louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02547610: MR/PET in the Evaluation of Patients With Esophageal Cancer
Official title: MR/PET in the Evaluation of Patients With Esophageal Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Esophageal Cancer
Keywords: MR/PET in the evaluation
patients
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2015-09-11
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In this prospective study, we will recruit newly diagnosed esophageal cancer patients and perform MR/PET before and after chemoradiation therapy.Total 80 patients will be recruited and followed after treatment complete for at least two years.

Brief summary: In this prospective study, we will recruit newly diagnosed esophageal cancer patients and perform MR/PET before and after chemoradiation therapy. In MR, new image sequences will be added to the conventional sequences, such as high resolution image, DWI, DCE, cine imaging.

Detailed description: Total 80 patients will be recruited and followed after treatment complete for at least two years. We will compare the staging accuracy of MR/PET and PET/CT, and also analyze parameters that are predictive of disease recurrence and patient survival.

Eligibility criteria: Inclusion Criteria:

1. newly diagnosed esophageal cancer patient
2. age older than 20 years

Exclusion Criteria:

1. For the safety reason, patients with the following conditions are contraindicated to enter magnetic resonance imaging (MRI) machine due to the high magnetic field, including: cardiac pacemaker, metallic artificial valve, intracranial and mediastinal vascular clips, cardiac defibrillator, nerve stimulator, implanted drug deliver system, metallic foreign body in the eye globe, cochlear implant, metallic fragments in the dangerous body part, Swan-Ganz catheter, and other metallic implants within 8 weeks: such as cardiac valve, stent, coil, filter, and clips.
2. patient who will receive endoscopic local therapy alone
3. unable to finish the standard surgical or radiation treatment
4. history of surgery or radiotherapy to the mediastinum
5. renal insufficiency, contraindication to MR imaging and contrast injection patient who have the severe allergic reaction the Gadollium contrast agent
6. patient who have the claustrophobic symptoms are also not suitable for this MR examination
7. pregnancy or lactating women

Primary outcomes:
measure: The imaging biomarkers determined by MR-PET
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Department of Medical Imaging, National Taiwan University Hospital.
name: Tiffany Ting-Fang Shih, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05805410: Neuromuscular Mechanisms of Specific Trunk Interventions in Children With CP
Official title: Neuromuscular Mechanisms of Specific Trunk Interventions in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Child Behavior
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
First posted: 2023-04-10
Enrollment: 44
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to two groups
Primary purpose: TREATMENT

Brief summary: Determine the effect of repeated pelvis perturbation training on trunk posture and locomotor function in children with CP.

Detailed description: We will determine whether repeat exposure to pelvis perturbation during sitting astride will induce functional improvements in trunk postural control and locomotion in children with CP.

Eligibility criteria: Inclusion Criteria:

* Children with a diagnosis of bilateral spastic CP attributed to complications of prematurity, intracranial hemorrhage and periventricular leukmalacia according to the definition of Bax.
* Children aged 4 to 12 years old without Botulinum toxin treatment within 6 months, and without surgeries (such as selective dorsal rhizotomy) within 12 months before the onset of the training.
* Subjects will be able to remain seated without help for ≥10s.
* GMFCS levels will be I to IV.
* Children must be able to signal pain, fear or discomfort reliably.
* Children with mild scoliosis (Cobb angle \< 20 °).
* Children with CP who have no prior hippotherapy experiences within 6 months.

Exclusion Criteria:

* severe lower extremity contractures, fractures, osseous instabilities, osteoporosis.
* severe disproportional bone growth.
* unhealed skin lesions in the lower extremities.
* thromboembolic diseases, cardiovascular instability.
* aggressive or self-harming behaviors.

Primary outcomes:
measure: Change in Trunk Control Measurement Scale (TCMS) score from baseline.
timeFrame: baseline, post 6 weeks of training and 8 weeks after the end of training.
Secondary outcomes:
measure: Change in Walking speed from baseline
timeFrame: baseline, post 6 weeks of training and 8 weeks after the end of training.
measure: Chang in 6-minute walking distance from baseline
timeFrame: baseline, post 6 weeks of training and 8 weeks after the end of training.
measure: Change in GMFM-66
timeFrame: baseline, post 6 weeks of training and 8 weeks after the end of training.
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Shirley Ryan AbilityLab
state: Illinois
Study officials:
affiliation: Shirley Ryan AbilityLab
name: Ming Wu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00290212: Natto Supplementation to Prevent Loss of Bone Mass in Women Immediately After Menopause
Official title: Phase II Study of Natto Supplementation to Prevent Loss of Bone Mass in Women Immediately After Menopause: a Randomised Double Blind Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Perimenopausal Bone Loss
Keywords: Women
Bone density
Menopause
Dietary Supplements
Vitamin K2
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
Collaborators: name: University of Tromso
name: The International Osteoporosis Foundation
name: Haukeland University Hospital
First posted: 2006-02-10
Enrollment: 304
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Study Objective: To determine whether Natto supplementation in women immediately after menopause might prevent severe bone loss

Study population: Women 50 - 60 years, 1-5 years after menopause

Study Design: Double-blind, placebo-controlled, randomized controlled trial. A "phase II" clinical trial.

Instruments Used to Measure Therapeutic Response: Lunar Prodigy DEXA bone densitometer

Study Treatment Group: Daily supplementation with Vitamin K2, "NATTO"

Study Control Group: Identically-looking placebo medication

Duration of treatment: 12 months

Duration of Subject Participation in Study: 12 months Assessment of Therapeutic response: Given an expected reduction of bone mass density of - 1.1% annually in the placebo group, the minimum clinically significant difference between the groups is 0.3 percentage points. The trial is therefore powered to detect a reduction in annual bone mass loss of 0.3 percentage points in the treatment group.

Numbers of Evaluable Subjects Required: 304 Maximum # Subjects 334


Eligibility criteria: Inclusion Criteria:

* Women living in the city of Tromsø, not using hormone replacement therapy, 1-5 years after menopause.

Exclusion Criteria:

* History of hip fracture
* Bone disease affecting bone mineral density
* Use of vitamin K antagonists
* Significant co-morbidity that makes it difficult to obtain BMD measurements
* Use of hormone replacement therapy or other therapy that influence bone remodeling

Primary outcomes:
measure: Bone mass density
Secondary outcomes:
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Tromsø
country: Norway
facility: Clinical Research Center, University Hospital of North Norway
Study officials:
affiliation: NAFKAM, Fac.of Medicine, Univ. of Tromsø, Norway
name: Nina Emaus, MSc PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of North Norway
name: Sameline Grimsgaard, MD, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: NAFKAM, University of Tromsø, Norway
name: Vinjar Fønnebø, MD, MSc, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06307912: Physiotherapists' Placebo or Nocebo Communication Regarding VR
Official title: The Effect of Physiotherapists' Placebo or Nocebo Communication About Virtual Reality on Treatment Beliefs in Healthy People
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Communication
Lead sponsor: HAN University of Applied Sciences
Sponsor class: OTHER
First posted: 2024-03-13
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Rationale: Chronic musculoskeletal pain (CMP) is a common and disabling condition. Physiotherapy is the most frequently administered nonpharmacological treatment option for patients with CMP and recently virtual reality (VR) was introduced in physiotherapy care as a novel treatment modality. Proper communication about physiotherapy treatment (modalities) is important to improve treatment outcomes, by applying placebo effects enhancing communication and avoiding nocebo effects enhancing communication. However, yet is still unknown to what extent this applies to communication of physiotherapists about VR in healthy participants.

Objective: To determine the effect of physiotherapists' placebo or nocebo therapeutic communication about VR, on treatment credibility and expectation in healthy participants.

Study design: Web-based randomized controlled trial.

Study population: 126 participants

Intervention: The placebo intervention group will be shown an educational video about VR, containing placebo effects enhancing verbal language. The nocebo intervention group will be shown an educational video about VR, containing nocebo effects enhancing verbal language.

Primary study parameters: The primary study parameters are treatment credibility and treatment expectation. Treatment credibility and treatment expectations will be measured using the Dutch credibility and expectancy questionnaire (CEQ).


Eligibility criteria: Inclusion Criteria:

* aged ≥ 18
* access to the internet
* provide informed consent

Exclusion Criteria:

* lacked comprehension of the Dutch language
* had experience with therapeutic VR
* suffers from CMP

Primary outcomes:
measure: Change in treatment expectancy measured using the Credibility and Expectancy Questionnaire (CEQ)
timeFrame: Baseline and immediately after the intervention
measure: Change in treatment credibility measured using the Credibility and Expectancy Questionnaire (CEQ)
timeFrame: Baseline and immediately after the intervention
Secondary outcomes:
measure: Change in openness to VR measured using a single question
timeFrame: Baseline and immediately after the intervention
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: HAN University of Applied Sciences
state: Overijssel
Study officials:
affiliation: HAN University of Applied Sciences
name: Bart Staal, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05635812: Brain and Eye Markers of Facial Expression Recognition and Disorders Associated with Autistic Symptoms
Official title: Brain and Eye Markers of Facial Expression Recognition and Disorders Associated with Autistic Symptoms
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Brain Markers
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2022-12-02
Enrollment: 120
Sex: ALL
Minimum age (years): 7
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ASD, 22q11.2 and neurotypical participants

Brief summary: In everyday life, it is necessary to adjust one's behavior and reactions in order to interact and communicate with others in an appropriate manner. This adaptation is done by taking into account the emotions of the people with whom we interact. This reading of emotions is done by using visible clues on the face, in particular by observing the eye area of the interlocutor.

The aim of the study is to investigate how processes such as attention or memory influence emotion recognition, as well as (i) their alteration in the disease, and (ii) their link with the emergence of autistic and/or psychotic symptoms. We also want to study the implementation of compensatory strategies (used to compensate for difficulties in recognizing or perceiving emotions) and the link between the correct use of these strategies and the emergence of autistic and/or psychotic symptoms.

The present project plans to include a total of 120 participants: 30 participants with ASD, 30 patients with a particular genetic deletion 22q11.2 and 60 control participants.

After the inclusion visit, participation in the study will be divided into two half-days in order to perform a neuropsychological assessment, an EEG study and an oculometry study.


Eligibility criteria: Inclusion Criteria:

* Person, and if necessary his or her legal representative, who has given his or her non-objection
* Person whose mother tongue is French.
* Person aged between 7 and 50 years old.
* Person diagnosed with ASD according to DSM-5 criteria, person with a genetic syndrome diagnosed by FISH or CGH array (22q11 deletion), person with typical development matched in age and gender.
* Psychotropic treatment unchanged for one month and stable symptomatology.

Exclusion Criteria:

* Recent addiction according to DSM-5 criteria, excluding tobacco.
* Pregnant women.
* Uncorrected visual acuity disorder.
* Use of somatic or psychic medication that may alter brain/psychic functioning (e.g. corticosteroids).
* Neurological disorder of vascular/infectious or neurodegenerative origin.

Primary outcomes:
measure: Electrical brain activity in response to visual stimulation measured by electroencephalography
timeFrame: at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourogne
Study officials:
References:
Clinical trial NCT03241212: Adolescent Self-Care and Knowledge Education in Diabetes--Improved by Texting
Official title: Adolescent Self-Care and Knowledge Education in Diabetes--Improved by Texting (ASKED-IT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Keywords: adolescent
young adult
knowledge
self-care
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2017-08-07
Enrollment: 148
Sex: ALL
Minimum age (years): 15
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is a randomized controlled trial assessing diabetes knowledge (using a Mercy-What I Know About Diabetes Test (MWIKAD) validated survey) and self-care practices (using a validated Self-management of Type 1 Diabetes-Adolescence (SMOD-A) survey) at baseline, 3 months and 6 months. The intervention group will receive a minimum of 78 text messages related to diabetes over the course of 26 weeks from study enrollment. Subjects are invited to respond to some text messages which will be in the form of a multiple-choice question and if they do, they will receive an additional text message in response to their answer.


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of type 1 diabetes mellitus
2. Receiving care in the pediatric clinic at the Barbara Davis Center (BDC)
3. Age 15-20 at study enrollment
4. English literate and English speaking
5. Ability to complete the required surveys
6. Have a personal cell phone with service compatible with EZTexting Platform
7. Able to provide informed assent or consent (if 18 years of age or older) and parental informed consent (if needed).

Exclusion Criteria:

1. Not planning to continue care in the pediatric clinic at BDC for at least the next 6 months.
2. Diabetes Diagnosis other than Type 1 Diabetes
3. Inability for the adolescent to respond to text messages (e.g. due to developmental delay)

Primary outcomes:
measure: Change in knowledge about type 1 diabetes
timeFrame: 6 months from intervention
Secondary outcomes:
measure: Change in diabetes self-care practices
timeFrame: at 3 months and 6 months
measure: Change in Hemoglobin A1c
timeFrame: at 3 months and 6 months
measure: Change in blood glucose testing frequency
timeFrame: at 3 months and 6 months
measure: Change in percent of blood glucoses high, in range and low
timeFrame: at 3 months and 6 months
measure: Percent of text messages responded to in the study.
timeFrame: After 6 months of texting intervention
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Barbara Davis Center
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Sonalee Ravi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00329212: The Pharmacokinetics Study of Concentrated Herbal Formula and Traditional Herbal Decoctions in Humans
Official title: Bioequivalence of Bioactive Markers Between Concentrated Herbal Formula and Traditional Herbal Decoctions in Humans
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Pharmacokinetics
Bioavailability
Therapeutic Equivalency
Lead sponsor: Committee on Chinese Medicine and Pharmacy
Sponsor class: OTHER_GOV
First posted: 2006-05-24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: The purpose of this study is to investigate the pharmacokinetics in humans of San Huang Xie Jin Tang (SHXJT) and evaluate the bioequivalence between herbal concentrate and traditional decoction.


Eligibility criteria: Inclusion Criteria:

* The volunteers about 6\~8 persons should be aged from 20 to 35 years old with a body weight between 50\~80 kg, no marriage and have a healthy body condition.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: China
facility: Committee on Chinese Medicine and Pharmacy, Department of Health
state: Taiwan
Study officials:
affiliation: School of Chinese Medicine, China Medical University
name: Y C Hou, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00461812: A Comparison of Mometasone to Advair in Patients With Milder Persistent Asthma
Official title: A Single-Blind, Randomized, Positive-controlled Study to Compare Monotherapy With an Inhaled Corticosteroid (Mometasone) to Combination Therapy With an Inhaled Corticosteroid + a Long-Acting Bronchodilator (Advair) in Patients With Milder Persistent Asthma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Asthma
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Schering-Plough
First posted: 2007-04-18
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The research hypothesis for the proposed study asks the question, can Asmanex® demonstrate comparable anti-inflammatory therapeutic efficacy to the combination product, Advair® in control of mild persistent asthma?

The purpose is to demonstrate that the anti-inflammatory protection afforded by monotherapy with an inhaled steroid (Asmanex®) is comparable to combination therapy with Advair® 100/50, when measured by this standard methodology (methacholine bronchoprovocation) in subjects with mild persistent asthma.


Eligibility criteria: Inclusion Criteria:

* subjects 18 to 65 years of age
* a \>2 year history of asthma
* FEV1 \> 80% for subjects currently using Advair®.

Exclusion Criteria:

* severe asthma
* current smokers
* pregnant or breast-feeding women
* other chronic significant illnesses

Primary outcomes:
measure: Efficacy as Assessed my Pulmonary Function Tests
timeFrame: change from baseline to study completion
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Asthma and Allergy Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Peter S Creticos, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02294812: Effects of Cognitive Training on Speech Perception
Official title: Effects of Cognitive Training on Age-Related Hearing Loss and Speech Perception
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hearing Loss
Deafness and Auditory Perception
Keywords: Hearing Loss
Speech Perception
Cognitive Training
Cognitive Fitness
Memory, Short-Term
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2014-11-19
Enrollment: 42
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, the investigators are testing whether cognitive training can lead to improvements in speech perception for individuals with hearing loss. Individuals will complete 20 hours of cognitive training that is designed to improve cognitive abilities such as short term memory and attention. The investigators predict that cognitive training that improves the cognitive abilities affected by hearing loss will improve speech perception.


Eligibility criteria: Inclusion Criteria:

* Able to come to Dalhousie University, Halifax, Nova Scotia, Canada for study visits
* Adults (50 years or older) with mild to moderate hearing loss
* Access to an internet-connected device that is able to use Flash media, basic computer skills
* Medically stable participants
* Not currently taking medication that may affect brain function (e.g., anti-anxiety medication)
* Normal or corrected-to-normal vision

Exclusion Criteria:

* Participants with neurological conditions such as epilepsy or concussions will be excluded for safety reasons
* Participants who are not native English speakers (materials used in the study are only in English)
* Participants who are unable to provide consent
* Participants with impaired cognition (assessed with the Montreal Cognitive Assessment)
* Participants with high accuracy on the Speech Perception in Noise task at the second study visit (to eliminate participants who may be performing at ceiling level)

Primary outcomes:
measure: Speech Perception in Noise Test - Improvement in speech perception accuracy from baseline to post-training for high and low predictability sentences
timeFrame: Baseline, Weeks 2, 10, and 18
Secondary outcomes:
measure: Working Memory Cognitive Training - Improvements in working memory abilities from baseline
timeFrame: Weeks 2, 10, and 18
measure: Brain Performance Test
timeFrame: Weeks 2 and 10
measure: Attention Cognitive Training - Improvements in attention abilities from baseline
timeFrame: Weeks 2, 10, and 18
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: NeuroCognitive Imaging Lab, Dalhousie University
state: Nova Scotia
Study officials:
affiliation: Dalhousie University, Canada
name: Aaron J Newman, PhD
role: PRINCIPAL_INVESTIGATOR
References: