louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01711996: The Correlation Between Renal Injury and Biomarkers in Pediatric Ureteropelvic Junction Obstruction Patients
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Ureteropelvic Junction Obstruction
Keywords: hydronephrosis
biopsy
biomarker
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2012-10-23
Enrollment: 0
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Group 1: 20 patients with UPJO undergo pyeloplasty Group 2: 20 patients with hydronephrosis who does not meet the indication of pyeloplasty Group 3: 20 normal control

Brief summary: Urinary Neutrophil gelatinase associated lipocalin (NGAL) has been recently reported to be related with the degree of hydronephrosis in pediatric ureteropelvic junction obstruction (UPJO) patients. We are trying to analyze whether it is related with the grade of renal injury in UPJO patients.


Eligibility criteria: Inclusion Criteria:

\<Group 1\>

1. 0-3 year old patients with SFU grade 2 or more hydronephrosis without ureteral dilatation
2. needs pyeloplasty due to differential renal function (DRF)\<40%, decreased DRF by more than 5%, development of urinary tract infection, development of urinary stone, and development of pain related with UPJO \<Group 2\>

1. 0-3 year old patients with SFU grade 3 or 4 hydronephrosis without ureteral dilatation 2. doesn't meet the above criteria for the indication of pyeloplasty \<Group 3\>

1. 0-3 year old children without any abnormality of urinary tract

Exclusion Criteria:

\<Group 1\>

1. patients with contralateral disease affecting DRF
2. history of previous urinary tract surgery
3. follow up loss before diuretic renogram performed at 6-12 months from operation \<Group 2, 3\>

1. patients with contralateral disease affecting DRF 2. history of previous urinary tract surgery

Primary outcomes:
measure: The level of urinary NGAL and the degree of renal injury
timeFrame: 6 month after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Urology, Urological Science Institute, Yonsei University, Colleage of Medicine
Study officials:
References:
Clinical trial NCT02341196: Randomized Clinical Trial of Polyester vs. Polyurethane Patch for Carotid Endarterectomy
Official title: Randomized Clinical Trial of Polyester vs. Polyurethane Patch for Carotid Endarterectomy. Long-term Results
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carotid Artery Thrombosis
Carotid Artery Stenosis
Stroke
Lead sponsor: University of Poitiers
Sponsor class: OTHER
Collaborators: name: University of Roma La Sapienza
First posted: 2015-01-19
Enrollment: 450
Sex: ALL
Minimum age (years): 25
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study examines the risk of thrombogenicity of the carotid patches in polyurethane compared to carotid patches in polyester including death, any stroke, carotid thrombosis at 30 days and long-term results including stroke and recurrent carotid stenosis at 10 years.

This study was run at the University of Roma, La Sapienza and at the University of Poitiers, randomisation was done in both enters after approval by the Ethical committee of the University of Roma (Record uploaded)

Detailed description: This study examines the risk of thrombogenicity of the carotid patches in polyurethane compared to carotid patches in polyester including death, any stroke, carotid thrombosis at 30 days and long-term results including stroke and recurrent carotid stenosis at 10 years.

598 patients were considered for randomisation between January 1995 and January 2004. The following patients were excluded for randomisation (Redo carotid surgery: N=34, radiation induced carotid stenosis:N=45, indication for carotid bypass: N=65, Refusal of randomisation: N=4).

In total, 450 patients were randomized in two groups, 225 received a polyester patch and 225 received a polyurethane patch.

All patients were operated under general anaesthesia and all received an intraoperative angiography. A shunt was selectively used in patients with a recent stroke (\<15 days) or with a contralateral carotid occlusion

Eligibility criteria: Inclusion Criteria:

* Carotid stenosis \> 60% NASCET criteria

Exclusion Criteria:

* Redo carotid surgery
* Radiation induced carotid stenosis
* Extensive carotid lesion \> 5 cm in length with involvement of the common carotid artery best treated by a carotid bypass

Primary outcomes:
measure: carotid artery restenosis
timeFrame: 5 to 10 years after surgery
Secondary outcomes:
measure: Any death occurring during follow-up
timeFrame: Time 0 (operation) to 10 years after surgery
measure: Any ipsilateral stroke
timeFrame: 0 days to 10 years
Other outcomes:
Locations:
Study officials:
affiliation: University of Roma La Sapienza
name: Giulio Illuminati, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05225896: Clinical-immunological Features of DNER Ataxia
Official title: Clinical-immunological Features of DNER Ataxia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: DNER Ataxia
Keywords: DNER antibodies
autoimmune cerebellar ataxia
Hodgkin lymphoma
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2022-02-07
Enrollment: 34
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: Patient with DNER antibodies

Brief summary: Using a retrospective cohort of 34 patients with DNER ataxia, we will characterize clinical presentation, tumor associations, and outcomes.


Eligibility criteria: Inclusion Criteria:

* Patient \> 18 years old
* Patient with neurological disorder
* Patient with DNER antibodies in sera or CSF

Exclusion Criteria:

* - No available clinical data
* Patient without DNER antibodies or neurological disorder

Primary outcomes:
measure: Modified Rankin scale (mRS)
timeFrame: 6 month after the beginning of study
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: HCL Hôpital Neurologique / Groupement EST
Study officials:
References:
Clinical trial NCT02618096: Concurrent Oxytocin With Membrane Sweeping Versus Dinoprostone Pessary in Labor Induction of Multiparous Women at Term
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Failed Induction of Labor
Keywords: membrane sweeping
dinoprostone
multiparas
labor induction
cesarean delivery
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2015-12-01
Enrollment: 154
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare concurrent oxytocin with membrane sweeping versus dinoprostone pessary in labor induction for multiparas at term with an unfavorable cervix.


Eligibility criteria: Inclusion Criteria:

* singleton pregnancy
* Multiparous women
* gestational age \>=37.0 weeks
* Bishop score \<=6
* intact amniotic membrane
* absence of labor
* live fetus with vertex presentation
* no previous uterine surgical procedure

Exclusion Criteria:

* Multiple pregnancy
* Placenta previa

Primary outcomes:
measure: Vaginal delivery within 24 hours
timeFrame: From the time of initiating intervention (i.e. membrane sweeping or dinoprostone) until the time of vaginal delivery, assessed up to 24 hours
Secondary outcomes:
measure: Successful labor induction
timeFrame: From the time of initiating intervention (i.e. membrane sweeping or dinoprostone) until the time of active phase of labor (defined as a cervical dilatation of >=4cm), assessed up to 24 hours
measure: Incidence of cesarean delivery
timeFrame: End of labor induction (assessed up to 120 hours)
measure: The interval from start of oxytocin to delivery
timeFrame: From the time of initiating oxytocin infusion until the time of delivery, assessed up to 120 hours
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Department of Obstetrics and Gynecology Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Hospital
name: Kyo Hoon Park,, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03136796: Glycocalyx Damage and Beta-lactam Antibiotics in Surgical Critically Ill
Official title: Alterations of Glycocalyx in Critical Illness and During Major Surgery and Approaches for Glycocalyx Protection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Lead sponsor: University Hospital Hradec Kralove
Sponsor class: OTHER
First posted: 2017-05-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients admitted to ICU due to sepsis or polytrauma in need for intravenous antibiotic therapy.

Brief summary: GCX damage and its relationship to pharmacodynamics and pharmacokinetics of beta lactam antibiotics in critically ill Hypothesis to be tested: GCX damage impairs pharmacodynamics and pharmacokinetics of beta-lactam antibiotics in critically ill patients. There is correlation between GCX damage and insufficient beta lactam levels in patients with commonly used dosing. The aim of the study: Evaluation of relationship between GCX damage and pharmacodynamics and pharmacokinetics of beta-lactam antibiotics in critically ill. Type of the study: Observational. Subjects: Adult patients admitted to ICU with beta-lactam antibiotic therapy (meropenem or piperacillin/tazobactam empirically or based on culture results). Sample size calculation: 20 patients (expected correlation coefficient 0,6, alpha error = 0,05) will lead to power study = 0,89. Intervention: none. Data to be recorded and analyzed: Demographics, type of patients (trauma, post surgical, medical, after cardiac arrest), severity score - Apache II, SOFA, fluid balance, a presence of delirium, clinical outcome, sublingual microcirculation by SDF imaging will be recorded three times during antibiotic treatment at the time points for blood samples required for pharmacodynamics and pharmacokinetic analysis, microcirculatory data and Perfused Boundary Region.


Eligibility criteria: Inclusion Criteria:

* Adult patients admitted to ICU with beta-lactam antibiotic therapy (meropenem or piperacillin/tazobactam empirically or based on culture results).

Exclusion Criteria:

* None.

Primary outcomes:
measure: Plasmatic concentrations of antibiotics
timeFrame: 6 months
Secondary outcomes:
measure: Perfused Boundary Region
timeFrame: 6 months
Other outcomes:
Locations:
city: Hradec Králové
country: Czechia
facility: University Hospital Hradec Kralove
state: Třebeš
Study officials:
References:
citation: Astapenko D, Jor O, Lehmann C, Cerny V. In situ assessment of the renal microcirculation in mechanically ventilated rats using sidestream dark-field imaging. J Microsc. 2015 Feb;257(2):161-5. doi: 10.1111/jmi.12198. Epub 2014 Dec 24.
citation: Arora N, Islam S, Wafa K, Zhou J, Toguri JT, Cerny V, Lehmann C. Evaluation of iris functional capillary density in experimental local and systemic inflammation. J Microsc. 2017 Apr;266(1):55-59. doi: 10.1111/jmi.12518. Epub 2017 Jan 19.
Clinical trial NCT05888896: Effect of Foot Reflexology on Preeclampsia
Official title: Effect of Foot Reflexology on Preeclampsia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mild Pre-eclampsia
Keywords: Foot reflexology - Preeclampsia - Proteinuria
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-06-05
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: anti-hypertensive drugs and foot reflexology
Primary purpose: TREATMENT

Brief summary: the aim of this study to investigate the effect of foot reflexology on mild preeclampsia during pregnancy

Detailed description: Preeclampsia is defined as arterial hypertension identified for the first time after the 20th week associated with proteinuria. It affects 5% to 7% of all pregnant women. It is more common in primigravida women, women with previous early onset preeclampsia, in age greater than 40 years, previous history of preeclampsia, pre-pregnancy obesity, women who become pregnant with donor eggs, embryo donation and donor insemination. It is responsible for over 70 000 maternal deaths and 500 000 fetal deaths worldwide every year. There are many risk factors for it as: Hypertension, diabetes mellitus, proteinuria, obesity, family history, null parity, multiple pregnancies, use of contraception, older women conception (\> 40) and thrombotic vascular disease,edema, renal failure, liver failure and hellp syndrome.Complementary therapies such as massage and foot reflexology are used with patients of preeclampsia, it is to normalize the body's function, break down tension, alleviate stress, improve nerve function and blood supply throughout the body. this trial has two groups; one will receive anti-hypertensive drugs and the second will receive anti-hypertensive drugs+foot reflexology sessions for 8 weeks (30 min, 2 session/ week).

Eligibility criteria: Inclusion Criteria:

* Their ages were ranged between 20-36 years old.
* Their body mass index was not exceeding 35 kg/m2.
* All women were diagnosed as mild preeclampsia.
* All women were primipara and multipara.

Exclusion Criteria:

* Any fractures in foot.
* Foot ulcer \& infection.
* Open skin wound in foot.
* History of stroke.
* Women less than 20 years and more than 36 years.
* BMI more than 35 Kg\\m2.
* Severe preeclampsia.

Primary outcomes:
measure: Mean arterial blood pressure
timeFrame: 8 weeks
Secondary outcomes:
measure: Overall quality of life questionnaire
timeFrame: 8 weeks
measure: Serum cortisol
timeFrame: 8 weeks
measure: Proteinuria
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Abeer Ali Ahmed Mansour
state: Assuit
Study officials:
References:
Clinical trial NCT02384096: A Study to Evaluate the Effect of Precision Spectra™ Programming Features and Lead Options on Patient Outcomes
Official title: COVERAGE - A Study to Evaluate the Effect of Precision Spectra™ SCS System's Programming Features and Lead Options on Patient Outcomes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Pain
Keywords: stimulation
implantable
pulse generator
back pain
chronic pain
leg pain
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2015-03-10
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The study is a prospective, on-label, multi-center, blinded, randomized controlled trial with a cross-over design to evaluate the effect of Precision Spectra™ SCS System's programming features and lead options.

Detailed description: The study is a sub-study of RELIEF - A Global Registry to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain (NCT01719055). The treatment will consist of permanent implant of a Precision Spectra™ SCS IPG with either a 32 contact CoverEdge™ Surgical Lead or with more than 2 percutaneous leads after a successful trial. Programming features and lead options of the Precision Spectra™ SCS System will be evaluated up to 3 months post-IPG activation. Following completion of the 3 month visit, subjects will continue to be followed for up to 36 months per the study requirements of the RELIEF Registry.

Eligibility criteria: Inclusion Criteria:

* Meets RELIEF Registry criteria for inclusion
* Primary complaint of persistent or recurrent low back pain, with or without leg pain
* Signed a valid, IRB/EC-approved informed consent form

Exclusion Criteria:

* Meets any RELIEF Registry criteria for exclusion

Primary outcomes:
measure: Number of Participants With Paresthesia Coverage ≥50%
timeFrame: 7, 14 days post activation
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Physicians Research Group, LLC
state: Arizona
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Greenville
country: United States
facility: PCPMG Clinical Research Unit, LLC
state: South Carolina
city: Rockwall
country: United States
facility: Spine Team Texas
state: Texas
Study officials:
affiliation: Boston Scientific Neuromodulation Corporation
name: Kristen Lechleiter, M.S.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00937196: Placebo Effects on Blood Pressure Induced by Expectancy Manipulation
Official title: Effects of Placebos and Verbal Suggestions on Blood Pressure - Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2009-07-10
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of the present study was to examine the effects of a single placebo intervention on blood pressure and to investigate autonomic and psychological mediating mechanisms.


Eligibility criteria: Inclusion Criteria:

* informed consent

Exclusion Criteria:

* not meeting inclusion criteria
* hypotension or hypertension
* treated or untreated hypertension or hypotension
* Severe systemic disorders (tumors, tbc, diabetes, asthma etc)
* diseases that influence the cardiovascular or gastrointestinal system
* intake of drugs affecting blood pressure and/or autonomic nervous system
* pregnancy and lactation phase
* body mass index \>= 32
* cardiovascular risk factors (diabetes, smoking)
* drug or alcohol abuse
* insufficient compliance
* participation in another trial within the last three months

Primary outcomes:
measure: Blood pressure (systolic, diastolic)
timeFrame: minutes 1 to 30 after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Institute of Medical Psychology, Ludwig-Maximilians-University Munich
Study officials:
affiliation: Ludwig-Maximilians - University of Munich
name: Karin Meissner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01124396: DSP-3025 A Phase 1 Study of Healthy Male Volunteers
Official title: A Double-blind, Placebo-controlled, Randomised Study to Investigate the Tolerability, Safety, Pharmacokinetics and Pharmacodynamics of Repeated Weekly Doses of DSP-3025 Administered Intranasally to Healthy Male Volunteers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: Sumitomo Pharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2010-05-17
Enrollment: 24
Sex: MALE
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE

Brief summary: Investigate safety/tolerability after repeated weekly doses intranasal administration of DSP-3025 comparator placebo to healthy male volunteers


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) between 18.5 and 25 kg/ m2 and a weight between 50 and 80 kg
* No clinically relevant abnormal findings

Exclusion Criteria:

* Acute illness which requires medical intervention
* Definite or suspected personal history of adverse drug reactions or drug hypersensitivity
* Clinical relevant disease or disorder (past or present)
* A history of respiratory disorder(s) such as asthma

Primary outcomes:
measure: Incidence/nature of adverse events, 12-lead ECG, pulse, BP, body temperature, spirometry
timeFrame: During the study
Secondary outcomes:
measure: Clinical chemistry, haematology, urinalysis, autoantibodies
timeFrame: During the study
measure: Nasal symptoms and peak nasal inspiratory flow
timeFrame: During the study
measure: Pharmacokinetics
timeFrame: During the study
measure: Biomarkers nasal lavage and blood
timeFrame: During the study
Other outcomes:
Locations:
city: Asamizodai 2-1-1, Minami-ku, Sagamihara
country: Japan
facility: Kitasato University East Hospital
state: Kanagawa
Study officials:
References:
Clinical trial NCT06369896: Digital Single-operator Cholangioscopy and Intraductal Ultrasound for Nonicteric Biliary Strictures
Official title: The Usefulness of Disposable Digital Single-operator Cholangioscopy and Intraductal Ultrasound in the Assessment of Nonicteric Biliary Strictures: A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cholangiocarcinoma
Biliary Stricture
Keywords: intraductal ultrasound
digital single-operator cholangioscopy
indeterminate biliary stricture
Lead sponsor: Soonchunhyang University Hospital
Sponsor class: OTHER
First posted: 2024-04-17
Enrollment: 36
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with indeterminate nonicteric (Bilirubin \&lt; 2mg/dL) biliary stricture

Brief summary: This study aims to evaluate the usefulness of disposable digital single-operator cholangioscopy (SOC) and intraductal ultrasound (IDUS) for the accurate diagnosis of indeterminate biliary stricture.

Detailed description: Although early and accurate diagnosis of cholangiocarcinoma from the biliary stricture is important, accurate differential diagnosis is still difficult even in computed tomography and magnetic resonance imaging. We planned to evaluate the usefulness of disposable digital single-operator cholangioscopy (SOC) and intraductal ultrasound (IDUS) for the accurate diagnosis of biliary stricture.

Eligibility criteria: Inclusion Criteria:

1. Patients aged 19 to under 80
2. Presence of nonicteric biliary stricture
3. Previous endoscopic sphincterotomy or papillary balloon dilatation

Exclusion Criteria:

1. Bleeding tendency (INR \&gt; 1.5 or platelets \&lt; 50000 mm3)
2. Contraindication to ERCP

Primary outcomes:
measure: diagnostic accuracy of SOC
timeFrame: From enrollment through study completion, an average of 1 year
Secondary outcomes:
measure: Diagnostic accuracy of IDUS
timeFrame: From enrollment through study completion, an average of 1 year
measure: Technical success of SOC
timeFrame: From the time the cholangioscope is inserted into the working channel of the endoscope until it is removed
measure: Technical success of IDUS
timeFrame: From the time the intraductal probe is inserted into the working channel of the endoscope until it is removed
measure: Adverse event
timeFrame: From enrollment through study completion, an average of 1 year
Other outcomes:
Locations:
Study officials:
References: