louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02132988: Trial of Active Immunotherapy With Globo H-KLH (OPT-822/821) in Women Who Have Non-Progressive Ovarian Cancer
Official title: An Open Labeled Phase II Trial of Active Immunotherapy With Globo H-KLH (OPT-822/821) in Women Who Have Non-Progressive Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Ovarian Cancer
Lead sponsor: Mackay Memorial Hospital
Sponsor class: OTHER
Collaborators: name: OBI Pharma, Inc
First posted: 2014-05-07
Enrollment: 110
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of OPT-822/OPT-821 on improving Progression-Free Survival (PFS) in subjects who have non-progressive epithelial ovarian, fallopian tube, or primary peritoneal cancer after cytoreductive surgery and platinum-based chemotherapy as initial treatment for primary disease or as salvage treatment for first relapse.


Eligibility criteria: Inclusion Criteria:

* Female subjects ≥ 21 years of age with histologically confirmed ≥ stage II epithelial ovarian, fallopian tube, and primary peritoneal cancer at diagnosis
* Who have not progressed after initial treatment with cytoreductive surgery and at least 4 cycles of platinum-based chemotherapy.

OR

* Female subjects ≥ 21 years of age with first relapsed epithelial ovarian, fallopian tube, and primary peritoneal cancer (regardless of stage at diagnosis)
* Who have not progressed after received at least 4 additional cycles of platinum-based chemotherapy with or without having undergone secondary cytoreductive surgery .

Exclusion Criteria:

* Subjects with evidence of disease progression according to the GCIG CA125 criteria or RECIST 1.1 criteria.
* Subjects who are currently receiving any other concomitant anticancer therapy.
* Subjects with evidence of extra-abdominal metastasis.

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: Until disease progression or up to 5 years after the enrollment
Secondary outcomes:
measure: Disease Recurrence Rate
timeFrame: At 2 years after the enrollment
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
Study officials:
References:
Clinical trial NCT02452788: Pharmaceutical Care in Ambulatory Hemodialysis Patients
Official title: Effectiveness of Pharmaceutical Care in Ambulatory Hemodialysis Patients: a Randomized Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Medication Adherence
Chronic Renal Diseases
Renal Failure Chronic Requiring Hemodialysis
Lead sponsor: Hospital Moinhos de Vento
Sponsor class: OTHER
First posted: 2015-05-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to evaluate the effectiveness of pharmaceutical care, compared to usual care, in improving medication adherence behaviour of ambulatory hemodialysis patients.


Eligibility criteria: Inclusion Criteria:

* Aged 18 years or more
* Chronic renal patients undergoing regular hemodialysis
* Receiving their scheduled medications (at least one drug)

Exclusion Criteria:

* Unable to answer the questionnaire or to sign the informed consent form
* Inability to obtain prescription drugs

Primary outcomes:
measure: Medication adherence
timeFrame: one month
Secondary outcomes:
measure: Quality of life
timeFrame: one month
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital Moinhos de Vento
state: Rio Grande do Sul
Study officials:
affiliation: Hospital Moinhos de Vento
name: Lisiane F Leal, MBA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03868488: Mental Imagery Tasks to Reduce Internet Gaming Disorder (IGD) Cravings
Official title: Mental Imagery Tasks to Reduce IGD Cravings: Visual Imagery and Auditory Imagery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Internet Gaming Disorder
Lead sponsor: Beijing Normal University
Sponsor class: OTHER
First posted: 2019-03-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: To test whether visual and auditory imagery tasks can effectively reduce the craving for IGD.

Detailed description: This project is to use imagery tasks to reduce the craving of internet gamers. To test whether visual and auditory imagery tasks can effectively reduce the craving for IGD. This project will be conducted in Beijing, China, based on a large sample of internet gamers.

Eligibility criteria: Inclusion Criteria:

* The scores of the 9 items of The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition(DSM-5) recommended diagnosis for Internet gaming disorder ≥ 5.
* Engagement in popular Internet games (e.g. Arena of Valor, League of Legends and Player Unknown's Battle Grounds) for over 20 hours per week for a minimum of 12 months.
* The scores of the Young-Internet Addiction Test(Y-IAT) ≥ 50

Exclusion Criteria:

* Current or history of use of illegal substances and gambling;
* Current or history of psychiatric or neurological illness;
* Current use of psychotropic medications.

Primary outcomes:
measure: The craving of internet gamers
timeFrame: 0-1 minutes before each set of cue
measure: The craving of internet gamers after cue
timeFrame: 0-1 minutes after showing cue
measure: The craving of internet gamers
timeFrame: 0-1 minutes after finishing each block of tasks
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: State Key Laboratory of Cognitive Neuroscience and Learning, Beijing Normal University
state: Beijing
Study officials:
affiliation: Beijing Normal University
name: Jin-Tao Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: May J, Andrade J, Panabokke N, Kavanagh D. Visuospatial tasks suppress craving for cigarettes. Behav Res Ther. 2010 Jun;48(6):476-85. doi: 10.1016/j.brat.2010.02.001. Epub 2010 Feb 7.
citation: Yates M, Kamboj SK. Alcohol related mental imagery: The effects of a priming dose in at risk drinkers. Addict Behav Rep. 2017 Aug 31;6:71-75. doi: 10.1016/j.abrep.2017.08.003. eCollection 2017 Dec.
Clinical trial NCT05197088: Tamsulosin Assisted Ureteral Access Sheath Insertion
Official title: Medication Facilitated Ureteral Access Sheath Deployment During Ureteroscopy: the Impact of One Week of Pre-operative Tamsulosin
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Renal Stone
Retrograde Intrarenal Surgery
Urolithiasis
Lead sponsor: Sengkang General Hospital
Sponsor class: OTHER
First posted: 2022-01-19
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Aim is to study if 1 week of pre operative tamsulosin would enable easier insertion of ureteral access sheath in primary retrograde intrarenal surgery for renal stone disease


Eligibility criteria: Inclusion Criteria:

* renal stone undergoing retrograde intrarenal surgery

Exclusion Criteria:

* not on tamsulosin or other alpha blockers regularly
* ureteral stricture
* concurrent ureteric stone

Primary outcomes:
measure: successful insertion of ureteral access sheath to the upper ureter (above the level of SI joint on fluoroscopy)
timeFrame: during operation
Secondary outcomes:
measure: grade of ureteric injury after ureteral access sheath removal
timeFrame: during operation
measure: post operative complications
timeFrame: 3 months
measure: stone free rate
timeFrame: 3 months
measure: need for additional procedures
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02663388: Epigenetic Mechanisms and Severe Obesity (Biological Tissue Collection)
Official title: Influence of Vitamins Status on Severe Obesity Related Complications
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity
Diabetes
Metabolic Diseases
Non-alcoholic Fatty Liver Disease
Lead sponsor: University of Lorraine
Sponsor class: OTHER
Collaborators: name: Central Hospital, Nancy, France
First posted: 2016-01-26
Enrollment: 20000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who undergo bariatric surgery following french national guidelines (HAS 2009)

Brief summary: The purpose of this study was to evaluate the role of vitamin status and epigenetic mechanisms on severe obesity related-complications.


Eligibility criteria: Inclusion Criteria:

* indication for bariatric surgery with BMI \> 35 kg/m2

Exclusion Criteria:

* unable to receive clear information
* refusal to sign the consent form

Primary outcomes:
measure: Evaluation of folate mediated one-carbon metabolic pathway parameters (Folates, Vitamin B12, Methionine, Homocysteine) on severe obesity-related complications before and after bariatric surgery
timeFrame: 10 years
Secondary outcomes:
measure: Evaluation of DNA Methylation on severe obesity-related complications before and after bariatric surgery
timeFrame: 10 years
Other outcomes:
Locations:
city: Vandoeuvre Les Nancy
country: France
facility: University of Lorraine, CHU Nancy
Study officials:
affiliation: University of Lorraine, CHU Nancy
name: laurent BRUNAUD, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Antoine D, Li Z, Quilliot D, Sirveaux MA, Meyre D, Mangeon A, Brunaud L, Gueant JL, Gueant-Rodriguez RM. Medium term post-bariatric surgery deficit of vitamin B12 is predicted by deficit at time of surgery. Clin Nutr. 2021 Jan;40(1):87-93. doi: 10.1016/j.clnu.2020.04.029. Epub 2020 Apr 25.
citation: Li Z, Gueant-Rodriguez RM, Quilliot D, Sirveaux MA, Meyre D, Gueant JL, Brunaud L. Folate and vitamin B12 status is associated with insulin resistance and metabolic syndrome in morbid obesity. Clin Nutr. 2018 Oct;37(5):1700-1706. doi: 10.1016/j.clnu.2017.07.008. Epub 2017 Jul 24.
Clinical trial NCT05119088: Development of a Test Battery for Measurement of Knee Function in Patients With Patellar Instability
Official title: Development of a Test Battery for Measurement of Knee Function in Patients With Patellar Instability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patella
Joint Instability
Patellofemoral Joint Dislocation
Lead sponsor: Haraldsplass Deaconess Hospital
Sponsor class: OTHER
Collaborators: name: Haukeland University Hospital
First posted: 2021-11-12
Enrollment: 120
Sex: ALL
Minimum age (years): 13
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: About six months after patella stabilizing surgery postoperative restrictions are commonly lifted and patients may consider whether a return to activity/sports is feasible. Currently, there are no evidence-based criteria to determine a patients readiness for sports and/or activity (RTS) following stabilizing surgery. The purpose of this project was therefore to investigate the feasibility of a test battery to evaluate knee function in postoperative follow-up evaluation - and in RTS decisions - for patients with patellar instability. Banff Patellofemoral Instability Instrument 2.0 and Norwich Patellar Instability Score is being translated and validatend in a Norwegian population. Furter is patients experience of living with patellar instability explored.


Eligibility criteria: Inclusion Criteria:

* Patients who have undergone surgical treatment for recurrent patellar dislocation in Helse Vest. The investigators will include patients with reconstruction of the medial patella femoral ligament, trochleaplasty, tibial tubercle osteotomy, Insall or concomitant procedures.

Exclusion Criteria:

* Unable to give written informed consent.
* Medial patellar dislocation.
* unable to understand written or spoken Norwegian.
* patients with other knee injuries.

Primary outcomes:
measure: Banff Patellofemoral Instability Instrument 2.0 change from pre- to postopertaive score
timeFrame: Baseline and 6 months after surgery.
measure: Norwich patellar Instability score change from pre- to postopertaive score.
timeFrame: Baseline and 6 months after surgery.
Secondary outcomes:
measure: Y-balance test
timeFrame: Baseline and 6 months after surgery.
measure: Single legged hop tests
timeFrame: Baseline and 6 months after surgery.
measure: Isokinetic strength test
timeFrame: Baseline and 6 months after surgery.
measure: IKDC-2000
timeFrame: Baseline and 6 months after surgery.
measure: KOOS
timeFrame: Baseline and 6 months after surgery.
measure: Tampa scale of kinesiophobia
timeFrame: Baseline and 6 months after surgery.
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haraldsplass Deaconess Hospital
Study officials:
References:
Clinical trial NCT01650688: Difference in Grades of Epiblepharon According to Positional Changes and General Anesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epiblepharon
Keywords: Epiblepharon, general anesthesia, positional change
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2012-07-26
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with epiblepharon which needed surgical correction

Brief summary: Epiblepharon is a very common condition among Asian children and is a fold of the skin and underlying pretarsal orbicularis muscle that overlaps the eyelid margin and pushes the lashes against the cornea. It is manifested by the anterior lamella overriding the posterior lamella which causes the lashes to brush against the cornea. Although the prevalence of epiblepharon is known to be high among Asians, its cause remains controversial. Several etiological factors may be involved in the pathogenesis of epiblepharon.

Although epiblepharon in the lower lids lessens and disappears with age in many cases, surgery must be performed at an early age in severe cases in order to prevent ocular trauma as the vertically oriented cilia of the lashes can erode the corneal epithelium. Induced keratitis and astigmatism are indications for surgical intervention.

Over our many years of surgical experience, the investigators came to realize that the severity of epiblepharon was reduced when patients were under general anesthesia during surgery. The purpose of this study was to investigate the role of the orbicularis muscle in the pathogenesis of lower lid epiblepharon and to analyze the differences in the severity of epiblepharon in the upright versus the supine position and before and after the induction of general anesthesia.


Eligibility criteria: Inclusion Criteria:

* subjects younger than 12 years
* more than 12 months' follow-up
* subjects demonstrating prominent corneal touch by cilia and/or related subjective symptoms
* subjects who underwent general anesthesia for surgical correction of epiblepharon

Exclusion Criteria:

* subjects older than 12 years
* less than 12 months' follow-up -. subjects who underwent surgery on local anesthesia

Primary outcomes:
measure: Degree of skin fold height
timeFrame: 1 hour before epiblepharon surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Institute of Vision Research, Department of Ophthalmology, Yonsei University College of Medicine
Study officials:
References:
citation: Rhiu S, Yoon JS, Zhao SY, Lee SY. Variations in the degree of epiblepharon with changes in position and induction of general anesthesia. Graefes Arch Clin Exp Ophthalmol. 2013 Mar;251(3):929-33. doi: 10.1007/s00417-012-2186-2. Epub 2012 Nov 1.
Clinical trial NCT00637988: Barrett's Esophagus - 315 - 3 Way Cross Over
Official title: A Multicenter, Open-label, Four-way Crossover Study of the Effects of Esomeprazole, Aspirin and Rofecoxib on Prostaglandin (PGE2) Production, Cyclooxygenase-2 Enzyme Activity and PCNA Expression in Patients With Barrett's Esophagus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Barrett's Esophagus
Keywords: Barrett's Esophagus
Nexium
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-03-18
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study evaluates PGE2 production, COX-2 enzyme activity and PCNA expression in Barrett's metaplastic tissue. All patients will have a baseline endoscopy with multiple biopsies. The patients will then be receive four dosing regimens (esomeprazole, esomeprazole and aspirin, esomeprazole and rofecoxib, or rofecoxib alone) consecutively each for a 10 day dosing period, whilst undergoing further follow up endoscopies and multiple biopsies.


Eligibility criteria: Inclusion Criteria:

* A biopsy-proven diagnosis of Barrett's esophagus segment length greater than 2cm with no dysplasia or adenocarcinoma.
* Clinically normal laboratory results and physical findings at screening.

Exclusion Criteria:

* A history of esophageal, gastric or duodenal surgery, including antireflux surgery or endoscopic antireflux procedures, except for simple closure of an ulcer.
* Evidence of the following diseases or conditions:
* Barrett's esophagus less than or greater than 2cm that is positive for high grade dysplasia or adenocarcinoma
* Signs and symptoms of gastric outlet obstruction
* Active peptic ulcer disease
* severe liver disease
* Pancreatitis
* Malabsorption
* Active inflammatory bowel disease
* Severe pulmonary, cardiovascular or renal disease
* Impaired renal function or abnormal urine sediment on repeated examinations
* esophageal stricture or active, severe esophagitis.

Primary outcomes:
measure: Measure PGE production in Barrett's metastatic tissue & determine the reduction from baseline of PGE production would be equivalent on Day 10 in esomeprazole 40mg bid + aspirin treatment compared to esomeprazole 40 mg bid + rofecoxib 25 mg qd treatment
timeFrame: Baseline esophageal biopsies will be taken and thereafter at Day 10 in each treatment period.
Secondary outcomes:
measure: To determine in which of the four treatment groups the reduction in the baseline in PGE2 production, COX-2 enzyme activity and PCNA expression in Barrett's metaplastic tissue is the greatest.
timeFrame: Baseline esophageal biopsies will be taken and thereafter at Day 10 in each treatment period
Other outcomes:
Locations:
Study officials:
affiliation: Nexium Global Product Director, AstraZeneca
name: Paula Fernstrom
role: STUDY_DIRECTOR
References:
Clinical trial NCT06135688: Effects of Lidocaine Bolus and Infusion on Bispectral Index Values and Spectrum During Anesthesia Maintenance
Official title: Effects of Lidocaine Bolus and Continuous Infusion on Bispectral Index Values and Spectrum During Maintenance of Total Intravenous Anesthesia With Target Controlled Infusion (Schnider Model)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia Brain Monitoring
Lidocaine
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women undergoing brast cancer surgery with general anesthesia with Propofol and Remifentanil TCI, and Lidocaine bolus and infusion for postoperative pain will be included.

Brief summary: Lidocaine has been shown to increase the hypnotic effects of Propofol, however no trials shows the effects on Bispectral Index Values (BIS) and spectral analysis during total intravenous anesthesia maintenance delivered with target controlled infusion (TCI) with stable Concnetration at the effector site of Propofol (CeP)

Detailed description: Lidocaine has been shown to increase the hypnotic effects of Propofol, however no trials shows the effects on Bispectral Index Values (BIS) and spectral analysis during total intravenous anesthesia maintenence delivered with target controlled infusion (TCI) with stable concentration at the effector site of Propofol (CeP).

Aim of this study is to analyze BIS values and power spectrum before and after a lidocaine bolus (1,5 mg/kg delivered in 10 minutes) and a subsequent continuous infusion (1,5 mg/kg/min for 30 minutes) delivered at anesthetist's discretion for postoperative analgesia.

Eligibility criteria: Inclusion Criteria:

* Undergo general anesthesia with Target Controlled Infusion of Propofol (Schnider model) and Remifentanil (Minto model) and Lidocaine bolus and continuous infusion for a total of 40 minutes.

Exclusion Criteria:

* Neurological disease
* Psychiatric disease
* Obesity

Primary outcomes:
measure: Correlation between BIS values and power spectrum before and after lidocaine administration
timeFrame: We collect data about propofol concentration (ng/ml)and BIS values during general anaesthesia. We will collect BIS and TCI Propofol values during all the duration of anesthesia, form the start o anesthesia until the emergence from anesthesia
Secondary outcomes:
Other outcomes:
Locations:
city: Treviso
country: Italy
facility: Treviso Regional Hospital
state: TV
Study officials:
References: