louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02831400: Changes in Circulatory I-FABP in Elderly Persons in Daily Life
Official title: Changes in Circulatory I-FABP in Elderly Persons in Daily Life: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Intestinal Integrity
Intestinal Fatty Acid Binding Protein (IFABP)
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2016-07-13
Enrollment: 34
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to detect changes in circulatory I-FABP values (50% increase) in elderly volunteers following the combination of moderate physical activity and a standard meal.


Eligibility criteria: Inclusion Criteria:

1. Age 75 years or older (both sexes)
2. Participating in the Embrace project.

Exclusion Criteria:

1. Previous gastrointestinal resections
2. Chronic inflammatory gastrointestinal disease

Primary outcomes:
measure: 50% increase of I-FABP in plasma.
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Medical Center Groningen
name: BL van Leeuwen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medical Center Groningen
name: JJ de Haan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02095600: Radiosurgery for Drug Resistant Invalidating Tremor
Official title: Deep Brain Stimulation and Frameless Stereotactic Radiosurgery in the Treatment of Drug Resistant Invalidating Tremor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe Upper Limb Tremor Refractory to Medical Therapy
Lead sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Sponsor class: OTHER
First posted: 2014-03-26
Enrollment: 6
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: Stereotactic lesioning of thalamus and basal ganglia for treatment of tremor is a well-known procedure which, prior to the introduction of deep brain stimulation, or DBS, was usually achieved using stereotactic surgical procedures.

Radiosurgery of invisible targets to treat movement disorders and intractable pain are still the domain of frame-based procedures, due to the need of a solid reference system registered to the anterior commissure-posterior commissure (AC-PC) line, which allows the use of stereotactic atlases.

In this study we want to utilize a mathematical method that uses atlas-derived stereotactic coordinates to perform frameless images-guided radiosurgery of such functional targets Particularly the aim of the present study is to investigate both the efficacy and the safety of the methodology to treat upper limb and hand tremor in elderly or in patients which are not ot susceptible of surgical procedures. For these reasons a dose escalation prospective trial have been designed.


Eligibility criteria: Inclusion Criteria:

* patients affected by severe upper limb tremor refractory to medical therapy and who are candidate for a deep brain stimulation (DBS) procedure.
* Age: ≥ 18 years old
* Refusal of DBS procedure
* Written consent

Exclusion Criteria:

* Pregnancy
* Allergy to contrast medium
* DBS procedure susceptibility, if not refused

Primary outcomes:
measure: Tremor control (improvement in FTMTRS and/or UPDRS motor)
timeFrame: 2 years
Secondary outcomes:
measure: Targeting methodology validation (the lesions position, if present, will be compared to the treatment plan target position, deviations will be registered).
timeFrame: 2 years
measure: The treatment safety will be evaluated. Toxicity will be registered according to NCI-CTCAE v3.
timeFrame: 2 years
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Neurologico C. Besta, Unit of Radiotherapy
Study officials:
References:
Clinical trial NCT04195100: Local Pilocarpine for Relieving Dry Mouth
Official title: Local Application of Pilocarpine for Relieving Dry Mouth Complaints: A Randomized Controlled Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Patients of Advanced Age (≥ 70 Years) With a Clinical Diagnosis of Chronic Dry Mouth
Keywords: Xerostomia
Pilocarpine
advanced age (≥ 70 years)
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2019-12-11
Enrollment: 14
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators intended for this study to deliver the "proof-of-concept" that locally administered pilocarpine drops in two doses are effective in a population of elderly (aged ≥ 70 years) with xerostomia at the expense of limited adverse events. To this end, the study aims to quantify the effect size of pilocarpine in two different dosages. In case the investigators observe clinically meaningful changes in xerostomia through measured NRS, a sufficiently-powered RCT will be prepared to compare pilocarpine to placebo.


Eligibility criteria: Inclusion Criteria:

* ≥ 70 years of age
* Clinical diagnosis of chronic dry mouth defined as a Numeric Rating Scale (NRS) score ≥ 5 (scale 0 - 10, with 0 = no dry mouth and 10= worst possible dry mouth) on severity of xerostomia for more than 3 months.

Exclusion Criteria:

* Existence of cognitive impairment and/or diagnosis of dementia appraised by treating physician
* Inability to fill out the questionnaires due to other reasons
* Prior radiation therapy of the head-and-neck region
* Known m. Sjögren disease
* Contra-indications for parasympathicomimetics (uncontrolled asthma, acute heart failure, active peptic ulceration, known hypersensitivity to pilocarpine, and when miosis is undesirable, e.g., in acute iritis and in narrow-angle (angle closure) glaucoma.

Primary outcomes:
measure: Change in xerostomia score (Numeric Rating Scale)
timeFrame: 3 weeks
measure: Change in oral health-related quality of life (Dutch Geriatric Oral Health Assessment Index)
timeFrame: 2 weeks
Secondary outcomes:
measure: Adverse effects
timeFrame: 3 weeks
measure: Global perceived effect
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre
state: Limburg
Study officials:
affiliation: Maastricht University Medical Centre
name: Marieke van den Beuken, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01470300: Reducing Energy Density by Different Methods to Decrease Energy Intake
Official title: Reducing Energy Density by Different Methods to Decrease Energy Intake
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2011-11-11
Enrollment: 62
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this research is to investigate how using different methods to reduce the energy density of entrees affects daily energy intake in adults. It is hypothesized that reducing the energy density of entrees will decrease energy intake. It is also hypothesized that reducing the energy density by incorporating fruit and vegetables will decrease energy intake more than reducing the energy density by decreasing fat content or adding plain water.


Eligibility criteria: Inclusion Criteria:

* Adults from Penn State and surrounding community

Exclusion Criteria:

* Currently dieting
* Food allergies

Primary outcomes:
measure: Energy intake
timeFrame: 1 month
Secondary outcomes:
measure: Food intake
timeFrame: 1 month
Other outcomes:
Locations:
city: University Park
country: United States
facility: The Pennsylvania State University
state: Pennsylvania
Study officials:
affiliation: Penn State University
name: Barbara J Rolls
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04115800: Liposomal Sirolimus in Dry Eye Disease
Official title: Subconjunctival Treatment of Liposomal Sirolimus as a Treatment for Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Dry Eye
Keywords: Sirolimus
Liposomal
Subconjunctival
Lead sponsor: Instituto de Oftalmología Fundación Conde de Valenciana
Sponsor class: OTHER
First posted: 2019-10-04
Enrollment: 52
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: Dry eye disease is a very frequent pathology that importantly affects the quality of life of patients; in spite of the common use of eye lubricants to ameliorate symptoms, there is still a large number of patients who do not present improvement of the disease or they worsen. Although its etiology is varied, the imbalance of the immune system plays a substantial role in the development of dry eye disease. Rapamycin or sirolimus is an anti-inflammatory and immunomodulatory drug that has an enormous potential in ocular surface pathologies such as dry eye disease. The aim of the present study is to determine the effectiveness and security of subconjunctival application of a new formulated drug of liposomal sirolimus in patients with moderate and severe dry eye disease. This is a randomized placebo-controlled double blind clinical trial. Patients presenting data of moderate or severe dry eye disease will be randomized into two groups. One group will receive additional to the conventional treatment, subconjunctival injections of liposomal sirolimus; meanwhile the other group will receive subconjunctival placebo injections. After intervention the effectiveness and the security of the liposomal sirolimus will be evaluated.


Eligibility criteria: Inclusion Criteria:

* Subjects with moderate or severe Dry Eye
* Subjects with OSDI score \> 22
* Subjects with Van Bijsterveld staining score \>4
* Subjects that accept to participate in the study

Exclusion Criteria:

* Subjects with refraction surgery antecedents
* Subjects with ophthalmic surgery six months previous to the study
* Subjects with Lagophthalmos
* Subjects with facial paralysis antecedents
* Subjects with herpetic keratitis
* Subjects using isotretinoin
* Pregnant subjects
* Subjects in lactating period
* Subjects with allergy or intolerant to the drug
* Subjects with hepatic disorders
* Subjects with abnormal thoracic X rays

Primary outcomes:
measure: Ocular Surface Disease Index (OSDI)
timeFrame: Six weeks after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Instituto de Oftalmología
Study officials:
References:
Clinical trial NCT02931500: Machine Learning for Identification of Future Disease Development: A Nationwide Cohort Study (MILESTONE)
Official title: MachIne LEarning for Identification of Future Development of cardiovaScular and meTabOlic Disease: a NationwidE Time-series Cohort Study (MILESTONE)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiovascular Disease
Metabolic Disease
Keywords: machine learning
cohort study
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2016-10-13
Enrollment: 510000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The data which is health checkup record about 510,000 Subjects between 2002 and 2013 from National Health Insurance Service (NHIS) in South Korea.

Brief summary: To develop machine learning algorithms for the identification of future development of cardiovascular and metabolic disease

Detailed description: The MILESTONE trial is retrospective and data review study with health checkup data from the National Health Insurance Services(NHIS) in Korea. The data will be included general health examination for individuals , type of health insurance, medical bill details, medical histories, treatment and prescriptions about 514,795 individuals who were over 40 years old.

Eligibility criteria: Inclusion Criteria:

* The Subject who is got health checkup between 2002 and 2013, and had been recorded the health checkup result to the National Health Insurance Service(NHIS) in South Korea.

Exclusion Criteria:

* Persons whose disease development is not identified from the records due to emigration or disappearance

Primary outcomes:
measure: Accuracy in prediction of development of cardiovascular and metabolic disease using machine learning algorithm
timeFrame: 6months
Secondary outcomes:
measure: Accuracy in prediction of development of cardiovascular and metabolic disease using logistic regression analysis
timeFrame: 6months
measure: Accuracy in prediction of development of cardiovascular and metabolic disease using Framingham risk score
timeFrame: 6months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Severance Hospital
Study officials:
affiliation: Yonsei Univerity
name: Hyuk-Jae Chang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cho IJ, Sung JM, Kim HC, Lee SE, Chae MH, Kavousi M, Rueda-Ochoa OL, Ikram MA, Franco OH, Min JK, Chang HJ. Development and External Validation of a Deep Learning Algorithm for Prognostication of Cardiovascular Outcomes. Korean Circ J. 2020 Jan;50(1):72-84. doi: 10.4070/kcj.2019.0105. Epub 2019 Aug 19.
citation: Cho IJ, Sung JM, Chang HJ, Chung N, Kim HC. Incremental Value of Repeated Risk Factor Measurements for Cardiovascular Disease Prediction in Middle-Aged Korean Adults: Results From the NHIS-HEALS (National Health Insurance System-National Health Screening Cohort). Circ Cardiovasc Qual Outcomes. 2017 Nov;10(11):e004197. doi: 10.1161/CIRCOUTCOMES.117.004197.
Clinical trial NCT01753700: Effect of UHT Treated Milk on Blolipid Profile
Official title: Effect of UHT Treated Milk on Blolipid Profile
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: To Investigate the Effect of UHT Treated Milk Versus Pasteurised Milk on Bloodlipid Profil
Keywords: crossover
UHT milk
Pasteurised milk
supplement
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Arla Foods
name: Hoeng Fonden
name: Bionor Pharma
First posted: 2012-12-20
Enrollment: 20
Sex: ALL
Minimum age (years): 22
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The studie are to investigate the effect of ultra heat treated (UHT) versus pasteurised milk on bloodlipid profile


Eligibility criteria: Inclusion Criteria:

* healthy men and women
* 22-50 years of age
* BMI 25-30
* non smokers

Exclusion Criteria:

* lactose intolerance
* milk allergy or other types of food allergy
* Intestinal, abdominal or endocrinnologic diseases
* daily use of dietary supplements incl. vitamins and minerals
* cronic diseases (diabetes, CVD etc.)
* user of medicin on perscription that can influence the resuts of the study
* allergic to paraamino benzoe acid
* Physical activity \> 10 h pr week
* Blood donor
* on a diet or change of dietary habits within 3 months
* body weigh change \> 3 kg within the last 3 month
* special diets
* concomitant participation on other studies
* not able to comply with protocol

Primary outcomes:
measure: Blood lipids
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Nutrition, Exercise and Sports
state: Frederiksberg
Study officials:
References:
Clinical trial NCT05583500: Phase Angle as a Marker of Muscle Damage, Muscle Fatigue and Inflammation, After Eccentric Exercise
Official title: Phase Angle as a Marker of Muscle Damage, Muscle Fatigue and Inflammation, After Eccentric Exercise
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Phase Angle
Lead sponsor: Universidad Francisco de Vitoria
Sponsor class: OTHER
First posted: 2022-10-17
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study will be to assess the effectiveness of bioimpedance device (BIA) as a safe, rapid, and non-invasive method of analyzing muscle damage induced by high intensity induced eccentric exercise as an alternative measurement tool against traditional assessment methods.

A sample of 28 sedentary subjects will be recruited, all participants will perform an eccentric exercise protocol.

Measurements will be done before performing the exercise protocol, immediately after finishing the protocol, 3h after the end of the exercise protocol, 24h after the end of the exercise protocol and 48h after the end of the exercise protocol.

The variables analyzed in all subjects will be phase angle, creatinkinase, jumping strength, VAS scale, white blood count cell, quadriceps muscle thickness, Borg scale and anxiety and depression questionnaires.


Eligibility criteria: Inclusion Criteria:

* Healthy subjets
* Sedentary subjects

Exclusion Criteria:

* Trained subjects
* Subjects with musculoskeletal pathology
* Previous Surgeries in the last 6 months
* Subjects under pharmacological treatment

Primary outcomes:
measure: Phase angle
timeFrame: change from baseline to 72 hours
Secondary outcomes:
measure: Pain: VAS
timeFrame: change from baseline to 72 hours
measure: Quadriceps thickness
timeFrame: change from baseline to 72 hours
measure: Creatinkinase (CK concentration)
timeFrame: change from baseline to 72 hours
measure: cellular inflammatory markers
timeFrame: change from baseline to 72 hours
measure: Leg power
timeFrame: change from baseline to 72 hours
Other outcomes:
Locations:
city: Pozuelo De Alarcón
country: Spain
facility: Universidad Francisco de Vitoria
state: Madrid
Study officials:
affiliation: Universidad Francisco de Vitoria
name: Jorge Buffet García
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00397475: Evaluation of Colecalciferol Substitution in Dialysis Patients
Official title: Evaluation of Colecalciferol Substitution in Dialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: RENAL INSUFFICIENCY, CHRONIC
Hyperparathyroidism, Secondary
Lead sponsor: University Hospital, Saarland
Sponsor class: OTHER
First posted: 2006-11-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
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 the effect of a colecalciferol substitution in dialysis patients on bone metabolism and immune system


Eligibility criteria: Inclusion Criteria:

1. Serum 25-OH-Vit.D-levels \< 60 ng/ml
2. Age \> 18 years
3. dialysis treatment \> 3 Months
4. signed written informed consent
5. Serum-Calcium-levels \< 2,6 mmol/l within the last 4 weeks
6. Serum-Phosphate-levels \< 7,0 mg/dl within the last 4 weeks
7. Ca x P-Product \< 75 mg2/dl2 within the last 4 weeks

Exclusion Criteria:

1. Serum 25-OH-Vit.-D-levels \> 60 ng/ml
2. concommitant participation in another interventional trial
3. psychiatric disorders preventing from valid informed consent
4. Hyperphosphatemia (\> 7,0 mg/dl) within the last 4 weeks
5. Hypercalcemia (\> 2,6 mmol/l) within the last 4 weeks
6. Ca x P-Product \> 75 mg2/dl2 within the last 4 weeks
7. pregnancy or lactation
8. known malignancy
9. liver disease, defined as 2-fold upper limit of ASAT-, or ALAT-levels
10. PTH levels \< 50 pg/ml
11. current clinically relevant infections treated with antibiotic therapy and raised hsCRP levels
12. Chronic viral Infectious diseases (e.g. HIV, Hepatitis B or C)
13. Immunosuppressant Medication
14. known hematologic disorders, other than renal anemia
15. age below 18 years
16. known anaphylactic reaction against the study medication or other ingredients of the study drug preparation
17. renal calculus
18. Pseudohypoparathyroidism
19. Medication including cardiac glycosides
20. Sarkoidosis

Primary outcomes:
measure: CD14/CD16-Monocyte-Subsets (Frequency)
Secondary outcomes:
measure: Production of Cytokines: IFN-γ, TNF-α
measure: Serum levels of Calcium, Phosphorus, iPTH, hsCRP, alkaline phosphatase
measure: Th1/Th2- and Tc1/Tc2-Lymphocyte-Frequency
Other outcomes:
Locations:
city: Homburg
country: Germany
facility: University Hospital of Saarland, Dpt. of Internal Medicine IV, Div. of Nephrology and Hypertension
state: Saarland
Study officials:
affiliation: University Hospital of Saarland, Dpt. of Internal Medicine IV, Div. of Nephrology and Hypertension
name: Eric Seibert, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04678375: Artificial Intelligence for Detecting Retinal Diseases
Official title: Classification of Retinal Diseases by Artificial Intelligence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Artificial Intelligence
Retinal Diseases
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Tulip Partner Technology Co., Ltd, China
First posted: 2020-12-21
Enrollment: 1000000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is derived from an anonymous database that contains health examination results of the general population.

Brief summary: The objective of this study is to apply an artificial intelligence algorithm to diagnose multi retinal diseases from fundus photography. The effectiveness and accuracy of this algorithm was evaluated by sensitivity, specificity, positive predictive value, negative predictive value, and area under curve.

Detailed description: The objective of this study is to apply an artificial intelligence algorithm to diagnose referral diabetes retinopathy, referral age-related macular degeneration, referral possible glaucoma, pathological myopia, retinal vein occlusion, macular hole, macular epiretinal membrane, hypertensive retinopathy, myelinated fibers, retinitis pigmentosa and other retinal lesions from fundus photography. The effectiveness and accuracy of this algorithm was evaluated by sensitivity, specificity, positive predictive value, negative predictive value, area under curve, and F1 score.

Eligibility criteria: Inclusion Criteria:

* fundus photography around 45° field which covers optic disc and macula
* complete identification information

Exclusion Criteria:

* insufficient information for diagnosis.

Primary outcomes:
measure: Area under curve
timeFrame: 1 week
measure: Sensitivity and specificity
timeFrame: 1 week
measure: Positive predictive value, negative predictive value
timeFrame: 1 week
measure: F1 score
timeFrame: 1 week
Secondary outcomes:
measure: Systemic biomarkers and diseases
timeFrame: 1 week
Other outcomes:
Locations:
city: Beijing
country: China
facility: Wen-Bin Wei
state: Beijing
Study officials:
affiliation: Beijing Tongren Hospital
name: Wenbin Wei
role: STUDY_CHAIR
References: