louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03090399: Fluid ORiented Therapy for yoUNg Asa 1patients
Official title: Effects of the Goal-directed Fluid Therapy on ASA 1 Patients Scheduled for Intensive Debulking Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodynamics
Keywords: Goal Directed Fluid Therapy
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2017-03-24
Enrollment: 60
Sex: FEMALE
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: In this retrospective analysis investigators will study the effects of using a minimally invasive hemodynamic monitoring (FloTrac-Edwards) on postoperative outcomes. Participants will compare a control group to a case group; in both groups ASA 1 patients suffering from advanced ovarian cancer underwent radical cytoreductive surgery. In case group hemodynamic was managed by using the FloTrac system; in the control group a standard hemodynamic monitoring was used.


Eligibility criteria: Inclusion Criteria:

* ASA 1

Exclusion Criteria:

* cardiac diseases
* pulmonary diseases
* renal diseases
* metabolic disorders

Primary outcomes:
measure: prevalence of complications
timeFrame: up to 30 days
Secondary outcomes:
measure: days of hospitalization
timeFrame: up to 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Department of Anesthesiology
name: Andrea MD Russo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02173899: Immunogenicity and Safety of 2 Doses of Live Attenuated Varicella Vaccine
Official title: A Study to Evaluate the Immunogenicity and Safety of 2 Doses of Live Attenuated Varicella Vaccine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Varicella
Lead sponsor: Changchun Keygen Biological Products Co., Ltd.
Sponsor class: OTHER
Collaborators: name: Guangdong Provincial Institute of Biological Products And Materia Medica
First posted: 2014-06-25
Enrollment: 716
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to observe the occurrence of adverse events, seroconversion rate and geometric mean titres(GMTs) of 2 doses of live attenuated varicella vaccine.


Eligibility criteria: Inclusion Criteria:

* Parent/legal acceptable representative is willing and able to understand the protocol requirements and provide informed consent
* Participant is aged ≥ 1 year to ≤ 7 years
* Participant without preventive inoculation of varicella vaccine and previous history of chickenpox and zoster
* Subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures
* Body temperature ≤ 37.5℃

Exclusion Criteria:

* Known allergy to any constituent of the vaccine
* Known acute illness, severe chronic disease, acute exacerbation of chronic disease and fever
* Known or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth
* Reported the history of allergies, convulsions, epilepsy, mental illness and brain disease and clear serious systemic reaction
* Failed to the Expanded Programme on Immunization(EPI)
* Receipt of any vaccine in the 4 weeks preceding the trial vaccination
* Plan to receive any vaccine in the 4 weeks following the trial vaccination
* Known bleeding disorder
* Receipt of whole blood, blood plasma or immunoglobulin in the 5 months preceding the trial vaccination
* Reported the history of acute illness had need systemic antibiotics or antiviral treatment of infections in the 7 days preceding the trial vaccination
* An acute illness with or without fever (temperature ≥ 38.0℃) in the 3 days preceding enrollment in the trial
* Participation in any other interventional clinical trial
* Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the vaccine

Primary outcomes:
measure: Seroconversion rate and GMTs for live attenuated varicella vaccine
timeFrame: 35-42 days after the second dose
Secondary outcomes:
measure: Occurrence of adverse events
timeFrame: within 30 days after the second dose
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen Luohu District Center for Disease Control and Prevention
state: Guangdong
Study officials:
affiliation: Guangdong Center for Disease Prevention and Control
name: Huizhen Zheng, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00639899: The Effect of Spermatic Vein Embolization on Prostatic Hypertrophy
Official title: Selective Retrograde Venography and Sclerotherapy of Internal Spermatic Veins and Associated Venous Bypasses and Retro-Peritoneal Collateral in Patients With Varicocele and Hypertrophy of Prostate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Varicocele
Keywords: Varicocele
Lead sponsor: Maaynei Hayesha Medical Center
Sponsor class: OTHER
First posted: 2008-03-20
Enrollment: 35
Sex: MALE
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In varicocele the venous pressure in the prostatic bed is increased .This may result in raised hydrostatic pressure which in turn may stimulate prostatic hypertrophy.

Restoring normal venous drainage is expected to lower hydrostatic pressure followed by inhibition of prostatic growth and possibly leading regression in prostatic dimensions.

Detailed description: 35 male patients, aged 45 years or older, with documented benign prostatic hypertrophy (BPH)and varicocele as visualized by ultrasound and/or termography examination will be enrolled.

Each patient will undergo a full urologic examination to exclude possible malignancy as well as a thorough medical examination to establish eligibility for treatment.

In all selected patients the varicocele will be obliterated by means of embolization of the spermatic veins.

The patients will be followed every three months by abdominal ultrasound as well as by serial PSA for a period of 6-12 months.

Eligibility criteria: Inclusion Criteria:

* Male
* Age \> 45 \< 80 years
* BPH
* Bilateral varicocele.

Exclusion Criteria:

* Coagulation disturbance
* CHF
* Malignancy
* Renal failure.

Primary outcomes:
measure: Safety performance of the procedure. Reduction of above 20% in prostatic calculated volume.
timeFrame: 1 year
Secondary outcomes:
measure: Reduction of above 20% in nocturia
timeFrame: 1 year
Other outcomes:
Locations:
city: Bnei Brak
country: Israel
facility: Maaynei Hayeshua Medical Center
Study officials:
affiliation: Maaynei Hayeshua Medical Center
name: Uriel Levinger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00136799: Efficacy and Safety of Fluvastatin in Different Doses in Adults With Mixed Dyslipidemia or Primary Hypercholesterolemia
Official title: Efficacy and Safety of Fluvastatin in Different Doses in Adults With Mixed Dyslipidemia or Primary Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Mixed Dyslipidemia
Hypercholesterolemia
Keywords: Mixed Dyslipidemia
high cholesterol
adults
fluvastatin
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-08-29
Enrollment: 325
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: The purpose of the study is to evaluate the safety and tolerability of fluvastatin 80 mg in a Chinese population. This study is not recruiting patients in the US.


Eligibility criteria: Inclusion Criteria:

* Mixed dyslipidemia
* Primary hypercholesterolemia

Exclusion Criteria:

* Pregnant or lactating women
* Age \> 18 years

Other protocol-defined inclusion and exclusion criteria may apply.

Primary outcomes:
measure: Percent change from baseline in low density lipoprotein cholesterol after 12 weeks
Secondary outcomes:
measure: Percent change from baseline in total cholesterol after 12 weeks
measure: Percent change from baseline in high density lipoprotein cholesterol after 12 weeks
measure: Percent change from baseline in total triglycerides after 12 weeks
Other outcomes:
Locations:
city: Shangai
country: China
facility: Novartis
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis
role: STUDY_DIRECTOR
References:
Clinical trial NCT01436799: Desflurane Versus Propofol in the Sitting Position
Official title: International Review Board of Gachon University Gil Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Ischemia
Keywords: propofol
desflurane
cerebrovascular circulation
sitting
Lead sponsor: Gachon University Gil Medical Center
Sponsor class: OTHER
First posted: 2011-09-20
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators hypothesized that both propofol and desflurane would decrease the regional oxygen saturation (rSO2) but propofol is likely to reduce rSO2 more than sevoflurane when patients are raised to the sitting position.

Detailed description: The investigators hypothesized that both propofol and desflurane would decrease the rSO2 but propofol is likely to reduce rSO2 more than sevoflurane when patients are raised to the sitting position. Therefore, the purpose of this study was to investigate the effect of desflurane and propofol on rSO2 values during the beach chair position for shoulder arthroscopy.

Eligibility criteria: Inclusion Criteria:

* Forty patients,
* ASA class I or II,
* undergoing shoulder arthroscopy

Exclusion Criteria:

* Patients with history of cerebrovascular disease, coronary occlusive disease and/or obesity (body mass index \> 30) were excluded from this study.

Primary outcomes:
measure: Regional Cerebral Oxygen Satuation (rSO2)
timeFrame: 1, 3, 5, 7, and 9 min after the beach chair position
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Gachon University Gil Medical Center
name: Hyun Jeong Kwak, MD.PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00893542: Bioequivalency Study of Mycophenolate Mofetil 250 mg Capsules Under Fasted Conditions
Official title: A Single Dose, 2-Period, 2-Treatment 2-Way Crossover Bioequivalency Study of Mycophenolate Mofetil 250 mg Capsules Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prophylaxis of Organ Rejection
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2009-05-06
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was to prove the bioequivalence of Mycophenolate Mofetil 250 mg Capsules under fasted conditions.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to mycophenolate mofetil or any comparable or similar product.

Primary outcomes:
measure: bioequivalence determined by statistical comparison Cmax
timeFrame: baseline, 2-period, 14 day washout
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: CEDRA Clinical Research, LLC
state: Texas
Study officials:
affiliation: CEDRA Clinical Research, LLC
name: William Allen Alexander, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03922542: Comparison of Standard vs. Accelerated Corneal Crosslinking
Official title: Randomized Comparison of Standard vs. Accelerated Corneal Crosslinking for Treatment of Progressive Keratoconus or Ectasia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Keratoconus
Ectasia Corneal
Lead sponsor: Price Vision Group
Sponsor class: INDUSTRY
First posted: 2019-04-22
Enrollment: 510
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study objective is to compare accelerated and standard corneal crosslinking for treatment of progressive keratoconus or corneal ectasia.


Eligibility criteria: Inclusion Criteria:

* Documented keratoconus or ectasia after refractive surgery

Exclusion Criteria:

* Insufficient corneal thickness
* Ocular condition that may predispose the eye to complications
* History of chemical injury or delayed epithelial healing
* Condition that would interfere with or prolong epithelial healing
* Known sensitivity to treatment medications
* Pregnancy

Primary outcomes:
measure: Change in maximum keratometry
timeFrame: 6 months
Secondary outcomes:
measure: Change in corrected distance visual acuity
timeFrame: 6 months
measure: Change in uncorrected distance visual acuity
timeFrame: 6 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Price Vision Group
state: Indiana
Study officials:
affiliation: Price Vision Group
name: Francis W Price, Jr., MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Price MO, Fairchild K, Feng MT, Price FW Jr. Prospective Randomized Trial of Corneal Cross-linking Riboflavin Dosing Frequencies for Treatment of Keratoconus and Corneal Ectasia. Ophthalmology. 2018 Apr;125(4):505-511. doi: 10.1016/j.ophtha.2017.10.034. Epub 2017 Dec 2.
citation: Lautert J, Doshi D, Price FW Jr, Price MO. Corneal Epithelial Remodeling After Standard Epithelium-off Corneal Cross-linking in Keratoconic Eyes. J Refract Surg. 2018 Jun 1;34(6):408-412. doi: 10.3928/1081597X-20180402-03.
citation: Price MO, Feng MT, Price FW Jr. Patient satisfaction with epithelium-off corneal crosslinking. J Cataract Refract Surg. 2018 Mar;44(3):323-328. doi: 10.1016/j.jcrs.2017.12.023. Epub 2018 Mar 28.
Clinical trial NCT03523299: Pilot Study to Define the Immune Response Following Cryoablation of Invasive Breast Cancer
Official title: Pilot Study to Define the Immune Response Following Cryoablation of Invasive Breast Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Invasive Ductal Carcinoma, Breast
Keywords: invasive ductal carcinoma
breast cancer
cryoablation
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
First posted: 2018-05-14
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will investigate the safety, feasibility, and immune response associated with cryoablation of early invasive breast cancer prior to lumpectomy. Based on mouse models, the investigators believe that cryoablation will initiate a stronger immune response relative to the control group.

Consenting patients will be randomized to one of two arms: standard of care (control) or cryoablation (intervention). Participants will undergo a blood draw at the time of consent. Those in the control arm will continue with their standard of care lumpectomy. The intervention arm will receive cryoablation 2 weeks before their scheduled lumpectomy and undergo a second blood draw before the lumpectomy.


Eligibility criteria: Inclusion Criteria:

* Ultrasound visible invasive ductal carcinoma (IDC) diagnosed by core needle biopsy;
* Tumor visible by ultrasound at time of treatment;
* Unifocal primary disease;
* Tumor size between 0.5 cm and 2.0 cm (as measured on ultrasound);
* Tumor depth ≥ 0.5 cm from the skin or nipple-areola complex;
* Planned lumpectomy

Exclusion Criteria:

* Pregnant patients
* Multifocal or metastatic disease
* Planned neoadjuvant chemotherapy or radiation
* Extensive ductal carcinoma in situ (DCIS; \>25% DCIS component) either diagnosed on core biopsy or strongly suggested by imaging
* Known allergy to both lidocaine and benzocaine

Primary outcomes:
measure: Incidence of treatment-emergent adverse events [safety]
timeFrame: 1 day after cryoablation
measure: Immune response
timeFrame: One week after lumpectomy
measure: Cosmetic outcome
timeFrame: Change from one month to one year after lumpectomy
measure: Tumor margin status [effectiveness]
timeFrame: 7-10 days after lumpectomy
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Johns Hopkins University
name: Cesar Santa-Maria, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02089399: Pharmacokinetics and Drug Interaction Study Between Amlodipine,Olmesartan and Rosuvastatin in Healthy Adult Volunteers
Official title: An Open Label, Randomized, 2-Sequence, Multiple-Dose, Cross-Over Study to Investigate the Drug-Drug Interaction of Sevikar and Crestor in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2014-03-17
Enrollment: 32
Sex: MALE
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to evaluate the pharmacokinetics profile and drug-drug interaction between amlodipine, olmesartan and rosuvastatin in healthy adult volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects aged 19 - 55 years
* A body mass index in the range 19 - 27 kg/m2
* Willingness to participate during the entire study period
* Written informed consent after being fully informed about the study procedures

Exclusion Criteria:

* Any past medical history of hepatic, renal, gastrointestinal, respiratory, endocrine, psychiatric, neurologic, haemato-oncologic or cardiovascular disease
* History of clinically significant drug hypersensitivity
* Use of medication within 7 days before the first dose
* Heavy drinker (\>140 g/week)
* Whole blood donation during 60 days before the study
* Judged not eligible for study participation by investigator

Primary outcomes:
measure: AUCtau
timeFrame: Multiple blood sample will be collected for 24 hours after last dosing in each of the treatment
measure: Css,max
timeFrame: Multiple blood sample will be collected for 24 hours after last dosing in each of the treatment
Secondary outcomes:
measure: Tss,max
timeFrame: Multiple blood sample will be collected for 24 hours after last dosing in each of the treatment
measure: Css,min
timeFrame: Multiple blood sample will be collected for 24 hours after last dosing in each of the treatment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung medical center
Study officials:
References:
Clinical trial NCT02044042: Vertical Transmission of Hepatitis C Virus
Official title: Mother-To-Child Transmission (MTCT) of Hepatitis C Virus and Spontaneous Viral Clearance in Infected Children: a Retrospective Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis C
Transmission
Lead sponsor: Hopital Lariboisière
Sponsor class: OTHER
First posted: 2014-01-23
Enrollment: 120
Sex: ALL
Minimum age (years): 9
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HCV chronically infected pregnant women with a positive HCV RNA who gave birth in the Maternity Department, Lariboisiere Hospital, Paris, France

Brief summary: Vertical HCV Transmission has been extensively studied, with a risk around 5% (range: 3 to 10%). Spontaneous viral clearance in infected children during childhood can occur, but data about this phenomenon are scarse, justifying the study.

Detailed description: Hepatitis C Virus (HCV) Mother-To-Child Transmission (MTCT) has been extensively studied, with a risk around 5% (range: 3 to 10%) from chronically infected pregnant women with a positive HCV RNA during pregnancy. Risk factors include: HCV RNA load level, HIV-HCV co-infection, duration of labour, HCV genotype, child gender, and invasive procedures either during pregnancy or at birth. Hepatitis C Virus (HCV) Mother-To-Child Transmission (MTCT) mainly occurs during the last trimester of pregnancy or at birth or around the birth (El-Shabrawi et al., World Journal of Gastroenterology 2013). Currently, using caesarian section to reduce the risk of Hepatitis C Virus (HCV) Mother-To-Child Transmission (MTCT) is still debated and not recommended in International Guidelines (EASL 2012). Spontaneous viral clearance in infected children during childhood seems to occur in 20% of cases, with predisposing genetic factors (Ruiz-Extremera A et al. Hepatology 2011 ; 53 : 1830-1838) but data about this phenomenon are scarse (Rerksuppaphol S et al. J Gastroenterol Hepatol 2004), justifying the study.

Eligibility criteria: Inclusion Criteria:

* HCV chronically infected pregnant women
* with a positive HCV RNA
* who gave birth in the Maternity Department, Lariboisiere Hospital, Paris, France

Exclusion Criteria:

* negative HCV RNA during pregnancy
* acute HCV infection during pregnancy (previous negative HCV test during pregnancy)
* MTCT not to be tested (early child death for instance)

Primary outcomes:
measure: HCV status in children born from chronically HCV infected pregnant women
timeFrame: up to 10 years (expected average: 5 years)
Secondary outcomes:
measure: HCV RNA in children with positive HCV antibodies (Ab)
timeFrame: up to 10 years (expected average: 5 years)
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Lariboisiere
Study officials:
affiliation: Hopital Lariboisiere
name: Pierre O SELLIER, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References: