linjc16/ctgov huggingface dataset:
Comparison of SoloSTAR With a Syringe-administered Glargine Insulin in Diabetic Patients From the Hospital

Study Overview
=================
Brief Summary
-----------------
In this study the investigators would like to test the hypothesis that in diabetic patients discharged from the hospital, SoloSTAR Glargine insulin will be superior to syringe-injected Glargine in terms of diabetes control, compliance, and patient satisfaction and preference. The investigators will test this hypothesis in a randomized, crossover trial.

Official Title
-----------------
Comparison of SoloSTAR With a Syringe-administered Glargine Insulin in Diabetic Patients Discharged From the Hospital

Conditions
-----------------
Diabetes

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with type 1 and 2 diabetes discharged from the hospital with recommendations to take Glargine Exclusion Criteria: Patients unwilling to participate and patients incapable of complying with the study regimen, such as patients with alcohol and drug addiction problems and patients with severe mental illness

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 70 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pen-administered vs syringe-admnistered Glargine<br>SoloSTAR pen-administered Glargine insulin then syringe-administered Glargine insulin | Drug: Glargine insulin<br>* 20-180 units per day<br>|
| Active Comparator: Syringe-administered vs pen-administered Glargine<br>Syringe-administered Glargine insulin and then pen-administered Glargine insulin | Drug: Glargine insulin<br>* 20-180 units per day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c at Three Months of Each Period of Treatment | Data was collected by group | Baseline, Month 3 (End of Intervention 1), Month 6 (End of intervention 2) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance and Patient Satisfaction |  | 6 months of treatment after discharge from the hospital | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes
Treatment of Depression in Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to evaluate the efficacy of Traditional Chinese Medicine-Xiaoyao Pill (Herb extracts)on depression, compared to placebo and Bupleurum+Ginkgo in patients with Parkinson's disease.

Detailed Description
-----------------
Depression as the most common non-motor comorbidity of Parkinson's disease (PD), have a negative impact on disability and quality of life. Traditional Chinese Medicine has shown effects on several depression. It is not known if TCM also is effective for depression in PD. This study is to investigate Xiaoyao Pill, an antidepressant in TCM, on depression in PD. A total of 60 patients with depression in PD will be randomized to each of the three arms.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled Study of Xiaoyao Pill Treatment of Depression in Patients With Parkinson's Disease

Conditions
-----------------
Depression in Parkinson's Disease

Intervention / Treatment
-----------------
* Drug: Xiaoyao Pill
* Drug: Bupleurum+Ginkgo
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parkinson's disease without dementia Depression Males or females Willing and able to give informed consent Exclusion Criteria: cognitive dysfunction other serious diseases

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 80 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group 1<br> | Drug: Xiaoyao Pill<br>* herb extracts,were received two times a day for 12 weeks without dose changing.<br>|
| Active Comparator: group 2<br> | Drug: Bupleurum+Ginkgo<br>* herb extracts, were received two times a day for 12 weeks without dose changing.<br>|
| Placebo Comparator: group 3<br> | Drug: placebo<br>* The placebo looked like herb extracts and were also received two times a day for 12 weeks without dose changing.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Depression Scale | Change of Hamilton Depression Scale score on week 12 from baseline. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the responder rate (defined as score reduction of HAMD-17>=50%) |  | 12 weeks | 
| the Geriatric Depression Scale | GDS-30 | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Depression;, Parkinson's disease;, antidepressant
Knowledge, Attitudes and Clinical Practices of Pediatric Dentists Regarding Covid-19

Study Overview
=================
Brief Summary
-----------------
This study aims to assess the level of knowledge, attitudes and clinical practices of pediatric dentists regarding COVID-19 pandemic outbreak and evaluate the psychological burden on the dentists and children

Detailed Description
-----------------
Aim: This cross sectional study aims to assess the level of knowledge, attitudes and clinical practices of pediatric dentists regarding COVID-19 pandemic outbreak and evaluate the psychological burden on the dentists and children. The study population is pediatric dentists recruited through five pediatric dentists Facebook groups. Web-based questionnaire was created using Google forms, structured of multiple-choice questionnaire, and divided into: (demographic, knowledge, practices, and behavior management techniques) sections. Descriptive statistical analysis was used to describe items included in the survey. Numbers and percentages were used to describe categorical data.

Official Title
-----------------
Knowledge, Attitudes and Clinical Practices of Pediatric Dentists Regarding Covid-19

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

Intervention / Treatment
-----------------
* Other: Questionaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Practicing pediatric dentists working in private practices or institutions Exclusion Criteria Dentists specialized in other disciplins
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pediatric dentists<br>Pediatric dentists following Facebook groups for pediatric dentists and practicing dentistry nowadays | Other: Questionaire<br>* Questionnaire addressing pediatric dentists behaviors and practices during the COVID-19 pandemic<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responses | Respondents answers to survey questions | 0 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, Pediatric Dentists, Attitudes, Clinical Practices
Penn Biobank Return of Research Results Program

Study Overview
=================
Brief Summary
-----------------
The overall goal of the proposed research is to assess the feasibility of a randomized study evaluating the non-inferiority of an electronic Health (e-Health) delivery alternative (e.g. private web portal) as compared to return of actionable genetic research results with a genetic counselor.

Official Title
-----------------
A Randomized Protocol Evaluating Return of Actionable Genetic Research Results to Biobank Participants

Conditions
-----------------
Cancer, Cardiovascular Diseases, Hereditary Cancer, Hereditary Cardiac Amyloidosis

Intervention / Treatment
-----------------
* Behavioral: e-Health (web-based) disclosure portal
* Behavioral: Provider mediated disclosure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consented participant in University of Pennsylvania Biobank who previously submitted a DNA sample for research testing English speaking Aged 18 years or older Agreed to be re-contacted in the future or did not indicate a preference on future contact regarding research results Have an actionable mutation or have been selected as a control participant Have not previously received actionable results of clinical genetic testing Exclusion Criteria: Deceased assessed by electronic medical record, death index or identified after contact Evidence in the electronic medical record that the subject has already received the same actionable result through clinical genetic testing

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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Actionable gene result for cancer risk<br> | Behavioral: e-Health (web-based) disclosure portal<br>* Patient uses secure web-based portal to access genetic research results<br>Behavioral: Provider mediated disclosure<br>* Patient has disclosure of genetic research result by a provider (genetic counselor)<br>|
| Experimental: Actionable gene result for cardiovascular disease risk<br> | Behavioral: e-Health (web-based) disclosure portal<br>* Patient uses secure web-based portal to access genetic research results<br>Behavioral: Provider mediated disclosure<br>* Patient has disclosure of genetic research result by a provider (genetic counselor)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion of surveys | Participant will self-complete surveys to collect psychological and knowledge outcomes | Baseline survey prior to disclosure of results, and then two post-disclosure surveys at 2-7 days and 6 months |
PROMs To Improve Care- Standardized vs Patient Specific

Study Overview
=================
Brief Summary
-----------------
To examine the impact of using 2 validated PROMs during the care of an orthopaedic condition on shared decision making, patient centered care, and patient outcomes.

Official Title
-----------------
PROMs To Improve Care: A Pragmatic RCT on Standardized and Patient Specific PROMs on Outcomes After Hand Surgery

Conditions
-----------------
Hand Injuries

Intervention / Treatment
-----------------
* Other: Patient Specific Functional Scale
* Other: PROMIS PF


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hand surgery patients over age 18, english fluency and literacy, able to take informed consent Exclusion Criteria: -

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

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PSFS group<br>Patients in this arm will complete the patient specific functional scale (PSFS) during their visits | Other: Patient Specific Functional Scale<br>* A validated patient reported outcome measure that asks patients to write down activities and score them 0 to 10.<br>|
| Experimental: PROMIS PF group<br>Patients in this arm will complete the PROMIS Physical Function during their visits | Other: PROMIS PF<br>* A computer adaptive, validated patient reported outcome measure that measures physical function on a 1 to 100.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decisional Conflict Scale (DCS) | DCS is a validated tool that measures patient uncertainty about decisions. it is scored 0 to 100, with higher scores indicating greater conflict about the decisions. | Immediately after the clinical encounter, same day as clinical encounter |
Effect of Salsalate on Bed Rest-Induced Vascular Dysfunction

Study Overview
=================
Brief Summary
-----------------
Physical inactivity induces vascular dysfunction and glucose intolerance during five days of bed rest. This study will investigate the effects of salsalate on these responses. Subjects will be randomized to treatment with salsalate or placebo for four days prior to initiation of bed rest. Vascular function in the brachial artery will be determined by ultrasound prior to treatment and before and after the 5-day bed rest protocol. We hypothesize that treatment with salsalate will be associated with protection again the development of glucose intolerance and vascular dysfunction in this setting.

Official Title
-----------------
Effect of Physical Inactivity on Endothelial Function

Conditions
-----------------
Insulin Resistance

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers Exclusion Criteria: Pregnancy History of Coronary Artery Disease Diabetes Mellitus Hypertension Cigarette smoking History or family history of deep vein thrombosis or pulmonary embolism Abnormal renal function Liver function tests greater than two times the upper limit of normal Anemia Use of viagra or other PDE5 inhibitor Hypercholesterolemia Aspirin allergy/sensitivity Asthma with nasal polyps Peptic ulcer disease/Gastrointestinal bleeding Any ongoing drug treatment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Salsalate<br>Salsalate | Drug: salsalate<br>* Salsalate 3-4 grams per day as tolerated for nine days<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reactive hyperemia in the femoral artery |  | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reactive hyperemia in the brachial artery |  | 5 days | 
| Oral glucose tolerance test |  | 5 days |
Flagyl Microbiome in Crohn's Disease

Study Overview
=================
Brief Summary
-----------------
This study will compare the types of bacteria in the colon before and after colon resection surgery. The investigator will also compare standard post-operative antibiotic treatment to flagyl (metronidazole) treatment post-operatively to see if giving the antibiotic, decreases the incidence of return of Crohn's disease.

Detailed Description
-----------------
Participants who are scheduled for colon resection for Crohn's disease will be invited to take part in this randomized study. Participants will be randomized 1:1 to either Metronidazole 250 mg three times a day, starting after surgery, for three months, or the local usual standard of care after surgery, which may be a different antibiotic prescribed by the physician. Participants will also provide a stool sample at the following time points: prior to surgery, the day of discharge, at their follow-up appointment (usually about two weeks after surgery), three months, and six months. Participants will also be followed to determine their clinical outcome.

Official Title
-----------------
Does the Microbiome Change With Flagyl Treatment After Ileocolic Resection for Crohn's Disease

Conditions
-----------------
Crohn Disease

Intervention / Treatment
-----------------
* Drug: Metronidazole Oral


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20-80 years old who is deemed an acceptable surgical candidate for ileocolic resection. Exclusion Criteria: any patients that are dependent on total parenteral nutrition and unable to tolerate oral intake patients who will undergo resection but will have an ileostomy created patients on maintenance antibiotics for their disease

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized 1:1 study groups
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Metronidazole<br>Metronidazole 250 mg three times a day | Drug: Metronidazole Oral<br>* 250 mg Three times a day<br>* Other names: Flagyl;|
| No Intervention: Standard care<br>Standard post-operative care, which may or may not include post-operative antibiotics | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in bacteria in the gut | Any change in the types of bacteria in the gut during the study period. This will be done by doing genetic analysis of differences in stool over time. | six months |
Vasoactive Hormones During the Night in Patients With Obstructive Sleep Apnea and Healthy Controls.

Study Overview
=================
Brief Summary
-----------------
Obstructive sleep apnea syndrome is complicated by considerable cardiovascular morbidity and mortality, at least partly due to hypertension. Nocturnal hypoxia, hypercapnia and acidosis stimulate chemoreceptors and presumably increased secretion of vasoactive hormones which might be responsible for hypertension in these patients. The aim of this study is to measure the secretion of vasoactive hormones at night and to analyse the relationship between vasoactive hormones, oxygen saturation and the blood pressure at night.

Conditions
-----------------
Healthy, Obstructive Sleep Apnea

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female Age 20-65 Obstructive sleep apnea Exclusion Criteria: Drug or alcohol abuse Pregnancy or breast feeding Cancer Clinical signs or history of disease in the heart, lungs, kidney or endocrine organs Abnormal laboratory tests Albuminuria or glucosuria Aterial hypertension for healthy subjects

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

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

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

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
-----------------
Obstructive sleep apnea, Vasoactive hormones, Blood pressure
Effectiveness and Safety of INGN 201 in Combination With Chemotherapy Versus Chemotherapy Alone

Study Overview
=================
Brief Summary
-----------------
There is a need for more treatment options for patients with recurrent squamous cell cancer of the head and neck (SCCHN). These tumors usually have a variety of genetic defects that include disruption of the p53 pathway, a pathway that would ordinarily work to prevent the development of tumors. In this study the transfer of the p53 gene to tumor cells using a modified adenovirus (INGN 201) in combination with chemotherapy (cisplatin and fluorouracil) will be compared to chemotherapy with cisplatin and fluorouracil in patients who have failed surgery and radiotherapy.

Conditions
-----------------
Carcinoma, Squamous Cell

Intervention / Treatment
-----------------
* Genetic: INGN 201


Participation Criteria
=================
Eligibility Criteria
-----------------
18 years or older Must have had radiation treatment Eligible for chemotherapy Not eligible for surgery

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: INGN 201|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
-----------------
Recurrent Squamous Cell Carcinoma of the Head and Neck