linjc16/ctgov huggingface dataset:
A Trial of Point of Care Information in Ambulatory Pediatrics

Study Overview
=================
Brief Summary
-----------------
Does presentation of clinical evidence for decision making at point-of-care improve prescribing patterns in ambulatory pediatrics?

Detailed Description
-----------------
We showed previously that an electronic prescription writer and decision support system improved pediatric prescribing behavior for otitis media in an academic clinic setting. This study assessed whether point-of-care evidence delivery could demonstrate similar effects for a wide range of other common pediatric conditions. We performed a randomized controlled trial in a teaching clinic/clinical practice site and a primary care pediatric clinic serving a rural and semi-urban patient mix. There were 36 providers at the teaching clinic/practice site, and 8 providers at the private primary pediatric clinic, and an evidence-based message system presented real time evidence to providers based on prescribing practices for acute otitis media, allergic rhinitis, sinusitis, constipation, pharyngitis, croup, urticaria, and bronchiolitis. We measured the proportion of prescriptions dispensed in accordance with evidence.

Official Title
-----------------
A Randomized Clinical Trial to Improve Prescribing Patterns in Ambulatory Pediatrics

Conditions
-----------------
Acute Otitis Media, Allergic Rhinitis, Sinusitis, Constipation, Pharyngitis, Croup, Urticaria, Bronchiolitis

Intervention / Treatment
-----------------
* Device: Electronic point-of-care delivery system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The 44 clinical providers at the two participating clinics. - Exclusion Criteria: Study investigators -

Ages Eligible for Study
-----------------
Minimum Age: 0 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Electronic point-of-care delivery system|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prescribing practices for acute otitis media, |  |  | 
| allergic rhinitis, |  |  | 
| sinusitis, |  |  | 
| constipation, |  |  | 
| pharyngitis, |  |  | 
| croup, |  |  | 
| urticaria, |  |  | 
| bronchiolitis |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
point of care, evidence based medicine
Sugammadex and Brain Waves

Study Overview
=================
Brief Summary
-----------------
According to our experience, electroencephalogram-based indices of anaesthetic state show elevated numbers after administration of sugammadex (new reversal of neuromuscular blockade). This can be due to altered anaesthetic state, or some kind of artefact. In this study, the phenomenon is evaluated in detail.

Detailed Description
-----------------
Rocuronium-induced neuromuscular blockade is antagonized with sugammadex or neostigmine. BIS, Entropy and the biosignal collected from the Entropy strip are collected on computer. The behaviour of these parameters before, during and after reversal on neuromuscular blockade will be analyzed in detail.

Official Title
-----------------
The Effect of Sugammadex of EEG-derived Index Values

Conditions
-----------------
Anaesthesia

Intervention / Treatment
-----------------
* Drug: Sugammadex
* Drug: Neostigmine and glycopyrrolate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: females giving informed consent age range 18-65 years elective surgery: gynaecological general anaesthesia ASA classification 1 or 2 Exclusion Criteria: pregnancy body mass index > 30 disease affecting CNS overuse of alcohol drug abuse unability to understand, read or use Finnish language

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Sugammadex|Sugammadex 200 mg iv, single dose, bolus.|
|Drug: Neostigmine and glycopyrrolate|Neostigmine 2.5 mg and glycopyrrolate 0,5 mg, iv, single dose, bolus, diluted in 2 ml volume with saline|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The behaviour of depth of anaesthesia indexes (BIS,SE,RE) |  | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The behaviour of electroencephalography |  | 30 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Electroencephalogram, Electromyogram, Entropy Index, Bispectral Index, Reversal of neuromuscular blockade
Feasibility Neurocognitive Outcome After Transplant

Study Overview
=================
Brief Summary
-----------------
This pilot study will primarily be evaluated by feasibility and adherence to an iPad-based neurocognitive intervention program. It will secondarily be evaluated by performance on the neurocognitive testing post-transplant and change in performance in subsequent years.

Official Title
-----------------
A Risk Stratification Model for Neurocognitive Outcome After Transplant and Feasibility of an Early Cognitive Intervention Program

Conditions
-----------------
Stem Cell Transplantation, Pediatric Cancer, Acute Lymphoblastic Leukemia

Intervention / Treatment
-----------------
* Behavioral: Cognitive rehabilitation program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients must have a histologic or cytological diagnosis of ALL treated with stem cell transplantation. There are no restrictions on prior therapy. Patients must be between the ages of 6 years and 21 years of age (inclusive), but there will be no discrimination based on gender, race, creed, or ethnic background. The age limits are set at 6 years of age in order to ensure that patients will be able to participate in these specific cognitive rehabilitation tasks. ECOG/KPS will not be employed. Patient and/or parents/guardians as appropriate must sign an informed consent, be mentally responsible, able to understand and willing to sign a written informed consent. Exclusion Criteria: Subjects with significant concurrent medical complications that in the judgment of the Principal Investigator(s) could affect the patient's ability to complete the planned trial. There are no therapy restrictions or restrictions regarding the use of other Investigational Agents. Pregnant patients will be excluded.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive rehabilitation arm<br>Cognitive rehabilitation program | Behavioral: Cognitive rehabilitation program<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who complete the post-transplant neurocognitive intervention program |  | 26 weeks after transplant |
Safety and Efficacy of Chronic Hypnotic Use 2

Study Overview
=================
Brief Summary
-----------------
This proposal will assess risks for transition from therapeutic hypnotic use to abuse in people with insomnia. The investigators will study a hypothesized at-risk sub-population, insomniacs with hyperarousal, and compare two hypnotics, a drug with mood effects, eszopiclone, versus one without mood effects, zolpidem.

Official Title
-----------------
Risks for Transition From Therapeutic Hypnotic Use to Abuse

Conditions
-----------------
Chronic Insomnia

Intervention / Treatment
-----------------
* Drug: placebo
* Drug: Zolpidem CR
* Drug: Eszopiclone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: DSM-5 diagnosis of insomnia Exclusion Criteria: acute or unstable medical disease, current or past history of psychiatric disease, alcoholism or drug abuse, and other primary sleep disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Intervention: Six months of nightly placebo | Drug: placebo<br> <br> |
| Active Comparator: Zolpidem CR<br>Intervention: Six months of zolpidem cr 12.5 mg nightly use | Drug: Zolpidem CR<br> <br> |
| Active Comparator: Eszopiclone<br>Intervention: Six months of eszopiclone 3 mg nightly use | Drug: Eszopiclone<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in number capsules chosen: nightly choice of 0, 1, 2, or 3 capsules | total possible nightly dose limited to upper clinical dose | last two weeks of month1 and 3 | 
| discontinuation difficulty: nightly choice of 0, 1, 2, or 3 capsules | instruction to stop nightly hypnotic use | last two weeks of month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in actigraphic determined sleep time | comparing the three treatment arms for hypnotic efficacy | first two weeks of months 1, 3, and 6 |
Multi-center Application of Quantitative FIT Technology in Colorectal Cancer Screening

Study Overview
=================
Brief Summary
-----------------
In order to control the incidence of colorectal cancer, improve the level of early diagnosis and early warning the occurrence of colorectal cancer, it is very necessary for us to explore the threshold value of FIT positive judgment in line with the Chinese population, and further contribute to the establishment of a colorectal cancer screening pathway suitable for Chinese healthy population

Detailed Description
-----------------
Feces were collected for quantitative FIT test. Those with positive results were further examined by colonoscopy. By comparing with pathological results of colonoscopy, the sensitivity, specificity, positive predictive value and negative predictive value of quantitative FIT technology for the diagnosis of colorectal tumors were confirmed.

Official Title
-----------------
Multi-center Application Study of Quantitative FIT Technology for Colorectal Cancer Screening in Chinese Physical Examination Population

Conditions
-----------------
Colorectal Cancer Screening Fecal Immunochemical Test

Intervention / Treatment
-----------------
* Device: Quantitative Fecal Immunochemical Test (qFIT)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy people aged 30 years and planning to undergo colonoscopy; No history of gastrointestinal tumor; No ulcerative colitis or Crohn's disease; No gastrointestinal hemorrhagic disease; No history of gastrointestinal surgery, able to understand and willing to sign informed consent. Exclusion Criteria: Other serious diseases of the digestive tract, such as Crohn's disease ulcerative colitis; Patients with gastric and esophageal cancer and other malignant tumors; Unable to cooperate after communication; Subjects who have received radiotherapy and chemotherapy; Other researchers believe that they are not suitable for inclusion in this clinical trial, such as mental illness patients, critical patients, pregnant women, illiterate minors, cognitive impairment PI, students of the researcher, PI, affiliated research units of the co-investigator or employees of the sponsor, etc

Ages Eligible for Study
-----------------
Minimum Age: 30 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Quantitative Fecal Immunochemical Test (qFIT)|The study only included quantitative FIT examination in the general physical examination population over 30 years old.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of quantitative FIT | The sensitivity of quantitative FIT application in Chinese physical examination population | 1year | 
| Specificity of quantitative FIT | The specificity of quantitative FIT application in Chinese physical examination population | 1year |
An Evaluation Of Mepolizumab In Therapy Of Eosinophilic Oesophagitis In Adult Patients

Study Overview
=================
Brief Summary
-----------------
Eosinophils play a key role in the pathogenesis of eosinophilic oesophagitis. Therapies that suppress eosinophil recruitment and activation may give a benefit. Mepolizumab is a humanised monoclonal antibody against interleukin-5 (IL-5). This study will evaluate the ability of mepolizumab to decrease the recruitment and infiltration of eosinophils into the oesophagus, thereby reducing the inflammation and symptoms of EE (eosinophilic oesophagitis) in adult patients.

Official Title
-----------------
A Randomised, Double-Blind, Placebo-Controlled, Single-Centre Study to Provide a Preliminary Evaluation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Intravenous Anti-human Interleukin-5 (Mepolizumab, 750mg and 1500mg) in the Treatment of Eosinophilic Oesophagitis in Adults

Conditions
-----------------
Oesophagitis, Eosinophilic

Intervention / Treatment
-----------------
* Drug: mepolizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Document evidence/presence of Oesophagitis prior to commencing trial drug. a)Histological evidence of Oesophagitis: greater than 20x eosinophils per high power field (X400) on histology of esophageal mucosal biopsy b. at least one episode of dysphagia per week c.Inadequate response to routine EE treatment D. No other known causes of oesophagitis, or esophageal or generalized eosinophilia Not pregnant or nursing Exclusion criteria: History of seasonal worsening of EE symptoms or requirement of Esophageal dilation. Churg-Strauss Syndrome Wegener's Granulomatosis Lymphoma, hematological malignancy, advanced and metastatic solid tumors Active H. pylori infection. Any previous treatment with anti-hIL-5, anti-IgE monoclonal antibody or other biological agents.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: mepolizumab|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Reduction of eosinophils in the oesophagus 2. Safety and tolerability of mepolizumab |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Effect of treatment on symptoms, Eosinophil levels, and on inflammation biomarkers in oesophagus tissue and blood. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anti IL-5, oesophagitis, eosinophils, mepolizumab, adults
Intramuscular Aripiprazole in Acutely Agitated Patients Diagnosed With Dementia

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to test the safety & tolerability of intramuscular aripiprazole in acutely agitated patients diagnosed with Dementia.

Official Title
-----------------
A Safety & Tolerability Study of Intramuscular Aripiprazole in Acutely Agitated Patients Diagnosed With Dementia

Conditions
-----------------
Dementia, Alzheimer's Disease

Intervention / Treatment
-----------------
* Drug: Aripiprazole
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute agitation in Patients with a DSM-IV diagnosis of Alzheimer's, vascular or mixed Dementia. Exclusion Criteria: Current DSM-IV Axis 1 diagnosis other than Alzheimer's, vascular or mixed Dementia.

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 95 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A1<br> | Drug: Aripiprazole<br>* IM Solution, IM, Cohort 1 - 2.5mg (.33cc) maximum dose 5.0mg; 2 injections 2nd injection 2 hours after first; Cohort 2 - 5.0mg (.67cc) maximum dose 10 mg; 2 injections 2nd injection 2 hours after first; Cohort 3 - 10 mg (1.3cc) or 5.0 mg (.67cc) maximum dose 15mg; 1 injection, 24 hour observation for all cohorts.<br>* Other names: Abilify;|
| Placebo Comparator: B1<br> | Drug: Placebo<br>* IM Solution, IM, Cohort 1 - 0mg; 2 injections 2nd injection 2 hours after first; Cohort 2 - 0mg; 2 injections 2nd injection 2 hours after first; Cohort 3 - 0mg; 1 injection, 24 hour observation for all cohorts.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tolerability |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety assessments |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute agitation in patients diagnosed with Dementia
VCRC Longitudinal Protocol for Aortitis

Study Overview
=================
Brief Summary
-----------------
The term 'aortitis' refers to inflammation of the aorta. Aortitis is known to occur in a variety of vasculitides and connective tissue diseases, such as giant cell arteritis (GCA), Takayasu arteritis (TAK), rheumatoid arthritis, and spondyloarthropathies, among others. This study will establish a longitudinal cohort for these diseases.

Detailed Description
-----------------
This study will develop a longitudinal cohort of patients with different types of aortitis to systematically study the natural history, optimal treatments, and outcomes in this group of diseases. This will provide a resource for future studies and for identification of new biomarkers of aortitis for purposes of diagnosis, disease activity measurement, disease damage assessment, determination of disease states, and evaluation of treatment response.

Official Title
-----------------
VCRC Longitudinal Protocol for Aortitis

Conditions
-----------------
Aortitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects will be included if they meet one of the following criteria: Previous or current microscopic evidence of aortitis (active or healed) on surgical specimen obtained during aortic resection Previous or current radiographic aortitis that could include circumferential aortic wall thickening of at least 3mm on CT or MRI or increased PET FDG uptake in the aorta at values equal to or greater than the liver, in absence of an alternative explanation for the radiographic findings. Exclusion Subjects already enrolled in one of the other VCRC longitudinal cohorts: 5502, 5503, 5504, 5505, and 5506. Inability of participants (or their guardians in the case of children) to give informed consent and to sign the consent form.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phenotypic correlates of genotype | Using longitudinally collected phenotypic data, this project aims to define the natural history (i.e. biochemical evidence of systemic inflammation, and systemic symptoms) of different types of phenotypes of aortitis and related disorders in patients using serum and genetic information collected through specimens. | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Idiopathic aortitis, Isolated aortitis, Vasculitis