linjc16/ctgov huggingface dataset:
Outcome After Treatment of Pulmonary Aspergilloma

Study Overview
=================
Brief Summary
-----------------
Retrospective analysis of surgery and/or bronchial embolisation for pulmonary aspergilloma.

Detailed Description
-----------------
A retrospective chart analysis, based on the search results from a thoracic surgery database and an interventional radiology database. Outcome analysis of all surgically treated patients for a confirmed invasive aspergilloma. Comparisson with (preoperative) embolisation of the bronchial circulation.

Official Title
-----------------
Outcome After Surgical Treatment or Bronchial Embolisation in Aspergilloma of the Lung: a Single Center Experience.

Conditions
-----------------
Pulmonary Fungal Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histological proven Aspergilloma of the lung Exclusion Criteria: Treatment limited to the use of systemic antifungal agents

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 89 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 |
| --- | --- |
| Embolisation<br>(preoperative) embolisation of the bronchial circulation | |
| Surgery<br>Any surgically treated patient with a functional lung resection (at least wedge resection) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival after treatment | estimated 10 yaer survival after treatment for pulmonary aspergilloma | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post treatment survival | survival status at 90 days after initiation of treatment | 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Catheterization, Bronchial, Pneumonectomy, Lobectomy, Thoracoplasty
Social Support and CHD Risk Factors--A Community Study

Study Overview
=================
Brief Summary
-----------------
To examine the mechanism through which social support affects morbidity and mortality from coronary heart disease.

Detailed Description
-----------------
BACKGROUND: Two hypotheses have been proposed to account for the effects of social support on cardiovascular morbidity and mortality. Both hypotheses operate through effects on risk factors for coronary heart disease, specifically arterial blood pressure and serum lipids. The stress- buffering hypothesis states that social support functions as a social resource for individuals exposed to social stressors; those persons with more support are less vulnerable to the risk-enhancing effects of stressors. The health behavior hypothesis states that persons with more support engage in more positive health behaviors, such as avoiding tobacco; moderate alcohol use; exercise; and, a prudent diet. A major limitation in research to evaluate these alternative hypotheses has been the failure to conceptualize and measure social support in a way appropriate to detect its effects in varying social and cultural contexts. This is a major issue in research in sub-cultural communities that are also high risk communities, such as African-Americans. DESIGN NARRATIVE: A cross-sectional survey of social stressors, social supports, health behaviors, and arterial blood pressure and serum lipids was conducted in a Black community in the rural South to evaluate the relative strengths of the stress-buffering versus the health behavior hypothesis. Social support was measured using a culturally appropriate technique which was sensitive both to the distinction between kin and nonkin social support, and the modification of the effects of that support by generational status. Multiple regression analysis and path analysis were used to evaluate the alternative hypotheses.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Coronary Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria
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 |
| --- | --- | --- |
Phase I Clinical Trial of GRID Therapy in Pediatric Osteosarcoma of the Extremity

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to evaluate the toxicity profile of GRID therapy using dose levels of 10Gy, 15 Gy and 20Gy in pediatric osteosarcoma of the extremity.

Detailed Description
-----------------
Subjects will receive GRID radiotherapy. GRID radiation therapy is considered a standard radiation therapy method however is not typically used in pediatric osteosarcoma patients. This protocol will evaluate whether or not the use of this therapy will provide benefit to this patient population.

Official Title
-----------------
Phase I Clinical Trial of GRID Therapy in Pediatric Osteosarcoma of the Extremity

Conditions
-----------------
Osteosarcoma in Children, Radiation Toxicity

Intervention / Treatment
-----------------
* Radiation: GRID radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of cytological or histological documentation of non-metastatic extremity osteosarcoma. 5-21 years of age. Subject is eligible for routine chemotherapy and routine surgery for the treatment of non-metastatic extremity osteosarcoma Informed consent is obtained Exclusion Criteria: Females with a positive urine pregnancy test. Unable to comply with study procedures

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 21 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GRID Radiotherapy<br>Patients will be treated with GRID Radiotherapy | Radiation: GRID radiotherapy<br>* Patients will be treated with GRID radiotherapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Toxicities Associated With GRID Radiotherapy | The study endpoint is dose-limiting toxicity (DLT), which is defined as a treatment-related AE of Grade 3 or higher. | An average of 12 months |
Safety and Pharmacokinetic Characteristics of HD203 Liquid in Healthy Male Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the safety and pharmacokinetic characteristics of HD203 liquid with those of etanercept (enbrel) prefilled injection after subcutaneous injection

Official Title
-----------------
A Randomized, Double-blind, Single-dosing, Crossover Study to Compare the Safety and Pharmacokinetic Characteristics of HD203 25 mg With Those of Enbrel® Injection 25 mg After Subcutaneous Injection in Healthy Male Volunteers

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

Intervention / Treatment
-----------------
* Biological: Etanercept (Enbrel)
* Biological: HD203


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20 to 40 years of healthy volunteers Exclusion Criteria: Subject who had been treated with Etanercept before

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HD 203<br>prefilled syringe | Biological: Etanercept (Enbrel)<br> <br> Biological: HD203<br> <br> |
| Active Comparator: Enbrel<br>prefilled syringe | Biological: Etanercept (Enbrel)<br> <br> Biological: HD203<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity |  | up to 56 days |
ImPACT Online Clinical Study

Study Overview
=================
Brief Summary
-----------------
The researchers want to find out more about a standalone software application, ImPACT Online and how it relates to other commonly used tests of memory, attention and reaction time. ImPACT Online is a computer-based neurocognitive test for concussion management. The test was designed to help measure the effects of concussion on cognitive processes (for example, memory, attention, brain speed) and visual functioning.

Official Title
-----------------
ImPACT Online Clinical Study

Conditions
-----------------
Brain Concussion

Intervention / Treatment
-----------------
* Device: ImPACT Online/Paper Pencil Tests
* Device: ImPACT Online


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 12-59 Primary English speaking or fluent in English. No known special education diagnosis excluding a 504 designation. Currently not suffering from a concussion or being treated for a concussion. No known physical or psychological impairment that would affect their ability to perform the test. An average or above average score on the RIST (Reynolds Intellectual Screening Test). Exclusion Criteria: Documentation of a known special education diagnosis other than a 504 designation. English is not their primary language nor are they proficient in the English language. Currently suffering from a concussion or being treated for a concussion. A below average score on the RIST.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 59 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Validity<br>ImPACT Online a computerized test will be administered to subjects. They will also receive a battery of paper and pencil neuropsychological tests. | Device: ImPACT Online/Paper Pencil Tests<br> <br> |
| Active Comparator: Test/Re-Test<br>ImPACT Online will be administered at 2 time points. | Device: ImPACT Online<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validity is established through correlation studies with well-known measures of memory and processing speed. |  | 12 Months | 
| Reliability will be established through a test/re-test to establish results should be stable over time. |  | 12 Months |
A Multicenter Prospective Study of Application of Platelet Mapping in Acute-on-chronic-liver Failure in China

Study Overview
=================
Brief Summary
-----------------
Ineffective hemostasis or a paradoxical prothrombotic state of Acute-on-chronic liver disease (ACLF) has been well established. Thrombelastography measures the dynamics of thrombin production and provides a global assessment of coagulation incorporating the cumulative effect of the interactions at various levels between plasma components and cellular component of coagulation. And through the platelet mapping, it can help provide a picture of patients' function of platelet. Based on the primary result of our derivation cohort(NCT03281278), ACLF patients with high ADP inhibition rate had high 28-day mortality.This multicenter validation cohort aims to validate the predictive role of platelet mapping in ACLF prognosis, organ failure developments and short term mortality.

Official Title
-----------------
A Multicenter Prospective Study of Application of Platelet Mapping in Acute-on-chronic-liver Failure in China

Conditions
-----------------
Thrombelastography, Acute on Chronic Liver Failure, Platelet, Multicenter Prospective Study

Intervention / Treatment
-----------------
* Other: standard treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: INR≥1.5 and total bilirubin≥85μmol/L Exclusion Criteria: INR≤1.5 or total bilirubin≤85μmol/L; those who had hepatocellular carcinoma or other types of malignancies; obstructive biliary diseases or other disease lead to bilirubin evaluation; those who had acute hemorrhage one week before admission those who received platelet, cryo transfusion or plasmapheresis one week before admission pregnancy and breastfeeding those who received liver transplantation or kidney transplantation; combine with other disease lead to organ failure including heart failure (NYHA IV),respiratory failure（PaO2<60mmHg),renal insufficiency(CKD 5) and conscious disturbance (GCS<8) readmission; death within 24 hours.

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

| Intervention/Treatment |
| --- |
|Other: standard treatment|standard medical treatment|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28-day mortality | death within 28-day | 28-day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28-day progression | progressed to EASL defined ACLF | 28-day | 
| 90-day mortality | death within 90-day | 90-day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thrombelastography, Acute on Chronic Liver Failure, Platelet, Multicenter Prospective Study
Mesh Fixation and Closure of Peritoneum Following Laparoscopic Hernia Repair Using N-butyl Cyanoacrylate

Study Overview
=================
Brief Summary
-----------------
Fixation of mesh and peritoneal closure during TAPP repair using n-butyl cyanoacrylate.

Detailed Description
-----------------
During transabdominal pre peritoneal (TAPP) hernia repair a mesh should be fixed at four pre-determined points. Number of attempts to fix the mesh with a novel non-penetrating fixation device (LiquiBandFix8) will be recorded. This novel device uses n-butyl cyanoacrylate and a defined amount of glue can be delivered with this 5mm laparoscopic instrument (liquid anchors). In addition, closure of peritoneum should be accomplished using this device.

Official Title
-----------------
Mesh Fixation and Closure of Peritoneum Following Laparoscopic Hernia Repair Using N-butyl Cyanoacrylate

Conditions
-----------------
Hernia, Inguinal

Intervention / Treatment
-----------------
* Device: LiquiBandFix8


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inguinal hernia, femoral hernia Exclusion Criteria: pregnancy, not able to understand patient information

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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: Inguinal herniation<br>In patients with bilateral herniations it should be explored if one glue device (LiquiBandFix8) for mesh fixation and closure of peritoneum is sufficient. | Device: LiquiBandFix8<br>* Using LiquiBandFix8 for mesh fixation and peritoneal closure following TAPP repair.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Safe Fixation of Mesh and Closure of Peritoneum by Clinical Investigation During Hospital Stay and Telephone Interview at Six Weeks Postoperatively. | Clinical examination during hospital stay to rule out any bowel obstruction due to insufficient closure of peritoneum. Telephone interview at six weeks postoperatively to record any adverse events in the early postoperative period such as recurrent hernia, pain or bowel obstruction. | During hospitalization and 6 weeks after surgery. |
Impact of Maltodextrin on Glycemic and Hemodynamic Management During Cesarean Section

Study Overview
=================
Brief Summary
-----------------
The goal is to evaluate the glycemic and hemodynamic stability in patients undergoing caesarean section in patients treated with maltodextrins two hours before the cesarean section

Detailed Description
-----------------
The patients undergoing elective cesarean section will be randomly divided in two groups: patients who drink 200 ml of clear liquid two hours before surgery or patients treated with 200 ml maltodextrins two hours before the surgery. The glycemic control will be done immediately before the maldodextrin administration and after the cesarean section by gluco stick. Standard hemodynamic monitoring ECG, Heart Rate, Blood pressure, Temperature, preipheral oxygen saturation will be done routinely.

Official Title
-----------------
Impact of Maltodextrin, Given 2 Hours Before Cesarean Section, on Glycemic and Hemodynamic Management of Pregnant

Conditions
-----------------
Cesarean Section Complications

Intervention / Treatment
-----------------
* Dietary Supplement: Maltodextrin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: informed consent first cesarean section single fetus ASA I-II Exclusion Criteria: BMI<18 BMI>35 contraindication to spinal anesthesia cardiovascular diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: preoperative clear liquid<br>Patients will drink 200 ml of clear liquid two hours before Cesarean section | |
| Active Comparator: preoperative maltodextrin<br>Patients will drink 200 ml of maltodexin two hours before Cesarean section | Dietary Supplement: Maltodextrin<br>* 200 ml maltodextrin given 2 hours before cesarean section<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic stability | blood glucose levels <180 mg/dl | perioperative | 
| hemodynamic stability | mean arterial pressure > 70 mmHg during perioperative time | perioperative |
Iron and the Breast-Fed Infant: Iron Status and Two Regimens of Iron Supplementation

Study Overview
=================
Brief Summary
-----------------
Normal breastfed infants can develop iron deficiency by 6 months of age. This trial tested the hypothesis that regular provision of a source of iron beginning at 4 months of age improves iron status and could prevent iron deficiency. This was a prospective randomized trial involving breastfed infants. To be eligible, infants had to be predominantly breastfed (<200 ml/day of formula) at 4 months of age. At 4 months infants were randomly assigned to one of two interventions or to control. The interventions consisted in the daily administration of medicinal iron in a dose of 7.5 mg (Medicinal Iron Group) or in the daily feeding of one jar of an iron-fortified cereal providing 7 mg of iron each day (Cereal Group). The control group received complementary foods chosen by he parents but no source of iron provided by the investigators. The interventions took place from 4 to 9 months. All infants were subsequently followed to 2 years of age.

Official Title
-----------------
Iron and the Breast-Fed Infant: Iron Status and Two Regimens of Iron Supplementation

Conditions
-----------------
Iron Deficiency

Intervention / Treatment
-----------------
* Dietary Supplement: Fer-In-Sol (ferrous sulfate)
* Dietary Supplement: Iron fortified cereal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Predominantly breastfed (at 4 months) term infants Exclusion Criteria: Not predominantly breastfed at 4 months Premature infants

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 24 Months

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Medicinal Iron | Dietary Supplement: Fer-In-Sol (ferrous sulfate)<br>* 7.5 mg/day in the form of 0.3 ml once each day<br>|
| Experimental: B<br>Iron fortified wet pack cereal | Dietary Supplement: Iron fortified cereal<br>* 1 jar each day of one of three wet pack cereals manufactured by the Gerber Company: Each jar provided 7 mg of ferrous sulfate.<br>|
| No Intervention: C<br>Control | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Iron status |  | 3 times during the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth |  | At the end of intervention | 
| Tolerance (gastrointestinal) |  | During intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Iron, breastfed infant