louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02580396: Evaluation Of CanADVICE+®M-Health System To Support Breast Cancer Patients Receiving Capecitabine
Official title: Evaluation Of CanADVICE+®M-Health System To Support Breast Cancer Patients Receiving Capecitabine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metastatic Breast Cancer
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
First posted: 2015-10-20
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This feasibility study will be conducted in order to provide proof of concept for the CanADVICE+® system comprising a smart phone app and a healthcare organization server side application based on Web 2 technologies. The main objective of this project is to optimise pharmaceutical counselling services by providing drug related information, in a digital format, to patients with metastatic breast cancer receiving Capecitabine.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with metastatic breast cancer
* Commencing first cycle of Capecitabine
* Familiar with and own an android smartphone
* Willing to participate

Exclusion Criteria:

* Patients \<18 years
* Patients taking part in any other trial containing Capecitabine
* Chemotherapy-naïve patients

Primary outcomes:
measure: Patient acceptability of the app using questionnaire provided when patients attend for their 3rd cycle and quantified using a 5-point Likert scale
timeFrame: 42 days
Secondary outcomes:
measure: Health care provider's acceptability of the app using questionnaires
timeFrame: 48 months
measure: Patients' interactivity with the app will be measured using mobile app and web server functions
timeFrame: 42 days
Other outcomes:
Locations:
city: Sutton
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
state: Surrey
Study officials:
affiliation: Royal Marsden NHS Foundation Trust
name: Jillian Noble
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00700596: Effects of Salvinorin A in Healthy Controls
Official title: Psychotomimetic Effects of Kappa Opioid Receptor Agonist Salvinorin A in Healthy Controls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy
Keywords: Salvia
SA
Salvinorin
Psychotomimetic Effects
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Alliance for Research on Schizophrenia and Depression
First posted: 2008-06-18
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study evaluates the effects of Salvinorin A (SA). SA is the active ingredient of the plant Salvia divinorum that is known to have been used by Mexican Indians as part of religious rituals. The purpose of this project is to understand what people experience when they consume Salvinorin A.


Eligibility criteria: Inclusion Criteria:

-Previous exposure to inhaled Salvinorin A (SA).

Primary outcomes:
measure: Positive and Negative Syndrome Scale, Clinician Administered Dissociative Symptoms Scale, Visual Analog Scale, Assessment of Opioid Effects, Cognitive Testing
timeFrame: Time Frame: -30, +10, +30, +90, +120. +200
Secondary outcomes:
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healthcare System
state: Connecticut
Study officials:
affiliation: Yale University School of Medicine, Dept of Psychiatry
name: Mohini Ranganathan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04737096: DAOIB Combined With tDCS for Early-phase Dementia
Official title: DAOIB Combined With tDCS for Early-phase Dementia - a Randomized, Double-blinded and Placebo Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Transcranial Direct Current Stimulation
Dementia
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2021-02-03
Enrollment: 97
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a 24-week randomized, double-blind, placebo-controlled trial. We will enroll patients with aMCI or mild AD. All patients will receive 2 weeks of tDCS (5 sessions per week, 10 sessions in total) during the first 2 weeks of the study, and will also be allocated randomly to either of 2 treatment groups for 24 weeks: (1) DAOIB group; (2) placebo group. We will assess the patients every 8 weeks during the treatment period (weeks 0, 8, 16, and 24). We hypothesize that augmentation with DAOIB will yield better effect than tDCS alone in improving the cognitive function, global functioning and quality of life in patients with aMCI or mild AD.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Alzheimer's disease or mild cognitive impairment
* MMSE between 10-26
* CDR 1 or 0.5

Exclusion Criteria:

* Hachinski Ischemic Score \> 4
* Substance abuse/dependence
* Parkinson disease, epilepsy, dementia with psychotic features
* Major depressive disorder
* Major physical illnesses
* Severe visual or hearing impairment

Primary outcomes:
measure: Change from baseline in the Alzheimer's disease assessment scale - cognitive subscale at week 8, 16 and 24
timeFrame: week 0, 8, 16, 24
Secondary outcomes:
measure: Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input score at week 8, 16 and 24
timeFrame: week 8, 16, 24
measure: Change from baseline in Mini-Mental Status examination score at week 8, 16 and 24
timeFrame: week 0, 8, 16, 24
measure: Change from baseline in Alzheimer's disease Cooperative Study scale for ADL in MCI (ADCS-MCI-ADL) score at week 8, 16 and 24
timeFrame: week 0, 8, 16, 24
measure: Change from baseline in Quality of life score at week 8, 16 and 24
timeFrame: week 0, 8, 16, 24
measure: Change from baseline in the composite score of a battery of additional cognitive tests at week 24
timeFrame: week 0, 24
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
Study officials:
References:
Clinical trial NCT02768896: Monitoring Brain Waves in Response to Visual and/or Auditory Stimulation in Parkinson's Disease Patients
Official title: Monitoring Brain Waves in Response to Visual and/or Auditory Stimulation in Parkinson's Disease Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson's Disease
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
Collaborators: name: Technion, Israel Institute of Technology
First posted: 2016-05-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Voltage fluctuation as a result of brain activity will be recorded into the computer using an EEG device.

Detailed description: Patients with Parkinson's disease may have gait disturbances including freezing of gait. Visual and auditory stimuli may improve gait. Investigators will analyze brain wave during walking while giving the subject different stimuli.

The voltage fluctuation (in hundreds of microvolts) will be recorded using the EEG cap and amplifier into a computer.

Eligibility criteria: Inclusion Criteria:

• Patients with Parkinson's disease that are ambulatory and can sign a written informed consent

Exclusion Criteria:

* Patients with Parkinson's disease who are not ambulatory
* Patients with dementia
* Patients that are blind
* Patients that have severe hearing impairment

Primary outcomes:
measure: Voltage fluctuation resulting from brain activity after visual stimuli
timeFrame: One hour
measure: Voltage fluctuation resulting from brain activity after auditory stimuli
timeFrame: One hour
measure: Voltage fluctuation resulting from brain activity after visual and auditory stimuli
timeFrame: One hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Rambam Health Care Campus
name: Ilana Schlesinger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03361696: Development, Optimization, Efficiency of the Interface System of Communication and Control of the Environment
Official title: Development, Optimization, Efficiency of the Interface System of Communication and Control of the Environment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Handicaps Physical
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2017-12-05
Enrollment: 40
Sex: ALL
Minimum age (years): 2
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with severe disabilities either of traumatic origin or of neurological origin or Patients over 55 with loss of autonomy.

Brief summary: The objective of this project is the realization of tests at home and in Hospitals or Functional Rehabilitation for the improvement of the communication with the family and medical entourage, the facility of the emotional expression, the evaluation of the pain, the control of home automation to increase their autonomy, facilitated their reintegration at home. The work is the last step of the research program started in 2009, with the optimization of the installation of the system, the improvement of physical and computer ergonomic aspects and the development of dedicated interfaces according to the type of disability and needs. of each one.

A work upstream of the definition of specifications taking into account the medical constraints was realized and the actions of improvement of the models, the algorithms, the robustness and the effectiveness of the treatment are in progress . The specific adaptation to concrete cases should lead to a system that allows 90% of the population of people with disabilities to exploit the system and significantly improve their level of communication, autonomy and in fact their daily lives.


Eligibility criteria: Inclusion Criteria:

* Patients (2-80 years old) with complete or near complete motor disability of both upper limbs or four limbs: Sequelae of trauma or advanced rheumatologic disease (spinal cord injury, upper limb amputation, head trauma, chronic polyarthritis), Diseases Congenital (myopathies, agenesis upper limbs), sequelae of vascular accident (medullary infarction, syringomyelia), neurodegenerative diseases (amyotrophic lateral sclerosis, multiple sclerosis, conduction block neuropathy, etc ..).
* Patients older than 55 years without disability but with a loss of dependence.
* Troubles of the communication and loss of autonomy.

Exclusion Criteria:

* Patient with severe visual contraindications (decreased visual acuity with correction of ± 6/7 dioptres, major oculomotor abnormalities).
* Patients with significant cognitive impairment to understand simple instructions related to the use of the system

Primary outcomes:
measure: Quality of life questionnaire SF36
timeFrame: change over baseline and end of follow-up at 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital
Study officials:
References:
Clinical trial NCT03889496: Quantitative GLP-1 Receptor Imaging Correlated to ex Vivo Distribution of In-111-exendin
Official title: Quantitative GLP-1 Receptor Imaging Correlated to ex Vivo Distribution of In-111-exendin
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: exendin-4
GLP-1 receptor imaging
SPECT
pancreas
surgery
quantification
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2019-03-26
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The main goal is to study the correlation of pancreatic uptake of In-111-DTPA-exendin-4 (measured by ex vivo counting) with the beta cell mass determined in the pancreatic specimens obtained after surgery.

Detailed description: In order to fully characterize the highly promising tracer In-111-DTPA-exendin-4 in humans, quantitative SPECT imaging will be correlated to the ex vivo tracer distribution in patients undergoing pancreatectomy or a Whipple procedure. In vivo imaging will be combined with post-pancreatectomy (micro)autoradiography, measurement of In-111-DTPA-exendin-4 concentrations in the pancreas using a gamma counter and morphometric determination of the actual beta cell mass. By this means, the relation between tracer uptake and beta cell mass in non-diabetic patients and T2D patients will be established. These highly relevant data will allow the improvement of the interpretation of clinical quantitative SPECT data in subsequent studies in patients with T1D and T2D. In addition, high uptake has been observed in the duodenum/pyloric area in patients in an ongoing study. At this point in time, it remains unclear which cells are responsible for this uptake. It would be of great interest to identify the GLP-1R positive cells in order to better understand the physiological actions of GLP-1 agonists.

Eligibility criteria: Inclusion Criteria:

* Scheduled for partial or complete pancreatectomy or Whipple procedure at Radboudumc

Exclusion Criteria:

* Resection that provides insufficient amount of tissue
* Previous treatment with synthetic Exendin (Exenatide, Byetta®) or Dipeptidyl- Peptidase IV inhibitors
* Breast feeding
* Pregnancy or the wish to become pregnant within 6 months
* Renal disease
* Liver disease
* Age \< 18 years

Primary outcomes:
measure: Correlation between the tracer uptake (counts) and beta cell mass (mg)
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud university medical center
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: Martin Gotthardt, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01342796: Humoral and Cell Mediated Immunity and Safety of MF59C.1-adjuvanted Subunit Influenza Vaccine or a Conventional Subunit Influenza Vaccine in Previously Unvaccinated Healthy Subjects
Official title: A Phase II, Randomized, Controlled, Observer-Blind, Clinical Study to Evaluate the Humoral and Cell Mediated Immunity and Safety of Two Intramuscular Doses of MF59C.1-adjuvanted Subunit Influenza Vaccine or Conventional Subunit Influenza Vaccine in Previously Unvaccinated Healthy Subjects Aged 6 to <36 Months
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Seasonal Influenza
Influenza
Influenza Due to Unspecified Influenza Virus
Human Influenza
Keywords: Cell mediated immunity
cell mediated immune response
Children
adjuvanted
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-04-27
Enrollment: 84
Sex: ALL
Minimum age (years): 6
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to evaluate the immunogenicity, by means of cell mediated immunity (CMI) and hemagglutination inhibition (HI) assay, and also the safety of a MF59C.1-adjuvanted subunit influenza vaccine compared with a conventional subunit vaccine in previously unvaccinated children aged 6 to \<36 months.


Eligibility criteria: Inclusion Criteria:

* Male and female previously unvaccinated healthy children aged 6 to \<36 months.

Exclusion Criteria:

* Any known or suspected impairment of the immune system, any serious disease.
* Any subjects receiving licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study.
* Individuals who have had influenza vaccine or documented suspected influenza disease prior to day 1.

Primary outcomes:
measure: Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination.
timeFrame: Day 1, Day 50
measure: Number of Subjects Reporting Unsolicited Adverse Events After Receiving Two Doses of aTIV and TIV
timeFrame: Day 1 to Day 50 post vaccination
Secondary outcomes:
measure: Percentage of Subjects Achieving Seroconversion or Significant Increase in HI Titer
timeFrame: Day 50
measure: Geometric Mean Ratios (GMR)
timeFrame: Day 50/Day 1
measure: Percentage of Subjects With HI Titers >1:40
timeFrame: Day 50
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: Site 21: GZA campus Sint Vincentius
city: Hasselt
country: Belgium
facility: Site 22: Kinderartsenpraktijk
Study officials:
References:
citation: Zedda L, Forleo-Neto E, Vertruyen A, Raes M, Marchant A, Jansen W, Clouting H, Arora A, Beatty ME, Galli G, Del Giudice G, Castellino F. Dissecting the immune response to MF59-adjuvanted and nonadjuvanted seasonal influenza vaccines in children less than three years of age. Pediatr Infect Dis J. 2015 Jan;34(1):73-8. doi: 10.1097/INF.0000000000000465.
Clinical trial NCT03707496: A Registry of De Winter Symdrome of Single Center
Official title: A Registry of De Winter Symdrome of Hainan General Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ACS - Acute Coronary Syndrome
Keywords: De Winter Syndrome
Lead sponsor: Hainan People's Hospital
Sponsor class: OTHER
First posted: 2018-10-16
Enrollment: 30
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: All acute coronary syndrome patients with a de Winter syndrome ECG pattern

Brief summary: This registry started January 1,2018 to collect patients who diagnosed as De Winter Symdrome for the first time in Hainan General Hospital.All enrolled patients will receive 30 days followed-up.


Eligibility criteria: Inclusion Criteria:

* Index ECG ST segment showed a 1- to 3-mm upsloping ST-segment depression at the J point in leads V1 to V6 that continued into tall, positive symmetrical T waves
* Received coronary angiography during hospitalization

Exclusion Criteria:

-No coronary angiography results was available during hospitalization

Primary outcomes:
measure: Number of Participants with MACEs within 30 days
timeFrame: 30 days
Secondary outcomes:
measure: Number of participants with MACEs In-hospital
timeFrame: throughout current hospitalization
measure: Number of Participants with MACEs within 7 days after admitted
timeFrame: 7 days after admitted
Other outcomes:
Locations:
city: Haikou
country: China
facility: Hainan General Hospital
state: Hainan
Study officials:
References:
Clinical trial NCT05900596: Fetal Scalp pH During Labour: is it Worth Repeating
Official title: Fetal Scalp pH During Labour: is it Worth Repeating
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abnormal Fetal Heart Rate
Keywords: fetal scalp blood sampling
fetal blood sampling
cesarean section
non-reassuring fetal heart rate
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2023-06-12
Enrollment: 130
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Regional University Maternity of Nancy

Brief summary: In order to reduce the cesarean sections rate, an adjunctive test is recommended in case of non-reassuring fetal heart rate tracing. In France, the reference adjunctive test is fetal scalp blood sampling. However, there is no study about the repetition of fetal blood sampling. Our hypothesis is that the repetition of fetal blood sampling is useful when fetal heart rate stays non-reassuring and may lead to vaginal delivery without impair neonatal prognostic. Therefore, our objective was to compare the patients with three or more fetal blood sampling with the patients with one or two.


Eligibility criteria: Inclusion Criteria:

* One fetal blood sampling during labour or more
* Singleton pregnancy
* Gestational age equal or above 37 weeks
* No contra-indication of fetal blood sampling
* No pregnancy complication

Exclusion Criteria:

* Sampling failure
* Incomplete file

Primary outcomes:
measure: Delivery
timeFrame: baseline
Secondary outcomes:
measure: Apgar score
timeFrame: baseline
measure: umbilical cord pH
timeFrame: baseline
measure: umbilical cord lactates
timeFrame: baseline
measure: neonatal care intensive unit transfer
timeFrame: baseline
Other outcomes:
Locations:
city: Nancy
country: France
facility: Regional University Maternity of Nancy
state: Meurthe-et-Moselle
Study officials:
References:
Clinical trial NCT01120496: Nebulized Hypertonic Saline Treatment in Hospitalized Children With Moderate to Severe Viral Bronchiolitis
Official title: A Randomized Controlled Trial of Nebulized Hypertonic Saline Treatment in Hospitalized Children With Moderate to Severe Viral Bronchiolitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchiolitis
Keywords: Hypertonic saline solution, bronchiolitis, RSV
Lead sponsor: Chongqing Medical University
Sponsor class: OTHER
First posted: 2010-05-11
Enrollment: 135
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is planned to investigate whether frequently inhaled hypertonic saline (HS) can relieve symptoms and signs faster than normal saline (NS) and shorten length of stay (LOS) significantly for moderately to severely ill infants with bronchiolitis without apparent adverse effects.

Detailed description: The treatment of bronchiolitis remains largely supportive with mechanical ventilatory support as needed .Other types of treatment remain controversial.We and other researchers have demonstrated that nebulized HS and bronchodilators decreased symptoms and LOS for infants with mild to moderate viral bronchiolitis .All the aforementioned studies used 3 times per day dosing, which is significantly less than the 3 to 6 times per hour regimens often used in children in respiratory distress.Frequently nebulized HS reduced the LOS for infants with moderately severe bronchiolitis.The present study is planned to investigate whether frequently inhaled HS can relieve symptoms and signs faster than NS and shorten LOS significantly for moderately to severely ill infants with bronchiolitis without apparent adverse effects.

PMID: 15266547 PMID: 12576370 PMID: 16599051 PMID: 17719935 PMID: 20014350 PMID: 12475841

Eligibility criteria: Inclusion Criteria:

* infants less than 24 months of age with first episode of wheezing.

Exclusion Criteria:

* age\>24 months,
* previous episode of wheezing,
* chronic cardiac and pulmonary disease,
* immunodeficiency,
* accompanying respiratory failure,
* requiring mechanical ventilation,
* inhaling the nebulized 3% hypertonic saline solution 12 hours before treatment,
* premature infants born at less than 34 weeks gestation.

Primary outcomes:
measure: To determine the efficacy of frequently nebulized HS in moderately to severely ill infants with bronchiolitis
timeFrame: 1 year
Secondary outcomes:
measure: To determine the safety of frequently nebulized HS in moderately to severely ill infants with bronchiolitis
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Chongqing Medical University
name: zhengxiu luo, doctor
role: PRINCIPAL_INVESTIGATOR
References: