louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02998424: Pupillary Diameter Under Different Concentrations of Propofol
Official title: Pupillary Diameter Without Stimulation Under Different Concentrations of Propofol Alone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Keywords: propofol
pupillary diameter
Lead sponsor: Hôpital Armand Trousseau
Sponsor class: OTHER
First posted: 2016-12-20
Enrollment: 40
Sex: ALL
Minimum age (years): 13
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Resting pupillary diameter was measured at a randomized Effect-site target concentration of propofol used as a sole anesthetic.


Eligibility criteria: Inclusion Criteria:

* patient who has reached puberty
* ASA I or II who is scheduled for elective surgery under general anesthesia

Exclusion Criteria:

* neurologic, metabolic, ocular disease
* chronic pain
* under medication that interferes with autonomic nervous system
* obesity
* patient requiering a rapid sequence induction

Primary outcomes:
measure: Pupillary diameter
timeFrame: Instantaneous measure, 10 minutes after the beginning of the study period
Secondary outcomes:
measure: Bispectral Index (BIS)
timeFrame: continuous measure, recorded10 minutes after the beginning of the study period
measure: Heart rate
timeFrame: continuous measure, recorded10 minutes after the beginning of the study period
measure: Observer's Assessment of Alertness/Sedation Scale (OAAS)
timeFrame: 10 minutes after the beginning of the study
Other outcomes:
Locations:
city: Paris
country: France
facility: Departement d'anesthesie Hopital Armand Trousseau
Study officials:
affiliation: Hopital Armand Trousseau, Université Paris 6, Département d'anesthésie
name: Isabelle Constant, MD-PHD
role: STUDY_DIRECTOR
References:
citation: Sabourdin N, Meniolle F, Chemam S, Rigouzzo A, Hamza J, Louvet N, Constant I. Effect of Different Concentrations of Propofol Used as a Sole Anesthetic on Pupillary Diameter: A Randomized Trial. Anesth Analg. 2020 Aug;131(2):510-517. doi: 10.1213/ANE.0000000000004362.
Clinical trial NCT03024424: Value of Genetic Counseling and Testing for Patients Who Would Like to Know More About Their Personal Risk of AMD
Official title: Value of Genetic Counseling and Testing for Patients Who Would Like to Know More About Their Personal Risk of AMD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Age-Related Macular Degeneration
Choroidal Neovascularization
Genetic Counseling
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2017-01-18
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goals of this study are:

To assess the impact of genetic testing based on how it alters behaviors, to assess the utility of serum biomarker measurement in combination with genetic testing, to assess the utility of genetic counseling in personal analysis of risk for age-related macular degeneration (AMD), and to assess the impact of presymptomatic genetic testing for choroidal neovascularization (CNV).


Eligibility criteria: Inclusion Criteria:

* Caucasian (this particular genetic test is only validated in Caucasians) Participants can have a positive family history of AMD but this is not necessary.

Exclusion Criteria:

* Individuals with a personal history of AMD are not eligible. Non-caucasian individuals are not eligible. Employees of the Moran Eye Center are not eligible.
* Individuals with a personal history of previous AMD genetic risk testing are not eligible.
* Individuals with a major psychiatric disorder

Primary outcomes:
measure: Change in carotenoid levels in the skin
timeFrame: Twelve months
measure: Change in carotenoid levels in the eyes
timeFrame: Twelve months
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah John A. Moran Eye Center
state: Utah
Study officials:
affiliation: University of Utah Moran Eye Center
name: Paul S. Bernstein, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01911624: Direct Thrombin Inhibitors Versus LMWH in Staphylococcus Aureus Bacteraemia
Official title: Direct Thrombin Inhibitors Versus LMWH in Staphylococcus Aureus Bacteraemia. A Prospective Randomized Controlled Academic Single-centre Feasibility Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Staphylococcus Aureus Bacteraemia
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2013-07-30
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Safety and efficacy of direct thrombin inhibitors versus enoxaparin in patients with staphylococcus aureus bacteraemia.

The study hypothesizes that inhibition of the coagulase-activity of S. aureus by direct thrombin inhibitors is safe and translates into a better outcome of patients with S. aureus bacteremia.

Detailed description: Single center randomized controlled trial of direct thrombin inhibitors versus standard enoxaparin.

* Feasibility: proportion of patients eligible for randomization; clinically attained concentration of DTI and resulting staphylothrombin inhibition
* Safety: bleeding events (major/ clinically relevant non-major)
* Efficacy: thrombotic events during the thromboprophylactic treatment + 3 days
* Secondary outcome measures

  * Coagulation parameters: evolution of D-dimers from day 0-4; other lab parameters of coagulation (PT/APTT/fibrinogen/platelet count)
  * Inflammatory parameters: CRP, white blood cell count, neutrophilia
  * Clinical outcomes: metastatic infections, assessed clinically or by PET/CT; relapse of S. aureus bacteremia; defervescence; persistent positive blood cultures; hospital stay, mortality.

Eligibility criteria: Inclusion Criteria:

* Positive blood culture for staphylococcus aureus
* Symptoms or signs of infection
* Indication for thromboprophylaxis

Exclusion Criteria:

* Contraindication for thromboprophylaxis
* Significant active bleeding or risk of excessive bleeding
* Heparin-induced thrombocytopenia
* Severe liver and kidney disease
* Pregnancy and lactation.

Primary outcomes:
measure: Primary Safety Outcome is the occurence of clinically-relevant bleeding events
timeFrame: From date of randomization up to end of study drug + 3 days
Secondary outcomes:
measure: The primary efficacy outcome is the occurence of metastatic infection
timeFrame: From randomization until month 3
Other outcomes:
measure: Laboratory markers of coagulation
timeFrame: From randomization until D7-10
measure: Laboratory markers of inflammation
timeFrame: From randomization until D7-10
measure: Clinical outcomes after S. aureus bacteremia
timeFrame: From randomization until M3
Locations:
city: Leuven
country: Belgium
facility: KUleuven/UZ Gasthuisberg
Study officials:
affiliation: Bloedings-en vaatziekten, UZ Gasthuisberg
name: Peter Verhamme, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00005324: Genetic and Epidemiologic Studies of Premature Coronary Artery Disease - SCOR in Arteriosclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Diseases
Coronary Disease
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To identify genetic mechanisms controlling apolipoprotein levels and other 'non-traditional' risk factors in families ascertained through probands with premature coronary artery disease (CAD).

Detailed description: BACKGROUND:

Preliminary work for this project was carried out as part of the Johns Hopkins Coronary Artery Disease study (R01-HL-34791) which provided extensive data on families ascertained through equal numbers of white male and female probands undergoing elective angiography.

DESIGN NARRATIVE:

The study, a subproject within an Arteriosclerosis SCOR, had three components. In Component 1, the group of 203 probands under study R01HL34791 was expanded with an additional 50 black patients undergoing angiography, meeting identical criteria. In Component 2, segregation analysis was carried out on lipoproteins, apolipoproteins, and selected non-traditional risk factors on families of all probands and the etiologic heterogeneity among different groups of families was tested. In Component 3, linkage was tested between putative Mendelian loci defined in Component 2 and markers in and around candidate loci involved in lipid metabolism. Preliminary results provided evidence of Mendelian control for apolipoprotein A1 and B, and the candidate loci examined included apo B, lipoprotein lipase, and the A1-CIII-A4 gene cluster. The major hypothesis was that these apolipoprotein levels and other non-traditional risk factors might be under genetic control. Genetic analysis of these risk factors was used to direct molecular studies to identify specific mutations.

The study completion date listed in this record was obtained from the "Completed Date" entered in the Query View Report System (QVR).

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Mal'tsev VI, Kovalenko VM. [The main trends in the development of a therapeutic service in Ukraine]. Lik Sprava. 1994 Feb;(2):3-9. No abstract available. Ukrainian.
citation: Coresh J, Beaty TH, Prenger VL, Xu J, Kwiterovich PO Jr. Segregation analysis of HDL3-C levels in families of patients undergoing coronary arteriography at an early age. Arterioscler Thromb Vasc Biol. 1995 Sep;15(9):1307-13. doi: 10.1161/01.atv.15.9.1307.
Clinical trial NCT02564224: Study Comparing Pursestring Wound Closure vs Conventional Closure to Reverse Stoma of Colorectal Cancer Patients
Official title: Randomized Clinical Trial of Stoma Reversal Comparing Pursestring Wound Closure vs Conventional Closure to Eliminate the VSS Score of the Scar for Colorectal Cancer Patients
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Colorectal Cancer
Stoma Closure Technic
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2015-09-30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: Temporary stomas has been performed to reduce complications after colorectal cancer surgery, especially in high-risk anastomosis. Different closure technics showed different outcome. The aim of this study is to compare the scar length , surgical site infection and pain score of purse-string wound closure vs conventional closure.


Eligibility criteria: Inclusion Criteria:

* Receiving temporary ostomy because of colorectal cancer at least 3 months ago;
* Age of≥18 and ≤80

Exclusion Criteria:

* Not willing or incapable to comply with all study visits and assessments
* Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that puts the patient at high risk for treatment-related complications

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital Zhejiang University College of Medicine
state: Zhejiang
Study officials:
References:
Clinical trial NCT00000224: Alternate-Day Buprenorphine. Phase V - 6
Official title: Alternate-Day Buprenorphine. Phase V
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Opioid-Related Disorders
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: University of Vermont
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 30
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate buprenorphine blockade challenge.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Drug use
measure: Opioid withdrawal
measure: Subjective dose estimate
measure: Drug effect characteristics: ARCI
measure: Physiological changes in: pupil diameter
measure: Physiological changes in: blood pressure
measure: Physiological changes in: heart rate
measure: Physiological changes in: respiration
measure: Physiological changes in: bup plasma levels
Secondary outcomes:
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Treatment Research Center
state: Vermont
Study officials:
affiliation: University of Vermont
name: Warren Bickel, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bickel, Amass, Badger (in preparation) A double-blind controlled trial of buprenorphine dosing every 72 hours in opioid dependenct humans. Bickel, Amass, Badger (in preparation) A double-blind controlled trial of buprenorphine dosing every 72 hours in opioid dependent humans.
Clinical trial NCT01737424: Study to Investigate the Safety and Pharmacokinetic Characteristics of LC28-0126 in Healthy Male Subjects
Official title: A Dose Blocked-randomized, Double-blind, Placebo-controlled, Single Dosing and Dose-escalation Phase I Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetic Characteristics of LC28-0126 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: LG Life Sciences
Sponsor class: INDUSTRY
First posted: 2012-11-29
Enrollment: 89
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the safety, tolerability and pharmacokinetic characteristics of LC28-0126 in healthy male subjects


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects between the ages of 20 and 45 years at screening.
* Subjects with BMI between 18.0(inclusive) and 27.0 kg/m2 (exclusive); and a total body weight between 55 kg (inclusive) and 90 kg (exclusive)

Exclusion Criteria:

* Participation in a clinical research study within the previous 2 months
* Regular alcohol consumption \>21 units per week.

Primary outcomes:
measure: Adverse events
timeFrame: 12 days
Secondary outcomes:
measure: Cmax
timeFrame: up to 6 days post-dose
measure: AUC
timeFrame: up to 6 days post-dose
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital, Clinical Trial Center
Study officials:
affiliation: Seoul National University Hospital
name: Kyung-Sang Yu, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03328624: A Preliminary Clinical Usability Study for the Recovery Force DVT II Cuff
Official title: A Preliminary Clinical Usability Study to Assess Design, Comfort, Wearability, and Acceptance of Recovery Force's Deep Vein Thrombosis (DVT) Cuff
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deep Vein Thrombosis
Venous Thrombosis
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: Recovery Force LLC
First posted: 2017-11-01
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: A preliminary clinical usability study to assess design, comfort, wearability, and acceptance of Recovery Force's Deep vein thrombosis (DVT) cuff

Detailed description: A single site, observational study will be conducted at the University of Southern California (USC) with participants who have and/or have had previous experience with DVT pneumatic cuffs. Study staff will examine participants overall experience, product functionality and perceived adherence to Recovery Force's DVT II cuff.

Eligibility criteria: Inclusion Criteria:

* Male or Female Age 18-65 who have had exposure with a DVT cuff on the calf within the last 6 months from a previous or current clinical condition

Exclusion Criteria:

-

Primary outcomes:
measure: Comfort and Patient Acceptance
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
affiliation: Professor of Surgery and Director, SALSA@USC
name: David G Armstrong, DPM, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00194324: Effect of Exercise on Spread of the Miconozole Nitrate OVULE in the Vagina
Official title: Vaginal Imaging Study to Evaluate the Effect of Exercise on the Distribution of Miconozole Nitrate OVULE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Health
Vulvovaginal Candidiasis
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Johnson & Johnson
First posted: 2005-09-19
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This study uses MRI to detect the spread of the Miconozole Nitrate OVULE within the vagina. The effect of moderate amounts of physical activity on the spread will be evaluated, and compared to no physical activity.


Eligibility criteria: Inclusion Criteria:

* Not at risk for pregnancy
* Willing to abstain from intercourse 24 hours prior to MRI
* Regular menstrual cycles (every 23-38 days)
* At least 10 weeks from most recent pregnancy outcome and had 2 spontaneous menstrual cycles since
* Normal pap smear within previous 12 months
* Negative test for yeast, bacterial vaginosis and trichomonas
* Not allergic to any component of the formulation
* No contraindications to MRI
* Not participated in another investigational trial within 30 days
* No history of condition, or finding on exam, that, in the opinion of the investigator, would make participation unsafe for the volunteer or complicate interpretation of the data

Primary outcomes:
measure: To compare between exercise and no exercise:
measure: Time needed for the capsule to dissolve;
measure: Quantify and describe product distribution at 20 minute intervals within the first 90 minutes after insertion;
measure: Quantify systemic levels of miconozole nitrate 90 minutes and 24 hours after insertion;
measure: Quantify amount of miconozole nitrate in the vagina 90 minutes and 24 hours after insertion
Secondary outcomes:
measure: Product distribution will be assessed by:
measure: Linear spread from the cervix covered by the product;
measure: Percent of maximal linear spread from the cervix;
measure: Surface area covered by the product;
measure: Percent of maximal surface contact;
measure: Presence bare spots in coating;
measure: Presence of product outside the introitus
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania Reproductive Research Unit
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Kurt T Barnhart, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00757224: Parental Education on Passive Smoke Exposure and Respiratory Diseases in Infants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tobacco Smoke Pollution
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2008-09-23
Enrollment: 150
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Parental smoking is associated with increased frequency of respiratory diseases including hospitalizations in infants.

Study hypothesis: Parental education regarding the association between parental smoking and respiratory diseases in the infant, and guidance on ways to decrease smoke exposure by the infant, provided shortly after the infant is born, will decrease infants' morbidity.

Detailed description: Mothers who are in Maternity ward following birth will fill a questionnaire regarding smoking habits. Parents will be divided into non-smokers and smokers. Half of the smoking mothers will receive guidance regarding the association between parents smoking and respiratory diseases in the infant. They will also get ideas on how to reduce smoke exposure by their infant. 3 months and 1 year later all parents will be contacted by phone and asked about their children's health.

Eligibility criteria: Inclusion Criteria:

* Infants born at Asaf Harofeh Medical Center
* Infants born at \>35W gestational age

Exclusion Criteria:

* Infants requiring any supportive treatment (supplemental O2, fluids, glucose, antibiotics)

Primary outcomes:
measure: The number of episodes of cough/wheeze/asthma/bronchitis during the first 3 months and 1 year.
timeFrame: 3 months and 1 year
Secondary outcomes:
measure: The number of ED visits and hospitalizations for respiratory diseases in the first 3 months and 1 year
timeFrame: 3 months and 1 year
Other outcomes:
Locations:
city: Zerifin
country: Israel
facility: Asaf Harofeh Medical Center
Study officials:
References: