linjc16/ctgov huggingface dataset:
Mobile Health Cognitive Stimulation in Heroin Users

Study Overview
=================
Brief Summary
-----------------
Heroin use has been related to brain dysfunction particularly in the prefrontal cortex. These effects are evident in neuropsychological impairments in attention, memory and executive functioning of heroin users. To assess these deficits and the application of a novel approach of cognitive stimulation to heroin users in treatment for opioid dependence, we have carried out a neuropsychological intervention program with mobile health technology. Patients diagnosed with opioid dependence were submitted to cognitive stimulation during four weeks in a three-day/week basis.

Official Title
-----------------
Executive Functioning in Heroin Users Following a Mobile Health Cognitive Stimulation Approach: a Randomized Controlled Trial

Conditions
-----------------
Substance Use Disorder

Intervention / Treatment
-----------------
* Behavioral: Mobile health cognitive stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Only patients that scored higher than the cutoff values for their age on the Mini Mental Examination Test and with no clinical scores on the Symptoms Checklist Revised will be included in the study. Exclusion Criteria: Patients with alcohol dependence or with history of previous neurological disorders will be excluded from the study. Patients will be also screened for minimal computer literacy.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Treatment-as-usual<br>This group consists of treatment-as-usual for opioid dependence syndrome. | |
| Experimental: Mobile health cognitive stimulation<br>Cognitive stimulation using mobile technology with m-Health applications. | Behavioral: Mobile health cognitive stimulation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the results of Frontal Assessment Battery - FAB | The participants were assessed in frontal lobe functions at the beginning of the rehabilitation and after 10 rehabilitation sessions, which had the approximate duration of one month. | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Opioid Abuse Disorder, Cognitive Therapy, Executive Function, Mobile Health, Rehabilitation
Osteoporosis Disease Management Demonstration Project (0000-040)

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the impact disease management interventions in treatment compliance among post-fracture and osteoporosis patients.

Official Title
-----------------
Three Methods of Delivering Health Care for Secondary Prevention of Osteoporosis

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Behavioral: Disease Management Assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Members of of the Kaiser Permanente Health Plan who have fractured a bone. Exclusion Criteria: Individuals who are not members of the Kaiser Permanente Health Plan.

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Disease Management Assessment|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment persistence |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction and knowledge |  |  |
Trial Comparing Moviprep and Phosphoral as Bowel Prep Before Colonoscopy

Study Overview
=================
Brief Summary
-----------------
Using Moviprep patients use shorter time to do a bowel prep before colonoscopy. No major single center has docuemted the advantage of using moviprep as bowel prep before colonoscopy.This randomised study was conducted to compare moviprep with the present standard: Phosphoral to investigate the degree of bowel cleasing before colonoscopy in patients suspected of colorectal cancer, and to investigate number of days where patients need to stay home.

Official Title
-----------------
Double Blind Randomised Trial Comparing Moviprep and Phosphoral as Bowel Prep Before

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

Intervention / Treatment
-----------------
* Drug: bowel prep before endoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients suspected of colorectal cancer scheduled for colonoscopy Exclusion Criteria: Patients with previous colorectal surgery Colonis Stenosis ASA > 2

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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Moviprep<br>Moviprep bowel preb | Drug: bowel prep before endoscopy<br>* bowel prep before colonoscopy<br>|
| Active Comparator: Phosphoral<br>Bowel prep | Drug: bowel prep before endoscopy<br>* bowel prep before colonoscopy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of bowel cleansing | Will be estimated by the patients and the colonoscopist | 1 Day of colonoscopy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bowel prep, Safety, Efficacy
Case-control Study- Cancer Pain: Uncontrolled Pain as Depression Development Predictor in Oncologic Patients (Fentanyl)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the relationship between cancer pain and risk of depression among cancer patients.

Detailed Description
-----------------
This is a retrospective observational and case-control multicenter study. The main objective of this study is determine the degree of association between cancer pain and depression by impact assessment of adequate control of pain associated with cancer risk depression in patients attending the Oncology Unit. The assessment of pain intensity will be performed by using visual analogue scales (EVAs) and verbal descriptive scales, as an observational study, not limit or modify the use of any drug. The patients included in this study have a medical history of cancer pain and mild depression (Beck = 8). The controls are patients with history of cancer pain and mild or absent depression (Beck = 7). n/a

Official Title
-----------------
DPRESS Study. Case-control Study in Cancer Pain: Uncontrolled Pain as Depression Development Predictor in Oncologic Patients

Conditions
-----------------
Cancer Pain

Intervention / Treatment
-----------------
* Other: Visual analogue scales (EVAs)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients =18 years old have medical data of = 3 months experience pain after cancer diagnosis and complete the Beck Depression Inventory (BDI) patients who give informed written consent patients with no mental or physical disorders that unable them to complete the BDI. Exclusion Criteria: Patients with diagnosis of depression before cancer diagnosis patients with chronic pain prior to the diagnosis of cancer, and cancer disease has not changed its course patients with other previous mental disorders patients who do not give their informed written consent.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 001<br>Visual analogue scales (EVAs) This scale measures the pain intensity. | Other: Visual analogue scales (EVAs)<br>* This scale measures the pain intensity.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck Depression Inventory |  | 3 months | 
| Visual scales analog (EVAs) |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with cancer pain. |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cancer, depression, pain
APHID- Primary Care Accuracy Study

Study Overview
=================
Brief Summary
-----------------
We are studying patients' abilities to correctly identify the prescription medications they are taking. We are interested in understanding what tools will help patients correctly identify their medications. People participating in this study will be asked to either review a paper printout of their medication list or a computer program with their medications. The program will show the names and pictures of the medications. In either situation, participants will be asked to indicate if they are taking the medications as prescribed. We will then compare reported adherence between each medication review process. Participation may help the program developers improve the product.

Detailed Description
-----------------
The trial compares a paper-based medication adherence questionnaire to an electronic medication adherence questionnaire. Results from each arm will be compared to the ambulatory medication list on file with the clinic and a separate medication review interview conducted by a trained clinician. We intend to compare adherence patterns and medication use discrepancy rates between each approach. This data will help us to determine what strategies work best to solicit an accurate medication history from the patient.

Official Title
-----------------
APHID- Sensitivity and Specificity of a Medication Reconciliation Technology - A Primary Care Randomized Controlled Trial

Conditions
-----------------
Medication Review

Intervention / Treatment
-----------------
* Other: Medication review software with pictures


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Veteran with Primary Care appointment at Portland VA Three or more medications in medication profile Exclusion Criteria: Visual impairment Upper extremity neuromuscular impairment Cognitive impairment Unable to speak and read English Never been seen at a VA

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Paper<br>Usual care -medication review on paper | |
| Experimental: Computer<br>Medication review software with pictures | Other: Medication review software with pictures<br>* The intervention is a self-service software program that displays each prescription on screen along with an image of the pharmaceutical product. Patients must use response buttons to describe adherence patterns and to advance through the questionnaire items.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of medication discrepancies from the reference standard |  | Baseline |
Pletaal SR Post Marketing Observational Study

Study Overview
=================
Brief Summary
-----------------
This is a Post Marketing Observational Study of cilostazol (Pletaal® SR capsule). As this study is observational in nature to collect the safety data after administrating the Pletaal SR capsule, from baseline to 16 weeks.

Detailed Description
-----------------
This study will be conducted in a prospective, single-arm, multi-center format. As this study is observational in nature, the patient's follow-up is not prescriptive in nature and must be left up to the judgment of the physician (investigator), within the period of observation set forth in the protocol.

Official Title
-----------------
A Prospective, Post Marketing Observational Study to Evaluate the Safety of Pletaal® SR Capsule

Conditions
-----------------
Ischemic Symptoms, Cerebral Infarction

Intervention / Treatment
-----------------
* Other: This is Non-interventional study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study : 1. Patients who are prescribed Pletaal® SR capsule treatment as per investigator's medical judgment for adults aged 19 and over. 2. Patients who gave written authorization to use their personal and health data Physician (Investigator) will refer to the product market authorization (package insert) for inclusion criteria. Exclusion Criteria: Patients presenting with any of the following will not be included in the study 1. Patients with hemorrhage 2. Patients with congestive heart failure 3. Patients with known hypersensitivity to Cilostazole or any ingredients of Pletaal® 4. Women who are pregnant or may possibly become pregnant 5. Patients who is not eligible to participate this study as investigator's medical judgment Physician (Investigator) will refer to the product market authorization (package insert) for exclusion criteria.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: This is Non-interventional study|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Incidence Rate and the Number of AE/ADRs | Incidence rates of overall AEs and ADRs that occurred during the study period | Follow-up at least once from baseline to 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Incidence Rate of Tarchycardia and Palpitation After Pletaal® SR Capsule Administration |  | Follow-up at least once from baseline to 16 weeks | 
| The Number and Percentage of Drop-out Patients According to Aes |  | Follow-up at least once from baseline to 16 weeks |
Evaluating the Effects of Tradipitant vs. Placebo in Atopic Dermatitis (EPIONE)

Study Overview
=================
Brief Summary
-----------------
This is a multi-center, randomized, double-blind, placebo-controlled study to be conducted in the United States in subjects with atopic dermatitis.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled Efficacy Study of The Neurokinin-1 Receptor Antagonist VLY-686 in Patients With Atopic Dermatitis

Conditions
-----------------
Atopic Dermatitis

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and non-pregnant, non-lactating female patients aged 18 - 70 years (inclusive); Diagnosed with atopic dermatitis; Suffering from chronic pruritus; Body Mass Index (BMI) of ≥18 and ≤40 kg/m2 Exclusion Criteria: Chronic pruritus due to condition other than atopic dermatitis (AD); A positive test for drugs of abuse at the screening or evaluation visits; Exposure to any investigational medication in the past 60 days

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tradipitant<br> | Drug: Tradipitant<br>* Oral Capsule<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Oral Capsule<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of worst itch in atopic dermatitis | As measured by Numerical Rating Scale (NRS) | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of disease severity in atopic dermatitis | As measured by SCORing Atopic Dermatitis (SCORAD) index | 8 weeks | 
| Improvement of disease severity in atopic dermatitis | As measured by Eczema Area and Severity Index (EASI) | 8 weeks | 
| Improvement of disease severity in atopic dermatitis | As measured by Investigator Global Assessment for Atopic Dermatitis (IGA-AD) | 8 weeks | 
| Safety and tolerability as measured by spontaneous reporting of adverse events (AEs) |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Pruritus, Eczema
Locally Delivered 1% Metformin Gel in Peri-implantitis

Study Overview
=================
Brief Summary
-----------------
This study evaluates the efficacy of 1% local metformin gel in deep periimplant pockets of type 2 diabetes mellitus patients. Half of the participants will receive 1% metformin gel with manual debridement while the other half will receive a placebo with manual debridement.

Detailed Description
-----------------
Metformin is an oral hypoglycemic drug categorized under biguanide and are considered the most efficient agents widely used in the treatment of type 2 diabetes mellitus.The general clinical benefits observed in therapy with MF seem to be greater than expected. They induce osteoblast cells to promote early bone formation through AMP kinase (AMPK) activity. Moreover, in a recent in vitro study, MF facilitated in the proliferation of MG63 osteoblast like cells. Thus, their action in stimulating bone formation has justified their use in the treatment of perimplantitis.

Official Title
-----------------
Efficacy of Locally Delivered 1% Metformin Gel in the Treatment of Peri-implantitis in Type2 Diabetes Mellitus Patients: A Randomized Controlled Clinical Trial

Conditions
-----------------
Peri-Implantitis

Intervention / Treatment
-----------------
* Drug: 1% local metformin gel
* Procedure: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes mellitus patients. Patients with peri-implantitis Exclusion Criteria: History of any other systemic diseases Cigarette smokers Smokeless tobacco users Patients who underwent scaling in the last 1 year Patients who took antibiotics in tje past 6 months
Sexes Eligible for Study
-----------------
All

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

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: Manual debridement and 1% metformin gel<br> | Drug: 1% local metformin gel<br>* After providing manual debridement in deep peri-implant probing depths, 1% metformin gel will be applied.<br>|
| Placebo Comparator: Manual debridement and placebo<br> | Procedure: Placebo<br> <br> * Other names: After providing manual debridement in deep peri-implant probing depths, placebo gel will be applied.;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Marginal bone loss | Marginal bone loss will be assessed on digital radiographs on calibrated computer screen. | 6 months | 
| Peri-implant prpbing depth | Will be measured with UNC-15 periodontal probe from crest of the gingival margin to the base of the peri-implant probing depth. | 6 months |
Evaluation of Rate of Progression With Perimetry in Newly Diagnosed Open Angle Glaucoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate rate of progression in newly diagnosed open angle glaucoma with different types of perimetry. Would it be possible to find the rapidly progressing individuals sooner by doing perimetry more often? Is there a difference between different types of perimetry in early glaucoma? What would be the optimal timing of perimetry in newly diagnosed glaucoma? In addition the quality of life in glaucoma patients will be evaluated with two types of questionnaires in three different time points. The enrolled patients will receive appropriate treatment according to glaucoma management guidelines.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recently diagnosed open angle glaucoma Exclusion Criteria: Significant visual impairment due to another disease (e.g. diabetic retinopathy or maculopathy, cataract, visual field defect after stroke) Inability to perform perimetry reliably

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 |
| --- | --- | --- |
| Change in mean defect in Octopus perimetry |  | Baseline, 2, 4, 8, 12, 16, 20, 22, 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in VF-7- instrument score | Change in quality of life | 2, 12, 24 months | 
| Change in 15D-instrument score | Change in quality of life | 2, 12, 24 months | 
| Differences in visual field defects between Octopus, frequency doubling technology, RareBit-perimeters |  | 2, 12, 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Visual Field Tests, Ocular Hypertension, Glaucoma, Open-Angle, Quality of Life, Glaucoma progression, Early glaucoma, Frequency Doubling Technology (FDT), RareBit, Octopus 900 perimetry