linjc16/ctgov huggingface dataset:
Web-delivered Provider Intervention for Tobacco Control

Study Overview
=================
Brief Summary
-----------------
This is a randomized control trial to determine the efficacy of a multi-modal intervention in improving smoking cessation processes of care and patient outcomes in community-based primary care practices. Our Overall Goal is to advance science related to the use and impact of the Internet in health services delivery, specifically smoking cessation, by targeting primary care clinical microsystems. A clinical microsystem is defined as the smallest functional healthcare unit. A clinical microsystem is not simply equivalent to a clinical team of doctors and nurses, but also the panel of patients cared for by the providers and the processes of care that are used.

Official Title
-----------------
QUIT-PRIMO: Web-Delivered Clinical Microsystem Intervention for Tobacco Control

Conditions
-----------------
Smoking Cessation

Intervention / Treatment
-----------------
* Behavioral: Decide2Quit
* Behavioral: Smoking Coach


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Community based primary care practices who have: Internet access in office Sees 4 - 5 smokers per week Exclusion Criteria: Practices with more than five providers

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Information Prescription<br>Providers will give usual care to patients who smoke and a paper prescription with the name and url of the Smoking Coach website. The smoking coach website is a tailored, public health intervention for smoking cessation. | Behavioral: Smoking Coach<br>* Control Patients will be referred by paper prescription to the control- Smoking Coach website.<br>|
| Experimental: QUIT-PRIMO<br>Providers will give usual care to patients who smoke and then refer patients to the online smoking cessation system electronically. | Behavioral: Decide2Quit<br>* Patient intervention website that includes 1) interactive calculators to assess readiness to quit, symptoms and quit plan, 2) motivational content, and 3) links to other high quality information.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician performance on refering patients that smoke cigarettes to the web intervention |  | pre-intervention, 6 months, 12 months and 24 months | 
| Of the smokers who are referred to the web intervention, the number who go to the site |  | preintervention, 6 months, 12 months, 24 months | 
| Point prevalence smoking cessation |  | 6 months |
Effect of Low-carbohydrate/High-fat Diet on Glucose Tolerance and Lipid Profile in Lean, Healthy Women

Study Overview
=================
Brief Summary
-----------------
Intervention studying the effect of a low-carbohydrate/high-fat (LCHF) diet as well as on bout of exercise in combination with either a normal diet or a LCHF diet, in relation to glucose metabolism, insulin sensitivity, lipid profile and body composition.

Official Title
-----------------
Effect of Low-carbohydrate/High-fat Diet on Glucose Tolerance and Lipid Profile in Lean, Healthy Women

Conditions
-----------------
Insulin Sensitivity, Weight

Intervention / Treatment
-----------------
* Other: LCHF diet and a bout of exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Females Normal weight BMI between 18.5 and 25 Moderately trained Exclusion Criteria: Smokers/tobacco users pregnancy familial cardio-vascular-disease diabetes or reduced glucose tolerance under- or overweight (BMI under 18.5 or over 25) top athletes

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: LCHF diet and a bout of exercise<br>LCHF diet for 3 weeks, where E% 70 fat, E% 20-25 proteins and 20g or less carbohydrates. Oral glucose tolerance test on the morning of day 21 followed by a bout of exercise in the afternoon (indoor bicycle, 60min at 75% HFpeak). The following morning (day 22) a new oral glucose tolerance test. Oral glucose tolerance test results from pre-tests used to determine the effect of LCHF and a bout of exercise on insulin sensitivity. | Other: LCHF diet and a bout of exercise<br>* Low-carbohydrate/high-fat diet; effect on insulin sensitivity, lipid profile, weight and body composition. Participants ingested LCHF diet for three weeks before undergoing an oral glucose tolerance test. The same afternoon the participated in an one hour indoor bicycle training at 75% at HFpeak. The following morning they underwent a new oral glucose tolerance test. Body composition and weight were measured before and after the intervention. Oral glucose tolerance test was also performed before the intervention for baseline. Blood samples were collected before and after the intervention for lipid profile analyses.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve glucose (0, 15, 30, 45, 60, 90 and 120 min) | performed by oral glucose tolerance test, 75 g glucose, 300 ml water | -1 week, 3 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Insulin sensitivity, Lipid profile, Body composition, Weight
Providing Access to the Visual Environment

Study Overview
=================
Brief Summary
-----------------
Providing Access to the Visual Environment is a pediatric low vision grant which has the ability to provide comprehensive, interdisciplinary low vision rehabilitation services to every child in Tennessee with a vision impairment. Children, ages 3-21, with best-corrected vision of 20/50 or worse in the better seeing eye are prescribed optical devices to improve their visual functioning and trained to use the devices.

Detailed Description
-----------------
Subjects are enrolled each school year based on referrals from school systems in Tennessee, ophthalmologists, and optometrists. A total of 90 new students are enrolled each year. Students are provided a comprehensive low vision rehabilitation evaluation by a low vision optometrist and prescribed optical devices to improve distance appreciation, near reading, and other tasks based on individual needs. Students are then trained to use the devices efficiently by master's level teachers of the visually impaired. The teachers travel to the students environment (school/home/work) for the training. Variables such as ocular disease, age, visual acuity, visual improvement with optical devices, type of optical device, and reading speed are defined for each student. Providing Access to the Visual Environment also provides...

Official Title
-----------------
Providing Access to the Visual Environment

Conditions
-----------------
Vision Impairment

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children age 3 to 21 years of age Enrollment in a school in Tennessee (private or public) - Children that are eligible for services due to visual impairment Low vision Exclusion Criteria: Children who do not have the potential to become readers or use their vision for reading

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 21 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 |
| --- | --- | --- |
| Success to utilize optical devices | Training with external optical devices to improve visual outcome | 3-4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vision, Aids
The Effect of Intravenous Magnesium Sulfate on Intraocular Pressure Following Tracheal Intubation

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to assess the effect of preoperatively administered intra venous magnesium sulfate in attenuating pressure response to laryngoscopy and endotracheal intubation in adult patients scheduled for elective non ocular surgery

Conditions
-----------------
Increased Intra Ocular Pressure (IOP)

Intervention / Treatment
-----------------
* Drug: Magnesium Sulfate
* Drug: normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 to 38 years old ASA I scheduled for elective ENT ambulatory surgeries under general anesthesia Exclusion Criteria: specific major hepatic, renal and cardio-vascular disease known to have allergic reaction to magnesium sulphate or other drugs , -hypermagnesemia hypocalcemia anuria heart block pregnancy any degree of renal insufficiency digitalised patients positive history of glaucoma or intra ocular hypertension refused to participate

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 38 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: magnesium sulfate<br> | Drug: Magnesium Sulfate<br> <br> |
| Placebo Comparator: normal saline<br> | Drug: normal saline<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra ocular pressure |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood pressure,heart rate |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IOP, ophthalmic anesthesia, magnesium sulfate
Efficacy and Safety of Clino-san on Vaginal Dryness of Breast Cancer Patients

Study Overview
=================
Brief Summary
-----------------
Although after treatment for breast cancer such as chemotherapy or hormonal therapy, urogenital atrophy is common, the patients are seldomly treated for several reasons. Management of this problem is important for improving quality of life. Clino-san is a kind of vaginal lubricant with pH 5 which is similar pH of premenopausal vaginal discharge. After randomization of patients, they are treated with Clino-san or placebo 3 times/week for 12 weeks. We check the vaginal symptoms, vag dryness severity score, and ultrasonography at baseline, 4, 8, and 12 weeks of treatment.

Official Title
-----------------
Prospective Randomized Study on Efficacy and Safety of Clino-san® in the Management of Vaginal Dryness in Breast Cancer Patients

Conditions
-----------------
Breast Cancer, Vaginal Atrophy

Intervention / Treatment
-----------------
* Drug: clino-san vaginal lubricant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: breast cancer patients who are treated with chemotherapy or hormonal therapy who experience no menstruation after the previous therapy who complain of vaginal dryness Exclusion Criteria: other cancer patients other severe disease poor compliance

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

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Clino-san 2ml vaginal application 3 times per week for 12 weeks | Drug: clino-san vaginal lubricant<br>* Clino-san 2ml vaginal application 3 times per week for 12 weeks<br>|
| Placebo Comparator: 2<br>placebo 2ml vaginal application 3 times per week for 12 weeks | Drug: clino-san vaginal lubricant<br>* Clino-san 2ml vaginal application 3 times per week for 12 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vaginal dryness score |  | for 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sexual dysfunction |  | for 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chemotherapy, hormonal therapy, urogenital atrophy
Prostate Cancer - Localized Adenocarcinoma Proton Therapy

Study Overview
=================
Brief Summary
-----------------
A Phase II Randomized Trial of Hypofractionated Proton Therapy in Patients With A Localized Prostate Adenocarcinoma

Detailed Description
-----------------
For Proton therapy with prostate adenocarcinoma patients. Arm 1: Proton therapy 3CGE x 20days = Total 60 CGE for 4 weeks. Arm 2: Proton therapy 4.7CGE x 10days = Total 47 CGE for 2 weeks.

Official Title
-----------------
A Phase II Randomized Trial of Hypofractionated Proton Therapy in Patients With a Localized Prostate Adenocarcinoma

Conditions
-----------------
Prostate Adenocarcinoma

Intervention / Treatment
-----------------
* Device: Proton Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Biopsy proven prostate adenocarcinoma Stage: T1-T2cN0M0 ECOG performance status:0-1 Signed study specific informed consent prior to study entry. Exclusion Criteria: Postoperative residual or recurrent tumor Evidence of distant metastasis previous irradiation for the tumor in the same location Adjuvant anti-androgenic hormonal therapy High risk group (NCCN guide line)
Sexes Eligible for Study
-----------------
Male

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Proton Therapy 60 CGE<br>60 CGE (3CGE X 20) for 4wks | Device: Proton Therapy<br> <br> |
| Experimental: Proton Therapy 47 CGE<br>47 CGE (4.7CGE X 10) for 2wks | Device: Proton Therapy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BCFFS | To evaluate biochemical failure-free survival (BCFFS) | up to 5 years from a initial follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute/late toxicity (CTCAE v4.0) | Common Terminology Criteria for Adverse Events (CTCAE) V 4.0 | up to 5 years from a initial follow-up | 
| Disease specific survival | follow-up | up to 5 years from a initial follow-up | 
| EPIC (Extended Prostate Cancer Index Composite) | questionnaire | up to 5 years from a initial follow-up |
Intradermal Vaccination With Stabilized Tumor mRNA - a Clinical Phase I/II Trial in Melanoma Patients

Study Overview
=================
Brief Summary
-----------------
vaccination protocol to induce specific immune responses against melanoma associated antigens by intradermal injections of mRNA coding for the corresponding antigen

Detailed Description
-----------------
vaccination protocol to induce specific immune responses against melanoma associated antigens by intradermal injections of mRNA coding for the corresponding antigen. Antigens used are Melan-A, Mage-A1, Mage-A3, Survivin, GP100 and Tyrosinase. GM-CSF is used as an adjuvans. Phase I/II clinical trial to analyse safety and immune respones in stage III/IV melanoma patients.

Official Title
-----------------
Induction of Specific Immune Responses Against Melanoma-Associated Antigens in Vivo by Intradermal Vaccination With Stabilized Tumor mRNA - a Clinical Phase I/II Trial

Conditions
-----------------
Malignant Melanoma

Intervention / Treatment
-----------------
* Biological: mRNA
* Drug: GM-CSF s.c.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: stage III/IV fresh frozen tumor-tissue age 18-75 informed consent given Karnofsky >= 70% Exclusion Criteria: systemic glucocorticoids brain metestasis other malignancies

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: mRNA|nan|
|Drug: GM-CSF s.c.|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| toxicity |  |  | 
| immune response |  |  |
Registry of Hospitalized Patients Treated With Fondaparinux

Study Overview
=================
Brief Summary
-----------------
Registry of Hospitalized patients at Brigham and Women's Hospital treated with Fondaparinux

Detailed Description
-----------------
The use of antithrombotic agents in the hospital is the mainstay of therapy for the treatment or prophylaxis of venous thromboembolism (VTE) and acute coronary syndrome (ACS). Concern with the administration of heparins and risk for adverse sequelae has led to the development of newer, longer-acting agents. Fondaparinux offers once daily administration with only an extremely small risk of developing heparin induced thrombocytopenia. Recent data have further demonstrated the efficacy and safety of Fondaparinux in VTE and ACS, expanding its use in clinical practice. We aim to: 1) determine how Fondaparinux is being used in a real life clinical setting, a tertiary-care academic medical center (BWH), and 2) assess the associated clinical outcomes at 90 days after initiation of Fondaparinux.

Official Title
-----------------
Registry of Hospitalized Patients Treated With Fondaparinux

Conditions
-----------------
Deep Vein Thrombosis, Pulmonary Embolism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BWH hospitalized patients receiving Fondaparinux
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 |
| --- | --- | --- |
| Venous Thromboembolism and Bleeding Events |  | 90 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | 30 Days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anticoagulation, Thrombosis, Bleeding, Clotting, Pulmonary Embolism, Deep Vein Thrombosis
A Study of Patients With Primary Open Angle Glaucoma or Ocular Hypertension Who Were Insufficiently Responsive to Monotherapy

Study Overview
=================
Brief Summary
-----------------
This is a retrospective chart review and will assess changes in IOP after treatment with any fixed combination in patients who previously received monotherapy.

Conditions
-----------------
Glaucoma, Open-Angle, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: Any Fixed Combination Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of glaucoma or ocular hypertension Previously treated with monotherapy followed by fixed combination therapy for at least 12 weeks Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| POAG or OHT<br>Patients with POAG or OHT previously treated with monotherapy and currently treated with any fixed combination therapy | Drug: Any Fixed Combination Therapy<br>* Patients with POAG or OHT previously treated with monotherapy and currently treated with any fixed combination therapy. This was a retrospective chart review study, so no treatment was administered in this study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Intraocular Pressure (IOP) | IOP is a measurement of the fluid pressure inside the eye. A negative change from baseline indicates an improvement. | Baseline, 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Assessment of Tolerability Using a 4-Point Scale | Patient assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The percentage of patients assessed as good and very good combined are reported. | 12 Weeks | 
| Physician Assessment of Tolerability Using a 4-Point Scale | Physician assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The percentage of patients assessed as good and very good combined are reported. | 12 Weeks | 
| Percentage of Patients Who Maintained Better Compliance With Treatment | Percentage of patients who maintained better compliance with treatment than prior therapy was assessed by the patient on a 3-point scale (better, equal, and worse compliance). | 12 Weeks | 
| Percentage of Patients Continuing on Therapy After 12 Weeks | Percentage of patients continuing on therapy after 12 weeks was assessed as Yes or No. | 12 Weeks |