louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01314989: Cyproheptadine as an Appetite Stimulant
Official title: Effect of Cyproheptadine on Weight Gain and Feeding Behavior in 2 to 4 Years Old Children With Failure to Thrive
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Failure to Thrive
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
First posted: 2011-03-15
Enrollment: 20
Sex: ALL
Minimum age (years): 2
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Cyproheptadine is currently clinically used as an appetite stimulant for children with failure to thrive without underlying organic disease. Otherwise, no randomised control trial demonstrates the efficacy of Cyproheptadine on those patients. This is precisely what the investigators intend to demonstrate on this randomised placebo control cross-over trial. Our hypothesis is that Cyproheptadine is more efficient than placebo to improve weight gain and feeding behaviour on 2 to 4 years old children with failure to thrive.


Eligibility criteria: Inclusion Criteria:

* 2 to 4 years of age
* failure to thrive

Exclusion Criteria:

* Medication affecting appetite
* Medication interacting with Cyproheptadine
* Prematurity under 36 weeks of gestation
* Neurologic impairment
* underlying organic disease

Primary outcomes:
measure: Weight gain
timeFrame: January 2011 to January 2012
Secondary outcomes:
measure: Feeding behaviour
timeFrame: January 2011 to January 2012
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Ste-Justine University Health Center
state: Quebec
Study officials:
References:
Clinical trial NCT06111989: Fitness to Drive Among Stroke Patients
Official title: To Drive or Not to Drive? A Machine Learning Data Analysis Approach Among Stroke Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Driving Impaired
Keywords: fitness to drive
neuropsychology
cognitive
machine learning
Lead sponsor: National Institute for Medical Rehabilitation, Hungary
Sponsor class: OTHER_GOV
Collaborators: name: Semmelweis University
First posted: 2023-11-01
Enrollment: 100
Sex: ALL
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of the National Institute for Medical Rehabilitation, Budapest, Hungary

Brief summary: The goal of this observational study is to learn more about who can continue driving a car after a stroke. The focus of this study is on the relationship between cognitive abilities and fitness-to-drive.

Participants will be asked to perform an extended neuropsychological testing and a real life on-road test, conducted by a professional driving instructor. Feedback will be given to the participants on request.

Detailed description: The relationship between cognitive abilities and driving skills is really complex. This study aims to introduce novel data analysing methods that can be used by medical professionals to decide whether the stroke patient is able to operate a vehicle safely or not.

The neuropsychological assessment will involve paper and pencil tests, computerized tests (such as reaction time measurements) and a driving simulator. This part will be approximately 2 hours. Since the first part is really tiresome, the test driving will be on an other day. The driving instructor will guide the participant on a standard route, and will evaluate the performance using standard criteria that will focus mainly on traffic safety.

Who can participate in the study:

* Aged 65 or younger
* Holds a driving licence
* Had an ischemic or hemorrhagic stroke
* Has sufficient physical abilities to operate a car
* Does not have certain medical conditions such epilepsy

Eligibility criteria: Inclusion Criteria:

* 65 or younger
* ischemic or hemorrhagic stroke
* at least 6 months has passed after the stroke
* holds a valid driver's licence

Exclusion Criteria:

* visual impairments (eg. visual field loss, nystagmus or diplopia)
* epilepsy
* serious movement disorders (eg. hemiplegia) that hider operating a car
* limb ataxia
* aphasia types that affect comprehension
* serious psychiatrical disorders

Primary outcomes:
measure: Driving test result
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: National Institute for Medical Rehabilitation
Study officials:
affiliation: National Institute for Medical Rehabilitation, Hungary
name: Gábor Fazekas, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02965989: Effectiveness of a Online Training Program With a Clinical Procedure Standardized in Units of Nursing (CPSUN)
Official title: Effectiveness of a Online Training Program With a Clinical Procedure Standardized: "Blood Culture in Units of Nursing". Quasi-experimental Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infection Control
Preventive Measures
Keywords: nursery care
nursery infection
online learning
Lead sponsor: Hospital Universitario 12 de Octubre
Sponsor class: OTHER
Collaborators: name: Hospital Universitario 12 de Octubre
First posted: 2016-11-17
Enrollment: 48
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study evaluates if the implementation of an online platform with procedures and protocols, improve the knowledge of professionals and can have a health impact related to decreased contamination of blood cultures.

Detailed description: This is a Quasi-experimental study, with parallel groups (experimental and control).

The aim of this study is to evaluate the efficacy of an Online Learning Platform used by nurses to improve the results of a blood culture technique. The online learning tool is studied in two of four internal medicine units of a tertiary hospital in Madrid. These two units have similar characteristics of personnel, materials and structure. Both units are at a great distance, preventing a professional talk to each other.

Eligibility criteria: Inclusion Criteria:

* Be nurse of the nursing unit selected.
* Foreseeing to remain in service during the study.
* Acceptance of voluntary participation in the study, prior information.
* Signature of informed consent.

Exclusion Criteria:

* Those professionals who for reasons beyond their control are transferred to other services or are on leave (in any form). They can not complete the various phases of the study.
* Professionals who, for whatever reason, decide to withdraw their consent to participate in the study.

Primary outcomes:
measure: Number of Contaminated Cultures in the Control and Experimental Group Before Intervention and After the Learning Obtained With the Online Training Platform.
timeFrame: assessed monthly, month 6 and 9 reported.
Secondary outcomes:
measure: Score on the Knowledge Test Related to Blood Culture Extraction Technique for Nurses (K-Blood-CT)
timeFrame: 6 month and 9 month of study.
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre de Madrid
Study officials:
affiliation: Hospital 12 de Octubre de Madrid
name: Ignacio Zaragoza GArcía, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00407589: Systemic Pharmacokinetics of BOL-303224-A
Official title: Systemic Pharmacokinetics of BOL-303224-A After Single and Multiple Instillations of BOL-303224-A in Subjects With Suspected Bacterial Conjunctivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Conjunctivitis, Bacterial
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2006-12-05
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multi-center, open-label, single dose/multiple dose, pharmacokinetic study in participants with bacterial conjunctivitis. The purpose of this study is to determine the extent of systemic exposure to BOL-303224-A following single and multiple topical administration of BOL-303224-A in participants with suspected bacterial conjunctivitis.


Eligibility criteria: Inclusion Criteria:

* must be at least 18 years of age, any race
* must have a clinical diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge and redness in both eyes
* women of childbearing potential must utilize reliable contraceptive methods and have a negative pregnancy test

Exclusion Criteria:

* Pregnant or nursing women
* known hypersensitivity to fluoroquinolones or to any of the ingredients in the study medication
* use of any antibiotic within 72 hours of enrollment
* participation in an ophthalmic drug or devise research study within 30 days prior to entry in this study

Primary outcomes:
measure: Assessment of systemic pharmacokinetics following a single dose and steady-state pharmacokinetics after multiple TID dosing
timeFrame: Blood samples will be collected from 0 to 6 hours on Day 1 and from 0 to 12 hours on Day 6. There will be additional sampling times at 0 hours on Day 2-5.
Secondary outcomes:
measure: Investigator ratings of ocular discharge and bulbar conjunctival injection, Visual Acuity, ophthalmoscopy findings and Adverse event collection
timeFrame: Througout the study
Other outcomes:
Locations:
city: High point
country: United States
facility: Cornerstone Eyecare
state: North Carolina
Study officials:
References:
Clinical trial NCT01300689: Human Papillomavirus Infection and Knowledge and Attitudes About HPV Vaccines Among Men Who Have Sex With Men (MSM)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HPV Infection
HIV Infection
Syphilis
Keywords: HPV
MSM
Vaccine
China
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2011-02-23
Enrollment: 3000
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: A total of 3,000 eligible men who have sex with men (MSM) with 300 from each city will be enrolled from ten cities (BeiJing, ShangHai, TianJin, ChongQing, GuangZhou, ZhengZhou, Harbin, ShenYang, ChengDu, and KunMing) by the local CDCs and non-government MSM organizations

Brief summary: This is a observational study aims to assess anal and genital human papillomavirus (HPV) infection status among men who have sex with men (MSM) in China, and their knowledge and attitude about HPV vaccine.


Eligibility criteria: Inclusion Criteria:

* ≥ 18 years old;
* Ever had homosexual behaviors in the past 12 months;
* Willing to take tests for HIV/HPV infection;
* Physically able and willing to provide written informed consent.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Institute of Pathogen Biology (IPB)
state: Beijing
Study officials:
affiliation: Institute of Pathogen Biology (IPB), CAMS&PUMC
name: Lei Gao, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gao L, Zhou F, Li X, Yang Y, Ruan Y, Jin Q. Anal HPV infection in HIV-positive men who have sex with men from China. PLoS One. 2010 Dec 6;5(12):e15256. doi: 10.1371/journal.pone.0015256.
Clinical trial NCT03930589: Remote Ischemic Conditioning in STEMI to Decrease Infarct Size
Official title: A Multi-center Randomized Trial of Remote Ischemic Conditioning to Reduce Infarct Size in Patients With an ST-Elevation Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: STEMI
CAD
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Canadian VIGOUR Centre
First posted: 2019-04-29
Enrollment: 251
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Remote ischemic condition versus standard of care
Primary purpose: TREATMENT

Brief summary: Following acute STEMI patients may have significant myocardial damage and subsequent heart failure. There is currently conflicting data regarding the benefit of remote ischemic conditioning to decrease the magnitude of infarction. Remote ischemic condition is a process where by repetitive intermittent limb ischemia is used to decrease the magnitude of myocardial damage caused by coronary artery occlusion and the subsequent reperfusion injury in STEMI patients. RemCon-STEMI is a multicenter randomized trial to test the impact of remote ischemic conditioning in acute STEMI.


Eligibility criteria: Inclusion Criteria:

Patients presenting with STEMI within 6 hours of symptom onset and:

1. Are expected to receive reperfusion therapy with either fibrinolysis or primary PCI.
2. Documented informed consent (verbal)

Exclusion Criteria:

1. Cardiogenic shock
2. History of anatomical deformity or vascular complication that limit ability to conduct remote ischemic preconditioning

Primary outcomes:
measure: Composite of all cause death
timeFrame: 90 days
Secondary outcomes:
measure: long term survival
timeFrame: up to 1 year
measure: myocardial infarction size
timeFrame: within 72 hours of hospital admission
measure: ECG infarct size
timeFrame: with 10 days or hospital discharge whichever occurs first
measure: Reperfusion
timeFrame: within 24 hours of admission to hospital
Other outcomes:
Locations:
Study officials:
References:
citation: Bainey KR, Zheng Y, Coulden R, Sonnex E, Thompson R, Mei J, Bastiany A, Welsh R. Remote ischaemic conditioning in ST elevation myocardial infarction: a registry-based randomised trial. Heart. 2022 May;108(9):703-709. doi: 10.1136/heartjnl-2021-319455. Epub 2021 Aug 20.
Clinical trial NCT06611189: A Comparative Analysis of Ray-Tech Sponge and Ice Bag Techniques in Kidney Transplantation
Official title: A Comparative Analysis of Ray-Tech Sponge and Ice Bag Techniques in the Elimination of Warm Ischemic Time in Kidney Transplantation
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Chronic Kidney Disease Stage V
Keywords: Kidney transplantation
Warm ischemia
Lead sponsor: Okan University
Sponsor class: OTHER
First posted: 2024-09-24
Enrollment: 172
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 individuals were selected from those who underwent Kidney transplantation at our institution between January 2020 and January 2023.

Brief summary: Warm ischemia during kidney transplantation is one of the important factors that negatively affect kidney function in the recipient. The investigators aimed to examine the effects of two techniques (Ray-Tech sponge technique and Ice bag technique) applied to protect the kidney from warm ischemia during kidney transplantation on long-term kidney function.

Detailed description: A prospective, randomized clinical trial was conducted at Istanbul Okan University Hospital, Istanbul, Turkey. All participants were selected from those who underwent kidney transplantation between January 2020 and January 2023.

Eligibility criteria: Inclusion Criteria:

-Underwent kidney transplantation surgery

Exclusion Criteria:

- Deceased donor transplantation

Primary outcomes:
measure: Creatinine decrease
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Murat Ferhat Ferhatoglu
state: Kadıköy
city: Istanbul
country: Turkey
facility: Istanbul Okan University
Study officials:
affiliation: Okan University
name: MURAT F FERHATOGLU, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ferede AA, Walsh AL, Davis NF, Smyth G, Mohan P, Power R, Forde J, O'Kelly P, Llittle D. Warm Ischemia Time at Vascular Anastomosis is an Independent Predictor for Delayed Graft Function in Kidney Transplant Recipients. Exp Clin Transplant. 2020 Feb;18(1):13-18. doi: 10.6002/ect.2018.0377. Epub 2019 Jul 2.
citation: Ide K, Sakai H, Nakano R, Imaoka Y, Tanimine N, Ide R, Tsukiyama N, Ono K, Mochizuki T, Arata R, Hakoda K, Imaoka K, Fukuhara S, Bekki T, Tahara H, Ohira M, Kobayashi E, Ohdan H. Effectiveness of Thermal Barrier Bag for Prolonged Vascular Anastomosis in Kidney Transplantation. Transplant Proc. 2023 May;55(4):752-755. doi: 10.1016/j.transproceed.2023.03.004. Epub 2023 Apr 6.
citation: Ide K, Nakano R, Imaoka Y, Sakai H, Ono K, Tanimine N, Tahara H, Ohira M, Ueda K, Hirata T, Kobayashi E, Ohdan H. Protection From Second Warm Ischemic Injury Using a Thermal Barrier Bag in Kidney Transplantation. Transplant Direct. 2023 Feb 17;9(3):e1454. doi: 10.1097/TXD.0000000000001454. eCollection 2023 Mar.
Clinical trial NCT06265389: Pentoxifylline as an Adjuvant Therapy in the Treatment of Pediatric Pneumonia; A New Perspective of an Old Drug
Official title: Pentoxifylline as an Adjuvant Therapy in the Treatment of Pediatric Pneumonia; A New Perspective of an Old Drug
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pentoxifylline as an Adjunct Therapy in the Treatment of Pneumonia
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pentoxifylline is a xanthine-derived, commercially produced drug approved for the management of intermittent claudication in patients suffering from a chronic occlusive arterial disease of the limbs. Pentoxifylline has been documented to display anti-inflammatory and immunomodulatory effects, as well as some antithrombotic and antiviral effects. This drug has also been shown to reduce lung fibrosis in patients with COVID-19, as well as to prevent thromboembolic events. This work aims to assess the benefit of oral Pentoxifyllin supplementation, in addition to standard antibiotic and other supportive therapy, in the management of hospitalized children with community-acquired pneumonia

Detailed description: This is a randomized clinical trial study that will be carried out on 100 children with Community-acquired pneumonia admitted to the Pulmonology Unit, Pediatric department.

Group 1: Pentoxifylline group, and group 2: Control group

Eligibility criteria: Inclusion Criteria:

* All children aged 2 months -18 years with community-acquired pneumonia diagnosed by signs and symptoms of CAP including; chest pain, dyspnea, tachypnea, or abnormal auscultatory findings plus focal findings on chest x-ray indicating community-acquired pneumonia

Exclusion Criteria:

* Children with immunodeficiency, chronic lung disease, malignancy, congenital lung anomalies, underlying disorders impacting respiration i.e. genetic, metabolic, neuromuscular disorders, and children with CHD affecting the pulmonary blood flow.

Primary outcomes:
measure: Respiratory distress
timeFrame: 3 days
measure: Temperature
timeFrame: 3 days
measure: Oxygen saturation
timeFrame: 3 days
measure: CRP
timeFrame: 5 days
measure: LDH
timeFrame: 5 days
measure: D-dimer
timeFrame: 5 days
measure: Interleukin 6
timeFrame: 5 days
Secondary outcomes:
measure: Hospital stays
timeFrame: 14 days
measure: Pneumonia complications
timeFrame: 14 days
Other outcomes:
measure: Surgical intervention
timeFrame: 14 days
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: Gharbia
Study officials:
References:
Clinical trial NCT00636389: Molecule Removal and Ease of Use: A Comparison of Two Different Dialyzers
Official title: Urea, Phosphate and b2-Microglobulin Removal and Ease of Use: Comparing the Polyflux HD-C4 With the Polyflux 210H
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Keywords: Hemodialysis
Dialysis, Renal
Dialysis, Extracorporeal
Extracorporeal Dialysis
Lead sponsor: Vantive Health LLC
Sponsor class: INDUSTRY
Collaborators: name: Gambro Renal Products, Inc.
name: Baxter Healthcare Corporation
First posted: 2008-03-14
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The Polyflux HD-C4 (Gambro Renal Products) is a new dialyzer based on the existing Polyflux H membrane and dialyzer technology, but which achieves a performance comparable to Polyflux 210H in a significantly smaller device.

The objectives of this study are:

1. To compare and contrast small and large molecule removal by the Polyflux HD-C4 and Polyflux 210H dialyzers under conditions of routine hemodialysis; and,
2. To compare and contrast the ease of use of the Polyflux HD-C4 dialyzer with that of the Polyflux 210H under conditions of routine clinical use for hemodialysis.


Eligibility criteria: Inclusion Criteria:

* Adults 18 years of age or older
* Stable hemodialysis prescription using Polyflux 210H or Polyflux 21R for at least 2 months prior to study enrollment
* Dialyzing through a native fistula or Gore-Tex graft.
* Blood access must be able to provide a blood flow rate of 400 ml/min.

Exclusion Criteria:

* Non-compliance with dialysis
* Hematocrit less than 28%
* Active Infection

Primary outcomes:
measure: Comparison of Urea Removal Under Conditions of Routine Hemodialysis.
timeFrame: 2 weeks = duration required for each subject to complete 6 consecutive dialysis treatments
measure: A Comparison of Pre- to Post-dialysis Reduction of Small and Large Molecules Under Conditions of Routine Hemodialysis.
timeFrame: 2 weeks = duration required for each subject to complete 6 consecutive dialysis treatments
Secondary outcomes:
measure: Comparison of Dialyzer Ease of Use Between the Polyflux HD-C4 Dialyzer and the Polyflux 210H
timeFrame: 2 weeks = duration required for each subject to complete 6 consecutive dialysis treatments
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: DaVita Clinical Research Facility
state: Minnesota
Study officials:
affiliation: Davita Clinical Research Facility
name: Harry Alcorn Jr., PharmD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Daugirdas JT. Second generation logarithmic estimates of single-pool variable volume Kt/V: an analysis of error. J Am Soc Nephrol. 1993 Nov;4(5):1205-13. doi: 10.1681/ASN.V451205.
citation: Daugirdas JT, Schneditz D. Overestimation of hemodialysis dose depends on dialysis efficiency by regional blood flow but not by conventional two pool urea kinetic analysis. ASAIO J. 1995 Jul-Sep;41(3):M719-24. doi: 10.1097/00002480-199507000-00107.