louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03445156: Effect of Violent First-Person Shooter (FPS) Video Games on Shooting Accuracy
Official title: "Boom, Headshot!": Violent First-Person Shooter (FPS) Video Games That Reward Headshots Train Individuals to Aim for the Head When Shooting a Realistic Firearm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gun Shot Wound
Keywords: First-person shooter (FPS)
Violent video game
Headshot
Gun
Operant conditioning theory
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2018-02-26
Enrollment: 327
Sex: ALL
Minimum age (years): 18
Maximum age (years): 46
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 (controller type) x 3 (video game type) factorial design. Participants used either a regular or gun shaped controller while playing a non-shooting, non-humanoid shooting, or humanoid shooting game.
Primary purpose: BASIC_SCIENCE

Brief summary: The present research tests the effects of violent shooting games on behavior within the game (Pilot Study) and on behavior after the game is turned off (Experiment Proper). The Experiment Proper is an exact replication of a previous study conducted in our lab that was retracted (see citation), but with a larger sample to get more reliable results (N=287 rather than N=151).

Detailed description: Violent shooting games are used to train soldiers and police officers. This research tests whether violent shooting can train people to shoot targets in the head, both during gameplay (Pilot Study) and after the game is turned off (Experiment Proper). Participants in both studies played a violent shooting game with humanoid targets that rewarded headshots, or a nonviolent shooting game that punished shots to bull's-eye targets with faces. Afterward, participants shot at a mannequin with a realistic CO2 gun. We anticipate that participants who play the violent game which rewards headshots to hit the mannequin's head more often than those who play the non-violent game.

Eligibility criteria: Inclusion Criteria:

* 18 and older
* Ohio State participant pool

Exclusion Criteria:

* Under age 18

Primary outcomes:
measure: Hits to Head and Face
timeFrame: Up to one hour
measure: Other Hits
timeFrame: Up to one hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Whitaker, J. L., & Bushman, B. J. (2014). "Boom, Headshot!": Effect of violent video game play and controller type on firing aim and accuracy. Communication Research, 41(7), 879-891. doi:10.1177/0093650212446622
Clinical trial NCT01621256: Efficacy, Safety, and Tolerability of Ancrod in Patients With Sudden Hearing Loss
Official title: Double-blind, Randomized, Placebo-controlled Study on Efficacy, Safety and Tolerability of Ancrod in Patients With Sudden Sensorineural Hearing Loss (SSHL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Hearing Loss
Deafness
Hearing Loss, Sensorineural
Hearing Disorders
Ear Diseases
Lead sponsor: Nordmark Arzneimittel GmbH & Co. KG
Sponsor class: INDUSTRY
Collaborators: name: ClinSupport GmbH
name: MWI Medizinisches Wirtschaftsinstitut GmbH
name: ProjectPharm s.r.o.
name: LCR Leading Clinical Research s.r.o.
name: X-act Cologne Clinical Research GmbH
First posted: 2012-06-18
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether ancrod is effective and safe in the treatment of sudden sensorineural hearing loss (SSHL).


Eligibility criteria: Inclusion Criteria:

* Unilateral idiopathic sudden sensorineural hearing loss ≥30 dB
* Symmetric hearing prior to onset of SSHL
* Enrollment has to be accomplished within 7 days after SSHL onset

Exclusion Criteria:

* Bilateral SSHL
* Incomplete recovery after previous SSHL
* Previously existing, known retrocochlear hearing loss
* Any history of any ear operation or local inflammatory disease in the past one year
* History of blunt or penetrating ear trauma, head trauma, barotrauma, or acoustic trauma immediately preceding SSHL
* History of Meniere's disease, autoimmune hearing loss, radiation-induced hearing loss, endolymphatic hydrops.
* Treatment with steroids for any reason within the preceding 30 days.
* Body weight \> 140 kg

Primary outcomes:
measure: Change in PTA (pure tone audiogram) in the affected ear
timeFrame: From baseline to Day 8
Secondary outcomes:
measure: Change in speech recognition in the affected ear
timeFrame: From baseline to Day 8
Other outcomes:
measure: Patient assessment of change in hearing impairment
timeFrame: From baseline to Day 8, Day 30 and Day 90
measure: Change in fibrinogen concentration
timeFrame: From baseline to Day 2 and Day 8
measure: Change in biomarkers
timeFrame: From baseline to Day 8
Locations:
city: Hradec Králové
country: Czechia
facility: Site CZ
city: Praha
country: Czechia
facility: Site CZ
city: Göttingen
country: Germany
facility: Site D
city: Hamburg
country: Germany
facility: Site D
city: Hannover
country: Germany
facility: Site D
city: Landsberg am Lech
country: Germany
facility: Site D
city: München
country: Germany
facility: Site D
Study officials:
affiliation: Department for Otorhinolaryngology, LM University Munich
name: Martin Canis, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03543956: Professional and Personal Toxic Exposure in Systemic Sclerosis : Type, Intensity and Probability of Exposition
Official title: Professional and Personal Toxic Exposure in Systemic Sclerosis : Type, Intensity and Probability of Exposition
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Systemic Sclerosis
Keywords: Silica
Organic Solvents
Toxic substances exposure
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2018-06-01
Enrollment: 226
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients affected by SSc according to EULAR 2013 criteria.

Brief summary: Systemic Sclerosis (SSc) is an inflammatory chronic disease that can lead to structural damage and handicap. The SSc physiopathology is multifactorial, including genetic and environmental risk factors. The identification of environmental factors implication is crucial to understand the SSc mechanism, and improves the diagnosis and the treatment of the disease.

Detailed description: Studies show that the risk associated with high cumulative exposure to silica and organic solvents appears to be strongly increased in SSc. Moreover, exposure to silica is associated with a specific type of SSc phenotype with a worse prognosis. However, the type, intensity and probability of these expositions are unknown.

The aim of the study is to precisely determine type, intensity and probability of toxic substances exposition in Systemic Sclerosis patients through an auto-questionnaire and integration of these data in a computer matrix.

Eligibility criteria: Inclusion Criteria:

* Patients aged over 18 years old
* Speaking and understanding French language
* Being informed about the study and having given his consent
* Affected by SSc according to EULAR 2013 criteria

Exclusion Criteria:

* Patient under tutorship
* Patient who refuse to participate

Primary outcomes:
measure: Analyse type, intensity and probability of toxic substances exposition in Systemic Sclerosis patients through an auto-questionnaire and integration of these data in a computer matrix
timeFrame: At baseline (day 0)
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux - service de rhumatologie
Study officials:
affiliation: University Hospital, Bordeaux
name: Marie-Elise TRUCHETET, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03458156: Umbilical Cord Mesenchymal Stem Cell Transplantation for Lupus Nephritis
Official title: Clinical Study of Umbilical Cord Mesenchymal Stem Cell Transplantation for Lupus Nephritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lupus Nephritis
Lead sponsor: The First Affiliated Hospital of Dalian Medical University
Sponsor class: OTHER
First posted: 2018-03-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the safety and efficacy of umbilical cord mesenchymal stem cell transplantation in patients with systemic lupus erythematosus (SLE) and lupus nephritis (LN).

Detailed description: Systemic lupus erythematosus (SLE) is a multisystem autoimmune disease. Lupus nephritis (LN) is one of the most serious complications of SLE. The current clinical treatments of LN mainly include steroids and immunosuppressive drugs, but drug side effects are obvious.

Eligibility criteria: Inclusion Criteria:

* Meeting the 1997 American College of Rheumatology (ACR) classification criteria of SLE.
* age 18-60 years.
* of either sex and of any ethnicity.
* Lupus nephritis (LN) group: (1) Receiving more than 6 months of regular treatment, 24-hour urine protein ≥ 1.0 g, serum creatinine ≥1.5 mg/dL; (2) renal biopsy: class III, IV or V LN included, and class VI excluded.
* After conventional treatment (glucocorticoid therapy and immunosuppressive drugs) prior to grouping, SLEDAI scores ≥ 10.
* Receiving 12 months of treatment while using birth control.
* Provision of informed consent.

Exclusion Criteria:

* Poor blood pressure control by drug treatment (≥ 160/100 mmHg)
* Abnormal hepatic function (a 3-fold increase in alanine aminotransferase level relative to normal liver).
* Renal failure (glomerular filtration rate \< 15 mL/min/1.73 m2).
* Severe heart and lung failure, or injury to other important organs
* Uncontrollable infection.
* Having not taken biological agents for 6 months.
* Pregnant or lactating women, or those women who are trying to get pregnant or those men who are trying to make their partners pregnant.

Primary outcomes:
measure: SLEDAI-2000 score
timeFrame: changes of month 3, month 6, month 9 and month 12 after treatment
Secondary outcomes:
measure: BILAG-2004 score
timeFrame: changes of month 3, month 6, month 9 and month 12 after treatment
measure: Health Assessment Questionnaire (HAQ) score
timeFrame: changes of month 3, month 6, month 9 and month 12 after treatment
Other outcomes:
Locations:
Study officials:
affiliation: The First Affiliated Hospital of Dalian Medical University
name: Liu Jing, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03729609: Drug Use Surveillance for Brentuximab Vedotin Intravenous Infusion "Untreated CD30-Positive Hodgkin's Lymphoma"
Official title: Drug Use Surveillance for ADCETRIS Intravenous Infusion "Untreated CD30-Positive Hodgkin's Lymphoma"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Untreated CD30-Positive Hodgkin's Lymphoma
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2018-11-02
Enrollment: 113
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with untreated CD30-positive Hodgkin's lymphoma on concomitant Brentuximab vedotin 1.2 mg/kg (body weight) and AVD as part of routine medical care.

Brief summary: The purpose of this survey is to monitor and identify the occurrence of neutropenia and febrile neutropenia in untreated CD30-positive Hodgkin's lymphoma participants on concomitant brentuximab vedotin and doxorubicin hydrochloride, vinblastine sulfate, and dacarbazine (AVD) in routine clinical practice.

Detailed description: The drug being tested in this survey is called brentuximab vedotin intravenous infusion 50 mg. This intravenous infusion is being tested to treat people with untreated CD30-positive Hodgkin's lymphoma.

This survey is an observational (non-interventional) study and will look at the occurrence of neutropenia and febrile neutropenia in untreated CD30-positive Hodgkin's lymphoma patients on concomitant brentuximab vedotin and AVD in the routine clinical setting. The planned number of observed patients will be approximately 100.

This multi-center observational trial will be conducted in Japan.

Eligibility criteria: Inclusion Criteria:

1. Untreated participants
2. CD30-positive participants
3. Participants on concomitant Brentuximab vedotin and AVD

Exclusion Criteria:

1. Participants contraindicated for Brentuximab vedotin

Primary outcomes:
measure: Percentage of Participants With Grade 3 or Higher Neutropenia and Febrile Neutropenia
timeFrame: Up to 2 weeks after the last dose (approximately 6 months)
Secondary outcomes:
measure: Tumor Response Rate Based on Investigator's Assessment
timeFrame: Baseline, Up to 2 weeks after the last dose (approximately 6 months)
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Takeda Selected Site
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03441009: Metabolism and the Activity of the Autonomic Nervous System in Patients With Paroxystic Sympathetic Hyperactivity, PSH
Official title: Metabolism and the Activity of the Autonomic Nervous System in Patients With Paroxystic Sympathetic Hyperactivity, PSH
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autonomic Nervous System Imbalance
Keywords: PSH, Rehabilitation, Medication, ANS
Lead sponsor: Region MidtJylland Denmark
Sponsor class: OTHER
First posted: 2018-02-22
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to NISU from tertiary health care facilities for intensive care in combination with early neurorehabilitation

Brief summary: Adult patients suffering from acquired brain damage run the risk of developing PSH. This group of patients is admitted to our unit, the Neurointensive Stepdown Unit, at Silkeborg Regional Hospital for intensive care and early neurorehabilitation. After weaning from intensive carethey are transferred to Hammel NeuroCentre.

Aim is to assess whether HRV-derived variables in the frequency domain mirror therapeutic and/or nursing and/or pharmacologic interventions. To the extent clinically available BRS and metabolism are included in the assessment.

Detailed description: See report:

Honore H, Eggertsen K, Sondergaard S: A study into the feasibility of using HRV variables to guide treatment in patients with paroxystic sympathetic hyperactivity in a neurointensive step-down unit. NeuroRehabilitation 2019, 44(1):141-155.

Eligibility criteria: Inclusion Criteria:

Symptoms of PSH according to Baguley scoring table

Exclusion Criteria:

No symptoms of PSH

Primary outcomes:
measure: Difference before vs after intervention in frequency domain parameters of HRV
timeFrame: immediate
measure: Qualitative description expressed as goal attainment scaling (GAS) of therapeutic interventions
timeFrame: immediate
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hammel Neuro- and Research Centre
name: Jørgen Feldbæk, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT05725109: Hepatitis C Diagnosis to Treatment Management
Official title: Hepatitis C Disease Management: Diagnosis to Treatment Alerts in CHORUS™
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C
Lead sponsor: Epividian
Sponsor class: INDUSTRY
Collaborators: name: Gilead Sciences
name: AIDS Healthcare Foundation
First posted: 2023-02-13
Enrollment: 1063
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinic Population: AIDS Healthcare Foundation Healthcare Centers across the United States and Puerto Rico are included in the study.

Patient Population: Adult patients with active, untreated HCV infection at AIDS Healthcare Foundation Healthcare Centers are included in the study.

Brief summary: The objective of this study is to evaluate whether sending alerts to healthcare providers and clinic staff to identify patients with untreated hepatitis C infection can increase the uptake of hepatitis C treatment. A period of time without alerts will be compared to a period of time with alerts.

Detailed description: The hepatitis C virus (HCV) is one of the most common bloodborne pathogens in the United States. A large proportion of people with HCV infection progress to chronic HCV infection despite the availability of effective treatment; chronic infection can result in cirrhosis, end-stage liver disease, liver cancer, and liver-related death. HCV infection can be cured most of the time with treatment. The objective of this before and after study is to evaluate whether sending alerts to healthcare providers and clinic staff to identify patients with untreated hepatitis C infection can increase the uptake of HCV treatment. A period of time without alerts will be compared to a period of time with alerts. Healthcare providers and clinic staff will not receive alerts during the before period of the study. Healthcare providers and clinic staff will receive alerts during the after period of the study.

Eligibility criteria: Inclusion Criteria:

* 18+ years of age
* In care at an AIDS Healthcare Foundation Healthcare Center
* Active, untreated HCV infection

Exclusion Criteria:

* \<18 years of age
* Patients with active HCV infection who have a current prescription for HCV treatment

Primary outcomes:
measure: Prescriptions for HCV treatment
timeFrame: End of follow-up, up to 9 months
Secondary outcomes:
measure: HCV RNA viral load tests
timeFrame: End of follow-up, up to 9 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: AIDS Healthcare Foundation
state: California
Study officials:
affiliation: AIDS Healthcare Foundation
name: Michael Wohlfeiler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03619109: Determination of Normal Reference Values of CRP, Procalcitonin, and Lactate Levels for the Nanōmix eLab® System
Official title: Evaluation of the Levels of C-Reactive Protein, Procalcitonin, and Lactate in a Normal Healthy Population When Tested With the Nanōmix eLab® System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: C-Reactive Protein
CRP
Procalcitonin
Lactate
In Vitro Diagnostic Product
IVD
Lead sponsor: Nanomix
Sponsor class: INDUSTRY
First posted: 2018-08-07
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy Volunteers

Brief summary: The main objective of this clinical study is to determine the normal reference range of the Nanōmix eLab® (eLab) C-Reactive Protein, Procalcitonin and Lactate Assay.

Detailed description: The purpose of this clinical study is to determine the normal reference range of the Nanōmix eLab® (eLab) C-Reactive Protein, Procalcitonin and Lactate Assay, whereby collected blood samples are used to characterize the distribution of C-Reactive Protein (CRP), Procalcitonin (PCT), and Lactate (LAC) in a population of healthy subjects. Approximately 4 mL of whole blood will be collected by venipuncture from normal healthy volunteers and tested with the eLab C-Reactive Protein, Procalcitonin, and Lactate assay within 30 minutes of collection. Following the whole blood test, the sample will be spun down to plasma and a plasma sample will be tested on the eLab with the eLab C-Reactive Protein, Procalcitonin, and Lactate assays within 30 min of the whole blood test. Demographic and health information will also be collected from each participant by having them complete a questionnaire. The test results will be collated to establish the normal range (2.5 - 97.5th percentile) for each analyte. The remaining plasma will be frozen and stored at -80° C.

Eligibility criteria: Inclusion Criteria:

* Must be 18 years of age or older
* Must have provided written informed consent
* Must self-report as being in good health

Exclusion Criteria:

* Under the care of a physician and currently receiving any therapy
* Obesity (BMI \> 35)
* Have had outpatient surgery or been hospitalized in the last 3 months for any reason
* Known to be pregnant or nursing
* Engaged in exertion resulting in an estimated HR\>120 bpm for \> 5 minutes in the last 4 hours

Primary outcomes:
measure: Normal reference ranges of CRP, Procalcitonin, and Lactate for the Nanōmix eLab® System
timeFrame: One timepoint at enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Zuckerberg San Francisco General Hospital
state: California
Study officials:
affiliation: Nanomix
name: Tina Landess
role: STUDY_DIRECTOR
References: