louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03785444: Comparison of Self-assessment vs. Assessment by Others of Critically Ill Patients
Official title: Agreement in Relatives' Assessment in Standardized Questionnaires of Patients Who Have Been Admitted to Intensive Care Compared to Patients Who Have Not Been Admitted to Intensive Care (ASTON Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Self-Assessment
Assessment, Self
Keywords: Assessment by others
Self-Assessment
Critically ill
Intensive care
standardized questionnaire
functional status
WHODAS
EQ5D
IADL
Barthel Score
SF-36
MoCA Blind
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
Collaborators: name: Charite University, Berlin, Germany
name: Translationales intensivmedizinisches Forschungsnetzwerk Organdysfunktion
First posted: 2018-12-24
Enrollment: 200
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: Surgical patients with a high risk to be admitted to intensive care

Brief summary: We will test the results of standardized questionnaires for patients admitted to intensive care assessed by relatives/caregivers compared to the patient itself. Furthermore we will compare results with patients not admitted to intensive care.


Eligibility criteria: Inclusion Criteria:

* patient with a postoperative risk to be admitted to intensive care
* signed informed consent

Exclusion Criteria:

* patient who is not able to fill out the questionnaires alone and independent
* patient without relatives or a caregiver who could answer the assessment after surgery

Primary outcomes:
measure: Agreement in assessment of ICU patients
timeFrame: 2 weeks before hospital admission
Secondary outcomes:
measure: Agreement in assessment of ICU vs. non-ICU patients
timeFrame: 2 weeks before hospital admission
measure: Agreement in assessment of non-ICU patients
timeFrame: 2 weeks before hospital admission
measure: Multivariate testing using the closeness of the relationship
timeFrame: 2 weeks before hospital admission
Other outcomes:
measure: Definition of criteria which define an appropriate close relationship to receive a reliable test result
timeFrame: 2 weeks before hospital admission
Locations:
city: Munich
country: Germany
facility: Klinikum rechts der Isar, School of Medicine, Technical University of Munich
state: Bavaria
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
Study officials:
affiliation: Technical University of Munich
name: Stefan J Schaller, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Charite University, Berlin, Germany
name: Steffen Weber-Carstens, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06949644: Pupillometry in Delayed Sleep Wake Phase Disorder
Official title: Pupillometry in DSWPD Type 1 and Type 2
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Delayed Sleep-Wake Phase Disorder
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2025-04-29
Enrollment: 220
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this observational study is to characterize the pupil light response in patients with delayed sleep-wake phase disorder. A subset of participants will take part in a clinical trial to determine if increasing serotonin can alter the circadian response to light. The main questions it aims to answer is:

Are there differences in the light response in patients with delayed sleep-wake phase disorder? Does citalopram increase melatonin suppression in patients with delayed sleep-wake phase disorder?

Participants will complete activity and melatonin testing at home to determine their circadian timing. This will be followed by an eye test looking at the pupil response to different light stimuli. A subset of participants will complete two inpatient admissions where melatonin levels will be sampled and they will be exposed to a bright light. During one round of testing they will receive a placebo and in the other round of testing they will take a single dose of citalopram, a selective serotonin reuptake inhibitor.


Eligibility criteria: Inclusion Criteria:

* Delayed sleep-wake phase disorder

Exclusion Criteria:

* Use of medications known to alter pupil diameter
* History of eye disease or eye surgery
* Unstable medical or psychiatric condition
* Shift work or self imposed irregular sleep schedules
* Caffeine consumption \>400mg/day

Primary outcomes:
measure: Melatonin suppression
timeFrame: 8 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01089244: FET-PET for Diagnosis and Monitoring in Patients With Low Grade Glioma
Official title: Molecular Correlates and Clinical Significance of Positron Emission Tomography With FET-PET in Combination With Perfusion-weighted Magnetic Resonance Imaging (PWI) in Patients With Low Grade Gliomas
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Astrocytoma
Oligoastrocytoma
Oligodendroglioma
Keywords: Low grade glioma
Astrocytoma
Molecular imaging
FET PET
Therapy monitoring
Temodar
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
Collaborators: name: Deutsche Krebshilfe e.V., Bonn (Germany)
First posted: 2010-03-18
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a suspected referred to a Neurosurgical Department in order to provide a diagnosis and therapy

Brief summary: The aim of the study is to compare the two imaging modalities perfusion weighted MR-imaging and FET-PET in their ability to provide an accurate histological evaluation of low grade glioma and to reveal focal abnormalities within a homogeneously appearing tumor. Additionally, therapeutic effects should be assessed during a time period of two years.


Eligibility criteria: Inclusion Criteria:

* neuroradiologically suspected low grade glioma (Astrocytoma WHOI-II, Oligodendroglioma WHO II, Oligoastrocytoma WHO II)
* histological verification will be obtained either by microsurgery or by stereotactic biopsy
* patients older than 18 years
* Karnofsky Performance Score \>=70
* pregnant or nursing female patients will not be included in this study

Exclusion Criteria:

* patients in whom informed consent cannot be obtained due to organic brain syndrome or insufficient language skills
* patients who cannot lie quiet for a time period of app. two hours during the FET-PEt scan
* medical history of a metastatic brain disease
* patients in whom an MRI scan cannot be performed due to claustrophobia metallic protheses or pacemakers etc.

Primary outcomes:
measure: Overall survival
timeFrame: 24 months
Secondary outcomes:
measure: Progression Free survival
timeFrame: 24 months
Other outcomes:
Locations:
city: Munich
country: Germany
facility: University Hospital Munich, Department of Neurosurgery
state: Bavaria
city: Duesseldorf
country: Germany
facility: University Hospital, Duesseldorf
state: North Rhine-Westphalia
Study officials:
affiliation: Department of Neurosurgery, LMU Munich
name: Joerg C. Tonn, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06714344: Efficacy of an Assisted Therapy Optimizing Module to Improve Physician Adherence
Official title: A Prospective Open Randomised Trial to Test the Efficacy of an Assisted Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Keywords: Heart failure
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
Collaborators: name: AIT Austrian Institute of Technology GmbH
First posted: 2024-12-03
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Heart failure patients within the HM programme

Detailed description: A prospective, randomized, multi-sectoral multi-centre study with parallel group design.

Application of guideline-directed medical therapy (GDMT) improves quality of life and decreases hospitalization for heart failure and mortality.

GDMT is in general underused. This also applies to patients who are cared for in the integrative, telemedicine-supported disease management program Herzmobil Tirol (HMT). The Assisted Therapy Optimizing Module has been designed to actively assist network physicians in adhering to and improving guideline-based medical therapy.

Eligibility criteria: Inclusion Criteria:

AMPEL, CIP, Version: 1.2 Date: 27.03.2024

1. Written, signed and dated informed consent for inclusion in the HM programme
2. Male and female patients over 18 years of age.
3. Hospitalised for decompensated heart failure requiring intravenous diuretics
4. Need for iv diuresis in nonhospital setting because of impending hospitalization for cardiac decompensation

Exclusion Criteria:

1. Multimorbidity (Charlson Comorbidity Index \> 6)
2. Dementia
3. Lack of willingness to participate

Primary outcomes:
measure: Primary Endpoints
timeFrame: 09/2027
Secondary outcomes:
measure: Secondary Endpoints
timeFrame: 09/2027
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz, University Hospital for Internal Medicine (Cardiology)
state: Styria
city: Innsbruck
country: Austria
facility: Medical University of Innsbruck, University Hospital for Internal Medicine III (Cardiology and Angiology)
state: Tyrol
Study officials:
References:
Clinical trial NCT01238744: Flaxseed Mucilage and Satiety
Official title: Effect of Flaxseed Mucilage Drinks and Tablets on Satiety and Energy Intake
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Appetite
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2010-11-11
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The effect of a single dose of flaxseed mucilage incorporated into either drinks or tablets will be tested in term of their effect on appetite sensation measured using visual analogue scales over 120 minutes and ad libitum energy intake hereafter in two studies.

Detailed description: Study I:

Control drink vs. Flaxseed drink consumed and appetite sensation registered over 120 minutes. Hereafter energy intake was measured.

Study II:

Flaxseed drink vs. Flaxseed tablets+control drink consumed and appetite sensation registered over 120 minutes. Hereafter energy intake was measured.

Eligibility criteria: Inclusion Criteria:

* healthy adults
* 18-40 years
* BMI 19-28

Exclusion Criteria:

* smoking
* pregnancy or lactation
* excessive exercise
* medication (oral contraceptives the only exception)

Primary outcomes:
measure: Appetite sensation
timeFrame: 120 minutes
Secondary outcomes:
measure: Energy intake
timeFrame: 120 minutes
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02408744: Utility of Prolonged-release Pirfenidone in the Progression of Chronic Kidney Disease
Official title: Utility of Prolonged-release Pirfenidone in the Progression of Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Fibrosis
Chronic Kidney Disease
Keywords: nephroprotection
pirfenidone
polymorphisms
Lead sponsor: University of Guadalajara
Sponsor class: OTHER
Collaborators: name: Cell Therapy And Technology, S.a. De C.v.
First posted: 2015-04-03
Enrollment: 30
Sex: ALL
Minimum age (years): 10
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study was to evaluate the impact in safety and efficacy of a new formulation of prolonged-released Pirfenidone in the progression of renal damage in patients with Chronic kidney Disease (CKD).


Eligibility criteria: Inclusion Criteria:

1. Patients between 10 and 40 years old with CKD
2. Diagnosis of CKD stage 1 to 4 according with KDIGO definition and classification
3. No glucocorticoids, cyclophasphamide, mycophenolate, or other immunosuppressive drugs for at least two months before starting PFD administration
4. Sign of consent forms

Exclusion Criteria:

1. Known intolerance to PFD
2. CKD stage V according with KDOQI classification
3. Post-transplant patients
4. History of peptic ulcer within six months
5. History of cerebrovascular disease within six months
6. Evidence of hepatic disease
7. Pregnancy or breast feeding
8. Malignancy

Primary outcomes:
measure: Evaluate the results of the use of Pirfenidone in the progression of renal damage in patients with Chronic Kidney Disease.
timeFrame: three years
Secondary outcomes:
measure: Effect of the use of Pirfenidone in renal function
timeFrame: Three years
Other outcomes:
Locations:
Study officials:
affiliation: Head, Molecular Biology and Genomics Department, University of Guadalajara
name: Juan Armendariz-Borunda, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00000244: Effects of Dynorphin 1-13 on Heroin Addiction - 1
Official title: Effects of Dynorphin 1-13 on Heroin Addiction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Opioid-Related Disorders
Substance Withdrawal Syndrome
Keywords: addiction
opiate
heroin
dynorphin
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effects of IV dynorphin in humans during acute heroin abstinence, in order to determine that dynorphin suppresses acute opiate withdrawal, reduces opiate craving, and is safe at doses required to produce the above effects.

Detailed description: Randomized double blinded study of the effects of a single IV dose of dynorphin A 1-13 on heroin withdrawal in human opiate addicts

Eligibility criteria: Inclusion Criteria:

opiate addict between the ages of 18-55

Exclusion Criteria:

Regular abuse of other drugs, unstable medical conditions

Primary outcomes:
measure: Craving scale
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: U of Minnesota School of Medicine
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Paul Pentel, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Specker S, Wananukul W, Hatsukami D, Nolin K, Hooke L, Kreek MJ, Pentel PR. Effects of dynorphin A(1-13) on opiate withdrawal in humans. Psychopharmacology (Berl). 1998 Jun;137(4):326-32. doi: 10.1007/s002130050626.
Clinical trial NCT00348244: Ketorolac vs. Steroid in the Prevention of CME
Official title: A Masked Comparison of Acular LS Plus Steroid Versus Steroid Alone for the Prevention of Macular Leakage in Cataract Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataract
Lead sponsor: Innovative Medical
Sponsor class: INDUSTRY
First posted: 2006-07-04
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Evaluate if the incidence of sub clinical CME can be significantly reduced by use of peri-operative Acular LS plus Pred Forte when compared with Pred Forte alone in normal cataract patients.


Eligibility criteria: Inclusion Criteria:

* · Male or female \> 18 years of age scheduled to undergo cataract surgery with surgeon expectation of 20/20 BCVA postoperatively

  * Must be in good general health. Patients with systemic diseases will be enrolled only if there are no ocular manifestations of their disease (ie diabetics with normal retinal exams)
  * Ability to provide informed consent and likely to complete all study visits

Exclusion Criteria:

* · Known contraindication to any study medication or any of their components

  * Uncontrolled systemic disease
  * Required use of ocular medications other than the study medications during the study
  * Abnormal pre-operative OCTs if obtainable
  * Diabetic patients with a history of macular edema or diabetic retinopathy
  * AMD patients with less than a 20/20 surgical outcome expectation, epi-retinal membranes, retinal vein occlusion, or any pre-existing macular disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Dr. Wittpenn
state: New York
Study officials:
affiliation: Ophthalmic Consultants of Long Island
name: John Wittpenn, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wittpenn JR, Silverstein S, Heier J, Kenyon KR, Hunkeler JD, Earl M; Acular LS for Cystoid Macular Edema (ACME) Study Group. A randomized, masked comparison of topical ketorolac 0.4% plus steroid vs steroid alone in low-risk cataract surgery patients. Am J Ophthalmol. 2008 Oct;146(4):554-560. doi: 10.1016/j.ajo.2008.04.036. Epub 2008 Jul 2.
Clinical trial NCT00172744: Effect of Cyclic Tensional Force on Osteogenic Differentiation of Human Periodontal Ligament Stem Cells
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy
Keywords: stem cells
periodontal cells
mechanical stress
differentiation
periodontal ligament
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 20
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: The purpose of this study is to observe cyclic tensional force on the osteogenic differentiation of human periodontal ligament stem cells.

Detailed description: This study is to investigate the effect of the cyclic mechanical strain on the osteogenic differentiation of mesenchymal stem cells. Mesenchymal stem cells will be cultured from the periodontal ligament tissue of the premolars extracted due to orthodontic reason.

Eligibility criteria: Inclusion Criteria:

* Orthodontic patients who need to have premolars extracted

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: School of Dentistry, College of Medicine, National Taiwan University
city: Taipei
country: Taiwan
facility: School of Dentistry, College of Medicine, National Taiwan University
Study officials:
affiliation: School of Dentistry, College of Medicine, National Taiwan University
name: Yi-Jane Chen, MSD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04886544: Clinical Study to Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected for Jawline Contouring
Official title: A Multicenter, Randomized, Evaluator-Blinded, No-Treatment Control Design Clinical Study to Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected for Jawline Contouring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Jaw Volume Deficit
Lead sponsor: LG Chem
Sponsor class: INDUSTRY
First posted: 2021-05-14
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Multicenter, Evaluator-Blinded, No-Treatment Control Design Clinical Study to Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected for Jawline Contouring

Detailed description: This is a Multicenter, Randomized, Evaluator-Blinded, No-Treatment Control Design Clinical Study to Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected for Jawline Contouring.

Eligibility criteria: Inclusion Criteria:

* Male or female adults 18 - 75 years of age (inclusive)
* 2 (moderate) or 3 (severe) on Jawline Contour Rating Scale (JCRS)
* want a filler injection procedure for the replacement of volume loss in the jawlines

Exclusion Criteria:

* have an active or infective skin disease
* have lower-face volume deficit due to congenital defect, trauma, abnormalities in adipose tissue related to immune-mediated diseases
* have a tattoo or excessive facial hair in the evaluation area
* have received permanent facial implants
* have undergone semi-permanent filler within 24 months
* have undergone temporary dermal filler treatment in the lower face (below the orbital rim) within 12 months
* have streptococcal disease
* have a medical history of hypertrophic cicatrix, hyperpigmentation or keloid
* have a history of anaphylaxis, multiple severe allergies, or allergy to lidocaine (or any amide-based anesthetic), or hyaluronic acid products
* have history of bleeding disorder
* have severe cardiovascular, hepatic or renal diseases considered as per Investigator's discretion
* have known malignant tumors or cancerous or precancerous lesion
* positive pregnancy test indicating pregnancy
* active COVID-19 infection and suspected COVID-19 infection within the past 14 days

Primary outcomes:
measure: The primary effectiveness endpoint is the Jawline Contour Rating Scale (JCRS) responder rate at 26 weeks after the last injection
timeFrame: 26 weeks from baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: LG Chem investigational site 01
city: Vienna
country: Austria
facility: LG Chem investigational site 02
city: Kraków
country: Poland
facility: LG Chem investigational site 03
Study officials:
affiliation: LG Chem Investigational site 01
name: Principal Investigator
role: PRINCIPAL_INVESTIGATOR
References: