louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03638310: Role of Psychiatric Profile in Prehabituated Patients After Vestibular Schwannoma Surgery
Official title: Assessment of Visual Sensitivity, Psychiatric Profile and Quality of Life Following Vestibular Schwannoma Surgery in Patients Prehabituated by Chemical Vestibular Ablation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vestibular Schwannoma
Vestibular Function Disorder
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2018-08-20
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two groups of patients, one group prehabituated by chemical labyrintectomy, the second control group without prehabituation before the surgery
Primary purpose: TREATMENT

Brief summary: The aim of this study is to assess effect of psychiatric profile on visual sensitivity and overall health status in patients who underwent surgery for vestibular schwannoma and were prehabituated by chemical vestibular ablation.


Eligibility criteria: Inclusion Criteria:

* T3, T4 vestibular schwannoma
* recorded growth of a tumour
* hearing loss greater than 50% in PTA

Exclusion Criteria:

* T1 vestibular schwannomas
* no growth progression
* normal hearing

Primary outcomes:
measure: change of optokinetic nystagmus measurement
timeFrame: change of the gain of optokinetic nystagmus among 3 time points is measured: before intervention, 1 week after intervention, 3 months after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Charles University
Study officials:
affiliation: Charles university Prague
name: Zdeněk čada, M.D., Ph.D.
role: STUDY_CHAIR
References:
citation: Cada Z, Balatkova Z, Chovanec M, Cakrt O, Hruba S, Jerabek J, Zverina E, Profant O, Fik Z, Komarc M, Betka J, Kluh J, Cerny R. Vertigo Perception and Quality of Life in Patients after Surgical Treatment of Vestibular Schwannoma with Pretreatment Prehabituation by Chemical Vestibular Ablation. Biomed Res Int. 2016;2016:6767216. doi: 10.1155/2016/6767216. Epub 2016 Dec 8.
citation: Balatkova Z, Cada Z, Hruba S, Komarc M, Cerny R. Assessment of visual sensation, psychiatric profile and quality of life following vestibular schwannoma surgery in patients prehabituated by chemical vestibular ablation. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2020 Dec;164(4):444-453. doi: 10.5507/bp.2019.056. Epub 2019 Dec 3.
Clinical trial NCT00570310: Neuropathic Pain Syndrome Patient Study (MK-0000-072)
Official title: A Double-Blind, Placebo-Controlled, Enriched-Enrollment, Randomized Withdrawal Study to Evaluate an Optimal Methodology for Conducting Proof of Concept Trials in Patients With Chronic Neuropathic Pain Syndromes Using Pregabalin as a Test Drug
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neuralgia, Postherpetic
Diabetic Neuropathy
Painful Small-Fiber Neuropathy
Idiopathic Distal Sensory Polyneuropathy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-12-10
Enrollment: 104
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 study is to determine the best way to conduct clinical trials in patients with neuropathic pain (nerve pain). This study will see if generic pregabalin has any effect on neuropathic pain.


Eligibility criteria: Inclusion Criteria:

* Patient has moderate to severe nerve pain due to one of the following conditions: Postherpetic neuralgia, Painful diabetic neuropathy, Small fiber neuropathy or idiopathic distal sensory polyneuropathy
* Patient is able to complete questionnaires in either English or Spanish
* Patient is at least 18 years of age

Exclusion Criteria:

* Patient is either pregnant or breastfeeding
* Patient has a history of angioedema (swelling beneath the skin surface) or peripheral edema (foot, leg, and/or ankle swelling)
* Patient has a history of congestive heart failure
* Patient has a seizure disorder
* Patient has a history of drug and/or alcohol abuse within the past 1 year
* Patient failed treatment due to lack of pain relief with more than three drugs for nerve pain
* Patient has had cancer (except basal cell carcinoma) within the past two years
* Patient anticipates the need for surgery while participating in the study
* Patient has a reported history of hepatitis B, C, or HIV infection
* Patient has another type of pain that is more painful than the nerve pain
* Patient has generalized anxiety disorder, untreated depression, psychosis, or post-traumatic stress disorder
* Patient is involved in litigation or receives worker's compensation related to nerve pain

Primary outcomes:
measure: Daily Evening Patient Reported Pain Intensity Scores
timeFrame: Baseline and 6 Weeks
Secondary outcomes:
measure: 'Time to Efficacy Failure' During the Randomized Withdrawal Portion of the Study
timeFrame: 6 Weeks
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Hewitt DJ, Ho TW, Galer B, Backonja M, Markovitz P, Gammaitoni A, Michelson D, Bolognese J, Alon A, Rosenberg E, Herman G, Wang H. Impact of responder definition on the enriched enrollment randomized withdrawal trial design for establishing proof of concept in neuropathic pain. Pain. 2011 Mar;152(3):514-521. doi: 10.1016/j.pain.2010.10.050. Epub 2010 Dec 23.
Clinical trial NCT02851810: Oculomotor Markers and Attachment in Adolescents
Official title: Oculomotor and Neurophysiological Markers of Emotion Regulation and Attachment Styles in Adolescence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emotion Dysregulation
Keywords: attachment
oculomotor marker
emotion regulation
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2016-08-02
Enrollment: 124
Sex: ALL
Minimum age (years): 13
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The study aims to identify specific visual scanning patterns of attachment pictures in adolescent with different attachment style.

Detailed description: Oculomotor parameters will be assessed during visualization of 2 sets of pictures. The first set presents a distress picture and is followed by a slide composed of 3 pictures (one representing comfort, one representing complicity and the last representing a neutral scene).

Psychophysiological parameters (skin conductance reactivity-SCR) is also assess during this visualization.

Eligibility criteria: Inclusion Criteria:

* non hospitalized child who is going to school

Exclusion Criteria:

* not french-speaker vision problem more than 20 cigarettes/day

Primary outcomes:
measure: number of entry in distress pictures
timeFrame: within 1 year after inclusion
measure: saccade duration in distress picture
timeFrame: within 1 year after inclusion
measure: average of the number of entry in comfort picture vs neutral and complicity pictures
timeFrame: within 1 year after inclusion
measure: average of the saccade duration in comfort picture vs neutral and complicity pictures
timeFrame: within 1 year after inclusion
Secondary outcomes:
measure: Amplitude of SCR
timeFrame: within 1 year after inclusion
measure: interaction with the parent: score to the GPACS (goal-corrected partnership in adolescence coding system)
timeFrame: within 1 year after inclusion
measure: Reaction time in SCR
timeFrame: within 1 year after inclusion
Other outcomes:
Locations:
city: Besancon
country: France
facility: CHU Besancon
state: Doubs
Study officials:
affiliation: Centre Hospitalier Universitaire de Besancon
name: Lauriane Vulliez-Coady, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Szymanska M, Monnin J, Tio G, Vidal C, Girard F, Galdon L, Smith CC, Bifulco A, Nezelof S, Vulliez-Coady L. How do adolescents regulate distress according to attachment style? A combined eye-tracking and neurophysiological approach. Prog Neuropsychopharmacol Biol Psychiatry. 2019 Mar 8;89:39-47. doi: 10.1016/j.pnpbp.2018.08.019. Epub 2018 Aug 27.
Clinical trial NCT00856310: A Single-Dose Study of the Safety and Tolerability of REGN475(SAR164877) in Healthy Subjects
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single-Dose Study of the Safety and Tolerability of REGN475 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy volunteers
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2009-03-05
Enrollment: 56
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind, placebo-controlled single-dose study of the safety and tolerability of intravenously administered REGN475 in healthy volunteers. The primary objective of the study is to assess the safety and tolerability of REGN475. The secondary objectives are to characterize the pharmacokinetic and immunogenicity profiles of REGN475.


Eligibility criteria: Key Inclusion Criteria:

* Male or female volunteers, in general good health and 21 to 65 years of age.
* Female volunteers must be post-menopausal for at least 1 year or surgically sterile.

Key Exclusion Criteria:

* Significant concomitant illness such as, but not limited to, cardiac, renal, neurological, endocrinological, GI, hepatic, metabolic or lymphatic disease that would adversely affect the subject's participation in this study or interpretation of safety/ PK data
* Participation in any clinical research study evaluating another investigational drug or therapy within 3 weeks or at least 5 half-lives of the investigational drug, whichever is longer, prior to the Screening Visit.

Primary outcomes:
measure: Incidence of treatment emergent adverse events in subjects treated with REGN475 or placebo.
timeFrame: 16 weeks
Secondary outcomes:
measure: Serum concentrations of REGN475.
timeFrame: 16 Weeks
measure: The presence or absence of antibodies against REGN475.
timeFrame: 16 Week follow up
Other outcomes:
Locations:
city: Altoona
country: United States
state: Pennsylvania
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References:
Clinical trial NCT00406510: Comparison of Frequency of Use of Optive and Systane
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dry Eye
Lead sponsor: Innovative Medical
Sponsor class: INDUSTRY
First posted: 2006-12-04
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is subjectively compare duration of action between Optive and Systane.


Eligibility criteria: Inclusion Criteria:

* Males or females \> 18 years old
* Mild to moderate dry eye symptoms
* Score of at least 2 and no more than 4 on the SESOD at the initial screening visit
* Likely to complete all study visits and able to provide informed consent

Exclusion Criteria:

* Current use of topical cyclosporine
* Known contraindications to any study medication or ingredients
* Active ocular diseases or uncontrolled systemic disease (blepharitis patients that are actively being treated or disease that is uncontrollable)
* Ocular surgery within the past 3 months,
* Active ocular allergies

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Azusa
country: United States
facility: Private Practice
state: California
Study officials:
affiliation: Private Practice
name: Milton Hom, OD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03864510: NAFLD in Diabetes Type 2 in Primary Care
Official title: Evaluating Prevalence and Severity of NAFLD In Primary Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: NAFLD
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2019-03-06
Enrollment: 317
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutively enrolled patients with diabetes type 2 in primary care.

Brief summary: The EPSONIP (Evaluating Prevalence and Severity Of NAFLD In Primary care) trial is a longitudinal cohort study of patients with T2DM recruited from primary health care centers in Östergötland, Sweden. The latest MRI techniques will be used to quantify the amount of hepatic fat, inflammation, liver fibrosis and body composition. Each patient will be investigated twice with three years apart to determine patients with progressive disease.


Eligibility criteria: Inclusion Criteria:

* Diabetes type 2
* Age 35-75 year

Exclusion Criteria:

* Contraindication to MR
* Alcohol dependance
* Previously diagnosed liver cirrhosis
* Previously known liver disease (other than fatty liver)

Primary outcomes:
measure: Prevalence of fatty liver
timeFrame: 2020
measure: Prevalence of advanced liver disease
timeFrame: 2020
measure: The association between physical activity and advanced liver disease (fibrosis >2)
timeFrame: 2020
measure: The association between physical activity and advanced liver disease (fibrosis >2)
timeFrame: 2020
measure: The association between fitness and advanced liver disease (fibrosis >2)
timeFrame: 2020
measure: Genetic factors associated with advanced liver disease (fibrosis >2)
timeFrame: 2020
Secondary outcomes:
measure: Health economic model for disease management
timeFrame: 2025
measure: Number of patients that develop symptoms of end-stage liver disease
timeFrame: 2030
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Ekholmen primary health care centre
state: Swedish
city: Norrköping
country: Sweden
facility: Åby primary health care centre
Study officials:
affiliation: LiU
name: Mattias Ekstedt, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nasr P, Iredahl F, Dahlstrom N, Radholm K, Henriksson P, Cedersund G, Dahlqvist Leinhard O, Ebbers T, Alfredsson J, Carlhall CJ, Lundberg P, Kechagias S, Ekstedt M. Evaluating the prevalence and severity of NAFLD in primary care: the EPSONIP study protocol. BMC Gastroenterol. 2021 Apr 20;21(1):180. doi: 10.1186/s12876-021-01763-z.
Clinical trial NCT06703710: To Evaluate the Safety/Tolerability and Pharmacokinetic Characteristics in Healthy Volunteers
Official title: A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose, Phase 1 Clinical Trial to Evaluate the Safety/Tolerability and PK Characteristics, and to Explore Food Effect and Ethnic Difference of JW2286 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy
Lead sponsor: JW Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2024-11-25
Enrollment: 72
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: This clinical trial is a randomized, double-blind, placebo-controlled, single ascending dose, phase 1 clinical trial to evaluate the safety/tolerability and pharmacokinetic characteristics, and to explore food effect and ethnic difference of JW2286 after oral administration in healthy adults.


Eligibility criteria: Inclusion Criteria:

* Healthy Korean or Caucasian volunteers

Exclusion Criteria:

* Individuals with a clinically significant disease or history
* Individuals with a history of a gastrointestinal disorder or surgery
* In the case of all female individuals with childbearing potential, except for those who are surgically sterile

Primary outcomes:
measure: Area under the plasma drug concentration-time curve from 0 to last (AUClast) of JW2286
timeFrame: 0 to 168 hours
measure: Area under the plasma drug concentration-time curve from 0 to infinity (AUCinf) of JW2286
timeFrame: 0 to 168 hours
measure: The maximum or peak concentration between zero and dosing interval (Cmax) of JW2286
timeFrame: 0 to 168 hours
measure: Time of Maximum Concentration (Tmax) of JW2286
timeFrame: 0 to 168 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital Clinical Trial Center
Study officials:
affiliation: Seoul National University Hospital
name: SeungHwan Lee
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06032910: Surgical Mesh in Radical Cystectomy to Prevent Parastomal Hernias
Official title: The Use of Surgical Mesh in Open Radical Cystectomy With Ileal Conduit Urinary Diversion to Prevent Parastomal Hernias
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bladder Cancer
Hernia
Ileal Conduit
Keywords: radical cystectomy
ileal conduit
parastomal hernia
mesh
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Radical cystectomy with ileal conduit urinary diversion serves as a foundational curative treatment strategy for selected patients afflicted with urothelial carcinoma of the bladder. Parastomal hernia after this procedure is an underestimated and undertreated clinical entity, which heavily impairs patients' quality of life due to symptoms of pain, leakage, application or skin problems. There is little evidence about prophylactic mesh placement for parastomal hernia prevention. In this study we examine the use of meshes during radical cystectomy and compare them with a control group.

Detailed description: Radical cystectomy with ileal conduit diversion is a procedure possible with complications. A primary stoma-related complication is the parastomal hernia (PH), which presents significant challenges to both the medical community and the patient. PH is classically defined as the protrusion of abdominal contents via the abdominal wall, especially in the direct vicinity of a stoma, whether it be a colostomy, ileostomy, or ileal conduit stoma. The incidence of PH post ileal conduit urinary diversion is especially concerning, with reports estimating its occurrence at around 17%. This data only emphasizes the need to reevaluate and optimize surgical treatments for PH, particularly as, in many cases, management strategies are extrapolated from experiences with colostomies or ileostomies. Notably, PHs are often described after these procedures rather than RC with ileal conduit urinary diversion. Further complicating the issue is the fact that estimates suggest around 30% of patients develop a PH within 12 months post any type of stoma site surgery. For those undergoing ileal conduit urinary diversion specifically, recurrence rates following PH repair can be alarmingly high, with figures as steep as 69% within a year.

Eligibility criteria: Inclusion Criteria:

* muscle-invasive or high-risk non-muscle-invasive bladder cancer patients

Exclusion Criteria:

* different than surgical therapy

Primary outcomes:
measure: Parastomal hernia
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hradec Králové
country: Czechia
facility: University Hospital Hradec Kralove
Study officials:
References:
Clinical trial NCT04547010: Effects of Soy Isoflavone on Bone Health Among Saudi Female Students Imam Abdulrahman Bin Faisal University.
Official title: Effects of Soy Isoflavone on Bone Health Among Saudi Female Students Imam Abdulrahman Bin Faisal University.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Soy Isoflavone Effect
Bone Density, Low
Bone Density Increased
Lead sponsor: Imam Abdulrahman Bin Faisal University
Sponsor class: OTHER
First posted: 2020-09-14
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Pre-post Quasi experimental study design.
Primary purpose: PREVENTION

Brief summary: Low bone mineral density (BMD) has recently increased among young women. Soy Isoflavone as a food supplement, has been found to have potent effect on bone health in postmenopausal women. However, the effect of soy isoflavone on pre-menopausal is not well understood. This research is done to examine the effect of soy isoflavones on BMD among young university female students.


Eligibility criteria: Inclusion Criteria:

* female
* University students
* aged between 18-25 years

Exclusion Criteria:

* Study participants who use medications and suffer from diseases that may interfere or effect on BMD, use calcium and vitamin D supplements and who suffer from glucose 6 phosphate deficiency (G6PD) were excluded from the study.

Primary outcomes:
measure: Bone Mineral Density (BMD)
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Dammam
country: Saudi Arabia
facility: Imam Abdulrahman Bin Faisal University
state: Eastern
Study officials:
References: