linjc16/ctgov huggingface dataset:
Learning Skills in Young Specialists and Residents in Operative Vaginal Delivery Using Simulator Models

Study Overview
=================
Brief Summary
-----------------
Evaluation of different learning programs on persistence of skills in operative vaginal delivery

Detailed Description
-----------------
Investigators enrolled residents and young specialist randomly exposed to simulation of operative vaginal delivery or a lecture before and after experience on simulator program. The two groups were exposed after 8-12 weeks to a second experience of simulator program due to evaluate the improve, deterioration of skills in operative vaginal delivery. 12-months persistence of skills were evaluated

Official Title
-----------------
Operative Vaginal Delivery in Residents and Young Specialists

Conditions
-----------------
Birth Disorder, Delivery Complication

Intervention / Treatment
-----------------
* Other: the better retaining of skills


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: residents or young specialists (less than 5 years after ending of residency) - Exclusion Criteria: medical students before MD -

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Simulator training before<br>group exposed directly to simulator training without knowing the topic of obstetric emergency | Other: the better retaining of skills<br>* identify which teaching program has the better retaining of skills<br>|
| lesson before simulation training<br>group undergoing formal lecture before the vacuum delivery simulation on mannequin | Other: the better retaining of skills<br>* identify which teaching program has the better retaining of skills<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improving and retaining skills in two different groups of teaching programs | evaluate video recorded simulations using items and total value during the operative vaginal delivery on manequin | 12 weeks and 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improve skills in obstetric emergencies considering year of formation and teaching programs | Comparison of quality scale per items | 12 weeks and 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vaginal birth, vacuum delivery, operative vaginal birth, mannequin training program
Effect of Growth Hormone on Insulin Signaling in Muscle Tissue

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the effects of a physiological bolus of growth hormone on insulin signaling pathways in muscle tissue in healthy lean men.

Official Title
-----------------
The Effect of a Physiological Bolus of Growth Hormone (GH) on Insulin Signaling Pathways in Muscle Tissue From Healthy Adults

Conditions
-----------------
Insulin Resistance

Intervention / Treatment
-----------------
* Device: Physiological Bolus of Growth Hormone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male Healthy Age between 18 and 30 years BMI ≤ 26 Exclusion Criteria: Known present disease including diabetes mellitus BMI > 26 Uses any medication Consumes > 21 units of alcohol per week

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Saline bolus + OGTT | Device: Physiological Bolus of Growth Hormone<br>* 0,5 mg Norditropin<br>|
| Other: 2<br>GH-bolus and OGTT | Device: Physiological Bolus of Growth Hormone<br>* 0,5 mg Norditropin<br>|
| Other: 3<br>GH-bolus | Device: Physiological Bolus of Growth Hormone<br>* 0,5 mg Norditropin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PI3-kinase activity i muscle tissue |  | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth Hormone Signaling Proteins in Muscle Tissue and other Insulin Signaling Proteins in Muscle Tissue |  | 2 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Growth Hormone, Insulin Signaling, GH signaling
Use of Laser Speckle to Study Cutaneous Blood Flow at Exercise in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
We aim to test the hypothesis that Laser speckle contrast imaging allows for the measurement of cutaneous blood flow during exercise.

Detailed Description
-----------------
Ischemia and post occlusive reactive hyperhemia in the skin is tested in healthy normal subjects at rest and during cycle exercise.

Official Title
-----------------
Evaluation Chez Des Sujets Sains d'Une Nouvelle Technique d'étude de la Microcirculation cutanée

Conditions
-----------------
Microcirculation

Intervention / Treatment
-----------------
* Other: tourniquet ischemia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers Affiliation to the French health system Exclusion Criteria: Any disease or chronic treatment

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| healthy volunteers<br> | Other: tourniquet ischemia<br>* Recording of cutaneous blood flow on the forearm at rest and during cycle exercise 50W before and following tourniquet ischemia<br>* Other names: Near infra-red spectrometry;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Microcirculation, laser flowmetry, Skin, Physiology
Osseointegrated Prostheses for the Rehabilitation of Amputees

Study Overview
=================
Brief Summary
-----------------
Patients with transfemoral amputations (TFA) frequently experience problems related to the use of socket-suspended prostheses 1-3. These problems increase with short or deformed stumps 4. The potential for improvement is substantial. Based on the very good long-term results with osseointegrated titanium implants for edentulous patients 5, osseointegrated hearing aids 6, cranio-facial prostheses 7 and prostheses for thumb-amputated patients 8, the clinical development of osseointegrated prostheses for TFA started in 1990, in Gothenburg, Sweden. The concept has gradually been modified and improved. In 1999, a prospective clinical trial began. The hypothesis is that the treatment will improve quality of life.

Official Title
-----------------
Osseointegrated Prostheses for the Rehabilitation of Amputees.

Conditions
-----------------
Transfemoral Amputation

Intervention / Treatment
-----------------
* Device: OPRA Implant System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Transfemoral amputation Exclusion Criteria: Transfemoral amputation due to vascular disease

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 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: Implant System<br> | Device: OPRA Implant System<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Q-TFA Prosthetic Use Score | The primary efficacy variable is the change in Q-TFA Prosthetic Use Score as compared baseline. | 0,1,2,3,5,7,10,15,20 years |
Dosage Study for Vigamox Eye Drops Prior to Intravitreal Injections

Study Overview
=================
Brief Summary
-----------------
Antibiotic eye drops are being used before and after intravitreal injections. Currently there is no study indicating the benefit of there usage or their dosage. In this study we compare the efficacy of Vigamox eye drops (antibiotic)starting 3 days prior to the injection versus 1 day prior to intravitreal injection.

Official Title
-----------------
To Compare the Efficacy of Topical Vigamox Eye Drops at Tid 3 Days Prior to Intravitreal Injection Versus Tid 1 Day Prior to Intravitreal Injection

Conditions
-----------------
Intravitreal Injection Patients

Intervention / Treatment
-----------------
* Drug: Vigamox


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient who need intravitreal injections patients who are willing to participate in the study Exclusion Criteria: Patients who are allergic to Vigamox or who have taken any eye drops within the past 3 weeks

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 100 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br>Arm 1: receives Vigamox eye drops 3Xday for 3 days prior to intravitreal injection | Drug: Vigamox<br>* eye drops 3 times day either 1 or 3 days prior to intravitreal injection<br>|
| Active Comparator: Arm 2<br>Arm 2: receives Vigamox eye drops 3Xday for 1 day prior to intravitreal injection | Drug: Vigamox<br>* eye drops 3 times day either 1 or 3 days prior to intravitreal injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed study |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vigamox, topical antibiotics, Intravitreal injections, macular degeneration, endophthalmitis
Vascular Function in the Framingham Third Generation

Study Overview
=================
Brief Summary
-----------------
To investigate the role of endothelial dysfunction and increased vascular stiffness as contributors to the pathogenesis of cardiovascular disease.

Detailed Description
-----------------
BACKGROUND: Increasingly, researchers understand that endothelial dysfunction and increased vascular stiffness contribute to the pathogenesis of cardiovascular disease (CVD). The Framingham Heart Study (FHS) has been examining vascular function in about 3600 middle-aged and elderly participants of the FHS Offspring and minority OMNI cohorts. DESIGN NARRATIVE: The study characterizes vascular function by performing noninvasive studies of endothelial function with brachial ultrasound flow-mediated dilation, and of vascular stiffness with arterial tonometry, in 3850 adult offspring of the FHS Offspring and OMNI cohorts. The total of over 7000 vascular examinations in an extensively studied multi-generational community-based cohort provides the opportunity to characterize the environmental and genetic determinants, and the prognosis of altered vascular function. The study hypotheses are: vascular function is determined by both environmental and genetic factors; endothelial function and vascular stiffness phenotypes are associated with each other: and vascular dysfunction predisposes to the development of hypertension (HTN) and cardiovascular disease.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria
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 |
| --- | --- | --- |
Real World Study of Pyrotinib in Human Epidermal Growth Factor Receptor-2 (HER2) Positive Breast Cancer

Study Overview
=================
Brief Summary
-----------------
This Non-Interventional Study will describe and analyze the clinical use of pyrotinib in clinical practice in the treatment of HER2 positive breast cancer in the real world.

Official Title
-----------------
Real World Study on the Efficacy and Safety of Pyrotinib in the Treatment of HER2 Positive Breast Cancer: An Observational,Multi-center,Prospective Study (Real Pretty Study)

Conditions
-----------------
HER2-positive Breast Cancer

Intervention / Treatment
-----------------
* Other: non-interventional


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥18 years old with histologically confirmed HER2 positive breast cancer. Documented HER2 overexpression by local laboratory ,defined as immunohistochemistry (IHC) 3+ or fluorescence in situ hybridization (FISH) positive. Physician has determined that treatment with pyrotinib is indicated. Traceable medical record available. Exclusion Criteria: Patients who are unable to understand the nature of the study and are unwilling to sign an informed consent . Pregnant or breast feeding patients Patients participating in any interventional clinical trial that includes investigational or marketed products at the time of enrollment. Patients not suitable for this study under investigators' consideration.

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 |
| --- | --- |
| non-interventional study<br> | Other: non-interventional<br>* This prospective, observational study will be conducted according to each site's routine clinical practice<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival(PFS) | Progression Free Survival(PFS) | 12 months | 
| Pathological Complete Response（pCR）Rate | Percentage of Participants With Pathological Complete Response | through study completion, an average of 1 year | 
| Incidences of adverse events and toxicities | Incidences of adverse events and toxicities | through study completion, an average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pyrotinib
Low Anterior Resection Syndrome and Rectal Irrigation Study

Study Overview
=================
Brief Summary
-----------------
Prospective study assessing treatment acceptability and the impact of rectal irrigation on patients with low anterior resection syndrome (LARS) in terms of quality of life and bowel function.

Detailed Description
-----------------
Aims: To assess if rectal irrigation improves patient symptoms and quality of life in patients with LARS and to see if the treatment is acceptable to patients. Methods: This is a mixed methods evaluation study on functional outcomes in patients who have undergone anterior resection for rectal neoplasia and who have had bowel continuity restored between Jan 2009 and Jan 2014. Those patients deemed to have LARS who consent to participation in the study will be offered rectal irrigation.

Official Title
-----------------
Low Anterior Resection Syndrome and Rectal Irrigation Study

Conditions
-----------------
Anterior Resection Syndrome

Intervention / Treatment
-----------------
* Device: Peristeen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who have undergone anterior resection for rectal neoplasia, patients who have had restored bowel continuity LARS score of >20 (defined LARS syndrome) patients > 18 years of age. Exclusion Criteria: previous use of rectal irrigation patients who are unable to give informed consent patients who are not physically capable of performing the treatment in their home

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Treatment<br>Peristeen given | Device: Peristeen<br>* rectal irrigation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF12 | quality of life | pre intervention and 6 months post | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EORTC | quality of life | pre intervention and 6 months post | 
| Low anterior resection score | bowel function | pre intervention and 6 months post | 
| St Marks Faecal incontinence score | bowel function | pre intervention and 6 months post | 
| treatment acceptability questionnaire |  | post training for treatment and 6 months post treatment |
Synthetic Mesh Explant Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether synthetic hernia mesh materials undergo physical and/or chemical changes while in the body.

Official Title
-----------------
Characterization of Explanted Hernia Meshes From Human Subjects: A Prospective Study

Conditions
-----------------
Herniorrhaphy, Humans, Polypropylene, Polytetrafluoroethylene, Histology, Materials Testing

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Age ≥ 18 yrs Previous placement of hernia mesh material Current need for excision of previous mesh placement or Current need for intra-abdominal surgical procedure Exclusion criteria: Age < 18 yrs No retained mesh prosthetic. Non surgical candidate Prisoner

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- | --- |
| Fibrosis level of explanted mesh | Each specimen will be graded and given fibrosis score of 0 - 4 to establish the degree of inflammation/foreign body reaction that occurred while mesh was in vivo. | Within 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tensile strength of explanted mesh | Each specimen will be tested for tensile strength to determine force versus displacement. | Within 2 weeks | 
| Collagen protein levels of explanted mesh. | The total amount of collagen and non-collagenous proteins in cultured cell layers and tissue sections by differential staining with two dyes, sirius red and fast green. Sirius Red binds to all types of collagen, whereas fast green stains non-collagenous proteins. | Within 2 weeks | 
| Number of subjects with history of radiation to abdomen/pelvis | Identify possible clinical characteristics which affect mesh degradation. | Within 2 weeks | 
| Number of subjects with history of chemotherapy | Identify possible clinical characteristics which affect mesh degradation. | Within 2 weeks | 
| Number of subjects with corticosteroid/immunosuppression therapy | Identify possible clinical characteristics which affect mesh degradation. | Within 2 weeks | 
| Number of subjects with history of tobacco use | Identify possible clinical characteristics which affect mesh degradation. | Within 2 weeks |
Betrnet Stem Cells and the Origins of Barrett's Esophagus Project 3 RF Ablation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine biomarkers which can predict response to ablation therapy in patients with Barretts esophagus.

Detailed Description
-----------------
This Project is designed to identify biologically-based and clinically-useful biomarkers of tissue at risk for neoplastic progression as well as of response to ablation therapy. These results will result in improved risk stratification in BE and better targeting of resources for patients who are candidates for ablative therapy, while simultaneously providing key information regarding the origins of Barrett's esophagus.

Official Title
-----------------
Stem Cells And The Origins Of Barrett's Esophagus:Identification Of Novel Biomarkers And Gene Signatures In Barrett's Esophagus

Conditions
-----------------
Barrett's Esophagus

Intervention / Treatment
-----------------
* Genetic: response to therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Barrett's esophagus with high grade dysplasia or intramucosal (early) adenocarcinoma. BE length ≥ 2 cm and ≤ 8 cm. Able to return every 3 months for one year after ablation Exclusion Criteria: Patients who are unable to be compliant with follow-up endoscopies patients who cannot tolerate Proton Pump inhibitors pre-existing esophageal strictures pregnant or nursing women

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 |
| --- | --- |
| Radiofrequency ablation<br>participants with barrett's esophagus with high grade dysplasia who undergo radiofrequency ablation (RFA) | Genetic: response to therapy<br>* evaluate specific markers for response to therapy at specific intervals pre and post therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to therapy | evaulation will be made at 3 month intervals for one year post ablation | one year post ablation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Barrett's esophagus, high grade dysplasia, ablation, radiofrequency ablation, esophageal cancer