linjc16/ctgov huggingface dataset:
Hydrosorb® Versus Control in the Management of Radio-induced Skin Toxicity: Multicentre Controlled Phase III Randomized Trial

Study Overview
=================
Brief Summary
-----------------
The primary objective consisted of avoiding deterioration and/or restoring the integrity of the skin of patients treated by radiotherapy, right from the first signs of grade 1 or 2 radiation dermatitis.

Official Title
-----------------
Hydrosorb® Versus Control (Water Based Spray) in the Management of Radio-induced Skin Toxicity: Multicentre Controlled Phase III Randomized Trial

Conditions
-----------------
Breast Cancer, Radiation Dermatitis

Intervention / Treatment
-----------------
* Device: Castalie water spray
* Device: Hydrogel Hydrosorb®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women treated by normo fractionated radiotherapy for breast cancer Presenting grade 1 or 2 radiation dermatitis during the treatment and who provided their written informed consent were included in the study. Exclusion criteria: Were male patients Radiation dermatitis already treated or caused by another treatment Subjects deprived of their freedom or under guardianship Subjects in whom medical follow-up was impossible A cancer wound or skin flap on the irradiated zone A history of allergic skin reaction Concomitant chemotherapy or concomitant bevacizumab therapy and bilateral irradiation.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydrosorb® arm<br>Hydrogel Hydrosorb® | Device: Hydrogel Hydrosorb®<br> <br> |
| Placebo Comparator: Placebo arm<br>Castalie water spray | Device: Castalie water spray<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| local treatment failure defined as interruption of radiotherapy because of skin radiotoxicity or change of local care because skin alteration. |  | through study completion, an average of 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| skin colorimetry measured by a colorimeter |  | day0, day 7, day 14, day 21, day 28 | 
| pain level assessed by the visual analog pain scale |  | day0, day 7, day 14, day 21, day 28 | 
| quality of life assessed with the Dermatology Life Quality Index questionnaire |  | day0, day 14, day 28 |
National Registry and Cohort Study of Pulmonary Vascular Disease

Study Overview
=================
Brief Summary
-----------------
This is a observational、multicenter, prospective cohort study for patients with pulmonary hypertension (PH). The purposes of this study were to evaluate the etiology、clinical characteristics、treatment modalities, and outcomes of patients with PH；also to set up registration system of PH in China, to build a database of Chinese PH, to establish a web-based international standard data acquisition system for PH and a multicenter clinical research platform. The results of the study will provide a basis for the future national health policy for prevention and treatment of PH.

Official Title
-----------------
National Registry and Cohort Study of Pulmonary Vascular Disease

Conditions
-----------------
Pulmonary Arterial Hypertension

Intervention / Treatment
-----------------
* Combination Product: The clinical course and disease management


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed or previously diagnosed patients with PH. Documentation of mean pulmonary arterial pressure (mPAP) >20 mm Hg by right heart catheterization, performed at any time prior to study enrollment. Exclusion Criteria: Have not had documentation of hemodynamic criteria for PH by right heart catheterization at some time preceding study entry and following development of symptoms associated with PH. Do not meet the required hemodynamic criteria for entry into the study.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>All consecutive consenting patients diagnosed with PH according to specific hemodynamic criteria at participating institutions. | Combination Product: The clinical course and disease management<br>* The clinical course and disease management of pulmonary hypertension patients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause Death |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Clinical Worsening | Clinical worsening during follow-up was defined as worsening PAH or atrial septostomy or listing for lung transplantation or all-cause death. Worsening PAH required the presence of worsening PAH symptoms and a decrease in 6-minute walk distance greater than 15% from baseline and the requirement for additional PAH treatments (all three conditions had to be present). | 5 years |
The Effect of Vitamin D Fortification of Bread and Milk in Danish Families

Study Overview
=================
Brief Summary
-----------------
Approximately 200 families corresponding to 800 persons are included in the study. The study investigate the efficacy of vitamin D fortification of bread and milk on vitamin D status in serum. Participants receive milk and bread twice a week. Half of the participants receive vitamin D fortified products and the other half similar non-fortified products. The study starts in September and runs for 6 months during winter, the period where it is not possible to produce vitamin D in the skin through sunlight exposure. The hypothesis is that the usual fall in vitamin D status can be prevented by vitamin D fortified food.

Official Title
-----------------
The Effect of Vitamin D Fortification of Bread and Milk in Danish Families

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

Intervention / Treatment
-----------------
* Other: Vitamin D fortification


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Family with at least one child between the age 4 to 18 years and at least one adult less than 60 years of age Permanent address in a specific geographical region. Exclusion Criteria: Use of medication (including dietary supplements with high levels of vitamin D) Diseases which influence vitamin D metabolism Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vitamin D fortified bread and milk<br> | Other: Vitamin D fortification<br>* Bread and milk fortified with vitamin D3<br>|
| No Intervention: Non-fortified bread and milk<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum 25-hydroxyvitamin D | serum 25-hydroxyvitamin D is measured at the start of the study, after 2-3 months (on adults only) and after approximately 6 months | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vitamin D status (serum 25-hydroxyvitamin D)
Dose Ranging Study

Study Overview
=================
Brief Summary
-----------------
Dose Ranging Study

Official Title
-----------------
A Dose Ranging Study of the Safety and Efficacy of LIPO-202 Healthy Patients With Subcutaneous Fat in the Periumbilical Area

Conditions
-----------------
Periumbilical Subcutaneous Adipose Tissue Reduction

Intervention / Treatment
-----------------
* Drug: Drug: salmeterol xinafoate
* Drug: Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >18 years of age inclusive Subcutaneous fat in the periumbilical area BMI <30 kg/msq Stable diet and exercise and body weight Exclusion Criteria: Prior treatment of subcutaneous fat in the periumbilical area (liposuction, abdominoplasty, etc.) Known hypersensitivity to drugs

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LIPO-202, Low<br>Drug: salmeterol xinafoate | Drug: Drug: salmeterol xinafoate<br> <br> * Other names: Salmeterol;|
| Experimental: LIPO-202, Mid<br>Drug: salmeterol xinafoate | Drug: Drug: salmeterol xinafoate<br> <br> * Other names: Salmeterol;|
| Experimental: LIPO-202, High<br>Drug: salmeterol xinafoate | Drug: Drug: salmeterol xinafoate<br> <br> * Other names: Salmeterol;|
| Experimental: LIPO-202, Placebo<br>Drug: Placebo | Drug: Drug: Placebo<br> <br> * Other names: Placebo;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | physical exam, vital signs, clinical assessment of injection, clinical laboratory tests, and adverse events | 8 weeks treatment | 
| Change in global clinician abdominal perception scale score (baseline and 9 weeks) |  | 9 weeks | 
| Change in global patient abdominal perception scale score (baseline and 9 weeks) |  | 9 weeks | 
| Change in abdominal circumference (baseline and 9 weeks) | abdominal circumference | 9 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Photonumeric abdominal perception scale score (baseline and 9 weeks) |  | 9 weeks | 
| Change in Patient Reported Outcome for abdominal perception score (baseline and 9 weeks) |  | 9 weeks |
Polyphenols and Risk of Dementia

Study Overview
=================
Brief Summary
-----------------
This project aims to leverage existing data from a large observational prospective study on dementia, the Three-City study, to investigate the relationship between intakes of polyphenols and the risk to develop dementia in the 12 years following dietary assessment.

Detailed Description
-----------------
The study sample includes 1,329 subjects followed for up to 12 years fro dementia after dietary assessment. The aim is to identify a pattern of polyphenol intake (based on 26 flavonoid and non-flavonoid polyphenol subclasses ascertained using a 24-hour dietary recall) associated with the risk of dementia and AD over 12 years in the 3C Bordeaux cohort.

Official Title
-----------------
Pattern of Polyphenol Intake and the Long-term Risk of Dementia in Older Persons

Conditions
-----------------
Diet, Polyphenols, Flavonoids, Stilbenes, Aged, Dementia, Alzheimer's Disease, Epidemiology

Intervention / Treatment
-----------------
* Other: observational study (no intervention)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 65 years or more, live in Bordeaux area (France) Exclusion Criteria: with dementia at the time of dietary assessment in year 2001-2002

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: observational study (no intervention)|Statistical association between adherence to a pattern of polyphenol intake and the risk to develop dementia and Alzheimer's disease over 12 years|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of dementia | incident cases of dementia diagnosed by the expert committee of neurologists at follow-up visits | 12 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of Alzheimer's disease | dementia with probable or possible Alzheimer etiology | 12 years |
A Study to Identify and Characterize LAL-D Patients in High-risk Populations

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to determine the frequency of Lysosomal Acid Lipase Deficiency (LAL D) by lysosomal acid lipase (LAL) enzyme activity assay in patients who are considered to be at risk.

Official Title
-----------------
A Study to Identify the Frequency of Lysosomal Acid Lipase Deficiency in At-Risk Patient Populations

Conditions
-----------------
Lysosomal Acid Lipase Deficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-obese** patients with elevated low-density lipoprotein (LDL) Non-obese** patients with low high-density lipoprotein (HDL) Non-obese** patients with unexplained and persistently elevated liver transaminases, Non-obese** patients with hepatomegaly Patients with cryptogenic cirrhosis Patients with biopsy-proven microvesicular or mixed micro/macrovesicular steatosis without a known etiology Patients with presumed Familial Hypercholesterolemia (FH) in which genetic analysis was performed for the genes encoding the low-density lipoprotein receptor (LDLR), Apo-B and PCSK9 genes and no disease-causing mutations were identified Patients with presumed FH with unclear family history Patients with autosomal recessive hypercholesterolemia (other than homozygous FH) Patients with autosomal recessive low HDL of unknown etiology Also, patient must meet the following: Patient or patient's parent or legal guardian (if applicable) consents to participate in the study and provides informed consent prior to any study procedures being performed. If the patient is of minor age; he/she is willing to provide assent where required per local regulations, and if deemed able to do so. Patient is willing and able to comply with protocol requirements. Patients who do not fall into one of the aforementioned categories (cohorts) but are considered highly suspicious for LAL D should be tested to rule out the disorder outside of the study at the discretion of the Investigator. Exclusion Criteria: Active viral hepatitis; Other confirmed genetic liver diseases (e.g., Wilson's disease, hemochromatosis, alpha 1-antitrypsin).

Ages Eligible for Study
-----------------
Minimum Age: 2 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 |
| --- | --- |
| At risk population<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LAL D frequency based on LAL enzyme assay. | The endpoint of this study is the frequency of LAL D in at-risk patients, based on results from the LAL enzyme assay. | approximately 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
LAL D, CESD, NASH, NAFLD, Wilson's, Niemann Pick, Familial Hypercholesterolemia
A Study to Assess the Efficacy and Safety of AXS-12 (Reboxetine) in Patients With Narcolepsy

Study Overview
=================
Brief Summary
-----------------
This study is a multi-center, double-blind, placebo-controlled, randomized Phase 3 trial to assess the safety and efficacy of AXS-12 in narcoleptic subjects with cataplexy and excessive daytime sleepiness (EDS).

Detailed Description
-----------------
Eligible subjects must have a diagnosis of narcolepsy per the International Classification of Sleep Disorders (ICSD-3), and exhibit symptoms of both cataplexy and EDS. Subjects meeting the entry criteria will be randomized in a 1:1 ratio to receive either AXS-12 or placebo for five weeks.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Multi- Center Study to Assess the Efficacy and Safety of AXS-12 in the Treatment of Cataplexy and Excessive Daytime Sleepiness in Subjects With Narcolepsy

Conditions
-----------------
Narcolepsy, Cataplexy, Excessive Daytime Sleepiness

Intervention / Treatment
-----------------
* Drug: AXS-12 (reboxetine)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subjects between 15 and 75 years of age, inclusive Primary diagnosis of narcolepsy with cataplexy Willing and able to comply with the study requirements Exclusion Criteria: Other clinically significant conditions potentially causing EDS Clinically significant psychiatric disorders

Ages Eligible for Study
-----------------
Minimum Age: 15 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AXS-12 (reboxetine)<br>Up to 5 weeks | Drug: AXS-12 (reboxetine)<br>* AXS-12 tablets, taken twice daily<br>|
| Placebo Comparator: Placebo<br>Up to 5 weeks | Drug: Placebo<br>* Placebo tablets, taken twice daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of cataplexy attacks | Average number of cataplexy attacks per week | Change from Baseline to Week 5 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AXS-12, Narcolepsy, Cataplexy, Excessive daytime sleepiness, Reboxetine, Axsome
Methods for Objective Selection of Competent Sperm

Study Overview
=================
Brief Summary
-----------------
In spite of the achievements and developement of the assisted reproduction techniques in the last years, there is still an elevated percentage of unsuccessful treatments, needing sometimes repeated attempts to reach pregnancy. The molecular physiology of sperm is being better characterized, and some reports have demonstrated the implication of different molecular processes in the pathophysiology of male infertility. Recently, different sperm selection methods have been based on these molecular differences, showing a better quality of the sperm population after selection. The main objective of this research project is to clinically apply these techniques in order to increase the pregnancy rates per cycle in infertile couples attending assisted reproduction treatments.

Conditions
-----------------
Sperm Selection

Intervention / Treatment
-----------------
* Other: Negative selection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: MEN: - >3million sperm after swimming process WOMEN: < 37 YEARS OLD NO GYNECOLOGICAL ANOMOLIES HORMONAL VALUES WITHIN CLINICAL RANGE Exclusion Criteria: NONE

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 37 Years

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 |
| --- | --- |
| No Intervention: Control<br>No sperm selection | |
| Experimental: Annexine V negative<br>Sperm selection with Annexine V protein | Other: Negative selection<br>* Sperm selection to continue the treatment with healthy sperm<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestation | Sperm selection and blood sample confirming gestation | 14 days |
Characteristics and Outcomes of Childhood Moyamoya in the UK

Study Overview
=================
Brief Summary
-----------------
This is a study to ascertain the number of children with moyamoya in the UK, their presenting features, clinical course and outcomes.

Detailed Description
-----------------
The study ahs 3 components: Patient identification via the British Paediatric Surveillance Unit, and the 21 collaborating centres Record review/patient interview to determine clinical features & outcomes Centralised review of imaging data to ascertain radiological phenotypes

Official Title
-----------------
Characteristics and Outcomes of Childhood Moyamoya in the UK

Conditions
-----------------
Moyamoya

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Radiological diagnosis of moyamoya Exclusion Criteria: Refuse consent

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- | --- |
| Number of children with moyamoya in UK |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical features & outcomes of childhood moyamoya |  | 2 years | 
| radioplogical features of childhood Moyamoya |  | 2 years |