linjc16/ctgov huggingface dataset:
The Impact of Baby-friendly Hospital Initiative to Breastfeeding, Breastfeeding Counselling and Breastfeeding Attitudes

Study Overview
=================
Brief Summary
-----------------
The impact of Baby-friendly Hospital Initiative (BFHI) to breastfeeding, breastfeeding counselling and breastfeeding attitudes will be examined in Satakunta Central Hospital, Finland. The baseline measurement will be conducted before the implementation of BFHI in 2017 and second measurement will be conducted in 2019 after the certification process. Both staff members and breastfeeding mothers will be recruited in the study. The main outcomes are the duration of breastfeeding and breastfeeding attitudes.

Official Title
-----------------
Vauvamyönteisyysohjelman Vaikutus Imetykseen, Imetysohjaukseen ja Imetysasenteisiin / The Impact of Baby-friendly Hospital Initiative to Breastfeeding, Breastfeeding Counselling and Breastfeeding Attitudes

Conditions
-----------------
Breastfeeding

Intervention / Treatment
-----------------
* Other: Baby-friendly Hospital Initiative


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Staff: All staff members taking care of mothers and/or infants in the hospital. Mothers: Mothers who have given birth in the study hospital during the data collection period. Exclusion Criteria: Mothers: who have given birth outside the hospital, whose infant's condition is critical, whose infants are transferred to another unit.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mothers and staff members<br>The mothers who will give birth at the study hospital and all the staff members taking care about mothers and/or infants | Other: Baby-friendly Hospital Initiative<br>* The intervention is Baby-friendly Hospital Initiative as described by WHO and UNICEF. The ten steps to successful breastfeeding will be implemented in the hospital.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of breastfeeding | Duration of breastfeeding will be asked from the mother | Six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breastfeeding attitude of the staff (questionnaire) | Attitude will be measured with a structured questionnaire | Two years | 
| Breastfeeding attitude of the mothers (questionnaire) | Attitude will be measured with a structured and validated questionnaire | Four months |
A Study to Evaluate the Effectiveness and Safety of Multiple Applications of Imiquimod 5% Cream for the Treatment of Actinic Keratoses in Organ Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to compare effectiveness and safety of multiple applications of imiquimod 5% cream and vehicle cream in graft recipients suffering from actinic keratosis.

Official Title
-----------------
Vehicle-Controlled, Double-Blind Study to Assess the Safety and Efficacy of Imiquimod 5% Cream Applied Once Daily 3 Days Per Week for the Treatment of Actinic Keratoses in Immunosuppressed Organ Transplant Recipients.

Conditions
-----------------
Actinic Keratosis

Intervention / Treatment
-----------------
* Drug: Imiquimod 5 % Cream


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have a total of 4-10 actinic keratosis (AK) lesions located on either face or scalp If female and of childbearing potential, have a negative urine pregnancy test at treatment initiation, and willing to use a medically acceptable method of contraception during the treatment period Renal, liver or heart transplant recipients Exclusion Criteria: Graft rejection with loss of the graft in the medical history Unstable status of organ transplant disease during the last 12 months Known to be pregnant or lactating

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: Imiquimod 5 % Cream|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary outcome of the study is to compare imiquimod 5% cream and vehicle cream with respect to safety assessments in graft recipients. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary outcome of the study is to compare imiquimod 5% cream and vehicle cream with respect to complete and partial clearance rates. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aldara, Actinic Keratosis, Graft Recipients
A Safety and Efficacy Study of BOTOX® (Botulinum Toxin Type A) in Patients With Urinary Incontinence Due to Neurogenic Detrusor Overactivity or Overactive Bladder in India

Study Overview
=================
Brief Summary
-----------------
This is a Post-Marketing Surveillance study in India to evaluate safety and efficacy of BOTOX® (Botulinum Toxin Type A) in the treatment of patients with urinary incontinence due to neurogenic detrusor overactivity or overactive bladder.

Official Title
-----------------
Evaluation of the Safety and Effectiveness of BOTOX® (Botulinum Toxin Type A) in the Treatment of Patients With Urinary Incontinence Due to Neurogenic Detrusor Overactivity or Overactive Bladder: A Phase IV Non-interventional Post-marketing Surveillance Study in India

Conditions
-----------------
Urinary Incontinence, Overactive Bladder

Intervention / Treatment
-----------------
* Biological: botulinum toxin Type A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with urinary incontinence due to NDO or OAB treated with BOTOX® as per local standard of care in clinical practice. Exclusion Criteria: None

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 |
| --- | --- |
| BOTOX®<br>Patients who receive botulinum toxin Type A (BOTOX®) treatment for Neurogenic Detrusor Overactivity or Overactive Bladder as per local standard of care in clinical practice. | Biological: botulinum toxin Type A<br>* Botulinum toxin Type A treatment for Neurogenic Detrusor Overactivity or Overactive Bladder as per local standard of care in clinical practice.<br>* Other names: onabotulinumtoxinA;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from the baseline value of the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) |  | at up to 4 months |
The Effect of Muscle Strengthening Associated With Neuromuscular Stimulus in Patients With Patellofemoral Pain During Negotiating Stairs

Study Overview
=================
Brief Summary
-----------------
Assess pain, function, hip and knee strength and kinematics of trunk and lower limbs during ascent and descent stairs after the addition of neuromuscular training to hip muscle strengthening.

Official Title
-----------------
The Effect of Muscle Strengthening Associated With Neuromuscular Stimulus in Patients With Patellofemoral Pain During Negotiating Stairs: A Randomized Controlled Trial

Conditions
-----------------
Patellofemoral Pain Syndrome

Intervention / Treatment
-----------------
* Other: Neuromuscular training
* Other: Muscle strengthening
* Device: Sensorimotor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sedentary women, previous knee pain last 3 months in at least two of the following activities: sitting for long periods, walk up or down stairs, squat, running and jumping Exclusion Criteria: Lower limb surgery, patella displacement knee instability Heart or locomotor disorders which might influence the evaluation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neuromuscular training<br>Neuromuscular, this arm will receive neuromuscular training and muscle strengthening. | Other: Neuromuscular training<br> <br> * Other names: Sensorimotor, balancing exercises, proprioceptive stimuli.;Device: Sensorimotor<br> <br> |
| Active Comparator: Strength<br>Strength, this arm will receive only muscle strengthening. | Other: Muscle strengthening<br> <br> * Other names: Hip abductors and lateral rotators and knee extensors strengthening;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3D kinematic range of motion of hip adduction during ascending and descending stairs | Kinematic analysis during ascent and descent stairs | 4 weeks | 
| 3D kinematic range of motion of hip internal rotation during ascending and descending stairs | Kinematic analysis during ascent and descent stairs | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Scores on the Numerical Pain Rating Scale |  | 4 weeks | 
| Strength of hip and knee extensor muscles measured through hand-held dynamometer |  | 4 weeks | 
| Lower Limb Function measured through the questionnaires Anterior Knee Pain Scale -AKPS and Functional Index Questionnaire- FIQ . |  | 4 weeks |
Automated Breast Ultrasound Case Collection Registry

Study Overview
=================
Brief Summary
-----------------
The contribution of automated breast ultrasound (ABUS) to the screening pathway for breast cancer is not fully understood. This prospective study aims to collect longitudinal data in women with dense breasts undergoing ABUS as a supplement to digital breast tomosynthesis (DBT). The data are intended for use in future research on the value and effectiveness of ABUS in routine clinical care. Data will be collected from eligible women who have been prescribed or have completed DBT and ABUS, screening within a 30-day window. Radiologist evaluations and, when performed, outcomes of biopsy and/or laboratory testing will be recorded. Subjects will be followed for breast cancer status and results of any diagnostic breast exams and/or treatment.

Official Title
-----------------
Automated Breast Ultrasound Case Collection Registry

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

Intervention / Treatment
-----------------
* Device: Automated Breast Ultrasound
* Device: Digital Breast Tomosynthesis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Are asymptomatic adult women (aged 18 years or older); Are eligible to complete or have completed (within 30 days) screening ABUS and DBT exams per the site standard of care;1 Have heterogeneously dense and extremely dense breasts (BI-RADS C or D, respectively) or are determined to have dense breasts prior to the study on initial screening mammography; Are able and willing to participate. Exclusion Criteria: 1. Have a breast cancer diagnosis (with or without metastasis) or are being treated for breast cancer within the year prior to the study.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All Subjects<br>All subjects will undergo scanning with both Automated Breast Ultrasound and Digital Breast Tomosynthesis devices. | Device: Automated Breast Ultrasound<br>* The ABUS system is designed to methodically scan a breast and capture multiple ultrasound images that can be rendered and reviewed in three dimensions.<br>Device: Digital Breast Tomosynthesis<br>* Digital Breast Tomosynthesis (DBT) systems are designed to collect 3-dimensional x-ray images of breast tissues.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Complete Breast Imaging Datasets |  | Up to 6 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type of Exams Performed Per Patient |  | Up to 6 years | 
| Breast Cancer Status |  | Up to 6 years |
Oat Phenolics Bioavailability

Study Overview
=================
Brief Summary
-----------------
A diet rich in whole grain is inversely associated with cardiovascular disease risk and this benefit could be partly attributed to the phenolic acid content of whole grains. The exact absorption, metabolism and excretion of whole grain phenolic acids, however, is not fully understood. In a small human intervention trial, the investigators will investigate to what extent phenolic acids from whole grain oats are absorbed, excreted in urine and how they are metabolised.

Official Title
-----------------
Absorption, Metabolism and Excretion of Oat Phenolic Acids in Healthy Men.

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Dietary Supplement: Oat bran
* Dietary Supplement: refined grain


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males 25 to 65 years old Exclusion Criteria: Allergies to oats Parallel participation in another research project Having flu vaccination or antibiotics within 3 months of trial start Taking food supplements within 3 months of trial start Past or existing medical history of vascular disease, diabetes, hepatic, renal, gastrointestinal, haematological, neurological, thyroidal disease or cancer

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Male

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

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 |
| --- | --- |
| Experimental: Oat bran<br>66g oat bran made up in 350ml skimmed milk | Dietary Supplement: Oat bran<br>* 66g oat bran made up in 350ml skimmed milk<br>|
| Placebo Comparator: Control<br>Refined grain product and 350ml skimmed milk | Dietary Supplement: refined grain<br>* refined grain product and 350ml skimmed milk<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in phenolic acid metabolite excretion |  | Baseline and 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
volunteers, oat, phenolic acid, bioavailability
Validity of Electronic Diary for Monitoring Varicose Veins Symptoms

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to contribute to the validation of an electronic daily diary to assess symptoms in patients with varicose veins.

Official Title
-----------------
Performance of Daily Electronic Diary to Capture Venous Symptoms Before and After Intervention for Great Saphenous Vein Incompetence

Conditions
-----------------
Varicose Veins

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sign informed consent and complete study assessments in written English Male or female age 18 to 75 Patients having Saphenofemoral Junction (SFJ) incompetence and scheduled to receive foam sclerotherapy treatment for varicose veins in one leg Screening Symptom score of 7 points or more as measured by Question 1 on the modified VEINES-QOL/Sym questionnaire Exclusion Criteria: Unable to comply with completing a daily diary for a total of 24 days Participation in any other investigational pharmaceutical product, or device study within the 3 months prior to Visit 1 Current venous leg ulcer in either leg

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 |
| --- | --- |
| Varicose veins<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the feasibility, variability, validity and sensitivity of patient's varicose vein symptoms using a disease-specific symptom questionnaire, administered as a daily electronic diary in patients undergoing treatment for varicose veins |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To establish the treatment effect size of foam sclerotherapy treatment |  | 8 weeks |
A Prospective Trial of Povidone-iodine Suppository Before Transrectal Ultrasound Guided Prostate Biopsy

Study Overview
=================
Brief Summary
-----------------
To assess the effect of povidone-iodine on infectious complication rate caused by transrectal prostate biopsy

Detailed Description
-----------------
the effect of povidone-iodine on infectious complication rate caused by transrectal prostate biopsy

Official Title
-----------------
A Prospective Randomized Trial of Povidone-iodine Suppository Before Transrectal Ultrasound Guided Prostate Biopsy

Conditions
-----------------
Infection, Prostatic Diseases, Misadventure During Aspirating Needle Biopsy

Intervention / Treatment
-----------------
* Drug: Povidone-Iodine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: who undergo transrectal prostate biopsy Exclusion Criteria: patients who refuse to be included, patients who have hypersensitivity to iodine, patients who have abnormal thyroid function, patients who do not visit follow-up, patients who have received prior radioactive-iodine therapy

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

Sexes Eligible for Study
-----------------
Male

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Povidone-iodine<br>povidone iodine pill | Drug: Povidone-Iodine<br>* 1 pill per biopsy<br>* Other names: Gynobetadine;|
| No Intervention: no intervention<br>no intervention | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with febrile infection | consider fever over 38 degree celsius or admission due to fever | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| voiding questionnaire | check International Prostate Symptom Score (IPSS) | 1-2 week | 
| sexual function questionnaire | International Index of Erectile Function-5 (IIEF-5) | 1-2 week | 
| quality of life questionnaire | European Organization for Research and Treatment fo Cancer (EORTC) Quality of life Questionnaire (QLQ)-C30 questionnaire | 1-2 week |
LapBand Adjustment to Improve Early Weight Loss

Study Overview
=================
Brief Summary
-----------------
Subjects having a gastric band fitted will have the first band adjustment done at surgery. The stoma will be set to 7mm using the EndoFLIP system to measure stoma size. Thereafter, band adjustments will be made using an adjustment chart, created at surgery, which shows stoma size versus band fill, to make adjustments in the normal follow-up visits. It is hypothesized that an early adjustment at surgery will promote earlier weight loss, and result in fewer band adjustments being required in the first year after surgery.

Official Title
-----------------
Effect on Early Weight Loss by Adjusting Gastric Band During Surgery

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Device: EndoFLIP device (FDA Device Listing Number : D091203)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing gastric band surgery Over 18 years of age Exclusion Criteria: Actively bleeding varices

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stoma Adjustment at Surgery<br>The first band adjustment will be made at surgery versus historical controls where the adjustment is not made for 3-4 weeks post-surgery. EndoFLIP device (FDA Device Listing Number : D091203)will be used to make the adjustment. | Device: EndoFLIP device (FDA Device Listing Number : D091203)<br>* The EndoFLIP balloon catheter will be introduced to the band and used to permit the band stoma size to be adjusted to 7mm.<br>|
| No Intervention: Historic<br>Weight loss profile over time for 50 patients in the first 12 months after surgery as derived from historic control records. Band adjustments are made in a heuristic fashion during the year after surgery using the experience of surgeon alone | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| %Excess Weight Loss 4-6 Weeks After Surgery (Large and Small Bands) |  | 4-6 weeks post surgery | 
| %Excess Weight Loss 4-6 Weeks After Surgery (Small Bands Only) |  | 4-6 weeks post surgery | 
| % Excess Weight Loss 12 Months After Surgery (Large and Small Bands) |  | 12m post surgery | 
| % Excess Weight Loss 12 Months After Surgery (Small Bands Only) |  | 12m post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Band Adjustments Required in the First Year After Surgery |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastric Band, LapBand, Bariatric Surgery