louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05298735: Pancreatic Calcium Handling in Islet Beta Cells in Patients With Type 1 Diabetes Mellitus
Official title: Pancreatic Calcium Handling in Islet Beta Cells in Patients With Type 1 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
First posted: 2022-03-28
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with type 1 diabetes mellitus (with or without detectable C-peptide levels)

Brief summary: Approximately 400,000 people are living with type 1 diabetes mellitus (T1DM) in the United Kingdom: one of the highest rates in the world. It is characterised by autoimmune loss of pancreatic beta cell mass leading to metabolic dysregulation, requiring lifelong insulin therapy. It is now recognised that there are micro-secretors of insulin and that preservation of insulin secretion in these cases is associated with decreased complications. Therefore, recent research has focussed on using immunomodulation to preserve pancreatic beta cell mass. Evaluation of novel therapies for T1DM requires reliable methods to measure beta-cell function, which is unattainable using traditional non-invasive imaging techniques. A new approach is manganese-enhanced magnetic resonance imaging (MEMRI). This proof-of-concept study was designed to investigate whether MEMRI can be used as a measure of beta-cell function in people with T1DM.


Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* No regular medications
* No known significant medical conditions

Exclusion Criteria:

* Inability to consent
* Renal failure (eGFR \<30 mL/min/1.73 m2)
* Standard MRI contraindications
* Pregnancy or breast feeding

Primary outcomes:
measure: Pancreatic calcium-handling: Rate of change of pancreatic T1 values with manganese-enhanced magnetic resonance imaging
timeFrame: 30 minutes after contrast administration
Secondary outcomes:
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: University of Edinburgh
state: Scotland
Study officials:
References:
Clinical trial NCT06029335: Clinical Risk Assessment of Cognitive Function in Systemic Autoimmune Diseases
Official title: Clinical Risk Assessment of Cognitive Function in Systemic Autoimmune Diseases
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Systemic Sclerosis
Systemic Lupus Erythematosus
Myopathies, Inflammatory
Rheumatoid Arthritis
Healthy
Lead sponsor: University of Pecs
Sponsor class: OTHER
First posted: 2023-09-08
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients were enrolled into the study originating from the Rheumatology and Immunology Department, Medical School, University of Pécs.

Control healthy groups including consecutive sex and age-matched healthy individuals are invited to participate.

Brief summary: Objectives: Systemic autoimmune diseases are chronic diseases characterized by chronic inflammation, vasculopathy, and autoimmune phenomena. Several organ involvements are typical, including the central nervous system. Formerly published investigations emphasize a mild cognitive impairment affecting attention, memory, and complicated solution tasks. However, these symptoms significantly impact patients' routines and quality of life. The study examined the associations between cognitive impairment and clinical parameters regarding systemic autoimmune diseases.

Methods: General clinical data, some serum biomarkers including CCl-18, YKL-40, COMP, VEGF, Galectin-3, and Pentraxin as well as results of functional, quality of life, and neuropsychological measures, the Mini-Mental State Examination (MMSE), the Digit Span Forward-Backward, the Trail making A, B and the Digit Symbol tests all were administered.


Eligibility criteria: Inclusion Criteria:

* Systemic autoimmune diseases
* Healthy individuals - as controls

Exclusion Criteria:

* Diseases of the central nervous system
* Presence of pregnancy

Primary outcomes:
measure: Mini-mental State Examination
timeFrame: 12 months
measure: The Functional Assessment of Chronic Illness Therapy F
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pécs
country: Hungary
facility: University of Pécs, Department of Rheumatology and Immunology
Study officials:
References:
citation: Olah C, Schwartz N, Denton C, Kardos Z, Putterman C, Szekanecz Z. Cognitive dysfunction in autoimmune rheumatic diseases. Arthritis Res Ther. 2020 Apr 15;22(1):78. doi: 10.1186/s13075-020-02180-5.
Clinical trial NCT06085235: An Investigation Into the Effects of Acute Exercise on Activities of Daily Living and Cognition in Older Adults
Official title: An Investigation Into the Effects of Acute Exercise on Activities of Daily Living and Cognition in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Inactivity
Lead sponsor: Ball State University
Sponsor class: OTHER
First posted: 2023-10-16
Enrollment: 62
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Control Trial: exercise or video control condition
Primary purpose: BASIC_SCIENCE

Brief summary: Research has demonstrated the positive effects of chronic exercise on cognitive functioning and performance of Activities of Daily Living (ADLs). However, minimal research exists regarding the effects of acute exercise. To address this gap in the literature, the present study investigated the effect of an acute bout of exercise on executive functions, balance, and ADLs among healthy older adults. Based on the current literature, we expected participants in the exercise group to perform better on executive function tasks and ADLs compared to participants in the control group.


Eligibility criteria: Inclusion Criteria:

* over the age of 60.

Exclusion Criteria:

* health complications preventing the ability to cycle on a recumbent bike and walking at moderate intensity as indicated by the health history questionnaire, taking anti-depressant medication, or having color blindness.

Primary outcomes:
measure: Executive functions
timeFrame: 1 week
measure: Balance
timeFrame: 1 week
measure: Activity of daily living
timeFrame: 1 week
measure: Functional ability
timeFrame: 1 week
measure: Fall risk
timeFrame: 1 week
measure: Grip strength
timeFrame: 1 week
measure: Commitment check
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Muncie
country: United States
facility: Ball State University
state: Indiana
Study officials:
affiliation: Ball State University
name: Jean-Charles Lebeau, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02995135: Sun Protection Factor Assay (341/2016)
Official title: Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay Minimal Persistent Pigment-Darkening Dose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreening Agents
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-12-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility criteria: Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female.
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF (Subject History Form).
* Signed and dated Informed Consent Form.
* Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form.
* An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose)

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.)which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma, diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.

Primary outcomes:
measure: Minimal Erythema Dose (MED)
timeFrame: Up to 15 minutes
measure: Minimal Persistent Pigment Darkening Dose (MPPD)
timeFrame: Up to 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Union
country: United States
state: New Jersey
Study officials:
References:
Clinical trial NCT04275635: Validation of a Predictive Algorithm to Determine the Effectiveness of Orthokeratology for Myopia Control
Official title: Validation of a Predictive Algorithm to Determine the Effectiveness of Orthokeratology for Myopia Control
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myopia
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2020-02-19
Enrollment: 3000
Sex: ALL
Minimum age (years): 8
Maximum age (years): 15
Standard ages: CHILD
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 3,000 children from Zhongshan Ophthalmic Center plan to wear orthokeratology lenses for myopia control.

Brief summary: This is a prospective study to validate a predictive algorithm for identifying fast progressing myopes.

Detailed description: Orthokeratology (ortho-K) has been demonstrated to slow myopic progression and reduce axial elongation in young patients, but this treatment is limited by the need for contact lens wear, which is the common cause for keratitis in children, and therefore cautious use is recommended. There is a need to identify the patients that could benefit most from this treatment. In order to do so, we conduct a retrospective study and create a large database (n = 10,000) of de-identified data to train an algorithm for identifying fast progressing myopes. In addition, we will perform a prospective study to validate this predictive algorithm and determine the effectiveness of Orthokeratology among different individual patients in China.

Eligibility criteria: Inclusion Criteria:

* -6.0D≤SER≤-0.5D
* Astigmatism≤2.0D

Exclusion Criteria:

* Contraindications of wearing Ortho-K.
* Diagnosis of strabismus, amblyopia and other refractive development of the eye or systemic diseases.
* Currently involved in other clinical studies.

Primary outcomes:
measure: AUROC of the prediction algorithm for identifying fast progressing myopes
timeFrame: 1 year
Secondary outcomes:
measure: Sensitivity and specificity of the prediction algorithm for identifying fast progressing myopes
timeFrame: 1 year
measure: Performance of an algorithm for predicting AL
timeFrame: 1 year
measure: Performance of an algorithm for predicting spherical equivalent refractive error
timeFrame: 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhognshan Ophthalmic Center (Zhujiang New Town Branch), Sun Yat-sen University
state: Guangdong
Study officials:
References:
citation: Wang D, Ding X, Liu B, Zhang J, He M. Longitudinal changes of axial length and height are associated and concomitant in children. Invest Ophthalmol Vis Sci. 2011 Oct 10;52(11):7949-53. doi: 10.1167/iovs.11-7684.
Clinical trial NCT02947035: Molecular Testing to Direct Extent of Initial Thyroid Surgery
Official title: Molecular Testing to Direct Extent of Initial Thyroid Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Thyroid Cancer
Keywords: thyroid cancer
thyroid nodule
thyroidectomy
personalized medicine
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2016-10-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The research study consists of the participant agreeing to 1) the use of preoperative molecular testing (ThyroSeq) to guide extent of initial surgery and 2) the prospective collection of medical record data related to treatment of thyroid cancer.

Detailed description: The aim of the proposed pilot study is to use a clinical algorithm that incorporates molecular, clinical and radiographic factors to inform surgical management. This study is the first to propose molecular-directed surgical management for this commonly diagnosed cancer.

Eligibility criteria: Inclusion Criteria:

* Thyroid nodule is \>1.5 cm
* Preoperative FNA biopsy that is positive for papillary thyroid cancer or suspicious for papillary thyroid cancer

Exclusion Criteria:

* Prior thyroid/parathyroid surgery
* Clinical indications for total thyroidectomy including hypothyroidism, history of head or neck radiation when \<18 years old
* Recurrent laryngeal nerve dysfunction
* Diagnosis of concurrent primary hyperparathyroidism

Primary outcomes:
measure: Number of patients who require completion thyroidectomy for aggressive histology features
timeFrame: 2 years
Secondary outcomes:
measure: Number of patients who had central compartment neck dissection but no lymph node metastasis were identified
timeFrame: 2 years
measure: Number of patients with operative complications
timeFrame: 2 years
measure: Recurrence
timeFrame: >2 years
measure: QOL metric - FACT-G cumulative score preop, postop, and at followup
timeFrame: 2 years
measure: QOL metric - QOL-Thyroid cumulative score preop, postop, and at followup
timeFrame: 2 years
measure: QOL metric - SF36 cumulative score preop, postop, and at followup
timeFrame: 2 years
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Pittsburgh
name: Linwah Yip, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02224586: Resting State Functional Magnetic Resonance Imaging Study of Jaundice Infants Before and After Light Treatment.
Official title: Resting State Functional Magnetic Resonance Imaging Study of Jaundice Infants Before and After Light Treatment.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Jaundice
Lead sponsor: Hangzhou Normal University
Sponsor class: OTHER
First posted: 2014-08-25
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: municipal hospitals

Brief summary: It is just an observation study. The investigates want to explore the signal changes of resting state functional Magnetic resonance Imaging (fMRI) after light treatment in jaundice infants. Signal changes contain blood oxygenation level dependent (BOLD) and arterial spin labeling (ASL).Indicator of BOLD is amplitude of low-frequency fluctuation（ALFF).Indicator of ASL is cerebral blood flow (CBF).

The investigates assume that the children with jaundice after light therapy, ALFF and CBF will change. Focus on the globus pallidus and subthalamic nuclei. The two brain regions were proved to be abnormal in MRI T1, T2 structure signal in kernicterus.

Doctors observe the status of infants aside.Using monitoring probe can see clearly.

Detailed description: resting state fMRI scan light therapy the second time resting state fMRI scan

Eligibility criteria: Inclusion Criteria:

* hyperbilirubinemia

Exclusion Criteria:

* asphyxia
* cerebral dysgenesis

Primary outcomes:
measure: amplitude of low-frequency fluctuation change before and after light treatment
timeFrame: before and after light treatment
Secondary outcomes:
measure: cerebral blood flow change before after light treatment
timeFrame: before and after light treatment
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Center for Cognition and Brain Disorders
state: Zhejiang
Study officials:
affiliation: Center for Cognition and Brain Disorders,Hangzhou Normal University
name: Ya-Fei Zhu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01006486: Outcomes of an Anticoagulation Clinic in an University Hospital
Official title: Evaluation of Impact of the Implantation of an Anticoagulation Clinic in an University Hospital in Brazil
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiopathy
Chagas Disease
Hemorrhage
Thrombosis
Keywords: Oral anticoagulants
Warfarin
Anticoagulation clinic
Thrombosis
Hemorrhage
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
First posted: 2009-11-01
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: A clinical trial designed to compare the oral anticoagulation control obtained by an anticoagulation clinic and the usual medical care in Chagas and Non-Chagas disease patients.

Detailed description: A Randomized, Crossover, Clinical Trial performed to compare the results of oral anticoagulation for Chagas and non-Chagas disease patients treated at an anticoagulation clinic and by the usual clinical practice. The primary endpoint was the time that the International Normalized Ratio (INR) was in the therapeutic range and the secondary endpoints were thromboembolic/haemorragic events.

Eligibility criteria: Inclusion Criteria:

* Outpatients
* Chagas and non-Chagas disease patients
* Any indication for chronic treatment with warfarin
* Anticoagulation for at least 30 days.

Exclusion Criteria:

* Refusal to participate in the study;
* Use of phenprocoumon;
* Expectation of treatment lower than 1 year;
* Difficulties to attend medical visits;
* Participation in other prospective clinical study involving anticoagulation care during the study period.

Primary outcomes:
measure: Time in therapeutic range
timeFrame: 1 year
Secondary outcomes:
measure: Hemorrhagic events
timeFrame: 1 year
measure: Thromboembolic events
timeFrame: 1 year
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Federal University of Minas Gerais
state: Minas Gerais
Study officials:
affiliation: Federal University of Minas Gerais
name: Antonio L Ribeiro, MD, PhD
role: STUDY_CHAIR
affiliation: Federal University of Minas Gerais
name: Manoel Otávio C Rocha, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Minas Gerais
name: Maria Auxiliadora P Martins, Pharmacist
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Minas Gerais
name: Cibele C César, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Minas Gerais
name: Daniel D Ribeiro, Physician
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Minas Gerais
name: Vandack Nobre, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02961686: Quality of Life and Sexuality in Patients With Prostate Cancer
Official title: Quality of Life and Sexuality in Patients Treated With Radical Radiotherapy for Prostate Cancer
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Quality of Life
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2016-11-11
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients affected by prostate cancer

Brief summary: The trial is to describe quality of life in patients affected by prostate cancer treated with exclusive radiotherapy and submitted to psychological and andrologic evaluation.

Detailed description: This trial is to describe quality of life and sexuality in patients with prostate cancer treated with exclusive radiotherapy. Descriptive analysis of baseline characteristics will be performed by using appropriate summary measures for continous and categorical data. Analysis of variation over time of FACT scores will be conducted by means of ANOVA analysis for repeated measures.

Eligibility criteria: Inclusion Criteria:

* Age 18-75 years.
* Histologically-proven of prostate cancer
* Indication to radical radiotherapy on prostate/ prostate + seminal vesicles / prostate + seminal vesicles + pelvic lymph nodes
* Informed consent

Exclusion Criteria:

* Other coexisting malignancies, uncontrolled intercurrent illness, active infectious processes, and exudative, bloody, or cytologically malignant effusions excluded patients from the trial.
* Previous surgery for prostate cancer, severe cardiac or vascular pathology
* Other major surgery in the preceding year or currently undergoing psychiatric care or psychological counseling.

Primary outcomes:
measure: Quality of life measurement
timeFrame: 2.5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Humanitas Research Hospital
state: Milan
Study officials:
affiliation: Istituto Clinico Humanitas
name: Ciro Franzese
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00694486: Eustachian Tube Testing in a Pressure Chamber -- Validation Study
Official title: Eustachian Tube Testing in a Pressure Chamber -- Validation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Otitis
Keywords: otitis
Eustachian tube function
Normal middle ear status
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2008-06-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy adults

Brief summary: This study will compare Eustachian tube function (ETF) testing in adults with intact tympanic membranes (TM) using a pressure chamber to that obtained using standard methods requiring a non-intact TM.

Detailed description: The investigators propose to introduce new test methods and protocols to our laboratory for better clinical characterization of Eustachian tube function in ears with intact TM's. These test will be done in a pressure-chamber and will use previously published and newly developed methods. Participation will require a minimum of 5 visits to the ENT Research Center, 1 for myringotomy (putting a small hole in the eardrum) and 4 for ETF testing. Hearing testing will be done at entry and exit; otoscopy (looking at the ears) and tympanometry (a test done with an earplug and varying pressures in the ear canal) are done at every visit.

Eligibility criteria: Inclusion Criteria:

* \>18 years old
* Normal middle-ear status

Exclusion Criteria:

* Chronic illness including asthma, pulmonary, or cardiac problems
* Pregnancy
* \>10 dB hearing loss in any of the speech frequencies
* Past history of sensitivity or allergic reaction to lidocaine or related compounds

Primary outcomes:
measure: Eustachian tube function testing results
timeFrame: up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: ENT Research Center Children's Hospital of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: William J Doyle, PhD
role: PRINCIPAL_INVESTIGATOR
References: