louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01697215: Novel Device to Assess Endotracheal Tube Migration
Official title: Novel Device (AirWave™) to Assess Endotracheal Tube Migration.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mechanically Ventilated Patients Admitted to a MICU
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2012-10-02
Enrollment: 42
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: MICU Based

Brief summary: To evaluate the ability of the SonarMed AirWave to provide clinicians with information that enables them to confirm continuous proper placement of the endotracheal tube. This initial study is prospective, observational, looking at CXR results, and comparing those to AirWave system output data.


Eligibility criteria: Inclusion Criteria

Subjects will be eligible for inclusion in the study if they meet ALL of the following criteria:

* Oral or nasal endotracheal intubation, anticipated to last at least 48 hours
* Adults that require ETT internal diameter sizes of 6.5 - 9.0 mm
* Subject must be at least 18 years old (no upper age limitation)
* English speaking patients/decision makers.

Exclusion Criteria

* Subjects ventilated through a tracheostomy
* Subjects under 18 years of age

Primary outcomes:
measure: Endotracheal Tube Displacement Bias Measured by a Novel Device (AirWave) Compared to CXR
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic Foundatin
name: Adriano Tonelli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00126815: Mathematical Modeling Analysis of Serum Prostate Specific Antigen After Radiotherapy
Official title: Mathematical Modeling Analysis of Serum Prostate Specific Antigen After Radiotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: prostate cancer
prostate specific antigen
radiotherapy
mathematical modeling
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
Collaborators: name: Cross Cancer Institute
First posted: 2005-08-05
Enrollment: 1000
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: Clinical data are being used to build a mathematical model to describe the clinical results of radiotherapy for prostate cancer.

Detailed description: Clinical data (prostate-specific antigen \[PSA\] response after radiotherapy) are being used to build a mathematical model to describe the clinical results of radiotherapy for prostate cancer.

Eligibility criteria: Inclusion Criteria:

* Prostate cancer treated with radiotherapy +/- hormones

Exclusion Criteria:

* Prostatectomy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
Study officials:
affiliation: AHS Cancer Control Alberta
name: Matthew Parliament, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00329615: Insulin Treatment in Cancer Cachexia
Official title: Insulin Treatment in Cancer Cachexia: Effects on Survival, Metabolism and Physical Functioning. A Randomized Prospective Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cancer Cachexia
Keywords: Cancer cachexia
Tumor host metabolism
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Swedish Cancer Foundation
name: Medical Research Council
First posted: 2006-05-25
Enrollment: 135
Sex: ALL
Minimum age (years): 25
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is designed to evaluate whether daily insulin treatment to weight losing cancer patients attenuates progression of cancer cachexia and improves metabolism.

Detailed description: Randomized study with long-term follow-up based on survival, health related quality of life, food intake, resting energy expenditure, body composition, exercise capacity and measurement of metabolic efficiency.

Eligibility criteria: Inclusion Criteria:

* Weight loss
* Systemic solid cancer

Exclusion Criteria:

* Diabetes
* Brain metastases
* Expectant survival of less than 6 months
* Serum creatinine above 200 umol/l
* Persistent of recurrent fever
* Cholestasis

Primary outcomes:
measure: Health related quality of life,
measure: food intake,
measure: resting energy expenditure,
measure: body composition,
measure: metabolic efficiency,
measure: spontaneous physical activity,
measure: blood and hormonal tests
measure: serum tumor markers
Secondary outcomes:
measure: Survival
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Department of Surgery, Inst of Clinical Sciences
Study officials:
affiliation: Department of Surgery, Göteborg University
name: Kent G Lundholm, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wallengren O, Bosaeus I, Lundholm K. Dietary energy density, inflammation and energy balance in palliative care cancer patients. Clin Nutr. 2013 Feb;32(1):88-92. doi: 10.1016/j.clnu.2012.05.023. Epub 2012 Jun 23.
Clinical trial NCT01489215: Interventions for Sleep Problems in Early Childhood
Official title: Interventions for Sleep Problems in Early Childhood:The Role of Child, Parental and Intervention Factors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep Disorder
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Israel Science Foundation
name: U.S. National Science Foundation
First posted: 2011-12-09
Enrollment: 180
Sex: ALL
Minimum age (years): 9
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study will inform the field about underlying mechanisms associated with infant sleep problems and will deepen the understanding of the intervention process. The study will provide detailed information on the intervention process itself and will explore how behavioral sleep interventions affect broader infant outcome.


Eligibility criteria: Inclusion Criteria:

* infants at age range 9-18 months;
* healthy infants with no significant health problems;
* two-parents families;
* parents who master the Hebrew language.
* significant sleep problem lasting more than 3 months:

Our definition for a significant sleep problem in this age range is based on meeting at least one of the following three criteria for the baseline week:

* an average of three or more night-wakings per night;
* an average wake period of at least 30 minute per night between sleep onset and morning rise time;
* more than 30 minutes to fall asleep each night with protests for attention.

Exclusion Criteria:

* Infants not meeting the inclusion criteria at the baseline assessment will be excluded from the study.

Primary outcomes:
measure: Improved infant sleep
timeFrame: base line to one month follow-up
Secondary outcomes:
measure: improvement in infant emotion regulation and in parent-infant interaction
timeFrame: one month follow-up to one year follow-up
Other outcomes:
Locations:
Study officials:
affiliation: Tel-Aviv Sourasky Medical Center
name: Yakov Sivan, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kahn M, Livne-Karp E, Juda-Hanael M, Omer H, Tikotzky L, Anders TF, Sadeh A. Behavioral interventions for infant sleep problems: the role of parental cry tolerance and sleep-related cognitions. J Clin Sleep Med. 2020 Aug 15;16(8):1275-1283. doi: 10.5664/jcsm.8488.
citation: Kahn M, Juda-Hanael M, Livne-Karp E, Tikotzky L, Anders TF, Sadeh A. Behavioral interventions for pediatric insomnia: one treatment may not fit all. Sleep. 2020 Apr 15;43(4):zsz268. doi: 10.1093/sleep/zsz268.
Clinical trial NCT00493415: The Effect of Nitroglycerine on Microcirculatory Abnormalities During Sepsis
Official title: The Evaluation of the Effect of Nitroglycerine Versus Placebo on the Microcirculation by Means of SDF Imaging in Septic Patients on the ICU
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sepsis
Septic Shock
Keywords: microcirculation
sepsis
nitroglycerine
SDF imaging
Lead sponsor: Frisius Medisch Centrum
Sponsor class: OTHER
First posted: 2007-06-28
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of nitro-glycerine on the microcirculation (smallest vessel type) in patients with severe sepsis and septic shock.

Nitro-glycerine is a well known medicine in cardiology and is used to improve circulation. In this ICU the investigators use nitro-glycerine to improve the organ perfusion; but it's no common therapy in the rest of the world. The investigators now compare nitro-glycerine and placebo by looking to the sublingual microcirculation by a small camera (SDF imaging).

Detailed description: This study starts at admission of the patient on the ICU. In the next 24 hours the patient receives nitro-glycerine or placebo (randomised). At time = 0, ½, 2, 12 and 24 hour we evaluate the microcirculation by SDF imaging and monitoring of hemodynamic parameters.

Informed consent is obtained of the relatives.

Eligibility criteria: Inclusion Criteria:

* Severe sepsis
* Proven infection
* Informed consent

Exclusion Criteria:

* Age \< 18 years
* Pregnancy
* Use of nitroglycerine within 24 hours prior to ICU admittance
* Necessity to use nitroglycerine iv for instable angina

Primary outcomes:
measure: increase of MFI by nitro-glycerine
timeFrame: 2 years
Secondary outcomes:
measure: decrease of length of stay decrease of SOFA decrease of morbidity/mortality
timeFrame: 2 years
Other outcomes:
Locations:
city: Leeuwarden
country: Netherlands
facility: Medical Centre Leeuwarden - Intensive Care Unit
Study officials:
affiliation: Frisius Medisch Centrum
name: E C Boerma, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boerma EC, Koopmans M, Konijn A, Kaiferova K, Bakker AJ, van Roon EN, Buter H, Bruins N, Egbers PH, Gerritsen RT, Koetsier PM, Kingma WP, Kuiper MA, Ince C. Effects of nitroglycerin on sublingual microcirculatory blood flow in patients with severe sepsis/septic shock after a strict resuscitation protocol: a double-blind randomized placebo controlled trial. Crit Care Med. 2010 Jan;38(1):93-100. doi: 10.1097/CCM.0b013e3181b02fc1.
Clinical trial NCT03729115: A Multi-Modality Surveillance Program for Women at High Risk for Breast Cancer
Official title: Chicago Alternative Prevention Study for Diverse Populations of High Risk Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2018-11-02
Enrollment: 400
Sex: FEMALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: This study is aimed to establish a registry of women undergoing intensive surveillance for the early detection of breast cancer in high-risk women.


Eligibility criteria: Inclusion Criteria:

- Known BRCA1 or BRCA2, TP53, PALB2, PTEN, CDH1 and STK11 carrier. Women with pathogenic mutations in any other cancer susceptibility genes are eligible only if they also have a high PRS.

OR

* With life time risk of 30% or higher, based on Polygenic Risk Score that integrates genetic and non-genetic factors OR
* 5-years risk ≥ 6% for women 40-64 OR
* 5-years risk ≥ 6% for women 65+ AND breast density C or D AND a lifetime risk \>= 20% (BCSC+PRS LTR or Tyrer-Cuzick LTR) OR
* Patients with history of chest wall radiation received before age 35. OR
* To promote health equity, women of African Ancestry \< 45 years with at least one 1st or 2nd degree relative with breast or ovarian cancer are eligible because PRS Scores are not currently reported for AA women.
* Must be at least 25 years old.
* Willing to travel to participating site for imaging studies as well as any necessary follow-up procedures.
* Be able to give informed consent.

  * Patients with prior history of breast or ovarian cancer are eligible if they have completed all active treatments and are cancer free for two years.

Exclusion Criteria

* Undergoing active cancer treatment at the time of enrollment.
* Current pregnancy or plans for pregnancy within two years of enrollment.
* Presence of a pacemaker or any other metallic foreign object in their body that interferes with an MRI.
* Breast surgery within two weeks of study entry.
* Women with history of bilateral mastectomy are not eligible
* History of kidney disease or abnormal kidney function.
* History of dye allergy unless it can be mediated with antihistamines and/or steroids

  * Women can be taking hormone replacement therapy, tamoxifen, raloxifene, aromatase inhibitors, Parp Inhibitors as adjuvant therapy or participating in a chemoprevention trial.

Primary outcomes:
measure: Development of faster MRI protocols for a for a Personalized Risk-based Imaging Surveillance Model for diverse populations of high risk women.
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University Of Chicago Medicine Comprehensive Cancer Center
state: Illinois
Study officials:
affiliation: University of Chicago
name: Olufunmilayo I Olopade, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03233815: Benefits of Total Intravenous Anesthesia Compared With Inhaled Anesthesia in Cardiovascular Surgery
Official title: Benefits of Total Intravenous Anesthesia Compared With Inhaled Anesthesia in Cardiovascular Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiovascular Surgical Procedure
Keywords: Inhaled anesthesia
Total intravenous anesthesia
Lead sponsor: Coordinación de Investigación en Salud, Mexico
Sponsor class: OTHER_GOV
First posted: 2017-07-31
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for cardiovascular surgery

Brief summary: This study compares the difference in proinflammatory markers Interleukin 6 (IL-6), Tumor necrosis factor alpha (TNFα) and cortisol in patients undergoing cardiovascular surgery to asses if there is a benefit of using intravenous total anesthesia (TIVA) over inhaled anesthesia for this procedures.

Detailed description: IL-6, TNFα and cortisol will be measure at the beginning of the cardiovascular surgery and 20 minutes after the cardiovascular bypass ends to calculate the difference between them and compare if there is any statistical difference between the proinflammatory markers with the two anesthesia techniques.

Eligibility criteria: Inclusion Criteria:

Scheduled for cardiovascular surgery American Society of Anaesthesiologists (ASA) physical status classification II-IV BMI \< 25 HbA1c \< 7%

Exclusion Criteria:

Diabetic patients Known allergy to propofol

Primary outcomes:
measure: IL-6
timeFrame: The difference between IL-6 at the begging of surgery and 20 minutes after the end of the cardiopulmonary bypass
Secondary outcomes:
measure: TNFα
timeFrame: The difference between TNFα at the begging of surgery and 20 minutes after the end of the cardiopulmonary bypass
measure: Cortisol
timeFrame: The difference between cortisol at the begging of surgery and 20 minutes after the end of the cardiopulmonary bypass
Other outcomes:
Locations:
city: Ciudad de mexico
country: Mexico
facility: Hospital de cardiología
state: Cdmx
Study officials:
affiliation: Instituto Mexicano del Seguroa Social
name: Ana Gallardo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02117115: Abdominal CT to Predict the Risk of Acute Graft-versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation
Official title: Early Post-transplant Contrast-enhanced Abdominal CT to Predict the Risk of Acute Graft-versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Myelodysplastic Syndromes
Leukemia, Myeloid, Acute
Leukemia, Myelogenous, Chronic
Multiple Myeloma
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2014-04-17
Enrollment: 21
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Contrast-enhanced abdominal CT will be performed 1-2 weeks after allogeneic stem cell transplant, and radiographic evidence of mucosal inflammation will be correlated with the subsequent development of acute graft versus host disease. The primary endpoint is the feasibility and safety of contrast-enhanced abdominal CT in the early post-transplant period, as defined by the risk of contrast-related nephropathy or allergic reaction.


Eligibility criteria: Inclusion Criteria:

* Biopsy-proven diagnosis of a hematologic malignancy
* Scheduled to undergo allogeneic SCT from a matched sibling donor or an unrelated donor who is 10/10 or 9/10 HLA match. Transplant eligibility is per standard and institutional criteria.
* Age 18-60 years
* Willing and able to provide informed consent

Exclusion Criteria:

* Documented or reported contrast allergy
* Estimated glomerular filtration rate (GFR) \< 60
* Deemed too sick by clinician to leave the floor for imaging
* "Nothing-per-mouth" status for other clinical reasons

Inclusion of Women and Minorities

-Both men and women and members of all races and ethnic groups are eligible for this trial.

Primary outcomes:
measure: Incidence of contrast related nephropathy
timeFrame: Baseline through 72 hours after intravenous contrast administration
measure: Incidence of contrast allergic reaction
timeFrame: Within 4 hours after contrast administration
Secondary outcomes:
measure: Correlation between CT risk scores and occurrence of acute GVHD
timeFrame: 180 days
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Amanda Cashen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02646215: Inspiratory Muscle Training in Ehlers Danlos Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ehlers Danlos
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2016-01-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Evaluation of the effect of inspiratory muscle training in Ehlers Danlos patients


Eligibility criteria: Inclusion Criteria:

* a diagnosis for Ehlers Danlos syndrome combining genetics and clinical examination
* no infectious exacerbation in the last four weeks

Exclusion Criteria:

* respiratory comorbidities

Primary outcomes:
measure: inspiratory muscle strength measured by sniff nasal inspiratory pressure
timeFrame: 2 minutes
Secondary outcomes:
measure: walked distance measured by six minutes walking test
timeFrame: 6 minutes
measure: lung function by spirometry
timeFrame: 5 minutes
measure: anxiety by hospital anxiety depression scale
timeFrame: 2 minutes
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Clinique universitaire Saint-Luc
Study officials:
References:
Clinical trial NCT03210415: Study on Prevention, Treatment and Mechanism of Preterm Labor for Chinese Pregnant Women ≥35 Years Old
Official title: Study on Prevention, Treatment and Mechanism of Preterm Labor for Chinese Pregnant Women ≥35 Years Old
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Preterm Labor
Keywords: Preterm Labor
China
Pregnant Women
≥35 Years Old
Lead sponsor: Ministry of Science and Technology of the People´s Republic of China
Sponsor class: OTHER_GOV
Collaborators: name: First Affiliated Hospital of Chongqing Medical University
name: Peking University Third Hospital
First posted: 2017-07-07
Enrollment: 1500
Sex: FEMALE
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Chinese pregnant women ≥ 35 years old with spontaneous preterm birth between 28-37 weeks of gestation.

Brief summary: In China, there's no effective prevention and treatment on preterm birth for pregnant women ≥35 years old, so this study is necessary.

Detailed description: Because the policy of "Two-child" in China, there are more and more women more than 35 years old choose to have another baby. It is necessary to find out a way to prevent them who is older than 35 from preterm labor. About 1500 pregnant women will be recruited at about gestational age of 14 weeks for this study. All of them will be taken samples (i.e. blood, hair, cervical secretion ) to be saved before and after delivery. After all data collected, the investigators will do analysis of all data and find out strategy and mechanism of preterm labor.

Eligibility criteria: Inclusion Criteria:

* Chinese pregnant women ≥ 35 years old

Exclusion Criteria:

* twins or multiple pregnancies, indicated preterm birth, \<35 years old, gestational ages ≥ 37 weeks, incomplete data of prenatal care。

Primary outcomes:
measure: Morbidity of Preterm birth
timeFrame: 1 years
Secondary outcomes:
measure: Social Burden
timeFrame: 1 years
measure: Morbidity of Chorioamnionitis
timeFrame: 1 years
measure: Respiratory distress syndrome, ischemic hypoxic encephalopathy, necrotizing enterocolitis, various infections
timeFrame: 1 years
measure: Cerebral palsy, chronic lung disease, blindness caused by retinopathy, auditory nerve abnormalities, mental retardation
timeFrame: 1 years
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The First Affilliated Hospital of Chongqig Medical University
state: Chongqing
Study officials:
affiliation: First Affiliated Hospital of Chongqing Medical University
name: Hongbo bo Qi, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Blencowe H, Cousens S, Oestergaard MZ, Chou D, Moller AB, Narwal R, Adler A, Vera Garcia C, Rohde S, Say L, Lawn JE. National, regional, and worldwide estimates of preterm birth rates in the year 2010 with time trends since 1990 for selected countries: a systematic analysis and implications. Lancet. 2012 Jun 9;379(9832):2162-72. doi: 10.1016/S0140-6736(12)60820-4.