louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04061395: Guselkumab for Hidradenitis Suppurativa, a Mode of Action Study.
Official title: Guselkumab for Hidradenitis Suppurativa, a Mode of Action Study. The HiGUS-trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hidradenitis Suppurativa
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: Janssen-Cilag Ltd.
First posted: 2019-08-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a multicenter open-label mode of action study. Twenty patients with moderate to severe hidradenitis suppurativa will be treated with guselkumab 200 mg Q4W subcutaneously. Main objectie is to investigate changes in inflammatory pathways induced by IL-23p19 blockade with guselkumab, in HS lesional skin.

The total duration of the treatment period per subject is 16 weeks.


Eligibility criteria: Key Inclusion Criteria:

* moderate to severe HS
* treatment history of at least one systemic anti-inﬂammatory / immunosuppressive agent;
* HS diagnosis of at least 1 year;
* minimum of two anatomical locations with HS lesions
* minimum of 4 active abscesses and/or inflammatory nodules (AN).

Key Exclusion Criteria:

* contra-indication for guselkumab;
* previous use of guselkumab;
* use of treatment with biologics or any immunosuppressives for HS in the last 3 months prior to randomization;
* presence of other uncontrolled major disease;
* pregnant or lactating women

Primary outcomes:
measure: Changes in inflammatory pathways induced by IL-23p19 blockade with guselkumab.
timeFrame: Week 0 and 16
Secondary outcomes:
measure: Clinical efficacy - Inflammatory lesion count and Hidradenitis Suppurativa Clinical Response (HiSCR)
timeFrame: Week 0, 4, 12, 16.
measure: Clinical efficacy - International Hidradenitis Suppurativa Severity Score System (IHS4).
timeFrame: Week 0, 4, 12, 16.
measure: Patient reported outcomes - Patient Global Assessment
timeFrame: Every four weeks
measure: Patient reported outcomes - Itch Numeric Rating Scale
timeFrame: Week 0, 4, 8, 12 and 16
measure: Patient reported outcomes - Pain Numeric Rating Scale
timeFrame: Week 0, 4, 8, 12 and 16
measure: Patient reported outcomes - Patient treatment satisfaction score
timeFrame: Week 0 and 16
measure: Patient reported outcomes - Dermatology Life Quality Index
timeFrame: Week 0, 4, 8, 12 and 16
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus MC, University Medical Center Rotterdam
state: Zuid-Holland
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
References:
Clinical trial NCT04208295: 24-hour Blood Pressure Dynamics and Autonomic Adrenergic Regulation in Type 2 Diabetics
Official title: 24-hour Blood Pressure Dynamics and Autonomic Adrenergic Regulation in Type 2 Diabetics
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus, Type 2
Polyneuropathy Diabetes
Autonomic Neuropathy
Diabetic Neuropathies
Diabetic Complications Neurological
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2019-12-23
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type 2 diabetics previously screened for diabetic polyneuropathy will be invited

Brief summary: Autonomic neuropathy is a common complication of type 2 diabetes mellitus. Symptoms from cardiovascular autonomic neuropathy include, dizziness, orthostatic hypotension and insufficient heart rate and blood pressure (BP) regulation during physical exertion. The degree of cardiovascular autonomic neuropathy is most commonly measured as cardiac autonomic neuropathy based on at least two abnormal cardiac reflex tests, which primarily measures parasympathetic indices of the autonomic nervous system (ANS).

Few measures are available for quantifying the sympathetic/adrenergic branch of the ANS.

Circadian changes in BP is a documented measure of BP variability, regulated centrally by a multitude of centers. A growing number of studies indicate that a diminished BP variability is associated with increased cardiovascular risk and injury. The ANS plays a pivotal role in the execution of these circadian BP changes, mainly through sympathetic adrenergic nerve fibers

Few studies have investigated the applicability of 24-hour indices as predictor for autonomic adrenergic dysfunction. No previous studies have investigated the association between clinical markers of adrenergic function, and 24-hour blood pressure indices in type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* Normal 12-lead ECG

Exclusion Criteria:

* Significant cardiovascular, muscular, lung, kidney or psychiatric disease
* Pregnancy
* Malignant disease, HIV, alcoholism or drug abuse
* Parkinson disease
* Ischemic heart disease
* Vital medicine that can affect the autonomic nervous system

Primary outcomes:
measure: 24 hour Blood Pressure
timeFrame: 0
measure: Autonomic adrenergic measure
timeFrame: 0
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Danish Pain Research Center, Aarhus University Hospital
state: Skejby
Study officials:
References:
Clinical trial NCT00589095: Early Detection of Glioblastoma Multiforme (GBM) Treatment Responses Using Multiple Magnetic Resonance Modalities
Official title: Early Detection of Glioblastoma Multiforme (GBM) Treatment Responses Using Multiple Magnetic Resonance Modalities
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Glioblastoma Multiforme
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2008-01-09
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred to the Yale Brain Tumor Center for management of glioblastome multiforme

Brief summary: The purpose of this study is to determine whether dynamic contrast enhanced MRI (DCE MRI) and high diffusion weighting MRI may be used to distinguish between favorable and unfavorable responses to therapy of glioblastoma multiforme. Imaging data will be correlated with histopathologic findings and clinical responses to radiation therapy with or without chemotherapy.


Eligibility criteria: Inclusion Criteria:

* The presence of a primary brain tumor that cannot be completely resected that requires radiation therapy with or without chemotherapy.

Exclusion Criteria:

* Patients who do not have a primary brain tumor or who are unable to tolerate the environment of the MRI scanner

Primary outcomes:
measure: To detect the early "local" treatment responses from the physician recognized GBM "gross tumor volume" (GTV)
timeFrame: Upon completion of study
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Jonathan Knisely, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04104295: The Use of Ultrasound in Nasogastric Tube Placement in Children Admitted to the Pediatric ICU
Official title: The Use of Ultrasound to Determine Correct Nasogastric Tube Placement in Children Admitted to the Pediatric ICU: a Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Nasogastric Tube
Keywords: nasogastric tube
ultrasound
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2019-09-26
Enrollment: 0
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine if ultrasound (US), when used by the clinician, can determine the presence of nasogastric tube (NGT) in the stomach of patients admitted to the pediatric intensive care unit (PICU).

Detailed description: Currently, the standard of care is to routinely obtain an X-ray (XR) after every nasogastric tube (NGT) placement in the pediatric intensive care unit (PICU). After obtaining informed consent and the child's assent, a short (less than 10 minutes) ultrasound (US) scan of the abdomen within 2 hours of the routine XR.

Eligibility criteria: Inclusion Criteria:

* PICU patient undergoing routine NGT insertion by nursing staff

Exclusion Criteria:

* Any contraindication for US probe placement such as skin infection and abdominal wounds.
* Hemodynamically unstable patients.
* Patients for whom NGT placement will not be verified by XR, such as Ataxia Telangiectasia patients.

Primary outcomes:
measure: Correct placement of NG tube
timeFrame: Up to 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Yale University - MEDPED Critical Care
name: Eitan Neeman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01470495: Combined Treatment of RFA and Sorafenib on Recurrent HCC
Official title: Radiofrequency Ablation Plus Sorafenib Administration in Early Recurrent Hepatocellular Carcinoma: a Prospective Multicenter Cohort Trial (Repeat) Tumors for BCLC B Stage HCC Undergone Curative Hepatectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HCC
Radiofrequency Ablation
Sorafenib
Lead sponsor: Southwest Hospital, China
Sponsor class: OTHER
Collaborators: name: Hunan Province Tumor Hospital
name: Tang-Du Hospital
name: Xijing Hospital
name: First Affiliated Hospital of Guangxi Medical University
name: First Affiliated Hospital Xi'an Jiaotong University
name: Anhui Provincial Hospital
name: Xiangya Hospital of Central South University
name: Xinqiao Hospital of Chongqing
name: Xinjiang Tumor Hospital
name: People's Hospital of Guangxi Zhuang Autonomous Region
name: Henan Cancer Hospital
name: People's Hospital of Sichuan
name: Huaxi Hospital
First posted: 2011-11-11
Enrollment: 430
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: RFA is a routaine treatment of recurrent HCC. Recently Sorafenib was reported to be a promising drug to treat late stage HCC. But few studies were related with its effectiveness on recurrent HCC. So the investigators hypothesized that combined RFA and Sorafenib might reduce the frequency of recurrence and improve the overall survival and disease free survial.


Eligibility criteria: Inclusion Criteria:

* recurrent HCC after curative resection
* without gender restriction
* age between 18 to 75 years
* The liver function showed no worse than Child-Pugh B
* tumor nodes were less than 5cm and no more than 3 nodules

Exclusion Criteria:

* Pregnancy patients
* With extrahepatic tumor or lymphnode metastasis
* Tumor invasion or thrombosis in portal vein,hepatic vein or inferior vena cava

Primary outcomes:
measure: time interval between new lessions emerging after the first HCC recurrence
timeFrame: 3 year
Secondary outcomes:
measure: 3-year overrall survival
timeFrame: 3 year
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Institute of hepatobiliary surgery,southwest hospital
state: Chongqing
Study officials:
affiliation: Southwest Hopstial
name: Kuansheng Ma, MD,Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06290895: Artificial Oocyte Activation
Official title: The Effect of Artificial Oocyte Activation on Blastocysts Rate in Patients With Low Fertilization Rate
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Ovarian Insufficiency
Lead sponsor: Clinique Ovo
Sponsor class: INDUSTRY
First posted: 2024-03-04
Enrollment: 54
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Data spreadsheet from 2018 to 2023 of patients having undergone an IVF cycle

Brief summary: Studies reported that calcium signal deficiency or insufficiency during oocyte activation are related with embryo arrest and blastocyst quality. The utilization of Artificial Oocyte Activation (AOA) is safe and does not increase birth defects, cognition, language and motor skills. AOA is the first line of treatment in patients with globozoospermia (round headed spermatozoa). Poor responders in in-vitro fertilization (IVF) cycles represent a major challenge for fertility specialists and comprises about 10-15% of patients undergoing controlled ovarian hyperstimulation. The absence of synergy between the oocyte and sperm leads to a negative impact on oocyte activation. The European Society of Human and REproduction (ESHRE) recommends AOA in cases with failed fertilization/ low fertilization.


Eligibility criteria: Inclusion Criteria:

* Patients with poor or no blastocyst development in their primary cycle
* Group 1 - second cycle using AOA following the poor blastocyst development cycle
* Group 2 - second cycle without AOA following the poor development cycle

Exclusion Criteria:

* All cycles who do not have repeat cycles following the poor blastocyst development cycle

Primary outcomes:
measure: Blastocyst rate
timeFrame: 5 days after oocyte fertilization
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Clinique Ovo
state: Quebec
Study officials:
affiliation: Clinique Ovo
name: Simon Phillips, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00508495: Analgesic Efficacy, Safety and Tolerability of Two Paracetamol-Containing Solutions in Post-Surgical Hip Replacement Pain
Official title: Single-Dose Comparison of the Analgesic Efficacy, Safety and Tolerability of Two Paracetamol 1%-Containing Solutions and Placebo in a Post-Surgical Total Hip Replacement Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain, Postoperative
Keywords: pain, postoperative
replacement, total hip
total hip replacement
arthroplasty, replacement, hip
Lead sponsor: Baxter Healthcare Corporation
Sponsor class: INDUSTRY
Collaborators: name: MDS Pharma Services
First posted: 2007-07-30
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the therapeutic efficacy, safety and local tolerability of two different paracetamol-containing solutions in postoperative total hip replacement. They will be compared to placebo (a dummy treatment which contains no active ingredient).


Eligibility criteria: Inclusion Criteria:

* ASA I, II or III and scheduled for elective total hip replacement, using a standard approach and a cemented implant.
* Moderate or severe pain within 4 hours after stopping the PCA in the morning of the first post-operative day.

Exclusion Criteria:

* Another acute or chronic painful physical condition
* Use of any other analgesics (within 24 hours), sedatives, or narcotic drugs as well as microsomal enzyme inducers
* Inability to use and understand Visual Analog Scale and Verbal Rating Score

Primary outcomes:
measure: Amount of PCA-administered morphine consumed during first six hours of study drug treatment
timeFrame: 6 hours from first (of four) study drug doses
Secondary outcomes:
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Semmelweis Egyetem Ortopédiai Klinika
city: Békéscsaba
country: Hungary
facility: Réthy Pál Kórház-Rendelőintézet
city: Esztergom
country: Hungary
facility: Esztergom Város Önkormányzat Vaszary Kolos Kórháza
city: Győr
country: Hungary
facility: Petz Aladár Megyei Oktató Kórház
city: Kecskemet
country: Hungary
facility: Bács-Kiskun Megyei Önkormányzat Kórháza
city: Szeged
country: Hungary
facility: SZTE ÁOK Ortopédiai Klinika
city: Szekesfehervar
country: Hungary
facility: Fejér Megyei Szent György Kórház
city: Szekszárd
country: Hungary
facility: Tolna Megyei Önkormányzat Balassa János Kórháza
Study officials:
affiliation: Baxter Deutschland GmbH
name: Keyvan Tadjalli Mehr, MD, MSc
role: STUDY_DIRECTOR
References:
Clinical trial NCT01807195: Acute Renal Injury Associated Contrast in Intensive Care Unit Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Renal Injury
Keywords: contrast
Intensive care unit
Acute kidney injury
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-03-08
Enrollment: 886
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: RIFLE (Risk, Injury, Failure, Loss, and End-stage kidney disease) categorization and the existing classification method were used to compare their predictive value for acute renal damage related to contrast media.

Brief summary: Generally, a contrast medium is used when performing a CT scan or radiographic tests such as angiography because it heightens image clarity and can increase diagnosis accuracy. Despite these advantages, contrast media can cause allergic reactions in the body or a decline in renal function. Therefore, they should be handled carefully and explained sufficiently to the patient. For intensive care patients, the use of contrast agents has been revealed as a major cause of acute renal damage, and many studies have investigated this complication by examining incidence rates and prevention strategies. Hypothesis: Among intensive care patients, the group in which a contrast medium was used will have a higher risk of renal function decline compared with the group in which a contrast medium was not used, and, hence, the use of contrast media becomes a cause of renal function deterioration. Categorizing patients with renal function decline according to the new RIFLE criteria can have an association with the prognosis of intensive care patients, such as hospitalization period and death rate, which can promote faster intervention.


Eligibility criteria: Inclusion Criteria:

* For the 5 years from January 2008 to December 2012, patients in whom a contrast medium was used in the intensive care unit were examined.

Exclusion Criteria:

* For the 5 years from January 2008 to December 2012, patients in whom a contrast medium was not used in the intensive care unit were examined.

Primary outcomes:
measure: The incidence of acute renal damage associated with contrast media in intensive care patients
timeFrame: each time evaluation of contrast medium usage
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine
Study officials:
References:
citation: Kim MH, Koh SO, Kim EJ, Cho JS, Na SW. Incidence and outcome of contrast-associated acute kidney injury assessed with Risk, Injury, Failure, Loss, and End-stage kidney disease (RIFLE) criteria in critically ill patients of medical and surgical intensive care units: a retrospective study. BMC Anesthesiol. 2015 Mar 3;15:23. doi: 10.1186/s12871-015-0008-x. eCollection 2015.
Clinical trial NCT03134495: the Impact of Paediatric Use of Proton Pump Inhibitors on the Risk of Community Acquired Infections.
Official title: A Cohort Study to Assess the Impact of Paediatric Use of Proton Pump Inhibitors on the Risk of Community Acquired Infections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Community Infections
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2017-05-01
Enrollment: 290286
Sex: ALL
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all children included in the LDP-CSD database (Cegedim©) aged 11 or below, between 01/01/2008 and 31/12/2013

Brief summary: Pharmacological treatment of physiologic Gastro-esophageal Reflux disease (GERD) is excessive in France, as 65%-85% of children below 11 years are being treated, frequently with Proton Pump Inhibitors (PPIs) PPI have been associated, in adults, with an increase of infection rate but data in pediatry are scarce, especially in community medecine. Recently a study conducted in England brought up controversial results suggesting that the use of PPIs can be associated with a reduced risk of community acquired pneumonia.

Our study was aimed to assess, on a population-based database, the association between PPI prescription and community infections in children of 11 years or under.


Eligibility criteria: Inclusion Criteria:

* Children aged 11 years or below with at least 2 consultations during the follow up

Exclusion Criteria:

* chronic pulmonary or cardiac
* muscoviscidosis
* immunodeficiency
* H. pylori infection
* Diabetes
* Denutrition
* known digestive upper tract malformation

Primary outcomes:
measure: Number of overall infections
timeFrame: 4 years
Secondary outcomes:
measure: Number of specific infections
timeFrame: 4 years
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu de Dijon
Study officials:
References:
Clinical trial NCT02314195: Music Therapy in Obsessive Compulsive Disorder
Official title: A Randomized Clinical Trial of Music Therapy as an Adjunct to Standard Treatment for Obsessive Compulsive Disorder and Co-morbid Anxiety and Depression in Iran
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Anxiety
Depression
Keywords: Obsessive Compulsive Disorder
Music Therapy/methods
Combined Modality Therapy
Anxiety Disorders/therapy
Lead sponsor: Islamic Azad University, Marvdasht
Sponsor class: OTHER
First posted: 2014-12-11
Enrollment: 30
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: Previous studies have highlighted the potential therapeutic benefits of receptive individual music therapy as an adjunct to standard care, in a variety of psychiatric ailments including mood and anxiety disorders. However, the role of music in the treatment of obsessive compulsive disorder have not been investigated to date. The present study therefore aimed to investigate the efficacy of music therapy as an adjunct to standard treatment, on obsessions in patients with treatment-naïve OCD. Moreover, given the fact that a significant proportion of patients with OCD have other comorbid mood or anxiety disorders, the question of whether therapeutic benefits of music could be expanded to also affect concurrent depressive and anxiety symptoms was explored.


Eligibility criteria: Inclusion Criteria:

* were at least 18 years or older;
* had axis I diagnosis of OCD according to the criteria delineated by the diagnostic and statistical manual of mental disorders - fourth edition diagnosed by an experienced psychiatrist
* had not received treatment previously for the disorder
* agreed to partake in the study

Exclusion Criteria:

* refused to partake in the study

Primary outcomes:
measure: Obsession (Maudsley Obsessive-Compulsive Inventory)
timeFrame: 1 month
Secondary outcomes:
measure: Obsession subtype (Maudsley Obsessive-Compulsive Inventory sub-types)
timeFrame: 1 month
measure: Anxiety symptoms (Beck Anxiety Inventory)
timeFrame: 1 month
measure: Depressive symptoms (Beck Depression Inventory - Short Form)
timeFrame: 1 month
Other outcomes:
Locations:
city: Esfahan
country: Iran, Islamic Republic of
facility: Shariati Hospital
Study officials:
References: