louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00766389: Retinal Nerve Fiber Layer Thickness Analysis With Cirrus HD OCT Versus Stratus Optical Coherence Tomography (OCT)
Official title: Retinal Nerve Fiber Layer Thickness Analysis With Cirrus HD OCT Versus Stratus OCT
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glaucoma
Keywords: Glaucoma
Retinal nerve fiber layer
Cirrus OCT
Stratus OCT
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2008-10-06
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Defined glaucoma patients and glaucoma suspects

Brief summary: The Cirrus HD OCT, a new spectral domain optical coherence tomography (OCT), has better resolution than the previous time domain Stratus OCT. Discriminating ability of these two OCTs for diagnosis of glaucoma and judgement of disease progression will be studied.

Detailed description: The Cirrus HD OCT is a new spectral domain OCT. Even though its resolution and speed are much better than the previous time domain Stratus OCT, its diagnostic power for glaucoma detection and judgement of disease progression should be directly compared with Stratus OCT. In the present study, we will review the data of peripapillary retinal nerve fiber layer thickness measurement using the Cirrus HD OCT and Stratus OCT. Their discriminating ability for diagnosis of glaucoma and judgement of disease progression will be compared using the ROC curves and Cohen's kappa.

Eligibility criteria: Inclusion Criteria:

* Retinal nerve fiber layer analysis with Cirrus OCT and Stratus OCT within 1 month

Exclusion Criteria:

* Intraocular surgeries history
* DM
* High refractive error ( \< -4.00 diopters, or \> + 4.00 diopters)
* Media opacity

Primary outcomes:
measure: Retinal nerve fiber layer thickness
timeFrame: When the OCT images are taking
Secondary outcomes:
measure: Visual field
timeFrame: When the OCT images are taking
measure: Red-free fundus photo
timeFrame: When the OCT images are taking
measure: Intraocular pressure
timeFrame: When the OCT images are taking
measure: Central corneal thickness
timeFrame: When the OCT images are taking
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gong Je Seong
Study officials:
affiliation: Yonsei University
name: Gong Je Seong, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02841189: King Vision Video Laryngoscope Ambu (aBlade) System for Use in Children
Official title: King Vision Video Laryngoscope aBlade System for Use in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Anesthesia
King Vision Video Laryngoscope Intubation
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: King Systems Corporation
First posted: 2016-07-22
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a single center trial to evaluate the performance of the King Vision video laryngoscope in pediatric patients between the ages of one month and 10 years of age. If the performance is satisfactory, this device may become a standard laryngoscope for tracheal intubation in elective and emergent tracheal intubations.


Eligibility criteria: Inclusion Criteria:

1. All children between the ages of 1 month to 10 years with a normal preoperative airway examination
2. Scheduled for a surgical procedure that requires tracheal intubation shall be included.

Exclusion Criteria:

1. Patients that will be excluded are those with an airway examination or previous anesthesia history that suggests difficulty with mask ventilation.

Primary outcomes:
measure: Ease of Endotracheal Intubation
timeFrame: During intubation
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Riley Hospital for Children at IU Health
state: Indiana
Study officials:
affiliation: Riley Hospital
name: Nicole Horn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02790489: Tolerance Study of the Dietary Supplement Valedia
Official title: Valedia Dietary Supplement Tolerance Study Based on Blood, Urinary and Hemodynamic Biological Parameters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Overweight
Lead sponsor: Valbiotis
Sponsor class: INDUSTRY
Collaborators: name: Centre d'Investigation Clinique INSERM 501, Clermont-Ferrand, France
name: Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques
First posted: 2016-06-06
Enrollment: 14
Sex: MALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objectives of this clinical study are to determine the tolerance of dietary supplement Valedia (blend of plant extracts) through the evaluation of several parameters :

* Various blood biological parameters for tolerance (preprandial): blood glucose, insulin, fructosamine, total cholesterol, triglycerides, HDL-cholesterol, LDL-cholesterol, oxidized LDL, us-CRP, creatinine, ASAT, ALAT, gGT, phosphatase alcaline, bilirubine, urea.
* Urinary parameters: urea, creatinine.
* Hemodynamic parameters: heart rate and blood pressure.
* Cardiac function: ECG.
* Weight.


Eligibility criteria: Main Inclusion Criteria:

* 25 \<= BMI \< 30 kg.m2

Main Exclusion Criteria:

* ASAT \<= 1,55 microkat/L
* ALAT \<= 1,70 microkat/L
* gGT \<= 2,55 microkat/L
* 55 \<= Creatinine \<= 104 micromol/L (+- 10%)
* Bilirubin \< 17,1 micromol/L (+- 10%)
* 1,7 \<= Urea \<= 8,3 mmol/L (+- 10%)
* us-CRP \<= 5 mg/L (+- 10%)
* 0,70 \<= Fasting glycemia \<= 1,25 g/L (+- 10%)
* HbA1c \<= 6%
* Medications for diabetes and/or dyslipidemia

Primary outcomes:
measure: Effect on urine urea
timeFrame: 10 weeks
measure: Effect on urine creatinine
timeFrame: 10 weeks
measure: Effect on fasting glycemia
timeFrame: 10 weeks
measure: Effect on insulin
timeFrame: 10 weeks
measure: Effect on fructosamine
timeFrame: 10 weeks
measure: Effect on total cholesterol
timeFrame: 10 weeks
measure: Effect on HDL cholesterol
timeFrame: 10 weeks
measure: Effect on LDL cholesterol
timeFrame: 10 weeks
measure: Effect on triglycerides
timeFrame: 10 weeks
measure: Effect on oxidized LDL cholesterol
timeFrame: 10 weeks
measure: Effect on inflammation
timeFrame: 10 weeks
measure: Effect on AST
timeFrame: 10 weeks
measure: Effect on ALT
timeFrame: 10 weeks
measure: Effect on gamma GT
timeFrame: 10 weeks
measure: Effect on alkaline phosphatase
timeFrame: 10 weeks
measure: Effect on bilirubin
timeFrame: 10 weeks
measure: Effect on cardiac function
timeFrame: 10 weeks
Secondary outcomes:
measure: The response during an oral glucide tolerance test after a standardized breakfast
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Centre d'Investigation Clinique
Study officials:
affiliation: Valbiotis
name: Sébastien L Peltier, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01064089: Dose Escalation of HSP990 in Japan/Korea
Official title: A Phase I Dose Escalation, Multi-center, Open-label Study of HSP990 Administered Orally Once Weekly in Adult Japanese and Korea Patients With Advanced Solid Malignancies
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Keywords: HSP990
HSP90
Japan/Korea
Phase I
advanced solid tumors
dose escalation
maximum tolerated dose
MTD
Japanese paatients
Korean patients
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-02-08
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a phase I dose escalation, multi-center, open-label study of HSP990 administered orally once weekly in adult Japanese and Korea patients with advanced solid malignancies.


Eligibility criteria: Inclusion Criteria:

1. Patients with advanced solid tumors (advanced cancer)
2. Patient's disease must be evaluable using the RECIST criteria
3. Patients must be 18 or older in Korea or 20 or older in Japan
4. Patients must be relatively healthy as measured by their performance status
5. Patients must have acceptable laboratory values as measured by blood tests
6. Patients must be able to swallow capsules
7. Patients must understand the study and give written permission to enter study

Exclusion Criteria:

1. Patients cannot have brain tumors
2. Patients cannot have had prior medicines that are similar to the study drug or an HDAC inhibitor medicine
3. Patients must not be classified as a "poor or intermediate CYP2C9 metabolizer" as measured using a sample of their blood
4. Patients must have recovered from all previous anti-cancer therapy
5. Patients must have finished taking their previous anti-cancer therapy before entering study
6. Patients must not have a severe disease at the time of study entry (for example: severe diarrhea, disease of the liver or kidney, other cancers, etc.)
7. Patients must have relatively good heart function

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: establish maximum tolerated dose (MTD)
timeFrame: 2.5 years
Secondary outcomes:
measure: Safety by measuring occurrence of dose limiting toxicity (DLT) and other adverse events
timeFrame: 2.5 years
measure: Efficacy by collecting data on response (complete response [CR], partial response [PR]) and stable disease (SD)
timeFrame: 2.5 years
measure: Establishment of a pharmacokinetic profile by collecting information on parameters including but not limited to Cmax, Tmax, T1/2 and AUC in plasma samples
timeFrame: 2.5 years
measure: Measurement of biomarkers for HSP90 pathway in blood and tissue
timeFrame: 2.5 years
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Kashiwa
country: Japan
facility: Novartis Investigative Site
state: Chiba
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT03744689: Erector Spinae Plane Block For Lumbar Disc Hernia Repair
Official title: The Effect Of Erector Spinae Plane Block On Postoperative Pain Management In Lumbar Disc Hernia Repair Operation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: Lomber disc hernia
Erector spinae plane block
Postoperative pain
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2018-11-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Pain management after lomber disc hernia repair surgery is a challenging issue for anesthetists. Erector Spinae plane block is a novel analgesic technique which could be used for this purpose. Primary aim of this double blinded randomized controlled study is to compare the analgesic efficacy of this new block technique with control group in this group of patients.


Eligibility criteria: Inclusion Criteria:

* ASA I-II
* Age 18-65 years
* Undergoing elective lomber disc hernia

Exclusion Criteria:

* obesity
* ASA III - IV
* infection of the skin at the site of needle puncture area
* patients with known allergies to any of the study drugs
* coagulopathy

Primary outcomes:
measure: Morphine consumption
timeFrame: postoperative first 24 hour
Secondary outcomes:
measure: Numeric rating scale
timeFrame: postoperative first 24 hour
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli University
Study officials:
affiliation: Kocaeli University
name: Dilek Icli
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yorukoglu HU, Icli D, Aksu C, Cesur S, Kus A, Gurkan Y. Erector spinae block for postoperative pain management in lumbar disc hernia repair. J Anesth. 2021 Jun;35(3):420-425. doi: 10.1007/s00540-021-02920-0. Epub 2021 Mar 22.
Clinical trial NCT04251689: The Effect of Intravenous Mannitol Plus Saline on the Prevention of Cisplatin-induced Nephrotoxicity: A Randomized, Double-blind, Placebo Controlled Trial
Official title: The Effect of Intravenous Mannitol Plus Saline on the Prevention of Cisplatin-induced Nephrotoxicity: A Randomized, Double-blind, Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Cis-Platinum Nephropathy
Mannitol Adverse Reaction
Lead sponsor: Phramongkutklao College of Medicine and Hospital
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study include cancer patients who had received chemotherapy that include cisplatin. Patients were randomly assigned to either a mannitol 20 g intravenous single dose after cisplatin or a placebo (saline). The primary outcome was to compare acute kidney injury (AKI), which was defined as increase creatinine 0.3 mg/dl in 48 hours by KDIGO criteria using serum creatinine and 24 hour urine creatinine to calculated.


Eligibility criteria: Inclusion Criteria:

1. Patients who was at least 18 years old.
2. Patients who had been diagnosed with cancer proven by tissue biopsy.
3. Patients who were scheduled to receive cisplatin or combination of cisplatin and other chemotherapy, which the dose of cisplatin was not exceeded 100 mg/m2.
4. Patients were required to have a normal renal function (GFR \> 60 mL/min/1.73m2).
5. Patients with an Eastern Cooperative Oncology Group (ECOG) score ≤ 2.
6. Patients with normal serum sodium and serum potassium level.

Exclusion Criteria:

1. Patients with any acute kidney injury event before randomized into trial not more than 6 months.
2. Patients with chronic kidney disease or hydronephrosis.
3. Patients with history of nephrectomy.
4. Patients who had previously received immunosuppressants for any immune deficiency disease.
5. Patients with who had received chemotherapy which induce nephrotoxicity.
6. Patients with had received drug which is nephrotoxic (amphotericin B, aminoglycoside or non-steroidal anti-inflammatory drug).
7. Patients who had cirrhosis with child pugh score more than 7.
8. Patients with or had a known allergy to cisplatin or mannitol.
9. Patients with chronic heart failure who cannot received fluid more than 1 liter.
10. Patients who were not comfortable to follow up at clinic for long term outcome.

Primary outcomes:
measure: Acute Kidney Injury
timeFrame: 48 hours
Secondary outcomes:
measure: Decline 24-hour urine creatinine clearance
timeFrame: 48 hours
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Phramongkutklao Hospital
Study officials:
References:
Clinical trial NCT03433989: ACTRAMAT-D: Impact of Post-Traumatic Stress Disorder After Pregnancy Loss After 12 Weeks of Gestation
Official title: Impact of Post-Traumatic Stress Disorder After Pregnancy Loss After 12 Weeks of Gestation (Termination of Pregnancy , Stillbirth, Late Miscarriage)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Loss
Keywords: Post-Traumatic Stress Disorder
Pregnancy loss
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2018-02-15
Enrollment: 115
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Monocentric, prospective, epidemiological, descriptive and analytical study.
Primary purpose: DIAGNOSTIC

Brief summary: In France The prevalence of Pregnancy Loss after 12 weeks of gestation is around 3%. This situation is probably associated to a risk of post-traumatic stress disorder.

As a part of the medical staff midwives are often confronted with this situation, however they can have difficulties to identify short and long term effects of a post-traumatic stress disorders.

The purpose of the present study is to estimate and analyze the prevalence of short-term (1 month) post-traumatic stress disorder in women with pregnancy loss after 12 weeks of gestation.The symptoms of post-traumatic stress disorder will be tracked using the Impact of Event Scale-revisited and the Peritraumatic Dissociative Experiences Questionnaires.The diagnosis of post-traumatic stress disorder will also be clinically confirmed by a psychiatrist during a specific consultation.


Eligibility criteria: Inclusion Criteria:

* loss pregnancy after 12 weeks of gestation
* consent to participate in the clinical study

Exclusion Criteria:

* no french speaking
* psychiatric disease
* participation in another clinical study

Primary outcomes:
measure: Assessment of short-term post-traumatic stress disorder in women with fetal loss after 12 weeks of gestation with IES-R scale recorded at 30 days after fetal loss.
timeFrame: Telephone interviews are planned 30 days after fetal loss
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
Study officials:
affiliation: Principal Investigator
name: lucile Abiola
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abiola L, Legendre G, Spiers A, Parot-Schinkel E, Hamel JF, Duverger P, Bouet PE, Descamps P, Quelen C, Gillard P, Riquin E. Late fetal demise, a risk factor for post-traumatic stress disorder. Sci Rep. 2022 Jul 20;12(1):12364. doi: 10.1038/s41598-022-16683-5.
Clinical trial NCT02588989: Fibrosis, Valvular and Ventricular Function in Patients With TGA
Official title: Fibrosis, Valvular and Ventricular Function in Patients With Transposition of the Great Arteries
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Transposition of Great Vessels
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2015-10-28
Enrollment: 37
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a transposition of the great arteries (TGA)

Brief summary: The aim of this project is to better evaluate the systemic right ventricular (RV) function in patients with transposition of the great arteries (TGA).

Detailed description: Patients with TGA frequently develop supraventricular and ventricular arrhythmia, conduction problems, systemic atrioventricular valve (SAVV) regurgitation, and congestive heart failure (CHF), all at young age. However, there is variation in time of onset of these adverse events. We want to evaluate ventricular and valvular function at rest, markers of RV fibrosis and cardiac reserve.

Eligibility criteria: Inclusion Criteria:

* Patients with a TGA
* Informed consent to participate. If the patient is under the age of 18, the assent of the patient and the permission of the parents to participate

Exclusion Criteria:

* Previous double-switch intervention
* Any medical contra-indication for cardiovascular magnetic resonance (CMR) imaging (e.g. pacemaker)
* The presence of exercise-induced arrhythmia, symptomatic myocardial ischemia, a resting systolic blood pressure \> 200 mm Hg and/or diastolic blood pressure \> 110 mm Hg, New York Heart Association (NYHA) class III or IV, or non-cardiac co-morbidity that could aggravate by exercise
* Additional exclusion criterion for delayed gadolinium enhancement CMR: any medical contra-indication for intravenous gadolinium

Primary outcomes:
measure: Event-free survival
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Werner Budts, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Jan Bogaert, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02978989: Solo and Non-solo Approach for Laparoscopic Cholecystectomy
Official title: A Randomized Controlled Trial Comparing a Solo and Non-solo Approach for Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cholecystectomy, Laparoscopic
Keywords: Laparoscopic cholecystectomy
Solo surgery
Camera holder
Cholecystitis
Lead sponsor: Daejeon St. Mary's hospital
Sponsor class: OTHER
First posted: 2016-12-01
Enrollment: 150
Sex: ALL
Minimum age (years): 15
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the safety and feasibility of solo laparoscopic cholecystectomy, which is defined as the application of solo surgery to laparoscopic cholecystectomy, by comparing consecutive non-solo procedures conducted by a surgeon in the presence or absence of human assistant(s).

Detailed description: Laporoscopic cholecystectomy usually requires three surgeons, including an operator, a camera assistant, and other instrument assistant. Recent advancement of technology made it possible to develop the conveniently adjustable holders for camera and other laparoscopic instruments. The application of these instruments enables "solo-surgery" wherein an operation is driven by single surgeon. During surgery, human assistant(s) are helpful because of their instant assistance according to the operation's need. Therefore, the utilization of instruments instead of human assistants would be cumbersome. However, the utilization of instruments would be helpful by enabling operation-driven repositioning of the camera and instrument(s). Currently, no attempt has been made to objectively compare the merits and demerits of these two procedures. Therefore, this study was conducted to determine the safety and feasibility of solo laparoscopic cholecystectomy, which is defined as the application of solo surgery to laparoscopic cholecystectomy, by comparing consecutive non-solo procedures conducted by a surgeon in the presence or absence of human assistant(s).

Eligibility criteria: Inclusion Criteria:

1. The patients planed to undergo elective laparoscopic cholecystectomy
2. Benign gallbladder diseases requiring surgery
3. The patients who are indicated for single-port laparoscopic cholecystectomy.

Exclusion Criteria:

1. the patients with complicated cholecystitis
2. the patients with the gallbladder with a thickness more than 4mm.
3. the patients who are expected to have severe peritoneal adhesion.
4. the patients with malignant gallbladder diseases.
5. the patients whose operation appears to need human assistant(s)

Primary outcomes:
measure: Operation time
timeFrame: day 1
Secondary outcomes:
measure: Pain score
timeFrame: day 3
Other outcomes:
Locations:
Study officials:
affiliation: Daejeon St. Mary's hospital, the Catholic University of Korea, 222, Banpo-dong, Seocho-gu, Seoul, 06591, South Korea
name: Say-June Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: