louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02663947: Comparison of Optic Nerve Sheath Diameter Measured by Ultrasonography Before and After Ventriculoperitoneal Shunt Surgery in Adult Patients With Hydrocephalus
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Hydrocephalus
Keywords: ventriculoperitoneal shunt
optic nerve sheath diameter
intracranial pressure
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2016-01-26
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are scheduled for elective ventriculoperitoneal shunt surgery under general anesthesia

Brief summary: Hydrocephalus is a disturbance of cerebrospinal fluid production, flow and absorption leading to intracranial hypertension. Assessment of the change in intracranial pressure after ventriculoperitoneal shunt surgery is important in guiding appropriate postoperative management. The optic nerve sheath diameter measured using ultrasonography has been verified as a non-invasive indicator of intracranial hypertension in various clinical studies. The investigators hypothesized that a change in optic nerve sheath diameter detected through ultrasonography could help ascertain a reduction in intracranial pressure following ventriculoperitoneal shunt surgery in adult patients without the risk of serious complications.


Eligibility criteria: Inclusion Criteria:

* Adult patients (20-90 years of age, ASA physical status 3 or less) who are scheduled for elective ventriculoperitoneal shunt surgery with non-communicating hydrocephalus and communicating hydrocephalus except for normal-pressure hydrocephalus
* Non-communicating hydrocephalus is defined as a pattern of ventricular system or at the level of the fourth ventricle's outlets by lesions including tumor, giant aneurysm, or aqueductal stenosis.
* Communicating hydrocephalus is defined as paraventricular enlargement resulting from postoperative complication after cranial surgery, meningitis, subarachnoid or intracerebral hemorrhage.

Exclusion Criteria:

* Patients with previous history of shunt operation, ocular disease and ocular surgery
* Patients with anatomical or functional abnormality of optic nerve
* emergency patient

Primary outcomes:
measure: ultrasonographic measurement of optic nerve sheath diameter
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Associate Professor Department of Anesthesiology and Pain Medicine
Study officials:
References:
citation: Dubost C, Le Gouez A, Jouffroy V, Roger-Christoph S, Benhamou D, Mercier FJ, Geeraerts T. Optic nerve sheath diameter used as ultrasonographic assessment of the incidence of raised intracranial pressure in preeclampsia: a pilot study. Anesthesiology. 2012 May;116(5):1066-71. doi: 10.1097/ALN.0b013e318246ea1a.
Clinical trial NCT02037347: Study to Evaluate the Use of Palifermin to Treat Toxic Epidermal Necrolysis
Official title: Palifermin Treatment of Toxic Epidermal Necrolysis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Toxic Epidermal Necrolysis
Stevens-Johnson Syndrome
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Swedish Orphan Biovitrum
First posted: 2014-01-15
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To test the ability of palifermin (a recombinant human keratinocyte growth factor) to decrease mucocutaneous injury and to promote epithelial repair in Toxic Epidermal Necrolysis and Stevens-Johnson Syndrome-Toxic Epidermal Necrolysis Overlap, diseases in which there is extensive sloughing of the skin and mucosa, including that of the eyes, gastrointestinal tract, respiratory and genitourinary systems.


Eligibility criteria: Inclusion Criteria:

* Skin biopsy in early disease showing apoptotic keratinocytes in the epidermis and in more advanced disease necrosis of the entire epidermis
* Epidermal detachment or erythematous to purpuric macules involving more than 10% of body surface area in addition to involvement of the oropharynx; there may be further involvement of other mucosal surfaces, ie. conjunctivae, gastrointestinal tract, respiratory and genitourinary epithelia
* Age of 18 years old or older
* The patient is expected to survive longer than 48 hours

Exclusion Criteria:

* Skin detachment above 90% of the body surface area
* Skin detachment has not progressed during the previous 48 hours
* A positive serum pregnancy test
* Age \< 18 years old
* Known hematologic or solid organ malignancy

Primary outcomes:
measure: Time-to-cutaneous Re-epithelialization
timeFrame: The number of days between the start of palifermin administration and complete re-epithelialization of skin up to 14 days
Secondary outcomes:
measure: Time-to-mucosal Re-epithelialization
timeFrame: The number of days between the start of palifermin administration and complete re-epithelialization of oral mucosa up to 14 days
measure: Time-to-cessation of Epidermal Necrosis
timeFrame: The number of days between the start of palifermin administration and cessation of further epidermal necrosis up to 14 days
Other outcomes:
Locations:
city: Bridgeport
country: United States
facility: Bridgeport Hospital
state: Connecticut
city: New Haven
country: United States
facility: Yale-New Haven Hospital
state: Connecticut
Study officials:
References:
Clinical trial NCT01707147: A Non Interventional Study to Monitor the Safety and Effectiveness of Trajenta (Linagliptin, 5 mg, q.d) in Korean Patients With Type 2 Diabetes Mellitus
Official title: A Regulatory Requirement Non Interventional Study to Monitor the Safety and Effectiveness of Trajenta (Linagliptin, 5 mg, q.d) in Korean Patients With Type 2 Diabetes Mellitus(SELINA Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2012-10-16
Enrollment: 3219
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Korean patients with T2DM

Brief summary: The aim of this study is to monitor safety and efficacy of treatment with linagliptin in Korean patients with type 2 diabetes mellitus in routine clinical settings.

Detailed description: Study Design:

Post Marketing study- Observational study

Eligibility criteria: Inclusion criteria:

Patients who have been started on Trajenta in accordance with the approved label in Korea Patients who have signed on the data release consent form

Exclusion criteria:

Patients with previous exposure to Trajenta and current participation in clinical trials

Primary outcomes:
measure: Percentage of Patients With Incidence of Adverse Events Who Had Taken at Least One Dose of Trajenta
timeFrame: Up to 26 weeks (long-term surveillance)
Secondary outcomes:
measure: Change From Baseline After 24 Weeks in Glycosylated Hemoglobin (HbA1c)
timeFrame: Baseline and Week 24
measure: Percentage of Patients With Occurrence of Treat to Target Effectiveness Response, That is HbA1c Under Treatment of < 6.5% After 24 Weeks of Treatment
timeFrame: 24 Weeks
measure: Percentage of Patients With Occurrence of Relative Effectiveness Response (HbA1c Lowering by at Least 0.5% After 24 Weeks of Treatment)
timeFrame: 24 Weeks
measure: Change From Baseline After 24 Weeks in Fasting Plasma Glucose (FPG)
timeFrame: Baseline and Week 24
Other outcomes:
Locations:
city: Multiple Locations
country: Korea, Republic of
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT00399347: Prevalence of Type 2 Diabetes Mellitus in Ethiopian Community in Israel: an Update
Official title: Prevalence of Diabetes Mellitus in Ethiopian Community in Israel: an Update
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Keywords: Diabetes Mellitus, prevalence , Ethiopians Jews, Israel
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2006-11-14
Enrollment: 2000
Sex: ALL
Minimum age (years): 33
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: residents of specific region

Brief summary: The prevalence and incidence of diabetes has been reported to vary among populations.Immigrants groups as that have undergone significant life-style changes tend to develop diabetes within a short time. The aim of the study is to assess the prevalence of diabetes mellitus in Ethiopian population ,15-20 years after immigration in Israel.

Detailed description: The study will be conducted in three primary care clinics of the Jezreel Valley (Omer, Givat Hamore and Afula Illit). The computerized medical charts of 500 Ethiopian adults will be reviewed. The following information will be obtained: age, date of arrival in Israel, known history of diabetes, hyperlipidemia, hypertension or other disease, drug therapy, body weight, blood pressure. Following laboratory data will be retrieved: blood glucose, HbA1c, lipid levels , creatinine and uric acid. The criteria used for the definition of diabetes will be based on the criteria proposed by the American Diabetes Association .

Eligibility criteria: Inclusion Criteria:

* Male and female Ethiopians Jews who immigrate in Israel in 1991 and were 18 years old or more at immigration.

Exclusion Criteria:

* Type 1 diabetes Mellitus

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Primary care clinics
Study officials:
affiliation: HaEmek Medical Center, Afula, Israel
name: Avraham Ishay MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05042947: A New Ligation Using the Double-loop Clips Technique Versus Traditional Techniques in the Treatment of Large Wounds After Endoscopic Resection
Official title: Feasibility of a New Ligation Using the Double-loop Clips Technique Versus Traditional Techniques in the Treatment of Large Wounds After Endoscopic Resection: a Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Polyps
Closure; Delay
Lead sponsor: Ningbo No. 1 Hospital
Sponsor class: OTHER
First posted: 2021-09-13
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Studies have shown that postoperative inflammation can be relieved by clipping the wound, and can reduce the bleeding rate and perforation rate.Scholars at home and abroad have proposed the use of adhesives and circular surgical lines to clamp the wound.In 2019, Satoshi Abiko and others proposed the use of double-loop clips technology to clamp the wound, and make double-loop clips of appropriate length outside the body.Therefore, our study is a prospective randomized controlled study to explore whether the double-loop clips technique is safe and effective for larger wounds in daily clinical work.


Eligibility criteria: Inclusion Criteria:

* Patients with wounds larger than 20mm
* Patients aged 18 to 75 years old

Exclusion Criteria:

* Have a serious medical condition, such as heart failure, acute liver failure, severe kidney disease (dialysis or predialysis patients) or New York heart association class iii-iv.
* Pregnant or breastfeeding.
* Allergy or intolerance to any study drug.
* Patients who have taken anticoagulant drugs (aspirin, clopidogrel, etc.) in the past week but are contraindicated for endoscopic polyp treatment.
* Other imaging findings suggest patients with advanced cancer.
* Patients with severe gastrointestinal diseases, such as intestinal obstruction or perforation, active ulcerative colitis, toxic colitis, and toxic megacolon

Primary outcomes:
measure: complete closure rate
timeFrame: 1 hour
Secondary outcomes:
measure: Operating time
timeFrame: 1 hour
measure: Closing speed
timeFrame: 1 hour
Other outcomes:
Locations:
city: Ningbo
country: China
facility: Ningbo first hospital
state: Zhejiang
Study officials:
References:
Clinical trial NCT03675347: Recurrent Events After Percutaneous Coronary INterventio for ACS
Official title: Incidence, Predictors and impAct on General Population of Recurrent Events After Percutaneous Coronary INterventio for ACS: the AGAIN a Multicenter Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Acute Coronary Syndrome
Lead sponsor: A.O.U. Città della Salute e della Scienza
Sponsor class: OTHER
First posted: 2018-09-18
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Acute Coronary Syndrome (ACS) treated with Percutaneous Coronary Intervention (PCI) who experienced a bleeding or ischemic event during the first year of follow-up

Brief summary: Patients undergoing PCI for ACS are exposed to a significant ischemic and bleeding risk.

The aim of our study is instead to analyze in detail the rates of recurrent events, but also their predictors and impact on outcomes, in a population of unselected real life patients treated with PCI for ACS discharged on either Clopidogrel, Prasugrel or Ticagrelor who already experienced an adverse event during the first year of follow up.

Detailed description: Patients undergoing PCI for ACS are exposed to a significant ischemic and bleeding risk. The rate, predictors and outcomes of an adverse event in this population has been already investigated. However, to the best of our knowledge, only two papers took specifically in analysis rates of recurrence after a first event; the first is a recently published article by Giustino et al; it took in consideration recurrent events in a selected population of patients with ST-elevation Myocardial Infarction (STEMI) participating in the HORIZONS-AMI Trial, discharged on Aspirin and Clopidogrel, analyzing their incidence in the first year of follow-up. The second is a paper by Fanaroff et al which primarily focused on the factors leading to a DAPT intensification in patients with recurrent events.

The aim of our study is instead to analyze in detail the rates of recurrent events, but also their predictors and impact on outcomes, in a population of unselected real life patients treated with PCI for ACS discharged on either Clopidogrel, Prasugrel or Ticagrelor who already experienced an adverse event during the first year of follow up.

Eligibility criteria: Inclusion Criteria:

* Inclusion criteria in the present study was the occurrence of an adverse event (bleeding or ischemic) during DAPT therapy in the follow-up after PCI for ACS

Exclusion Criteria:

* none

Primary outcomes:
measure: Rates of recurrent bleeding and ischemic events after PCI for ACS
timeFrame: 2018 - 2019
Secondary outcomes:
Other outcomes:
Locations:
city: Torino
country: Italy
facility: San Giovanni Battista
Study officials:
affiliation: Molinette
name: biole carloalberto, doctor
role: STUDY_CHAIR
References:
Clinical trial NCT04738747: Impact of a Wearable Fitness Tracker on Otolaryngologists' Burnout
Official title: Impact of a Wearable Fitness Tracker on Otolaryngologists' Burnout
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Burnout
Stress
Sleep Deprivation
Wellness
Keywords: Burnout
Fitness Tracker
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2021-02-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study the impact of the WHOOP fitness tracker
Primary purpose: PREVENTION

Brief summary: Study the impact of the WHOOP fitness tracker on burnout in attending and resident otolaryngologists

Detailed description: The study will be a randomized controlled trial of attending and resident otolaryngologists who will be randomized to either wearing a WHOOP fitness tracker or a control group. Participants will take two Maslach burnout inventory (MBI) surveys prior to the start of the intervention to set a baseline burnout score, and then at 3 months and 6 months into the study. Baseline cardiac status will also be established by taking a pre-intervention heart rate and blood pressure.

Eligibility criteria: Inclusion Criteria:

* All attending and resident Otolaryngologists at Wake Forest Baptist Health

Exclusion Criteria:

* Users of a WHOOP device currently
* Current interns will be excluded given they do not work with the Otolaryngology team the whole year

Primary outcomes:
measure: Change in Maslach Burnout Inventory (MBI) Scores - emotional exhaustion
timeFrame: Baseline through Month 6
measure: Change in Maslach Burnout Inventory (MBI) Scores - emotional exhaustion
timeFrame: Baseline through Month 3
measure: Change in Maslach Burnout Inventory (MBI) Scores - depersonalization
timeFrame: Baseline through Month 3
measure: Change in Maslach Burnout Inventory (MBI) Scores - depersonalization
timeFrame: Baseline through Month 6
measure: Change in Maslach Burnout Inventory (MBI) Scores - personal achievement
timeFrame: Baseline through Month 3
measure: Change in Maslach Burnout Inventory (MBI) Scores - personal achievement
timeFrame: Baseline through Month 6
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wake Forest Health Sciences
name: Lyndsay Madden, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00652847: Randomized Parallel Group Trial Of The Efficacy And Safety Of Ezetimibe With A Statin Versus Statin Dose Doubling In Patients With Persistent Primary Hypercholesterolemia (0653-152)(COMPLETED)
Official title: Randomized Parallel Group Trial Of The Efficacy And Safety Of Ezetimibe With A Statin Versus Statin Dose Doubling In Patients With Persistent Primary Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypercholesterolemia
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2008-04-04
Enrollment: 1140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the percent (%) change in plasma LDL-C concentration, after a six week course of treatment with ezetimibe 10 mg/day co-administered with an existing statin versus doubling of the existing statin dose


Eligibility criteria: Inclusion Criteria:

* Patients With A Diagnosis Of Primary Hypercholesterolemia And
* Who Are Defined As Being "High Risk" (10-Year Risk Of Coronary Artery Disease \> 20 % Based On The Framingham Model Or History Of Diabetes Mellitus Or Any Atherosclerosis Disease)
* And Have Not Reached Their Recommended Ldl-C Target Levels Of 2.5 Mmol/L While On A Statin Alone

Exclusion Criteria:

-

Primary outcomes:
measure: The primary measure of efficacy will be the percent change in plasma LDL-cholesterol between baseline and the final study assessment after six weeks of treatment.
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Shekhar Pandey A, Bissonnette S, Boukas S, Rampakakis E, Sampalis JS. Effectiveness and tolerability of ezetimibe co-administered with statins versus statin dose-doubling in high-risk patients with persistent hyperlipidemia: The EZE(STAT)2 trial. Arch Med Sci. 2011 Oct;7(5):767-75. doi: 10.5114/aoms.2011.25550. Epub 2011 Nov 8.
Clinical trial NCT06115447: Polypropylene vs Polyglactin in Suturing of the Lung
Official title: Polypropylene vs Polyglactin in Suturing of the Lung
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Lung Injury
Bleb Lung
Lung Cancer
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-11-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients presented to cardiothoracic surgery department and trauma department with the inclusion criteria applied

Brief summary: Comparative study comparing polypropylene and Polyglactin in suturing of the lung

Detailed description: Lung tear or, pulmonary laceration is an injury in lung parenchyma, said injury can be caused by several reasons:

Blunt chest trauma Penetrating trauma such as stab wounds or firearm wounds Iatrogenic, such as faulty intercostal tube insertion

Eligibility criteria: Inclusion Criteria:

* Patients admitted to Assiut University Hospital And will undergo surgery for lung tear repair.
* Patients admitted to Assiut University Hospital And will undergo surgery for bullectomy or lobectomy.

Exclusion Criteria:

* Patients with lung injury repaired with a stapler

Primary outcomes:
measure: duration in days of intercostal tube air leak with each group
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Regan T, Lawrence N. Comparison of poliglecaprone-25 and polyglactin-910 in cutaneous surgery. Dermatol Surg. 2013 Sep;39(9):1340-4. doi: 10.1111/dsu.12265. Epub 2013 Aug 13.
citation: Rendeki S, Molnar TF. Pulmonary contusion. J Thorac Dis. 2019 Feb;11(Suppl 2):S141-S151. doi: 10.21037/jtd.2018.11.53.
citation: Romby P, Carbon P, Westhof E, Ehresmann C, Ebel JP, Ehresmann B, Giege R. Importance of conserved residues for the conformation of the T-loop in tRNAs. J Biomol Struct Dyn. 1987 Dec;5(3):669-87. doi: 10.1080/07391102.1987.10506419.