louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06792487: Immune Infiltrate Analysis of Psoriasis Skin During Therapy With Anti-interleukin 23 (IL-23)
Official title: Analysis of the Immune Infiltrate in Lesional Skin During Anti-interleukin 23 (IL-23) Therapy in Patients With Moderate-severe Plaque Psoriasis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Psoriasis
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2025-01-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients affected by moderate-severe psoriasis under anti IL-23 therapy

Brief summary: Psoriasis is an immune-mediated inflammatory skin disease characterized by the presence of erythematous and itchy plaques.

Psoriasis has a multifactorial pathogenesis, environmental and genetic factors contribute to its development.

Although interleukin-23 blockade has been shown to be highly effective in the treatment of psoriasis, relapses have occurred during therapy.

Our study aims to identify the cellular source of key cytokines involved in disease recurrence or persistence of at least one psoriatic lesion in patients affected by moderate- severe psoriasis treated with an anti-IL-23 biologic drug. The immune infiltrate of resistant or relapsed plaques during anti-IL-23 therapy will be analysed from skin biopsies.


Eligibility criteria: Inclusion Criteria:

* moderate-severe psoriasis PASI\>10
* anti IL 23 biologic therapy for at least 6 months (for the group under treatment)
* during therapy at least one area resistant to treatment or at least one flare of disease (for the group under treatment)
* patients able to express informed consent

Exclusion Criteria:

* patients unable to express informed consent
* patients with complete response to anti IL23, without resistant plaques or disease flare-ups

Primary outcomes:
measure: Identify the cellular source of key cytokines involved in disease recurrence or persistence of at least a psoriatic lesion
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: immune biomarkers of sustained and prolonged response to treatment
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Dermatologia
state: Lazio
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Ketty Peris, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00599287: Methylphenidate, Rivastigmine or Haloperidol in Hypoactive Delirium in Intensive Care Patients
Official title: Methylphenidate, Rivastigmine or Haloperidol in Hypoactive Delirium in Intensive Care Patients: a Randomized, Mono-blind Pilot Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Delirium
Keywords: ICU delirium
Hypoactive delirium
Haloperidol
Methylphenidate
Rivastigmine
Hypoactive ICU delirium
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2008-01-23
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this pilot-trial is the feasibility of a large randomized, placebo controlled, doubleblind clinical trial to investigate the use of methylphenidate, rivastigmine or haloperidol in hypoactive ICU-delirium. In addition we will compare duration of delirium, severity of delirium, length of ICU/hospital stay and side effects between the different interventions.


Eligibility criteria: Inclusion Criteria:

* Older than 18 years
* Diagnosed as hypoactive delirium
* Informed consent given

Exclusion Criteria:

* Pregnancy
* Epilepsy
* M. Parkinson
* Lewy-body dementia
* Prolonged QT-time
* Known allergy to the medicinals used
* Renal replacement therapy
* Hepatic encephalopathy
* Hyperthyroid
* Glaucoma
* Previous suicide attempts
* Syndrome of Gilles de la Tourette
* Patients which cannot receive the medication oral or through a nasogastric tube

Primary outcomes:
measure: duration of delirium
timeFrame: Days
Secondary outcomes:
measure: duration of ICU-stay
timeFrame: days
measure: duration of in hospital stay
timeFrame: days
measure: delirium severity
timeFrame: duration of delirium
measure: frequency of side effects
timeFrame: duration of intervention
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: University Medical Center
Study officials:
affiliation: UMC Utrecht
name: Jozef Kesecioglu, MD PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01025687: Television Viewing (TVV) & Puberty on Lunchtime Food Intake
Official title: Effect of Television Viewing (TVV) & Puberty on Lunchtime Food Intake & Subjective Appetite in Girls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity Prevention
Keywords: girls
obesity
television viewing
puberty
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2009-12-03
Enrollment: 25
Sex: FEMALE
Minimum age (years): 9
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The investigators hypothesize that television viewing will affect food intake in adolescent girls, and will depend on pubertal stage. Food intake will be measured at 30 min following a glucose(1 g of glucose/kg body weight) or sweetened noncaloric beverage with or without the presence of TV. Subjective appetite will be measured as well.


Eligibility criteria: Inclusion Criteria:

* healthy girls with no emotional, behavioral or learning problems

Exclusion Criteria:

* boys

Primary outcomes:
measure: food intake (kcal)
timeFrame: at 30 min after the treatment
Secondary outcomes:
measure: subjective appetite
timeFrame: 0-120 min
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Department of Nutritional Sciences
state: Ontario
Study officials:
affiliation: University of Toronto
name: Harvey Anderson, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Patel BP, Bellissimo N, Thomas SG, Hamilton JK, Anderson GH. Television viewing at mealtime reduces caloric compensation in peripubertal, but not postpubertal, girls. Pediatr Res. 2011 Nov;70(5):513-7. doi: 10.1203/PDR.0b013e31822d783e.
Clinical trial NCT03207087: The WEB®-IT China Clinical Study
Official title: WEB® Intrasaccular Therapy Study China Clinical Trial Protocol
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Wide Neck Bifurcation Intracranial Aneurysms
Lead sponsor: Microvention-Terumo, Inc.
Sponsor class: INDUSTRY
First posted: 2017-07-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group assignment
Primary purpose: TREATMENT

Brief summary: This trial is a prospective, multicenter, single-arm confirmatory clinical trial. The study is to confirm the safety and effectiveness of the WEB Aneurysm Embolization System demonstrated in the US WEB-IT Study for the treatment of intracranial wide-neck bifurcation aneurysms. The study's primary endpoints include a primary effectiveness endpoint and a primary safety endpoint. The study device must meet both endpoints. The primary effectiveness endpoint is adjudicated by an independent third party core lab.


Eligibility criteria: Inclusion Criteria:

* Patient whose age ≥ 18 and ≤75 years old
* Patient must have a single ruptured or unruptured IA(intracranial aneurysm)requiring treatment
* Patient must sign and date IRB/EC approved written informed consent prior to initiate of any study procedures

Exclusion Criteria:

* Patient has an IA with characteristics unsuitable for endovascular treatment
* Patient has stroke-in-evolution within the prior 60-days
* Patient has had an SAH(subarachnoid hemorrhage) from a nonindex IA or any other intracranial hemorrhage within 90 days
* Patient's index IA was previously treated
* Patient is pregnant

Primary outcomes:
measure: Primary Effectiveness Endpoint: Complete (angiographic) aneurysm occlusion as assessed by Core Lab, without parent artery stenosis
timeFrame: 12 month
measure: Primary Safety Endpoint: Proportion of death and major stroke
timeFrame: 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital Affiliated to The Second Military Medical University ( Shanghai Changhai Hospital)
state: Shanghai
city: Chengdu
country: China
facility: West China
state: Sichuan
city: Beijing
country: China
facility: Tiantan Hospital
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
city: Hangzhou
country: China
facility: The Second affiliated Hospital of Zhejiang University School of Medicine
city: Shanghai
country: China
facility: Huashan Hospital
city: Shenyang
country: China
facility: The General Hospital of Shenyang Military
city: Xi'an
country: China
facility: Tangdu Hospital, the Fourth Military Medical University
Study officials:
References:
Clinical trial NCT02722187: The Role of Microsurgery in Surgical Treatment of Varicocele.
Official title: The Role of Microsurgery in Surgical Treatment of Varicocele.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Varicocele
Infertility
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2016-03-29
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to set the place of microsurgery in surgical treatment od varicocele in infertile male. Fourty patients will undergo microsurgical subinguinal varicocelectomy while the control group consisting of 20 patients wil undergo laparoscopic varicocelectomy.


Eligibility criteria: Inclusion Criteria:

* clinical varicocele
* infertility duration of min one year
* poor semen quality
* otherwise unexplained infertility in the couple

Exclusion Criteria:

* female infertility

Primary outcomes:
measure: pregnancy rate after the intervention
timeFrame: one yaer after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Chair and Department of Urology Warsaw Medical University.
Study officials:
References:
citation: Diegidio P, Jhaveri JK, Ghannam S, Pinkhasov R, Shabsigh R, Fisch H. Review of current varicocelectomy techniques and their outcomes. BJU Int. 2011 Oct;108(7):1157-72. doi: 10.1111/j.1464-410X.2010.09959.x. Epub 2011 Mar 24.
citation: Ollandini G, Liguori G, Ziaran S, Malek T, Mazzon G, de Concilio B, Bucci S, Benvenuto S, Belgrano E, Trombetta C. Varicocele treatment: a 2-centers comparison between non microsurgical open correction, laparoscopic approach and retrograde percutaneous sclerotization on 463 cases. Arch Ital Urol Androl. 2013 Sep 26;85(3):143-8. doi: 10.4081/aiua.2013.3.143.
citation: Abdel-Meguid TA, Al-Sayyad A, Tayib A, Farsi HM. Does varicocele repair improve male infertility? An evidence-based perspective from a randomized, controlled trial. Eur Urol. 2011 Mar;59(3):455-61. doi: 10.1016/j.eururo.2010.12.008. Epub 2010 Dec 21.
citation: Cayan S, Shavakhabov S, Kadioglu A. Treatment of palpable varicocele in infertile men: a meta-analysis to define the best technique. J Androl. 2009 Jan-Feb;30(1):33-40. doi: 10.2164/jandrol.108.005967. Epub 2008 Sep 4.
citation: Al-Kandari AM, Shabaan H, Ibrahim HM, Elshebiny YH, Shokeir AA. Comparison of outcomes of different varicocelectomy techniques: open inguinal, laparoscopic, and subinguinal microscopic varicocelectomy: a randomized clinical trial. Urology. 2007 Mar;69(3):417-20. doi: 10.1016/j.urology.2007.01.057.
citation: Watanabe M, Nagai A, Kusumi N, Tsuboi H, Nasu Y, Kumon H. Minimal invasiveness and effectivity of subinguinal microscopic varicocelectomy: a comparative study with retroperitoneal high and laparoscopic approaches. Int J Urol. 2005 Oct;12(10):892-8. doi: 10.1111/j.1442-2042.2005.01142.x.
Clinical trial NCT01643187: Comparison of the Effect of Two Treatments on the Nutritional and Micronutrient Status of Malnourished Children
Official title: Comparison of the Effect of Two Treatments on the Nutritional and Micronutrient Status of Malnourished Children From the Takalik Abaj
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Malnutrition
Lead sponsor: Association for the Study and Prevention of HIV/AIDS
Sponsor class: OTHER
First posted: 2012-07-18
Enrollment: 1000
Sex: ALL
Minimum age (years): 6
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to measure the impact of a fortified food on the nutritional and micronutrient status of malnourished children, compared with milk. The changes to be evaluated include the indicators weight for height, height for age, weight for age, mid-arm circumferance for age; and levels of hemoglobin, serum zinc, serum ferritin, serum folic acid, erythrocyte folic acid, serum vitamin B12, and urinary iodine.

Detailed description: Chronic malnutrition evidenced by short height for age is a common nutritional problem in underdeveloped countries which is generally accompanied by iron deficiency anemia and zinc deficiency. It has many consequences on the adult including limited capacity to work and higher risk of obesity and chronic disease. The present study will offer a fortified food, culturally accepted and locally produced. The effectiveness of this fortified food compared to lactose-free milk, in a controlled dose and with no risk to the health of the study participants, will be determined. Both will be distributed for free to be consumed as an atole or in liquid form, respectively, at a community level in an environment controlled as much as possible. This will allow to determine adherence, acceptability, consumption and distribution within the family.

Eligibility criteria: Inclusion Criteria:

* Some degree of malnutrition according to weight for height or height for age
* Reside in one of the six communities chosen for the study

Exclusion Criteria:

* Leukemia
* Diabetes
* Handicap
* Down syndrome
* Renal failure

Primary outcomes:
measure: Change in Nutritional status
timeFrame: Months 0, 3, 6, 9, 12 and 15 months
Secondary outcomes:
measure: Iron Status
timeFrame: Months 0 and 16
measure: Zinc status
timeFrame: Months 0 and 16
Other outcomes:
Locations:
city: Retalhuleu
country: Guatemala
facility: APEVIHS
Study officials:
affiliation: Mathile Institute
name: Gregory Reinhart
role: STUDY_CHAIR
References:
citation: Brown KH, Peerson JM, Rivera J, Allen LH. Effect of supplemental zinc on the growth and serum zinc concentrations of prepubertal children: a meta-analysis of randomized controlled trials. Am J Clin Nutr. 2002 Jun;75(6):1062-71. doi: 10.1093/ajcn/75.6.1062.
citation: Ministry of Social Health and Public Assistance et al. Micronutrient National Survey. Guatemala MSPAS 56pp. 2011
citation: Ministry of Public Health and Social Assistance. Maternal Infant Health Survey. Guatemala, MSPAS, 634 pp. 2010
Clinical trial NCT06816654: Retrospective Evaluation of the Impact of Epidural on the Risk of Postpartum Hemorrhage
Official title: Retrospective Evaluation of the Impact of Epidural on the Risk of Postpartum Hemorrhage
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postpartum Hemorrhage
Keywords: Epidural anesthesia
Postpartum hemorrhage
Obstetric analgesia
Neuraxial anesthesia
Instrumental delivery
Obstetrical trauma
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2025-02-10
Enrollment: 5753
Sex: FEMALE
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 gave birth vaginally at the Brugmann University Hospital Horta site between January 1, 2020 and December 31, 2021

Brief summary: Postpartum hemorrhage (PPH) is a major complication of childbirth. Epidurals are often implicated in the onset of postpartum hemorrhages. Given the paradoxical data in the literature, the investigators wished to retrospectively evaluate the impact of epidurals on the risk of PPH, instrumental delivery and the occurrence of PPH risk factors.

The investigators retrospectively analyzed 5753 records of patients who gave birth vaginally at Brugmann University Hospital between January 1, 2020 and December 31, 2021. The primary objective was to assess whether epidurals pose a risk of postpartum hemorrhage. Secondly, the investigators assessed whether epidurals pose a greater risk of instrumentation of delivery and emergence of PPH risk factors.


Eligibility criteria: Inclusion Criteria:

* Patients who gave birth vaginally at the Brugmann University Hospital Horta site between January 1, 2020 and December 31, 2021.

Exclusion Criteria:

* Patients who gave birth before 25 weeks.
* Patients who gave birth outside of hospital.
* Patients who had recourse to a medical termination of pregnancy (MTP).
* Patients who gave birth by cesarean section.

Primary outcomes:
measure: Postpartum blood loss
timeFrame: Up to 24 hours after the birth of the baby
Secondary outcomes:
measure: PPH risk factors
timeFrame: Data extraction in medical files from January 1st 2020 till December 31th 2021
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Brugmann
Study officials:
affiliation: CHU Brugmann
name: Thomas Botti, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00575354: Comparison of Sevoflurane and Isoflurane Anesthesia for Benign Breast Tumor Excision
Official title: Anesthesia With Sevoflurane and Isoflurane for Excision Surgeries in Benign Breast Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Breast Neoplasms
Keywords: Sevoflurane
Isoflurane
Breast tumor
Anesthesia
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2007-12-18
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Generally, benign breast tumors are excised under the local anesthesia. But such action was so invasive that every patient would experience the physiological and psychological stimuli unavoidably. Sevoflurane was advised as a better inhalational anesthesic for its "easy come,easy go" property during short-lasting operations than isoflurane. We purposed that sevoflurane would be a superior anesthesic for benign breast tumor excision than isoflurane with relative less alteration in hemodynamics, less postoperative side effects and easily-control the depth of anesthesia.


Eligibility criteria: Inclusion Criteria:

* Chinese
* Diagnosed benign breast tumor patients
* 18-64 yrs

Exclusion Criteria:

* Allergic to any interventional drugs
* Organic dysfunction
* Long-lasting PACU staying

Primary outcomes:
measure: Time of induction, maintenance and resuscitation
timeFrame: 0h to the end of the operation
Secondary outcomes:
measure: Intraoperative hemodynamics; Postoperative side effects;
timeFrame: 0h to 24h after the end of the operation
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Maternal and Child Care Hospital
state: Jiangsu
Study officials:
affiliation: Nanjing Medical University
name: XiaoFeng Shen, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05978154: Thigh Muscle Mass and Muscle Wasting in Patients in the Emergency Department
Official title: Thigh Muscle Mass and Muscle Wasting in Patients in the Emergency Department
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sepsis
Cardiac Arrest
Acute Respiratory Failure
Patients Who Visit Emergency Department
Shock
Trauma
Lead sponsor: Korea University Ansan Hospital
Sponsor class: OTHER
First posted: 2023-08-07
Enrollment: 600
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who visit the emergency department with informed consent and then who undergo point-of-care ultrasound to evaluate thigh muscle mass.

Brief summary: The goal of this observational study is to evaluate whether thigh muscle mass and muscle wasting are associated with mortality in patients who visit the emergency department. The main questions it aims to answer are:

* Is thigh muscle mass associated with mortality in patient who visit the emergency department?
* Does muscle wasting exist during staying in the emergency department?
* Is muscle wasting associated with mortality in patient who visit the emergency department? Participants will be evaluated for serial thigh muscle mass using point-of-care ultrasound at the emergency department.


Eligibility criteria: Inclusion Criteria:

* patients who visit the emergency department of Korea University Ansan Hospital during study period
* patients with age within the limits
* patients who are willing to be participate the study with informed consent
* patients who undergo point-of-care ultrasound to evaluate thigh muscle mass

Exclusion Criteria:

* patients with age out of limits
* patients who have deformities on lower leg
* patients who is unable to maintain appropriate position to undergo point-of-care ultrasound
* patients who decline to participate the study
* patients who have 'do-not-resuscitate' order or are not willing to be resuscitated
* patients of whom point-of-care ultrasound on thigh muscle mass was not performed

Primary outcomes:
measure: 28 day mortality
timeFrame: 28 days after study enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Ansan-si
country: Korea, Republic of
facility: Korea University Ansan Hospital
state: Gyeonggi-do
Study officials:
References: