louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01123759: Healthful Seafood Consumption for Sensitive Populations
Official title: Consuming Fish to Reduce Mercury Intake While Optimizing Omega-3 Fatty Acid Status
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Brain Health
Keywords: Fish
mercury
omega-3 fatty acids
infant
brain development
pregnancy
nursing mother
dietary recommendations
Hair mercury
Blood mercury
Recommendations for pregnant or nursing women
Infant brain health
Lead sponsor: Purdue University
Sponsor class: OTHER
Collaborators: name: Florida A&M University
First posted: 2010-05-14
Enrollment: 71
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Fish can provide pregnant women with omega-3 fatty acids for fetal brain development but some fish contains high levels of mercury which is detrimental to fetal brain development. The hypothesis is that women who have previously consumed high mercury fish can reduce the mercury level in their bodies and improve their omega-3 levels in three months by eating fish that is high in omega-3 fatty acids and low in mercury.

Detailed description: Exposure to methylmercury, a developmental toxicant found primarily in fish. Fish is nutritionally important for providing long chain omega-3 fatty acids that are important for perinatal health. Since maternal transfer of mercury and omega-3 fatty acids are the primary routes for fetal (placental transfer) or infant (maternal milk) exposure, there is a critical need to develop specific advice for childbearing-aged women based upon the 2004 Dietary Guidelines Advisory Committee's recommended intake i.e., consume 8 ounces of fish per week. This clinical trial investigates whether weekly consumption of selected fish species for 12 weeks can improve plasma concentrations of the omega-3 fatty acids (eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)) while reducing hair or blood mercury concentrations.

Eligibility criteria: Inclusion Criteria:

* Hair mercury levels equal to or greater than 0.8 ppm

Exclusion Criteria:

* Pregnant or planning to become pregnant in the next 3 months
* Nursing

Primary outcomes:
measure: Hair Mercury
timeFrame: 3 months
Secondary outcomes:
measure: Blood mercury concentration
timeFrame: 3 months
measure: Blood omega-3 fatty acid concentrations
timeFrame: 3 months
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Florida A&M University
state: Florida
city: West Lafayette
country: United States
facility: Purdue University, Department of Foods and Nutrition
state: Indiana
Study officials:
affiliation: Purdue University, Department of Foods and Nutrition
name: Charles Santerre, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01548859: Comparison of the Effects of Sevoflurane and Midazolam Used for the Maintenance of Anaesthesia on the Levels of Postoperative Cardiac Troponin I in Pediatric Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Myocardial Injury
Anaesthetic Preconditioning
Keywords: Myocardial protection
Myocardial injury
Anaesthetic preconditioning
Pediatric cardiac surgery
Troponin I
Sevoflurane
Midazolam
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2012-03-08
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to compare two different anaesthetic agent effect on postoperative Troponin I levels in pediatric cardiac surgery


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for elective pediatric surgery
* Patients written informed consent for study participation

Exclusion Criteria:

* Redo surgery
* History of myocarditis
* Renal failure
* Pulmonary embolism
* Hypothyroidism

Primary outcomes:
measure: myocardial protective effect of sevoflurane
timeFrame: postoperative 48 hours
Secondary outcomes:
measure: Hemodynamic and respiratory data
timeFrame: Postoperative 48 hours
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Baskent University, Faculty of Medicine
state: Çankaya
Study officials:
References:
Clinical trial NCT00242359: A Pilot Study Investigating the Effect of Omalizumab (Xolair) in Work-Related Animal Induced Asthma
Official title: A Pilot Study Investigating the Effect of Omalizumab (Xolair) in Work-Related Animal Induced Asthma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Allergy Induced Asthma
Lead sponsor: Bernstein Clinical Research Center
Sponsor class: OTHER
First posted: 2005-10-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Management of animal induced occupational asthma is mainly avoidance, but this is not feasible for many occupations. Treatment with avoidance and conventional treatment is also not always successful. Omalizumab is FDA approved for the treatment of allergic asthma and may be effective at reducing symptoms and disease progression in the animal handlers population.


Eligibility criteria: Inclusion Criteria:

1. ages 18-65
2. occupation that involves close contact with animals
3. stable dose of ICS for 30 days
4. Skin test positive to one or more animals
5. evidence of asthma on spirometry
6. demonstrate PEFR variability-

Exclusion Criteria:

1. on allergen immunotherapy
2. on prohibited medications
3. unstable asthma
4. recent URI
5. known hypersensitivity to omalizumab-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00018759: Treatment Effects on Platelet Calcium in Hypertensive and Depressed Patients
Official title: Treatment Effects on Platelet Calcium in Hypertensive and Depressed Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Depression
Hypertension
Keywords: Serotonin, Hypertension, Depression
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: SmithKline Beecham
First posted: 2001-07-05
Sex: MALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to determine if treatment with an SSRI antidepressant medication, paroxetine, is associated with cellular calcium response to serotonin, platelet serotonin receptors, and improvement in mood in depressed patients with or without hypertension. It is hypothesized that platelets of hypertensive patients with depressive symptomatology with be hyper-responsive to serotonin. Additionally, treatment with an SSRI antidepressant is expected to produce a down-regulation of the serotonin receptor with an associated reduction in platelet cytosolic calcium response as well as improved mood.


Eligibility criteria: Subjects for all study groups will be male and between the ages of 25 and 65

Hypertension \& Depression Group: Hypertension controlled with an ACE-inhibitor anti-hypertensive; no co-morbid medical conditions known to influence psychological functioning or platelet calcium responses including uncontrolled diabetes, MI or CVA within 6 months of enrollment, secondary hypertension; depression as diagnosed by structured interview and HDRS score of 18; no active participation in another clinical trial; no current suicidal/ homicidal ideation

Hypertension Group: Hypertension controlled with an ACE-inhibitor anti-hypertensive; no co-morbid medical conditions known to influence psychological functioning or platelet calcium responses including uncontrolled diabetes, MI or CVA within 6 months of enrollment, secondary hypertension; no active participation in another clinical trial; no current suicidal/ homicidal ideation

Depression Group: No co-morbid medical conditions known to influence psychological functioning or platelet calcium responses including uncontrolled diabetes, MI or CVA within 6 months of enrollment, secondary hypertension; depression as diagnosed by structured interview and HDRS score of 18; no active participation in another clinical trial; no current suicidal/ homicidal ideation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hines
country: United States
facility: Edward Hines Jr. Hospital
state: Illinois
Study officials:
References:
Clinical trial NCT01191359: Efficacy and Tolerability of Two Different Administration Routes With SLITonePLUS Birch
Official title: A Multicentre Randomised Phase II Clinical Pilot Study to Compare the Pharmacodynamic Efficacy and Tolerability of the Sublingual and the Vestibular Administration Route for SLITonePLUS® Birch
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Allergy
Lead sponsor: ALK-Abelló A/S
Sponsor class: INDUSTRY
First posted: 2010-08-30
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Multicentre Phase II trial, comparing two different administration routes of SLITonePLUS Birch in regard to pharmacodynamic efficacy and tolerability.


Eligibility criteria: Inclusion Criteria:

* A history of Birch pollen allergy
* Positive skin prick test to birch
* Positive specific IgE to birch

Exclusion criteria:

* Uncontrolled or severe asthma (FEV1\<70% of predicted value in spite of adequate pharmacologic treatment)
* Previous treatment by immunotherapy with birch or a cross-reactingtree pollen allergen within the previous 5 years
* Concomitant SLIT with any allergen

Primary outcomes:
measure: Pharmacodynamic efficacy of two different administration routes of SLITonePLUS Birch
timeFrame: after 4, 8, 12, 24, 36 weeks of treatment
Secondary outcomes:
measure: Comparison of the two administration routes with regard to safety aspects
timeFrame: 36 weeks
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: Universitätsklinik Bonn, Dermatology
Study officials:
affiliation: Universitäsklinik Bonn, Dermatology
name: Thomas Bieber, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04029259: Pre- and Post-operative Brain MRI in Carotid Endarterectomy
Official title: Evaluation of Pre- and Post-operative Brain MRI in Carotid Endarterectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carotid Artery Stenoses
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2019-07-23
Enrollment: 320
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 referred to the Department of Vascular Surgery at Oslo University Hospital for carotid endarterectomy. International guidelines on indications for surgery are followed, and the majority of the patients have symptomatic carotid stenosis occluding \> 70% of the lumen of the internal carotid artery. Patients characteristics and indications for surgery are registered

Brief summary: Patients undergoing carotid endarterectomy in the Department of Vascular Surgery at Oslo University Hospital are consecutively included in this evaluation og pre- and postoperative brain MRI.

Detailed description: Patients undergoing surgery for carotid stenosis in our Department are examined by brain MRI before and after carotid surgery to evaluate the rationale for the MRI. Brain lesions on MRI before and after carotid surgery are registered, and related to clinical findings. The purpose of the study is to evaluate whether brain MRI in relation to carotid endarterectomy gives additional information to clinical findings, and to CT scan of the brain.

Eligibility criteria: Inclusion Criteria:

* Indication for carotid surgery

Exclusion Criteria:

* Contraindications to MRI

Primary outcomes:
measure: Brain lesions on MRI
timeFrame: 30 days
Secondary outcomes:
measure: Time from Transient Ischemic Attack (TIA) or minor stroke to surgery
timeFrame: Days before surgery, maximum 6 months
Other outcomes:
measure: Complications to carotid surgery
timeFrame: Within 30 days after surgery
Locations:
Study officials:
affiliation: Oslo University Hospital, Dep. of Vascular Surgery
name: Toril Rabben, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04268459: Estimation of Benefit From Regular Versus Leakage-related Exchange of Voice Prosthesis in Patients Post Laryngectomy.
Official title: Estimation of Benefit From Regular Versus Leakage-related Exchange of Voice Prosthesis in Patients Post Laryngectomy Considering Complications Rate, Fistula Colonization by Candida Species and Patients Satisfaction Feedback.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Laryngectomy
Voice
Prosthesis Failure
Keywords: voice prosthesis, laryngectomy, complications
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2020-02-13
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial
Primary purpose: PREVENTION

Brief summary: The tracheoesophageal voice with voice prosthesis is currently the mainstay of voice rehabilitation post laryngectomy. The primary surgical technique of tracheoesophageal fistula formation with insertion of prosthesis and quick and easy process of voice rehabilitation are main encouraging factors. However, the usage of the prosthesis relates to a significant number of complications rated from 10 to 60%. The most common reported complication is transprosthetic leakage that determines the need of device exchange. However in some patients occur more serious complications eg. periprosthetic leakage, granulation or atrophy of mucosa around the fistula, dislocation of prosthesis, that may require anti-inflammatory treatment, temporary nasogastric tube feeding or surgical procedure. The standard protocol is voice prosthesis exchange due to transprosthetic leakage. Optionally the device could be replaced regularly to prevent both transprosthetic leakage and other complication occurrence.

In the study we plan to compare the benefits from regular (each three month) versus leakage-related exchange of voice prosthesis post laryngectomy including the rate of complications, fistula colonization by Candida species and patients feedback.


Eligibility criteria: Inclusion Criteria:

* patients post laryngectomy with primary insertion of voice prosthesis

Exclusion Criteria:

* patients post laryngopharyngectomy with digestive tract reconstruction with jejunum of free flap

Primary outcomes:
measure: Comparison of complications rate.
timeFrame: Control will be continued for 12 months post laryngectomy.
Secondary outcomes:
measure: Fistula colonization with Candida species.
timeFrame: Control will be continued for 12 months post laryngectomy.
measure: Prosthesis replacement scheme and patient satisfaction.
timeFrame: Control will be continued for 12 months post laryngectomy.
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Department of Otorhinolaryngology, Head andNeck Surgery of Medical University of Warsaw
Study officials:
affiliation: Medical University of Warsaw
name: Anna Rzepakowska, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04355559: The Value of Diaphragmatic Ultrasound in Non-invasive Oxygen Therapy
Official title: Department of Pulmonary & Critical Care Medicine, Chinese PLA General Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diaphragm Ultrasound
Intensive Care Unit
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2020-04-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients older than 18 years without Invasive mechanical ventilation when entering the intensive care unit.

Brief summary: In this study, a single-center, prospective, observational study was adopted to set the cut-off values of diaphragmatic ultrasound results and arterial blood gas results，with the choice of non-invasive oxygen therapy as the gold standard,so as to evaluate the diagnostic value of diaphragmatic ultrasound in the selection of non-invasive oxygen therapy.

Detailed description: 1. the cut-off values of diaphragmatic ultrasound results and arterial blood gas results were established by the selection results of non-invasive oxygen therapy of 120 patients in the intensive care unit and using receiver operating Characteristic curve.

diaphragm excursion，inspiratory time，diaphragm contraction velocity，diaphragm excursion time

Eligibility criteria: Inclusion Criteria:

* patients older than 18 years
* without Invasive mechanical ventilation when entering the intensive care unit.

Exclusion Criteria:

* have noninvasive ventilation or high flow nasal cannula contraindications
* history of neuromuscular disease chest wall deformities
* previously assessed diaphragmatic palsy
* shock or severe hemodynamic instability
* known pregnancy, and/or need for immediate endotracheal intubation

Primary outcomes:
measure: the data diaphragmatic ultrasound
timeFrame: When the intervention which is the first time to change the oxygen therapy
Secondary outcomes:
measure: Arterial blood gas analysis results
timeFrame: When the intervention which is the first time to change the oxygen therapy
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Pulmonary and Critical Care Medicine, Chinese PLA General Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT05210400: Prospectively Assessing Pain After Breast Surgery
Official title: Prospectively Assessing Pain After Breast Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pain, Postoperative
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2022-01-27
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Recruitment will depend on referral by one of the study co-investigators, at the time that they schedule a patient for axillary surgery with or without concurrent lumpectomy.

Brief summary: Reducing post-operative pain and reducing the use of opioid narcotics are independently valuable goals. Before studying newer techniques that may help us achieve these goals, we need objective data on how much pain normally occurs after breast surgery done with standard-of-care techniques. This study was designed to obtain baseline data.

Detailed description: Breast surgeons may be able to reduce post-operative pain and the need for opioid narcotics by utilizing regional anesthesia techniques (modified regional blocks) during surgery. To test this hypothesis, we need baseline (pre-intervention) data on how much pain patients experience when breast surgery is done without blocks.

In this study, we will gather data on (1.) pain pills used after surgery, and (2.) pain scores in the recovery room. This will allow us to establish how much pain normally occurs after axillary surgery (sentinel node biopsy or axillary dissection), with or without concurrent lumpectomy, done by a participating breast surgeon.

After analyzing this data, our plan is to do a second study, with a new group of patients, to assess whether there is any change in outcome after surgeons implement these new techniques.

Eligibility criteria: Inclusion Criteria:

1. Provision of signed and dated informed consent form.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Female, age 18 or older.
4. Scheduled for axillary surgery (sentinel node biopsy or axillary dissection), with or without concurrent lumpectomy.
5. Able to take oral narcotics and be willing to adhere to the prescribed regimen.

Exclusion Criteria:

1. A history of chronic pain
2. Any previously diagnosed chronic pain syndrome.
3. Prior use of narcotics, on more than 5 days in the past 3 months or 10 days in the past year.

Primary outcomes:
measure: Pain scores in recovery room
timeFrame: The day of surgery
measure: Number of narcotic pain pills used after surgery
timeFrame: Assessed approximately a week after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01431300: Dose-varied Evaluation of Ablavar-enhanced MR Angiography of the Central Veins of the Chest in Healthy Participants
Official title: Dose-varied Evaluation of Ablavar-enhanced MR Angiography of the Central Veins of the Chest in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: central veins
thorax
superior vena cava
Central vein imaging
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Lantheus Medical Imaging
First posted: 2011-09-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to assess the image quality of Ablavar-enhanced MR angiography of the central veins of the chest, and to determine whether dose reduction can be performed while maintaining image quality. This will be a prospective randomized study, in which healthy volunteers will be recruited to undergo a central veins magnetic resonance angiogram (MRA). They will receive either the FDA-approved dose or a lower dose of Ablavar. Quantitative and qualitative analysis will be performed on the images.


Eligibility criteria: Inclusion Criteria:

* healthy male or female subjects between 18-45 years of age

Exclusion Criteria:

* Pregnant and lactating females
* known renal impairment
* allergy to gadolinium-based contrast
* metallic implanted devices
* claustrophobia.

Primary outcomes:
measure: Imaging Quality Score
timeFrame: 14 weeks
Secondary outcomes:
measure: Quantitative Analysis Noise Ratios
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Charles Y Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim CY, Heye T, Bashir MR, Gebhard TA, Merkle EM. Gadofosveset-enhanced magnetic resonance angiography of the thoracic vasculature in the equilibrium phase: feasibility and impact of dose. J Comput Assist Tomogr. 2013 Sep-Oct;37(5):732-6. doi: 10.1097/RCT.0b013e318299dde9.