linjc16/ctgov huggingface dataset:
Monitoring the Response of Port Wine Stain Birthmarks to Laser Therapy With Wide-field Functional Imaging Technologies

Study Overview
=================
Brief Summary
-----------------
The researcher develop non-invasive imaging modalities for assessment of port wine stain during laser therapy treatment of Port Wine Stain. The imaging modalities will be used to guide immediate retreatment of regions of persistent perfusion during the procedure.

Detailed Description
-----------------
The researcher can use imaging system operates by projecting low-power near-infrared structured light patterns on to the tissue of interest in a non-contact, reflection geometry and then capturing the reflectance with a camera.The system can image the depth-resolved optical properties of in-vivo tissues, allowing rapid, non-invasive visualization of sub-surface structures of Port Wine Stain.

Official Title
-----------------
Monitoring the Response of Port Wine Stain Birthmarks to Laser Therapy With Wide-field

Conditions
-----------------
PORT WINE STAIN

Intervention / Treatment
-----------------
* Device: Image-guided remove Port Wine Stain


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All minors, birth to 18 years of age or older with Port Wine Stain birthmark Ability to understand and carry out subject instructions Sign photograph release form Exclusion Criteria: Inability to understand and/or carry out instructions Pregnant women Do not sign photograph release form

Ages Eligible for Study
-----------------
Minimum Age: 1 Day

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Image-guided remove Port Wine Stain<br>Image-guided surgery remove Port Wine Stain | Device: Image-guided remove Port Wine Stain<br>* Image-guided surgery remove Port Wine Stain<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Image-guided surgery remove Port Wine Stain | Image-guided surgery remove Port Wine Stain | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
birthmark
Control of Colic in Infants by Dietary Supplementation With the Probiotic Lactobacillus Reuteri

Study Overview
=================
Brief Summary
-----------------
It is believed that probiotic Lactobacillus reuteri will improve the symptoms of breast-fed infants with colic.

Official Title
-----------------
Control of Colic in Infants by Dietary Supplementation With the Probiotic Lactobacillus Reuteri

Conditions
-----------------
Colic

Intervention / Treatment
-----------------
* Dietary Supplement: Lactobacillus reuteri


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ifants aged between 14 and 60 days Breast fed, exclusively during length of trial Diagnosis of infantile colic according to Wessel's criteria i.e paroxysmal fussing in infancy for more than three hours per day, at least three days per week. Debut of colic symptoms 6+/-1 days before randomization Gestational age between 37 and 42 weeks Apgar score higher than 7 at 5 minutes Mothers willing to follow a cows mild-free diet (free from mild, yoghurt, cheese etc) during the study period Written informed consent from one or both parents Stated availability throughout the study period Exclusion Criteria: Major chronic disease Gastrointestinal disease but controlled GERD with or without medication is not an exclusion criteria Administration of anitbiotics the week before randomization Administration of probiotics the week before randomization Participation in other clinical trials

Ages Eligible for Study
-----------------
Minimum Age: 14 Days
Maximum Age: 60 Days

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: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: Lactobacillus reuteri|5 drops of study product 30 minutes before feeding.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| * Reduction of daily average crying time to less than 3 hours from baseline to the end of the study period as measured using a daily reporting of crying time by the parents. |  | 7, 14 and 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of responders versus non-responders with L. reuteri versus placebo at end of the study. |  | 21 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colic, Colic in Breast-fed Infants
Aspirin Use and Postoperative Bleeding From Dental Extractions in a Healthy Population

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if aspirin is associated with bleeding complications following a single tooth extraction

Detailed Description
-----------------
Aspirin is a common chronically administered preventive treatment for cardiovascular disease, but is often discontinued prior to invasive dental procedures because of concern of bleeding complications. As the goal of aspirin is often to prevent MI and stroke, the risk of these CVD outcomes with discontinuation of aspirin must be weighed against the perceived adverse event of bleeding during or following an invasive dental procedure with continuation of aspirin. The current study is a randomized controlled trial evaluating bleeding complications of aspirin vs. placebo in healthy patients schedule for a single tooth extraction.

Official Title
-----------------
Aspirin Use and Postoperative Bleeding From Dental Extractions in a Healthy Population

Conditions
-----------------
Bleeding Complication

Intervention / Treatment
-----------------
* Drug: Aspirin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Require a simple tooth extraction Exclusion Criteria: Use of previous aspirin or NSAID

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Aspirin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral bleeding time |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Report of bleeding at phone follow-up at 3-7 (first follow-up) and 40-55 hours (second follow-up) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aspirin, Bleeding, Clinical Trial, Dental Extraction
Study of BH4, a New and Simple Treatment of Mild PKU

Study Overview
=================
Brief Summary
-----------------
The main purpose is to test whether treatment with BH4-tablets can replace the protein restrictive diet in patients with mild PKU caused by a certain frequent mutation.

Detailed Description
-----------------
PKU, phenylketonuria, is a rare, inherited metabolic disorder that results in mental retardation if not a very strict low-protein diet is started within the first weeks of life. The conversion of phenylalanine, phe, to tyrosine is defect, phe accumulates, leading to brain damage. There are different degrees of severity, reflecting the spectrum of mutant genes. BH4, tetrahydrobiopterin, is a co-enzym for the conversion of phe to tyrosine. It is known that BH4 can lower phe in some patients with milder forms of PKU. The main purpose is to test whether treatment with oral BH4 can replace the protein restrictive diet in patients with mild PKU caused by the frequent mutation Y414C in the phenylalanine hydroxylase gene.

Official Title
-----------------
Study of the Response of Tetrahydrobiopterin on S-Phenylalanine in Patients With PKU Housing the Y414C Mutation

Conditions
-----------------
Phenylketonuria

Intervention / Treatment
-----------------
* Drug: 5,6,7,8-tetrahydrobiopterin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed mild PKU with 2 known mutations in the PAH gene, hereof at least one Y414C From the age of eight Informed consent - Exclusion Criteria: Less than 8 years of age Pregnancy or treated with the intensive diet of pregnancy -

Ages Eligible for Study
-----------------
Minimum Age: 8 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

| Intervention/Treatment |
| --- |
|Drug: 5,6,7,8-tetrahydrobiopterin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting S-phenylalanine at day 0, 1, 2, 5, 7 in each week of treatment with BH4. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mild PKU, Y414C, 5,6,7,8-tetrahydrobiopterin, BH4, treatment without protein restriction
to Investigate the Pharmacokinetic Interactions and Safety Between Rosuvastatin and Ezetimibe in Healthy Male Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the drug interaction of pharmacokinetics of rosuvastatin and ezetimibe.

Detailed Description
-----------------
drug interaction : rosuvastatin, ezetimibe

Official Title
-----------------
A Phase I Clinical Trial to Investigate the Pharmacokinetic Interactions and Safety Between Rosuvastatin and Ezetimibe in Healthy Male Volunteers

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

Intervention / Treatment
-----------------
* Drug: Crestor+Ezetrol
* Drug: Ezetrol
* Drug: Crestor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male subjects age between 19 and 45 singed informed consent Exclusion Criteria: Hypotension or hypertension has a history of allergy reaction of this drug or other drugs

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 45 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: Crestor+Ezetrol<br>rosuvastatin+ezetimibe | Drug: Crestor+Ezetrol<br>* rosuvastatin+ezetimibe<br>* Other names: rosuvatatin+ezetimibe;|
| Active Comparator: Ezetrol<br>ezetimibe | Drug: Ezetrol<br>* ezetimibe<br>* Other names: ezetimibe;|
| Active Comparator: Crestor<br>rosuvastatin | Drug: Crestor<br>* rosuvastatin<br>* Other names: rosuvastatin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under Curve |  | 0-24h |
Evaluation of the German Version of a Validated Keratoconus Questionaire

Study Overview
=================
Brief Summary
-----------------
Keratoconus, which results in thinning of the cornea, affects mainly young patients. The causes are currently only partially known. The aim of this study is the evaluation of a keratoconus questionnaire in German. Until now this questionnaire is only in use in English. Within the study patients will be asked to fill out a questionnaire. The questionnaire deals with issues that are influenced by keratoconus: Visual impairment and its impact on quality of life. This questionnaire (KORQ) is an already validated questionnaire in English. Within this study we would like to translate the questionnaire and validate it in German. Within this study 50 patients will be included for the validation of the questionnaire. Based on previous studies evaluating the Keratoconus Questionnaire (KORQ) in other languages, a number of 50 patients has been shown to be sufficient for validation. No control examination is necessary for this study.

Official Title
-----------------
Evaluation of the German Version of a Validated Keratoconus Questionaire

Conditions
-----------------
Keratoconus, Unspecified, Bilateral

Intervention / Treatment
-----------------
* Other: questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Keratoconus Signing of a written consent form for participation in the study Exclusion Criteria: Difficulty in understanding patient information

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 105 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: questionnaire|the patients are asked to fill in a questionnaire|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of Keratoconus Outcome Research Questionnaire (KORQ) | validation of a questionnaire in german language | at screening visit |
Multi-Center, Prospective, Randomized, Comparison of AWBAT™-D vs. Xeroform™ or Glucan II™ for Treatment of Donor Sites in Burn Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the rate of healing and the non-adherence of three types of dressings. The study will also compare rate of infection, scarring and perception of pain associated with treatment.

Detailed Description
-----------------
The purpose of this study is to evaluate AWBAT™-D compared to Xeroform™ or Glucan II™ for the treatment of donor sites in burn surgery. Primary Study Goals: To compare the rate of healing of donor sites. To compare patient reported perception of pain To compare the potential clinical complication rates of: non-adherence, seroma hematoma infection Secondary Study Goal: • To compare clinical outcome of donor sites: scarring based on the Vancouver Scar Scale.

Official Title
-----------------
Multi-Center, Prospective, Randomized, Comparison of AWBAT™-D vs. Xeroform™ or Glucan II™ for Treatment of Donor Sites in Burn Surgery

Conditions
-----------------
Treatment of Donor Site Burns

Intervention / Treatment
-----------------
* Device: AWBAT™-D and XEROFORM™ OR GLUCAN II™ dressings


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Burn wounds measuring 1% - 30% TBSA requiring skin grafting Anterior bilateral donor sites of approximately the same size taken from the thighs or abdomen Exclusion Criteria: Ventilator dependence Pregnancy /Lactation Mechanism of injury was electrical, chemical or frostbite Co-morbidity which may compromise healing Known allergy to porcine or porcine products

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: AWBAT™-D and XEROFORM™ OR GLUCAN II™ dressings|Dressing, donor site dressings|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • To compare the rate of healing of donor sites. • To compare patient reported perception of pain • To compare the potential clinical complication rates of: o non-adherence, o seroma o hematoma o infection |  | 2 year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • To compare clinical outcome of donor sites: scarring based on the Vancouver Scar Scale. |  | 2 year follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Burn, donor site, skin graft, dressing, AWBAT™-D, XEROFORM™, GLUCAN II™
Effect of Early vs Late Drainage Removal in Women After Radical Mastectomy With Axillary Clearance

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to assess whether early drainage removal in patients with less than 150ml of lymph in postoperative day 1 can reduce total lymphorrhoea

Detailed Description
-----------------
Patients with early drainage removal will be compared with patients in whom drainage will be kept until daily lymphorrhoea is 30ml

Official Title
-----------------
Prospective Randomised Clinical Trial Comparing the Effect of Early and Late Drainage Removal in Female Patients After Radical Mastectomy With Axillary Clearance

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

Intervention / Treatment
-----------------
* Procedure: Early drainage removal
* Procedure: Late drainage removal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stage IIA and IIB breast cancer treated with radical mastectomy Obtaining informed consent Total amount of lymph in postoperative day 1 <150ml Exclusion Criteria: Stage I, III-IV breast cancer History of benign breast neoplasm or malignant disease of any origin Any breast surgery in the past Weight <50kg

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Early drainage removal<br>Patients randomised to early drainage removal arm will have the drain removed in postoperative day 1. Lymph will be punctured on a regular basis | Procedure: Early drainage removal<br>* Drainage will be removed in postoperative day 1<br>|
| Other: Late drainage removal<br>Patients randomised to late drainage removal arm will have the drains kept until total daily drainage is 30ml and then removed | Procedure: Late drainage removal<br>* Drains will be kept until daily drainage is 30ml and then removed<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total lymph volume and time | Assessment of total lymph volume and lymphorrhoea time up to 3 months after the surgery | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post operative pain assessment | Post operative pain assessment using VAS (Visual Analogue Scale) scale until 30 days after surgery | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast cancer, Axillary clearance, lymphorrhoea
A Study of TAS-114 in Combination With S-1 in Patients With Advanced Solid Tumors

Study Overview
=================
Brief Summary
-----------------
This is a phase 1 study of TAS-114 in combination with S-1 in patients with advanced solid tumors.

Detailed Description
-----------------
This is a phase 1, open-label, non-randomized, dose-escalating safety, tolerability, and pharmacokinetic study of TAS-114 in combination with S-1 in patients with advanced solid tumors.

Official Title
-----------------
A Phase 1 Study of TAS-114 in Combination With S-1 in Patients With Advanced Solid Tumors

Conditions
-----------------
Advanced Solid Tumors

Intervention / Treatment
-----------------
* Drug: TAS-114 + S-1


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Life expectancy of at least 3 months Histological or cytological documentation of advanced solid tumors ECOG Performance Status of ≤ 1 (ECOG: Eastern Cooperative Oncology Group) Adequate bone marrow, liver and renal function Women of childbearing potential and men must agree to use adequate contraception

Ages Eligible for Study
-----------------
Minimum Age: 20 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: TAS-114/S-1<br>TAS-114 plus S-1 | Drug: TAS-114 + S-1<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum tolerated dose of TAS-114 when used in combination with S-1 |  | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic profiles (peak plasma concentration (Cmax) and area under the plasma concentration versus time curve (AUC) of TAS-114, S-1 components and its metabolite) |  | 4 years | 
| Response rate |  | 4 years | 
| Disease control rate |  | 4 years | 
| Progression free survival |  | 4 years |