louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01499823: Permeability Map to Distinguish Progression From Pseudoprogression in High-Grade Glioma
Official title: Permeability Map As an Imaging Biomarker to Distinguish Progression From Pseudoprogression in High-Grade Glioma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: High Grade Glioma
Keywords: Permeability Map
High-Grade Glioma
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2011-12-26
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with high-grade glioma (glioblastoma multiforme or anaplastic astrocytoma), who receive concurrent chemoradiation (CCRT) with temozolomide

Brief summary: The aim of the present study is to assess whether a new method of quantifying therapy-associated hemodynamic alterations based on DCE MR imaging may help to distinguish pseudoprogression from true progression in patients with high grade glioma, who received CCRT.

Detailed description: Combination temozolomide and radiation significantly prolongs survival compared with radiation alone and has become standard treatment for glioblastoma multiforme (GBM). Response assessment in GBM is difficult as a result of the frequent occurrence of early imaging changes indistinguishable from tumor progression, termed pseudoprogression. The majority of patients remain clinically stable. It is often unclear whether current therapy should be maintained or second-line therapy initiated. The incidence of pseudoprogression after concurrent chemoradiation is15%to 30%. A potential mechanism of pseudoprogression is that radiation-induced vascular changes may lead to focal transient increase in gadolinium enhancement. Dynamic contrast-enhanced (DCE) MR imaging provides a noninvasive means for quantifying tumor vascular properties.

Eligibility criteria: Inclusion Criteria:

* Among the patients with high-grade glioma (glioblastoma multiforme or anaplastic astrocytoma), who received concurrent chemoradiation (CCRT) with temozolomide, the patients show the measurable enhancing portion (1 cm in the long diameter according to the RANO criteria) in the immediate f/up MRI after CCRT.

Exclusion Criteria:

* Among the patients with high-grade glioma (glioblastoma multiforme or anaplastic astrocytoma), who received concurrent chemoradiation (CCRT) with temozolomide, the patients do not show the measurable enhancing portion (1 cm in the long diameter according to the RANO criteria) in the immediate f/up MRI after CCRT.

Primary outcomes:
measure: Permeability Map to Distinguish Progression From Pseudoprogression in High-grade glioma
timeFrame: 2year
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital(Radiology)
name: SeungHong Choi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06274723: Responses to E-cigarette Message Source and Presentation
Official title: Identifying and Examining the Effects of Source and Presentation on Responses to Electronic Cigarette Public Education Messages in Young Adult Vapers and Non-vapers - Part 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaping
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-02-23
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this clinical trial is to use crowdsourcing to test the effects of a message source (expert and peer) and message presentation types (one-sided and two-sided) to identify the optimal message type for young adults who vape and do not vape.


Eligibility criteria: Inclusion Criteria:

* US residents ages 18-24
* Fluent in English
* Reporting either vaping in the past 30 days or not having vaped in the past 30 days but susceptible to vaping

Exclusion Criteria:

* Age less than 18 or above 24
* Not fluent in English
* Not a member of partnering crowdsourcing behavioral research platform conducting the study

Primary outcomes:
measure: Message acceptance
timeFrame: 20 minutes
measure: Harm perceptions
timeFrame: 20 minutes
Secondary outcomes:
measure: Psychological reactance
timeFrame: 20 minutes
measure: Message liking
timeFrame: 20 minutes
measure: Source trust
timeFrame: 20 minutes
measure: Attitudes
timeFrame: 20 minutes
measure: Behavioral intentions to vape or try vaping
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Worcester
country: United States
facility: UMass Chan Medical School
state: Massachusetts
Study officials:
affiliation: UMass Chan Medical School
name: Donghee N Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01819623: Effect of Non-pharmacological Therapy on Cognitive Function of Patients With Cognitive Impairment
Official title: Effect of Non-pharmacological Therapy on Cognitive Function of Patients With Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Mild Cognitive Impairment
Cognitive training
Lead sponsor: National Institute of Medical Sciences and Nutrition, Salvador Zubiran
Sponsor class: OTHER
First posted: 2013-03-27
Enrollment: 0
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Supervised nonpharmacologic therapy improve cognitive function in patients with Mild Cognitive Impairment


Eligibility criteria: Inclusion Criteria:

* Patients 60 years and older with Mild Cognitive Impairment according to Petersen Criteria
* Phone number available

Exclusion Criteria:

* Untreated depression
* Evidence of a reversible cause of cognitive decline
* Dementia of any type and stage
* Severe sensory deficit unresolved
* Metastatic cancer
* Hemoglobin level \< 8g/dL
* Chronic Obstructive Pulmonary Disease Gold stage 3 or 4
* Congestive Heart Failure decompensated, unstable angina o Functional Class IV according to New York Heart Association
* Participation in another protocol that prevents its participation in this research
* Chronic use of benzodiazepines, tricyclic antidepressants
* Patients whose place of residence can not attend the sessions

Primary outcomes:
measure: Cognitive function
timeFrame: six months
Secondary outcomes:
measure: Cognitive function six months after completing intervention
timeFrame: one year
measure: Depressive symptoms
timeFrame: six months
Other outcomes:
measure: quality of life
timeFrame: six months
Locations:
city: Mexico City
country: Mexico
facility: National Institue of Medical Sciences and Nutrition Salvador Zubirán
Study officials:
affiliation: National Institute of Medical Sciences and Nutrition Salvador Zubirán
name: JOSÉ ALBERTO MD ÁVILA, Geriatrician
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05875623: Impact of Medications Review on Potentially Inappropriate Medications and Clinical Outcomes Among Hospitalized Older Adults
Official title: Impact of Medications Review on Potentially Inappropriate Medications and Clinical Outcomes Among Hospitalized Older Adults: A Randomized Controlled Trial (REVMED RCT) Protocol
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Deprescriptions
Aged
Inappropriate Prescribing
Potentially Inappropriate Medications
Polypharmacy
Lead sponsor: Monash University
Sponsor class: OTHER
Collaborators: name: Hospital Raja Permaisuri Bainun
First posted: 2023-05-25
Enrollment: 500
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this randomized controlled trial is to assess the effectiveness of a pharmacist-led medication review using the locally developed Malaysian Potentially Inappropriate Prescribing Screening tool in Older Adults (MALPIP), an explicit criteria in hospitalized older adults. The main questions it aims to answer are:

1. The effectiveness of the intervention in reducing the number of PIMs and chronic medications after discharge
2. The impact of the intervention on quality of life, falls events, emergency department visits, readmissions and survivals

Researchers will compare the control group to see if there is corresponding changes to the outcomes specified above.


Eligibility criteria: Inclusion Criteria:

* Patients aged 60 years and above
* Taking more than five regular drugs
* Having at least one chronic medical condition
* Ability to understand and speak Malay, English, or Mandarin language

Exclusion Criteria:

* Admitted for end-of-life care
* Diagnosed with terminal illness
* Diagnosed with active cancer
* Participated in another drug trial
* Refused or unable to give consent
* Visited the Emergency Department without admission to ward
* Readmitted and have been previously enrolled in the trial

Primary outcomes:
measure: Number of potentially inappropriate medications
timeFrame: Admission up to 18 months
measure: Number of chronic medications
timeFrame: Admission up to 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Subang Jaya
country: Malaysia
facility: Shaun Lee
state: Selangor
Study officials:
affiliation: Monash University Malaysia
name: Chee Tao Chang, Msc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06751823: Evaluation of Zinc in Patients With Type 2 Diabetes
Official title: "Serum Zinc Levels and Intake in Type 2 Diabetes: Impact on Pathogenesis and Glycemic Control"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Keywords: type 2 DM,
zinc
Lead sponsor: Heliopolis University
Sponsor class: OTHER
First posted: 2024-12-30
Enrollment: 195
Sex: ALL
Minimum age (years): 40
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: type 2 DM patients with no complication in comparison with health volunteers

Brief summary: investigation of the impact of zinc level on the development of DM and to elaborate on whether daily consumption of zinc affects the disease's evolution.

Detailed description: The relationship between the pathophysiology of diabetes mellitus and trace element dysregulation emphasizes how crucial it is to maintain appropriate micronutrient status in order to manage this chronic metabolic disease. One promising strategy for enhancing glycemic control and lowering the risk of diabetic complications may be to address these underlying dietary imbalances.

Accordingly, the aim is to investigate the impact of zinc level on the development of DM and to elaborate on whether daily consumption of zinc affects the disease's evolution.

Eligibility criteria: Inclusion Criteria:

* confirmed Type 2 DM with no known complication
* more than or equal 40 years old

Exclusion Criteria:

pregnancy and lactation type 1DM known DM complication other endocrinological disorders malignancy

Primary outcomes:
measure: zinc serum level in the participnats
timeFrame: "through study completion, an average of 1 year"
measure: Dietary micronutrient assessment using food questionnaire
timeFrame: "through study completion, an average of 1 year"
measure: Trace elements daily intake calculation
timeFrame: "through study completion, an average of 1 year"
measure: the dietary intake by kilogram (kg) of body weight (bw)
timeFrame: "through study completion, an average of 1 year"
Secondary outcomes:
measure: HbA1C mesurements
timeFrame: "through study completion, an average of 1 year"
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University Hospitsl
Study officials:
affiliation: Helioplis university
name: sara eladwy, lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06272123: Endotypic Stability in CRS
Official title: Comparison of Endotypic Stability in Various Populations With Chronic Sinusitis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Sinusitis
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2024-02-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Chronic sinusitis (with or without polyps) undergoing endoscopic sinus surgery.

Brief summary: A Case control study with 150 cases and 50 controls will be conducted. Immunologic (cytokines measurements in nasal secretions and sinonasal tissues), histopathologic (tissue eosinophilia) and clinical parameters (Lund-Mackay and Lund-Kennedy score, lung function tests), surveys (SNOT- 22, SF-36 quality of life survey) will be compared between different groups of patients


Eligibility criteria: Inclusion Criteria:

* Patients with Chronic sinusitis (with or without polyps)
* Undergoing endoscopic sinus surgery during the study period
* More than 18 years
* No chronic illness/ malignancy

Primary outcomes:
measure: Endotypic markers
timeFrame: 1 year
Secondary outcomes:
measure: SF-36
timeFrame: 1 year
measure: SNOT-22
timeFrame: 1 year
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University Department of Otolaryngology
state: Pennsylvania
Study officials:
References:
Clinical trial NCT06749223: AQT90 FLEX D-dimer Clinical Sensitivity and Specificity
Official title: AQT90 FLEX D-dimer Clinical Sensitivity and Specificity
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: VTE (Venous Thromboembolism)
Keywords: D-dimer
Lead sponsor: Radiometer Medical ApS
Sponsor class: INDUSTRY
First posted: 2024-12-27
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of adult patients presenting with signs and symptoms of VTE and getting clinical evaluation of the pretest probability of VTE scored as low or moderate corresponding to a Well's score between 0-2 for DVT and between 0-6 for PE.

Brief summary: The goal of this study is evaluate the clinical performance of the AQT90 FLEX D-dimer Test as an aid in the diagnosis of Venous Thromboembolism.

Detailed description: The objective is to evaluate the clinical performance of the AQT90 FLEX D-dimer Test as an aid in the diagnosis of VTE in patients presenting with low or moderate pretest probability (PTP), by determining the clinical sensitivity, specificity, negative predictive value (NPV), positive predictive value (PPV), positive likelihood ratio (LR+) and negative likelihood ratio (LR-) of the assay.

Eligibility criteria: Inclusion Criteria:

* Subject is 18 years of age and older
* Subject, who presents with signs and symptoms of VTE and had low or moderate pre-test probability of DVT or PE assessed by Well's score
* Subject must be able to understand information given, and be willing and able to voluntarily give their consent to participate in this study

Exclusion Criteria:

* Subject, who is pregnant
* Subject, who has received fibrinolytic therapy within the previous seven days
* Subject, who has received treatment with anticoagulants (unfractionated heparin, LMWH, VKA (vitamin K-antagonists), DOACs (direct oral anticoagulants) within the previous seven days
* Subject, who has had trauma or surgery within the previous four weeks
* Subject with malignancy
* Subject with disseminated intravascular coagulation (DIC)
* Subject, who has an invalid written informed consent or has withdrawn consent

Primary outcomes:
measure: Sensitivity and Specificity
timeFrame: From enrollment to blood sample collection; ~1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Viborg
country: Denmark
facility: Viborg Regional Hospital
Study officials:
References:
Clinical trial NCT02035423: Community Interventional Trial (CITFOMIST)
Official title: Community Interventional Trial (CITFOMIST) to Study the Efficacy and Compliance of Different Degrees of Vitamin D Fortified Milk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D Deficiency
Keywords: Vitamin D Deficiency
Compliance
Milk
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: UNICEF
First posted: 2014-01-14
Enrollment: 6000
Sex: ALL
Minimum age (years): 15
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The cluster randomized trial (CITFOMIST) was conducted on 15-19-year old guidance and high school students of both genders from different districts of Tehran, the Iranian capital, in winter 2011. The 36 schools enrolled in this study were randomly assigned to receive one of the three groups of milk -- whole milk, milk that contained 600 IU Vit D/1000cc, milk that contained 1000 IU Vit D /1000cc -- for a 30-day period. In order to study the effect of vitamin D-fortified milk on the circulating concentrations of 25(OH)D, a serum vitamin D levels were checked in a subgroup before and after the intervention.

Detailed description: The cluster randomized trial (CITFOMIST) was conducted on 15-19-year old guidance and high school students of both genders from different districts of Tehran, the Iranian capital, in winter 2011.

The 36 schools enrolled in this study were randomly assigned to receive one of the three groups of milk -- whole milk, milk that contained 600 international unit (IU) Vit D/1000cc (120IU), milk that contained 1000 IU Vit D /1000cc (200IU)-- for a 30-day period. In order to study the effect of vitamin D-fortified milk on the circulating concentrations of 25(OH)D, a serum vitamin D levels were checked in a subgroup before and after the intervention.

Eligibility criteria: Inclusion Criteria:

* 15-19-year old guidance and high school students of both genders from different districts of Tehran, the Iranian capital

Exclusion Criteria:

* Those taking vitamin D supplements
* Those with underlying disease affecting bone health
* Those taking medication affecting bone metabolism
* Those taking fortified products on a regular basis
* Those following special diets

Primary outcomes:
measure: Compliance with milk consumption
timeFrame: 1 month
Secondary outcomes:
measure: Serum 25(OH)D levels
timeFrame: 1 month
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: EMRI
Study officials:
affiliation: Endocrinology and Metabolism Research Institute
name: Patricia Khashayar
role: PRINCIPAL_INVESTIGATOR
affiliation: Endocrinology and Metabolism Research Institute
name: Abbasali Keshtkar
role: STUDY_DIRECTOR
affiliation: Endocrinology and Metabolism Research Institute
name: Bagher Larijani
role: STUDY_CHAIR
References:
Clinical trial NCT06547723: MBSR Program and Evaluating Its Effectiveness on Relieving Chronic Pain in the Elderly
Official title: Developing and Compiling a Mindfulness-Based Stress Reduction Program and Evaluating Its Effectiveness on Relieving Chronic Pain in the Elderly
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Chronic Pain
Keywords: Mindfulness-based stress reduction program
Chronic pain
Elderly
Physiotherapy
Lead sponsor: University of Tehran
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a feasibility study with a control group along with randomized double-blind parallel groups on 40 elderly patients with chronic pain.
Primary purpose: OTHER

Brief summary: It has been shown that MBSR could be effective in different types of chronic pain in geriatrics, but more evidence in the interdisciplinary context is needed.

This study is conducted to develop and compile a mindfulness-based stress reduction (MBSR) program within a context of physiotherapy rehabilitation to manage chronic pain in the elderly in an Iranian clinical setting.

The 8-session MBSR treatment protocol was translated, revised for the Iranian elderlies, and compiled as a one-on-one therapy using a unique protocol with 20-session physiotherapy. 40 volunteers aged 65 or more with musculoskeletal chronic pain will be selected and receive the program for 8 consecutive weeks with a 3-month follow-up. Treatment satisfaction levels, adherence to treatment sessions, and patient-reported clinical outcome measures were used at baseline, immediately post-intervention, and three months following the intervention, measuring pain, anxiety, fatigue, sleep disturbance, pain interference levels, and kinesiophobia.


Eligibility criteria: Inclusion Criteria:

* Aged 65 or more
* Have chronic pain
* Have ability of reading and writing in Persian
* Visiting the clinic in which the study was took place

Exclusion Criteria:

* Dose not have any diagnosed Cognitive Impairment
* Failure to approve the consent form

Primary outcomes:
measure: . The Patient Global Assessment of Treatment Satisfaction (PGATS)
timeFrame: At the baseline, immediately after last session, and 3-month follow-up.
measure: The Numerical Rating Scale-11 (NRS-11).
timeFrame: At the baseline, immediately after last session, and 3-month follow-up.
Secondary outcomes:
measure: The Patient Reported Outcomes Measurement Information System (PROMIS-29 v2.0).
timeFrame: At the baseline, immediately after last session, and 3-month follow-up.
measure: The Tampa Scale Kinesiophobia (TKS-11).
timeFrame: At the baseline, immediately after last session, and 3-month follow-up.
Other outcomes:
Locations:
city: Mashhad
country: Iran, Islamic Republic of
facility: Bahar physiotherapy clinic
state: Razavi-khorasan
Study officials:
affiliation: Faculty of Psychology and Education, the University of Tehran.
name: Reza poorhosein, PhD
role: STUDY_CHAIR
References: