louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03602911: A Comparison of NETSPOT Imaging Versus F-FDG-PET in Head and Neck Cancer Patients
Official title: A Comparison of NETSPOT Imaging Versus F-FDG-PET in Head and Neck Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck Squamous Cell Carcinoma
Lead sponsor: West Virginia University
Sponsor class: OTHER
First posted: 2018-07-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Proof of Concept
Primary purpose: DIAGNOSTIC

Brief summary: This is a proof-of-concept trial to compare 18F-FDG-PET/CT with NETSPOT (68Ga-DOTA-TATE), a commercially available radiotracer packet that utilizes 68Ga to image SSTR-specific tissue.

Detailed description: Patients meeting inclusion criteria will be consented at the time of scheduling. All patients will undergo 18F-FDG-PET/CT per established protocol. Following 18F-FDG-PET/CT, the patient will undergo NETSPOT imaging with the AAA-provided dose. These scans will be performed no less than 8 hours, no more than 7 days apart. For patients undergoing same-day imaging, NETSPOT imaging will be performed prior to 18F-FDG-PET/CT. Following imaging, both 18F-FDG-PET/CT and NETSPOT imaging will be compared by trained neuroradiologists for SUV values and concordance with known sites of disease. Biopsies will be performed as is standard to verify all sites of primary or metastatic disease. Patients with oropharyngeal tumors will have HPV testing performed via the standard of care surrogate marker p16. Patients with p16-positive tumors will be recorded and analyzed separately for the above measures. Patients will be followed for a total of 1 year after the study and outcomes of overall survival, disease-free survival, presence and site of recurrence and development of metastatic disease will be recorded. All gathered data will be compared between reported 18F-FDG-PET/CT and NETSPOT imaging for true positive, true negative, positive predictive value and negative predictive value of patient groups.

Eligibility criteria: Inclusion Criteria:

Patients with suspected or diagnosed HNSCC undergoing planned 18F FDG PET/CT at the time of primary diagnosis or after completion of treatment.

Exclusion Criteria:

Inability to undergo 18F-FDG-PET/CT imaging due to medical comorbidities

Primary outcomes:
measure: Detection and Staging of Head and Neck Squamous Cell Carcinoma Using Standard Uptake Value for NETSPOT Imaging
timeFrame: From Baseline up to day 7 post imaging
Secondary outcomes:
measure: Detection of Primary Site for Head and Neck Squamous Cell Carcinoma Using SUV Measurements With NETSPOT Imaging
timeFrame: From Baseline up to day 7 post imaging
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: West Virginia University Medicine
state: West Virginia
Study officials:
affiliation: West Virginia University
name: Rusha Patel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01888211: Effect of Omega 3 Fatty Acids on Vascular Function
Official title: Effect of Omega 3 Fatty Acid Supplementation on Endothelial Function, Endogenous Fibrinolysis and Platelet Activation in Patients With a Previous Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Previous Myocardial Infarction
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
First posted: 2013-06-27
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The mechanisms through which omega-3 fatty acids reduce adverse cardiac events remain uncertain. The aim of the study was to investigate the effect of omega-3 fatty acid supplementation on endothelial vasomotor function, endogenous fibrinolysis, and platelet and monocyte activation in patients with coronary heart disease.

Detailed description: Twenty patients with a previous myocardial infarction were recruited into a randomised, double-blind, placebo-controlled, crossover trial of omega-3 fatty acid supplementation (2g/day for 6-weeks). Peripheral blood was taken for analysis of platelet and monocyte activation, and forearm blood flow was assessed in a subset of 12 patients during intrabrachial infusions of acetylcholine, substance P and sodium nitroprusside. Stimulated plasma tissue plasminogen activator (t-PA) concentrations were measured during substance P infusion.

Eligibility criteria: Inclusion Criteria:

• Myocardial infarction at least 3 months previously.

Exclusion Criteria:

* Dietary fish allergy or intolerance
* Women of child bearing potential
* Malignant arrhythmias
* Renal or hepatic failure
* Severe or significant co-morbidity
* Previous history of blood dyscrasia
* Unable to tolerate the supine position
* Lack of informed consent
* Blood donation within last 3 months

Primary outcomes:
measure: Endogenous fibrinolysis (net release of plasma t-PA,IU mL-1)
timeFrame: Measured at 6 weeks after omega 3 fatty acids or placebo
Secondary outcomes:
measure: Endothelial vasomotor function (forearm blood flow, mL l00 mL-1 min-1)
timeFrame: Measured at 6 weeks after omega 3 fatty acids or placebo
measure: Circulating platelet-monocyte aggregates (%).
timeFrame: Measured at 6 weeks after omega 3 fatty acids or placebo
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Centre for Cardiovascular Sciences, University of Edinburgh
state: Scotland
Study officials:
affiliation: University of Edinburgh
name: David E Newby
role: STUDY_CHAIR
affiliation: University of Edinburgh
name: Jehangir N Din
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01737411: Surgical vs. Medical Treatment of Urge Urinary Incontinence in Women
Official title: Surgical vs. Medical Treatment of Urge Urinary Incontinence in Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Urge Urinary Incontinence
Keywords: surgery, solifenacin, urge urinary incontinence
Lead sponsor: Klinikum der Universität Köln
Sponsor class: OTHER
First posted: 2012-11-29
Enrollment: 120
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if pelvic surgery can improve urge urinary incontinence in women more than standard medical treatment.

Detailed description: Urge Urinary Incontinence affects 30% of postmenopausal women. The etiology is unknown therefore treatment is symptomatic. For that purpose the nerval stimulation of the bladder muscle is interfered by several drugs, e.g. solifenacin.

We observed that the surgical repair of critical pelvic structures, i.e. the uteri-sacral ligaments (USL) can restore continence in a considerable number of patients.

In this study the surgical treatment is compared with the solifenacin treatment. According to outcome after three months patients who are still incontinent are referred to the opposite treatment group.

Outcome will be differentiated in cure (primary aim) and improvement of symptoms (secondary aim).

Eligibility criteria: Inclusion Criteria:

* urge urinary incontinence

Exclusion Criteria:

* stress urinary incontinence
* cancer disease of the females genital tract
* pregnancy
* neurologic/psychological reasons for incontinence
* body weight \>100kg
* previous urogynecological surgery (TVT)
* syndrome of dry overactive bladder (\>20 micturitions within 24 hours)

Primary outcomes:
measure: cure from urge urinary symptoms
timeFrame: 12 months
Secondary outcomes:
measure: cure from urge urinary symptoms
timeFrame: 12 months
Other outcomes:
measure: stress incontinence
timeFrame: 12 months
Locations:
city: Köln
country: Germany
facility: Abt. Beckenbodenchirugie der Universitäts-Frauenklinik Köln
state: NRW
Study officials:
affiliation: Study Supervisor
name: Wolfram H Jager, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01507311: Effect of Liraglutide on Pulsatile Insulin Secretion in Subjects With Type 2 Diabetes
Official title: Effect of NNC90-1170 on Pulsatile Insulin Secretion in Type 2 Diabetic Patients. A Double-blind, Placebo-controlled, Randomised, Single-dose, Cross-over Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-01-10
Enrollment: 11
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to assess the effect of NNC 90-1170 (liraglutide) on pulsatile insulin secretion and insulin secretion after a standard meal in subjects with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with type 2 diabetes, either newly diagnosed with at least two months of diet treatment, or in current OHA (oral hypoglycaemic agent) treatment with stable dose for at least six months
* BMI (Body Mass Index) between 24 and 35 kg/m\^2 (both inclusive)
* Fasting plasma glucose between 6 and 15 mmol/l (both inclusive)
* Anti-GAD (glutamic acid decarboxylase) negative

Exclusion Criteria:

* Known or suspected allergy to trial product or related products
* Receipt of any investigational drug within three months prior to this trial
* Recurrent severe hypoglycaemia as judged by the investigator
* Cardiac disease or any clinically significant abnormal ECG (electrocardiogram)
* Use of any drug (except oral hypoglycaemic agents (OHAs)) which in the investigator's opinion could interfere
* with the blood glucose level (i.e., insulin, systemic corticosteroids, thiazides)
* Liver or renal disease

Primary outcomes:
measure: Insulin secretory burst mass
Secondary outcomes:
measure: Insulin secretory pulse mass, amplitude, frequency and regularity
measure: Insulin secretion
measure: Glucagon response
measure: Gastric emptying rate
measure: Adverse events
Other outcomes:
Locations:
city: Århus C
country: Denmark
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Juhl CB, Hollingdal M, Sturis J, Jakobsen G, Agerso H, Veldhuis J, Porksen N, Schmitz O. Bedtime administration of NN2211, a long-acting GLP-1 derivative, substantially reduces fasting and postprandial glycemia in type 2 diabetes. Diabetes. 2002 Feb;51(2):424-9. doi: 10.2337/diabetes.51.2.424.
Clinical trial NCT06336811: Virtual Reality Distraction During Phlebotomy in Children
Official title: The Effects of Virtual Reality on Procedure-Related Emotional Appearance, Pain, Fear, and Anxiety During Phlebotomy in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Acute
Child, Only
Anxiety and Fear
Keywords: phlebotomy
virtual reality
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2024-03-29
Enrollment: 150
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This randomized controlled study was conducted to evaluate the effect of distraction methods using virtual reality on the emotional appearance, pain, fear, and anxiety associated with the procedure during phlebotomy in children aged 6-12 in a private blood collection unit.

Detailed description: The data of the study was collected with Socio-demographic Data Collection Form, Emotional Appearance Scale for Children, Facial Expression Rating Scale, Child Anxiety Scale-State, and Child Fear Scale. Demographic data and mean scores obtained from the scales were compared between the virtual reality groups, and the control group.

Eligibility criteria: Inclusion Criteria:

* The child agrees to participate in the study voluntarily.
* The parent agrees to participate in the study voluntarily.
* Obtaining consent forms from the child and parent

Exclusion Criteria:

* The child has a physical and psychological deficit that will prevent him from wearing the glasses that will be placed on his head to watch virtual reality.
* Having fever (\>37.5C) and severe dehydration
* The patient did not take analgesics before the intervention

Primary outcomes:
measure: procedure related pain
timeFrame: 3 minutes after the phlebotomy
measure: anxiety
timeFrame: 3 minutes before and after the phlebotomy
measure: fear
timeFrame: 3 minutes before and after the phlebotomy
measure: emotional apperance
timeFrame: 3 minutes before and after the phlebotomy
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Gülçin Özalp Gerçeker
Study officials:
affiliation: Dokuz Eylul University
name: Gulcin Ozalp
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05931211: Motor Function and Activity of Daily Life in Spinal Muscular Atrophy
Official title: Translation of Motor Function to Daily Activity Performance in Individuals With SMA
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spinal Muscular Atrophy
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-07-05
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Spinal muscular atrophy (SMA) is an autosomal recessive neuromuscular disease that causes progressive muscle weakness and atrophy and eventually leads to loss of function.

Brief summary: This study will incorporate patients/ caregivers' perspectives to investigate the performance in daily activities of individuals with SMA and how it relates to their motor function abilities.

Detailed description: Spinal muscular atrophy (SMA) is an autosomal recessive neuromuscular disease that causes progressive muscle weakness and atrophy and eventually leads to loss of function. Despite recent advances in disease-modifying treatments, SMA can still significantly impact an individual's functioning in daily living and quality of life. This study will incorporate patients/ caregivers' perspectives to investigate the performance in daily activities of individuals with SMA and how it relates to their motor function abilities.

Eligibility criteria: Inclusion Criteria:

* Having a diagnosis of SMA with genetics confirmed as 5q SMA.
* Above 3 years of age (capable of performing motor assessments).

Exclusion Criteria:

* Having severe respiratory and other medical conditions precluding safe participation in standardized motor function tests.
* Having any orthopedic surgery during the past 6 months.
* Women who are pregnant.

Primary outcomes:
measure: Revised Upper Limb Module
timeFrame: 15-20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Hsi-Wen Huang, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05606211: Pain in Long COVID-19: the Role of Sleep
Official title: Pain in PASC - the Role of Sleep Disturbances
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Long COVID
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2022-11-04
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals who have been infected with the corona virus and developed or did not developed Long COVID.

Brief summary: Pain is among the most frequently reported symptoms in Long COVID, along with sleep disturbances, fatigue, and cognitive impairments. Sleep plays a critical role in maintaining a pain-free state. The goal of this study is to characterize the type and severity of pain in Long COVID, to characterize sleep and sleep disturbances in Long COVID, and to understand the role of sleep in the development and persistence of pain symptoms in Long COVID.


Eligibility criteria: Inclusion Criteria:

* Females and males \>18 years
* Confirmed history of SARS-CoV-2 infection

Exclusion Criteria

* History of chronic pain prior to SARS-CoV-2 infection
* Raynaud syndrome
* Pregnant/nursing

Primary outcomes:
measure: Pain reporting
timeFrame: 14 days
measure: Pain sensitivity
timeFrame: 1 day
measure: Central pain modulation
timeFrame: 1 day
measure: Wearable based sleep characteristics
timeFrame: 2 weeks
measure: PSG based sleep characteristics
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
References:
Clinical trial NCT05866211: Lung Function in Post-COVID-19 Nursing Home Residents
Official title: Associated Factors for Impaired Lung Function in Post-COVID Nursing Home Residents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-COVID-19 Syndrome
Lead sponsor: University of Vic - Central University of Catalonia
Sponsor class: OTHER
Collaborators: name: Catalan Board of Physiotherapists
First posted: 2023-05-19
Enrollment: 184
Sex: ALL
Minimum age (years): 65
Maximum age (years): 95
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population will be institutionalised older adults previously infected with SARS-CoV-2, either symptomatic or asymptomatic.

Brief summary: The coronavirus disease 2019 (COVID-19) took a toll in institutionalised older adults, who represent a vulnerable population in European countries.

The aim of this study is to identify the predictive factors that worsens lung function in post-COVID nursing home (NH) residents.

This is a multicenter case-control study in nursing homes of Osona (Catalonia), where individuals with worsened (cases) and normal (controls) lung function will be studied. The inclusion criteria are: female and male from 65 to 95 years old, preserved cognitive capacity and positive diagnosis of COVID-19 at least 3 months prior.

We will assess sociodemographic variables, lung function \[spirometry\], fatigue \[Chalder Fatigue Scale\], frailty \[Clinical Frailty Scale\], and activities of daily living (ADL) \[modified Barthel index\].


Eligibility criteria: Inclusion Criteria:

* male and female
* preserved cognitive function
* previous positive diagnosis of COVID-19 at a minimum of 3 months to the day of data collection
* individuals living permanently in a nursing home

Exclusion Criteria:

* individuals in coma or palliative care
* any contraindication to perform spirometry (severe hypertension, myocardial infarction in the past week, non compensated heart failure, etc).

Primary outcomes:
measure: Lung function
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Sociodemographic variables
timeFrame: Through study completion, an average of 1 year
measure: Anthropometric variables
timeFrame: Through study completion, an average of 1 year
measure: Health variables
timeFrame: Through study completion, an average of 1 year
measure: COVID-19 variables
timeFrame: Through study completion, an average of 1 year
measure: Fatigue
timeFrame: Through study completion, an average of 1 year
measure: Frailty
timeFrame: Through study completion, an average of 1 year
measure: Dependency levels
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Vic
country: Spain
facility: Faculty of Health Sciences and Welfare
state: Barcelona
Study officials:
References:
Clinical trial NCT06461611: Effect of Health Diary on Self-management in Adolescent Patients With Fixed Orthodontic Appliance
Official title: Effect of Health Diary on Self-management in Adolescent Patients With Orthodontic Fixed Appliance: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Oral Hygiene
Self-Management
Keywords: Malocclusion
Fixed Orthodontic Treatment
Adolescent
Self-Management
Self-Efficacy
Health Diary
Oral Health-Related Quality of Life
Oral Hygiene
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-06-17
Enrollment: 140
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study aims to use two-arm randomized clinical trials to evaluate the effectiveness of the health diary in helping adolescents wearing fixed orthodontic appliances improve their oral hygiene status, self-management skills, oral health-related quality of life, self-efficacy, intention，number of breakages, and on-time and return visit status.


Eligibility criteria: Inclusion Criteria:

* Patients with malocclusion eligible for fixed appliance orthodontic treatment;
* The age of patients ranged from 12 to 18 years;
* The patients received orthodontic treatment for the first time;
* The patient was alert and had no cognitive or psychiatric impairment;
* The patient was able to read and fill out the questionnaires, and had good listening, speaking and understanding skills in Chinese.

Exclusion Criteria:

* The patient's disease was diagnosed as jaw deformity associated with other diseases. Malocclusion secondary to trauma, tumor, cleft lip and palate;
* Patients treated with orthodontic-orthognathic surgery;
* The patient currently participating in other oral related intervention studies.

Primary outcomes:
measure: Plaque Index
timeFrame: Change from baseline plaque index at 24-weeks follow-up.
measure: Bleeding Index
timeFrame: Change from baseline plaque index at 24-weeks follow-up.
Secondary outcomes:
measure: Self-Management Ability
timeFrame: Change from baseline plaque index at 24-weeks follow-up.
measure: Self Efficacy
timeFrame: Change from baseline plaque index at 24-weeks follow-up.
measure: Oral Health Related Quality of Life
timeFrame: Change from baseline plaque index at 24-weeks follow-up.
measure: The number of appliance damage in each follow-up period
timeFrame: The number of appliance damage in each follow-up period change over 24 weeks during intervention from baseline.
measure: On-time follow-up visits
timeFrame: On-time follow-up visits change over 24 weeks during intervention from baseline.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Wei Xia, PhD
role: PRINCIPAL_INVESTIGATOR
References: