louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02048657: The Effectiveness of Foley Airway Stylet Tool on Proseal LMA Insertion
Official title: The Efficiency of ProSeal Laryngeal Mask Airway Insertion: Compared the Techniques of Foley Airway Stylet Tool With Introducer-Tool
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia Insertion Complication
Airway Morbidity
Keywords: LMA, Foley Airway Stylet Tool (FAST), introducer-tool (I-Tool)
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2014-01-29
Enrollment: 140
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Due to its soft cuff easily folded to impede ProSeal LMA insertion, many tools are developed. The aim of the study is to investigate the efficiency of ProSeal LMA insertion guided by a soft, direct optical Foley airway stylet tool (FAST) and compared with the standard introducer-tool (I-Tool).


Eligibility criteria: Inclusion Criteria:

1. patients with American Society of Anesthesiologists physical status I-II
2. aged 20-65 years
3. requiring LMA Intubation under general anesthesia
4. unlimited mouth open
5. unlimited neck motion

Exclusion Criteria:

1. mouth open \< 3 cm
2. limited neck motion
3. BMI≧35 kg/m2

Primary outcomes:
measure: Number of participants with successful airway establishment
timeFrame: half an hour
Secondary outcomes:
measure: postoperative sore throat
timeFrame: 2 days
measure: hoarseness
timeFrame: 2 days
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
Study officials:
affiliation: Department of anesthesiology, Kaohsiung Medical University, Taiwan
name: Kuang I Cheng, MD, PhD.
role: STUDY_DIRECTOR
References:
citation: Chen MK, Hsu HT, Lu IC, Shih CK, Shen YC, Tseng KY, Cheng KI. Techniques for the insertion of the ProSeal laryngeal mask airway: comparison of the Foley airway stylet tool with the introducer tool in a prospective, randomized study. BMC Anesthesiol. 2014 Nov 18;14:105. doi: 10.1186/1471-2253-14-105. eCollection 2014.
Clinical trial NCT00294957: Psychological and Physiological Status of Former Prisoners of War
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: PTSD
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2006-02-22
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Time perspective: RETROSPECTIVE

Brief summary: Assessing the psychological and physiological status of Israeli former prisoners of war (POW).


Eligibility criteria: Inclusion Criteria:

* Former POW

Exclusion Criteria:

* Was not defined

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat-Gan
country: Israel
facility: Chaim Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Joseph Zohar, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02610426: Whole Exome Sequencing in Finding Causative Variants in Germline DNA Samples From Patients With Congestive Heart Failure Receiving Therapy for Breast Cancer
Official title: Exploratory Next Generation Sequencing to Identify Causative Variants for Therapy-Induced Congestive Heart Failure From Breast Cancer Study E5103 Germline DNA Samples
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Carcinoma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2015-11-20
Enrollment: 162
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with breast cancer enrolled on E5103 with or without congestive heart failure.

Brief summary: This research trial studies whole exome sequencing in finding causative variants in germline deoxyribonucleic acid (DNA) samples from patients with congestive heart failure receiving therapy for breast cancer. Studying samples of germline DNA in the laboratory from patients with congestive heart failure receiving therapy for breast cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to congestive heart failure.

Detailed description: PRIMARY OBJECTIVES:

I. To identify, using next generation sequencing, rare variants of large effect size that impact the risk of congestive heart failure (CHF) in patients from the clinical trial ECOG-5103 (E5103).

OUTLINE:

Previously collected germline DNA samples are analyzed via whole exome sequencing.

Eligibility criteria: Inclusion Criteria:

* European American patients with DNA available
* European American patients who developed CHF and patients who did not develop CHF following a full course of treatment with an anthracycline and bevacizumab
* African American cases (based on a drop in left ventricular ejection fraction \[LVEF\] \< 50 or a drop from baseline \> 20 points) and African American controls

Primary outcomes:
measure: Identification of rare coding variants of large effect that predict the risk of CHF
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Eastern Cooperative Oncology Group
state: Massachusetts
Study officials:
affiliation: Eastern Cooperative Oncology Group
name: Bryan P Schneider
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01367626: Bioequivalency Study of Letrozole 2.5 mg Tablets Under Fed Conditions
Official title: A Single Dose, 2-Period, 2-Treatment 2-Way Crossover Bioequivalency Study of Letrozole Tablets Under Fed Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Cancer
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2011-06-07
Enrollment: 28
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was to prove the bioequivalence of Letrozole Tablet under fed conditions.


Eligibility criteria: Inclusion Criteria:

- No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to letrozole or any comparable or similar product.

Primary outcomes:
measure: bioequivalence determined by statistical comparison Cmax
timeFrame: 31 days
Secondary outcomes:
Other outcomes:
Locations:
city: Fargo
country: United States
facility: PRACS Institute, Ltd.
state: North Dakota
Study officials:
affiliation: PRAC Institute, Ltd.
name: Alan K Copa, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03036826: Computer-based Dosage Calculation for Antibiotics
Official title: Computer-basierte Dosierungsregime Von Antiinfektiva Bei eingeschränkter Nierenfunktion Und Kontinuierlichen Nierenersatztherapieverfahren (Computer-based Dosage Calculation for Antibiotics in Patients With Impaired Renal Function or Renal Replacement Therapy)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Acute Kidney Insufficiency
Anti-Infective Agent Toxicity
Keywords: renal replacement therapy
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2017-01-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: critically ill patients with impaired renal function and antiinfective therapy

Brief summary: Adequate dosing of antiinfective therapy in critically ill patients with impaired or lost renal function or continuous renal replacement therapy is nearly impossible without measuring the drug concentration in blood samples. In many hospitals that is still not an option. The investigators aim to show, that computer based calculation can avoid over- or under-dosing.

Detailed description: Adequate dosing of antiinfective therapy in critically ill patients is most important to improve outcome. Patients with impaired or lost renal function or continuous renal replacement therapy are hard to calculate using drug information sheets or "lists" with recommendations. It is nearly impossible to avoid drug levels that are much to low or much to high without measuring the concentration in blood samples. Since that possibility is still not available in every clinic we aim to show, how a computer based calculation can help to find the adequate dosing.

Eligibility criteria: Inclusion Criteria:

* patients requiring antiinfective therapy
* patients with impaired renal function or requiring continuous renal replacement therapy

Exclusion Criteria:

* plasmapheresis or liver replacement therapy
* renal replacement therapy with integrated CytoSorb®-Membrane
* extracorporal live support

Primary outcomes:
measure: drug levels (blood)
timeFrame: 3 days
Secondary outcomes:
measure: dosing changes
timeFrame: 3 days
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: University Hospital Tuebingen
Study officials:
affiliation: University Hospital Tuebingen
name: Stefanie Prohaska, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04546126: Positron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59 in Normal Human Subjects (Groups 2, 3 & 4)
Official title: Positron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59 in Normal Human Subjects (Groups 2, 3 & 4)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Radiotracer
Hypertension
Cholesterol
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2020-09-11
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will evaluate the feasibility of using a sub-therapeutic dose of a fluorine-18 analogue of NP-59 (\[18F\]FNP-59) to image the adrenal gland. Some participants are healthy normal subjects but have undergone interventions to manipulate hormones while other participants have known adrenal pathology.

Detailed description: Groups 2 \& 3 used hormone manipulation using information gathered from Group 1 which identified radiation dosimetry and optimal uptake time.

Group 4 (added to the study later) includes participants with known adrenal pathology. They will not have study associated hormone manipulation.

All groups will be given a radio-tracer and PET/CT scans.

The researchers believe that a fluorine-18 analogue of NP-59, \[18F\]FNP-59, would greatly improve the imaging characteristics, by providing a PET imaging cholesterol analogue with significantly improved radiation dosimetry, and improved localization / sensitivity / specificity without concern of thyroid exposure.

Eligibility criteria: Inclusion Criteria (Groups 2 \& 3):

* Participants without any known adrenal pathology as normal controls for undergoing endocrine manipulation

Exclusion Criteria (Groups 2 \& 3):

* Pregnancy
* Unable to do imaging
* Body weight greater than 400 lbs (181 Kg)
* Prisoners are not eligible
* Subjects unable to provide own consent are not eligible
* Current use of steroids, Oral contraceptives (OCP), spironolactone, estrogen, androgen, progesterone, Angiotensin-converting enzyme (ACE inhibitors)/ Angiotensin II receptor blockers (ARBs), or supplements that are hormone analogues.
* Known adrenal pathology

Inclusion Criteria (Group 4):

* Abnormal adrenal cortical hormone secretion

Exclusion Criteria (Group 4):

* Pregnant

Primary outcomes:
measure: Change in [18F]FNP-59 chemistry uptake as measured by the standardized uptake value (SUV) based gland segmentation
timeFrame: Day 0, Day 4
Secondary outcomes:
measure: PET/CT image uptake score as measured by investigator visual assessment for each volume of interest (VOI)
timeFrame: Day 4
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Grand Rapids
country: United States
facility: BAMF Health, Inc.
state: Michigan
Study officials:
affiliation: University of Michigan
name: Benjamin L Viglianti, M.D, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05434026: Chinese Colorectal Cancer Database
Official title: Chinese Colorectal Cancer Database
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colonic Cancer
Rectal Cancer
Prospective Studies
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Chao Yang Hospital
name: Peking University People's Hospital
name: Peking University Cancer Hospital & Institute
name: Peking Union Medical College Hospital
name: The First Hospital of Jilin University
name: Ruijin Hospital
name: First Hospital of China Medical University
First posted: 2022-06-27
Enrollment: 200000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: colorectal cancer patients who are suitable and willing to accept the surgery and also agree with the trial

Brief summary: 1. To establish the Chinese people's own clinical data database of colorectal cancer, reflecting the law and characteristics of colorectal cancer patients in China.
2. Based on colorectal cancer surgery, collect clinical data, especially data on clinical manifestations, complications, laboratory tests, auxiliary examinations, postoperative clinical effects, surgical complications, and colorectal cancer recurrence, so as to lead the direction of clinical practice and academic research of colorectal cancer surgery in China. It provides a certain basis for future research on colorectal cancer.
3. Provide academic consultation and data support to national health authorities.


Eligibility criteria: Inclusion Criteria:

* adenocarcinoma of the colon by biopsy
* tolerable to surgery
* be able to understand and willing to participate in this trial with signature

Exclusion Criteria:

* can not tolerate the surgery
* history of serious mental illness
* the researchers believe the patients should not enrolled in

Primary outcomes:
measure: Positive rate of circumferential resection margin (CRM) of the specimens
timeFrame: 10 days after surgery
measure: The grade score of the specimens integrity
timeFrame: 10 days after surgery
measure: The distance between lower tumor margin and the lower reaction margin
timeFrame: 10 days after surgery
measure: local recurrence rate
timeFrame: 3 years after surgery
measure: the operative time
timeFrame: 30 days after surgery
measure: postoperative hospital stay
timeFrame: 3 year after surgery
measure: the score of postoperative life
timeFrame: 6 months after surgery
measure: disease free survival rate
timeFrame: 3-year after surgery
measure: overall survival rate
timeFrame: 3-year after surgery
measure: the rate of postoperative complications
timeFrame: 30 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Zhongtao Zhang
Study officials:
References:
Clinical trial NCT00612326: Feasibility Evaluation of Magnetic Resonance Imaging and Positron Emission Tomography for Bladder Cancer Diagnosis and Staging
Official title: Feasibility Evaluation of Magnetic Resonance Imaging and Positron Emission Tomography for Bladder Cancer Diagnosis and Staging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bladder Cancer
Transitional Cell Carcinoma
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2008-02-11
Enrollment: 26
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 will be recruited through the outpatient clinics of the Departments of Urology and Medical Oncology of MSKCC.

Brief summary: The purpose of this study is to to find out if the MRI and PET scans can truly stage patients with bladder cancer. Both scans use newer ways to find out if your disease has grown beyond the bladder. The radioactive tracer used for the PET scan is called C-11 Acetate. We want to see if PET scan will be able to take a picture of the inside of your body that is better than other scans such as the CT scan and MRI. Therefore, the findings of the PET scan will be compared with other imaging studies as well as the surgical findings.


Eligibility criteria: Inclusion Criteria:

* Thirty (30) patients will be enrolled in this pilot study.
* All patients will have a clinical or histologic diagnosis of bladder cancer with active disease identified within the bladder at the time of consent and imaging.
* Patients with primary resectable lesions, and localized or regionally extensive disease will be eligible with residual disease in the bladder at the time of imaging.
* All patients will have consented to treatment at MSKCC

Exclusion Criteria:

* Prior pelvic radiation for bladder cancer
* Non-transitional cell histologies
* Patients deemed not appropriate surgical candidates
* Patients that are pregnant or lactating
* Patients that cannot tolerate being in the PET or MRI scanner for the duration of the study. Patients deemed unable to receive a contrast enhance CT will remain eligible.
* Vulnerable patients (minors, mentally retarded, prisoners, etc.)

Primary outcomes:
measure: Evaluate the logistical and technical parameters that are needed to use 11C acetate-PET, and MRI for the preoperative detection of nodal metastases in patients with invasive bladder cancer.
timeFrame: conclusion of the study
Secondary outcomes:
measure: Evaluate the logistical and technical parameters needed to use contemporary pelvic MRI for preop primary tumor staging in pts with invasive disease (>T2) through detailed comparison of MRI imaging and pathologic findings following radical cystectomy.
timeFrame: conclusion of the study
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Bernard Bochner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05358626: Seroprevalence of Infection-induced SARS-CoV-2 Antibodies (COVID-19) in Children
Official title: Seroprevalence of Infection-induced IgG Antibodies to SARS-CoV-2 in Children Seeking Medical Care in Vietnam
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: SARS-CoV-2
Seroprevalence
IgG Antibodies
Children
Vietnam
Covid-19
Lead sponsor: National Children's Hospital, Vietnam
Sponsor class: OTHER
First posted: 2022-05-03
Enrollment: 4032
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In-patient or out-patient children aged from 0 to 18 years old, who have not have not been previously diagnosed and are presumed/confirmed COVID-19 negative, have blood specimens collected for routine biochemistry tests.

Brief summary: It is unknown what proportion of children have been exposed to SARS-CoV-2 and how many have antibodies among children seeking medical care for non-Covid-19 related conditions.

The aim of this study is to identify children with IgG antibodies to SARS-CoV-2 who have not been previously diagnosed and are presumed/confirmed Covid-19 negative, then determine the level of immunity in this population which could inform further decisions about covid-19 vaccine strategies for children

Detailed description: Enrolled participants will have a survey about demographic information, history of previous suspected/confirmed Covid-19 infection or exposed to SARS-CoV-2, Covid-19 vaccination status. For participants aged less than 12 months, participants' mothers' status of Covid-19 vaccination and/or previous infection will be recorded. Participants will then complete serologic testing for SARS-CoV-2 IgG antibodies using residual plasma specimens collected/stored for routine laboratory tests on the date of enrollment. The study will characterize the prevalence of antibody positivity in this population and assess whether there is a correlation between demographic characteristics and antibodies levels.

Eligibility criteria: Inclusion Criteria:

* Age ≤ 18 years old.
* Seeking medical care at Vietnam National Children's Hospital for any condition not related to acute Covid-19
* Have not been previously diagnosed and are presumed/confirmed COVID-19 negative
* Have blood specimens collected for any routine biochemistry test on the date enrollment

Exclusion Criteria:

* Refusal to participate in this study.

Primary outcomes:
measure: The percentage of children with IgG SARS-CoV-2 antibodies in Plasma
timeFrame: 6 month
measure: Immunoglobulins (G) to SARS-CoV-2 in plasma
timeFrame: 6 month
Secondary outcomes:
measure: Measure of association between SARS-CoV-2 IgG seropositivity and characteristics
timeFrame: 6 month
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Vietnam National Children's Hospital
Study officials:
affiliation: Vietnam National Children's Hospital
name: Phuc H Phan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03279926: Preschoolers Learning and Active in PlaY
Official title: Preschoolers Learning and Active in PlaY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-09-12
Enrollment: 181
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The overall aim of this proposal is to develop and test early childhood education setting-based physical activity (PA) interventions that are innovative by using wearable technology to facilitate monitoring, feedback and motivation for physical activity across multiple levels (child, parent, educator). We posit that our intervention strategies will promote behavior changes in parents and educators, leading to greater awareness and communication about physical activity, more active play opportunities, and ultimately more physical activity for preschoolers. In the R21, we will test the acceptability, feasibility and initial efficacy of three 6 month early childhood education setting- based, multi-level interventions to promote preschoolers' PA using wearable technology and additional behavior change techniques to engage educators and parents. The results of this study will inform a larger intervention trial.


Eligibility criteria: Inclusion Criteria:

* attends preschool in a child care center participating in this study
* no physical/health restrictions on participating in physical activities

Exclusion Criteria:

* unable to participate in all physical activities

Primary outcomes:
measure: Post-intervention physical activity (children)
timeFrame: Month 6 compared to baseline
measure: Post-intervention physical activity (children)
timeFrame: Month 1 compared to baseline
Secondary outcomes:
measure: Active play opportunities at child care
timeFrame: Month 6 compared to baseline
Other outcomes:
measure: activity tracker wear
timeFrame: Month 1
measure: activity tracker wear
timeFrame: Month 6
Locations:
city: Seattle
country: United States
facility: Seattle Children's Research Institute
state: Washington
Study officials:
affiliation: Seattle Children's Hospital
name: Pooja Tandon, MD
role: PRINCIPAL_INVESTIGATOR
References: