louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04955925: Effect of Sevoflurane and Propofol on the Optic Nerve Sheath Diameter
Official title: Comparison of the Effect of Sevoflurane and Propofol on the Optic Nerve Sheath Diameter in Patients Undergoing Middle Ear Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Optic Nerve Sheath Diameter
Lead sponsor: SMG-SNU Boramae Medical Center
Sponsor class: OTHER
First posted: 2021-07-09
Enrollment: 58
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing middle ear surgery under general anesthesia

Brief summary: In the present study, we compare the effect of sevoflurane and propofol on the optic nerve sheath diameter in patients undergoing middle ear surgery.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing middle ear surgery

Exclusion Criteria:

* History of cerebrovascular diseases
* Increased intracranial pressure
* History of ophthalmic surgery or diseases

Primary outcomes:
measure: Change of the optic nerve sheath diameter
timeFrame: At 1 minute after the induction of anesthesia and at 1 minute after the end of surgery
Secondary outcomes:
measure: Optic nerve sheath diameter at each time point
timeFrame: At 1 minute after the induction of anesthesia and at 1 minute after the end of surgery
measure: Nausea and vomiting
timeFrame: At 1 hour after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center
Study officials:
References:
Clinical trial NCT00288925: Z-360 in Unresectable Advanced Pancreatic Cancer in Combination With Gemcitabine Treatment
Official title: Phase Ib/IIa, to Evaluate the Safety and Pharmacokinetics of Z-360 in Subjects With Unresectable Advanced Pancreatic Cancer in Combination With Gemcitabine Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Pancreatic Cancer
Lead sponsor: Zeria Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2006-02-08
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the safety of two doses of Z-360 with Gemcitabine administration for subjects with unresectable advanced pancreatic cancer in order to determine the optimal dosage for PhaseII study


Eligibility criteria: Inclusion Criteria:

* Subjects with unresectable locally advanced or metastatic pancreatic cancer
* KPS \> 70%
* Life expectancy of at least 3 months

Exclusion Criteria:

* received previous chemotherapy for the current indication
* received previous radiotherapy for the current indication
* Currently receiving chemotherapy

Primary outcomes:
measure: Safety, Pharmacokinetics
Secondary outcomes:
measure: Tumour shrinkage, Tumour objective response rate
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal Free Hospital
Study officials:
affiliation: Royal Free Hospital NHS Foundation Trust
name: Tim Meyer, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03031925: Detection of Annexin A2 in Systemic Lupus Erythematosus
Official title: Detection of Annexin A2 in Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Systemic Lupus Erythematosus (SLE)
Lupus Nephritis
Keywords: Annexin A2
biomarker
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2017-01-26
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: There is substantial clinical and biological intra and inter-patient variability in SLE. Vascular, renal and neurologic deficiency can be organ-threatening or even life-threatening, leading to increased morbidity and mortality.

Thus, biomarkers of disease activity and prognosis are required for regular follow-up of SLE patients.

Implication of Toll-like Receptors (TLRs) in SLE has been extensively studied in mice models and humans. Self nuclear antigens bind to TLRs which are located on the surface of dendritic cells, B-cells, and endothelial cells, leading to production of pro-inflammatory cytokines and pathologic autoantibodies involved in organ dysfunction of SLE patients. Moreover, TLR expression in SLE is significantly higher and significantly correlated with disease activity.

Annexin A2 (ANXA2) is a member of the annexins superfamily which exists as a monomer or heterotetramer and is implicated in several biological processes. Most notably, it binds to ẞ2GP1/anti-ẞ2GP1 antibodies and mediates endothelial cell activation via a TLR4 signaling pathway, highlighting its key role in Antiphospholipid Syndrome (APS) frequently associated with SLE.

ANXA2 is also involved in the physiopathology of SLE. Anti-DNA autoantibodies can bind with ANXA2 expressed on mesangial cells in lupus nephritis. Besides, a french study carried out in Amiens' University Hospital showed that vascular lesions in lupus nephritis were associated with a significant increase in vascular expression of ANXA2.


Eligibility criteria: Inclusion Criteria:

Inclusion criteria for patients :

* Age ≥ 18 years old
* All SLE patients fulfilling the 1997 ACR criteria, followed at the Departments of Internal Medicine and Nephrology at CHU Amiens-Picardie, regardless of clinical status, treatment, and disease activity.
* Written informed consent

Inclusion criteria for control subjects :

* Age ≥ 18 years old
* Written informed consent

The patients will be compared with age- and sex-matched control subjects.

Exclusion Criteria:

* drug-induced lupus erythematosus
* refusal or incapacity to provide a written informed consent

Primary outcomes:
measure: serum concentration of ANXA2
timeFrame: Day 0
measure: urinary concentration of ANXA2
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
affiliation: CHU Amiens
name: Valéry SALLE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00195325: Study Evaluating TTI-237 in Advanced Malignant Solid Tumors.
Official title: A Phase 1 Dose Escalation Study of TTI-237 Administered Intravenously (IV) Once Weekly in Subjects With Advanced Malignant Solid Tumors.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Tumors
Neoplasms
Keywords: Advanced Malignant Solid Tumors
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: ECT

Brief summary: The purpose of this study is to evaluate the safety, tolerability, and MTD (maximum tolerated dose) of TTI-237 for the treatment of subjects with advanced malignant solid tumors.


Eligibility criteria: Inclusion Criteria:

* Documented diagnosis of malignant solid tumor with measurable disease
* Life expectancy of at least 12 weeks
* ECOG (The Eastern Cooperative Oncology Group scale) performance status of 0, 1, or 2

Exclusion Criteria:

* Recent major surgery, radiation therapy or anti-cancer treatment
* History of any other prior malignancy within the last 5 years

Primary outcomes:
measure: To determine safety, tolerability, and MTD of TTI-237 - patients are monitored during the duration of their participation on the trial.
Secondary outcomes:
measure: Preliminary pharmacokinetics (during cycle 1) and anti-tumor activity of TTI-237 (approximately every 8 weeks).
Other outcomes:
Locations:
city: Lexington
country: United States
state: Kentucky
city: Cleveland
country: United States
state: Ohio
city: Nashville
country: United States
state: Tennessee
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04669925: COVID-19 Impact on the Lombardy Region's Emergency System
Official title: Tsunami Project - Description and Prediction of COVID-19 Impact on the Lombardy Region's Emergency System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Keywords: Emergency Department
Emergency Medical Services
Lead sponsor: Mario Negri Institute for Pharmacological Research
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 10000
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: patients who asked for assistance to the Lombardy region's emergency system during the pandemic period and the previous two years

Brief summary: This study has 3 main goals:

* to quantitavely describe the Covid-19 impact on the organization and functioning of the Lombardy's emergency system;
* to create statistical model able to predict the flow of patients to the emergency room during the epidemic period and their destination (ex: discharge, hospitalization, death);
* to value the impact on the non Covid-19 patients, both for their possibility to receive medical treatment and as an outcome on their health

Detailed description: The aim of this study is to evaluate the impact that Covid-19 had on the Emergency System of Lombardy. For instance, it affected the job organization and the possibility of responding to general health needs.

First of all, the study will consider the calls to the Emergency Medical Service, the number of accesses to the Emergency Department, the waiting time before hospitalization, the ED output home (discharge, hospitalization, death, self-discharge before the end of the visit).

Secondly, a statistical model will be implemented, in order to predict the number of patients in need of hospitalization for each day during the pandemic period. This model could help the re-organization of the hospital itself in case of a new Covid-19 outbreak.

Finally, it will evaluate the impact on non-Covid patients, to see the difference in the mortality trends and their possiblity to be cured in a proper way.

Eligibility criteria: Inclusion Criteria:

* over 18y

Exclusion Criteria:

* none

Primary outcomes:
measure: Daily calls to the Emergency System
timeFrame: jan 2020 - dec 2020
measure: Daily count of Emergency Department visits
timeFrame: jan 2020 - dec 2020
measure: Daily average boarding time
timeFrame: jan 2020 - dec 2020
measure: Outcome at ED discharge
timeFrame: jan 2020 - dec 2020
measure: Mortality
timeFrame: jan 2020 - dec 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Bergamo
country: Italy
facility: Ospedale Papa Giovanni XXIII
city: Lodi
country: Italy
facility: Presidio Ospedaliero di Lodi
city: Milan
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
city: Milan
country: Italy
facility: Ospedale San Carlo Borromeo
Study officials:
affiliation: Istituto Di Ricerche Farmacologiche Mario Negri
name: Guido Bertolini
role: STUDY_CHAIR
References:
Clinical trial NCT01807325: RNA Sequencing of Solid and Cystic Lesions of the Pancreas
Official title: RNA Sequencing of Solid and Cystic Lesions of the Pancreas
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreas Cyst
Pancreas Mass
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Providence Health & Services
First posted: 2013-03-08
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adult, nonpregnant patients referred for endoscopic ultrasound to evaluate solid or cystic lesion of the pancreas.

Brief summary: The nature of cysts and solid masses in the pancreas can be difficult to diagnose. They may be benign, precancerous, or cancer. Current tests such as cytology (looking under a microscope) and tumor markers do not always give us the answer. The investigators are looking for genetic markers on biopsy specimens from the pancreas that will give us a better test for diagnosis. This study is only for diagnosing these lesions. The investigators are not treating any patients.


Eligibility criteria: Inclusion Criteria:

* greater than 18 years old,
* not pregnant,
* referred for endoscopic ultrasound,
* have a cyst or mass of the pancreas needing diagnosis.

Exclusion Criteria:

* pregnant,
* less than age 18,
* no mass or cyst found.

Primary outcomes:
measure: Gene classifier that will classify lesions as benign or malignant with 95% certainty
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Providence St Vincent Hospital
state: Oregon
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Sarah Rodriguez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00547625: Study to Determine Safety and Effectiveness of Tadalafil on Prostate Related Sex Organ/Urinary Tract Problems
Official title: A Multicenter, Parallel-Arm, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of Tadalafil Administered Once Daily to Men With Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostatic Hyperplasia
Prostate
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: ICOS Corporation
First posted: 2007-10-22
Enrollment: 275
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study to look at safety and effectiveness of different doses of tadalafil on prostate related genital/urinary tract problems.


Eligibility criteria: Inclusion Criteria:

* 6 month history of lower urinary tract symptoms either obstructive and/or irritative secondary to prostate related problems as diagnosed by a urologist.
* Stopped using treatments at least four weeks prior to study and agree to not use any other treatments during the study.
* Meet required prostate symptom score and urine flow rate.

Exclusion Criteria:

* Serum prostate specific antigen (PSA) greater than 10 (between 4 and 10, inclusive, without a negative biopsy w/in the last 6 months.
* Prostate removal and various other pelvic surgeries.
* Neurological disease or condition known to affect the bladder.
* Clinical evidence of prostate cancer, urinary tract inflammation or infection, including prostatitis.
* Have taken medications such as nitrates, finasteride, or dutasteride within the year.

Primary outcomes:
measure: International Prostate Symptom Score (IPSS) sum total of questions 1-7
timeFrame: 6 and 12 weeks
Secondary outcomes:
measure: Evaluate different domains of the IPSS sums along with other questionnaires such as the LUTS GAQ and BII.
timeFrame: 12 weeks
measure: Measure Uroflowmetry parameters
timeFrame: 12 weeks
measure: Evaluate safety by PSA levels and postvoid residual volume (PVR)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon- Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Illinois
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT04036825: Liquid Nutritional Supplement on Malnutrition Hospitalized Patient
Official title: Effectivity of Liquid Nutritional Supplementation in Improving Nutritional Status of Hospitalized Malnutrition Patients: A Single-Blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Malnutrition
Keywords: Liquid Nutritional Supplement
Lead sponsor: Fakultas Kedokteran Universitas Indonesia
Sponsor class: OTHER
First posted: 2019-07-30
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to know the effectivity of liquid nutritional supplementation in malnutrition hospitalized patients


Eligibility criteria: Inclusion Criteria:

* aged ≥ 18 years old to 60 years old
* malnutrition hospitalized patient based on European Society for Clinical Nutrition and Metabolism (ESPEN) 2015 criteria
* agreed to participate

Exclusion Criteria:

* malignancy
* chronic kidney disease stage III-V
* decompensated hepatic cirrhosis
* allergic to milk or lactose intolerance
* could not be randomised and participate in this study by clinical judgement

Primary outcomes:
measure: Change of Body Mass Index (BMI)
timeFrame: 0 and 14 days
Secondary outcomes:
measure: Change of Subjective Global Assessment (SGA) rank
timeFrame: 0 and 14 days
measure: Change of body fat percentage
timeFrame: 0 and 14 days
measure: Change of handgrip strength test score
timeFrame: 0 and 14 days
measure: Change of hemoglobin level
timeFrame: 0 and 14 days
measure: Change of prealbumin level
timeFrame: 0 and 14 days
measure: Change of Blood Urea Nitrogen (BUN) level
timeFrame: 0 and 14 days
measure: Change of lipid profile level
timeFrame: 0 and 14 days
measure: Change of blood glucose level
timeFrame: 0 and 14 days
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: RSUPN dr. Cipto Mangunkusumo (Cipto Mangunkusumo Hospital)
Study officials:
affiliation: Division Of Gastroenterology Department Of Internal Medicine Faculty Of Medicine Universitas Indonesia
name: Marcellus Simadibrata
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01302925: PEP005 Gel - Evaluation of Local Tolerability After Exposure to Ingenol Mebutate Gel Followed by Hand Washing in Healthy Subjects
Official title: PEP005 Gel - Evaluation of Local Tolerability After Exposure to Ingenol Mebutate 0.05% and 0.015% Gel Followed by Hand Washing in Healthy Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Actinic Keratosis
Lead sponsor: Peplin
Sponsor class: INDUSTRY
Collaborators: name: LEO Pharma
First posted: 2011-02-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this phase 1 trial is to investigate the local tolerability on the finger following exposure to PEP005 Gel 0.015% or 0.05% and hand washing once daily, for 2 or 3 consecutive days.


Eligibility criteria: Inclusion Criteria:

* Must be male or female and at least 18 years of age
* Female patients must be of: non-childbearing potential or if of childbearing potential then have a negative serum and urine pregnancy test and using effective contraception
* Ability to provide informed consent

Exclusion Criteria:

* Have received treatment with immunomodulators, or interferon/interferon inducers or systematic medications that suppress the immune system in the last 4 weeks
* Exposed to prescribed systemic (take as tablet, injection etc) or topical (gel, cream, lotion) medication within the last 7 days
* Have any signs of skin irritation or damaged skin at or around the dominant index finger
* Have worked in an occupation with a high risk of being in contact with irritative material (eg. chemicals, painting) on their hands, especially fingers
* Those who are currently participating in any other clinical trial
* Those known or suspected of not being able to comply with the requirements of the protocol
* Females who are pregnant or are breastfeeding

Primary outcomes:
measure: Local Skin Responses
timeFrame: Up to 8 days
Secondary outcomes:
Other outcomes:
Locations:
city: Paramus
country: United States
facility: TKL Research
state: New Jersey
Study officials:
affiliation: TKL Research
name: Jonathan Dosik, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06508125: Cross-linked and Non-cross-linked Hyaluronic Acid in Subdeltoid Bursitis
Official title: Comparing the Efficacy of Cross-Linked and Non-Cross-Linked Hyaluronic Acid in Treating Subdeltoid Bursitis: A Double-Blind, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Subdeltoid Bursitis
Hyaluronic Acid
Keywords: Subdeltoid Bursitis
Hyaluronic acid
cross linked
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2024-07-18
Enrollment: 52
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to compare the efficacy of different structures of hyaluronic acid, namely cross-linked and non-cross-linked hyaluronic acid, in treating subdeltoid bursitis.

Detailed description: A double-blind, randomized clinical trial will be conducted to collect 52 patients with subdeltoid bursitis. The patients will be injected with cross-linked or non-cross-linked hyaluronic acid under ultrasound guidance. Before treatment, one week after treatment (i.e., one week after injection), one month after treatment, and three months after treatment to detect shoulder pain (visual analog scale; pressure ergometer to measure pain pressure threshold), function (including Disabilities of the Arm, Shoulder, and Hand: DASH and Shoulder Pain and Disability Index: SPADI), quality of life (Brief version of the World Health Organization Quality of Life Scale: WHOQOL-BREF) will be arranged.

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of subdeltoid bursitis
* age 20 or older 20
* at least one positive in the painful arc, neer test, or Hawkins test
* can attend three months of intervention and follow-up

Exclusion Criteria:

* history of malignancy
* previous shoulder operation or injury
* previous shoulder injections in the past three months

Primary outcomes:
measure: Shoulder pain and disability index
timeFrame: score change from baseline to 1 week, 1 month and 3 months after treatment
Secondary outcomes:
measure: Disabilities of the arm, shoulder, and hand
timeFrame: score change from baseline to 1 week, 1 month and 3 months after treatment
measure: Visual analog scale
timeFrame: score change from baseline to 1 week, 1 month and 3 months after treatment
measure: range of motion
timeFrame: score change from baseline to 1 week, 1 month and 3 months after treatment
measure: Brief version of the World Health Organization Quality of Life Scale
timeFrame: score change from baseline to 1 week, 1 month and 3 months after treatment
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Shin Kong Wu Ho-Su Memorial Hospital
Study officials:
affiliation: Shin Kong Wu Ho-Su Memorial Hospital
name: Ru-Lan Hsieh, MD
role: STUDY_CHAIR
References: