic cerclage placement
* Temperature greater than 100.4
* Known major fetal congenital anomaly
* Prior cerclage placement during the current pregnancy
* Recent (within 7 days) receipt of ibuprofen or indomethacin

Primary outcomes:
measure: Gestational latency
timeFrame: From cerclage placement to delivery
Secondary outcomes:
measure: Preterm birth
timeFrame: At delivery
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Woman's Hospital
state: Louisiana
Study officials:
affiliation: Woman's Hospital, Louisiana
name: Pamela Simmons, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00841685: The Implantation Under Echography of Fiducial Markers in the Intraprostatic Lesion and Prostate
Official title: The Implantation Under Echography of Fiducial Markers in the Intraprostatic Lesion and Prostate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: IBA, Germany
name: Hospimed, Netherland
name: Bard Ltd
First posted: 2009-02-11
Enrollment: 25
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Implantation of fiducial markers in the prostate and daily check of the positioning during radiotherapy based on the implanted fiducial markers


Eligibility criteria: Inclusion Criteria:

* histological proven adenocarcinoma of the prostate
* T1-T4 tumors
* Radiotherapy as primary therapy +/- androgen deprivation
* Presence of an intraprostatic lesion (IPL) on MRI/MRS
* Presence of an intraprostatic lesion (IPL) on ultrasound
* WHO 0-2

Exclusion Criteria:

* Other primary tumor, except non-melanoma skin cancer
* No written informed consent

Primary outcomes:
measure: Acute toxicity after implantation of the fiducial gold markers
timeFrame: 1 week after implantation
Secondary outcomes:
measure: Feasibility of insertion 1 fiducial gold marker in the intraprostatic lesion combined with extra gold markers in the rest of the prostate upto 3 goldmarkers in total
timeFrame: 1 week after implantation
measure: Visualization of the implanted gold markers by ultrasound
timeFrame: After implantation
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Gert De Meerleer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: