linjc16/ctgov huggingface dataset:
Incentive Programs for Female Substance Abusers Who Smoke - 3

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the effects of incentive programs for the treatment of nicotine dependence in women who have problems with substance dependence.

Detailed Description
-----------------
This study will determine the influence of voucher-based CM on reducing smoking (and other drug) use during pregnancy or in post-partum women with children under 1 year of age living with them, or in non-pregnant females who smoke. We are targeting smoking cessation since cigarette use is so prevalent in our service. We will compare a control group to two different voucher-based contingent-reinforcement procedures: one that targets smoking abstinence alone vs. one that offers additional incentives for negative BAL and urinalysis results.

Official Title
-----------------
Incentive Programs for Female Substance Abusers Who Smoke

Conditions
-----------------
Tobacco Use Disorder

Intervention / Treatment
-----------------
* Behavioral: Behavior Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant and or post-partum with at least one child under 1 year old living with them, or non-pregnant, non-post-partum females or previous participant in this study protocol Nicotine Dependent as confirmed by DSM-IV checklist Current cigarette smoker Breath CO reading of at least 8 ppm at the time of the initial study screening Current client with the Shields for Families (Shields) treatment programs Exclusion Criteria: Non-smoker

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 99 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Behavior Therapy|nan|

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nicotine dependence
Study Evaluating the Effects of AIR645 on Allergen-Induced Airway Responses in Subjects With Mild Atopic Asthma

Study Overview
=================
Brief Summary
-----------------
To assess the efficacy of inhaled AIR645 in the suppression of the Asthmatic Responses in subjects with mild asthma inhaling an allergen.

Official Title
-----------------
A Phase 2a, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Bronchial Allergen Challenge Study to Assess the Safety, Tolerability, and Efficacy of Inhaled AIR645 in Subjects With Mild Allergic Asthma

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: AIR645
* Drug: Physiologic saline solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women with well controlled mild allergic asthma, aged 18 to 65 years Only asthma med is short-acting bronchodilator used not more than twice weekly FEV1 greater than 70% predicted and a demonstrated baseline late response to allergen induction

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Experimental: AIR645<br>AIR645 (an IL-4/IL-13 dual cytokine signaling inhibitor) solution (diluent: physiologic saline solution) | Drug: AIR645<br>* AIR645 (blinded) by nebulization, range of doses, maximum of one dose per day, maximum of 6 doses in 22 days.<br>|
| Placebo Comparator: Physiologic saline solution<br>Physiologic saline solution | Drug: Physiologic saline solution<br>* Placebo (blinded) by nebulization, range of doses, maximum of one dose per day, maximum of 6 doses in 22 days.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve (AUC) of the percentage decrease forced expiratory volume in one second (FEV1) from baseline between AIR645 and placebo |  | 36 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypersensitivity, Lung Diseases, Obstructive, Immune System Diseases, Respiratory Tract Diseases, Bronchial Diseases, Lung Diseases, Hypersensitivity, Immediate, Asthma, Respiratory Hypersensitivity
COVID-19 & Psychiatry: A Retrospective Chart Review

Study Overview
=================
Brief Summary
-----------------
A retrospective chart review study to determine the effects of psychotropic medications and prior psychiatric diagnoses on COVID-19 patients' disease progression, and severity.

Detailed Description
-----------------
The goal of this study would be to study the association between use of psychotropic medications and prior psychiatric diagnoses on COVID-19 patients' disease progression and severity.

Official Title
-----------------
A Retrospective Chart Review Study to Determine the Effects of Psychotropic Medications and Prior Psychiatric Diagnoses on COVID-19 Patients' Disease Progression, and Severity.

Conditions
-----------------
COVID-19

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Individuals with a positive COVID-19 test between March 15 2020 to November 30 2021 at Northwestern Medicine hospitals. Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| COVID+<br>COVID + positive individuals from March 15 2020 to Nov 30, 2021 | Other: No intervention<br>* Observational study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hazard Ratio | HR of using psych drugs or having psych diagnosis | March 15 2020 to Nov 30 2021 |
Tablet-based Mobile Health Ultrasound for Point-of-care Breast Cancer Diagnosis in Nigeria (Mobile Health: Technology and Outcomes in Low and Middle-Income Countries)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to train Nigerian radiologists to perform ultrasound-guided breast biopsies. Researchers will use mHealth devices to create a sustainable and practical way of training radiologists in Nigeria to perform and clinically implement US-guided breast biopsies into their practice.

Official Title
-----------------
Tablet-based Mobile Health Ultrasound for Point-of-care Breast Cancer Diagnosis in Nigeria

Conditions
-----------------
Breast Cancer, Breast Cancer Female

Intervention / Treatment
-----------------
* Procedure: mHealth US-breast biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 and older female. Breast ultrasound demonstrating a solid mass that is suspicious for cancer, which would typically undergo either a blind biopsy or surgical excision at the Nigerian hospital where the patient is seeking diagnosis. Exclusion Criteria: Participants unwilling to sign consent. Participants under the age of 18.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with a solid mass on breast ultrasound<br>Participants will have a solid mass on breast ultrasound that is suspicious for breast cancer. | Procedure: mHealth US-breast biopsy<br>* During this study, women will undergo an US-guided breast biopsy by a radiologist instead of what is typically performed in Nigerian hospitals, which is either a blind biopsy or surgical excision. US-guided breast biopsy is the standard of care in the United States of America because the accuracy is better than blind biopsy and equal to surgical excision.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of successful US-guided breast biopsy | Trainees will be evaluated using a passing criterion of 80% on a validated test that assesses competency based on the The Ottawa Surgical Competency Operating Room Evaluation (O-Score). There are 8 variables rated on a scale of 1-5. A trainee will be given a passing grade if the responses on all 8 variables are 4 or 5 and this is achieved in at least 80% of the unsupervised simulation and patient biopsies. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast ultrasound, breast cancer, breast biopsy, breast cancer diagnosis, 21-325, Memorial Sloan Kettering Cancer Center
Remission in Rheumatoid Arthritis in the Asian-Pacific Region

Study Overview
=================
Brief Summary
-----------------
This study is the multi-center, open and cross-sectional study of RA remission in Asia Pacific region. The objectives is to explore remission rate of RA patients in different countries in the Asian-Pacific area using different criteria of remission (DAS28, CDAI, SDAI, ACR/EULA remission criteria, RAPID3 and Clin28) and investigate the associated factors of remission in RA patients.

Official Title
-----------------
Remission in Rheumatoid Arthritis in the Asian-Pacific Region

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Other: observational study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: RA patients fulfilled the American College of Rheumatology 1987 criteria or the 2010 ACR/EULAR classification criteria. Patients aged > 18 years. Exclusion Criteria: No

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| RA patients<br>As routinary clinical practice and observational study | Other: observational study<br>* as clinical practice<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| remission rate of RA patients in different countries in the Asian-Pacific area | according to the different criteria of clinical remission in RA patients | 12-24 months |
Gastroprotected Superoxide Dismutase in Combination With UVB vs Placebo and UVB for Treating Vitiligo.

Study Overview
=================
Brief Summary
-----------------
The role of the oxidative stress in vitiligo is supported by many studies but robust data are lacking concerning their interest as therapeutic agents. The objective of the study is to compare the association of GLISODIN (a gastro-protected superoxide dismutase) and Nb-UVB to Nb-UVB and placebo for treating vitiligo. Adult patients with non-segmental vitiligo affecting more than 5% of body surface area will be included. The main criteria of evaluation will be the VES score at 6 months compared to baseline in both groups.

Official Title
-----------------
Gastroprotected Superoxide Dismutase in Combination With UVB vs Placebo and UVB for Treating Vitiligo. A Randomized Double Blind Placebo Controlled Monocentric Study

Conditions
-----------------
Vitiligo

Intervention / Treatment
-----------------
* Drug: Glisodin tablet
* Drug: Placebo tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Vitiligo Vitiligo, SOD, UVB Non-segmental vitiligo with BSA>5% Exclusion Criteria: Criteria of non-inclusion Segmental or mixed vitiligo Pregnancy Vitiligo lesions localized only on hands and feet Immuno-suppressive drugs Corticosteroids Photosensitive drugs Photodermatosis Personal history of skin cancer Allergy to gluten

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug<br>4 pills a day (1000mg) for 3 months then 2 pills a day (500 mg) for 3 months | Drug: Glisodin tablet<br>* 4 pills a day (1000mg) for 3 months then 2 pills a day (500 mg) for 3 months<br>|
| Placebo Comparator: Placebo<br>4 pills a day (1000mg) for 3 months then 2 pills a day (500 mg) for 3 months | Drug: Placebo tablet<br>* 4 pills a day (1000mg) for 3 months then 2 pills a day (500 mg) for 3 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation Vitiligo | Change from Baseline VES (Vitiligo Extend Score) at 6 months | At Baseline and at 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life of patient | Change from baseline DLQI at 6 months | At Baseline and at 6 weeks |
Automated ICD Coding of Primary Diagnosis Based on Machine Learning

Study Overview
=================
Brief Summary
-----------------
This study aims to develop and validate machine learning model in ICD-10 coding of primary diagnosis related to cardiovascular diseases in Chinese corpus.

Detailed Description
-----------------
The accuracy and productivity of ICD coding has always been a concern of clinical practice. Errors of ICD codes may result in claim denials and missed revenue. However, ICD coding process is complex, time-consuming and error-prone. More experienced coders are in need, but there is an increasing lack of supply. Automated ICD coding has potential to facilitate clinical coders for improved efficiency and quality. Model performance of related studies is still far below coders and both the accuracy and interpretability need to be improved in great demand. Besides, studies in Chinese corpus are not sufficient. In this study, the investigators will implement automated ICD coding study based on inpatient' data collected from electronic medical records from Fuwai Hospital, the world's largest medical center for cardiovascular disease. Feature engineering and machine learning methods will be used to develop classification models with good performance, interpretability and practicability for ICD codes of primary diagnosis.

Official Title
-----------------
Automated ICD Coding of Primary Diagnosis Based on Machine Learning

Conditions
-----------------
Cardiovascular Diseases

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Admissions in Fuwai Hospital, from January 1, 2019, to December 31, 2020 Exclusion Criteria: Admissions stayed in nephrology department, Fuwai Hospital
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Model training and test group<br>Data set will be split into training group and test group, where training group will be used for model building, and test group for subsequent evaluation and verification. | Other: No intervention<br>* No intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICD code of primary diagnosis | Each admission will be a sample in this study. The ICD code of primary diagnosis assigned by medical coders for each admission will be collected as the primary outcome. | At the end of enrollment |
Antiseptic Use and Dressing Application

Study Overview
=================
Brief Summary
-----------------
The purposes of the study are: To compare the local efficacy (skin colonization) of 2 commercialized antiseptics used for the disinfection of the dressing application for an epicutaneocavous catheter (EPI). To evaluate whether the bacteria responsible for nosocomial infection is comparable to the flora diagnosed at the EPI site.

Detailed Description
-----------------
Epicutaneocavous catheter is a significant risk factor for nosocomial infection in newborn infants. These infections have been related to local bacterial colonisation. Therefore thorough disinfection should lower the risk of nosocomial infection. However, the local efficacy of antiseptic use has not yet been clearly evaluated in this situation.

Official Title
-----------------
Comparison of Amukin Versus Biseptine Use for Dressing Application of Epicutaneocavous Catheters for Nosocomial Infection Prevention

Conditions
-----------------
Skin Colonization, Catheterization, Bacterial Infection

Intervention / Treatment
-----------------
* Procedure: disinfection efficacy using Biseptine
* Procedure: disinfection efficacy using Amukin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All infants admitted to the Neonatal Intensive Care Unit Epicutaneocavous catheter insertion indication Exclusion Criteria: Epicutaneocavous catheter not inserted within the Unit

Ages Eligible for Study
-----------------
Maximum Age: 3 Months

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2<br>Biseptine | Procedure: disinfection efficacy using Biseptine<br>* Detersion and antiseptic application when changing catheter dressing<br>* Other names: Biseptine;|
| Active Comparator: 1<br>Amukin | Procedure: disinfection efficacy using Amukin<br>* Detersion and antiseptic application when changing catheter dressing<br>* Other names: Amukin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy on skin colonization of two commercially available antiseptics |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In case of nosocomial infection, relationship with skin bacteria |  | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Skin colonization, Antiseptic, Epicutaneocavous catheter dressing, Infant
A Pharmacokinetic-pharmacodynamic Dose Comparison Study of 8 mg/kg of Inhaled or Parenteral Gentamicin in 12 Mechanically Ventilated Critically Ill Patients Treated for Ventilator-associated Pneumonia

Study Overview
=================
Brief Summary
-----------------
Ventilator associated pneumonia (VAP) remains in the intensive care unit the infection associated with the highest morbidity and mortality. Respiratory infection with resistant organism are increasing in prevalence. Because of lack of alternatives, amino glycoside, old antibiotics family, can be used for several infection. Aerosolized Amikacin or Tobramycin are used in mechanically ventilated patients for respiratory infections. Gentamicin,which is effective against numerous multi drug resistant Gram-negative organism and Gram-positive like Staphylococcus aureus, could be a great option for nebulisation. The investigators assume that nebulisation of gentamicin allows to obtain a higher lung concentration while assuring a systematic toxicity much lesser than a parenteral administration.

Conditions
-----------------
Ventilator-associated Pneumonia

Intervention / Treatment
-----------------
* Drug: gentamicin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: to be in critical care unit to be mechanically ventilated to have a ventilator-associated pneumonia requiring a treatment by gentamicin to be affiliated to a national insurance scheme to have given an informed consent (patient or close person) Exclusion Criteria: to be obese (BMI > 40 kg/m²) to have been treated by gentamicin for 7 days to be allergic to aminoglycoside to have a severe respiratory failure (PaO2 / FiO2 < 150) to have a renal failure (Cl creat < 60 ml/min/1.73m²) to be under reinforced protection measure

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gentamicine injectable(day 1+2)and then gentamicine inhalation<br> | Drug: gentamicin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Plasma Concentration (Cmax) |  | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PaO2/FiO2 ratio deterioration above 20%. | Bronchodilators used. | 3 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
VAP, Critical care, Pharmacokinetics, Gentamicin