louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04408274: Remediation of Emotional Deficits in Multiple Sclerosis and Traumatic Brain Injury
Official title: Remediation of Emotional Deficits in Multiple Sclerosis and Traumatic Brain Injury: A Piolt Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Traumatic Brain Injury
Keywords: Processing Speed
Intervention
Multiple Sclerosis
Traumatic Brain Injury
Cognition
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
First posted: 2020-05-29
Enrollment: 29
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: This study will examine the efficacy of a clinical intervention for improving emotional processing in individuals with MS and TBI.(1)The main outcome measure will be changes in emotional processing measures from pre to post treatment.

(2)This study will also assess the impact of the emotional processing intervention on changes in pre and post treatment depression and anxiety, as well as fatigue.(3) This study will additionally measure the impact of the emotional processing intervention on cognitive functioning, specifically processing speed, attention and executive abilities. This will be accomplished through the completion of a neuropsychological battery prior to and following the completion of treatment.(4)Finally, the investigators will measure the impact of the intervention on quality of life and social functioning, utilizing a pre and post treatment assessment consisting of measures of self-efficacy, quality of life, functional abilities, and awareness.


Eligibility criteria: Inclusion Criteria:

* diagnosis of Multiple Sclerosis or Traumatic Brain Injury
* Fluent in English
* processing speed impairment (based on evaluation)

Exclusion Criteria:

* currently taking steroids and/or benzodiazepines
* prior stroke or neurological diease
* history of significant pyschiatric illness (for example, bipolar disorder, schizophrenia, or psychosis) or a current diagnosis of Major Depressive Disorder, Schizophrenia, Epilepsy, Bipolar Disorder
* significant alcohol or drug abuse history

Primary outcomes:
measure: Change in scores on Facial Expression Identification Task (FEIT)
timeFrame: Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)
Secondary outcomes:
measure: Change in scores on Emotion Regulation Questionnaire (ERQ)
timeFrame: Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)
measure: Change in scores on Satisfaction with Life Scale (SWLS)
timeFrame: Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
References:
Clinical trial NCT04360174: CLN-0045: Safety, and Efficacy of OTX-TIC in Participants With Open Angle Glaucoma or Ocular Hypertension
Official title: A Prospective, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of OTX-TIC (Travoprost) Implant in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Ocular Hypertension
Open Angle Glaucoma
Lead sponsor: Ocular Therapeutix, Inc.
Sponsor class: INDUSTRY
First posted: 2020-04-24
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Sequential: Groups of participants are assigned to receive interventions based on prior milestones being reached in the study, such as in some dose escalation and adaptive design studies
Primary purpose: TREATMENT

Brief summary: To assess the safety, tolerability and efficacy of a single sustained release dose of OTX-TIC, a sustained release travoprost drug product, in subjects with primary open-angle glaucoma or ocular hypertension.

Detailed description: This is a prospective, multicenter, open label study, to evaluate the safety, tolerability and efficacy of OTX-TIC intracameral implant in subjects with primary open-angle glaucoma or ocular hypertension. The subjects will be followed for approximately 7 months (one-month washout and 6 months follow-up after injected of the OTX-TIC implant).

Eligibility criteria: Inclusion Criteria:

* Have a documented diagnosis of ocular hypertension or primary open-angle glaucoma
* Have IOP that is currently controlled as assessed by the Investigator
* Have open, normal appearing anterior chamber angles as determined by gonioscopy

Exclusion Criteria:

* Have closed angle glaucoma, narrow angle glaucoma, pseudoexfoliation syndrome, pseudoexfoliation glaucoma, pigment dispersion or pigmentary glaucoma, glaucoma diagnosis prior to 15 years of age, inflammatory, neovascular or other secondary
* Have a known or suspected allergy and/or hypersensitivity to a prostaglandin (i.e. travoprost), fluorescein or to any component of the study products

Primary outcomes:
measure: Ocular Treatment Emergent Adverse Events
timeFrame: Through study completion, 6 months
measure: Efficacy Outcome
timeFrame: Diurnal IOP [12 Week Visit]
Secondary outcomes:
Other outcomes:
Locations:
city: Petaluma
country: United States
facility: Ocular Therapeutix, Inc.
state: California
city: Torrance
country: United States
facility: Ocular Therapeutix, Inc.
state: California
city: Roswell
country: United States
facility: Ocular Therapeutix, Inc
state: Georgia
city: Austin
country: United States
facility: Ocular Therapeutix, Inc.
state: Texas
city: Racine
country: United States
facility: Ocular Therapeutix, Inc.
state: Wisconsin
Study officials:
References:
Clinical trial NCT02489474: Association of Genetic Polymorphism and Acute Kidney Injury After Liver Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Transplantation
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-07-03
Enrollment: 124
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: Adult patients scheduled for liver transplantation

Brief summary: Some of the liver transplantation recipients experience postoperative acute kidney injury due to various causes including genetic factors. Prevention of postoperative acute kidney injury is essential for postoperative care in liver transplantation recipients. The aim of this study is to investigate the relationship between gene polymorphisms which have been known to be associated with postoperative acute kidney injury, and the occurrence of acute kidney injury after liver transplantation.


Eligibility criteria: Inclusion Criteria:

1) adult patients scheduled for liver transplantation

Exclusion Criteria:

1. Patients on dialysis
2. patients not able to read, or understand the consent form
3. ethnicity, other than asian
4. patients refusal

Primary outcomes:
measure: Acute kidney injury after liver transplantation
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
Study officials:
References:
Clinical trial NCT01038674: Safety and Tolerability of Anti-IL-20 in Subjects With Rheumatoid Arthritis
Official title: A Randomised, Double Blind, Placebo-controlled, Multiple Dose, Dose-escalation, Phase 1 Trial of Anti-IL-20 in Subjects With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Inflammation
Rheumatoid Arthritis
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2009-12-24
Enrollment: 16
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: This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety and tolerability of the drug Anti-IL-20 in subjects with rheumatoid arthritis.


Eligibility criteria: Inclusion Criteria:

* Informed consent obtained before any trial-related activities
* A diagnosis of rheumatoid arthritis made at least 3 months prior to screening
* Active rheumatoid arthritis, characterised by a DAS28 equal or above 3.2
* Methotrexate treatment (stable dose, equal or below 25 mg/week) for at least 4 weeks prior to study start (subjects receiving stable doses of oral corticosteroids, and/or non-steroidal anti-inflammatory drugs and/or acetaminophen and/or opioids according to prescribed recommended doses can be included)
* Male subjects and female subjects of non-child bearing potential

Exclusion Criteria:

* Body mass index (BMI) less than 18.5 or above 35.0 kg/m2
* Subjects with chronic inflammatory autoimmune disease other than rheumatoid arthritis
* History of or current inflammatory joint disease other than rheumatoid arthritis
* Chronic or ongoing infectious disease requiring systemic anti-infectious treatment within 2 weeks prior to study start
* Past or current malignancy (as judged by the investigator)
* Clinically significant cardiac or cardiovascular disease
* Positive for human immunodeficiency virus (HIV), hepatitis or tuberculosis
* Blood donation or blood loss of more than 0.45L within 2 months prior to study start, or longer if required by local regulations
* Breast-feeding women

Primary outcomes:
measure: Adverse events
timeFrame: 0 - 21 weeks after dosing
Secondary outcomes:
measure: Terminal serum half-life
timeFrame: 0 - 21 weeks after dosing
measure: Maximum observed serum concentration (Cmax)
timeFrame: 6 - 10 weeks after dosing
measure: Change in ACR20, ACR50 and ACR70
timeFrame: 0-21 hours after dosing
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Novo Nordisk Investigational Site
city: Warszawa
country: Poland
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Lundblad MS, Overgaard RV, Gothberg M, Fjording MS, Watson E. Clinical pharmacokinetics of the anti-interleukin-20 monoclonal antibody NNC0109-0012 in healthy volunteers and patients with psoriasis or rheumatoid arthritis. Adv Ther. 2015 Mar;32(3):228-38. doi: 10.1007/s12325-015-0191-7. Epub 2015 Mar 7.
Clinical trial NCT04139174: Assessment of Root Parallelism Following Orthodontic Treatment in Adolescent vs Adult Patients Treated With Maxillary First Premolar Extraction
Official title: Assessment of Root Parallelism Following Orthodontic Treatment in Adolescent vs Adult Patients Treated With Maxillary First Premolar Extraction: Observational -Analytical Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Frequency of Root Paralellism
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-10-25
Enrollment: 180
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the collected data will be divided into two groups according to age either adolescent (12-18 years old) or adult group (after 18 years old).

Brief summary: Panoramic radiographs of finished orthodontic cases will be collected after fulfilling the inclusion and exclusion criteria. Then the collected data will be divided into two groups according to age either adolescent (12-18 years old) or adult group (after 18 years old).

in the panoramic views the long axes of canines and second premolar will be traced digitally using Digital softwares (microDicom vierwer Simeo Antonov Stoykov 0.7.7) \& (IC Measure 2.0.0.161).

The objective of this study is to assess the root parallelism between maxillary canines and second premolars in adolescents versus adults group of patients requiring maxillary first premolar extraction during the orthodontic treatment.


Eligibility criteria: Inclusion Criteria:

* Adults group of Patients (above 18 years old). .
* Adolescent group of patients (from 12 to 18 years old).
* Extraction of permanent maxillary first premolar in at least one quadrant.
* Same head position at scanning time.
* Same machine: Orthopantomograph Planmeca Promax 2P (Planmeca USA) with a kilovoltage of 55 to 85 and an exposure time of 15 seconds at a focal distance of 46 cm.
* Same type of bracket (Roth prescription, slot size #22).
* Full set of teeth (not necessarily including third molars)

Exclusion Criteria:

* Systematic diseases.
* non extraction cases.
* severe divergence or convergence between roots of maxillary canine and second premolar.

Primary outcomes:
measure: Frequency of Good Root Parallelism
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Oshagh M, Momenidanaei S, Sardarian A, Alipour A, Roeinpeykar M, Khaksar Y. Root Parallelism of Canine and Second Premolar. 2014;3(3):176-81.
citation: Mayoral G. Treatment results with light wires studied by panoramic radiography. Am J Orthod. 1982 Jun;81(6):489-97. doi: 10.1016/0002-9416(82)90428-6.
Clinical trial NCT00295074: The Effect of Mild Traumatic Brain Injury on Recovery From Injury
Official title: The Effect of Mild Traumatic Brain Injury on Recovery From Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Trauma
Head Injury
Brain Concussion
Keywords: traumatic brain injury
head injury
concussion
neuropsychologic test
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2006-02-22
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Mild traumatic brain injury (TBI) is a common injury that can produce significant functional sequelae and ongoing disabling symptoms. Predicting who will have an uncomplicated recovery and who will suffer ongoing symptoms is difficult. This protocol evaluates the use of neuropsychologic testing after mild TBI in injured patients to attempt to objectively establish predictors of long term disability and functional recovery.

Detailed description: Patients who are hospitalized and who have suffered mild TBI (loss of consciousness or post-traumatic amnesia; Glasgow Coma Score 13-15; admitted within 24 hours of injury; able to read, speak, and understand English) who do not have pre-injury dementia or significant cognitive impairment will undergo computerized neuropsychologic testing using a previously validated tool that has been effective in sports-related mild TBI. Sequential testing will be performed during recovery and patients who report disabling symptoms and/or functional impairment will be compared to patients who recover uneventfully. Goal is to identify those parameters that predict early who may suffer long term sequelae or functional impairment and therefore benefit from early cognitive rehabilitation. Secondary goals are to establish objective parameters for functional recovery after mild TBI.

Eligibility criteria: Inclusion Criteria:

* Mild TBI
* Admitted within 24 hours of injury
* Able to read, speak,and understand English

Exclusion Criteria:

* Expected to die of their injuries
* Pre-existing dementia or significant cognitive impairment
* Neurologically impaired and incapable of completing testing
* Physically incapable of using arms/hands to complete computerized testing

Primary outcomes:
measure: functional outcome
measure: subjective symptoms
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center-Presbyterian
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Brian G Harbrecht, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04260074: Epigenetic Changes in Head and Neck Cancer
Official title: Biomarkers in Head and Neck Cancer - Epigenetic Changes and Hypermethylation of Promoter-regions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Cancer
Squamous Cell Carcinoma
Head and Neck Squamous Cell Carcinoma
Head and Neck Neoplasms
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2020-02-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cancergroup:

Patients referred to The Department of Otolaryngology - Head and Neck surgery

Controlgroup:

Patients referred to a private clinic for oral and maxillofacial surgery

Brief summary: With this study, the investigators will investigate the epigenetic changes, which may contribute to the development of head and neck squamous cell carcinomas.


Eligibility criteria: Cancer group:

Inclusion Criteria :

* Written informed consent
* Histologically confirmed oral squamous cell carcinoma

Exclusion Criteria:

* History of cancer
* Uncontrolled comorbidity

Control group:

Inclusion Criteria :

* Written informed consent
* Normal buccal mucosal surface.
* Normal ENT-examination

Exclusion Criteria:

* History of cancer
* Uncontrolled comorbidity

Primary outcomes:
measure: Differences in epigenetic changes
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Department of Otolaryngology - Head and Neck Surgery
Study officials:
affiliation: Department of Otolaryngology - Head and Neck Surgery
name: Michael Gaihede, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06390774: A Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of SSGJ-705 Monotherapy in Patients with Advanced Malignant Tumors
Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of SSGJ-705 Monotherapy in Patients with Advanced Malignant Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Locally Advanced, Recurrent or Metastatic Malignancies
Keywords: advanced malignancies
Lead sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-04-30
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study was an open-label phase I study to evaluate the safety, tolerability, PK profile and potential efficacy of SSGJ-705 as a single agent in patients with advanced malignancies.

Detailed description: This study includes 4 Parts: Part 1 (dose escalation and dose extension for QW administration), Part 2 (dose escalation and dose extension for Q2W administration), Part 3 (dose escalation and dose extension for Q3W administration), and Part 4 (indication extension, such as HER2 expression, PD-L1 high expression, driver gene negative newly treated advanced NSCLC, or other tumors).

Eligibility criteria: Inclusion Criteria:

1. Males and/or females over age 18
2. Histologically and/or cytologically documented local advanced or recurrent or metastatic malignancies
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
4. Expected survival \>3 months.
5. Signed informed consent form.
6. Must have adequate organ function.

Exclusion Criteria:

1. Any remaining AEs \> grade 1 from prior anti-tumor treatment as per CTCAE v5. 0, with exception of hair loss, fatigue, and grade 2 peripheral neurotoxicity.
2. Pregnant or nursing women or women/men who are ready to give birth
3. Symptomatic central nervous system metastasis.
4. Allergy to other antibody drugs or any excipients in the study drugs.
5. Severe dyspnea at rest due to complications of advanced malignant tumors, or needing supplemental oxygen therapy.
6. Participated in any clinical study of medical devices or drugs within 1 month prior to screening (excluding non-intervention clinical studies or follow-up period of intervention clinical studies) .

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Primary outcomes:
measure: DLTs
timeFrame: 14 days
measure: AE
timeFrame: up to 1 year
measure: MTD or MAD
timeFrame: up to 1 year
measure: RP2D
timeFrame: up to 1 year
Secondary outcomes:
measure: ORR
timeFrame: up to 1 year
measure: PFS
timeFrame: up to 1 year
measure: Cmax
timeFrame: up to 1 year
measure: T1/2
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Jinan
country: China
facility: Affiliated Cancer Hospital of Shandong First Medical University
state: Shandong
Study officials:
References:
Clinical trial NCT02293174: Retinal Fundus Camera Evaluation
Official title: TRC-NW400 Retinal Fundus Camera Image Evaluation and Instrument Comparison Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Normal Healthy Subjects With no Known Ocular Diseases
Lead sponsor: Topcon Corporation
Sponsor class: INDUSTRY
First posted: 2014-11-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Normal subjects will be recruited from Topcon Medical Systems.

Brief summary: Establish a normal baseline setting configuration for image capture using the Topcon TRC-NW400 non-mydriatic retinal camera.

Detailed description: Establish a normal baseline setting configuration for image capture using the Topcon TRC-NW400 non-mydriatic retinal camera. While also comparing the images to other manufacturer's retinal cameras

Eligibility criteria: Inclusion Criteria:

* Subjects with no known ocular diseases

Exclusion Criteria:

* Subjects with known ocular diseases

Primary outcomes:
measure: Fundus Image Grading
timeFrame: 1 Hour
Secondary outcomes:
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Topcon Medical Systems, Inc.
state: New Jersey
Study officials:
affiliation: Clinical Trial Manager
name: Danny Leung
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01506674: Metabolomic in Critical Ill Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Metabolomic
Lead sponsor: Università Vita-Salute San Raffaele
Sponsor class: OTHER
First posted: 2012-01-10
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critical ill patients

Brief summary: Analysis of blood, urinary, and intrathecal metabolites of critical ill patients will be checked for possible correlations between metabolomics patterns and patients' outcomes.


Eligibility criteria: Inclusion Criteria:

* patients with severe left or right ventricular dysfunction undergoing cardiac surgery
* patients undergoing ablation of ventricular tachycardia
* patients with febrile neutropenia after chemotherapy or allogeneic transplant for haematological diseases
* patients undergoing thoracoabdominal vascular surgery

Exclusion Criteria:

* pregnant women
* no written consent

Primary outcomes:
measure: Metabolomic patterns to identify poor outcome
timeFrame: hospital stay (approximately two weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Università Vita-Salute San Raffaele
state: Mi
Study officials:
References: