louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00272233: Effects of Sleep Loss on Endothelial Function and Cytokine Levels in Internal Medicine Residents
Official title: Effects of Sleep Loss on Endothelial Function and Cytokine Levels in Internal Medicine Residents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Deprivation
Keywords: Inflammation Mediators [D23.469]
Cardiovascular Physiologic Phenomena [G09.330.553]
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: National Center for Research Resources (NCRR)
First posted: 2006-01-04
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: Work requirements for medical trainees result in substantial sleep loss. Sleep loss has been associated with increased levels of certain inflammatory hormones that could have negative impact on blood vessel function. The purpose of this study is to determine the effects of sleep loss on blood hormone levels and blood vessel function in medical trainees.

Detailed description: Context: Sleep loss is associated with increased blood levels of interleukin-6 (IL-6) and C-reactive protein (CRP). Medical residents are often deprived of normal sleep during extended work shifts, but the effects of work-related sleep loss on biomarkers of vascular inflammation and function are unknown.

Objective: We sought to test the hypothesis that sleep loss during extended work shifts during medical training is associated with increased circulating levels of pro-inflammatory biomarkers and evidence of vascular dysfunction.

Design: Outcome measures were assessed after extended 30-hour work shifts and non-extended 6-hour work shifts in a single-blind, randomized crossover design.

Setting: University hospital medical intensive care unit

Patients or Other Participants: Twenty-two healthy medical residents were studied during a medical intensive care unit rotation.

Main Outcome Measure(s): Sleep related cytokines (interleukin-6 and tumor necrosis factor), serum markers of vascular inflammation (C-reactive protein), and flow-mediated dilation in the brachial artery.

Eligibility criteria: Inclusion Criteria:

* Medical resident in MICU rotation
* Non-smoker
* Body mass index \<28 kg/m2

Exclusion Criteria:

* Systolic blood pressure \>140 mmHg; Diastolic blood pressure \>90 mmHg
* Known history of diabetes mellitus, hypertension, hyperlipidemia
* Known history of acute or chronic inflammatory or infectious disease
* Known history of sleep disturbance unrelated to work
* Pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Stuart D Katz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00642187: New Version Pulmicort Turbuhaler USA Adults
Official title: A Placebo-controlled Comparison of the Efficacy and Safety of the Current US Version of Pulmicort (Budesonide) Turbuhaler and the New Version of Pulmicort Turbuhaler in Asthmatic Adults Currently Treated With Inhaled Steroids.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Asthma
Pulmicort
Turbuhaler
Budesonide
Flexhaler
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-03-24
Enrollment: 525
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: A comparison of the safety, efficacy and budesonide pharmacokinetics of the currently approved Pulmicort Turbuhaler with a new version of the inhaler, in adult patients who have asthma and are currently being treated with inhaled steroids. In addition the study evaluated the functionality of the new inhaler at the end of its intended life.


Eligibility criteria: Inclusion Criteria:

* Males and females at least 18 years old with a diagnosis of asthma (as defined by the ATS) for at least 6 months.
* To enter the run in period, subjects were also required to have the following:
* A forced expiratory volume (FEV1) in 1 second of 60% to 90% of predicted normal, airway reversibility of at least 12% and 0.20 L, use of orally inhaled corticosteroids for at least 3 months prior to the study.
* At Visit 2, subjects who met additional entry criteria related to rescue medication use and asthma symptom scores during the run in period plus visit specific FEV1 requirements were assigned to randomized treatments

Exclusion Criteria:

* Life threatening asthma, Two or more overnight hospitalisations for asthma within 1 year or any emergency room visit for asthma within 6 months of starting study.
* Use of steroid tablets or injections during the month (28 days) prior to Visit 1 and use of other asthma medicines (except rescue medication) within 2 weeks prior to the study.
* Any acute exacerbation of asthma or a respiratory tract infection within 30 days prior to the study. Subject must not smoke or have smoked within 6 months of the study.

Primary outcomes:
measure: Change from Baseline in Forced Expiratory Volume in 1 second
timeFrame: Week 2, 4 and 8, then at week 12
Secondary outcomes:
measure: Change from baseline in Forced Vital Capacity, Morning Peak Expiratory Flow, Daytime and nighttime asthma symptom scores, beta-agonist use and discontinuation rate.
timeFrame: Week 2, 4 and 8, then at week 12
measure: Incidence of Adverse Events
timeFrame: Week 2,4 and 8, then at week 12
measure: Pharmacokinetics of budesonide (AUC, maximum concentration and time to maximum concentration)
timeFrame: 6 or 12 hours post dose
Other outcomes:
Locations:
Study officials:
affiliation: AZ employee
name: Bertil Andersson
role: STUDY_DIRECTOR
affiliation: AZ employee
name: Lars-Göran Carlsson
role: STUDY_DIRECTOR
References:
Clinical trial NCT02635087: microRNAs Tool for Stratifying Stage II Colon Cancer
Official title: microRNAs Tool for Stratifying Stage II Colon Cancer:a Perspective Study of Adjuvant Chemotherapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colonic Neoplasms
Effects of Chemotherapy
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2015-12-18
Enrollment: 630
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients who had stage II colon cancer and received surgery.They agree to use miRNA tool to test their postoperative specimen.

Brief summary: The investigators discover the investigators' miRNA tool can be a useful tool to predict the patients with stage II colon who can benefit from chemotherapy.Then the investigators plan to make an observation study that may validation this tool.

Detailed description: This is an observation study. The investigators recruit patients who agree to use their postoperative specimen for miRNA tool examination and receive the investigators' follow up.Their receiving chemotherapy or not will decided by their doctors. The investigators just see whether the stratifying tool could predict prognosis.

Eligibility criteria: Inclusion Criteria:

* The informed consent has been obtained from the patient.
* With confirmed diagnosis of stage II colon cancer.
* With moderate/good ECOG health rating (PS): 0-1 score.
* The patient receive no anti-cancer treatment before primary surgery.
* The patient receive radical operation for colon cancer with negative margin.

Exclusion Criteria:

* With severe comorbidities, such as cardiovascular disease, chronic obstructive pulmonary disease, diabetes mellitus, and chronic renal dysfunction.
* With bad compliance or contraindication to enrollment.
* Pregnant woman or lactating woman.
* With contraindication to receive adjuvant chemotherapy.

Primary outcomes:
measure: DFS
timeFrame: 3 years
Secondary outcomes:
measure: OS
timeFrame: 5 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: FisrtSunYetsen
state: Guangdong
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Wu Song, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03723187: Study of Standard Maintenance Method of Intravenous Port and Post-operation Pain Analysis
Official title: Study of Standard Maintenance Method of Intravenous Port and Post-operation Pain Analysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: intravenous port
port maintenancem
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2018-10-29
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1. Cancer patients in need of chemotherapy
2. Newly accepted Port-A Implant
3. port maintenance:Catheter irrigation with 20 ml N/S,10 ml N/S sealing tube
Primary purpose: OTHER

Brief summary: Investigators deconstructed the port that removed from patients and identified there were structural weakness, old blood clot and fibrin deposits. Investigators consider the problem may be exist in maintenance. After thoroughly examination the maintenance protocol, Investigators identified the problem and try to remodel the maintenance protocol. The Goal of this study was to testify the clinical value of standard maintenance protocol.

Detailed description: A secure and easily feasible vascular access is crucial for oncology patients because of the therapeutic need. Although intravenous port has been utilized for 3 decades, catheter-related complication still remain and had to deal with. According to investigators clinical experience, investigators summarized a standard algorithm as a recommendation for intravenous sport implantation. The complication before and after standard algorithm was 20 % and 3.5 %, respectively. However, catheter related infection and malfunction still could not be avoided. If patient was identified with these 2 complications, re-intervention is needed and cancer-related therapy has to be postpone. Investigators deconstructed the port that removed from patients and identified there were structural weakness, old blood clot and fibrin deposits. Investigators consider the problem may be exist in maintenance. After thoroughly examination the maintenance protocol, investigators identified the problem and try to remodel the maintenance protocol. The Goal of this study was to testify the clinical value of standard maintenance protocol.

Eligibility criteria: Inclusion Criteria:

* Volunteer with new Port-A inserted

Exclusion Criteria:

* No

Primary outcomes:
measure: Port- A Catheter complication
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Po-Jen Ko, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chang Gung Memorial Hospital
name: Chien-Hung Chiu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05872087: Comparative Study Between Nebulised Dexmedetomidine and Nebulised Midazolam in Children Undergoing Lower Abdominal Surgeries
Official title: Comparative Study Between Nebulised Dexmedetomidine and Nebulised Midazolam in Reducing Preoperative Anxiety and Emergence Delirium in Children Undergoing Lower Abdominal Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Emergence Delirium
Anxiety Preoperative
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-05-24
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Comparative study between nebulised dexmedetomidine and nebulized midazolam in reducing preoperative anxiety and emergence delirium in children undergoing lower abdominal surgeries

Detailed description: Dexmedetomidine is widely used in children and is replacing midazolam as the drug of choice for preoperative anxiolysis and sedation. However, there are limited studies comparing nebulized route in reducing preoperative anxiety and emergence delirium in children undergoing lower abdominal surgeries

Eligibility criteria: Inclusion Criteria:

* Children aged 3-8 years
* ASA I\&II
* Undergoing lower abdominal surgeries for example hernia repair and circumcision

Exclusion Criteria:

* Children with chest infection, respiratory disease, cardiac disease
* Children with mental or physical disabilities, treatment with sedatives and anticonvulsants
* Parental refusal
* Allergy to study drugs

Primary outcomes:
measure: level of preoperative anxiety
timeFrame: 30 minutes after drug administration
measure: Incidence of emergence delirium
timeFrame: immediate postoperative
Secondary outcomes:
measure: the level of sedation
timeFrame: 30 minutes after drug administration
measure: hemodynamic changes
timeFrame: perioperative
measure: PONV
timeFrame: perioperative
measure: recovery time
timeFrame: up to 2 hours postoperative
measure: total fentanyl use
timeFrame: intraoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ainshams University
Study officials:
References:
Clinical trial NCT03078387: The Extreme Significance of Bilateral Embolic Retinal Phenomena That Can be Life Saving
Official title: Bilateral Retinal Embolic Phenomena Always Necessitates Immediate and Intensive Investigation. Careful, Documented, Ophthalmic Examination is All we Require to Initiate Life Saving Investigations.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Life Threatening Diseases
Embolic Shower
Lead sponsor: Dr. S.S. Michel Clinic
Sponsor class: OTHER
First posted: 2017-03-13
Enrollment: 2
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: any patient in which signs of bilateral retinal emboli are seen and documented (imaged).

Brief summary: This study shows how careful ophthalmic examination of two patients showed signs of simultaneous bilateral retinal emboli. Starting from this point significant, life threatening, underlying reasons were found and treated.

Detailed description: Two patients were found to have signs of simultaneous bilateral retinal emboli. One patient was asymptomatic and routine ophthalmic examination showed bilateral retinal hemorrhages and exudates close to both optic discs. This patient was on anti-coagulant treatment for atrial fibrillation. The finding of bilateral signs of retinal emboli necessitated immediate blood tests and dose adjustments of her medication.

The second case did not have general symptoms other than mild evening chills and her eye examination again was the start point of intensive investigation to find the reason of her bilateral retinal emboli. Ultrasound studies revealed a life threatening reason that was urgently treated.

Eligibility criteria: Inclusion Criteria:

* any patient who is found to have sure signs of bilateral retinal emboli.

Exclusion Criteria:

* all other bilateral retinal diseases.

Primary outcomes:
measure: The extreme significance of immediate investigation of cases of bilateral retinal emboli (non-diabetic bilateral posterior pole retinal nerve fiber or pre-retinal hemorrhages).
timeFrame: through study completion, an average of one year
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Dr. S.S. Michel Clinic
state: Alberta
Study officials:
affiliation: Dr. S.S. Michel Clinic, 214 MHC, 156 street and 87 Ave, Edmonton, AB, Canada
name: shawkat s. Michel, MD, FRCS Ed
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04635787: Vital Sensor Monitors for CV19 Detection
Official title: ICU-Grade Wearable Sensors With Novel Respiratory Biomarkers to Diagnose and Detect Pre- and Very Early Symptomatic COVID-19 Infection Using Predictive Machine Learning Algorithms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2020-11-19
Enrollment: 324
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adults and adults exposed to or diagnosed with COVID19

Brief summary: This study will monitor physical bio-markers such as heart rate, respiratory rate, and temperature to detect potential COVID-19 infections.

Detailed description: The purpose of this research is to assess the accuracy of wearable sensors at detecting and monitoring COVID-19 infections. Our small, wearable sensor can get data on your respiration, body temperature, heart rate, and blood oxygen level, which may help physicians better identify if a respiratory condition is worsening overtime. If successful, our sensor could help healthcare professionals detect early symptoms of COVID-19 respiratory infection and monitor recovery and treat people before their condition worsens significantly.

Eligibility criteria: Inclusion Criteria:

* Adults aged 18 years old or over
* Recent (within 1 week) occupational or home exposure to a newly diagnosed COVID-19 infected individual
* Able and willing to give written consent and comply with study procedures

Exclusion Criteria:

* Inability to understand instructions and follow a three step command
* The subject is pregnant, nursing or planning a pregnancy
* Inability to provide written consent
* Past confirmed COVID-19 infection with resolution of symptoms
* Past confirmed COVID-19 active infection moderate or severe symptoms

Primary outcomes:
measure: 1.Efficacy of wearable device to detect respiratory infection parameters: cough count
timeFrame: 1 year
Secondary outcomes:
measure: 2.Monitoring of respiratory infection symptoms, WURSS-11 Survey
timeFrame: Time Frame: 1 year
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
Study officials:
References:
Clinical trial NCT02875587: Cabergoline Versus Calcium Gluconate Infusion in the Prevention of Ovarian Hyperstimulation Syndrome
Official title: Cabergoline Versus Calcium Gluconate Infusion in the Prevention of Ovarian Hyperstimulation Syndrome. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: OHSS
Keywords: OHSS
Infertility
Cabergoline
Calcium gluconate
IVF-ET
Lead sponsor: Aljazeera Hospital
Sponsor class: OTHER
First posted: 2016-08-23
Enrollment: 170
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to compare the efficacy of calcium gluconate infusion versus cabergoline in the prevention of ovarian hyperstimulation syndrome (OHSS) in patients pretreated with GnRH agonist long protocol who are at high risk for OHSS.

Detailed description: Ovarian hyperstimulation syndrome (OHSS) is a serious complication of assisted reproduction.

Previous studies revealed that calcium gluconate infusion reduced the risk of OHSS. Other studies revealed that cabergoline (potent dopamine receptor agonist on D2 receptors)was effective in preventing OHSS.

The aim of this study is to compare the efficacy of calcium gluconate infusion versus cabergoline in the prevention of ovarian hyperstimulation syndrome (OHSS) in patients pretreated with GnRH agonist long protocol who are at high risk for OHSS.

Eligibility criteria: Inclusion Criteria:

* Patients who are stimulated using the long luteal GnRH agonist protocol and at high risk for developing OHSS \[have more than 18 follicles (\> 11mm) and serum estradiol ≥ 3000 pg/ml on the day of HCG administration\].

Exclusion Criteria:

* Fibrosis of lung
* Swelling or inflammation around the heart or lung
* Hypertension
* Liver disease
* Heart valve disease and allergy to cabergoline or ergot derivatives.

Primary outcomes:
measure: Moderate or severe ovarian hyperstimulation syndrome
timeFrame: Within 4 weeks of HCG adminstration
Secondary outcomes:
measure: The Number of Participants Who Achieved Ongoing Pregnancy
timeFrame: 18 weeks after embryo transfer
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Aljazeera hospital
city: Giza
country: Egypt
facility: Riyadh Fertility and Reproductive Health center
Study officials:
affiliation: Aljazeera( Al Gazeera) hospital
name: Usama M Fouda, M.D,PhD
role: STUDY_CHAIR
References:
citation: Gurgan T, Demirol A, Guven S, Benkhalifa M, Girgin B, Li TC. Intravenous calcium infusion as a novel preventive therapy of ovarian hyperstimulation syndrome for patients with polycystic ovarian syndrome. Fertil Steril. 2011 Jul;96(1):53-7. doi: 10.1016/j.fertnstert.2011.04.094. Epub 2011 May 31.
Clinical trial NCT03546387: Determining Whether Multiple Anesthesia Exposures Affect Cognitive Function for Retinoblastoma Patients
Official title: Incidence of Neurocognitive Deficits in Patients After Treatment for Retinoblastoma With Multiple Anesthesia Exposures
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pediatric Retinoblastoma
Retinoblastoma
Keywords: 18-126
Memorial Sloan Kettering Cancer Center
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2018-06-06
Enrollment: 75
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pediatric patients with retinoblastoma, between 6 and 16 years of age, at MSK.

Brief summary: The purpose of this study is to see if there is a difference between the development of the brain (neurodevelopment) in children who have been treated for retinoblastoma with multiple anesthetic exposures, compared with brain development in children who have never had anesthesia.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 6 and \< 17 years old

Exclusion Criteria:

* Diagnosis of any secondary disease associated with developmental delay
* History of second cancer diagnosis
* Legal Blindness
* Past surgery of any type, with the exception of enucleation for retinoblastoma
* Past exposure to anesthesia for purposes other than retinoblastoma examination
* More than one anesthesia encounter before diagnosis at MSK
* Past External Beam Radiation for treatment of retinoblastoma
* Past systemic chemotherapy
* Non-native speaker of English; however, children whose parents speak only Spanish will be included, because the tests for parents are available in Spanish

Primary outcomes:
measure: Comparing scores in neuropsychological testing results
timeFrame: 6 weeks
Secondary outcomes:
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: Vittoria Arslan Carlon, MD
role: PRINCIPAL_INVESTIGATOR
References: