linjc16/ctgov huggingface dataset:
Triple Blockade of the Renin Angiotensin Aldosterone System in Diabetic (Type 1&2) Proteinuric Patients

Study Overview
=================
Brief Summary
-----------------
Study Hypothesis: Reduction in albuminuria has been shown to decrease progression of diabetic nephropathy. In diabetic nephropathy patients treated with maximal antihypertensive doses with dual RAAS blockade (total daily dose valsartan 320 mg and either enalapril 40 mg or benazepril 40 mg daily, or losartan 100mg), persistent albuminuria reflects further additional RAAS activation. Microvascular renal disease due to increased RAAS activation may be more effectively treated with triple blockade by the addition of a direct renin inhibitor (DRI) Aliskiren.

Official Title
-----------------
Study of Triple Blockade of the Renin Angiotensin Aldosterone System (RAAS) in Diabetic (Type 1&2) Proteinuric Patients With (ACE-, ARB, DRI)

Conditions
-----------------
Microalbuminuria, Macroalbuminuric Diabetic Nephropathy, Diabetes, Proteinuria, Albuminuria

Intervention / Treatment
-----------------
* Drug: Aliskiren
* Drug: Aliskiren


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Macroalbuminuria > 300mg/g Microalbuminuria 30-300mg/g Stable on max dose of an ACE-I or ARB (Can also be titrated to max dosage of ACE-I and ARB and stable on those doses for at least 2 weeks) Blood pressure <130/80 mm Hg at time of enrollment Diabetic either Type 1 or 2 Exclusion Criteria: GFR <60 m/min Potassium > 5mg/dl at time of enrollment Pregnant History of Angioedema ACE-I cough Allergic to ARB, ACE-I, DRI A1C > 9%

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 |
| --- | --- |
| Active Comparator: Aliskiren in Macroalbuminuria<br>Aliskiren 150 mg daily for 2 weeks and then increased to 300 mg daily for 4 weeks. | Drug: Aliskiren<br>* Aliskiren 150mg daily for 2 weeks and increased to 300 mg daily for 4 weeks.<br>* Other names: Tekturna;|
| Active Comparator: Aliskiren Microalbuminuria<br>Aliskiren 150 mg daily for 2 weeks and then increased to 300mg daily for 4 weeks | Drug: Aliskiren<br>* Aliskiren 150mg daily for 2 weeks and increased to 300 mg daily for 4 weeks.<br>* Other names: Tekturna;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in albuminuria/proteinuria |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of Triple RAAS inhibition with ACE-I, ARB and DRI |  | 6 weeks |
A Study to Determine the Location of the Blind Spot and the Macula-disc Centre Distance on a Fundus Photograph

Study Overview
=================
Brief Summary
-----------------
The study is aimed to develop a new reaction-time based method for examining the visual field and to study the effect of refractive error on the magnification of a fundus photograph in order to evaluate the true size of a retinal feature.

Official Title
-----------------
A Study to Develop Both a Novel Method for Evaluating the True Size of a Retinal Object on Fundus Photographs and a New Reaction-time Based Method for Studying the Visual Field on Healthy Volunteers

Conditions
-----------------
Generalized Visual Field Contraction or Constriction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No disease that effect the fundus photograph or visual field Exclusion Criteria: any disease that effects the fundus photograph or visual field

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Macula-disc centre distance | Measurement is done on a fundus photograph (one visit and one examination for each patient) | one measurement at the start of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Location of the blind spot | The location of the blind spot is screened using Octopus custom made visual field program at the one visit (one visit and one study for each patient) and a novel reaction-time based visual field device. | one measurement at the start of the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Keyword: blind spot
An Exploration of Antenatal Hand Expression.

Study Overview
=================
Brief Summary
-----------------
The study is an exploration of mother's experiences of antenatal hand expression of colostrum, and the effects upon breastfeeding continuation and maternal emotional health

Detailed Description
-----------------
Second-line feeding strategies including hand expression and syringe feeding are used as an aid to breastfeeding, however little is known about their efficacy. This research explores the experiences of women who have used antenatal hand expression to identify how it affects maternal emotional health and breastfeeding continuation. UK women with recent experience of the practice were interviewed and the data analysed using thematic analysis. The results identified five themes in relation to these experiences including; The emotional distress of struggling with breastfeeding, Support as panacea but inconsistent, A crisis of confidence, Discord between knowledge, expectations and reality, and Syringe feeding as challenging but constructive. The study concludes that hand expression and syringe feeding supports women to establish breastfeeding, however, those struggling with breastfeeding need extra practical and emotional support to protect breastfeeding self-efficacy, emotional health and breastfeeding continuation. The findings highlight the importance of realistic, antenatal breastfeeding education to achieve this. Further research into second-line strategies and antenatal education programmes could contribute to the improvement of women's infant feeding experiences and improve UK breastfeeding rates.

Official Title
-----------------
An Exploration of Mother's Experiences of Antenatal Hand Expression of Colostrum, and the Effects Upon Breastfeeding Continuation and Maternal Emotional Health.

Conditions
-----------------
Feeding; Difficult, Newborn

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women over the age of 18, Women with experience of antenatal hand expression within the last three months, Women with a good grasp of the English language. Exclusion Criteria: Mothers of babies born before 37 weeks or with a medical issue (eg. tongue tie), Women with a mental health diagnosis

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Semi-structured interview | Semi-structured interviews carried out with participants to collect qualitative data, analysed using thematic analysis. | One hour |
Sugars-containing Beverage and Food Intake in Children

Study Overview
=================
Brief Summary
-----------------
The purpose is to determine the effect of sugars in solution on food intake and subjective appetite in 9- to 14-year-old normal weight boys. The investigators hypothesize that food intake after all sugars-containing solutions will be decreased in comparison to the control solution, with similar reductions in FI between high-fructose corn syrup -55 (HFCS-55) and sucrose. Food intake will be measured 60 minutes after consumption of 50g of HFCS-55, sucrose or glucose, or a control treatment. Subjective appetite will be measured at 15, 30, 45, 60 and 90 minutes.

Official Title
-----------------
Role of Sugars in Solution on Subjective Appetite and Short-term Food Intake in Normal Weight 9-14 Year Old Boys

Conditions
-----------------
Childhood Obesity

Intervention / Treatment
-----------------
* Dietary Supplement: water with Sucralose
* Dietary Supplement: water with HFCS
* Dietary Supplement: water with glucose
* Dietary Supplement: water with sucrose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy, boy, born at full term and normal birth weight Exclusion Criteria: Girl, on restricted diet, taking medication that affect appetite or food intake, have significant learning, behavioral, or emotional difficulties

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 14 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Calorie-free control<br>Calorie-free control | Dietary Supplement: water with Sucralose<br> <br> |
| Experimental: HFCS-55 drink<br>HFCS-55 drink | Dietary Supplement: water with HFCS<br> <br> |
| Experimental: Glucose drink<br>Glucose drink | Dietary Supplement: water with glucose<br> <br> |
| Experimental: Sucrose drink<br>Sucrose drink | Dietary Supplement: water with sucrose<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Food intake (kcal) |  | measured at 60 minutes after the treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective appetite (mm) | Subjective appetite (in mm) by visual analogue scale will be determined at 0, 15, 30, 45, 60 and 90 minutes. | 0-90 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
boys, obesity, glucose, sucrose, high-fructose corn syrup-55
New Strategy Study of Functional Cure of Chronic Hepatitis B

Study Overview
=================
Brief Summary
-----------------
As HBsAg clearance is uncommon in chronic hepatitis B (CHB) patients on nucleoside analogues (NAs) therapy. The purpose of this study is to optimize HBsAg clearance in CHB Patients with sequential treatment of pegylated interferon alpha-2b and NAs.

Detailed Description
-----------------
CHB Patients who had received, and responded to, NAs for more than 12 months are switched to receive peginterferon alfa-2b 80 micrograms/week for 48 weeks and follow up for 48 weeks.

Official Title
-----------------
A Study on Optimizing HBsAg Clearance in CHB Patients With Sequential Treatment of Pegylated Interferon Alpha-2b and Nucleoside Analogues

Conditions
-----------------
Hepatitis B, Chronic

Intervention / Treatment
-----------------
* Drug: Peginterferon alfa-2b


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CHB patients who had received NAs for more than 12 months. Hepatitis B e antigen (HBeAg)-negative and anti-HBeAg positive. Hepatitis B surface antigen (HBsAg) positive and <1500 IU/mL. Hepatitis B virus DNA not detectable. Exclusion Criteria: Patients with liver cirrhosis, Hepatocellular Carcinoma or other malignancies. Patients with other factors causing liver diseases. Pregnant and lactating women. Patients with concomitant HIV infection or congenital immune deficiency diseases. Patients with diabetes, autoimmune diseases. Patients with important organ dysfunctions. Patients with serious complications ( e.g., infection, hepatic encephalopathy, hepatorenal syndrome, gastrointestinal bleeding. ) Patients who receive antineoplastic or immunomodulatory therapy in the past 12 months. Patients who can't come back to clinic for follow-up on schedule.

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CHB patients<br>Hepatitis B e antigen (HBeAg)-negative CHB patients who had received NAs for more than 12 months, with HBsAg <1500 IU/ mL and Hepatitis B virus DNA not detectable, are to receive peginterferon alfa-2b 80 micrograms/week for 48 weeks. | Drug: Peginterferon alfa-2b<br>* peginterferon alfa-2b 80 micrograms/week for 48 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HBsAg loss |  | Week 48 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic hepatitis B, Peginterferon alfa-2b, Nucleotide analogue
Combined Vibrations, Passive Motion and Thermotherapy for Knee Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
The study evaluated the efficacy of combined mechanical vibrations, continuous passive motion and heat on the severity of pain in management of osteoarthritis of the knee

Official Title
-----------------
Efficacy of Combined Local Mechanical Vibrations, Continuous Passive Motion and Thermotherapy in the Management of Osteoarthritis of the Knee

Conditions
-----------------
Osteoarthritis, Knee Pain

Intervention / Treatment
-----------------
* Device: Kineticure System followed by sham
* Device: sham followed by Kineticure System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of OA of the knee by ACR criteria symptoms consistent with radiographic OA grades 2, 3 or 4 by Kellgren and Lawrence criteria moderate to severe knee pain (≥35mm on a 100mm visual analog pain scale (VAS)). Exclusion Criteria: knee or hip surgery

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AB<br>First active then Sham | Device: Kineticure System followed by sham<br>* 20 minutes sessions with knee brace (integrated heating pad, a vibration unit and a foot pedal that delivers continuous passive motion) during the first 4 weeks followed by 2 weeks wash out and 4 weeks of sham device<br>* Other names: Kineticure System;|
| Sham Comparator: BA<br>First sham then active | Device: sham followed by Kineticure System<br>* sham device during the first 4 weeks then 2 weeks wash out period followed by 4 weeks for 20 minutes sessions with knee brace (integrated heating pad, a vibration unit and a foot pedal that delivers continuous passive motion)<br>* Other names: kineticure system;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intensity of pain as measured on a 100 mm non-marked VAS and the total Western Ontario McMaster (WOMAC) OA index using a Likert scale, |  | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| satisfaction of use of the Kineticure device as measured on a 0-100 mm non-marked scale |  | 10 weeks | 
| range of motion (ROM) of the knee (using goniometer) |  | 10 weeks |
Validation of a Food Frequency Questionnaire

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect nutritional information from young children aged 15-36 months to validate a newly developed food frequency questionnaire.

Detailed Description
-----------------
The primary purpose of this study is to validate a semi-quantitative food frequency questionnaire (FFQ) against a reference method (2-day weighed food records) in a sample of young children aged 15-36 months. In addition to dietary data, the investigators also collected information on parental demographics, toddler health with regards to allergies and intolerance, parental feeding practices, parent and child weight and height and lastly, saliva samples to study inflammatory markers. Therefore, in addition to the validation of the FFQ- the data will also be used to study associations between dietary patterns, food and nutrient intake and (i) parental feeding practices and (ii) inflammatory biomarkers from saliva

Official Title
-----------------
Validation of Dietary Patterns and Inflammatory Salivary Biomarkers Among Healthy Toddlers of 15-36 Months Old in Singapore

Conditions
-----------------
Nutrition

Intervention / Treatment
-----------------
* Other: this study is observational, it is not an intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 15-36 months old boys and girls who are healthy Toddlers who are from either Chinese, Malay or Indian ethnic group Exclusion Criteria: Toddlers with any acute or chronic illness, such as chronic inflammatory bowel disease, or illness that negatively affects food intake (e.g. Crohn's disease or ulcerative colitis). Toddlers with history of antibiotics used in the last 1 week before the study. Toddlers with history of vaccination in the last 2 weeks before the study Toddlers with one or both parents of Caucasian origin.

Ages Eligible for Study
-----------------
Minimum Age: 15 Months
Maximum Age: 36 Months

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: this study is observational, it is not an intervention|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validated Food Frequency Questionnaire | Ninety-one parents completed the sqFFQ and a 2-day weighed food record as the reference method. Intake of energy and nutrients (energy, carbohydrates, fat, protein, fibre, sugars, calcium and iron) were determined for each method and compared using Pearson correlations. | up to 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Salivary Inflammatory Biomarkers | C-reactive protein, salivary IgA, alpha amylase | up to 1 month |
Long Term Follow-up of Bone Mineral Density in Hormone Treated Turner Syndrome

Study Overview
=================
Brief Summary
-----------------
Turner Syndrome (TS) is associated with osteopenia and osteoporosis. Reduced bone mineral density (BMD) and increased risk of fractures are present in many younger and middle-aged women with TS. The objective is therefore to describe longitudinal changes in BMD in TS. The study is an observational follow-up study. Examinations at baseline, after 5 and 10 years. Bone mineral density is measured by dual energy x-ray absorptiometry (DEXA) and bone turnover by bone markers. Main Outcome Measures: Bone mineral density (BMD; grams/ square centimetre) were measured at lumbar spine, hip and the non-dominant forearm.

Official Title
-----------------
Long Term Follow-up of Bone Mineral Density in Hormone Treated Turner Syndrome

Conditions
-----------------
Turner Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Turner syndrome verified by karyotyping Exclusion Criteria: untreated hypothyroidism or hyperthyroidism present or past malignant diseases clinical liver disease treatment with drugs known to interfere with bone metabolism (e.g. glucocorticoids)

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 |
| --- | --- |
| 1<br>Women with Turner syndrome | |
| 2<br>Healthy control women | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone Mineral Density in columna lumbalis, collum femoris and distal ulnae Bone mineral density (BMD; grams/ square centimetre) were measured at lumbar spine, hip and the non-dominant forearm. |  | Evey 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Turner Syndrome, bone mineral density, estrogen replacement therapy, dual energy x-ray absorptiometry