louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00223587: Seasonal Allergic Rhinitis and Driving Ability
Official title: Study to Investigate the Effects of Seasonal Allergic Rhinitis on Over-the-Road Driving Performance and Memory Functioning
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Seasonal Allergic Rhinitis
Keywords: driving
memory
Lead sponsor: Utrecht Institute for Pharmaceutical Sciences
Sponsor class: OTHER
Collaborators: name: UCB Pharma
First posted: 2005-09-22
Enrollment: 22
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: On-the-road driving performance of untreated seasonal allergic rhinitis patients during the allergic season (exposed) is compared to driving performance outside the allergic season (in winter, not-exposed).

Detailed description: This study was set-up to examine whether untreated seasonal allergic rhinitis has an effect on driving ability. In addition to the driving tests, patients perform a memory test in the laboratory.

Eligibility criteria: Inclusion Criteria:

* outpatients with seasonal allergic rhinitis
* a valid driver's licence
* written informed consent
* a T5SS score \>8 during the allergic season and \<3 in winter

Exclusion Criteria:

* use of medication or medical conditions that are known to affect driving ability
* associated ENT disease or asthma

Primary outcomes:
measure: Driving test: Standard Deviation of Lateral Position (SDLP, cm); i.e. the weaving of the car [after 1 week of treatment discontinuation]
timeFrame: allergic season and winter
Secondary outcomes:
measure: Other driving test parameters: standard deviation of speed, mean speed, meal lateral position [after 1 week of treatment discontinuation]
timeFrame: allergic season and winter
measure: Memory test: immediate and delayed recall, delayed recognition [after 1 week of treatment discontinuation]
timeFrame: allergic season and winter
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: Utrecht Institute for Pharmaceutical Sciences
Study officials:
affiliation: Utrecht Institute for Pharmaceutical Sciences
name: Edmund Volkerts, PhD
role: STUDY_DIRECTOR
affiliation: Utrecht Institute for Pharmaceutical Sciences
name: Joris Verster, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01055587: Diagnostic of Infections Following Major Abdominal Surgery and Burn Injury
Official title: Impact of Biomarkers for Early Diagnostic of Infections Following Major Abdominal Surgery and Severe Burn Injuries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Third Degree Burn
Second Degree Burn
Keywords: major abdominal surgery
severe burn injury
infection
diagnostic
Lead sponsor: Klinikum St. Georg gGmbH
Sponsor class: OTHER
Collaborators: name: Martin-Luther-Universität Halle-Wittenberg
First posted: 2010-01-25
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Group 1: patients who undergo major abdominal surgery Group 2: patients following severe burn injury

Brief summary: This study was designed to investigate, if new biomarkers may improve the early diagnostic of infections following major abdominal surgery and severe burn injuries.


Eligibility criteria: Inclusion Criteria:

* patients with major abdominal surgery (e.g. gastrectomy, hemi-/colectomy, resection of sigma or rectum, resection of liver, esophagectomy)
* patients following severe burn injury (burn surface area \>= 15%)
* age \>= 18 years
* informed consent

Exclusion Criteria:

* no informed consent
* emergency surgery
* immunocompromising diseases (e.g. HIV+, AIDS, Lymphoma or NonHodgkin-Lymphoma, Autoimmune-Diseases)
* pre-existing liver or renal failure
* chronic therapy with corticoids

Primary outcomes:
measure: rate of infections
timeFrame: day 28 post intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Klinikum St. Georg gGmbH
state: Sachsen
Study officials:
affiliation: Klinikum St. Georg gGmbH
name: Armin R Sablotzki, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gille J, Schmidt J, Kremer T, Sablotzki A. Evaluation of MR-proANP and copeptin for sepsis diagnosis after burn injury. J Crit Care. 2019 Aug;52:149-155. doi: 10.1016/j.jcrc.2019.04.031. Epub 2019 Apr 30.
citation: Gille J, Ostermann H, Dragu A, Sablotzki A. MR-proADM: A New Biomarker for Early Diagnosis of Sepsis in Burned Patients. J Burn Care Res. 2017 Sep/Oct;38(5):290-298. doi: 10.1097/BCR.0000000000000508.
Clinical trial NCT04734587: Evaluation of Brain Damage Due to Coronary Angioplasty in Percutaneous Intervention Patients
Official title: Assessment of Silent Brain Injury in Chronic Total Occlusion Patients With Percutaneous Coronary Intervention
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Silent Stroke
Coronary Disease
Keywords: silent brain injury
chronic total occlusion
percutaneous coronary intervention
Neuron specific enolase
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2021-02-02
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who were planned to have revascularization due to CTO in at least one coronary artery (CTO Group) and patients who were scheduled for single-vessel elective coronary intervention other than CTO were defined as Non-CTO (control group).

Brief summary: This study examines the formation mechanism and patient-related factors of silent cerebral infarcts, whose importance has become increasingly recognized in patients undergoing percutaneous coronary intervention.

Detailed description: This study was produced from the assistant's thesis and was previously accepted as a poster at EuroPCR 2020. We recently completed the full-length article.

This thesis study was supported by Ondokuzmayis University.

Eligibility criteria: Inclusion Criteria:

* CTO and Non-CTO patients undergoing percutaneous coronary intervention

Exclusion Criteria:

* baseline NSE elevation
* acute coronary syndromes or cardiac surgery within 4 weeks
* patients with a cerebrovascular accident
* intracranial hemorrhage
* and head trauma
* central nervous system tumor
* degenerative central nervous system disorders and neuroendocrine tumors

Primary outcomes:
measure: Baseline Neuron-specific Enolase (NSE) measurement
timeFrame: NSE blood levels were measured 1-2 hours before the procedure.
measure: Silent Brain Injury diagnosis
timeFrame: 12-18 hours after percutaneous coronary intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Ondokuzmayis University
Study officials:
affiliation: Ondokuz Mayıs University
name: Muhammet Uyanık, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04208087: PK and Safety of SI-722 in IC/BPS
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of SI-722 Intravesical Instillation in Interstitial Cystitis/Bladder Pain Syndrome Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Interstitial Cystitis
Bladder Pain Syndrome
Keywords: Bladder
Intravesical Injection
Interstitial Cystitis
Lead sponsor: Seikagaku Corporation
Sponsor class: INDUSTRY
First posted: 2019-12-23
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This study is designed randomized, double-blind, placebo-controlled trial in Interstitial Cystitis/Bladder Pain Syndrome patients.


Eligibility criteria: Inclusion Criteria:

* Males or females, ≥18 and ≤80 years of age
* A score of 19 or greater on the Bladder Pain/Interstitial Cystitis Symptom Score (BPIC-SS)

Exclusion Criteria:

* Urinary tract infection ≤30 days
* Treatment with intravesical therapy ≤60 days
* Treatment with any opioid therapy ≤7 days
* History of bladder hydrodistension ≤3 months
* Has cancer or a past history of any cancer ≤5 years
* Body mass index (BMI) ≥40 kg/m2

Primary outcomes:
measure: Maximum Plasma Concentration (Cmax) for SI-722
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: American Institute of Research
state: California
city: Murrieta
country: United States
facility: TriValley Urology Medical Group
state: California
city: The Villages
country: United States
facility: Premier Medical Associates
state: Florida
city: Garden City
country: United States
facility: AccuMed Research Associates
state: New York
city: Houston
country: United States
facility: Centex Studies
state: Texas
Study officials:
References:
Clinical trial NCT02436187: Guideline Recommended Care and Excess Mortality for Non ST-elevation Myocardial Infarction : A National Cohort Study
Official title: Guideline Recommended Care and Excess Mortality for Non ST-elevation Myocardial Infarction : A National Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non ST-elevation Myocardial Infarction
Keywords: NSTEMI
excess mortality
evidence-based care
MINAP
Lead sponsor: University of Leeds
Sponsor class: OTHER
First posted: 2015-05-06
Enrollment: 389057
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: The study population comprised of 389,052 patients with non ST-elevation myocardial infarction admitted to hospital and were entered into Myocardial Ischaemia National Audit Project database between January 2003 and December 2013.

Brief summary: The aim of the study is to quantify the excess mortality associated with non-adherence to care for non ST-elevation myocardial infarction in England and Wales over the last decade.


Eligibility criteria: Inclusion Criteria:

* aged 18 years or more
* patients hospitalised with non ST-elevation myocardial infarction

Exclusion Criteria:

* patients hospitalised with phenotypes other than non ST-elevation myocardial infarction

Primary outcomes:
measure: Mortality
timeFrame: Participants will be followed up for an expected average of 8 years 6 months
Secondary outcomes:
measure: Number of missed guideline recommended care opportunities
timeFrame: Participants will be followed up for an expected average of 8 years 6 months
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: University of Leeds
Study officials:
affiliation: University of Leeds
name: Christopher P Gale, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dondo TB, Hall M, Timmis AD, Gilthorpe MS, Alabas OA, Batin PD, Deanfield JE, Hemingway H, Gale CP. Excess mortality and guideline-indicated care following non-ST-elevation myocardial infarction. Eur Heart J Acute Cardiovasc Care. 2017 Aug;6(5):412-420. doi: 10.1177/2048872616647705. Epub 2016 May 3.
citation: Dondo TB, Hall M, Timmis AD, Yan AT, Batin PD, Oliver G, Alabas OA, Norman P, Deanfield JE, Bloor K, Hemingway H, Gale CP. Geographic variation in the treatment of non-ST-segment myocardial infarction in the English National Health Service: a cohort study. BMJ Open. 2016 Jul 12;6(7):e011600. doi: 10.1136/bmjopen-2016-011600.
Clinical trial NCT03368287: Activity Trackers for Monitoring During Rehabilitation After Total Knee Arthroplasty
Official title: Activity Trackers for Monitoring During Rehabilitation After Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Total Knee Arthroplasty
Keywords: Total Knee Arthroplasty
steps
rehabilitation
activity tracker
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2017-12-11
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study aims to estimated the change of the steps of daily life of osteoarthritis patients before and in 6 weeks, 3 months, 6 months, 1 year after the total knee arthroplasty (TKA) through a kind of activity tracker: Fitbit ONE.

Detailed description: A total of 100 participants who will receive total knee arthroplasty will be recruited in this study. Fitbit ONE, the activity tracker, will be used for all of them to monitor the daily steps during the rehabilitation, to be exact, before and at 6 weeks, 3 months, 6 months, 1 year after TKA. Moreover, pain score, self reported questionnaire will also be estimated at those time points.

Eligibility criteria: Inclusion Criteria:

* Ready to receive single-side TKA

Exclusion Criteria:

* contraindication of surgery
* self-reported diseases that cause lower limb disability (for example, cerebrovascular disease especially stroke)

Primary outcomes:
measure: The change of steps of daily life
timeFrame: before operation and 6 weeks, 3 months, 6 months, 1 year after operation
Secondary outcomes:
measure: The change of pain score
timeFrame: before operation and 6 weeks, 3 months, 6 months, 1 year after operation
measure: The change of knee joint symptoms.
timeFrame: before operation and 6 weeks, 3 months, 6 months, 1 year after operation
Other outcomes:
Locations:
Study officials:
affiliation: arthritic clinic and research center
name: Jianhao Lin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Patel S, Park H, Bonato P, Chan L, Rodgers M. A review of wearable sensors and systems with application in rehabilitation. J Neuroeng Rehabil. 2012 Apr 20;9:21. doi: 10.1186/1743-0003-9-21.
citation: Kooiman TJ, Dontje ML, Sprenger SR, Krijnen WP, van der Schans CP, de Groot M. Reliability and validity of ten consumer activity trackers. BMC Sports Sci Med Rehabil. 2015 Oct 12;7:24. doi: 10.1186/s13102-015-0018-5. eCollection 2015.
citation: Cook DJ, Thompson JE, Prinsen SK, Dearani JA, Deschamps C. Functional recovery in the elderly after major surgery: assessment of mobility recovery using wireless technology. Ann Thorac Surg. 2013 Sep;96(3):1057-61. doi: 10.1016/j.athoracsur.2013.05.092.
Clinical trial NCT06312787: A Study to Evaluate the Relative Bioavailability and Food Effect of a VX-118 Tablet Formulation
Official title: A Phase 1, Open-label, Randomized, Crossover Study to Evaluate the Relative Bioavailability and Food Effect of a Tablet Formulation of VX-118 in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cystic Fibrosis
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2024-03-15
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the relative bioavailability, effect of food on the pharmacokinetic parameters, and safety and tolerability, of a tablet formulation of VX-118 in healthy participants.

Detailed description: This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Eligibility criteria: Key Inclusion Criteria:

* Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (Kg/m\^2), both inclusive
* A total body weight greater than (\>) 50 kg
* Participants of non-childbearing potential

Key Exclusion Criteria:

* History of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug
* Any condition possibly affecting drug absorption
* Hypersensitivity to any component of the investigational drug product

Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of VX-118
timeFrame: Pre-dose up to 192 hours Post-dose
measure: Area Under the Concentration Versus Time Curve (AUC) of VX-118
timeFrame: Pre-dose up to 192 hours Post-dose
Secondary outcomes:
measure: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs)
timeFrame: Day 1 up to Day 27
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Celerion - Lincoln
state: Nebraska
Study officials:
References:
Clinical trial NCT03928587: Effect of 12 Months Supplementation With a Symbiotic Lozenge on Caries Increment in Healthy Children
Official title: Effect of 12 Months Supplementation With a Symbiotic Lozenge on Caries Increment in Healthy Children: A Randomized, Parallel-grouped, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Lead sponsor: Chr Hansen
Sponsor class: INDUSTRY
Collaborators: name: University of Copenhagen
First posted: 2019-04-26
Enrollment: 343
Sex: ALL
Minimum age (years): 5
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary objective of this trial is to investigate the effect of a symbiotic lozenge on dental caries in young children.

Detailed description: The study is a multicentre, randomized, double-blind, placebo-controlled, parallel-group study in healthy children aged 5-8 years. The objective is to investigate the effect of a symbiotic lozenge on caries increment in primary molar teeth, primary canines and erupted occlusal surfaces at the first permanent molar teeth.The study will take place in Helsingør and Fredensborg municipality.

The study consists of a baseline visit prior to a 12 months intervention period, followed by a visit after completion. During the intervention period, two to four months after the baseline visit, a saliva sample will be collected.

All guardians to the subjects are encouraged to 1) brush their children's teeth twice daily with the fluoride toothpaste provided, 2) avoid the food provided in appendix D and 3) to continue the subject's dental appointments at local Public Dental Health Service (PDHS). No further specific oral hygiene or dietary instructions/restrictions are provided.

Assuming a dropout rate of 12.5%, 175 children will be included in each treatment group.

Eligibility criteria: Inclusion Criteria:

1. Healthy children with absence of severe chronic disease
2. Age 5-8 years, both inclusive, at inclusion
3. Ability to cooperate at dental examination
4. Ability to cooperate to a daily intake of a lozenge
5. Parents/legal guarding provided voluntary written informed consent

Exclusion Criteria:

1. Children with severe medical conditions
2. Mentally or physically disabled children
3. Children of parents with language barriers and not able to give written informed consent

Primary outcomes:
measure: Increase in caries incidence
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: University of Copenhagen
Study officials:
affiliation: University of Copenhagen
name: Azam Bakhshandeh, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00000187: Ritanserin in Treatment of Cocaine Dependence - 1
Official title: Ritanserin in Treatment of Cocaine Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cocaine-Related Disorders
Keywords: Cocaine Dependence
ritanserin
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 1999-09-21
Enrollment: 80
Sex: MALE
Minimum age (years): 28
Maximum age (years): 47
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess ritanserin as a pharmacotherapy for cocaine dependence.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Cocaine use
measure: Cocaine craving
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: James Cornish, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cornish JW, Maany I, Fudala PJ, Ehrman RN, Robbins SJ, O'Brien CP. A randomized, double-blind, placebo-controlled study of ritanserin pharmacotherapy for cocaine dependence. Drug Alcohol Depend. 2001 Jan 1;61(2):183-9. doi: 10.1016/s0376-8716(00)00140-x.