louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02324283: Comparison of Emergence and Oxygenation During One-lung Ventilation With Desflurane and Propofol Anesthesia
Official title: Comparison of Emergence and Recovery Time, and Evaluation of Oxygenation During One-lung Ventilation With Desflurane and Propofol Anesthesia in Lung Surgery- A Pilot Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lung Cancer
Keywords: one-lung ventilation, oxygenation
Lead sponsor: Juntendo University
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
First posted: 2014-12-24
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Which is more adequate general anesthetic agent, desflurane or propofol, for emergence and recovery time, and perioperative oxygenation in lung resection surgery?

Detailed description: The investigators plan to investigate the effects of desflurane on oxygenation (prevention of HPV) of OLV compare with propofol which is used in general anesthesia for lung resection.

Transesophageal echocardiography (TEE) wiill be used to measure pulmonary blood flow during surgery visible and successively. To confirm the effect of HPV by measuring the change in pulmonary blood flow. The correlation between the blood oxygen concentration and attenuation of blood flow will be investigated.

Eligibility criteria: Inclusion Criteria:

* Patients agree to participate in the study
* Patients undergoing lung cancer surgery requiring one-lung ventilation.
* American Society of Anesthesiologists Physical Status Class 1 or 2

Exclusion Criteria:

* Patients with any of the following will be excluded from lung cancer patients.
* New York Heart Association Classification more than 2
* Respiratory dysfunction Vital Capacity or percent predicted Forced expiratory volume in one second is less than 50 %
* Pulmonary hypertension with mean pulmonary arterial pressure more than 30 mmHg
* Coagulation dysfunction
* The administration of steroids and immunosuppressive agents within 3 months prior to surgery
* Infection with active inflammation
* Pneumonectomy patients
* Cases of epidural anesthesia is contraindicated

Primary outcomes:
measure: Oxygenation
timeFrame: prior to surgery to one-hour after extubation
Secondary outcomes:
measure: Rapidity of Emergence From Anesthesia
timeFrame: one minute after cessation of anethetic agents to one hour after extubation
measure: Quality of Consiousness
timeFrame: after extubation
measure: Postoperative Nausea and Vomiting
timeFrame: on the postoperative day 1
Other outcomes:
Locations:
city: Bunkyo-ku
country: Japan
facility: University of Juntendo
state: Tokyko
Study officials:
affiliation: Juntendo University
name: Eiichi Inada, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00718783: Molecular Analysis of Retinoblastoma
Official title: Molecular Analysis of Retinoblastoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinoblastoma
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
Collaborators: name: National Eye Institute (NEI)
First posted: 2008-07-21
Enrollment: 41
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with retinoblastoma

Brief summary: Retinoblastoma is a childhood tumor of the retina that affects approximately 1 in 18,000 children. Retinoblastoma is more prevalent in Central America, where most patients present with advanced intraocular and extraocular disease. Therefore, we have formed collaboration with Central American investigators to provide us with frozen retinoblastoma tumors from patients undergoing routine enucleation. The objective of this protocol is to begin to identify the mutations and gene expression changes that occur in retinoblastoma cells following RB1 gene inactivation in order to more effectively target chemotherapy for treating bilateral retinoblastoma.

Detailed description: This is a biology protocol with no treatment regimen associated. Following routine enucleation of the retinoblastoma affected eye, a portion of the tumor will be removed and flash frozen and sent to St. Jude for RNA and DNA analysis. Some tissue will undergo histopathological analysis and tissue microarrays will be isolated.

Eligibility criteria: Inclusion Criteria:

* Must have clinical diagnosis of retinoblastoma (to be confirmed histologically after enucleation)
* Legal guardians must willing to sign an informed consent indicating that they are aware of this study and its possible benefits. Legal guardians will be given a copy of the consent form.
* Patient is being seen at this AHOPCA institution:

Exclusion Criteria:

* Ophthalmologist or oncologist is concerned that sampling will interfere with staging.
* Diagnosis other than retinoblastoma.
* Affiliated hospital is unable to provide pathologic evidence of retinoblastoma.

Primary outcomes:
measure: Identify genes exhibiting differential expression within intraocular disease tissue between patients having only intraocular involvement and those having extraocular involvement.
timeFrame: Indefinite
Secondary outcomes:
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Hospital Calvo Mackenna
city: Tegucigalpa
country: Honduras
facility: Hospital Escuela Bloque Materno Infantil
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Rachel Brennan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00034983: Treatment of Patients With Major Depressive Disorder With MK0869 (0869-066)(COMPLETED)
Official title: A Worldwide, Multicenter, Double-Blind, Parallel, Active-Controlled, Long-Term Safety Study of MK0869 in Outpatients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2002-05-03
Enrollment: 900
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 clinical study to determine the efficacy and safety of an investigational medication (MK0869) in the treatment of depression

Detailed description: The duration of treatment is 1 year.

Eligibility criteria: Major Depressive Disorder

Primary outcomes:
measure: Long-term safety and tolerability.
timeFrame: Duration of treatment
Secondary outcomes:
measure: Sexual dysfunction adverse experiences and gastrointestinal disturbance adverse experiences
timeFrame: Duration of treatment
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Snyder E, Cai B, DeMuro C, Morrison MF, Ball W. A New Single-Item Sleep Quality Scale: Results of Psychometric Evaluation in Patients With Chronic Primary Insomnia and Depression. J Clin Sleep Med. 2018 Nov 15;14(11):1849-1857. doi: 10.5664/jcsm.7478.
Clinical trial NCT05639283: Primary Obstructive Megaureter Management in Eastern Interregional Area
Official title: Primary Obstructive Megaureter Management in Eastern Interregional Area : Current Status and Perspectives
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Obstructive Megaureter
Keywords: Congenital obstructive megaureter
Urinary malformation
Ureterovesical junction
Hydronephrosis
Renal dysplasia
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2022-12-06
Enrollment: 120
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Minor patient (from 1 to 17 years old) treated between January 2010 and December 2017 for an obstructive congenital mega-ureter

Brief summary: Congenital obstructive megaureter is a urinary malformation affecting the ureterovesical junction and causing obstruction to the flow of urine. It is the second most common cause of hydronephrosis. This malformation affects four times more boys than girls and is bilateral in 25% of cases. It is also associated with contralateral renal dysplasia in 15% of cases. The obstruction is linked to aperistalsis and hypertrophy of the circular muscle bundles and increased collagen 1 level. This malformation is accessible to antenatal screening from the second trimester. It falls within the scope of CAKUT and requires regular monitoring. Indeed, this uropathy can cause repeated pyelonephritis, kidney scarring and affected kidney function.


Eligibility criteria: Inclusion Criteria:

* Minor patient (from 1 to 17 years old)
* Patient treated between January 2010 and December 2017 in one of the participating centers for an obstructive congenital mega-ureter
* Subject (and/or his parental authority) not having expressed, after information, his opposition to the reuse of his data for the purposes of this research

Exclusion Criteria:

* Subject (and/or his parental authority) having expressed, after information, his opposition to the reuse of his data for the purposes of this research

Primary outcomes:
measure: Determine over the past seven years, the operability factors of patients aged 0 to 5 years regardless of the surgical technique used
timeFrame: Files analysed retrospectively from January 01, 2010 to December 31, 2017 will be examined
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Chirurgie pédiatrique - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT02792283: Platelet Function in Hemodialysis Patient
Official title: Evaluation of the Bleeding Risk in Patient Undergoing Hemodialysis by the Analysis of Platelet Function by PFA-100®
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2016-06-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The objective is to evaluate the function of the platelet in patients undergoing hemodialysis. The investigators will use the assay called PFA-100, an in vitro whole blood assay with three pathways of platelet activation to describe a platelet response profile.

The hypothesis is that patients undergoing hemodialysis present a platelet dysfunction, that may be reversed by hemodialysis. The effect of heparin, used during hemodialysis session to anticoagulate the hemodialyzer, on platelet function will be assessed.

Detailed description: The aim of this study is to evaluate the platelet function during hemodialysis. One hundred patients with end-stage renal disease undergoing hemodialysis (2 to 3 sessions per week, 3 to 4 hours per session) will be included.

Patients who meet the inclusion criteria will be included after oral and written information and signature of written consent.

The study consists in recording clinical and biological and the evaluation of platelet function by the PFA-100 assay. This is a whole blood platelet function assay, with 3 pathways of platelet activation (collagen-epinephrine, collagen-ADP and specific P2Y cartridge - Innovance®).

Whole blood is collected in the arterial line of the arteriovenous vascular access (fistula or graft) before and after the hemodialysis session.

PFA-100 is assayed within 2 hours after blood collection and the platelet response profile is interpreted according to the manufacturers instructions.

Clinical informations, especially hemorragic and thrombotic history, are collected the day of inclusion and 6 months after inclusion.

Eligibility criteria: Inclusion criteria :

patient with end-stage chronic kidney disease undergoing hemodialysis age ≥ 18 years old hemodialysis on a peripheral vascular access (arteriovenous fistula or graft) hematocrit between 0.35 and 0.50 and platelet count between 150 and 500 G/L written consent after oral and written information

Exclusion criteria :

pregnancy, breast feeding legal guardianchip hemodialysis on a catheter inability to sign the consent

Primary outcomes:
measure: PFA-100 quantification
timeFrame: at the day of inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Chu Reims
Study officials:
References:
Clinical trial NCT04809883: A Study to Evaluate Endoflip Normal Ranges Data in Healthy Volunteers
Official title: Normative EndoFlip Data on the Diameter and Distensibility of the Pylorus During Fasting and Postprandially in Healthy Females and Male Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-03-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy adults between the ages of 18 and 65 with body mass indices between 18 and 35 kilograms/meter squared will be recruited for this study

Brief summary: The purpose of this research is to establish the normal range of diameter and distensibility of pylorus and the fasting and postprandial antro-pyloric motility in healthy adults.

Detailed description: An Endoflip catheter will be placed through the mouth into the stomach in order to measure distal antral contractile activity and pyloric diameter and distensibility during fasting and after the ingestion of a standard meal

Eligibility criteria: Inclusion Criteria:

* Females and males.
* Between the ages of 18 and 65 years.
* Body mass index between 18 and 35 kg/m\^2.

Exclusion Criteria:

* Heartburn, regurgitation, or symptoms suggestive of gastroparesis such as nausea, early satiety, postprandial bloating, and upper abdominal pain.
* Pregnant

Primary outcomes:
measure: fasting and postprandial pyloric diameter
timeFrame: 1 hour prior to meal and 1 hour following standardized meal
measure: fasting and postprandial pyloric distensibility index
timeFrame: 1 hour prior to meal and 1 hour following standardized meal
measure: fasting and postprandial distal antral motility index
timeFrame: 1 hour prior to meal and 1 hour following standardized meal
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Michael Camilleri
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Michael Camilleri, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00259883: Combination Of PAXIL Tablet And Benzodiazepines
Official title: Post-marketing Clinical Study on PAXIL Tablet in Patients With Depression or Depressive Mood - A Study on Combination of PAXIL Tablet and Benzodiazepines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Mental Disorders
Keywords: depressive episodes
paroxetine
PAXIL
depression
benzodiazepine
combination
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-12-01
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study was designed to assess the efficacy and safety of combination therapy of PAXIL and benzodiazepine anxiolytics. PAXIL Tablet will be administered to patients with depression or depressive episodes who have received Benzodiazepines for at least 4 weeks, and changes in the symptoms of depression will be evaluated by use of the rate and extent of decrease in Hamilton Rating Scale for Depression (HAM-D).


Eligibility criteria: Inclusion criteria:

* Patients with depression or depressive episodes who are diagnosed to have major depressive disorders according to the DSM-IV criteria.
* Patients with 14 or higher points in total scores for Items No.1 - 17 on HAM-D.
* Patients who have continuously received Benzodiazepine anxiolytics.

Exclusion criteria:

* Patients with a strong suicide tendency.

Primary outcomes:
measure: The rate and extent of decrease in Hamilton Rating Scale for Depression (HAM-D)
timeFrame: 8 weeks
Secondary outcomes:
measure: The rate and extent of decrease in each item of HAM-D. The rate and extent of decrease of SRQ-D. Percentage of subjects who started tapering Benzodiazepine dose. Success rate in Benzodiazepine tapering Extent increase of SF-8. CGI responder rate.
timeFrame: 8 weeks
Other outcomes:
Locations:
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02161783: Treatment of Graft Failure After Hematopoietic Stem Cell Transplantation
Official title: Treatment of Graft Failure After Hematopoietic Stem Cell Transplantation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Primary Graft Failure
Secondary Graft Failure
Keywords: Hematopoietic stem cell transplant
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
First posted: 2014-06-12
Enrollment: 50
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: Graft failure for

Brief summary: This is a guideline for the treatment of graft failure after hematopoietic stem cell transplant (HSCT). This regimen, consisting of cyclophosphamide and fludarabine with low dose total body irradiation (TBI) is designed to promote donor engraftment by day 42 after initial graft failure.

The graft will consist of bone marrow or G-CSF mobilized peripheral blood from a haploidentical related donor. The source of stem cells will be determined by the transplant team based on factors such as patient's age, medical history, donor availability and will be according to the current University of Minnesota Blood and Marrow Transplantation Program selection guidelines.


Eligibility criteria: Inclusion Criteria:

* Patients with primary or secondary graft failure, as defined below, may receive a second transplant:

  * Primary graft failure is defined as not achieving an ANC ≥0.5x10\^9/L for three consecutive days by day 35 - 42 following the first transplant.
  * Secondary graft failure is defined as achieving an ANC ≥0.5x10\^9/L for three consecutive days by day 35 - 42, but subsequently drops below 0.5x10\^9/L without recovery.
  * Loss of chimerism is defined as achieving an ANC ≥0.5x10\^9/L for three consecutive, but with less than 10% CD15+ donor cells in the marrow or peripheral blood.
* Recipients should have acceptable organ function defined as:

  * Renal: creatinine \< 2.0 (adults) and creatinine clearance \> 30. For creatinine clearance \< 70, consultation with a BMT pharmacist is necessary for chemotherapy dose adjustments.
  * Hepatic: bilirubin, AST/ALT, ALP \< 10 x upper limit of normal
  * Cardiac: left ventricular ejection fraction \> 40%

Exclusion Criteria:

* Uncontrolled infection at the time of transplant.
* Patients with Fanconi Anemia or other DNA breakage syndromes.

Primary outcomes:
measure: Rate of donor engraftment
timeFrame: day 42
Secondary outcomes:
measure: Rate of treatment related mortality
timeFrame: day 100
measure: Rate of survival
timeFrame: Day 100
measure: Rate of survival
timeFrame: 1 year
measure: Incidence of acute graft-versus-host disease
timeFrame: Day 100
measure: Incidence of chronic graft-versus-host disease
timeFrame: 1 year
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center, Fairview
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Troy C Lund, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04661683: Secondhand Effects of Hookah (i.e., Waterpipe) Smoke and Aerosol
Official title: Investigating the Secondhand Effects of Hookah Smoking and Vaping
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hookah Smoking
Secondhand Aerosol
Vascular Stiffness
Vaping
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2020-12-10
Enrollment: 12
Sex: ALL
Minimum age (years): 21
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: In the United States, secondhand smoke is the third leading preventable cause of death. Flavored hookah (waterpipe) tobacco smoking, a highly social activity common in hookah bars, is a key source of SHS exposure. While smoke-free air laws have decreased exposure to secondhand smoke, the majority of laws do not include hookah smoking. Thus, as a social outlet for youth and young adults, hookah smoke exposure may harm non-smokers, including women of reproductive age or pregnant, hookah bar workers, children, and individuals with heart and lung disease. While more is known on the acute effects of active hookah smoking and the literature is emerging on active e-hookah vaping, little is known about the acute vascular effects of secondhand exposure to hookah smoke and aerosol. The study aims to examine the acute effects of secondhand exposure of hookah smoke and aerosol on endothelial and vascular function. Eligible volunteers will be invited to participate in a total of 3 study visits (2-3 hours each): e-hookah aerosol exposure, charcoal-heated hookah smoke exposure and smoke-free room air. Non-invasive blood pressure and blood flow measurements will be taken before and after the exposure sessions.


Eligibility criteria: Inclusion Criteria:

* 21-49 years old
* Never a smoker: do not use any tobacco products or nicotine delivery systems, including cigarettes, cigars (traditional and filtered), cigarillos, hookah, smokeless tobacco (i.e., loose snus, moist snuff, dip, spit, or chewing tobacco), pipe tobacco, snus pouches, dissolvable tobacco or vaping.
* no evidence of cardiopulmonary disease by history/physical
* blood pressure (BP) \< 140/90 mmHg
* resting heart rate (HR) \< 100 bpm
* BMI \>18 or \< 30kg•m2
* no prescription medication
* No exposure to environmental tobacco smoke for at least one week prior to the study date.

Exclusion Criteria:

* exhaled carbon monoxide \>6 ppm
* (+) pregnancy test
* other conditions deemed unsafe to participate, such as breastfeeding

Primary outcomes:
measure: Flow-Mediated Dilation (FMD)
timeFrame: Pre- and post- the 60-minute exposure sessions
measure: Arterial stiffness
timeFrame: Pre- and post- the 60-minute exposure sessions
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
Study officials:
References: