linjc16/ctgov huggingface dataset:
Safety Study Providing 12 Months Follow-up From First Exposure to HP802-247 in Subjects With Venous Leg Ulcer

Study Overview
=================
Brief Summary
-----------------
This observations safety study is intended for subject who participated in the 802-247-09-029 study with the investigational product HP802-247 for venous leg ulcers and received at least one application of HP802-247 or Vehicle (an inactive substance). This study is being done for the following purposes: to identify new adverse events, to examine ongoing adverse events not resolved in subjects who participated in the 802-247-09-029 trial, to record wound status, and to determine if there are differences in Health Related Quality of Life (HRQoL) associated with the treatment assignment from the 802-247-09-029 Trial. Investigational means that HP802-247 has not been approved by the U.S. Food and Drug Administration (FDA).

Official Title
-----------------
A Non-Interventional Safety Study Providing 12 Months Follow-up From First Exposure to HP802-247 in Subjects With Venous Leg Ulcer

Conditions
-----------------
Venous Leg Ulcer

Intervention / Treatment
-----------------
* Biological: HP802-247


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provide informed consent document Subject was randomized in 802-247-09-029 and received at least one application of a test article. Subject has ended their participation in 802-247-09-029 by virtue of completing the study, or by dropping out prior to completion. Exclusion Criteria: Subjects who refuse to provide written informed consent will be excluded from this trial.

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

| Intervention/Treatment |
| --- |
|Biological: HP802-247|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Objective | The objectives of this study are to identify new adverse events, examine ongoing adverse events not resolved in subjects who participated in the 802-247-09-029 trial, and record wound status. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exploratory Objectives | The Health Economic objective for this study is to determine if there are differences in Health related Quality of Life (HRQoL) associated with the treatment assignment from the 802-247-09-029 Trial. | 12 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Venous leg ulcer, ulcer, venous stasis, compression, venous, venous stasis ulcer, vlu, hp802-247-09-029
Impact of Sarpogrelate in the Function of Endothelial Progenitor Cells

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects of Sarpogrelate in endothelial progenitor cells of patients with atherosclerosis.

Detailed Description
-----------------
Endothelial progenitor cells play an important role in vasculogenesis and vascular repair. Sarpogrelate, a inhibitor of HT2A, is used an an anti-platelet drug, however, a direct effect in vascular cells is supposed.

Official Title
-----------------
Impact of Sarpogrelate in the Function of Endothelial Progenitor Cells

Conditions
-----------------
Atherosclerosis

Intervention / Treatment
-----------------
* Drug: Sarpogrelate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with atherosclerosis Exclusion Criteria: Patients with high risk of bleeding Patients with pregnancy Patients with allergic reaction of Salpogrelate

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

| Intervention/Treatment |
| --- |
|Drug: Sarpogrelate|Sarpogrelate 300mg/day|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number and function of endothelial progenitor cells |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endothelial progenitor cells
Illness Related Distress in Women With Clinically Localized Cutaneous Melanoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the experiences and quality of life of women who have been treated for melanoma. By quality of life, we mean how they are feeling about different aspects of their life. In this study, we are especially interested in their feelings about survival, physical appearance and any family concerns. We will administer a series of QOL questionnaires, data sheets with many questions, to get their response to measure their feelings about these issues.

Official Title
-----------------
Illness Related Distress in Women With Clinically Localized Cutaneous Melanoma

Conditions
-----------------
Melanoma

Intervention / Treatment
-----------------
* Behavioral: questionnaire on-line or if uncomfortable with a computer interface, paper copies will be provided


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years or older Clinically node-negative primary cutaneous melanoma. Patients participating must be female Patients must have completed surgical treatment for melanoma at least 10 days ago and less than 2 years at the time of study entry. Exclusion Criteria: Prior history of cancer with the exception of squamous or basal cell carcinoma of the skin.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>female patients undergoing surgical treatment of cutaneous melanoma within two years of diagnosis and treatment | Behavioral: questionnaire on-line or if uncomfortable with a computer interface, paper copies will be provided<br>* This pilot study will measure illness related distress in female patients undergoing surgical treatment of cutaneous melanoma within two years of diagnosis and treatment. Areas of particular focus will be survival anxiety, family functioning/childbearing concerns, and aesthetic impact of surgery. Patients will complete a one time only set of quality of life assessments these questionnaires will take 30-45 minutes to complete.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure illness related distress regarding survival, family planning and functioning, and aesthetic satisfaction and QOL in post-surgical female patients diagnosed with clinically localized primary cutaneous melanoma. |  | conclusion of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To examine the impact of illness related distress on QOL in women treated for clinically localized primary cutaneous melanoma. |  | conclusion of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Skin
Endoscopy With Short Fasting

Study Overview
=================
Brief Summary
-----------------
Upper gastrointestinal (GI) endoscopy is widely used in the clinical practice. An empty stomach is required to ensure quality and safety. For this reason, endoscopy is conventionally performed after 8 or more hours of fasting, which is potentially related to discomfort to the patients. In recent studies, surgical cholecystectomy has been described to be safe after two hours of fasting on liquids. The aim of this study is to assess safety, quality and comfort of upper GI endoscopy after two hours of fasting.

Official Title
-----------------
Safety, Quality and Comfort of Upper Gastrointestinal Endoscopy With Conscious Sedation After Fasting for Two Hours

Conditions
-----------------
Upper Gastrointestinal Symptoms

Intervention / Treatment
-----------------
* Procedure: endoscopy after short fasting
* Procedure: conventional fasting


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elective endoscopy Exclusion Criteria: poor clinical condition

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: conventional fasting<br>patients were evaluated after fasting for 8 hours | Procedure: conventional fasting<br>* patients were evaluated after fasting for 8 hours<br>|
| Experimental: Short fasting<br>patients who were evaluated with endoscopy after fasting for two hours | Procedure: endoscopy after short fasting<br>* patients were evaluated with endoscopy after fasting for two hours<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety | safety of endoscopy after fasting for two hours will be assessed by means of a questionnaire replied by the endoscopists, questioning occurrence of aspiration and regurgitation of gastric contents into the esophagus. | 10 min (endoscopy duration) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality | Quality of endoscopy will be assessed by means of a questionnaire replied by the endoscopists, including (1) presence of liquid in the gastric lumen (2) quality of mucosa visualization (3)period needed for gastric aspiration | 10 min (endoscopy duration) | 
| Endoscopy comfort | Endoscopy comfort will be evaluated by the patients by means of a questionnaire replied after the procedures. It will include questions about thirst, hunger, anxiety, weakness and nausea. | 8 hours |
National Polish Registry of Minimally Invasive Liver Surgery

Study Overview
=================
Brief Summary
-----------------
After the two consensus meetings on laparoscopic liver resection in Louisville (2008) and in Morioka (2014) minimally invasive approach for liver resection was finally widely established in liver surgery practice. Successively more countries follow laparoscopic liver pioneers and apply laparoscopic liver surgery for everyday practice. Primary aim of the study is to assess the evolution and diffusion of minimally invasive liver surgery in Poland. Secondly, it will allow to assess the actual short- and long-term results of laparoscopic liver resections and compare it to the international benchmark values. The National Polish Registry of Minimally Invasive Liver Surgery will include data about all cases of laparoscopic liver resections performed in Poland since the first case in 2010. All surgical departments, where laparoscopic liverresection is regularly performed, will be invited. Data of demography, previous medical history, preoperative assessment, intraoperative and postoperative period, histopathological findings and long-term follow-up will be included in the registry. This study will be the first national report about diffusion of minimally invasive surgery in Poland.

Official Title
-----------------
National Polish Registry of Minimally Invasive Liver Surgery

Conditions
-----------------
Liver Tumor

Intervention / Treatment
-----------------
* Procedure: Laparoscopic liver resection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age >18 years underwent laparoscopic liver resection

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

| Intervention/Treatment |
| --- |
|Procedure: Laparoscopic liver resection|Liver tumors are resected with minimally invasive approach, laparoscopically.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications | Complications in the postoperative period classified by type and their severity according to the Clavien-Dindo grading system | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient survival |  | 5 years | 
| Postoperative hospital stay |  | 1 year | 
| Number of patients scheduled for reoperation after laparoscopic liver resection |  | 30 days | 
| Number of patients readmitted to hospital after discharge |  | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
laparoscopic liver resection, short-term results, long-term results
Assessing the Effects of Tretinoin Cream on Human Skin With Optical Imaging Technologies

Study Overview
=================
Brief Summary
-----------------
The researchers will assess the effects of treatment with tretinoin cream on human skin by using non-invasive optical imaging technologies.

Detailed Description
-----------------
The researchers will evaluate changes in the dermis and skin properties as the effect of treatment with Tretinoin cream (0.1%) by using the following optical imaging techniques. Multiphoton microscopy using a clinical tomograph (MPTflex, Jenlab, Germany) Multispectral Imaging using a device developed at Beckman Laser Institute, UC Irvine

Official Title
-----------------
In-vivo Non-invasive Skin Imaging Pilot Study to Assess the Effects of Tretinoin Cream Using Multi-photon Microscopy and Multi-spectral Imaging

Conditions
-----------------
Collagen Fibril Alteration

Intervention / Treatment
-----------------
* Drug: Tretinoin cream 0.1%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female 45 years of age or older - Skin type scale I to III Exclusion Criteria: Large amount of dark, coarse hair on the arms History of allergies to alpha hydroxy acids (AHAs), retinoids, soaps, fragrances, sunscreens or Latex Currently using over-the-counter AHA or retinol within one month or prescription retinoid within three months of the start of the study. History of skin cancer, including squamous or basal cell carcinoma at the treatment site or history of malignant melanoma. History of diabetes Currently pregnant or nursing

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

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

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

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: Tretinoin cream 0.1%<br>Assessment of the skin change | Drug: Tretinoin cream 0.1%<br>* Assessment of the skin change<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin Collagen/Elastin ratio over time - Change from baseline in sun exposed, and non sun exposed skin areas. | The effects of tretinoin cream on human skin will be measured. | up to 2 months |
Endoresection of the Tumor Scar or Transpupillary Thermotherapy for the Treatment of Large Uveal Melanomas (Endoresection-Laser)

Study Overview
=================
Brief Summary
-----------------
Study the efficacy of endoresection of the tumor scar or, when surgery is not possible, transpupillary thermotherapy on the tumor scar to prevent neovascular glaucoma and secondary enucleation

Official Title
-----------------
Phase II Evaluating Endoresection of the Tumor Scar or Transpupillary Thermotherapy When Endoresection is Not Feasible After Proton Beam Therapy for the Treatment of Large Uveal Melanomas

Conditions
-----------------
Uveal Melanoma, Melanoma, Uveal

Intervention / Treatment
-----------------
* Procedure: Endoresection
* Procedure: Laser diode


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Tumor of 7 mm of thickness or more Patients treated by proton beam therapy Patients aged at least 18 years Patients clearly informed of the study, having received the letter of information and signed the consent Exclusion Criteria: Massive extrascleral extension posterior to the equator Patients with metastasis at diagnosis. Patients with glaucoma before the radiation therapy Patients with opaque media preventing transpupillary thermotherapy Patients for whom follow up will be difficult due to geographical, social or psychological reasons

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>endoresection of the tumor scar or, when surgery is not possible, transpupillary thermotherapy on the tumor scar | Procedure: Endoresection<br>* Endoresection of the tumor scar<br>Procedure: Laser diode<br>* Transpupillary thermotherapy by laser diode on the tumor scar<br>* Other names: Thermotherapy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-treatment complication incidence. | observed complications are : Number of glaucomas, numbrer of retinal detachment and number of secondary enucleations. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of tumor scar thickness |  | 3 years | 
| Toxicity and side effects evaluation according to NCI-CTCAE v4.0 scale |  | 3 years |
Production of iPSC Derived RPE Cells for Transplantation in AMD

Study Overview
=================
Brief Summary
-----------------
No treatments exist for Age-related Macular Degeneration (AMD) when there is cell loss such as in late wet AMD or dry AMD. The differentiation of RPE cells from patient derived iPSC will offer valuable source of tissue for transplantation in these forms of AMD and may form basis for a future treatment option in terms of cell transplantation.

Detailed Description
-----------------
It has been shown that adult human skin cells or human blood cells can be reprogrammed to become stem cells. This type of stem cell is called an induced Pluripotent Stem Cell (iPSC).It has been shown specifically that this type of stem cell can be produced from adult human skin cells or blood cells can in turn be converted into Retinal Pigment Epithelial (RPE) cells. These RPE cells are a very important cell type in the human retina that are abnormal and ultimately lost in Age-related Macular Degeneration (AMD). Although it has been shown to be possible to make RPE cells from adult human skin, it has not been done to a level to fulfil regulatory requirements for human transplantation in AMD. This is a feasibility study involving 10 patients. The efficiency of creating an iPSC-Derived RPE cells from a patient's own skin or blood will be examined. A sample size of 10 patients will allow us to potentially consolidate the safety and efficacy of this method in order to create these cells within the context of a future transplantation trial.

Official Title
-----------------
Feasibility of Production of Induced Pluripotent Stem Cell Derived Retinal Pigment Epithelial Cells Fulfilling Regulatory Requirements for Human Transplantation in Dry Age-related Macular Degeneration

Conditions
-----------------
Age Related Macular Degeneration (AMD)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects over the age of 18 years Subjects with the ability to give informed consent Subjects with known AMD (both wet and dry) Exclusion Criteria: Unable to give informed consent Subjects unable to give blood sample for medical reasons Subjects with coagulopathies Subjects who are known to be at risk of keloid scarring

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 100 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 |
| --- | --- | --- |
| Successful production of a Retinal Epithelial (RPE) layer that fulfils Regulatory Regulation for transplantation. This will be confirmed with standard laboratory characterisation of RPE and completed toxicity and safety studies on the cell layer. |  | 1 year |
Analysis of Survival Status of KRAS Mutation Advanced Non-small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
this study is to analyze the survival condition of different groups about non-small cell lung cancer patients with KRAS mutations。The groups are made according to the treatment regime,brain metastases and gene mutation

Official Title
-----------------
Analysis of Survival Status of KRAS Mutation Advanced Non-small Cell Lung Cancer Based on NGS Test Results in Hunan Province China

Conditions
-----------------
KRAS Gene Mutation Advanced Non-small Cell Lung Cancer

Intervention / Treatment
-----------------
* Genetic: kras


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: advanced non-small cell lung cancer stage IIIB/IV KRAS mutation non-squmous Exclusion Criteria: squmous non-small cell lung cancer

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Cohorts 1<br>Treatment plan | |
| Cohorts 2<br>brain metastases | |
| Cohorts 3<br>Concomitant KRAS mutation | Genetic: kras<br>* the gene mutation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS | Overall survival | Approximately 1 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression free survival | Approximately 1 years |