linjc16/ctgov huggingface dataset:
Regional Native American Community Networks Program (RNACNP)

Study Overview
=================
Brief Summary
-----------------
Aim: Determine the overall effectiveness of a targeted digital messaging intervention at improving colorectal cancer (CRC) screening rates compared to care as usual. Hypothesis: Screening rates will be higher for patients who receive the digital messaging intervention, compared to the control group in which patients receive care as usual.

Detailed Description
-----------------
Native People for Cancer Control is one of the projects under Partnerships for Native Health, and is 1 of 23 Community Networks Programs funded by the National Cancer Institute. The aim of Native People for Cancer Control is to reduce cancer health disparities by conducting training, research, education and outreach, in collaboration with American Indian and Alaska Native communities. We do this work in partnership with Native people, communities, and organizations in an 8-state area, including: Alaska, Washington, Wyoming, Oregon, Idaho, Montana, North Dakota, and South Dakota. Our program consists of 4 cores: Administrative Core: assists with grant administration, budgeting, sub-contracts with Tribes, program planning, and reporting. Outreach/Education Core: assists with cancer education, outreach, health promotion, and cancer prevention activities among urban and rural AI/AN people. Training Core: builds capacity for Native faculty-level investigators, and students, to conduct research. Research Core: conducts community-based participatory research on colorectal cancer screening, health literacy, health communication, and cancer risk factors among American Indian and Alaska Native people. The main research project under Native People for Cancer Control is titled, Innovations in Enhancing Colorectal Cancer Screening. The goal of this project is to develop, implement, and evaluate a community wide, multi-media campaign to improve colorectal cancer screening among American Indians and Alaska Natives in 3 communities.

Official Title
-----------------
Innovations in Enhancing Colorectal Cancer Screening

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Behavioral: Lifestyle, screening


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: AI/AN Age 50-75 Active clinical patient Exclusion Criteria: Not AI/AN

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 75 Years

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

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

Design Details

Primary Purpose: Screening
Intervention Model: Crossover Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Text Messaging<br> | Behavioral: Lifestyle, screening<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Colorectal Cancer Screening, beginning age 50 |  | 9 month intervention |
Pharmacogenomics Studies of Antidepressants

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to establish the clinical effectiveness of antidepressants by pharmacogenomic approach, and to determine the levels of inflammatory factors between the baseline and the end point of the study in Taiwanese major depressive disorder (MDD) patients.

Conditions
-----------------
Major Depressive Disorder, Antidepressive Agents, Pharmacogenetics, Venlafaxine, Fluoxetine

Intervention / Treatment
-----------------
* Drug: Venlafaxine
* Drug: Fluoxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 16-65 years old Signed informed consent by patient or legal representative Hamilton Rating Scale for Depression (HDRS) scores ≥ 16 A diagnosis of MDD according to DSM-IV criteria made by a specialist in psychiatry Exclusion Criteria: monoamine oxidase inhibitor or antidepressant treatment within two weeks prior to entering the study A DSM-IV diagnosis of substance abuse within the past three months An organic mental disease, mental retardation or dementia A serious surgical condition or physical illness Patients who were pregnant or breastfeeding

Ages Eligible for Study
-----------------
Minimum Age: 16 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: venlafaxine<br> | Drug: Venlafaxine<br>* The initial dose of venlafaxine was 37.5 mg once daily for 4 days titrated to 75 mg once daily, which could be increased by 75 mg in divided doses to a maximal daily dose of 225 mg.<br>|
| Experimental: fluoxetine<br> | Drug: Fluoxetine<br>* The initial dose of fluoxetine was 20 mg once daily, which could be increased by 20 mg in divided doses to a maximal daily dose of 80 mg.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Depression Rating Scale (HDRS) |  | baseline | 
| Hamilton Depression Rating Scale (HDRS) |  | 2 weeks | 
| Hamilton Depression Rating Scale (HDRS) |  | 4 weeks | 
| Hamilton Depression Rating Scale (HDRS) |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C-reactive Protein and IL-6 |  | baseline | 
| fasting blood glucose, lipid profiles |  | baseline | 
| C-reactive Protein and IL-6 |  | 6 weeks | 
| fasting blood glucose, lipid profiles |  | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Major Depressive Disorder, Antidepressants, Pharmacogenetics, venlafaxine, fluoxetine
Cell Free DNA for the Diagnosis and Treatment in Early NSCLC

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate whether peripheral circulating cell-free tumor DNA (cfDNA) can aid screening of recurrence after complete resection of early stage non-small cell lung cancer.

Detailed Description
-----------------
During evolution of primary tumor, tumor cells can be released into the bloodstream. It has also been shown that circulating cell-free tumor DNA (cfDNA) is released from apoptotic or necrotic tumor cells. In a study of cfDNA level after surgery in colon cancer patients, they suggested that cfDNA could detect recurrence of cancer several months earlier than the conventional follow up studies. Following several reports have suggested that cfDNA can invade host cells and alter host cell biology to cause cancer metastasis. In this regard, we will collect from non-small cell lung cancer patients cohort who underwent curative resection, and will evaluate whether peripheral cfDNA can aid early detection of cancer recurrence. We will also study the genomic signature of cfDNA to assess the relationship between cfDNA and clinical outcome of non-small cell lung cancer patients.

Official Title
-----------------
Prospective Feasibility Study of Cell Free Circulating Tumor DNA for the Diagnosis and Treatment Monitoring in Early-stage Non-small Cell Lung Cancer

Conditions
-----------------
Non-small Cell Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All subjects need to sign the informed consent form All subjects have Non-small cell lung cancer which suspected on chest CT or confirmed pathologically preoperatively. Non-small cell lung cancer have to confirmed pathologically after operation Clinical stage I - IIIA by AJCC 7th staging system Exclusion Criteria: Have been undergone chemotherapy or radiotherapy due to non-small call lung cancer Have been diagnosed any type of cancer other than cancer of skin, thyroid, uterine cervix with 3 years before enrollment Recurrent lung cancer Stage IIIB, IV by AJCC 7th staging system

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| Recurrence | Recurrence of primary tumor documented by diagnostic imaging with or without biopsy | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non-small cell lung cancer, Recurrence, cfDNA
An Open-Label, Long-Term Study With AL-4943A Ophthalmic Solution, 0.2% in Patients With Allergic Conjunctivitis

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to assess safety and efficacy of long-term use of AL-4943A (Olopatadine Hydrochloride Ophthalmic Solution, 0.2%) in patients with allergic conjunctivitis.

Official Title
-----------------
An Open-Label, Long-Term Study With AL-4943A Ophthalmic Solution, 0.2% in Patients With Allergic Conjunctivitis

Conditions
-----------------
Allergic Conjunctivitis

Intervention / Treatment
-----------------
* Drug: Olopatadine Hydrochloride Ophthalmic Solution, 0.2%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must provide written consent. Subjects must have a diagnosis of allergic conjunctivitis. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Itching and/or hyperemia associated with diseases other than allergic conjunctivitis. Retinal detachment, diabetic retinopathy, or any progressive disease in posterior segment of the eye. Known history of ocular infection. Contact lens wear during study. Pregnant, nursing. Participation in another clinical study within 30 days of Informed Consent. Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 12 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: AL-4943A<br>Olopatadine Hydrochloride Ophthalmic Solution, 0.2%, 2 drops instilled in each eye twice daily for 10 weeks | Drug: Olopatadine Hydrochloride Ophthalmic Solution, 0.2%<br> <br> * Other names: PATADAY®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Itching Score by Visit | Ocular itching will be assessed by the subject and graded on a 6-point scale, where 0=did not occur and 5=virtually all the time over the past 3 days. | Up to Week 10 | 
| Mean Total Hyperemia Score by Visit | Ocular hyperemia (redness) will be assessed by the investigator. Total hyperemia score is defined as the sum of the palpebral and bulbar conjunctival scores. | Up to Week 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Subjective Symptoms by Visit |  | Up to Week 10 |
Detection of Peripheral Blood Biomarkers in Intermediate Phase Spinal Cord Injury: Correlation With Neurological and Functional Outcomes, and Comparison to Other Central and Peripheral Neurological Conditions.

Study Overview
=================
Brief Summary
-----------------
This research looks for markers in the blood of people with spinal cord injury that may be a sign of injury severity, or serve as a clue to the degree of recovery. Investigators would also like to compare the marker profile of these patient with that of other neurological conditions such as stroke and Guillain-Barre syndrome. Patients participating in this trial will be those accepted to neuro-rehabilitation in Sheba medical center, Israel. They will join the trial at their arrival to the ward, no less than 2 week after the beginning of their condition, but no later than 3 months. Patients will be examined by the research staff three times: At arrival, the patients will be neurologically examined and their functional abilities will be assessed. Blood will be drawn and sent to the lab. At 6 months after the beginning of the neurological condition the same will be repeated: the patients will be neurologically examined and their functional abilities will be assessed, and blood will be drawn and sent to the lab. The final examination will take place 1 year after the beginning of the neurological condition. This time only the neurological and functional abilities will be assessed without blood tests. The blood samples will be tested in the research lab. Then investigators shall compare the clinical findings with the laboratory findings, and see if any of the markers found reflect the injury severity or predict the recovery.

Conditions
-----------------
Spinal Cord Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of traumatic or non-traumatic Spinal cord injury, Guillain-barre syndrome or Stroke No more than 3 months after injury or disease onset Condition severe enough to necessitate hospital/day care unit Signed the informed consent form Exclusion Criteria: Psychiatric or cognitive situations that may interfere with the trial

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| spinal cord injury<br> | |
| other neurological conditions<br> | |

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
-----------------
spinal cord injury, biomarkers, rehabilitation, functional independence, prognosis
Randomized Trial of Follow-up Strategies in Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether family physician 'routine follow-up care' of women with breast cancer in remission is an acceptable alternative to the existing system of specialist follow-up. Primary outcome measure are event rates of oncological catastrophes and quality of life.

Detailed Description
-----------------
see above

Official Title
-----------------
A Randomized Trial of Follow-up Strategies in Breast Cancer

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Behavioral: Follow-up Strategy for Breast Cancer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with breast cancer on well follow-up at regional cancer centres in Ontario and Manitoba Diagnosed at least 12 months previously (range 9-15 months) Without evidence of active disease (i.e., stages IIIB and IV excluded) Free from any primary treatment complications Exclusion Criteria: Primary treatment at least 3 months previously, except for continued use of tamoxifen Still experiencing complications of primary treatment (patients will become eligible once complications resolve provided they are within the 6 month window) Unable to identify an acceptable family physician to provide follow-up Language or literacy skills inconsistent with completing questionnaires Unable to comply with study protocol including completion of questionnaires Previously enrolled in a study which requires continued follow-up in specialist or peripheral clinics Actively followed at a cancer centre for another primary cancer
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Follow-up Strategy for Breast Cancer|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of clinically catastrophic events |  | Up to 5 yrs after randomization | 
| Rate of Karnofsky performance status < 70 |  | Up to 5 yrs after randomization | 
| Psychosocial well being of patients in remission |  | Up to 5 yrs after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Related Quality of Life after recurrence |  | Up to 5 yrs after randomization | 
| Survival |  | Up to 5 yrs after randomization | 
| Economic evaluation |  | Up to 5 yrs after randomization | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast Cancer, Follow-up Strategy, Follow-up Care, Family Physician, Oncologist
High-sensitivity C-reactive Protein and United Kingdom Prospective Diabetes Study (UKPDS) Risk Score in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The UKPDS risk score is recommended to assess global risk for future coronary heart disease (CHD) events in primary prevention. Recently, high-sensitivity C-reactive protein (hsCRP) has emerged as a strong independent risk factor for CHD. 18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) is a promising imaging technique for the evaluation of vascular inflammation that reflects vulnerable atherosclerotic plaque.

Official Title
-----------------
High-sensitivity C-reactive Protein and UKPDS Risk Score in Type 2 Diabetes: Nalysis With 18F-Fluorodeoxyglucose Positron Emission Tomography

Conditions
-----------------
Atherosclerosis, Type 2 Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes Exclusion Criteria: Myocardial infarction, unstable angina, stroke, peripheral artery disease, or cardiovascular revascularization Resting blood pressure ≥160/100 mmHg Malignancy, or severe renal or hepatic disease Participants were free of any lipid-lowering therapies and postmenopausal hormone replacement therapy at least the 6 month period prior to enrollment History of inflammatory condition or those taking medications that might affect inflammatory status within 6 months

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 80 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 |
| --- | --- | --- |
Reliability of Spasticity Measurement With Lokomat

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the reliability of spasticity measurement with Lokomat

Conditions
-----------------
Spasticity, Lokomat

Intervention / Treatment
-----------------
* Other: L-stiff
* Other: Ashworth


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients affected by lower limbs spasticity Exclusion Criteria: medical contraindications to mobilization with Lokomat

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| spasticity<br>patients affected by spasticity of the lower limbs | Other: L-stiff<br>* spasticity measurement with Lokomat<br>Other: Ashworth<br>* spasticity measurement with Ashworth scale<br>|
| controls<br>healthy subjects | Other: L-stiff<br>* spasticity measurement with Lokomat<br>Other: Ashworth<br>* spasticity measurement with Ashworth scale<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation of spasticity measurement obtained with L-Stiff (Lokomat) and Ashworth scale |  | 1 day |
Pregabalin Epilepsy Add-On Trial

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy of pregabalin as adjunctive therapy, using a flexible, optimized dose schedule with dose adjustment based on clinical response and tolerability, compared to placebo in subjects with partial seizures

Official Title
-----------------
Pregabalin Add-On Titration Trial: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of Pregabalin (150 mg - 600 mg/Day) Using a Flexible, Optimized Dose Schedule in Subjects With Partial Seizures

Conditions
-----------------
Partial Seizures

Intervention / Treatment
-----------------
* Drug: pregabalin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have a diagnosis of epilepsy with partial seizures (as defined in the ILAE Classification of Seizures) and be currently taking 1-3 AEDs Have a minimum of 4 partial seizures occurring over at least 2 days during the 6-week baseline with no 28-day period free of partial seizures Exclusion Criteria: Have a treatable cause of seizures Are currently receiving treatment with CNS-active compounds (exception: single antidepressant, hypnotics, and standard AEDs), vigabatrin, Felbatol (felbamate), Neurontin (gabapentin)

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: pregabalin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response ratio (RRatio or symmetrized percent change) for all partial seizures |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder rate, Percent change, Percent of SGTC responders, Seizure freedom measures, Change in number of seizure-free days (SFD) per a 28-day period, Analysis by seizure type, HADS, Weekly and endpoint mean sleep interference scores from DSIS, QOLIE-31 |  |  |