louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01312324: Neoadjuvant Chemotherapy for Locally Advanced Thymic Cancer
Official title: A Prospective, Phase II Trial of Induction Chemotherapy With Docetaxel/Cisplatin for Masaoka Stage III/IV Thymic Epithelial Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Locally Advanced Stage III or IV Thymic Cancer
Keywords: neoadjuvant chemotherapy
thymic cancer
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2011-03-10
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: We try to evaluate whether neoadjuvant docetaxel plus cisplatin can increase the complete resection rate in advanced thymic carcinoma.


Eligibility criteria: Inclusion Criteria:

* histologically confirmed thymic carcinoma
* surgically inoperable Masaoka stage III or IV
* ECOG 0-2
* at least one measurable disease

Exclusion Criteria:

* previous myocardiac infarct history within 1 year before the enrollment.

Primary outcomes:
measure: Complete resection rate
timeFrame: 4-8 weeks later after completion of neoadjuvant chemotherapy
Secondary outcomes:
measure: the number of patients with adverse events
timeFrame: from enrollment to 6 months after completion of chemotherapy
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT04393324: The Critical Care Response to the COVID-19 Pandemic in Madrid
Official title: The Critical Care Resources Adaptation to the SARS-CoV-2 Pandemic in Madrid
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
ARDS, Human
Keywords: COVID-19
ARDS
Relocation
ICU capacity
Lead sponsor: Hospital San Carlos, Madrid
Sponsor class: OTHER
Collaborators: name: FUNDACION PARA LA INVESTIGACION HOSPITAL CLINICO SAN CARLOS
First posted: 2020-05-19
Enrollment: 2500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Critically ill patients admitted to ICUs in Madrid for COVID-19

Brief summary: Description of the adaptation of ICUs in the region of Madrid to que surge in demand of critical care due to COVID-19

Detailed description: Background

The worldwide SARS-CoV-2 pandemic has put healthcare systems under the extreme pressure, with intensive care units being faced with a previously unseen number of patients with severe respiratory failure requiring admission for endotracheal intubation and mechanical ventilation.

Methods

The study describes how the critical care resources adapted to the sudden surge of severe Covid-19 in the province of Madrid, which developed at the beginning of March 2020. The response consisted of a swift increase in ICU capacity and the relocation of patients. ICU beds were mounted outside the usual intensive care areas. Transfer of critically ill intubated patients with COVID-19 was managed in an instant messenger service group composed of representatives of 53 intensive care units and performed by the Madrid Emergency Medical Systems (EMS). The investigators will compare transferred with non-transferred patients matched for risk factors for cardiovascular and respiratory complications.

Eligibility criteria: Inclusion Criteria:

* Admitted to ICU in Madrid with COVID-19

Exclusion Criteria:

* Admitted to ICU without COVID-19

Primary outcomes:
measure: Mortality
timeFrame: 9 weeks
Secondary outcomes:
measure: Length of ICU stay
timeFrame: 9 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
Study officials:
affiliation: Hospital San Carlos, Madrid
name: Miguel Sánchez García, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01391624: Study on the Possible Effects of Diet Supplementation With Essential Fatty Acids in Chocolate Craving Volunteers
Official title: Study on the Possible Effects of Diet Supplementation With Essential Fatty Acids in Chocolate Craving Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Addictive Behavior
Abstinence Syndrome
Keywords: chocolate
craving
addiction
compulsion
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Associação Fundo de Incentivo à Pesquisa
name: Fundação de Amparo à Pesquisa do Estado de São Paulo
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2011-07-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether essential polyunsaturated acids (omega 3) are capable of reducing chocolate craving symptoms in healthy patients.

Our hypothesis is that the omega 3 fatty acids have properties which stabilize and normalize neuronal functioning in many conditions, including chocolate craving.

Detailed description: Polyunsaturated fatty acids (of the omega 3 subtype) are fundamental in human diet, as they are components of cellular membranes, guaranteeing their fluidity and their functions of separating intracellular and extracellular means and transporting several substances to and from cellular microenvironment.

Modern theories profess that lack of omega 3 fatty acids in western diets may be the cause of several deletery changes in neuronal physiology, which may cause or make worse several pathological conditions, such as depression, mood instability, and drug craving. The role of serotonin as the main lacking component in the conditions is well documented, and it is thought that omega 3 is important in the synthesis, transportation, and ultimately the activity of this neurotransmitter.

Out theory states that supplementation with these acids can restore normal neuron balance, improving the condition of chocolate craving patients.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of chocolate compulsion or craving, ECAP score \> 12.

Exclusion Criteria:

* Psychiatric disease of any sort (by the DSM IV criteria, Use of psychoactive drugs of any sort, BMI \> 25 (kg/m2).

Primary outcomes:
measure: Changes in the MBES score (used to quantify chocolate compulsion) from baseline.
timeFrame: 2 months after enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Universidade Federal de São Paulo (Federal University of São Paulo); Departamento de Psicobiologia (Department of Psychobiology)
Study officials:
affiliation: Student
name: Pedro L Prior, Student
role: STUDY_CHAIR
References:
Clinical trial NCT02737124: Acetaminophen Randomized Controlled Trial
Official title: Prospective Randomized Control Trial Assessing Effects of Pre-Operative Acetaminophen in Isolated Meniscectomy Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Post Operative Pain
Keywords: Acetaminophen
Surgery
Meniscectomy
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-04-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Patients that are to undergo isolated meniscectomy will be randomized to 2 cohorts: one will take the FDA recommended dose of acetominophen (1000mg) 24hrs before surgery, one will be given a similarly looking placebo pill. A multitude of post-op variables will be included, mainly pain scores and morphine equivalent doses at different time points.


Eligibility criteria: Inclusion Criteria:

* Must be at least 18 years of age
* ASA Class I-II
* Patients scheduled for meniscectomy

Exclusion Criteria:

* Contraindication to acetaminophen (hypersensitivity, extensive alcohol history, liver disease, actively breastfeeding)
* Legally incompetent or mentally impaired (e.g., minors, Alzheimer's subjects, dementia, etc.)
* Younger than 18 years of age or older than 65
* Any patient considered a vulnerable subject
* Patients on pain medication prior to surgery

Primary outcomes:
measure: Morphine-equivalent dose consumption
timeFrame: 7 days
measure: Pain using the visual analogue scale
timeFrame: 7 Days
measure: Narcotic Use
timeFrame: 7 Days
measure: Measure of time to discharge from the PACU
timeFrame: 7 Days
measure: Measure of time to discharge from hospital
timeFrame: 7 Days
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University Medical Center
state: New York
Study officials:
affiliation: NYU Langone Health
name: Eric Strauss, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00685724: A Pilot SMART Design for Pathological Gamblers
Official title: A Pilot SMART Design for Pathological Gamblers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pathological Gambling
Keywords: pathological gambling
cognitive-behavioral therapy
motivational enhancement therapy
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2008-05-28
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Pathological gambling is serious problem, with significant psychological, financial, and public health consequences. Nevertheless, controlled trials examining the efficacy of therapeutic interventions for pathological gamblers are sparse, and many pathological gamblers recover on their own, or with only minimal interventions. In this initial study of a SMART design for pathological gamblers, we will offer a brief intervention to all (n = 100), and subsequently randomize individuals based upon their initial treatment response to varying intensities of additional care from none to 8 sessions of individual cognitive behavioral therapy (CBT) plus 14 weeks of Aftercare. Gambling outcomes will be assessed pre-treatment and at about weeks 10, 24, 36 and 52.


Eligibility criteria: Inclusion Criteria:

* age \> 18 years old, DSM-IV criteria for pathological gambling
* \>2 gambling episodes in past 60 days
* spent \>$100 wagering in the past 60 days
* willingness to accept random assignment after the brief intervention.

Exclusion Criteria:

* Reading level below 5th grade
* uncontrolled psychiatric conditions (e.g., active suicidal intention, psychosis, bipolar disorder)

Primary outcomes:
measure: self and collateral indices of gambling and gambling related problems
timeFrame: baseline and each follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
Study officials:
affiliation: UConn Health
name: Nancy M Petry, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03066024: Electroencephalogram Dynamics in Children During Different Levels of Anesthetic Depth
Official title: Electroencephalogram Dynamics in Children During Different Levels of Anesthetic Depth
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depth of Anesthesia
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2017-02-28
Enrollment: 94
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children and adolescents during anaesthesia / surgery procedure

Brief summary: As part of the clinical routine of the Department of Anesthesiology and Intensive Care Medicine CVK/CCM in the Charité - University Medicine Berlin intraoperative electroencephalography data and clinical routine data are recorded and evaluated in surgical children and adolescents according to different age groups.


Eligibility criteria: Inclusion Criteria:

* Children and adolescents undergoing surgery procedure

Exclusion Criteria:

* Neurosurgery
* Pre-existing neurological conditions

Primary outcomes:
measure: Electroencephalography monitoring changes
timeFrame: Up to the end of surgery
Secondary outcomes:
measure: Anesthetic depth
timeFrame: Up to the end of surgery
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charité - University Medicine Belrin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Claudia Spies, MD, Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05715424: Community Intervention and Demonstration Area Construction
Official title: Research on Precise Myopia Prevention and Control Technology and Demonstration Application for Children and Adolescent
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myopia
Refractive Errors
Lead sponsor: Anhui Medical University
Sponsor class: OTHER
Collaborators: name: Shanghai Eye Disease Prevention and Treatment Center
name: Beijing Center for Disease Control and Prevention
First posted: 2023-02-08
Enrollment: 1000000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The objective of this intervention study was to understand the visual health status of nearly one million children and adolescents in ten provinces in China, and then to conduct intervention and evaluate the effect of intervention measures with the development of myopia as the outcome indicator. The study will be conducted in the form of a stepped intervention and will answer the following questions.

Current China children and adolescent's vision health, including the different degrees of myopia prevalence, and farsightedness reserve status. To evaluate the implementation and effect of eight appropriate technologies and six interventions developed in this study, to reduce the incidence of myopia among children and adolescents in China, to achieve the purpose of nationwide application.

In the early stage of this study, a baseline survey will be conducted on participants. In the middle stage, participants will be required to adjust the seat height regularly and increase the time for outdoor activities, etc. In the later stage, intervention measures will be evaluated based on the overall research situation to consider national promotion.


Eligibility criteria: Inclusion Criteria:

* ● Kindergarten kids.

  * Grade of 1 to 6 in elementary schools.
  * Grade of 1 to 3 in middle schools.
  * Grade of 1 to 3 in high schools.
  * Sign the informed consent.

Exclusion Criteria:

* ●Visual defect or other eye diseases.

  * wearing orthokeratology; refractive surgery history.
  * Not considered suitable for inclusion in the study by the investigator.

Primary outcomes:
measure: Changes in questionnaire survey
timeFrame: Baseline, 6 months, 1 year, 1.5 years, 2 years
measure: Changes in uncorrected vision within two years
timeFrame: Baseline, 6 months, 1 year, 1.5 years, 2 years
measure: Changes in visual acuity in computer optometry
timeFrame: Baseline, 6 months, 1 year, 1.5 years, 2 years
measure: Changes in visual acuity during dilated pupil optometry
timeFrame: Baseline, 6 months, 1 year, 1.5 years, 2 years
Secondary outcomes:
measure: Eye protection diary
timeFrame: Three months.
measure: Qualitative interview
timeFrame: Baseline, 1 year, 2 years
Other outcomes:
Locations:
city: Anqing
country: China
facility: Anqing myopia scene
state: Anhui
Study officials:
affiliation: Anhui Medical University
name: FangBiao Tao, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02159924: Posture and Mobility Measurements of the Upper Quadrant in Asymptomatic Subjects by Means of a Smartphone
Official title: Posture and Mobility Measurements of the Upper Quadrant in Asymptomatic Subjects by Means of a Smartphone
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Posture and Mobility of the Upper Quadrant
Keywords: Smartphone measurements
Orientation
Range of motion
Median nerve neurodynamic test
Posture
Thoracic spine
Shoulder girdle
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
Collaborators: name: Instituto Politécnico de Leiria
First posted: 2014-06-10
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Asymptomatic subjects from scholar community

Brief summary: This study aims to investigate posture-mobility associations in the upper quadrant by means of smartphone measurements

Detailed description: One purpose of this study is to measure the magnitude of the thoracic kyphosis, thoracic spine extension, and side-to-side differences in scapular protraction and elbow extension range of motion during the median nerve neurodynamic test through a smartphone (iPhone 4, app Compass, iOS 7.1.1), and to assess the intrarater agreement parameters.

Another purpose is to assess associations between thoracic kyphosis, thoracic spine extension, scapular protraction and the resting length of the pectoralis minor muscle through smartphone, photographs and tape measurements.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years old
* Normal mobility in the joints of the upper quadrant

Exclusion Criteria:

* complaints in the upper quadrant over the past 3 months
* significant deformities in the upper quadrant
* leg length discrepancy \> 1.5 cm

Primary outcomes:
measure: Elbow extension range of motion
timeFrame: At the time of the assessment
measure: Thoracic kyphosis orientation
timeFrame: At the time of the assessment
measure: Thoracic spine extension range of motion
timeFrame: At the time of the assessment
measure: Scapular protraction orientation
timeFrame: At the time of the assessment
measure: Pectoralis minor muscle resting length
timeFrame: At the time of the assessment
measure: Thoracic kyphosis orientation
timeFrame: At the time of the assessment
measure: Thoracic spine extension range of motion
timeFrame: At the time of the assessment
Secondary outcomes:
Other outcomes:
Locations:
city: Leiria
country: Portugal
facility: Escola Superior de Saúde do Instituto Politécnico de Leiria
Study officials:
affiliation: Instituto Politécnico de Leiria
name: Nuno V Morais, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cruz J, Morais N. Intrarater Agreement of Elbow Extension Range of Motion in the Upper Limb Neurodynamic Test 1 Using a Smartphone Application. Arch Phys Med Rehabil. 2016 Nov;97(11):1880-1886. doi: 10.1016/j.apmr.2016.05.001. Epub 2016 May 17.
Clinical trial NCT04913324: Early Virtual Intervention for Infants With CP Following HIE Diagnosis
Official title: The RECOVER Study - Remote Early Intervention for Cerebral Palsy to Improve Outcomes Using Virtual Care Following pERinatal Asphyxia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Hypoxic-Ischemic Encephalopathy
Brain Injuries
Perinatal Hypoxia
Keywords: HIE
Cerebral Palsy
Infant
Virtual Care
Hypoxic-Ischemic Encephalopathy
Follow-Up
Brain Injuries
Perinatal Hypoxia
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2021-06-04
Enrollment: 150
Sex: ALL
Minimum age (years): 4
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This will be a five year study that will be a prospective, randomized, controlled trial (RCT) to assess the effect of a virtual early intervention care delivery model in the provision of therapy to enhance the neurodevelopmental trajectory of infants with brain injury. In addition, the investigators will enhance understanding of the social and parental contributors to outcomes and the early health economic impact of a virtual clinic. The results of this study will help inform the design of a larger, multi-center randomized controlled trial.


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of moderate to severe hypoxic ischemic encephalopathy as defined based on Sarnat criteria 35
2. Received therapeutic hypothermia
3. Abnormal brain MRI (deep grey matter, watershed or mixed patterns of injury) in the first seven days of life
4. Greater than or equal to 34 weeks gestation
5. Patients are followed by the Neonatal Follow-Up Clinic at SickKids
6. Abnormal GMA (abnormal or absent fidgety movements) at 12 weeks of age

Exclusion Criteria:

1. Known or high suspicion of a genetic syndrome
2. Residence post-discharge will not be with biological parents
3. Limited fluency in English
4. No internet access

Primary outcomes:
measure: Motor outcomes at 18 months between groups using the the motor function score as measured using the Bayley Scales of Infant and Toddler Development
timeFrame: 18 months
Secondary outcomes:
measure: Correlation between parent mental health using the modified Perinatal PTSD Questionnaire, Parent Stress Index, and neurodevelopmental outcomes of patients at 18 months using the Bayley Scales of Infant and Toddler Development
timeFrame: 18 months
measure: Sociodemographic factors that contribute to improved neurodevelopmental outcomes at 18 months as reported using a Sociodemographics Questionnaire
timeFrame: 18 months
measure: Cost-effectiveness of providing remote, early, intensive therapy for children at risk for cerebral palsy versus standard of care as reported using a Health Economics Questionnaire.
timeFrame: 18 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Linh Ly, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00928824: Can Japanese Traditional Foods Lower Blood Pressure in Healthy Volunteers
Official title: Dietary Nitrate in Japanese Traditional Foods Lowers Diastolic Blood Pressure in Healthy Volunteers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Lead sponsor: Kyorin University
Sponsor class: OTHER
Collaborators: name: Japanese Society for the Promotion of Science
First posted: 2009-06-26
Enrollment: 25
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine whether traditional japanese diet blood pressure in healthy volunteers.

Detailed description: Japanese traditional diet contains considerably more nitrate/nitrite than the European foods. 80% of dietary nitrate originates from vegetables. Green leafy vegetables, especially spinach, salad and seaweed are rich in nitrates. Other vegetables contain nitrate at lower concentrations, but because they are consumed in greater quantity, they may contribute more nitrate and thus nitrite from the diet. Nitrate/nitrite is attributed multiple health benefits. Japanese people have an exceptional longevity and the lowest rate of heart diseases. On the other hand, gastric cancer rate is high too. Nitrate/nitrite is strongly correlated with these phenomena. Is this high nitrate consumption protective or damaging? Understanding dietary nitrite and nitrate consumption and its metabolism therefore becomes very important.

Aim: To compare conversion of nitrate to nitrite in Japanese people, measured in blood and in saliva during consumption of traditional Japanese foods vs European diet.

Eligibility criteria: Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

* high/low blood pressure

Primary outcomes:
measure: Blood pressure
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Kyorin Univessity School of Medicine
state: Mitaka shi
Study officials:
References: