linjc16/ctgov huggingface dataset:
Observational Study Describing Conditions for Administering Slow-acting Insulin Analogue With Oral Antidiabetic Agents in Type 2 Diabetes on Blood Glucose Control

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Europe. The aim of this observational study is to describe the conditions for the concomitant administration of a slow-acting insulin analogue with oral antidiabetics (OADs) in order to improve blood glucose control in type 2 diabetes.

Official Title
-----------------
Observational Study on Efficacy on Glycaemic Control of Slow-acting Insulin Analogue in Type 2 Diabetes

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: insulin detemir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes HbA1c level greater than 7% despite treatment with two (or three) oral antidiabetic drugs (OADs) at an optimal dose level Patient agreeing to take part in the study and capable of completing a self-questionnaire. Exclusion Criteria: Hypersensitivity to insulin or to one of the excipients Treatment with insulin for at least 6 months Participant in a clinical trial for diabetes on entry into the observational study

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| A<br> | Drug: insulin detemir<br>* initiation of an long acting insulin treatment in association with OAD at the discretion of the physician/diabetologist<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | After 3 months |
Understanding the Natural History of REM Sleep Behavior Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to determine if safe, simple and non-invasive tests such as an electrocardiogram (EKG), a smell test, or a blood test could be used to identify neurological disorders before typical symptoms occur. Researchers believe that early identification of these disorders could lead to treatments to prevent, delay, or slow the development of one of more of these diseases. Some people with REM sleep behavior disorder (RBD) may go on to develop Parkinson's disease or another related neurological disorder, but many do not.

Official Title
-----------------
Understanding Autonomic Function in REM Sleep Behavior Disorder, Parkinsonism and Controls

Conditions
-----------------
REM Sleep Behavior Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Idiopathic REM sleep behavior Exclusion Criteria: Parkinson's disease Alzheimer's disease Multiple system atrophy Dementia Minors

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

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

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

Study Plan
=================
How is the study designed?
-----------------
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
-----------------
REM Sleep Behavior Disorder, RBD, Dream, Dreams
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Disease

Study Overview
=================
Brief Summary
-----------------
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.

Detailed Description
-----------------
The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records.

Official Title
-----------------
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Disease

Conditions
-----------------
Gut Microbiome, Gastrointestinal Microbiome

Intervention / Treatment
-----------------
* Other: There is no intervention in this study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study 2. Male or female patients of any age (interest is given to children to compare with mothers). Exclusion Criteria: 1. Refusal to sign informed consent form 2. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy. 3. Postoperative stoma, ostomy, or ileoanal pouch 4. Participation in any experimental drug protocol within the past 12 weeks 5. Treatment with total parenteral nutrition 6. Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial 7. Inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| General Population<br>The general population will have their microbiome sequenced from stool samples provided. | Other: There is no intervention in this study<br>* There is no intervention in this study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing | Relative abundance of bacterial classes within taxonomic phyla and, more broadly, within their domain will be analyzed by sequencing the gut microbiome. These data will then be categorized among specific gastrointestinal disease types. | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of Sequencing Methods | To validate the methods used to sequence samples | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Microbiome
Atopic Dermatitis-Like Skin Disease in Pediatric Heart Transplant Patients

Study Overview
=================
Brief Summary
-----------------
The skin disease found in pediatric heart transplant patients represents an atopic dermatitis-like rash that is refractory to systemic immunomodulation.

Detailed Description
-----------------
We want to determine whether pediatric heart transplant patients with an atopic dermatitis-like rash report a personal and/or family history of atopy (asthma, allergies and atopic dermatitis). In addition comparisons will be made between the presence of atopy between patients with and without the skin rash. Comparisons will be made of systemic immunosuppressive therapies between patients with and without the atopic dermatitis-like rash. Determination will be made as to whether histologic characterization of a skin biopsy specimen is consistent with AD. Thorough evaluations will be made of patients in the clinic with this rash and the presence of bacterial superinfection will be ruled out.

Official Title
-----------------
Atopic Dermatitis-Like Skin Disease in Pediatric Heart Transplant Patients

Conditions
-----------------
Dermatitis

Intervention / Treatment
-----------------
* Procedure: Skin Biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have had a heart transplant. Patients must be less than 16 years of age. Exclusion Criteria: Patients who have not had a heart transplant. Patients who are greater than 16 years of age.

Ages Eligible for Study
-----------------
Maximum Age: 16 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Skin Biopsy|Skin biopsy.|

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
-----------------
Post Pediatric Heart Transplant
Assessment Of The Inhalation Profiles Of Four Dry Powder Inhalers In Patients With Variable Degrees Of Lung Obstruction

Study Overview
=================
Brief Summary
-----------------
Assessment of the inhalation profiles of four dry powder inhalers in patients with variable degrees of lung obstruction

Detailed Description
-----------------
Randomized to device sequence

Official Title
-----------------
A Randomized Cross-Over Study Investigating The Inhalation Profiles Of Four Dry Powder Inhalation Devices In Subjects With Asthma And Chronic Obstructive Pulmonary Disease.

Conditions
-----------------
Asthma, Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
-----------------
* Device: CRC-749
* Device: Diskus
* Device: Twisthaler
* Device: Miat Monohaler


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with a physician documented history or diagnosis of asthma for at least 6 months Reversibility, defined as an increase in FEV1 at the Screening visit of greater than or equal to 12% and 200 mL Subjects with a physician documented history or diagnosis of mild or severe Chronic Obstructive Pulmonary Disease Exclusion Criteria: Female subjects who are pregnant Subjects who have a history of life-threatening asthma/COPD or who have experienced two or more exacerbations requiring hospitalization in the 12 months prior to screening Evidence of lower respiratory tract infection Subjects diagnosed with pulmonary fibrosis, bronchiectasis, pneumoconiosis, sarcoidosis or tuberculosis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Dry Powder Inhalers<br> | Device: CRC-749<br>* There is no drug being used. This is a device.<br>Device: Diskus<br>* There is no drug being used. This is a device.<br>Device: Twisthaler<br>* There is no drug being used. This is a device.<br>Device: Miat Monohaler<br>* There is no drug being used. This is a device.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Inspiratory Flow Rate |  | Day 3-10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pressure Slope |  | Day 3-10 | 
| Peak Pressure Drop |  | Day 3-10 | 
| Time to Peak Pressure Drop |  | Day 3-10 | 
| Inhaled Volume |  | Day 3-10 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Inhalation profiles, asthma, COPD
Pain Management After Forefoot Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to compare the efficacy of transdermal fentanyl to placebo both administered together with peroral nonsteroidal antiinflammatory drug (NSAID) and paracetamol in treatment of postoperative pain after hallux valgus or hallux rigidus surgery.

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Drug: Fentanyl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: unilateral hallux valgus or hallux rigidus surgery 18-75 yrs old ASA I-III Exclusion Criteria: previous history of intolerance to the study drug history of alcoholism drug abuse psychological or other emotional problems that are likely to invalidate informed consent sleep apnoea BMI ≥ 35 kg/m2

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fentanyl<br> | Drug: Fentanyl<br> <br> |
| Placebo Comparator: placebo<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Consumption of rescue opioid | Also adverse effects were evaluated but this evaluation was not the first or secondary outcome measure | on the 1st postoperative day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain on a numerical scale | The adverse effects were evaluated but the evaluation was not the first or secondary outcome measure | on the 1st postoperative day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hallux valgus, Forefoot, transdermal fentanyl
The Kunshan Elderly Health Study

Study Overview
=================
Brief Summary
-----------------
The Kunshan Elderly Health Study (KEHS) is a community-based prospective cohort study of chronic disease, mortality and associated factors among elderly adults in Kunshan, Eastern China.

Detailed Description
-----------------
The Kunshan Elderly Health Study (KEHS) is a project organized by the Soochow University, in collaboration with the Kunshan & Suzhou Centers for Disease Control and Prevention. It was primarily designed to assess risk factors (nutritional, metabolic, lifestyle, etc.) for chronic diseases and mortality among community residents aged 65 years and above, and explore effective intervention measures, so as to ultimately reduce the burden of disease and promote healthy aging. In addition, findings of this study would contribute to further understanding of pathogenesis of the chronic diseases and provide new ideas for precise prevention, drug development and risk prediction.

Official Title
-----------------
The Kunshan Elderly Health Study - a Community-based Prospective Cohort Study of Chronic Disease, Mortality and Associated Factors Among Elderly Chinese

Conditions
-----------------
Cancer, Cardiovascular Diseases, Diabetes Mellitus, Cognitive Impairment, Sarcopenia, Frailty, Depression

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Locally registered-residents in Kunshan Aged 65 years or above Voluntary agreement to participate in the study (with written informed consent) Exclusion Criteria: Patients with stroke, coronary heart disease or cancer Patients with severe physical or mental illness People unable to complete the survey

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- |
| The Kunshan Elderly Health Study (KEHS)<br>Community-based observational cohort. | Other: No intervention<br>* No intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of chronic diseases | Chronic diseases including cardiovascular disease, diabetes, cancer, etc. will be identified by chronic disease registries and active follow-up | Trough study completion, an average of 10 years | 
| Mortality | Total and cause-specific mortality | Trough study completion, an average of 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cohort, Nutrition, Lifestyle, Elderly
What do Patients Expect After Scaphoid Fractures?

Study Overview
=================
Brief Summary
-----------------
This study will assess patients expectations pre-op and assess their views on their outcome at one year follow up

Detailed Description
-----------------
Using Trauma expectation factor and trauma outcome measure questionnaire. At fracture time and at one year post fracture Analyse according to age, sex, fracture pattern, type of intervention

Official Title
-----------------
What do Patients Expect After Scaphoid Fractures?

Conditions
-----------------
Expectations

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed diagnosis of a scaphoid fracture Age > 18 Consent for one year follow up Exclusion Criteria: Age <18 Polytrauma (Multiple systems/ Multiple fractures) Ipsilateral fractures of the upper limb that may become distracting or affect rehabilitation Delayed presentation with higher risk of non-union or avascular necrosis

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient expectations after scaphoid fractures | Trauma Expectation Factor (TEF) questionnaire will be used at the time of injury - followed by the Trauma Outcome Measure (TOM) questionnaire at 1 - year post injury. - Together = TEFTOM. A higher TEF score indicates higher expectations of recovery, while a lower indicated poor expectations. Discrepancy between the two scores demonstrate poor correlation between what the patient expects and what the outcome is. | 1 Year |
Acceptability and User Perceptions of Artificial Intelligence-based Mobile Applications Adoption for Weight Management: A Sequential Explanatory Study

Study Overview
=================
Brief Summary
-----------------
To understand the user perceptions of AI and non-AI-based mobile apps for weight management in people with overweight and obesity.

Official Title
-----------------
Acceptability and User Perceptions of Artificial Intelligence-based Mobile Applications

Conditions
-----------------
Weight Management

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants will be recruited if they are above 21 years old, have a BMI ≥23kg/m2 and understand English language. Exclusion Criteria: There will be no exclusion criteria to maximize representation of the general population of Singaporean who are overweight and obese.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: no intervention|National University Health System,|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unified Theory of Acceptance and Use of Technology 2 (UTAUT2) |  | 2021-2023 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qualitative interviews |  | 2021-2023 |
Outcome Study Following Reimbursement Changes in the Use of Fixed Combination Inhalers in Patients With Asthma or Chronic Obstructive Pulmonary Disease

Study Overview
=================
Brief Summary
-----------------
To investigate how a switch from fixed combination treatment (ICS and LABA) to other treatments influence asthma or COPD treatment failure

Official Title
-----------------
Outcome Study Following Reimbursement Changes in the Use of Fixed Combination Inhalers in Patients With Asthma or COPD in Iceland

Conditions
-----------------
Asthma, Chronic Obstructive Pulmonary Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who was on treatment with fixed combination asthma or COPD therapy by January 1 2010
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>All patients who was on treatment with fixed combination asthma or COPD therapy by January 1 2010 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate how a switch from fixed combination treatment (ICS and LABA) to other treatments influence asthma or COPD treatment failure |  | Data will be extracted from the medical records and registries on one occassion, covering a period of 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To map out the development of asthma and COPD treatment in Iceland after the change in reimbursement |  | Data will be extracted from the medical records and registries on one occassion, covering a period of 3 years | 
| To investigate health economic outcomes |  | Data will be extracted from the medical records and registries on one occassion, covering a period of 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Epidemiological, asthma, COPD, reimbursement, switch, outcomes associated with the change in reimbursement