linjc16/ctgov huggingface dataset:
Clinicopathological and Molecular Correlation of Acrochordon in Relation to Human Papillomavirus Infection

Study Overview
=================
Brief Summary
-----------------
Acrochordon, or soft fibroma, is a common benign skin tumor which is generally regarded as a sign of cutaneous aging or as a reaction to friction since it occurs in the intertriginous areas. Recent studies have shown the presence of human papillomaviruses, especially the mucosal types, on some of the intertriginous lesions. This study is to analyze the different clinical presentations of acrochordon and correlate them with pathologic and molecular human papillomavirus findings. Further goal is to improve the ability to differentiate acrochordon and its possible prevention and treatment. Also, it may have an implication on the transmission and prevention of cervical carcinoma.

Detailed Description
-----------------
Acrochordon, also called soft fibroma, skin tag or fibroepithelial polyp, is a common cutaneous disorder characterized by a polypoid growth composed of fibroblasts in a loose collagenous stroma, sometimes with proliferation of blood vessels. They appear as soft, skin-colored or light brownish skin tumors. Three types of lesions may occur, (1) multiple small, furrowed papules, especially on the neck and in the axillae, (2) single or multiple filiform smooth growths in various locations, and (3) solitary bag-like pedunculated growth, seen most commonly on the lower trunk. Most regard them as a sign of cutaneous aging. The presence of human papillomaviruses (HPVs), especially the mucosal types, has been demonstrated in acrochordon. Our previous experience on HPV typing of skin tags also confirms this finding. Though HPV is a ubiquitous virus, the presence of mucosal type HPV in non-mucosal sites is exceptional. This investigation is trying to correlate the clinicopathological and HPV molecular typing of acrochordons. A better understanding of acrochordon and its relation to HPV infection may improve the ability to prevent and treat.

Official Title
-----------------
Clinicopathological and Molecular Correlation of Acrochordon in Relation to Human Papillomavirus Infection

Conditions
-----------------
Acrochordon, Skin Tag, Soft Fibroma, Human Papillomavirus, HPV

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients with multiple acrochordon on non-anogenital sites who ask to remove the lesions and have signed consent to surgery will be asked to participate in the study Exclusion Criteria: No special exclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- | --- |
An Observational Study of Herceptin SC Safety in Breast Cancer

Study Overview
=================
Brief Summary
-----------------
This is a phase IV, prospective, multicenter, observational study (regulatory post-marketing surveillance) in approximately 600 patients who are to receive Herceptin SC (trastuzumab, subcutaneous administration) per approved local labeling. Patients will be under observation according to standard of care in Korea.

Official Title
-----------------
Post-Marketing Surveillance of Herceptin Subcutaneous in Breast Cancer

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - All patients administered Herceptin SC for the locally approved indications Exclusion Criteria: N/A

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 |
| --- | --- |
| Cohort<br>Method of continuous surveillance per standard of care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (composite outcome measure): Incidence of adverse events (AEs), serious adverse events (SAEs), adverse events of special interest, pregnancies, adverse drug reactions (ADRs); unexpected ADRs; expected ADRs |  | Up to 6 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: Pathological Complete Response (pCR) in neoadjuvant early breast cancer (EBC) |  | Up to 6 years | 
| Efficacy: Overall response per Response Evaluation Criteria in Solid Tumors (RECIST) |  | Up to 6 years |
Follow-up of the Cardiomyopathy Cohort SFB/TR19

Study Overview
=================
Brief Summary
-----------------
Follow-up of a cohort of inflammatory cardiomyopathy patients (suspected or validated inflammatory cardiomyopathy) recruited at baseline by the SFB-TR19 project. Standardized protocols will be used for the assessment of medical history and examinations, laboratory biomarkers, and the collection of various biomaterials for biobanking purposes.

Detailed Description
-----------------
Periodical follow-up of a cohort of inflammatory cardiomyopathy patients (suspected or validated inflammatory cardiomyopathy) recruited at baseline by the SFB/TR19 project. Participants will be followed up at least every year - or more frequently based on clinical need. Standardized protocols will be used for the assessment of medical history and examinations, laboratory biomarkers, and the collection of various biomaterials for biobanking purposes.

Official Title
-----------------
Follow-up of the Inflammatory Cardiomyopathy Cohort of SFB/TR19

Conditions
-----------------
Cardiomyopathies, Heart Failure

Intervention / Treatment
-----------------
* Other: Observational


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participation in baseline examination of SFB/TR19 Exclusion Criteria: none

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 |
| --- |
|Other: Observational|None, observational only|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of cardiovascular events | Number of hospitalization (HF based. all-cause), interventions (ICD, pacemaker), myocardial infarction | 1-year follow-ups up to 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LVEF (left ventricular ejection fraction) | Left ventricular ejection fraction at time of follow-ups (through study completion, every year) | 1-year follow-ups up to 10 years | 
| VO2peak | Exercise capacity by CPET (cardiopulmonary exercise testing) | 1-year follow-ups up to 10 years | 
| QOL | Quality of life by MLHF questionnaire | 1-year follow-ups up to 10 years | 
| Mortality | Mortality (HF-related, cardiovascular disease, all-cause mortality) | 1-year follow-ups up to 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
heart failure, cardiomyopathy, myocarditis
TESS Shoulder Arthroplasty Data Collection

Study Overview
=================
Brief Summary
-----------------
This observational study intends to collect efficacy and safety data on TESS shoulder system

Detailed Description
-----------------
The T.E.S.S.® shoulder system has been developed to provide a complete solution for all the indications for Shoulder Arthroplasty, Arthritis, Rotator Cuff Arthropathy, Proximal Humeral Fracture, minimising bone resection and restoring the natural anatomy of the patient.

Official Title
-----------------
A Prospective, Multicentre Study Evaluating the Clinical Performance of the T.E.S.S Anatomic and Reverse Shoulder Prostheses

Conditions
-----------------
Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A pre-operative level of pain and function the same as for conventional joint replacement A likelihood of obtaining relief of pain and improved function Full skeletal maturity Ability to follow instructions Good general health for age Willing to return for follow-up evaluations Exclusion Criteria: Glenohumeral joint infection, osteomyelitis Neuro-muscular complications Inability to co-operate with and complete the study

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 |
| --- | --- |
| TESS prosthesis<br>Consecutive series of patients with a TESS prosthesis. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Constant Murley Score | Improvement in this score will be collected at every follow-up visit.This is a 100-point score, containing 8 questions. Higher score indicate a better outcome. | 6 months, 1 year, 2 year, 3 year, 4 year, 5 year, 7 year and 10 year | 
| Change in Oxford Score | Improvement in this score will be collected at every follow-up visit.This is a 60-point score, containing 12 questions. Higher score indicate a better outcome. | 6 months, 1 year, 2 year, 3 year, 4 year, 5 year, 7 year and 10 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | General and shoulder specific complicatons are collected any time. | Any time | 
| Patient Satisfaction | Binary question. | 6 months, 1 year, 2 year, 3 year, 4 year, 5 year, 7 year and 10 year |
Macugen (Pegaptanib Sodium) Alone, Versus Macugen in Combination With PDT (Photodynamic Therapy) With Visudyne (Verteporfin) in Patients With Age-Related Macular Degeneration (AMD)

Study Overview
=================
Brief Summary
-----------------
The purpose of the trial is to compare whether Macugen (pegaptanib sodium) in combination with PDT with Visudyne (verteporfin) is safe and effective in slowing down the leakage of fluid within the eye and thereby stabilizing or improving vision when compared to Macugen alone. Patients must be recently diagnosed with predominantly classic wet AMD and must be eligible for PDT.

Official Title
-----------------
A Phase IIIb/IV Randomized, Double-Masked, Active Controlled, Dose-Ranging, Multi-Center Comparative Trial, in Parallel Groups, to Compare the Safety and Efficacy of Intravitreal Injections of Pegaptanib Sodium (Macugen) Given Every 6 Weeks for 102 Weeks, to Pegaptanib Sodium Plus Photodynamic Therapy (PDT) With Visudyne, in Patients With Exudative Age-Related Macular Degeneration (AMD)

Conditions
-----------------
Age-Related Macular Degeneration

Intervention / Treatment
-----------------
* Drug: Photodynamic Therapy (PDT) with Visudyne (verteporfin)
* Drug: Macugen (pegaptanib sodium)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects of either gender; aged 50 years or greater. Subfoveal choroidal neovascularization (CNV) due to AMD with predominantly classic lesion composition Best corrected visual acuity in the study eye between 20/40 and 20/200 Exclusion Criteria: Any prior PDT with Visudyne to the study eye Any previous AMD thermal laser therapy to the study eye

Ages Eligible for Study
-----------------
Minimum Age: 50 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

| Intervention/Treatment |
| --- |
|Drug: Photodynamic Therapy (PDT) with Visudyne (verteporfin)|nan|
|Drug: Macugen (pegaptanib sodium)|nan|

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
-----------------
Macugen, AMD, Age-Related Macular Degeneration, Macular Degeneration, Photodynamic Therapy, PDT, Visudyne, pegaptanib sodium, verteporfin, Predominantly Classic, Age-Related Macular Degeneration (AMD)
Effect of Malnutrition on Primary and Permanent Dentation

Study Overview
=================
Brief Summary
-----------------
The caries index delayed eruption and enamel malformation will recorded for a 2 group of participants

Detailed Description
-----------------
The participants suffering from malnutrition will be divided into age group from 4 to 6 to study the primary dentition and another group age from 13 to 16to study the primary dentition caries index with dmf and DMF score Modified DDE index for measurement of developmental defects in enamel

Official Title
-----------------
Effect of Malnutrition on Primary and Permanent Dentition a Cross Sectional Study

Conditions
-----------------
Study Focus on the Effect of Malnutrition and Dental Problem

Intervention / Treatment
-----------------
* Diagnostic Test: Dmf score


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: parent accept to sign the informed consent Participants not suffering from any other systematic disease Exclusion Criteria: non coopreative patient Suffering from systematic disease

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 16 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Primary dentition<br>Children from 4 to 6 years old suffering from malnutrition | Diagnostic Test: Dmf score<br>* A chart to calculate the caries index<br>|
| Age 13 to 16<br>Adolecentsfrom 13 to 16 suffering from malnutrition at present time or during their childhood | Diagnostic Test: Dmf score<br>* A chart to calculate the caries index<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caries index | Score obtained from DMF index | 1month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| E amel malformation | Modified DDE index | 1month |
Dexamethasone for the Prevention of Recurrent Laryngeal Nerve Palsy

Study Overview
=================
Brief Summary
-----------------
Recurrent laryngeal nerve dysfunction and hypoparathyroidism are well-recognized important complications of thyroid surgery. The duration of convalescence, after non complicated thyroid operation, may depend on several factors of which pain and fatigue are the most important. Nausea and vomiting occur mainly on the day of operation. Glucocorticoids are well known for their analgesic, anti-inflammatory, immune modulating and antiemetic effects. The investigators therefore undertook the present study to investigate whether preoperative dexamethasone could improve surgical outcome in patients undergoing thyroid surgery.

Official Title
-----------------
Dexamethasone for the Prevention of Recurrent Laryngeal Nerve Palsy (and Not Only) After Thyroid Surgery. A Randomized Double-blind Placebo-controlled Trial.

Conditions
-----------------
Benign Neoplasm of Thyroid Gland, Malignant Neoplasm of Thyroid

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing thyroid surgery Exclusion Criteria: ASA physical class III or IV age > 75 years pregnancy

Ages Eligible for Study
-----------------
Maximum Age: 75 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 |
| --- | --- |
| dexamethasone<br>Patients who receive dexamethasone (8 mg; Decadron; Merck Sharp & Dohme) intravenously 90 min before skin incision | |
| placebo<br>Patients who receive saline placebo intravenously 90 min before skin incision | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Development and Validation of a Predictive Model for Postoperative Pulmonary Complications in Elderly Patients

Study Overview
=================
Brief Summary
-----------------
Although several clinical predictive models have been developed to predict postoperative pulmonary complications, few predictive models have been developed for elderly patients. In this study, the researchers aimed to develop a new, simplified model to assess the risk of postoperative pulmonary complications in elderly patients using perioperative database information.

Detailed Description
-----------------
Postoperative pulmonary complications occur frequently, which is an important cause of death and morbidity. Age has always been an significant predictor of postoperative pulmonary complications. With an aging population worldwide, more and more elderly people are undergoing surgery due to the expansion of surgical indications. As a result of this phenomenon, the elderly are also an important group for the prediction and intervention of postoperative pulmonary complications. In order to better assess the risk of postoperative pulmonary complications in elderly patients, we constructed a model using database information.

Official Title
-----------------
Development and Validation of a Predictive Model for Postoperative Pulmonary Complications in Elderly Patients

Conditions
-----------------
Postoperative Pulmonary Complications

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 65 years or older receiving invasive ventilation during general anesthesia for surgery Exclusion Criteria: preoperative mechanical ventilation operations related to previous postoperative complications a second operation after surgery organ transplantation discharged within 24 hours after surgery cardiac and thoracic surgery

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- |
| Training set<br>The whole cohort is randomly assigned to a training cohort and validation cohort. | |
| validation set<br>The whole cohort is randomly assigned to a training cohort and validation cohort. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pulmonary complications |  | within one week after surgery |
Patient Education Study to Determine Knowledge Acquisition in Patients Preparing to Undergo Lung Transplantation

Study Overview
=================
Brief Summary
-----------------
The Lung Transplant Team at Tampa General Hospital has identified a need to improve both the quality and quantity of the education that is provided to patients listed for lung transplantation. We propose to change the method and timing of our transplant patient education. The objective of this prospective data collection will be to collect and analyze pre and post test scores of patients when patient education is provided via compact disc as compared to individualized teaching.

Official Title
-----------------
A Comparison of 2 Different Methods of Patient Education to Determine Knowledge Acquisition in Patients Preparing to Undergo Lung Transplantation

Conditions
-----------------
Lung Transplantation

Intervention / Treatment
-----------------
* Other: Education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age- 18-75 Exclusion Criteria: None

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

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

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

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

Design Details

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Traditional teaching<br> | Other: Education<br> <br> |
| Experimental: DVD<br> | Other: Education<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of patient education when provided via compact disk as compared to individualized teaching as assessed by pre and post test scores. |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lung transplantation
Etiology of Blood Dyscrasias: Analysis of the International Agranulocytosis and Aplastic Anemia Study Data

Study Overview
=================
Brief Summary
-----------------
To quantify the role of drugs and other factors in the etiology of agranulocytosis and aplastic anemia.

Detailed Description
-----------------
BACKGROUND: Agranulocytosis and aplastic anemia are rare but serious blood diseases that can be caused by drugs and other environmental factors. In 1980, there were only limited quantitative estimates of the risk between various exposures, particularly drugs, and the two dyscrasias. The data were collected in the IAAAS, a multicenter population-based case-control study conducted from 1980 to 1986 in eight regions. The study was funded by a pharmaceutical company to investigate a single hypothesis, but information was obtained on all drugs and on other factors, enabling a general investigation of the dyscrasias. DESIGN NARRATIVE: The study was for retrospective data analysis only. Standard case-control methods were used. In most instances, multivariate analysis was used to control confounding, especially by simultaneous use of other causal drugs. Adverse effects and the relative safety of drugs in relation to the two dyscrasias were documented. Because the IAAAS was population-based, incidence rates were provided directly, and excess risks were estimated for associated drugs. Such quantitative measures of association were generally unavailable. Among the drugs that were analyzed were various categories such as psychotropics, antihistamines, and cardiovascular drugs, and individual drugs such as allopurinol. Factors other than drugs were also evaluated, including exposure to radiation and chemicals such as benzene and insecticides, history of viral infection, and history of allergy and other conditions. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Anemia, Aplastic, Blood Disease, Agranulocytosis

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |