louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01485419: Characterization of the Early Sex Hormone Milieu Post Injury and Relationship With Resuscitation Requirements and Coagulopathy
Official title: Characterization of the Early Sex Hormone Milieu Post Injury and Relationship With Resuscitation Requirements and Coagulopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Injury
Keywords: Sex hormones
Testosterone
Estradiol
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2011-12-05
Enrollment: 292
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Injured patients requiring ICU admission who arrive within 6 hours of injury

Brief summary: Traumatic injury is a major public health problem with an immense societal cost. Despite improvements in trauma management, patients continue to suffer significant morbidity and mortality. Evidence suggests that males and females tolerate severe injury differently with a greater protection afforded to females. Determining the mechanisms responsible for these sex-based outcome differences after injury, focusing specifically on the early sex-hormone environment post-injury, may allow those at highest risk for poor outcome to be predicted and promote interventions that can improve outcomes for all injured patients. The goal of this study is to determine if the early sex hormone environment soon after injury has effects on the intensity of the immune response, resuscitation and blood transfusion requirements, and important clinical outcomes including mortality, organ failure and infection, following significant injury.


Eligibility criteria: Inclusion Criteria:

Injury, ICU admission

Exclusion Criteria:

Isolated TBI, Admission beyond 6 hours

Primary outcomes:
measure: Multiple Organ Failure
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Jason Sperry, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03089541: Electronic Cigarette Use in Young Adult Men and Women
Official title: Electronic Cigarette Use in Young Adult Men and Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cigarette Smoking
Tobacco Use
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: APT Foundation, Inc.
name: National Institute on Drug Abuse (NIDA)
First posted: 2017-03-24
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 30 non-treatment seeking young adult e-cigarette/cigarette dual users (15 males/15 females) will participate in a contingency-management reinforced 1 week observation period
Primary purpose: TREATMENT

Brief summary: This one-year pilot study of 30 non-treatment seeking young adult e-cigarette/combustible tobacco product dual users (15 males/15 females) will use smartphone-based ecological momentary assessment (EMA) to gather real-time data of e-cigarette and combustible tobacco product behaviors during a 1-week cigarette/e-cigarette dual use period .(1) Participants will respond to daily random prompts assessing in-the-moment use of e-cigarettes/cigarettes and the subjective factors (ratings of satisfaction and withdrawal) and contextual factors (location, activity, social cues) associated with each episode of use. Participants will also complete daily electronic diaries to document e-cigarette use episodes/day, and satisfaction with the e-cigarette experience during the study.


Eligibility criteria: Inclusion Criteria:

1. be 18 through 29 years of age;
2. Smoke cigarettes;
3. have experience with e-cigarette use;
4. fluent in English;
5. have a functioning cell phone for personal use ;
6. have access to wireless networks at least once daily;
7. have self-reported good health.

Exclusion Criteria.

1. report serious medical illness;
2. are women who are currently/planning to be pregnant or breastfeeding.

Primary outcomes:
measure: Contextual Factors Associated With Tobacco Use Episode Reported Via Ecological Momentary Assessment
timeFrame: week 1
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Deepa R Camenga, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Camenga DR, Haeny AM, Krishnan-Sarin S, O'Malley SS, Bold KW. Pilot Ecological Momentary Assessment Study of Subjective and Contextual Factors Surrounding E-Cigarette and Combustible Tobacco Product Use among Young Adults. Int J Environ Res Public Health. 2021 Oct 20;18(21):11005. doi: 10.3390/ijerph182111005.
Clinical trial NCT03930641: Study of the Safety of Brolucizumab 6 mg in Prefilled Syringe in Patients With Neovascular Age Related Macular Degeneration
Official title: An Open-Label, Single-Arm, Multicenter, Phase IIIb Study in Patients With Neovascular Age-Related Macular Degeneration to Evaluate the Safety of Brolucizumab 6 mg in Prefilled Syringe
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neovascular Age Related Macular Degeneration
Keywords: brolucizumab 6 mg prefilled syringe PFS
open label study
neovascular age related macular degeneration intravitreal injection IVT
observation
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2019-04-29
Enrollment: 34
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: study with a single arm: brolucizumab 6 mg PFS
Primary purpose: TREATMENT

Brief summary: This was a multicenter, open label study that is designed to evaluate the safety of brolucizumab 6 mg in a prefilled syringe in subjects with neovascular age related macular degeneration and to support collection of observations of the prefilled syringe use for intravitreal injection.

Detailed description: The primary objective of this study was to evaluate the safety of brolucizumab 6 mg delivered in a pre-filled syringe (PFS) in subjects with neovascular age-related macular degeneration (nAMD) with the primary endpoint being the incidence of ocular and non-ocular adverse events (AEs). There were no other objectives for this study.

Eligibility criteria: Inclusion Criteria:

1. Written informed consent must be obtained before any assessment is performed.
2. Study eye is diagnosed with neovascular age related macular degeneration and would need an intravitreal injection.
3. Subjects \>= 50 years of age.

Exclusion Criteria:

1. Active infection or inflammation in the eyes.
2. Uncontrolled glaucoma.
3. History of a medical, ocular or non-ocular conditions, resulting in that the study medication cannot be safely administered.
4. Treatment with anti-VEGF intravitreal injection in the study eye within one month prior to enrollment.
5. The use of intraocular corticosteroids in the study eye within the last three months prior to enrollment.
6. Recent intraocular surgery, prior long-acting therapeutic agent, or ocular drug release device implantation.
7. Uncontrolled hypertension.

Other protocol defined inclusion and exclusion criteria may apply.

Primary outcomes:
measure: The Safety of Brolucizumab 6 mg Delivered in Prefilled Syringe in Patients With Neovascular Age Related Macular Degeneration
timeFrame: Up to Day 31
Secondary outcomes:
Other outcomes:
Locations:
city: Altamonte Springs
country: United States
facility: Novartis Investigative Site
state: Florida
city: Pensacola
country: United States
facility: Novartis Investigative Site
state: Florida
city: Richmond
country: United States
facility: Novartis Investigative Site
state: Virginia
Study officials:
References:
Clinical trial NCT05112341: Adjuvant Whole Breast Irradiation in Five Fractions Versus Fifteen Fractions in Early Breast Cancer
Official title: Adjuvant Whole Breast Irradiation in Five Fractions Versus Fifteen Fractions in Early Breast Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Study on Breast Cancer Patients
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-11-08
Enrollment: 50
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: the study includes patients with early breast cancer recieving adjuvant radiotherapy in hypofractionation pattern the first arm recieving 15 fraction and the seconed arm recieving five fractions

Brief summary: the study aiming for compairing results of hypofractionaton radiotherapy treatment in patient with early breast cancer between two arms the first arm recieving five fractions and the other arm recieving fifteen fraction


Eligibility criteria: Inclusion Criteria:

* age group ( 18-80) years
* breast conservation surgery
* Stages (pT1-3, pN0-1, M0) breast cancer.
* Any histological type of invasive breast cancer.
* All grades of breast cancer (I,II,III)

Exclusion Criteria:

* Stage (III or IV) breast cancer.
* Metastatic breast cancer (MBC)
* Recurrent breast cancer.
* Patients' co-morbidities that contraindicate radiotherapy

Primary outcomes:
measure: 1-disease free survival
timeFrame: 2 years
measure: 2- overall survival
timeFrame: 2 years
measure: 3- toxicity from treatment
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
citation: Ibrahim AS, Khaled HM, Mikhail NN, Baraka H, Kamel H. Cancer incidence in egypt: results of the national population-based cancer registry program. J Cancer Epidemiol. 2014;2014:437971. doi: 10.1155/2014/437971. Epub 2014 Sep 21.
citation: Mascaro A, Farina M, Gigli R, Vitelli CE, Fortunato L. Recent advances in the surgical care of breast cancer patients. World J Surg Oncol. 2010 Jan 20;8:5. doi: 10.1186/1477-7819-8-5.
citation: Coates AS, Winer EP, Goldhirsch A, Gelber RD, Gnant M, Piccart-Gebhart M, Thurlimann B, Senn HJ; Panel Members. Tailoring therapies--improving the management of early breast cancer: St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2015. Ann Oncol. 2015 Aug;26(8):1533-46. doi: 10.1093/annonc/mdv221. Epub 2015 May 4.
Clinical trial NCT01217541: Collaboration Between Department of Old Age Psychiatry and Nursing Homes
Official title: Collaboration Between Department of Old Age Psychiatry and Nursing Homes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Alzheimer's Disease
Behavioral Symptoms
Agitation
Keywords: Dementia
BPSD
Quality of Life
Person-centred care
Job satisfaction
Nursing home
Primary care
Lead sponsor: Sykehuset Innlandet HF
Sponsor class: OTHER
Collaborators: name: Helse Sor-Ost
name: Norwegian Department of Health and Social Affairs
First posted: 2010-10-08
Enrollment: 700
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Dementia is a serious health problem showing an increasing prevalence rate with increasing age. In Norway, about 80% of nursing home patients have dementia. The mean age of nursing home residents in Norway is around 84 years. Disruptive and agitated behaviour affect 30-50% of all individuals with dementia at some point in the course of the illness. In addition, they have a combination of physical and psychological diseases which necessitates a close collaboration between different specialities in medicine and Old Age psychiatry. In collaboration with the communalities, our Old Age psychiatry services want to provide a new approach to this challenge and validate it on patient and personnel level.


Eligibility criteria: Inclusion Criteria:

* All patients at nursing home units

Exclusion Criteria:

* Patients that are in a final state and patients that have not been at the nursing home unit more than two weeks

Primary outcomes:
measure: Quality of Life in Severe Dementia (QUALID), Person-Centred Care Assessment Tool (P-CAT, 2010)
timeFrame: 12 months after baseline assessment
Secondary outcomes:
measure: Neuropsychiatric Inventory - Nursing Home version, Cornell Scale of Depression in Dementia, Registration of Constraints (Kirkevold, 2004)
timeFrame: 12 months after baseline assessment
Other outcomes:
Locations:
city: Lillehammer
country: Norway
facility: Lillehammer sykehjem
state: Oppland
Study officials:
affiliation: Sykehuset Innlandet HF
name: Geir Selbæk, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Selbaek G, Kirkevold O, Engedal K. Psychiatric and behavioural symptoms and the use of psychotropic medication in Special Care Units and Regular Units in Norwegian nursing homes. Scand J Caring Sci. 2008 Dec;22(4):568-73. doi: 10.1111/j.1471-6712.2007.00576.x. Epub 2008 Sep 16.
citation: Kirkevold O, Laake K, Engedal K. Use of constraints and surveillance in Norwegian wards for the elderly. Int J Geriatr Psychiatry. 2003 Jun;18(6):491-7. doi: 10.1002/gps.883.
Clinical trial NCT01322841: Universal Screening for Tuberculosis and Anemia With the CHICA System
Official title: Universal Screening for Tuberculosis and Anemia With the CHICA System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tuberculosis
Iron Deficiency Anemia
Keywords: CHICA
clinical decision support
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Library of Medicine (NLM)
First posted: 2011-03-25
Enrollment: 2239
Sex: ALL
Minimum age (years): 3
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The CHICA system is a clinical decision support system that uses adaptive turnaround documents to provide point-of-care information to clinicians. The investigators will be studying whether it can help in the diagnosis and treatment of tuberculosis and iron deficiency anemia.

Detailed description: The CHICA system is a clinical decision support system that uses adaptive turnaround documents to provide point-of-care information to clinicians. We will be studying whether it can help in the diagnosis and treatment of tuberculosis and iron deficiency anemia.

Eligibility criteria: Inclusion Criteria:

Age 3 to 11 years old and seen in a study clinic

Exclusion Criteria:

None

Primary outcomes:
measure: Percentage of Patients Screened Positive for One of the Disorders
timeFrame: six months
Secondary outcomes:
measure: Percentage of Patients Diagnosed With One of the Disorders
timeFrame: six months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Children's Health Services Research
state: Indiana
Study officials:
affiliation: IUSM
name: Aaron E Carroll, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03800641: A Study of Dexmedetomidine Pharmacokinetics for Preoperative Sedation
Official title: A Study of Dexmedetomidine Pharmacokinetics for Preoperative Sedation With Administration of Oral, Intravenous and Nasal Drops
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anxiety
Preoperative Care
Pharmacokinetics
Emergence Delirium
Keywords: Dexmedetomidine
Lead sponsor: Eye & ENT Hospital of Fudan University
Sponsor class: OTHER
First posted: 2019-01-11
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Proper preoperative sedation can reduce patients' anxiety, enhance patients' cooperation and reduce perioperative complications. The investigators would explore the sedative effects of dexmedetomidine (DEX) with the administration of oral, intravenous and nasal drops, and detect DEX blood concentration in 15 participants, respectively. Pharmacokinetic parameters are detected at 8 time points ( before DEX administration, 10 min, 20 min, 30 min, 45 min, 60min, 90min and 120 min after administration). 3 ml arterial blood was collected at each time point. The blood samples are detected by mass spectrometer. The aim of this study is to investigate appropriate administration time and route for DEX sedation.


Eligibility criteria: Inclusion Criteria:

* 45 participants who undergo tympanoplasty would be enrolled after signment the informed consent.

Exclusion Criteria:

* The participants were excluded with any diseases about respiration, circulation, liver and kidney.

Primary outcomes:
measure: Dexmedetomidine pharmacokinetic curve
timeFrame: 120 min DEX pharmacokinetics
Secondary outcomes:
measure: Effect of sedation
timeFrame: 10min after administration
measure: Evaluation of surgical field
timeFrame: 30min after administration
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Eye, Ear, Nose and Throat Hospital
state: Shanghai
Study officials:
References:
citation: Wu J, Han Y, Lu Y, Zhuang Y, Li W, Jia J. Perioperative Low Dose Dexmedetomidine and Its Effect on the Visibility of the Surgical Field for Middle Ear Microsurgery: A Randomised Controlled Trial. Front Pharmacol. 2022 Feb 8;13:760916. doi: 10.3389/fphar.2022.760916. eCollection 2022.
Clinical trial NCT02387541: Effects of Total Knee Replacement on Early Postoperative Cognitive Function in Elderly Patients
Official title: Effects of Total Knee Replacement on Early Postoperative Cognitive Function in Elderly Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Perioperative Complications
Keywords: Postoperative cognitive dysfunction
Lead sponsor: General Hospital of Ningxia Medical University
Sponsor class: OTHER
First posted: 2015-03-13
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We included 96 ASA I or Ⅱ patients aged ≥65 years performed total knee replacement under general anesthesia.

Brief summary: To investigate the effects of total knee replacement is harmful to Postoperative cognitive dysfunction

Detailed description: Postoperative cognitive dysfunction (POCD) is reported to occur after major surgery in elderly patients. They may especially experience problems in the weeks and months after surgery. Recent studies vary greatly in methods of evaluation and diagnosis of POCD, and the pathogenic mechanisms are still unclear. The investigators evaluated a large uniform cohort of elderly patients in a standardized approach after total knee replacement.

Eligibility criteria: Inclusion Criteria:

* aged ≥65 years;
* ASA I or Ⅱ;
* total knee replacement

Exclusion Criteria:

* Mini Mental State Examination \[MMSE\] score too low.
* Parkinson or other neurological disease causing functional impairment.
* Patients with a history of alcohol abuse (≥35 U per week) or daily use of anxiolytics were also excluded, as well as those with severe hearing or visual impairment.

Primary outcomes:
measure: Effects of operation on early postoperative cognitive function in elderly patients
timeFrame: up to 7days postoperatively
Secondary outcomes:
measure: Postoperative cognitive dysfunction (POCD) was defined by Mini-Mental State Examination (MMSE) score
timeFrame: up to 7days postoperatively
Other outcomes:
measure: serum concentration of inflammatory cytokine
timeFrame: The blood samples were reserved before anesthesia induction and 24h after surgery
Locations:
Study officials:
References:
Clinical trial NCT02356341: NovaTears® Eye Drops Observational Study NT-002
Official title: NovaTears® Observational Study NT-002
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dry Eye Syndromes
Lead sponsor: Novaliq GmbH
Sponsor class: INDUSTRY
First posted: 2015-02-05
Enrollment: 72
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 dry eye disease due to meibomian gland dysfunction

Brief summary: This observational study is intended to collect outcome data from a cohort of 90 patients suffering from symptoms of dry eye disease due to meibomian gland dysfunction who are treated with the medical device NovaTears® eye drops for a duration of 6 to 8 weeks.


Eligibility criteria: Inclusion Criteria:

* According to NovaTears® instruction for use
* ≥ 18 years
* Patients with dry eye disease due to meibomian gland dysfunction applying eye lid hygiene for at least 14 days
* Ability and willingness to provide written Informed Consent
* Ability and willingness to participate in all examinations
* Willingness and ability to return for follow up visit

Exclusion Criteria:

* Patients with hypersensitivity to any of the components of NovaTears®
* Patients with contact lenses, pregnancies, or who are breast feeding
* Patients with dry eye disease not caused by meibomian gland dysfunction
* Patients taking lipid containing eye drops or requiring topical pharmacological treatment of dry eye disease

Primary outcomes:
measure: Subjective symptom severity
timeFrame: 6 to 8 weeks
Secondary outcomes:
measure: Tear-Film Break-up Time
timeFrame: 6 to 8 weeks
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: Prof. Dr. Norbert Schrage
city: Duesseldorf
country: Germany
facility: University Eye Hospital of the HHU Duesseldorf
city: Erlangen
country: Germany
facility: University Eye Hospital of the FAU Erlangen-Nuremberg
city: Heidelberg
country: Germany
facility: University Eye Hospital Heidelberg
city: Heidelberg
country: Germany
facility: Dr. Thomas Kaercher
city: Jena
country: Germany
facility: JenVis Research Institute
city: Karlsruhe
country: Germany
facility: Staedtisches Klinikum Karlsruhe
city: Munich
country: Germany
facility: University Eye Hospital, LMU Munich
Study officials:
affiliation: Novaliq GmbH
name: Novaliq GmbH
role: STUDY_DIRECTOR
References:
citation: Steven P, Augustin AJ, Geerling G, Kaercher T, Kretz F, Kunert K, Menzel-Severing J, Schrage N, Schrems W, Krosser S, Beckert M, Messmer EM. Semifluorinated Alkane Eye Drops for Treatment of Dry Eye Disease Due to Meibomian Gland Disease. J Ocul Pharmacol Ther. 2017 Nov;33(9):678-685. doi: 10.1089/jop.2017.0042. Epub 2017 Sep 18.