louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04851925: MR Fingerprinting for Vestibular Schwannomas
Official title: MR-Fingerprinting for the Prediction of the Response of Vestibular Schwannomas to Gamma Knife Radiosurgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Vestibular Schwannoma
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2021-04-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with vestibular schwannoma of minimum 1cm, who will undergo Gamma Knife radiosurgery

Brief summary: MR Fingerprinting (MRF) will be performed in patients who will be treated with Gamma Knife radio surgery for a vestibular schwannoma before the intervention. Fifty patients will be included with a vestibular schwannoma of minimum 1cm in size. During follow-up, response of the tumor to radiosurgery will be evaluated for each patient with MRI. The aim of the study is to find patterns of vestibular schwannomas in MRF data which correlate with the type of response to radio surgery, i.e. tumor control after radiosurgery, further tumor growth despite radiosurgery, cystic transformation after radiosurgery.


Eligibility criteria: Inclusion Criteria: Planned Gamma Knife radiosurgery for vestibular schwannoma of minimum 1cm in size -

Exclusion Criteria: Vestibular Schwannoma of less than 1cm in size. Other a priori treatment than Gamma Knife radiosurgery

-

Primary outcomes:
measure: Tumor control
timeFrame: 3 years
measure: Tumor growth
timeFrame: 3 years
measure: Cystic transformation
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Josa Frischer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00688025: Magnetoencephalographic (MEG) Localization of Ramelteon's Effects on Brain Function and Cortical Arousal in Insomnia
Official title: Magnetoencephalographic Localization of Ramelteon's Effects on Brain Function and Cortical Arousal in Insomnia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Insomnia
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
Collaborators: name: Takeda Pharmaceuticals North America, Inc.
First posted: 2008-06-02
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Insomniacs, individuals with difficulty falling asleep or staying asleep.

Brief summary: The present protocol will utilize simultaneous recording of brain activity during attention and memory tasks in insomnia participants after ramelteon vs. zolpidem vs. placebo administration. The investigators hypothesize that amplitudes of associated with memory will be unchanged by ramelteon, whereas zolpidem will significantly reduce brain activity associated with stimulus processing as evidenced by abnormal reduction in the amplitude of specific brain regions relative to placebo.

Detailed description: The proposed research has two specific aims: 1) demonstrate that ramelteon has no effect on event related potential components that reflect basic sensory processes (P1 and N1), and will not impair attention and memory processes, whereas the benzodiazepine receptor agonist zolpidem will significantly reduce (relative to placebo) the amplitude of these event related potential components throughout the cerebral cortex and 2) show that ramelteon reduces the abnormal hyperarousal in insomnia as reflected through a reduction in the contingent negative variation component of the event related potential across frontal and parietal brain regions.

Eligibility criteria: Inclusion Criteria:

* Healthy individuals with no secondary condition to insomnia.

Exclusion Criteria:

* Healthy individuals with no insomnia.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Hospital Sleep Disorders & Research Center
state: Michigan
Study officials:
affiliation: Henry Ford Hospital Sleep Disorders & Research Center
name: Christopher Drake, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05000125: Comparison of the Hologic Genius Digital Diagnostics System With the ThinPrep Imaging System
Official title: Comparison of the Hologic Genius Digital Diagnostics System With the ThinPrep Imaging System - a Retrospective Assessment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Cancer Screening
Lead sponsor: Hologic Deutschland GmbH
Sponsor class: INDUSTRY
First posted: 2021-08-11
Enrollment: 1994
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: As part of the German National Cancer Plan, women over the age of 35 years will be given a cotest comprising a Pap smear and an HPV test, every three years.

Brief summary: Quality assurance of the laboratory examinations. Retrospective non-interventional study with ThinPrep slides collected as part of the German Co-Screening Program for routine diagnostic. These slides will retrospectively be used to validate the Hologic Genius Digital Cytology (DC) system vs. the ThinPrep Imaging system (TIS).

Detailed description: The cause of cervical cancer is a persistent infection with high-risk types of human papillomavirus (HPV). Cytology has been the gold standard for cervical screening since the introduction of routine screening with the Pap test in the 1950s due to its effect on mortality in regions with screening programs. Since that time, there have been several technological advances (LBC, Imaging) to improve and automate cervical cytology, resulting in increased disease detection and efficiency. The Hologic's Genius Digital Diagnostics System is a CE-IVD (CE-marked in vitro diagnostic device) marked digital cytology platform. For quality assurance and to retrospectively validate the Hologic Genius Digital Cytology (DC) system selected slides earlier measured with TIS will be additionally reviewed with the Genius Digital Diagnostic System in order to demonstrate clinical performance and efficiency.

Hologic's Digital Image Analysis Algorithm uses AI to identify diagnostically relevant objects of interest.Only anonymized results will be evaluated.

Eligibility criteria: Inclusion Criteria:

* LBC ThinPrep® samples are collected by gynaecologists and sent routinely to cytology laboratory CytoMol as part of the German Cervical cancer screening program.

Primary outcomes:
measure: Sensitivity and specificity of detection of pre-cancerous lesions using Hologic Genius Digital Cytology Imaging scanner
timeFrame: 3 months
Secondary outcomes:
measure: Change in time needed to screen 80 slides using Hologic Genius Digital Cytology Imaging scanner.
timeFrame: 3 months
measure: Clinical performance of Hologic Genius Digital Cytology Imaging scanner using cells on a ThinPrep® slide.
timeFrame: 3 months
Other outcomes:
Locations:
city: Frankfurt am Main
country: Germany
facility: CytoMol - MVZ für Zytologie und Molekularbiologie Frankfurt GbR
Study officials:
References:
Clinical trial NCT00990925: Lifestyle Modification for Weight Loss in Schizophrenia
Official title: Lifestyle Modification for Weight Loss in Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Schizophrenia
Schizoaffective Disorder
Keywords: Obesity
Schizophrenia
Schizoaffective disorder
weight loss
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2009-10-07
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
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 find out how effective lifestyle modification group therapy is on reducing body weight when compared to usual care in individuals with schizophrenia and/or schizoaffective disorder.


Eligibility criteria: Inclusion Criteria:

1. Subjects will be between 18 and 65 years of age.
2. Have a BMI of 28 or greater.
3. Meet DSM-IV criteria for schizophrenia or schizoaffective disorder.
4. Be on a stable dose of antipsychotic medication for at least one month, with positive symptoms stability as judged by the clinical team and investigator.

Exclusion Criteria:

1. A history of dementia or mental retardation.
2. Not capable of giving informed consent for participation in this study.
3. Ongoing pregnancy.
4. Living in a structured environment where the meals are provided as part of the program, e.g., a group home, nursing home, etc.

Primary outcomes:
measure: The primary outcome measure is change in body weight from baseline.
timeFrame: 16 weeks, 6 month follow-up
Secondary outcomes:
measure: Change in lab values from baseline (fasting serum glucose, glycosylated hemoglobin, insulin, LDL cholesterol, triglyceride levels)
timeFrame: 16 weeks, 6 month follow-up
measure: Change in questionnaires and assessments (Q-LES-Q, QLS, PANSS, Food craving scales, Food frequency scales, Food preference scales)
timeFrame: 16 weeks, 6 month follow-up
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Connecticut Mental Health Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Cenk Tek, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02424825: Rouxbe Pilot for MS
Official title: A Low-fat, Plant-based Cooking Course for Patients With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: diet
cooking
multiple sclerosis
fatigue
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Rouxbe Cooking School
First posted: 2015-04-23
Enrollment: 15
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
Primary purpose: TREATMENT

Brief summary: The purpose of this protocol is to collect data from approximately 15 multiple sclerosis (MS) patients who are participating in a pilot cooking course. This online cooking training program is currently available to general public through the company "Rouxbe" for a fee. Data gathered from this cooking course will be used to develop novel ways of promoting healthy eating habits in people with MS. The investigators will use the data from blood tests, questionnaires, and demographics to assess the feasibility and effectiveness of this program. This is an outpatient program designed for people with MS that would occur regardless of whether participant data is collected.

This pilot cooking course will run for approximately four weeks. The investigators intend start to the training course in mid-March 2015. Subjects will be followed prior to course initiation for baseline data gathering, at four weeks from baseline, twelve weeks from baseline, and twenty-four weeks from baseline.


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of MS
* Willingness to comply with the diet and values set forth in the course

Primary outcomes:
measure: Program Feasibility and Efficacy (composite of student perception, learning, and adherence by surveys)
timeFrame: 6 months
Secondary outcomes:
measure: Weight Change measured by body weight, body mass index, waist circumference
timeFrame: 6 months
measure: Diet Change measured by NutritionQuest Block Food Frequency Questionnaire, Opening Survey, Program Evaluation Survey
timeFrame: 6 months
measure: Program Evaluation through Program Evaluation Survey
timeFrame: 6 months
measure: Fatigue measured by Modified Fatigue Impact Scale-5 and Fatigue Severity Scale
timeFrame: 6 months
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University Multiple Sclerosis Center.
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Vijayshree Yadav, MBBs, MCR
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06829225: Single Dose Study of Tulisokibart (MK-7240) in Healthy Chinese Participants (MK-7240-002)
Official title: A Phase 1, Double-Blind, Placebo-Controlled, Single-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MK-7240 in Healthy Chinese Participants.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Colitis, Ulcerative
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2025-02-17
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this study is to learn about the safety of tulisokibart in healthy participants and what happens to tulisokibart over time when participants receive treatment intravenously versus subcutaneously.


Eligibility criteria: Inclusion Criteria:

Inclusion Criteria include, but are not limited to:

* Be in good health
* Has a body mass index (BMI) ≥18 and ≤28 kg/m\^2 and weight ≥40.0 kg
* Continuous non-smoker who has not used tobacco or nicotine-containing products for at least 3 months prior to the dosing of study drug

Exclusion Criteria:

Exclusion Criteria include, but are not limited to:

* History of cancer (malignancy)
* Has positive serum test for human immunodeficiency virus (HIV), hepatitis C or hepatitis B virus infection

Primary outcomes:
measure: Number of Participants Who Experience an Adverse Event (AE)
timeFrame: Up to 99 Days
measure: Number of Participants Who Discontinued the Study Due to AEs
timeFrame: Up to 99 days
measure: Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of Tulisokibart
timeFrame: Predose and at designated timepoints (up to 99 days postdose)
measure: Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of Tulisokibart
timeFrame: Predose and at designated timepoints (up to 99 days postdose)
measure: Maximum Concentration (Cmax) of Tulisokibart
timeFrame: Predose and at designated timepoints (up to 99 days postdose)
measure: Time to Maximum Concentration (Tmax) of Tulisokibart
timeFrame: Predose and at designated timepoints (up to 99 days postdose)
measure: Apparent Terminal Half-life (t1/2) of Tulisokibart
timeFrame: Predose and at designated timepoints (up to 99 days postdose)
measure: Apparent Clearance (CL/F) of Tulisokibart
timeFrame: Predose and at designated timepoints (up to 99 days postdose)
measure: Apparent Volume of Distribution (Vz/F) of Tulisokibart
timeFrame: Predose and at designated timepoints (up to 99 days postdose)
Secondary outcomes:
measure: Absolute Bioavailability Expressed as a Percentage (F%) of SC Tulisokibart
timeFrame: Predose and at designated timepoints (up to 99 days postdose)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital (Site 0001)
state: Beijing
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03263325: Evaluation of UDP-glucose as a Urinary Biomarker for Early Detection of Cardiac Surgery-associated Pediatric Acute Kidney Injury
Official title: Evaluation of UDP-glucose as a Urinary Biomarker for Early Detection of Cardiac Surgery-associated Pediatric Acute Kidney Injury
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Kidney Injury
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2017-08-28
Enrollment: 250
Sex: ALL
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children ≤ 8 years of age having cardiac surgery with cardiopulmonary bypass

Brief summary: Acute kidney injury (AKI) is common in children after cardiac surgery with a reported incidence of 20-40%. Pediatric AKI has been found to be associated with important short and long-term adverse outcomes.

A major challenge to management of AKI after cardiac surgery and cardiopulmonary bypass is the lack of early diagnostic markers. Current diagnostic criteria for AKI in children relies exclusively on elevation of serum creatinine concentration and oliguria. Both of these markers lack sensitivity and specificity, and result in delayed detection of kidney injury.

This study aims to determine if UDP-glucose can be used as a urinary biomarker to detect subclinical acute kidney injury following pediatric cardiac surgery with cardiopulmonary bypass.


Eligibility criteria: Inclusion Criteria:

* less than or equal to 8 years of age
* scheduled for cardiac surgery

Exclusion Criteria:

* severe pre-existing renal insufficiency

Primary outcomes:
measure: AKI
timeFrame: within 72 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Douglas Atkinson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02223325: Evaluation of Prognosis and Prognostic Scores in Geriatric Patients With Acute Pancreatitis
Official title: Evaluation of Prognosis and Prognostic Scores in Geriatric Patients With Acute Pancreatitis: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Pancreatitis
Keywords: Elderly
Prognosis
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2014-08-22
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Tertiary care patients

Brief summary: * To compare the prognosis of acute pancreatitis between geriatric and other adult patients
* To evaluate the efficacy of various prognostic scores in geriatric patients with acute pancreatitis


Eligibility criteria: Inclusion Criteria:

Acute pancreatitis Hospitalisation Adult patients

Exclusion Criteria:

* Recurrent pancreatitis
* Chronic pancreatitis
* Outpatient follow up
* Loss of follow up within 3 months of discharge

Primary outcomes:
measure: Mortality rate in geriatric patients with acute pancreatitis
timeFrame: Within 3 months
Secondary outcomes:
measure: Morbidity rate in geriatric patients with acute pancreatitis
timeFrame: Within 3 months
Other outcomes:
measure: The validity of various prognostic scores in geriatric patients with acute pancreatitis
timeFrame: Within 3 months
Locations:
Study officials:
References:
Clinical trial NCT02163148: Predictors of Exposure Success in Public Speaking Anxiety
Official title: Predictors of Exposure Success in Public Speaking Anxiety
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Performance Anxiety
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2014-06-13
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample

Brief summary: Anxiety disorders are common and impairing. Although exposure therapy is one of the most effective treatments for anxiety, some individuals do not fully respond to treatment, and these individual differences are not well understood. Exposure therapy involves repeated, deliberate, safe engagement with a feared stimulus without the feared outcome occurring. This treatment is thought to work through a type of emotional learning called fear extinction. This study aims to look at links between fear extinction learning and exposure success, with the overall goal of better understanding who is likely to respond best to exposure therapy and why.


Eligibility criteria: Inclusion Criteria:

* Score of at least 20 on the PRCS
* Age 18-55
* English fluency

Exclusion Criteria:

* Psychotropic medication use in the past 4 weeks
* Past experience with exposure based therapy
* History of bipolar disorder, psychotic disorder, or substance dependence
* Current major depressive disorder of greater than moderate severity (defined as a score on the 9 item Patient Health Questionnaire of greater than 14)
* Clinically significant suicidal or homicidal ideation
* Non-removable ferrous metal
* Current significant neurological conditions
* History of loss of consciousness greater than 5 minutes duration
* Pregnant
* Claustrophobic

Primary outcomes:
measure: Change in peak Subjective Unit of Distress (SUDS) rating from first to fourth (last) exposure
timeFrame: 90 minutes
Secondary outcomes:
measure: Change from baseline on the Liebowitz Social Anxiety Scale (LSAS) at 2 weeks
timeFrame: Baseline, week 2
measure: Change from baseline on the Personal Report of Confidence as a Speaker (PRCS) at 2 weeks
timeFrame: Baseline, week 2
Other outcomes:
measure: Change from baseline on the Sheehan Disability Scale (SDS) at week 2
timeFrame: Baseline, week 2
Locations:
city: San Diego
country: United States
facility: UCSD Psychiatry Research
state: California
Study officials:
affiliation: UCSD
name: Tali M Ball, MA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ball TM, Knapp SE, Paulus MP, Stein MB. Brain activation during fear extinction predicts exposure success. Depress Anxiety. 2017 Mar;34(3):257-266. doi: 10.1002/da.22583. Epub 2016 Dec 6.