louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04301817: Changes in Optic Nerve Sheath Diameter in Patients Undergoing Spinal Surgery in the Prone Position
Official title: Changes in Optic Nerve Sheath Diameter in Patients Undergoing Spinal Surgery in the Prone Position
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Optic Nerve Sheath Diameter
Lead sponsor: SMG-SNU Boramae Medical Center
Sponsor class: OTHER
First posted: 2020-03-10
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing prone position surgery in out institute.

Brief summary: Long standing prone position could affect vision or optic nerve. To measure the optic nerve sheath diameter using ultrasound is quick and useful assessments of patients.

This study will look at the change of optic nerve sheath diameters of patients undergoing surgery in prone position


Eligibility criteria: Inclusion Criteria:

* Patients undergoing surgery in prone position

Exclusion Criteria:

* Patients who did not agree to participate in the study
* Patients has ophthalmic diseases
* Patients has previous history of ophthalmic surgery.
* Patients has neurological disorders.
* Patients has history of head surgery.
* Severe anaphylactic allergy to ultrasound gel or Tegaderm

Primary outcomes:
measure: Change optic nerve sheath diameter
timeFrame: 0,1,3,6,24 and 48 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Yu J, Hong JH, Park JY, Hwang JH, Cho SS, Kim YK. Propofol attenuates the increase of sonographic optic nerve sheath diameter during robot-assisted laparoscopic prostatectomy: a randomized clinical trial. BMC Anesthesiol. 2018 Jun 20;18(1):72. doi: 10.1186/s12871-018-0523-7.
citation: Chin JH, Seo H, Lee EH, Lee J, Hong JH, Hwang JH, Kim YK. Sonographic optic nerve sheath diameter as a surrogate measure for intracranial pressure in anesthetized patients in the Trendelenburg position. BMC Anesthesiol. 2015 Mar 31;15:43. doi: 10.1186/s12871-015-0025-9. eCollection 2015.
Clinical trial NCT03459417: Safety and Efficacy of Intrathecally Administered Magnesium Sulfate
Official title: Safety and Efficacy of Intrathecally Administered Magnesium Sulfate Added to Morphine and Local Anesthetics for Major Abdominal Cancer Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Cancer
Abdominal Pain
Lead sponsor: South Egypt Cancer Institute
Sponsor class: OTHER
First posted: 2018-03-08
Enrollment: 90
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Magnesium sulfate safety profile has been documented by histopathological analysis in experimental studies. magnesium sulfate added to local anesthetics decrease postoperative opioid requirements.

Detailed description: Spinal anesthesia is commonly used for the major abdominal cancer surgery because of decreasing the risks of general anesthesia.The quality and duration of sensory and motor block and decrease post operative pain is important in the major abdominal cancer surgery and patient's content satisfaction. Opioids in high doses and other drug such as clonidine and neostigmine added to local anesthetics to this purpose, but significant side effects.

Magnesium sulfate block the N- methyle -D- aspartate (NMDA) channels in a voltage-dependent way to be improve the quality and duration of spinal block. However, the use of magnesium sulfate safety profile has been documented by histopathological analysis in experimental studies. Systemic delivery of magnesium sulfate decrease postoperative opioid requirements. In experimental studies, spinal injection of magnesium sulfate reduces the respond to painful stimulus in rats.

Eligibility criteria: Inclusion Criteria:

* patients with ASA physical status II or III, 21-year-old or older with major abdominal cancer surgery

Exclusion Criteria:

* significant coexisting, hepatorenal, or other end organ disease, obesity (BMI \> 38 kg/m2), contraindication to regional anesthesia and sensitivity to local anesthetic drugs

Primary outcomes:
measure: change pain sensation using VAS scores
timeFrame: at 0, 4, 8, 12, 18, 24, 36 and 48 hours post operative
Secondary outcomes:
measure: change in MAP
timeFrame: at 0, 4, 8, 12, 18, 24, 36 and 48 hours post operative
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: South Egypt Cancer Institute, Assiut University, Arab Republic of Egypt
Study officials:
References:
Clinical trial NCT01076517: A Humanitarian Device Exemption Treatment Protocol of TheraSphere For Treatment of Unresectable Hepatocellular Carcinoma
Official title: A Humanitarian Device Exemption Treatment Protocol of TheraSphere For Treatment of Unresectable Hepatocellular Carcinoma
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Liver Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: BTG International Inc.
First posted: 2010-02-26
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To provide Therasphere treatment for patients diagnosed with unresectable liver cancer.


Eligibility criteria: Inclusion Criteria:

Patients of any age, of any race or sex, who have hepatocellular carcinoma of the liver, and who are able to give informed consent, will be eligible. Patients must have an ECOG Performance Status score of \</= 2, with a life expectancy of \>/= 3 months, non-pregnant with an acceptable contraception in premenopausal women. Patients must be \>4 weeks since prior radiation or prior surgery and at least 1 month post other chemotherapy.

Exclusion Criteria:

* Contraindications to angiography and selective visceral catheterization
* Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs
* Evidence of any detectable Tc-99m MAA flow to the stomach or duodenum, after application of established angiographic techniques to stop or mitigate such flow (ex. placing catheter distal to gastric vessels)
* Significant extrahepatic disease representing an imminent life-threatening outcome
* Severe liver dysfunction or pulmonary insufficiency
* Active uncontrolled infection
* Significant underlying medical or psychiatric illness
* Pregnancy

Patients will be excluded: if they have a co-morbid disease or an acute or chronic condition that would preclude safe delivery of TheraSphere treatment and place the patient at undue risk.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Daniel Yung-Ho Sze
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02865317: Cortical Effects of Peripheral Nerve Injury At Birth
Official title: Investigating the Long-Term Cortical Effects of Peripheral Nerve Injury At Birth
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Peripheral Nerve Injury
Lead sponsor: Gazi University
Sponsor class: OTHER
Collaborators: name: Ataturk Training and Research Hospital
First posted: 2016-08-12
Enrollment: 15
Sex: ALL
Minimum age (years): 10
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with obstetrical brachial plexus palsy

Brief summary: Cortical activity during rest and with stimulation by functional magnetic resonance imaging will be investigated in patients with OBPI.

Detailed description: Peripheral nerve injury results in a number of cortical changes due to the lack of sensory and motor stimuli. Although functional magnetic resonance imaging (fMRI) studies that revealed the changes in the cortical activation exist, the cortical activation changes in obstetrical brachial plexus injury is poorly known. For this reason, the aim of this study is to investigate the cortical activity during rest and with stimulation by fMRI in patients with OBPI.

Patients with OBPI diagnosis in the cervical 5-6 (C5-6) (upper trunk) who are followed up in Gazi University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation Division of Hand Rehabilitation will participate in the study. Patients with a surgery history at least 5 years ago and over 10 years age will be included. Clinical motor and sensory assessments will be performed to help in explaining the analyses of cortical activation. In their first visit, clinical assessments including Active Movement Scale, modified Mallet Classification (MMC) and sensory tests will be performed; while fMRI scanning will be carried out in the second visit. Patients will be scanned for 3 paradigms at one single fMRI session: at rest and during sensory stimulation and watching videos of motor movements. Video images will include the 5 movements used in MMC and will be watched by glasses integrated in the MRI device. Images obtained from MR scanning will be analyzed with analysis programs like Leonardo, Fresurfer, SPM, BrainVoyager and clinical results will be compared to MR images.

Eligibility criteria: Inclusion Criteria:

* upper trunk (cervical 5-6) involvement
* cooperated

Exclusion Criteria:

* illiterate
* surgical history for his arm in the previous 5 years
* other than only C5-6 involvement
* any impairment that prevents positioning in MRI machine

Primary outcomes:
measure: voxels
timeFrame: 6 months
Secondary outcomes:
measure: Active Movement Scale score
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00854217: Cardioprotective Effects of Endogenous Erythropoietin in Patients Undergoing Coronary Artery Bypass Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Surgery
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2009-03-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Several studies have highlighted the cardioprotective effects of acute normovolemic hemodilution during cardiac surgery. The aim of our study is to show that an increase in endogenous erythropoietin (EPO) might explain the cardioprotective effects of acute normovolemic hemodilution against ischemia-reperfusion phenomena.

Detailed description: The major physiologic function of EPO is thought to be the induction of erythropoiesis. However, a growing body of evidence indicates that EPO has tissue-protective effects and prevents tissue damage during ischemia. In an ex vivo proof-of-concept, protective effects of EPO have been shown in human myocardium.

Several studies have demonstrated that acute normovolemic hemodilution before aortic cross clamping decreases perioperative myocardial damage. We hypothesized that the onset of acute anemia increases the endogenous EPO concentration, which explains the cardioprotective effects of acute normovolemic hemodilution.

Eligibility criteria: Inclusion Criteria:

* patients between 18 and 80 years old undergoing CABG with or without cardiopulmonary bypass

Exclusion Criteria:

* emergencies
* redo operations
* combined surgery
* men with Hb\< 120g/dL and women with Hb\< 110g/ dL
* patients with preoperative creatinine\> 2.2 mg/dL
* poor ventricular function (EF \< 50%)
* subjects with a pulmonary disease, hepatic disease
* subjects with carotid stenosis

Primary outcomes:
measure: Decrease in Troponin -I values
timeFrame: 4 h
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques Universitaires saint Luc
Study officials:
References:
citation: Licker M, Sierra J, Kalangos A, Panos A, Diaper J, Ellenberger C. Cardioprotective effects of acute normovolemic hemodilution in patients with severe aortic stenosis undergoing valve replacement. Transfusion. 2007 Feb;47(2):341-50. doi: 10.1111/j.1537-2995.2007.01111.x.
citation: Licker M, Ellenberger C, Sierra J, Kalangos A, Diaper J, Morel D. Cardioprotective effects of acute normovolemic hemodilution in patients undergoing coronary artery bypass surgery. Chest. 2005 Aug;128(2):838-47. doi: 10.1378/chest.128.2.838.
Clinical trial NCT06004817: Evaluation of Severity in Juvenile and Adult-onset Dermatomyositis
Official title: Evaluation of Severity in Juvenile Dermatomyositis and Adult-onset Dermatomyositis: a National Multicentric Retrospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dermatomyositis
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2023-08-22
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients followed in pediatric and adult units during January 2010 and December 2022

Brief summary: Dermatomyositis (DM) are rare and heterogeneous systemic autoimmune diseases, characterized by the association of muscle inflammation, skin inflammation and vasculopathy. DM concern both adults and children. DM can be life-threatening (interstitial lung disease, infectious complications) and responsible of significant functional disability (muscle weakness). Age of onset appear to be an independent prognostic factor. Juvenile-onset DM is characterized by a higher frequency of calcinosis, skin ulceration and digestive vasculitis. In adults, interstitial lung disease and cancer are more frequent with higher mortality. Data concerning the comparison of the initial severity between juvenile and adult-onset DM are limited.

The main objective is to compare global severity between juvenile DM and adult-onset DM at initial diagnosis.

Secondary objectives are:

* to compare organ-specific severity between juvenile DM and adult-onset DM at diagnosis.
* to compare damage during follow-up and at last follow-up between juvenile DM and adult-onset DM.
* to compare activity at the last follow-up between juvenile DM and adult-onset DM.
* to compare iatrogenic complications between juvenile DM and adult-onset DM.


Eligibility criteria: Inclusion Criteria:

* Patient with dermatomyositis according to 2017 American College of Rheumatology (ACR)/ European Alliance of Associations for Rheumatology (EULAR) classification

Exclusion Criteria:

* Patient with cancer-associated dermatomyositis (within 3 years before or after diagnosis of dermatomyositis)
* Patient with antisynthetase syndrome

Primary outcomes:
measure: number of patients with global severity
timeFrame: baseline (J0)
Secondary outcomes:
measure: number of patients with muscular severity
timeFrame: baseline (J0)
measure: number of patients with pulmonary severity
timeFrame: baseline (J0)
measure: number of patients with digestive severity
timeFrame: baseline (J0)
measure: number of patients with cutaneous severity
timeFrame: baseline (J0)
measure: myositis damage index (MDI) score
timeFrame: 2 years of follow-up, at 5 years of follow-up and at last follow-up
measure: number of patients with remission at last follow-up
timeFrame: up to 10 years
measure: number of patients with disease activity at last follow-up
timeFrame: up to 10 years
Other outcomes:
Locations:
city: Nancy
country: France
facility: Chu Nancy
Study officials:
affiliation: CHU NANCY
name: Paul Decker, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06823817: Quality Control of Colposcopy Application
Official title: Quality Control of Colposcopy Application: a Retrospective Cohort Study in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Cancers
Cervical Intraepithelial Neoplasia (CIN)
Keywords: Cervical Cancers
Cervical Intraepithelial Neoplasia
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2025-02-12
Enrollment: 10000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The outpatient population of our hospital since 2005 10,000 cases are expected to be included.

Brief summary: Colposcopy has become an important link and tool in the prevention and treatment of cervical cancer. The quality and pathological assessment of colposcopy is a key point in follow-up and treatment.The main purpose of this study was to analyze the correlation between colposcopy indications and pathological findings.

Detailed description: 1. inclusion/exclusion criteria inclusion：(1) at least 18 years of age; (2) Complete colposcopy report; (3) Clear pathological diagnosis was reported after colposcopic biopsy.

   exclusion：Not all of the above criteria are met
2. study purpose Main purpose

1）analyze the correlation between colposcopy indications and pathological findings Secondary purpose

1. Influence of colposcopic transformation area type on pathological evaluation
2. Colposcopic follow-up results
3. The differences and causes of colposcopic biopsy pathology and histology
4. Quality of colposcopy in our hospital （3）Retrospective study Data of out-patient population in our hospital from 2005 were included

Eligibility criteria: Inclusion Criteria:

1. at least 18 years of age;
2. Complete colposcopy report;
3. Clear pathological diagnosis was reported after colposcopic biopsy.

Exclusion Criteria:

1. Under 18 years of age;
2. Lack of colposcopic reports;
3. Lack of cervical biopsy pathology results;
4. Other conditions deemed inappropriate by the investigator to participate in this study.

Primary outcomes:
measure: Correlation between colposcopic results and histopathology
timeFrame: Since this study was a retrospective study, colposcopic biopsy results were available at the time of enrollment. Pathological results were available on average 14 days after colposcopy.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01257217: A Comparison of Visual Function After Bilateral Implantation of Presbyopia-Correcting Intraocular Lenses (IOLs)
Official title: A Randomized, Subject-Masked Comparison of Visual Function After Bilateral Implantation of Presbyopia-Correcting IOLs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Keywords: Intraocular Lens
Presbyopia
multifocal
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2010-12-09
Enrollment: 31
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate visual and refractive parameters in a series of subjects bilaterally implanted with presbyopia-correcting intraocular lenses (IOLs) during cataract surgery.

Detailed description: Each subject completed a preoperative examination of both eyes, implantation of IOL at the operative visit for each eye, and up to 4 postoperative visits (each eye examined at Day 1-2, with binocular visits at Month 1 and Month 3 after the second implantation). The second implantation occurred within 30 days of the first.

Eligibility criteria: Inclusion Criteria:

* Sign informed consent;
* Able to attend postoperative examinations per protocol schedule;
* Diagnosed with bilateral cataracts;
* Planned cataract removal by phacoemulsification with implantation of an intraocular lens (IOL);
* Preoperative astigmatism ≤ 2.5 diopter;
* Good ocular health, with the exception of cataracts;
* Free of disease(s)/condition(s) listed in the "Caution" section of the AcrySof IQ and Acri.LISA package inserts;
* Able to undergo second eye surgery within one month of the first eye surgery;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Previous corneal surgery;
* Planned multiple procedures during cataract/IOL implantation surgery;
* Any ocular disease and/or condition that may compromise study results;
* Pregnant or planning pregnancy during course of study;
* History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.)
* Diabetic retinopathy;
* Macular degeneration;
* History of retinal detachment;
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Mean Binocular Defocus VA at Month 3
timeFrame: Month 3 from second eye implantation
Secondary outcomes:
measure: Best Corrected Visual Acuity (BCVA) Across a Range of Distances at Month 3
timeFrame: Month 3 from second eye implantation
measure: Uncorrected Visual Acuity Across a Range of Distances at Month 3
timeFrame: Month 3 from second eye implantation
measure: Mean Refractive Spherical Equivalent at Month 3
timeFrame: Month 3 from second eye implantation
measure: Mean Radner Reading Speed
timeFrame: Month 3 from second eye implantation
measure: Patient Reported Outcomes at Month 3
timeFrame: Month 3 from second eye implantation
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Brand Lead, Surgical, Global Medical Affairs
role: STUDY_DIRECTOR
References:
Clinical trial NCT00117117: A Study to Assess Symptom Burden in Subjects With Nonmyeloid Malignancies Receiving Chemotherapy and Aranesp®
Official title: A Study to Assess Symptom Burden in Subjects With Nonmyeloid Malignancies Receiving Chemotherapy and Aranesp®
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anemia
Keywords: Chemotherapy induced anemia
Amgen
Aranesp®
darbepoetin alfa
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2005-07-04
Enrollment: 2423
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to prospectively assess the relationship between changes in hemoglobin (hgb) and changes in symptom burden associated with anemia in cancer patients receiving chemotherapy supported with Aranesp®.


Eligibility criteria: Inclusion Criteria:

* Subjects with nonmyeloid malignancy(ies)
* Anemia (hgb less than or equal to 11.0 g/dL) due to cancer and chemotherapy

Exclusion Criteria:

* Subjects with acute myelogenous leukemia (AML), chronic myelogenous leukemia (CML), myelodysplastic syndromes (MDS)
* Unstable cardiac disease or anemia due to other causes

Primary outcomes:
measure: Patient reported outcomes
Secondary outcomes:
measure: Changes in hemoglobin endpoints and RBC transfusion requirements
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Gregory SA. Efficacy of Darbepoetin Alfa in the Treatment of Chemotherapy-Induced Anemia in Non-Hodgkin's Lymphoma. Support Cancer Ther. 2006 Jul 1;3(4):232-9. doi: 10.3816/SCT.2006.n.021.
citation: Gabrilove JL, Perez EA, Tomita DK, Rossi G, Cleeland CS. Assessing symptom burden using the M. D. Anderson symptom inventory in patients with chemotherapy-induced anemia: results of a multicenter, open-label study (SURPASS) of patients treated with darbepoetin-alpha at a dose of 200 microg every 2 weeks. Cancer. 2007 Oct 1;110(7):1629-40. doi: 10.1002/cncr.22943.