louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00155090: Proton Magnetic Resonance Spectroscopy of Normal Breast Tissues in Women Volunteers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Neoplasms
Keywords: Magnetic resonance imaging,
breast disease
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 80
Sex: FEMALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: Magnetic resonance spectroscopy (MRS) is a diagnostic technique in MRI that distinguishes various metabolites on the basis of their slightly different chemical shifts or resonance frequencies. The Proton is the most abundant nucleus in the body. We will try to establish the typical proton MRS pattern of normal women breasts to be a guideline for future further investigations.

Detailed description: There are few reports regarding proton MRS in normal female breasts. The fibroglandular tissues and fat are the two major gross components in the breast. The water content in the fibroglandular tissues is much higher than that in the fat. There is still no documented report discussing proton MRS in normal female breasts of premenopausal and postmenopausal women. Our study is to evaluate the proton MRS findings among normal premenopausal and postmenopausal women breasts, to find out if there are statistical differences on the main proton MRS patterns, water and lipid peak intensities and ratios between the two groups.

Eligibility criteria: Inclusion Criteria:

* women age ranged 30 years of age or older, with normal mammograms or ultrasound in recent 3 months

Exclusion Criteria:

* any women not fulfilling the inclusion criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Jane Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kvistad KA, Bakken IJ, Gribbestad IS, Ehrnholm B, Lundgren S, Fjosne HE, Haraldseth O. Characterization of neoplastic and normal human breast tissues with in vivo (1)H MR spectroscopy. J Magn Reson Imaging. 1999 Aug;10(2):159-64. doi: 10.1002/(sici)1522-2586(199908)10:23.0.co;2-0.
Clinical trial NCT05173090: Influence of Intra-abdominal Ropivacaine 0.5% Spray on Postoperative Analgesia in Laparoscopic Surgery.
Official title: Influence of Intra-abdominal Ropivacaine 0.5% Spray on Postoperative Analgesia in Laparoscopic Surgery.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Acute
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2021-12-29
Enrollment: 120
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: TREATMENT

Brief summary: Assessing postoperative pain after ropivacin 0.5% spray in the abdominal cavity during laparoscopic surgery.


Eligibility criteria: Inclusion Criteria:

* Appendectomy or cholecystectomy surgery

Exclusion Criteria:

* Allergy to local anesthetics
* Intolerance to tramadol HCl
* Patient with peritonitis
* Pregnant women
* Surgery without laparoscopy
* Chronic pain before the operation

Primary outcomes:
measure: Patient's pain
timeFrame: During appendectomy and cholecystectomy surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01634490: Effects of Different Dietary Regimens on Tolerance Acquisition in Children With Cow's Milk Allergy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cow's Milk Allergy
Keywords: cow's milk allergy
formulas
probiotics
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2012-07-06
Enrollment: 300
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We prospectively evaluated otherwise healthy infants (1-12 months of age at the diagnosis) visit one the Pediatric Gastroenterology and Allergology Centre because of the necessity of a diagnostic oral food challenge for cow's milk proteins. Children were in stable clinical condition without signs of CMA already on exclusion diet with an hypoallergenic formula for a period of 7-15 days as presented by the general paediatrician, immediately the symptoms appear and before being attended at the Center for diagnosis of CMA.

Brief summary: Otherwise healthy infants (1-12 months of age at the diagnosis) with CMA were prospectively evaluated. Patients with cow's milk protein-induced anaphylaxis, eosinophilic disorders of the gastrointestinal tract, and food protein induced enterocolitic syndrome were excluded. A food challenge was performed 6 and 12 months after the diagnosis to assess clinical tolerance acquisition. Main demographic and clinical characteristics were collected for each patient.


Eligibility criteria: Inclusion Criteria:

* Otherwise healthy infants (1-12 months of age at the diagnosis) with cow's milk allergy were prospectively evaluated

Exclusion Criteria:

* Patients with cow's milk protein-induced anaphylaxis, eosinophilic disorders of the gastrointestinal tract, and food protein induced enterocolitic syndrome were excluded.

Primary outcomes:
measure: the effect of different dietotherapeutic approaches on the time of tolerance acquisition in children with cow's milk allergy
timeFrame: about 4 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Berni Canani R, Nocerino R, Terrin G, Frediani T, Lucarelli S, Cosenza L, Passariello A, Leone L, Granata V, Di Costanzo M, Pezzella V, Troncone R. Formula selection for management of children with cow's milk allergy influences the rate of acquisition of tolerance: a prospective multicenter study. J Pediatr. 2013 Sep;163(3):771-7.e1. doi: 10.1016/j.jpeds.2013.03.008. Epub 2013 Apr 10.
Clinical trial NCT00261690: Virtual Reality Pain Control During Burn Wound Care
Official title: Use of Virtual Reality for Adjunctive Treatment of Burn Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Burn
Keywords: Virtual Reality Distraction
Lead sponsor: National Institute of General Medical Sciences (NIGMS)
Sponsor class: NIH
Collaborators: name: National Institutes of Health (NIH)
First posted: 2005-12-05
Enrollment: 184
Sex: ALL
Minimum age (years): 6
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Using Virtual Reality as a form of Distraction during Burn Care.

Detailed description: The purpose of the study is to investigate the effectiveness of virtual reality (a form of distraction) in order to reduce patients' procedural burn pain.

Eligibility criteria: Inclusion Criteria:

* Able to complete subjective evaluations of pain
* English-speaking
* Not demonstrating delirium, psychosis, or any form of Organic Brain Disorder
* Able to communicate orally

Exclusion Criteria:

* Incapable of indicating subjective evaluation of pain
* Non-English-speaking
* Severe head or neck injury or other medical conditions that prohibit patient from wearing VR helmet
* Demonstrating delirium, psychosis, or Organic Brain Disorder
* Unable to communicate verbally
* Significant developmental disability
* Extreme susceptibility to motion sickness
* Reports having no problem with pain during wound care.

Primary outcomes:
measure: We use GRS, McGill to measure the outcome.
timeFrame: once a day
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington; Harborview Medical Center
state: Washington
Study officials:
affiliation: University of Washington
name: David R. Patterson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hoffman HG, Patterson DR, Magula J, Carrougher GJ, Zeltzer K, Dagadakis S, Sharar SR. Water-friendly virtual reality pain control during wound care. J Clin Psychol. 2004 Feb;60(2):189-95. doi: 10.1002/jclp.10244.
Clinical trial NCT00395590: Polymorphisms in Inflammatory Cytokines Genes in Subjects With Obstructive Sleep Apnea
Official title: A Cross Sectional Study of Patients With Obstructive Sleep Apnea for Polymorphisms in Genes of Inflammatory Cytokines.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sleep Apnea
Keywords: OSA inflammatory cytokines, metabolic syndrome
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2006-11-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: Obstructive sleep apnea is a common sleep disorder. It is known to be related with increased body mass, abdominal obesity, insulin resistance and hypertension. It is currently believed to be a feature of the metabolic syndrome. Other features of the metabolic syndrome-such as insulin resistace were found related to inflammation and inflammatory cytokines. Several polymorphisms in the genes that encode interleukin 6,inteleukin 10 and TNF-alpha have significant influence on the amounts of cytokine production. we thus hypothesize that polymorphisms related to increased pruduction are more common in subjects with OSA than in matched controls

Detailed description: Patients attending a sleep apnea clinic for evluation will be recruited. Patients found positive for OSA will be compared to the patients with a negative study for OSA for the prevalence of polymorphisms in genes of inflammatory cytokines and cytokine levels

Eligibility criteria: Inclusion Criteria:

* Patients attending the sleep apnea clinic for evaluation

Exclusion Criteria:

* patients known to have inflammatory conditions

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ben-Gurion University of the Negev
name: mates mates, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02820090: The Predictive Effect of the Inflammatory Response on the Evacuation of Mechanical Ventilation and the Mechanism
Official title: The Predictive Effect of the Inflammatory Response on the Evacuation of Mechanical Ventilation and the Mechanism
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Systemic Inflammatory Response Syndrome
Ventilator Weaning
Keywords: Inflammatory Factor
Mechanical Ventilation
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2016-06-30
Enrollment: 300
Sex: ALL
Minimum age (years): 14
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patient with oral or nasal tracheal intubation and mechanical ventilation in respiratory failure

Brief summary: Infection and trauma take a important role in the acute respiratory failure.There are different causes and degrees of inflammatory reaction in the critically ill patient. The inflammatory reaction should also affect patients on mechanical ventilation dependence with body physiological response and disease prognosis in patients. Therefore, the investigators hypothesize that inflammation may have an important role in the prediction of weaning from mechanical ventilation.

Detailed description: In the process of mechanical ventilation, the patients were divided into two groups according to the failure of spontaneous breathing test and spontaneous breathing test.In the index of predicting mechanical ventilation, the investigators will take the index of inflammatory response, the function index of diaphragm and the amount of exhaled CO2 into account to reduce the failure rate of mechanical ventilation.

Eligibility criteria: Inclusion Criteria:

* oral, nasal tracheal intubation and mechanical ventilation in patients with respiratory failure
* mechanical ventilation time over than 48 hours
* Glasgow score greater more than or equal to 13 points

Exclusion Criteria:

* Aged less than 14 years or more than 80 years old
* patients with neuromuscular disease
* pure heart failure pulmonary edema patients
* patients with tracheotomy

Primary outcomes:
measure: The relationship between mechanical ventilation of ventilator and inflammatory response
timeFrame: January 2014 to December 2016
Secondary outcomes:
measure: The relationship between diaphragm movement function and weaning from mechanical ventilation
timeFrame: January 2016 to December 2017
measure: the output of CO2
timeFrame: January 2016 to December 2017
Other outcomes:
Locations:
Study officials:
affiliation: Beijing Chao Yang Hospital
name: MA yingmin, professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04750590: Relationship Between Methods of Bladder Tumor Extraction and Local Recurrence Rate
Official title: Relationship Between Methods of Bladder Tumor Extraction and Local Recurrence Rate
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bladder Cancer
Lead sponsor: I.M. Sechenov First Moscow State Medical University
Sponsor class: OTHER
First posted: 2021-02-11
Enrollment: 180
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: According to clinical guidelines, endoscopic surgery (mono- or bipolar TURBT, laser resection, en bloc resection) is a standard treatment option for patients with primary non-muscle invasive bladder cancer (NMIBC) (excluding carcinoma in-situ). However, more than half of patients will experience local recurrence after surgery. It is believed that one of the main causes for this local recurrence is the reimplantation of tumor cells during endoscopic surgery. It is crucial to limit contact between the resected tumor and the bladder wall during the operation and to extract the specimen as quickly as possible. In the case of a small tumor, the surgeon can immediately remove it using an endoscopic instrument. There are a number of methods available for removing large tumors, but it is not yet clear which one is most optimal. Therefore, comparing the oncological results from evacuating bladder tumors using various methods is very timely.

Based on the previously mentioned studies, the investigators assume that the rate of bladder cancer relapse out site of the resection area would be lower in the morcellation group compared with piecemeal resection of the tumor. In order to prove this, the investigators plan to conduct a randomized study comparing the relapse rate in these two groups.


Eligibility criteria: Inclusion Criteria:

1. Patients scheduled for endoscopic bladder tumor removal
2. Non-muscle invasive bladder cancer on contrast-enhanced MRI or CT (stage cT1N0M0 and lower)
3. Diameter of tumor \>3cm

Exclusion Criteria:

1. Patient refused to participate in the trial
2. Multiple (more than 2) bladder tumors
3. Previous cold-cup biopsy or any other surgery for bladder tumor
4. Muscle-invasive bladder cancer on postoperative histological evaluation
5. Other malignant/benign tumors of the bladder (non-urothelial cancer)

Primary outcomes:
measure: Recurrence free survival
timeFrame: 3 months
Secondary outcomes:
measure: Relapse-free rate in-site of previous surgery
timeFrame: 3 months
measure: Relapse-free rate out-site of previous surgery
timeFrame: 3 months
measure: Duration of surgery
timeFrame: Intraoperatively
measure: Adverse events
timeFrame: 3 months
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Institute for Urology and Reproductive Health, Sechenov University.
Study officials:
affiliation: Sechenov University
name: Dmitry Enikeev, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05274490: COPD Prognosis in Covid Patients
Official title: Chronic Obstructive Pulmonary Disease Prognosis in Sars-covid 2 Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Failure
Keywords: copd, prognosis, covid
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-03-10
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: male or female patient more than 20 years old, recently diagnosed covid positive

Brief summary: In this prospective observational study, patients were selected from attendees of the intensive care unit. Different measures and outcomes had been studied and compared between patients with and without COPD, including hospitalization, medical costs, length of Intensive care stay, respiratory failure, and death rate.


Eligibility criteria: Inclusion Criteria:

* Age: more than 20 years old.

  * Both Males and females will be included.
  * COPD patients.
  * Recent confirmed the diagnosis with SARS-COV-2.

Exclusion Criteria:

* Pregnancy.

  * Malignancy.
  * Immunodeficiency disease

Primary outcomes:
measure: SOFA score measurement in both groups
timeFrame: 2 weeks
Secondary outcomes:
measure: prognosis of the disease
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Faculty of Medicine, Sohag University
Study officials:
References:
Clinical trial NCT05330390: Study on the Population Pharmacokinetics of Levetiracetam in Epileptic Patients With Diabetic Kidney Disease
Official title: Study on the Population Pharmacokinetics and Individualized Administration of Levetiracetam in Epileptic Patients With Diabetic Kidney Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Epilepsy
Diabetic Nephropathy
Keywords: Levetiracetam
Population pharmacokinetics
Lead sponsor: The Second Hospital of Shandong University
Sponsor class: OTHER
First posted: 2022-04-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The method of continuous and non random enrollment was adopted.

Brief summary: The individualized drug delivery system of levetiracetam based on population pharmacokinetics and quantitative pharmacology model in patients with epilepsy complicated by diabetic kidney disease was established. To clarify the clinical feasibility of model-based individualized drug administration scheme.

Detailed description: A quantitative pharmacological model for the development of levetiracetam in epileptic patients with diabetic nephropathy is proposed. First, a model based active levetiracetam based individualized initial dose regimen was established by using clinical simulation techniques. A simulation model was established for patients with diabetes mellitus and kidney disease, including information on patients' gender, age and other factors, diabetes mellitus, renal disease history, creatinine clearance rate, glomerular filtration rate, urinary protein level and blood lipid level. Secondly, the simulated clinical trial combining simulation model and population pharmacokinetic model is used to compare the compliance rate of levetiracetam blood concentration in patients with different dose treatment schemes, so as to obtain the optimal individualized administration scheme. Finally, Bayesian feedback technology is used to improve the passive dose adjustment scheme, and model-based Bayesian feedback technology is used to establish a dose adjustment scheme based on area under curve (AUC), so as to clarify the optimal blood sampling scheme and monitoring method.

Eligibility criteria: Inclusion Criteria:

- Patients with seizures and diabetic nephropathy who were treated with levetiracetam.

Exclusion Criteria:

* patients who rejected

Primary outcomes:
measure: Blood drug concentration
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Second Hospital of Shandong University
state: Shandong
Study officials:
References:
Clinical trial NCT02725190: Effects of Sleep Deprivation on Diaphragm Command During an Inspiratory Endurance Trial in Healthy Volunteers.
Official title: Effects of Sleep Deprivation on Diaphragm Command During an Inspiratory Endurance Trial in Healthy Volunteers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Deprivation
Healthy Volunteers
Diaphragm
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2016-03-31
Enrollment: 20
Sex: MALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to assess the impact of sleep deprivation on subjective inspiratory endurance in healthy subjects.

Detailed description: Sleep in intensive care unit is altered and few studies have suggested that sleep deprivation (SD) could impact respiratory muscle endurance. A lack of inspiratory endurance could lengthen weaning from invasive ventilation. The purpose of this study is to confirm whether SD alters inspiratory endurance and to identify brain mechanisms involved in SD-induced decreased endurance. A group of 20 male healthy subjects will perform an inspiratory load trial after a normal sleep night and after a sleepless night. Electrophysiological parameters (EEG, motor evoked potentials) of the inspiratory motor command and sensory perceptions will be assessed before, during and after each trial.

Eligibility criteria: Inclusion Criteria:

* Male adult volunteers
* Aged 25 to 45 years
* Regularly sleeping more than 6 hours per night
* Not excessive coffee consumers (\< 3 expressos / day)
* Non smokers
* Absence of respiratory, cardiac, muscular or neurological disease or diabetes
* With a neutral Horne \& Ostberg score

Exclusion Criteria:

* Previous history of respiratory disease or otorhinolaryngological (asthma, respiratory allergies, swallowing disorders, oropharyngeal malformations)
* History of epilepsy or syncope during sleep deprivation
* Taking medications that interfere with sleep (antidepressants, benzodiazepines...)

Primary outcomes:
measure: Time, in minutes, measured from the beginning of the inspiratory endurance test and the end, defined by the patient's wish to stop.
timeFrame: The day after one normal night or one sleepless night.
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: CHU de Poitiers
Study officials:
affiliation: CHU Poitiers
name: Xavier Drouot, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Westphal WP, Rault C, Robert R, Ragot S, Neau JP, Fernagut PO, Drouot X. Sleep deprivation reduces vagal tone during an inspiratory endurance task in humans. Sleep. 2021 Oct 11;44(10):zsab105. doi: 10.1093/sleep/zsab105.