louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00875589: Eye Movement Recordings in the Diagnosis of Traumatic Brain Injury
Official title: Eye-movement Recordings in the Diagnosis of Traumatic Brain Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Brain Injury
Keywords: Traumatic Brain Injury
Eye movement recording
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2009-04-03
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult betwenn 18 and 55 years old with and without a diagnosis of MTBI

Brief summary: The study investigates whether the use of eye movement recordings can provide a reliable diagnostic of previously undiagnosed mild traumatic brain injury (blast and impact) in Operations Enduring Freedom or Iraqi Freedom (OIF/OEF) veterans.

Detailed description: Eye movements are recorded for Operations Enduring Freedom or Iraqi Freedom (OIF/OEF) veterans with mild traumatic brain injury (mTBI) and compared to the eye movements of those without mTBI. By analyzing and characterizing the differences between the two groups, a diagnostic measure of mTBI through the use of eye movements can be developed.

Eligibility criteria: Inclusion Criteria:

* OIF/OEF Veteran;
* Neuropsych diagnosis of MTBI

Exclusion Criteria:

* chronically abusing alcohol or illicit drugs.
* uncorrected vision prevents subject from effectively viewing the stimuli, unless they can wear contact lenses during the recording session.
* inability to make normal eye movements (i.e.: saccades, smooth pursuit) required by study paradigms. Note: Deficit can be caused by taking medications that can potentially affect eye movements or any neurological condition that can interfere with making normal eye movement.
* psychological or psychiatric conditions that preclude sustained concentration or ability to perform the tasks.

Primary outcomes:
measure: Stability of Fixation
timeFrame: During eye movement recording session (20 sec).
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Louis Stokes VA Medical Center, Cleveland, OH
state: Ohio
Study officials:
affiliation: Louis Stokes VA Medical Center, Cleveland, OH
name: Jonathan Jacobs, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04150289: A Disease Registry Encompassing the Care Of Patients With Multiple Myeloma on Panobinostat
Official title: A Disease Registry Encompassing the Care of Patients With Multiple Myeloma on Panobinostat (RECOMM)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Keywords: Farydak
panobinostat
Lead sponsor: pharmaand GmbH
Sponsor class: INDUSTRY
First posted: 2019-11-04
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be any adult who is clinically diagnosed with multiple myeloma who is actively taking panobinostat.

Brief summary: This study aims to describe current treatment patterns in the real-world setting among patients with multiple myeloma who are initiating treatment with (or changing treatment to) panobinostat and explore the associations with baseline patient characteristics, healthcare resource utilization, and clinical outcomes.


Eligibility criteria: Inclusion Criteria:

* Willing and able to provide written informed consent
* At least 18 years of age
* Clinical diagnosis of multiple myeloma that meets published diagnostic criteria
* Initiating panobinostat within 60 days of enrollment
* ECOG performance status 0-1
* Availability of documentation from the patient's medical records regarding previous myeloma treatment, response, and duration of response
* Willing and able to complete the PRO questionnaire

Exclusion Criteria:

* Diagnosed with any B-cell malignancy other than myeloma
* Estimated life expectancy \<6 months
* Currently enrolled in any interventional clinical trial at study entry (note: patients who enroll in an interventional clinical trial after enrollment may remain in the registry)

Primary outcomes:
measure: Response to treatment
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: American Health Network Indiana
state: Indiana
city: Las Vegas
country: United States
facility: Southern Nevada Cancer Research Foundation and Optum Cancer Care
state: Nevada
city: Charlotte
country: United States
facility: Oncology Specialists of Charlotte
state: North Carolina
city: Huntersville
country: United States
facility: Southern Oncology Specialists
state: North Carolina
city: Gettysburg
country: United States
facility: Gettysburg Cancer Center
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: Coastal Cancer Center
state: South Carolina
city: Rock Hill
country: United States
facility: Carolina Blood and Cancer Care Associates
state: South Carolina
Study officials:
References:
Clinical trial NCT04164589: EFFECTIVENESS OF THE NEUROADAPTATIVE FOR URGE INCONTINENCE
Official title: EFFECTIVENESS OF THE NEUROADAPTATIVE REGULATION TECHNIQUE FOR THE TREATMENT OF URGE INCONTINENCE AND MIXED INCONTINENCE
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urge Incontinence
Lead sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias
Sponsor class: OTHER
First posted: 2019-11-15
Enrollment: 62
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, single blind placebo controlled clinical trial.
Primary purpose: TREATMENT

Brief summary: In this clinical trials the sponsor want to assess a self-controlled-energo-neuroadaptative-regulation in patient with urge incontinence

Detailed description: In this clinical trials the sponsor want to assess a self-controlled-energo-neuroadaptative-regulation in patient with urge incontinence and mixted incontinence

Eligibility criteria: Inclusion Criteria:

* Urge incontinence or mixed incontinence without urethral hypermobility
* Over 3 months of disease evolves.

Exclusion Criteria:

* Severe physical limitations that might interfere with applying the treatment.
* Severe mental disorders that need pharmacology treatments that may influence in neuronal activity
* Oncological processes in the lower abdomen that had required radical surgery.
* Neurogenic bladder.
* Blockage of the bladder
* Vaginal infection
* Bladder infection or disorder of kidney function
* Have received, in the last year, botulinum toxin in bladder or pelvic organs.
* Have received pharmacological treatment for urge incontinence in the last month (before entry date in the trial)
* Be receiving pharmacological treatment for urge incontinence.
* Stress incontinence due to urethral hypermobility which was treatable with surgery.
* Pregnant women
* Patients with pacemarker

Primary outcomes:
measure: Resultant value achieved in the assessment scale of urge incontinence.
timeFrame: 2 years
measure: Sandvik Test for Urinary Incontinence
timeFrame: 2 years
Secondary outcomes:
measure: Intervals between voiding
timeFrame: 2 years
measure: Frequency of nocturia
timeFrame: 2 years
measure: Quality of life index (Potenziani-14-CI-IO-QOL-2000 index)
timeFrame: 2 years
measure: Satisfaction with the treatment (Visual analogue scale.)
timeFrame: 2 years
measure: Duration of the response to treatment
timeFrame: 2 years
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Álvaro Zapico-Goñi
Study officials:
References:
Clinical trial NCT03107689: Prospective Cohort Study of Intravenous Lipid Emulsion for Resuscitating Critically-ill Poisoned Patients
Official title: Prospective Cohort Study of Intravenous Lipid Emulsion for Resuscitating Critically-ill Poisoned Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overdose
Keywords: ILE
lipid
overdose
resuscitation
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: American College of Medical Toxicology
First posted: 2017-04-11
Enrollment: 134
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who receive intravenous lipid emulsion by a toxicologist, participating in the ToxIC registry, who complete the lipid subregistry

Brief summary: The purpose of this project is to evaluate the case characteristics of patients who receive intravenous lipid emulsion therapy. Previous literature to date has focused on animal studies or has been primarily limited to case reports or small case series. This prospectively collected data set will permit a much more detailed description of the use of lipid, its potential benefits, and potential harms.

Detailed description: The purpose of this project is to evaluate the case characteristics of patients who receive intravenous lipid emulsion therapy. A secondary objective is to determine the mortality in this critically ill population of individuals.

Previous literature to date has focused on animal studies or has been primarily limited to case reports or small case series. This prospectively collected data set will permit a much more detailed description of the use of lipid, its potential benefits, and potential harms.

Eligibility criteria: Inclusion Criteria:

* receiving intravenous lipid emulsion for treatment of a drug toxicity
* Evaluation of a medical toxicologist as part of the ToxIC registry consortium

Exclusion Criteria:

* not evaluated by a medical toxicologist participating in ToxIC

Primary outcomes:
measure: Survival
timeFrame: Survival is measured at hospital discharge. The study is open to enrollment indefinitely. It is estimated approximately 100 subjects will be enrolled in 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: ACMT; ToxIC participating sites
state: Arizona
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
affiliation: University of Southern California
name: michael levine, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01444989: Development and Validation of a Quality of Life Instrument for Actinic Keratosis
Official title: Development and Validation of a Quality of Life Instrument for Actinic Keratosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Actinic Keratosis
Keywords: "Sun spots"
"Pre-cancerous skin lesion"
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2011-10-03
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Actinic keratoses (AKs) are some of the most common lesions seen by dermatologists. Flesh colored to erythematous, these lesions often present with scaling or crusting in sun damaged regions of the body. While they are physically visible and often palpable, these changes can also result in psychosocial changes in patients, including embarrassment about their skin or reduction in leisure activities to avoid further sun exposure. At the same time, AKs are known to progress in a significant number of cases to squamous cell carcinoma (SCC), a concern in terms of its metastatic potential.

The primary purpose of developing this questionnaire is to examine how well it can potentially identify patients with actinic keratoses. However, since AK is associated with significant detriment to quality of life for validity/reliability assessment, the investigators propose to give a compilation of four self-assessment questionnaires (not specific to AK but validated for skin health in general) to subjects with at least one actinic keratosis and age- and sex- matched participants without AKs, defined as the control population. These will include the SKINDEX-16, the DLQI and the Skin Health Calculator, as well as a questionnaire composed of items specific to predisposition to AKs to be able to better assess the discriminatory power of the questionnaire.


Eligibility criteria: Inclusion Criteria:

* Male or female, age 18 years or older being seen in a dermatology clinic
* Informed consent of participation must be given by subject

Exclusion Criteria:

* Inability to complete all study questionnaires.
* Subjects who are unable to read and write English

Primary outcomes:
measure: Difference in questionnaire score in patients with Actinic keratosis and with out actinic keratosis
timeFrame: Baseline
Secondary outcomes:
measure: Correlation between AKRQ and DLQI scores
timeFrame: Baseline
measure: The correlation between AKRQ and Skindex-16 scores
timeFrame: Baseline
measure: The correlation between the AKRQ and Skin Health Calculator scores.
timeFrame: Baseline
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Health Sciences Dermatology
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Steven R Feldman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06310889: Evaluation of Palliative Care Co-treatment by Attending Physicians and Nurses: an Online Survey as Part of the Project
Official title: Evaluation of Palliative Care Co-treatment by Attending Physicians and Nurses: an Online Survey as Part of the Project (EPIC-Baseline-Survey)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Palliative Medicine
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: European Commission
name: National and Kapodistrian University of Athens
name: King's College Hospital NHS Trust
First posted: 2024-03-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Doctors or nursing staff involved in the intensive medical care of patients which can be contacted by a list of a specialist association

Brief summary: The subject of the study is an online survey of doctors and nurses who provide (intensive) medical care to patients.

Detailed description: Charité will support this international survey as part of the preparatory phase of the "Europe-wide harmonized and recommended palliative care practice for ICU" approved HORIZON grant application EPIC (EA2/291/23), to which this ethics application refers.

Participants will be contacted via the mailing list of ESAIC (European Organization for Anaesthesia, Intensive Care, Pain and Perioperative Medicine), ESICM (European Society of Intensive Care Medicine), DIVI (German Interdisciplinary Association for Intensive Care and Emergency Medicine (DIVI) and the European Association for Palliative Care (EAPC).

Eligibility criteria: Inclusion Criteria:

* All doctors or nursing staff involved in the intensive medical care of patients and consent to the survey via the distribution list of a specialist association

Exclusion Criteria:

* Incomplete data

Primary outcomes:
measure: Barriers 1
timeFrame: 01.04.2024 - 30.06.2024
measure: Barriers 2
timeFrame: 01.04.2024 - 30.06.2024
Secondary outcomes:
measure: Measures 1
timeFrame: 01.04.2024 - 30.06.2024
measure: Measures 2
timeFrame: 01.04.2024 - 30.06.2024
measure: Resources 1
timeFrame: 01.04.2024 - 30.06.2024
measure: Resources 2
timeFrame: 01.04.2024 - 30.06.2024
Other outcomes:
Locations:
Study officials:
affiliation: Charite University, Berlin, Germany
name: Claudia Spies, MD, Prof.
role: STUDY_CHAIR
References:
Clinical trial NCT03474289: Safety and Tolerability of SHR-1316 in Subjects With Advanced Tumors
Official title: A Phase 1 Study to Evaluate the Safety and Tolerability of SHR-1316 in Subjects With Advanced Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Tumor
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-03-22
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to access the safety and tolerability of the study drug known as SHR-1316 in metastatic/advanced malignancies

Detailed description: This is an open-label, non-randomized, dose escalation/expansion phase I study, SHR-1316 is a humanized IgG4 monoclonal antibody that binds specifically to human PD-L1.The major aims of the study are to define the safety profile of this new drug, and to determine a recommended dose and schedule for potential additional trials.

Eligibility criteria: Inclusion Criteria:

1. Male or female ≥18 years of age
2. Subjects with confirmed advanced malignancies (histologically or cytologically)
3. ECOG Performance status of 0 or 1
4. Adequate organ functions
5. Life expectancy ≥12 weeks;

Exclusion Criteria:

1. Subjects with active autoimmune disease.
2. Systemic cytotoxic chemotherapy, biological therapy, or major surgery within 4 weeks of the first dose of trial treatment
3. Previous received PD-1 or PD-L1 therapy
4. Known Active central nervous system (CNS) metastases
5. Known Clinically significant cardiovascular condition
6. Active infection or an unexplained fever \>38.5°C
7. History of immunodeficiency

Primary outcomes:
measure: Adverse Events
timeFrame: at the end of cycle one(each cycle is 21 days)
measure: Dose-limiting toxicities (DLTs)
timeFrame: at the end of cycle one(each cycle is 21 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
Study officials:
affiliation: Fudan University
name: Xichun Hu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06928389: Ivonescimab in Combination With Docetaxel in Advanced Non-Small Cell Lung Cancer
Official title: A Randomized, Double-blind, Multicenter Phase 3 Clinical Trial of Ivonescimab Versus Placebo, Combined With Docetaxel in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) That Has Progressed on or After PD-(L)1 Inhibitor-based Therapy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Akeso
Sponsor class: INDUSTRY
First posted: 2025-04-15
Enrollment: 536
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 is a Phase 3 Randomized, double-blind, Multicenter Study of Ivonescimab Combined with Docetaxel Versus Placebo Combined with Docetaxel in Patients with Locally advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) that has progressed on or after PD-(L)1 inhibitor-based therapy. The purpose of this study is to evaluate the efficacy and safety of ivonescimab versus placebo, combined with docetaxel in patients with advanced NSCLC.


Eligibility criteria: Inclusion Criteria:

* Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures).
* Age ≥ 18 years old and ≤ 75 years old at the time of randomization.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Expected life expectancy of at least 3 months.
* Histologically or cytologically confirmed diagnosis of NSCLC.
* Locally advanced or metastatic NSCLC (American Joint Committee on Cancer \[AJCC\] 8th edition).
* Previously received systemic platinum-based chemotherapy and PD-1/L1 inhibitors.
* At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
* Adequate organ function.

Exclusion Criteria:

* Histologic or cytopathologic evidence of the presence of small cell lung carcinoma.
* Other malignancies within 3 years prior to randomization.
* Known actionable genomic alterations.
* Prior administration of any immunotherapy targeting immune mechanisms other than PD-1/PD-L1 inhibitors.
* Previous treatment with docetaxel.
* History of severe bleeding tendency or coagulation dysfunction.
* Active autoimmune disease requiring systemic therapy within 2 years prior to randomization.
* History of myocarditis, cardiomyopathy, and malignant arrhythmia.

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: approximately 5 years
Secondary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: approximately 3 years
measure: Adverse Event (AE)
timeFrame: From the patient signs the ICF to 30 days (AE) and 90 days (SAE) after the last dose of study treatment or initiation of other anticancer therapy, whichever occurs first
Other outcomes:
Locations:
Study officials:
affiliation: Shanghai East Hospital
name: Caicun Zhou
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01152489: A Test of the Effectiveness of a Device and Distraction for Pediatric Immunization Pain
Official title: Phase II Study of the Effectiveness of a Device and Distraction for Pediatric Immunization Pain in Multiple Age Groups
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Procedural Pain
Keywords: Pain
Lead sponsor: MMJ Labs LLC
Sponsor class: INDUSTRY
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2010-06-29
Enrollment: 345
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The hypothesis of this study is that distraction cards used by the caretaker along with a vibrating cold pack placed proximal to the site of immunization will decrease the pain of routine pediatric immunizations when compared to a placebo device or standard care.

Detailed description: Needle pain is the most common and the most feared source of childhood pain, resulting in needle phobia for 10$ of adults. Current standard of care for immunizations in the US is no pain relief. An inexpensive, immediately effective form of needle pain control could reduce needle phobia or vaccine refusal in the long term if demonstrated to be effective for immunization pain.

Distraction can decrease procedural distress in children by 50%. The effect of using a multi-modal pain and distraction relieving approach has not been rigorously studied.

Eligibility criteria: Inclusion Criteria:

* children receiving routine immunizations

Exclusion Criteria:

* no caregiver present
* chronic illness requiring frequent injections
* clear cognitive impairments affecting communication

Primary outcomes:
measure: Pain of immunization
timeFrame: 5 minutes during or immediately after immunizations
Secondary outcomes:
measure: Pain from immunization using observational measures
timeFrame: 5 minutes immediately following immunization
measure: Treatment satisfaction
timeFrame: 5 minutes after immunizations
Other outcomes:
Locations:
Study officials:
affiliation: MMJ Labs LLC
name: Amy Baxter, MD
role: PRINCIPAL_INVESTIGATOR
References: