louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01693016: Validation of Non-invasive Hemoglobin (SpHb) Measurement in Children
Official title: Validation of Non-invasive Hb-measurement (SpHb) in Children With the Masimo@ Radical 7
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-invasive Hb Measurement in Children
Keywords: non-invasive Hb measurement in children
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2012-09-26
Enrollment: 81
Sex: ALL
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate the value of the new technique of non-invasive measurement of Hb in children undergoing a surgical procedure.

Detailed description: Several surgical procedures require haemoglobin monitoring due to possible blood loss and the need of blood transfusion. The standard for monitoring hemoglobin (Hb) is the measurement of blood samples. The novel technique of non-invasive continuous measurement of Hb using Pulse CO-Oximetry may allow measuring Hb without obtaining blood samples.

This new technique has not been tested yet in children undergoing anesthesia for elective surgical procedures. In this study the investigators compare the non-invasive Hb measurement with Masimo® technology (SpHb) with the standard Hb measurement using ABL-800 Flex (BGA) and Siemens Advia (labHb, reference method) before the children undergo the surgical procedure.

Eligibility criteria: Inclusion Criteria:

* children (\>= 3 kg until 8 years)
* ASA I-III
* written informed consent of legal representative

Exclusion Criteria:

* children \<= 3kg or \> 8 years
* emergency surgery
* allergy against sensor of SpHb(®)
* artery occlusive disease
* sepsis
* haemoglobinopathy
* specific medical or psychological circumstances which do not allow the consent of the legal representative or the performance of the study

Primary outcomes:
measure: correlation between SpHb(®) and the Hb measured by the ABL800Flex and the Siemens Advia
timeFrame: one day
Secondary outcomes:
measure: influence of inhalation anesthetics
timeFrame: one day
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Dr. Eva Wittenmeier
Study officials:
affiliation: Johannes Gutenberg University Mainz
name: Eva Wittenmeier
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wittenmeier E, Bellosevich S, Mauff S, Schmidtmann I, Eli M, Pestel G, Noppens RR. Comparison of the gold standard of hemoglobin measurement with the clinical standard (BGA) and noninvasive hemoglobin measurement (SpHb) in small children: a prospective diagnostic observational study. Paediatr Anaesth. 2015 Oct;25(10):1046-53. doi: 10.1111/pan.12683. Epub 2015 Jul 14.
Clinical trial NCT04393116: Patients' Guidance With Onco-Coaching and CANKADO on Systemic Chemotherapy for Metastatic Colorectal Cancer
Official title: Patients' Guidance With Onco-Coaching and CANKADO on Systemic Chemotherapy for Metastatic Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Colorectal Cancer
Lead sponsor: Cankado GmbH
Sponsor class: INDUSTRY
First posted: 2020-05-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with metastatic colorectal cancer in first line treatment treated in "Gemeinschaftspraxis für Hämatologie und Onkologie Langen" or "Hämato-Onkologische Schwerpunktpraxis am Klinikum Aschaffenburg"

Brief summary: This is a prospective, single arm, non-interventional project to evaluate the benefit/influence of individualized patient education and guidance with a web-based e-Health platform called CANKADO on patient reported outcomes (PRO) for patients with metastatic colorectal cancer. The focus will be on patient reported outcomes (PRO), distress, Quality of Life (QoL), Global Health Status, complaints and therapy relevant decisions. All patients will be medically treated according to the standards. The experimental arm will include 40 patients. Those patients will receive one initial coaching before start of therapy. Further appointments for coaching will be scheduled depending on individual patient's need. During treatment period the patient is encouraged of joining therapy actively documenting his state of health and occurring health complaints via CANKADO to give the physician a better overview on the process of patient's health behaviour and preparing him for the next doctor-patient consultation.


Eligibility criteria: Inclusion Criteria:

* Minumum age of 18 years
* Patient with metastatic colorectal cancer

Exclusion Criteria:

-

Primary outcomes:
measure: Development of patients' Distress
timeFrame: 6 months
Secondary outcomes:
measure: Patient's Quality of Life (QoL)
timeFrame: 6 months
measure: Patient's global health status
timeFrame: 6 months
Other outcomes:
Locations:
city: Aschaffenburg
country: Germany
facility: Hämato-onkologischer Studienkreis am Klinikum Aschaffenburg
city: Langen
country: Germany
facility: Gemeinschaftspraxis für Hämatologie und Onkologie
Study officials:
affiliation: Cankado GmbH
name: Timo Schinköthe, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01184716: The Effect of Vitamin D Fortification of Bread and Milk in Danish Families
Official title: The Effect of Vitamin D Fortification of Bread and Milk in Danish Families
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Vitamin D status (serum 25-hydroxyvitamin D)
Lead sponsor: Technical University of Denmark
Sponsor class: OTHER
First posted: 2010-08-19
Enrollment: 782
Sex: ALL
Minimum age (years): 4
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Approximately 200 families corresponding to 800 persons are included in the study. The study investigate the efficacy of vitamin D fortification of bread and milk on vitamin D status in serum. Participants receive milk and bread twice a week. Half of the participants receive vitamin D fortified products and the other half similar non-fortified products. The study starts in September and runs for 6 months during winter, the period where it is not possible to produce vitamin D in the skin through sunlight exposure. The hypothesis is that the usual fall in vitamin D status can be prevented by vitamin D fortified food.


Eligibility criteria: Inclusion Criteria:

* Family with at least one child between the age 4 to 18 years and at least one adult less than 60 years of age
* Permanent address in a specific geographical region.

Exclusion Criteria:

* Use of medication (including dietary supplements with high levels of vitamin D)
* Diseases which influence vitamin D metabolism
* Pregnancy

Primary outcomes:
measure: serum 25-hydroxyvitamin D
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Søborg
country: Denmark
facility: Division of Nutrition, National Food Institute, Technical University of Denmark
Study officials:
affiliation: National Food Institute, DTU
name: Lone B Rasmussen, M.Sc., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nissen J, Vogel U, Ravn-Haren G, Andersen EW, Madsen KH, Nexo BA, Andersen R, Mejborn H, Bjerrum PJ, Rasmussen LB, Wulf HC. Common variants in CYP2R1 and GC genes are both determinants of serum 25-hydroxyvitamin D concentrations after UVB irradiation and after consumption of vitamin D(3)-fortified bread and milk during winter in Denmark. Am J Clin Nutr. 2015 Jan;101(1):218-27. doi: 10.3945/ajcn.114.092148. Epub 2014 Nov 5.
Clinical trial NCT02899416: Better Life by Nutrition During Adulthood
Official title: Better Life by Nutrition During Adulthood : Identification of Factors Present in Adolescence Cardiovascular Risk in Young Adults
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiovascular Risk Factor
Keywords: cardiovascular risk
young adulthood
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2016-09-14
Enrollment: 330
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: BELINDA is a follow'up of subjects included 10 years ago in HELENA study which was a cross-sectional study carried out from 2006 to 2007 in more than 3500 adolescents aged from 12.5 to 17.5 years old through 10 Europeans towns from 9 countries.

BELINDA will retest subjects from Lille and Ghent

Brief summary: BELINDA is a follow'up of subjects included 10 years ago in HELENA study which was a cross-sectional study carried out from 2006 to 2007 in more than 3500 adolescents aged from 12.5 to 17.5 years old through 10 Europeans towns from 9 countries.

BELINDA main objective is to assess CV risk using PDAY score (Pathobiological Determinants of Atherosclerosis in Youth) during young adulthood (20 to 31 years) and analyze lifestyle risk factors from adolescence (12 to 18 years). This analyze may define new CV risk factors and risk population cluster.

Detailed description: BELINDA subjects from Lille, Ghent , Zaragoza and Roma will be re-tested using a part of HELENA test battery and some new evaluation criteria.

Eligibility criteria: Inclusion Criteria:

* Women of men participating to HELENA study 2006-2007
* Aged from 20 to 35 years.
* Signed informed consent

Exclusion Criteria:

* Pregnant or lactating women

Primary outcomes:
measure: PDAY score (Pathobiological Determinants of Atherosclerosis in Youth)
timeFrame: one day
Secondary outcomes:
measure: Diet Quality Index Score
timeFrame: 2 days
measure: Ratio total energy intake
timeFrame: 2 days
measure: ratio of dietary n-6/n-3 polyunsaturated fatty acids (PUFA)
timeFrame: 2 days
measure: consumption in dietary salt intake
timeFrame: 2 days
measure: Physical activity
timeFrame: 7 days
measure: Endurance
timeFrame: 1 day
measure: Ratio waist-to-hip
timeFrame: 1 day
measure: Fat mass
timeFrame: 1 day
measure: Education level
timeFrame: 1 day
Other outcomes:
Locations:
city: Lille
country: France
facility: CHRU,Hôpital Jeanne de Flandres
Study officials:
affiliation: University Hospital, Lille
name: Frédéric Gottrand, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02591316: Nutrition, Physical Activity, and Cognition in Breast Cancer Survivors
Official title: Lifestyle Factors, Inflammation, and Cognition in Breast Cancer Survivors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Cognitive Impairment
Cognition
Keywords: nutrition
physical activity
breast cancer survivor
cognition
Lead sponsor: Texas State University, San Marcos
Sponsor class: OTHER
First posted: 2015-10-29
Enrollment: 68
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female breast cancer survivors and women who have never had a previous cancer diagnosis

Brief summary: The purpose of this study is to examine the relationship between nutrition, physical activity and brain function in breast cancer survivors.

Detailed description: The current study will examine the potential relationships between physical activity, dietary intake, body composition and cognition in breast cancer cancer survivors and age-matched women without a previous cancer diagnosis. Additionally, we will measure blood inflammatory markers to explore the relationship between lifestyle factors and inflammation.

The study involves two, 1hr appointments at Texas State University. The first visit will include cognitive testing and body composition assessment. Participants will be given an activity monitor to wear for one week and a packet of questionnaires to complete at home. At the second visit, a fasted blood sample will be collected, and participants will complete a food frequency questionnaire.

Eligibility criteria: Inclusion Criteria:

* Breast cancer survivors must have completed primary treatment (chemotherapy, radiation therapy or both) within past 60 months
* age-matched controls must have no previous cancer diagnosis
* Female
* no history of stroke, heart attack or transient ischemic attack
* not currently pregnant; can speak, read, and write English
* can attend all testing sessions
* not blind or legally blind; nonsmoker
* no current use of computer-based brain training games (e.g. Lumosity ®, BrainHQ ®).

Exclusion Criteria:

* male
* \< 30 or \> 70 years of age
* breast cancer survivor \> 60 months from last treatment or currently undergoing primary treatment
* breast cancer survivor never treated with chemotherapy and/or radiation
* previous cancer diagnosis other than breast cancer

Primary outcomes:
measure: Cognition
timeFrame: Baseline
Secondary outcomes:
measure: Physical Activity
timeFrame: Baseline
measure: Diet Quality
timeFrame: Baseline
measure: Body Composition (objectively measured)
timeFrame: Baseline
measure: Inflammatory Markers
timeFrame: Baseline
Other outcomes:
measure: Medical History
timeFrame: Baseline
measure: Quality of Life
timeFrame: Baseline
Locations:
city: San Marcos
country: United States
facility: Texas State University
state: Texas
Study officials:
affiliation: Texas State University, San Marcos
name: Krystle E Zuniga, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00759616: Outcome Analysis of the Oxford Partial Knee Arthroplasty
Official title: Outcome Analysis of the Oxford Partial Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Arthroplasty
Keywords: Knee Replacement
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
Collaborators: name: Dartmouth General Hospital
First posted: 2008-09-25
Enrollment: 156
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Prospectively monitor the patients receiving the Oxford Partial knee arthroplasty

Detailed description: Utilization of systematic outcome measurements and specific designated time frames to monitor patient satisfactions will assist in analysing this type of prosthesis and the post operative period. Data collected will be added to the compiled information from previous studies in relation to the Oxford knee.

Eligibility criteria: Inclusion Criteria:

* Patient Suitable for Knee Replacement

Exclusion Criteria:

Primary outcomes:
measure: WOMAC, SF12, oxford Knee,KSCRS
timeFrame: 3weeks, 3months,6months, yearly
Secondary outcomes:
measure: Length of Hospital Stay
timeFrame: Postop
Other outcomes:
Locations:
city: Dartmouth
country: Canada
facility: Dartmouth General Hospital
Study officials:
References:
Clinical trial NCT01334216: Using Computers to Assist in Parental Smoking Cessation in a Pediatric Setting
Official title: Using Computers to Assist in Parental Smoking Cessation in a Pediatric Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cigarette Smoking
Keywords: smoking
quitting
tobacco
Parental
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2011-04-13
Enrollment: 362
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 to support parents in their efforts to quit smoking.

Detailed description: 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 in a randomized controlled trial whether it can help to support parents in their efforts to quit smoking.

Eligibility criteria: Inclusion Criteria:

Parent of child in our clinics who reported cigarette smoking

Exclusion Criteria:

Not smoking

Primary outcomes:
measure: Parental Smoking Quit Rate
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Children's Health Services Research
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Stephen M Downs, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01152216: An Extension of the CONCERT Protocol (DIM18)
Official title: An Open-Label Extension of the CONCERT Protocol (DIM18) Evaluating Dimebon (Latrepirdine) in Patients With Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Alzheimer's Disease
Lead sponsor: Medivation, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2010-06-29
Enrollment: 672
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An open-label extension study of the CONCERT (DIM18) protocol evaluating the safety of dimebon (latrepirdine) in subjects with With Mild-to-Moderate Alzheimer's Disease on Donepezil.


Eligibility criteria: Inclusion Criteria:

* Successful completion of the 12 month DIM18 CONCERT study
* Mild-to-moderate Alzheimer's disease
* Probable AD, Diagnostic and Statistical Manual of Mental Disorders-IV-Text Revised (DSM-IV-TR)
* Mini-Mental State Exam (MMSE) score between 12 and 24, inclusive
* Stable on donepezil for at least 6 months

Exclusion Criteria:

* Other causes of dementia
* Major structural brain disease
* Unstable medical condition or significant hepatic or renal disease

Primary outcomes:
measure: Safety
timeFrame: Through study discontinuation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06232616: Vitrectomy Combined With Intravitreal Dexamethasone Implant for Idiopathic Epiretinal Membrane With Macular Oedema
Official title: Vitrectomy Combined With Intravitreal Dexamethasone Implant for the Treatment of Idiopathic Epiretinal Membrane With Cystoid Macular Oedema
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Epiretinal Membrane
Lead sponsor: Shanghai Eye Disease Prevention and Treatment Center
Sponsor class: OTHER
First posted: 2024-01-31
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to evaluate the efficacy and safety of 25-gauge pars plana vitrectomy combined with intravitreal dexamethasone implant for the treatment of idiopathic epiretinal membrane with cystoid macular oedema. The main questions it aims to answer are:

* mean changes in best corrected visual acuity and central macular thickness from baseline to post-operative 24 weeks
* mean change in proportion of cystoid macular oedema area from baseline to post-operative 24 weeks
* intraocular pressure throughout postoperative 24 weeks
* concentrations of inflammatory factors in vitreous samples Participants will undergo a standard three-port 25-gauge pars plana vitrectomy and epiretinal membrane peeling combined with phacoemulsification, aspiration, and intraocular lens implantation. The dexamethasone implant will be injected into the vitreous cavity at the end of the operation.


Eligibility criteria: Inclusion Criteria:

* symptomatic patients aged 40 years or above with idiopathic stage 3-4 epiretinal membrane defined on the basis of spectral-domain optical coherence tomography classification;
* central retinal thickness \>300 µm;
* cystoid oedema within a 1 mm diameter range with the macular fovea as the center;
* ocular axial length less than 25.00 mm.

Exclusion Criteria:

* concomitant or previous macular diseases that may hinder visual improvement other than epiretinal membrane (e.g., age-associated macular degeneration, retinal vein occlusion, or diabetic macular oedema);
* previous vitreoretinal surgery or intravitreal injection history;
* history of glaucoma or optic neuropathy of any kind;
* patients with uncontrolled systemic diseases or infectious diseases;
* patients who took medicines that may have ocular side effects, such as glucocorticoid or hydroxychloroquine.

Primary outcomes:
measure: improvement of visual acuity
timeFrame: from baseline to postoperative 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Eye Disease Prevention & Treatment Center
state: Shanghai
Study officials:
affiliation: Shanghai Eye Diseases Prevention & Treatment Center
name: Tao Sun, Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT05024916: Blueberry Intervention Study for Brain Aging
Official title: The Effect of Blueberry Consumption on Brain Health in Older Adults: in Vivo Measures of Cerebral Antioxidant and Cerebral Blood Flow
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Aging
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: U.S. Highbush Blueberry Council
First posted: 2021-08-27
Enrollment: 63
Sex: ALL
Minimum age (years): 65
Maximum age (years): 89
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine if increased blueberry intake helps increase brain antioxidant (glutathione) and cerebral blood flow in older adults.

Detailed description: Consuming blueberries may improve brain health of older adults by increasing the antioxidant levels in the brain to protect nerve cells in the aging brain. Researchers think that there may be a relationship between the brain's antioxidant defense system and blueberry intake due to the high antioxidant content in blueberries.

This study will investigate if blueberry intake may aid in enhancing glutathione levels and cerebral blood flow using special Magnetic Resonance Imaging (MRI) scans.

Participants will be asked to make a total of up to 4 visits to the research site. Participation will last about 3 months.

Eligibility criteria: Inclusion Criteria:

* Speak English as the primary language and be able to read and write.
* Good general health with no concomitant diseases
* Low berry consumption (≤1 serving/week)
* Cognitively normal (Mini-Mental State Exam Score ≥24)
* BMI range=18.5-35 kg/m2.

Exclusion Criteria:

* Presence of any central neurological diseases or prior major head trauma with loss of consciousness
* Presence of an active unstable and life-threatening systemic illness
* Presence of major psychiatric disorders within the past 3 years including depression, anxiety, and alcohol or drug abuse
* Presence of diabetes mellitus; metabolic syndrome or uncontrolled hypertension
* Use of psychoactive and investigational medications
* MRI contraindications (pacemaker, aneurysm clips, artificial heart valves, metal fragments, foreign objects or claustrophobia)
* Blueberry or salicylate allergy
* Pregnancy

Primary outcomes:
measure: Change in brain glutathione (GSH) levels
timeFrame: Change from baseline to 3 months
measure: Change in cerebral blood flow (CBF)
timeFrame: Change from baseline to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: Department of Neurology
name: In-Young Choi, PhD
role: PRINCIPAL_INVESTIGATOR
References: