louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02853864: Influence of Gender on Interaction of Propofol and Dexmedetomidine
Official title: Influence of Gender on Interaction of Propofol and Dexmedetomidine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia
Keywords: Gender
Propofol
Dexmedetomidine
Interaction
Lead sponsor: Guangzhou General Hospital of Guangzhou Military Command
Sponsor class: OTHER
First posted: 2016-08-03
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effect of gender on pharmacodynamic interaction of propofol and dexmedetomidine, exploring the effect of gender on propofol unconsciousness median effective concentration with different dose dexmedetomidine.

Detailed description: 60 cases male patients were randomly divided into four groups,and 60 female patients were also randomly divided into four groups.In each group, dexmedetomidine target plasma concentration are 0,0.4,0.6,0.8 ng/ml. Dexmedetomidine administered 15 min before target controlled infusion of propofol. The propofol infusion is started to provide a target effect-site concentration of 1.0 ug/ml, and increased by 0.2 ug/ml until loss of consciousness when the effect-site concentration and target concentration are equilibrium.

Eligibility criteria: Inclusion Criteria:

1. Weight:18≦ BMI≦25
2. Written informed consent from the patient or the relatives of the participating patient.

Exclusion Criteria:

1. A previous history of intolerance to the study drug or related compounds and additives.
2. Existing significant haematological, endocrine, metabolic or gastrointestinal disease.

Primary outcomes:
measure: the effect-site EC50 of propofol on loss of consciousness with different gender
timeFrame: within 30 min during the induction of anesthesia
Secondary outcomes:
measure: The EC95 of propofol for loss of consciousness with different gender
timeFrame: within 30 min during the induction of anesthesia
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Military Region General Hospital, Department of Anesthesiology
state: Guangdong
Study officials:
References:
citation: Kodaka M, Johansen JW, Sebel PS. The influence of gender on loss of consciousness with sevoflurane or propofol. Anesth Analg. 2005 Aug;101(2):377-381. doi: 10.1213/01.ANE.0000154534.71371.4F.
Clinical trial NCT04419064: Confirmation of Ventilation and Intubation by Determination With Ultrasonography
Official title: Confirmation of Ventilation and Intubation by Determination With Ultrasonography: A Multicenter Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Mechanical Ventilation
Keywords: intubation
bedside ultrasound
point-of-care ultrasound
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Kadlec Regional Medical Center
name: The Cleveland Clinic
name: Baylor College of Medicine
name: Oregon Health and Science University
First posted: 2020-06-05
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients, \> 18 years of age, undergoing intubation and mechanical ventilation from 4 multiple intensive care units from 4 different academic and community hospitals.

Brief summary: Chest radiography is the gold standard for confirming tracheal intubation. Bedside ultrasound can be a useful alternative. The investigators are conducting a multi-center, observational study from January 2019 to May 2020 (COVID-US Study) to determine the feasibility of tracheal and lung ultrasound in confirming endotracheal tube placement in the critically ill.

Detailed description: Endotracheal intubation is an important aspect of managing critically ill patients. Chest radiography remains the gold standard for confirming endotracheal tube positioning, however, ultrasonography can be a useful alternative. The objective of this study is to determine the feasibility of a combination of tracheal and thoracic ultrasonography to confirm adequate positioning of endotracheal tube placement in a cohort of critically ill participants including those with novel coronavirus-2019.

Eligibility criteria: Inclusion Criteria:

* Adult patients (\> or equal to 18 years of age) requiring intubation and mechanical ventilation as a part of their routine care

Exclusion Criteria:

* Recent neck or chest surgery
* Cervical spine immobilization
* Lack of availability of operators or equipment for performing the ultrasound protocol

Primary outcomes:
measure: Concordance with next occurring chest radiograph
timeFrame: within 24 hours
Secondary outcomes:
measure: Esophageal Intubation detection
timeFrame: within intubation attempt
measure: Right main or endobronchial intubation
timeFrame: within intubation attempt
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Houston
country: United States
facility: Baylor St. Luke's Medical Center
state: Texas
city: Richland
country: United States
facility: Kadlec Regional Medical Center
state: Washington
Study officials:
affiliation: University of Pittsburgh
name: Mourad H Senussi, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01934764: Identification of Correlations Between Reaction to Biotine and Autoimmune Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Autoimmune Disease
Lead sponsor: Ziv Hospital
Sponsor class: OTHER_GOV
First posted: 2013-09-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: People with autoimmune disease

Brief summary: Working hypothesis and aims: Biotin is conjugated covalently to several proteins and use as a co-factor. Conjugation of biotin to non-targeted, unspecific proteins (e.g. immunoglobulins) leads to the breakage of the immune tolerance and to the formation of anti-biotin antibodies. Anti-biotin antibodies will be found in correlation with the progression and the present of autoimmune disease. In this research the correlation between immune response against biotin and the formations of autoimmune disease, will be studied:

A. Assessment of the possibility that biotin elicit immune response involved in the developmental stage of the autoimmune disease.

B. Assessment of the possibility that anti-biotin antibodies indicate the developmental stage of the autoimmune disease and therefore can serve as an disease early stage marker.

Methods: A. Patient recruitment. Gathering participant's medical record and blood samples. B. Records of clinical and biochemical measures. C. Serum of all patient will be tested for the correlation between biotin level, biotin bound to antibodies and anti-biotin antibodies to liver functions tests. D. Controlled test for repeatedly injected mice with biotinilated self-antibodies. Level of anti-biotin will be tested and their influence on the mouse. E. Determination of the correlation between biotinilated antibodies or anti-biotin antibodies to disease eruption or severance and autoimmune disease.

Expected results :Serum biotin-protein levels and Anti biotin antibodies levels are increased in patients with active autoimmune liver diseases.

Importance: The proof of connection between biotin-carrying immunoglobulins, anti biotin antibodies and autoimmune diseases will open new research direction of possible factors that cause to autoimmune disease.

Probable implications to Medicine: Identification of correlations between reaction to biotine and autoimmune diseases will enable their usage as biomarkers for autoimmune diseases, severity of the disease and personalization of treatment.


Eligibility criteria: Inclusion Criteria:

* Freely given informed consent
* Autoimmune disease

Exclusion Criteria:

Primary outcomes:
measure: Biotin level Test
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Safed
country: Israel
facility: Ziv Medical Center
Study officials:
References:
Clinical trial NCT05183464: Analysis of New Salivary Biomarkers to Evaluate Excessive Diurnal Sleepiness in Children With Hypersomnia
Official title: Analysis of New Salivary Biomarkers to Evaluate Excessive Diurnal Sleepiness in Children With Hypersomnia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypersomnia
Sleepiness, Excessive Daytime
Keywords: Excessive Diurnal Sleepiness
Salivary biomarkers
Children, a-amylase
oxalate
Hypersomnia
sleep
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2022-01-10
Enrollment: 116
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children hospitalized for an evaluation of their excessive diurnal sleepiness will be included in this study.

Brief summary: Excessive diurnal sleepiness is characterized by an incapacity to stay awake, in favour of sleep occurrence. This sleepiness might be secondary to a sleep disorder; when it is not the case, it is primary hypersomnia (including narcolepsy and idiopathic hypersomnia).

To date, objective measures of sleepiness can only be achieved in laboratory. Subjective techniques as scales and questionnaires are highly sensitive to inter-individual differences and cannot constitute a reliable diagnosis tool of sleepiness.

Recent studies suggested that some salivary biomarkers are sensitive to sleep characteristics and thus, may allow the objective and easy evaluation of sleepiness.

The objective of the study is to explore the usability of salivary biomarkers (a-amylase and oxalate) as a new non-invasive technique to evaluate sleepiness and to diagnose primary hypersomnia in children.

The hypothesis of this study is that there will be a modification of salivary biomarkers concentrations with the variations of diurnal sleepiness.


Eligibility criteria: Inclusion Criteria:

* Children with excessive diurnal sleepiness hospitalized for an evaluation of hypersomnia symptoms
* Age\> 6 years old and \<18 years old
* Non opposition by both parents

Exclusion Criteria:

* Opposition of the child or parents to participate
* Patients under measure of deprivation of rights and liberty

Primary outcomes:
measure: Salivary a-amylase concentration (U/ml)
timeFrame: 3 days following the inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Mère-Enfant - Service d'épileptologie clinique, des troubles du sommeil et de neurologie fonctionnelle de l'enfant
Study officials:
References:
Clinical trial NCT04335864: Comparing the Impact of 2 Different Techniques in Management of Hydrosalpinx on Pregnancy Rates Following ICSI
Official title: A Clinical Trial Comparing Laparoscopic Salpingectomy Versus Hysteroscopic Proximal Tubal Occlusion on Pregnancy Rates Following ICSI (Intra-Cytoplasmic Sperm Injection) in Infertile Cases of Hydrosalpinx.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hydrosalpinx
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-04-06
Enrollment: 78
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Assessment and comparing pregnancy outcomes in hydrosalpinx patients treated by hysteroscopic tubal occlusion and laparoscopic salpingectomy before ICSI.

Detailed description: Hydrosalpinx has a detrimental effect on the rates of implantation, pregnancy and early pregnancy loss following IVF. A meta-analysis demonstrated that the implantation rate and clinical pregnancy rate decreased by 50% in patients with hydrosalpinx. The negative consequences could be due to embryotoxic properties, a decrease in endometrial receptivity, and hydrosalpinx fluid mechanically flushing the embryo from the uterus.

Although laparoscopic salpingectomy and laparoscopic proximal ligation increase ongoing pregnancy rates in women with hydrosalpinges, those interventions are invasive and carry anaesthetic and surgical risks, especially in the presence of extensive adhesions, often seen in women with hydrosalpinges. In view of the possible adverse effects of laparoscopic surgery, an alternative less-invasive treatment for hydrosalpinges prior to IVF would be useful.

The effectiveness of hysteroscopic tubal occlusion when compared with salpingectomy has not been established. Randomized clinical trials comparing both procedures prior to IVF are lacking.

The present study was designed to compare hysteroscopic tubal occlusion and laparoscopic salpingectomy in the treatment of hydrosalpinges prior to IVF.

This study hypothesized that in women scheduled for IVF/ICSI hysteroscopic proximal occlusion of hydrosalpinges would be non-inferior to laparoscopic salpingectomy in terms of ongoing pregnancy rates following IVF/ICSI.

Eligibility criteria: Inclusion Criteria:

* primary or secondary infertility cases
* unilateral or bilateral hydrosalpinx proved by HSG (hystersalpingogram) or by TVUS(transvaginal ultrasound) .

Exclusion Criteria:

* Uterine factor of infertility
* male factor of infertility
* preexisting ovarian pathology
* Presence of septic focus
* medical or surgical conditions that contraindicated pregnancy

Primary outcomes:
measure: Clinical pregnancy rate following ICSI
timeFrame: 14 days after Embryo transfer
Secondary outcomes:
measure: Ongoing pregnancy following ICSI
timeFrame: 8 weeks after Embryo transfer
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy hospital-cairo University
Study officials:
References:
Clinical trial NCT00001164: Studies of Patients With Skin Disease, Patients With Neurological Degenerations, and Normal Volunteers
Official title: Studies of Patients With Skin Disease, Patients With Neurological Degenerations, and Normal Volunteers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Muscular Dystrophy
Retinal Degeneration
Skin Diseases
Virus Diseases
Keywords: Genetic Evaluation
Immunologic Evaluations
Inflammatory Skin Disease
Muscular Dystrophies
Neoplastic Skin Diseases
Neuronal Degenerations
Retinal Degenerations
Viral Diseases
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2002-12-10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: It is proposed that patients with skin disease due to presumed immunologic, genetic or viral-induced abnormalities, patients with neurological degenerations, and normal controls be evaluated with various in vitro studies of immunologic, genetic, and virologic function. This is to include studies of peripheral blood (cells and serum) as well as studies of skin obtained with a biopsy instrument. In addition, studies of gastrointestinal function will be performed where appropriate.

Detailed description: It is proposed that patients with skin disease due to presumed immunologic, genetic or viral-induced abnormalities, patients with neurological degenerations, and normal controls be evaluated with various in vitro studies of immunologic, genetic, and virologic function. This is to include studies of peripheral blood (cells and serum) as well as studies of skin obtained with a biopsy instrument. In addition, studies of gastrointestinal function will be performed where appropriate.

Eligibility criteria: Patients with skin diseases of presumed genetic, immunologic, or virologic origin are eligible.

Patients with neurological degenerations are eligible, including patients with inflammatory, neoplastic and viral skin diseases and also heterozygous carriers of such inherited diseases.

Volunteers without skin diseases are eligible, except children.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Cancer Institute (NCI)
state: Maryland
Study officials:
References:
citation: Kraemer KH, Coon HG, Petinga RA, Barrett SF, Rahe AE, Robbins JH. Genetic heterogeneity in xeroderma pigmentosum: complementation groups and their relationship to DNA repair rates. Proc Natl Acad Sci U S A. 1975 Jan;72(1):59-63. doi: 10.1073/pnas.72.1.59.
citation: Yaoita H, Katz SI. Immunoelectronmicroscopic localization of IgA in skin of patients with dermatitis herpetiformis. J Invest Dermatol. 1976 Oct;67(4):502-6. doi: 10.1111/1523-1747.ep12664534.
Clinical trial NCT01033864: A Pharmacokinetic Study of CellCept (Mycophenolate Mofetil) Versus Mycophenolate Sodium in Kidney Transplant Patients
Official title: Comparison of Pharmocokinetics of Mycophenolate Mofetil and Enteric Coated Mycophenolate Sodium in Calcineurininhibitor-free Treated Patients After Renal Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Transplantation
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2009-12-17
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This open-label, 2-arm study will compare the pharmacokinetics of CellCept and mycophenolate sodium in kidney transplanted patients on a calcineurininhibitor-free mycophenolic acid-based therapy. On the study day patients will take their prescribed medication (either CellCept or mycophenolate sodium). Blood samples will be drawn directly before and at intervals up to 12 hours after intake of the study medication. Anticipated time on study treatment is 12 hours and target sample size is 24.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>/=18 years of age
* kidney transplantation \>/=6 months ago
* on mycophenolic acid-based, calcineurininhibitor-free therapy for \>/=3 months, \>/=1 month on stable dose
* co-therapy with 5mg prednisone for \>/=1 month

Exclusion Criteria:

* active gastrointestinal ulcus
* severe diarrhea od gastrointestinal disease
* severe impairment of renal function
* current malignancy
* Lesch-Nyhan- or Kelley-Seegmiller-Syndrome

Primary outcomes:
measure: Pre-dose Trough Concentration (C0)
timeFrame: Day 1 predose
measure: Dose-Normalized C0
timeFrame: Day 1 predose
measure: Minimum Plasma Concentration (Cmin)
timeFrame: Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours
measure: Dose-Normalized Cmin
timeFrame: Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours
measure: Maximum Plasma Concentration (Cmax)
timeFrame: Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours
measure: Dose-Normalized Cmax (mg/L)
timeFrame: Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours
measure: MPA Area Under the Curve From 0 to 12 Hours (AUC0-12)
timeFrame: Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours
measure: Dose-Normalized MPA AUC0-12
timeFrame: Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours
measure: Percentage of Participants By Time to Maximum Plasma Concentration (Tmax)
timeFrame: Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours
Secondary outcomes:
measure: Regression Coefficients For Participants Receiving MMF
timeFrame: Day 1 at 30 minutes and 1 and 2 hours postdose
Other outcomes:
Locations:
city: Frankfurt Am Main
country: Germany
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT03454464: Evaluation of Central Compartment Dissection Without Thyroidectomy
Official title: To Evaluate the Practicable, Thoroughness and Clinical Value of Bilateral Central Compartment Dissection While Preserve Contrary Thyroid Glands
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thyroidectomy
Thyroid Cancer
Central Compartment Neck Dissction
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2018-03-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In accordance with the current guidelines,papillary thyroid microcarcinoma such as turmo invasive nerve or trachea, requires total thyroidectomy for follow-up iodine-131 treatment.In the course of clinical work, if the patient can achieve R0 resection, most of the patients do not need iodine-131 treatment,Therefore, there is no need to continue total thyroidectomy.To evaluate the practicable, thoroughness and Clinical value of bilateral central compartment dissection while preserve contrary thyroid glands.

Detailed description: In accordance with the current guidelines,papillary thyroid microcarcinoma such as turmo invasive nerve or trachea, requires total thyroidectomy for follow-up iodine-131 treatment.In the course of clinical work, if the patient can achieve R0 resection, most of the patients do not need iodine-131 treatment,Therefore, there is no need to continue total thyroidectomy.This study assesses new procedures by adjusting the sequence of procedures. complications and the thoroughness of the operation were evaluated, thus Clinical value of bilateral central compartment dissection with preserve contrary thyroid glands were ananlyed.

Eligibility criteria: Inclusion Criteria:

Tumor diameter less than 1cm The tumor is located in the lower part of the gland No lateral cervical lymph node metastases Traditional open surgery

Exclusion Criteria:

Select the endoscopic surgery or robotic surgery patients Tumor invades the surrounding trachea and esophagus Patients refused to participate

Primary outcomes:
measure: number of the lymph node
timeFrame: 2 day post operation
measure: number of postive lymph node
timeFrame: 2 day post operation
measure: The weight of the central compartment tissue.
timeFrame: introoperation
Secondary outcomes:
measure: thyroid volume
timeFrame: The day before the operation
measure: recurrent laryngeal nerve palsy
timeFrame: 1 day ,2weeks,3months,6months post operation
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Wen-xin ZHAO
state: Fujian
Study officials:
affiliation: fujian meidcal university
name: wen-xin zhao, md
role: STUDY_DIRECTOR
References: