louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03289598: Effect of Involving Community-dwelling Older Adults in Activities in Relation to Meals
Official title: A Cluster Randomised Feasibility Trial Evaluating Involving Community-dwelling Older Adults in Activities in Relation to Meals in a Rehabilitation Program; Recruitment, Data Collection and Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frail Older Adults
Lead sponsor: The Danish Dietetic Association
Sponsor class: OTHER
Collaborators: name: The Danish Meal Partnership
name: Ministry of Environment and Food of Denmark
name: Metropolitan University College
name: National Board of Health, Denmark
name: The City of Odense
name: Danish Diet & Nutrition Association
First posted: 2017-09-21
Enrollment: 130
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Community-dwelling older adults receiving support at home such as meals-on-wheels may lose the ability to preserve social, cognitive, and functional abilities, when becoming accustomed to and dependent of community aged care. When still able to cook older adults often hold some control over the foods that are prepared and which they eat, and which helps to foster identity. The purpose of this study is to evaluate community-dwelling older adults being involved in activities in relation to meals in a rehabilitation program.


Eligibility criteria: Inclusion Criteria:

* Community dwelling older people (64+ years)
* Able to eat and drink
* Receive meals-on-wheels from the municipality at the time of recruitment
* Live in the city of Odense

Exclusion Criteria:

* Moderate-severe dementia as judged by the home -care staff
* Being deaf and/or not understand the language of Danish.
* Not being able to sign the informed consent
* Receiving (or likely to receive in the next 6 months) enteral tube feeding or parenteral nutrition;
* Participating in other project in the municipality about nutritional support in the form of dietetic advice;
* Or on an end-of-life care pathway

Primary outcomes:
measure: Quality of life
timeFrame: Up to 6 months
Secondary outcomes:
measure: 30 seconds chair-stand
timeFrame: Up to 6 months
measure: Weight
timeFrame: Up to 6 months
measure: Height
timeFrame: Up to 6 months
measure: Loneliness
timeFrame: Up to 6 months
measure: Mental well-being
timeFrame: Up to 6 months
measure: Self-efficacy
timeFrame: Up to 6 months
measure: Satisfaction with food-related life
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: The Danish Dietetic Association
Study officials:
affiliation: The Danish Dietetic Association
name: Mette Pedersen
role: STUDY_DIRECTOR
References:
citation: Husted MM, Beck AM, Ulrikkeholm LK. A cluster randomised feasibility pilot trial evaluating involving community-dwelling older adults in activities in relation to meals in a rehabilitation program; recruitment, data collection and protocol. Pilot Feasibility Stud. 2018 Aug 6;4:134. doi: 10.1186/s40814-018-0323-3. eCollection 2018.
Clinical trial NCT06146998: Three-dimensional Thyroid Education Model
Official title: Development of 3D Printing High-Fidelity Thyroid Fine Needle Aspiration Exam Medical Education Model to Facilitate Patient Education
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Satisfaction, Patient
Keywords: 3D printing
medical education model
high-fidelity simulation
thyroid
fine needle aspiration
Lead sponsor: Fu Jen Catholic University
Sponsor class: OTHER
First posted: 2023-11-27
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of our study is to develop a high-fidelity thyroid education model, that can be utilized for patient education. This model can assist them in gaining a better understanding of the thyroid's structure, providing patients with insights into their own conditions and thyroid fine needle aspiration examinations.

Detailed description: Background： Thyroid nodular disorder is one of the most common diseases in Endocrine clinics. And thyroid fine needle aspiration examination is the most important exam in evaluating the nature of thyroid nodules. In previous studies, 3D thyroid models have been introduced for patient education before thyroid surgery. Nevertheless, thyroid models that can be used to practice thyroid fine needle aspiration examination were scarce.

Study Design： This is a prospective study.

Methods： In our study, 3D printing technology will be used to create the thyroid high-fidelity model. We plan to choose 3D printing materials that explain thyroid fine needle aspiration for patient education efficacy evaluation.

Effect： Through the creation of this thyroid fine needle aspiration model, we hope to enhance patients' comprehension of the thyroid and thyroid nodules. The results of our study could be applied in hospitals to improve patient education.

Key words： 3D printing; medical education model; high-fidelity simulation; thyroid; fine needle aspiration

Eligibility criteria: Inclusion Criteria:

* Thyroid nodule detected
* Thyroid ultrasound-guided fine-needle aspiration is needed

Exclusion Criteria:

* Previously underwent thyroid ultrasound-guided fine-needle aspiration
* Refused to participate in the study

Primary outcomes:
measure: Medical education effectiveness questionnaire
timeFrame: immediately after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Fu Jen Catholic University Hospital, Fu Jen Catholic University
Study officials:
affiliation: Fu Jen Catholic University Hospital
name: Ke-Yun Chao, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02909998: Biomarkers in Chronic Arthritis
Official title: Evaluation of Predictive Genetic Markers of Response to Biologic Therapies in Chronic Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Arthritis
Keywords: Biomarkers
Genetic
Chronic arthritis
Treatment
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2016-09-21
Enrollment: 379
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients referred for chronic arthritis

Brief summary: Use of genotyping for the optimization of treatment with biologics in chronic arthritis by looking for an association between certain alleles and response to treatment.

Detailed description: Chronic arthritis in children and in adults represent a public health problem in number and difficulty of treatment. 30% of patients are non-responders and / or relapse upon discontinuation of treatment. Some of these treatments are not always well tolerated, sometimes with infectious complications including tuberculosis limiting the use of biological therapies. This study will validate a battery of genetic markers to predict responders biotherapy, determine the prognosis of patients, these treatments are reserved for the most severe forms, and thus improve the care of patients.

Eligibility criteria: Inclusion Criteria:

* All patients treated with biotherapy may be included in this study with all information necessary for regular medical consultations (filling specific monitoring by GPs questionnaires), physical therapists visits, occupational therapists, psychologists.. etc

Exclusion Criteria:

* Patients treated with biological therapy for non rheumatic disease
* Other inflammatory diseases such as Crohn's disease
* Refusal to participate in the collection

Primary outcomes:
measure: Proportion of responsive patients with a given polymorphism (%)
timeFrame: At the inclusion
Secondary outcomes:
measure: Distribution of patients with a given biotherapy (%)
timeFrame: At the inclusion
measure: Distribution of patients presenting a given polymorphism (%)
timeFrame: At the inclusion
Other outcomes:
Locations:
Study officials:
affiliation: Montpellier Hospital University
name: Isabelle TOUITOU, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ladhari C, Le Blay P, Vincent T, Larbi A, Rubenstein E, Lopez RF, Jorgensen C, Pers YM. Successful long-term remission through tapering tocilizumab infusions: a single-center prospective study. BMC Rheumatol. 2020 Feb 28;4:5. doi: 10.1186/s41927-019-0109-0. eCollection 2020.
Clinical trial NCT00220298: Assessment of Long Term Treatment With Testosterone Undecanoate in Males With Hypogonadism
Official title: Open One-arm Study to Investigate Safety and Efficacy of Intramuscular Injections of 1000 mg Testosterone Undecanoate (TU) in Hypogonadal Men at Variable Intervals During a 136-week to 192-week Treatment Including Pharmacokinetics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypogonadism
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 96
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the preparation of testosterone undecanoate under conditions which resemble real-life situations.

Detailed description: The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Eligibility criteria: Inclusion Criteria:

* Hypogonadal men, aged 18-75 years with low serum total testosterone (TT) levels and symptoms of androgen deficiency

Exclusion Criteria:

* Tumors of the prostate or the male mammary gland including suspicion thereof. Past or present liver tumors or chronic hepatic disease with impairment of liver function, Severe acne.

Primary outcomes:
measure: Efficacy and Safety of long term treatment with TU under real-life conditions
timeFrame: Every 3 months during treatment and after final injection
Secondary outcomes:
measure: Assessment of treatment satisfaction by patient
timeFrame: 6,10, and 14 injections
Other outcomes:
Locations:
city: Nürnberg
country: Germany
state: Bayern
city: Marburg
country: Germany
state: Hessen
city: Wolfsburg
country: Germany
state: Niedersachsen
city: Münster
country: Germany
state: Nordrhein-Westfalen
city: Halle
country: Germany
state: Sachsen-Anhalt
city: Naumburg
country: Germany
state: Sachsen-Anhalt
city: Leipzig
country: Germany
state: Sachsen
city: Jena
country: Germany
state: Thueringen
city: Jena
country: Germany
state: Thueringen
city: Eisenberg
country: Germany
state: Thüringen
city: Gera
country: Germany
state: Thüringen
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Leipzig
country: Germany
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Behre HM and Elliesen J. Safety and efficacy of intramuscular injections of 1000 mg testosterone undecanoate: A prospective multicenter study in hypogonadal men under conditions resembling real-life situations. Proceedings of the 22nd Annual European Association of Urology (EAU); 2007 Mar 22; Berlin, Germany. Eur Urol Suppl 2007;6(2):108.
Clinical trial NCT02376998: Endovascular Repair for the Descending Thoracic Aorta
Official title: Endovascular Repair for Acute Traumatic Transection of the Descending Thoracic Aorta
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aorta Thoracic; Traumatic Rupture
Keywords: Thoracic Aorta
Trauma
Endovascular
Lead sponsor: University of Catanzaro
Sponsor class: OTHER
First posted: 2015-03-03
Enrollment: 20
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: Most blunt aortic injuries occur in the proximal proximal descending aorta causing acute transection of this vessel. Generally, surgical repair of the ruptured segment of aorta is associated with high rates of morbidity and mortality and in this view endovascular treatment seems to be a valid and safer alternative. Aim of this study is to review the experience of a single center with endovascular approach for the treatment of acute traumatic rupture of descending thoracic aorta

Detailed description: From April 2002 to November 2014, patients referred to our Department with a diagnosis of acute transection of thoracic aorta will be studied by preoperative Computed Tomography (CT) evaluation in order to perform thoracic endovascular aortic repair (TEVAR) with left subclavian artery coverage. Then patients will be followed up with clinical and instrumental (CT, Duplex ultrasound) controls at discharge, 1, 3 and 6 months and yearly thereafter. We will evaluate the presence of major and minor neurological complications, episodes of left arm claudication, cardiovascular, respiratory and bleeding complications. Furthermore we will evaluate the technical success of the technique evaluating the onset of failure, collapse, leak or distal migration of the graft.

Eligibility criteria: Inclusion Criteria:

* patients with a diagnosis of acute transection of thoracic aorta;
* a time frame range from trauma of 1-10 hours.

Exclusion Criteria:

* Patients who do not fall into the above categories

Primary outcomes:
measure: Number of Participants With Major Adverse Events
timeFrame: from hospital discharge to 1 month after the procedure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Serra R, de Franciscis S, Grande R, Butrico L, Perri P, Indolfi C, Mastroroberto P. Endovascular repair for acute traumatic transection of the descending thoracic aorta: experience of a single centre with a 12-years follow up. J Cardiothorac Surg. 2015 Nov 21;10:171. doi: 10.1186/s13019-015-0388-5.
Clinical trial NCT04064398: Evaluation of Gastric Residuals and Feedings Progression
Official title: Evaluation of Gastric Residuals in Preterm Newborns: What Impact Does It Have on Feedings Progression?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Infant, Premature, Diseases
Nutrition, Enteral
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
First posted: 2019-08-21
Enrollment: 203
Sex: ALL
Minimum age (years): 1
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study evaluates the utility of measuring gastric residuals in premature infants born between 26+0 and 33+6 weeks and to determine if its routine use is related with a delay in feedings advancement in this babies compared with no measurement.

Detailed description: The evaluation of gastric residuals as a measure of enteral tolerance in term and especially preterm newborns is a widely used practice in different centers worldwide. However, until now, it continues to be a controversial practice, since its real usefulness is not clear.

Our study proposes to evaluate and compare two groups of preterm newborns born between 26 + 0/7 and 33 + 6/7 weeks, randomized to measure or not measure gastric residuals and determine if this practice delays the full feeding achievement.

Eligibility criteria: Inclusion Criteria:

* Preterm infants born between 26+0 to 33+6 weeks post-menstrual gestational age.
* Enteral feeds starting during the first week of life.
* Signed informed consent from parents or guardians.

Exclusion Criteria:

* Perinatal asphyxia
* Sepsis and hemodynamic instability
* Major congenital malformations
* Surgical requirement during the first week of life
* Hemodynamic instability and vasoactive drugs requirement
* Moderate or severe respiratory failure with Oxygenation Index \> 8

Primary outcomes:
measure: Time to reach full feeds
timeFrame: Baseline to 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Pontificia Universidad Católica de Chile
state: Región Metropolitana
Study officials:
affiliation: Pontificia Universidad Catolica de Chile
name: Valentina A Salas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pontificia Universidad Catolica de Chile
name: Jorge G Fabres, MD, MSPH
role: STUDY_DIRECTOR
References:
Clinical trial NCT03010098: The Effect on the Older's Cognition of Dual-loop Target Controlled Infusion Guided by Narcotrend Index
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Anesthesia
Keywords: POCD
narcotrend
closed-loop of target controlled infusion
Lead sponsor: Guangzhou General Hospital of Guangzhou Military Command
Sponsor class: OTHER
First posted: 2017-01-04
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the effect on older's cognition of the application of closed target-controlled infusion(TCI) of propofol and remifentanil guided by Narcotrend index .

Detailed description: Two hundreds of patients scheduled for surgery under general anesthesia were randomly divided into two groups:closed-loop (group A,n=100) and open-loop group(group B,n=100).The procedure during induction of anesthesia was same in two groups.In group A,if Narcotrend index(NI) fall down to 46 and keep more than 30 seconds,propofol and remifentanil were intravenously infused as feedback automatically to achieve the target NI of 26-46.However,the NI in group B was controlled manually.Taking an exam of MMSE before and after the surgery which measures if the older's cognition changed. Furthermore.we will measure the levels of protein S100beta and NSE.

Eligibility criteria: Inclusion Criteria:

1. ASA Ⅰ \~ Ⅱ women undergoing Laparoscopic surgery.
2. Written informed consent from the patient or the relatives of the participating patient.
3. BMI:18.0～25 kg/m2

Exclusion Criteria:

1. Mental illness can not match
2. epidural anesthesia contraindicated
3. People who have Slow-type arrhythmias
4. Chronic renal failure
5. Alcohol or drug abuse
6. Already taking gabapentin, pregabalin, benzodiazepin or antidepression dru

Primary outcomes:
measure: MMSE scores
timeFrame: up to 1 week
Secondary outcomes:
measure: protein s100beta
timeFrame: up to 24 hours
Other outcomes:
measure: NSE
timeFrame: up to 24 hours
Locations:
city: Guangzhou
country: China
facility: Guangzhou Military Region General Hospital, Department of Anesthesiology
state: Guangdong
Study officials:
References:
Clinical trial NCT04265898: Validating the Digital Virginia Tech Carilion Cognitive Examination
Official title: Validating the Digital Virginia Tech Carilion Cognitive Examination - A Unique Tool for Cognitive Assessment
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Cognitive Change
Lead sponsor: Carilion Clinic
Sponsor class: OTHER
Collaborators: name: Digitally Enhanced Screening Applications
First posted: 2020-02-12
Enrollment: 0
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants must be 50-80 years old with no diagnosis of dementia who speak English, have no acute mental health concerns, and have a Carilion Clinic medical provider.

Brief summary: Currently, cognitive screening is performed in-person after the individual expresses symptoms or it is noticed by someone close to them and are largely done in clinical settings. The digital Virginia Tech Carilion Cognitive Examination (VTC-Cog) utilizes smart devices and allows for the early establishment of an individual's cognitive baseline. VTC-Cog has been designed to test all major aspects of cognition, as currently assessed using the Montreal Cognitive Assessment (MoCA) and Mini-Mental Status Examination (MMSE) but on a digital platform. The VTC-Cog allows for standardized scoring with no clinician bias and provides a clinician report that breaks down distinct changes in different areas of cognition (executive, visuospatial, memory, etc.) in order to refine clinician analysis.


Eligibility criteria: Inclusion Criteria:

* Age 50-80 years
* No current diagnosis of dementia
* Current stable mental health
* English speaker
* Carilion Clinic Medical Provider

Exclusion Criteria:

* \<50 years old or \>80 years old
* Current diagnosis of dementia
* Unstable mental health
* Non-English speaker
* Medical provider outside the Carilion Clinic system

Primary outcomes:
measure: Validation of the Digital Virginia Tech Carilion Cognitive Examination against the Montreal Cognitive Assessment
timeFrame: 18-24 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Physician
name: Azziza Bankole, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02131298: Effect Of Itraconazole On The Pharmacokinetics Of Palbociclib
Official title: A Phase 1, Open-Label, Fixed-Sequence 2-Period Study To Investigate The Effect Of Multiple Doses Of Itraconazole On The Single Dose Pharmacokinetics of Palbociclib (PD-0332991) In Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Palbociclib
Itraconazole
Pharmacokinetics
Drug-Drug Interaction Study
Healthy Volunteers
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-05-06
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study is designed to evaluate the potential effect of itraconazole on the pharmacokinetics of palbociclib.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive.
* Body mass index of 17.5 to 30.5 kg/m2, and a total body weight \>50 kg (110 lbs).
* Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
* Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic diseases.
* Any condition possibly affecting drug absorption.
* A positive urine drug screen or alcohol breath test.
* Pregnant female subjects; breast feeding female subjects, female subjects of childbearing potential, male subjects with partners currently pregnant, male subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for 90 days after the last dose of investigational product.

Primary outcomes:
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
timeFrame: 0 to 168 hours
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 0 to 168 hours
Secondary outcomes:
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
timeFrame: 0 to 168 hours
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: 0 to 168 hours
measure: Plasma Decay Half-Life (t1/2)
timeFrame: 0 to 168 hours
measure: Apparent Oral Clearance (CL/F)
timeFrame: 0 to 168 hours
measure: Apparent Volume of Distribution (Vz/F)
timeFrame: 0 to 168 hours
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: