linjc16/ctgov huggingface dataset:
Utilization of the OncoCEE™ Platform to Evaluate Selected Biomarker Alterations in CTCs Isolated From Patients With MBC

Study Overview
=================
Brief Summary
-----------------
This study evaluates the performance of a blood test for detecting biomarkers in metastatic breast cancer patients at one clinic against standard testing.

Detailed Description
-----------------
The primary objective of this pilot study is to detect the expression of FGFR1 and AR on circulating tumor cells (CTCs) isolated from the peripheral blood of metastatic breast cancer (MBC) patients using the OncoCEE™ platform. No procedures will be associated with this study, as these mutations will be evaluated from the leftover blood that has already been sent for standard of care ER and HER2 using the same platform. Results from this testing will be correlated with results obtained from standard testing to calculate the rate of concordance between tests.

Official Title
-----------------
Utilization of the OncoCEE™ Platform to Evaluate Selected Biomarker Alterations in CTCs Isolated From Patients With MBC

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Current patient at participating clinic Metastatic breast cancer diagnosis 18 years of age or older 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concordance with standard test | determined by the comparison between OncoCEE test and conventional test | 6 months |
Descriptive and Risk Factors Analysis of All-cause Postoperative Death in Patients Undergoing Elective Surgery

Study Overview
=================
Brief Summary
-----------------
The investigators are aimed to develop and externally validate a prediction model of clinical risk factors that quantifies postoperative death after elective surgery. We identify all patients treated with elective surgery, between 2000 and 2020, within the Wuhan Union hospital and all collaborators. The surgical patient cohort will be matched with the National Death database to determine the patient's postoperative death data. 60% patients were randomly selected to the development cohort. Logistic regression analysis for prediction of postoperative death adjusted for different covariates. The model was externally validated in the remaining 40% patients.

Official Title
-----------------
Descriptive and Risk Factors Analysis of All-cause Postoperative Death in Patients Undergoing Emergency Surgery

Conditions
-----------------
Postoperative Death

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients Undergoing Elective Surgery Exclusion Criteria: Patients with incomplete electronic medical record information
Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Death |  | The mortality within 5 years after the elective surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prediction model, Postoperative death, Elective surgery
Patient Satisfaction With Virtual Postoperative Visit

Study Overview
=================
Brief Summary
-----------------
This is a prospective, randomized study designed to evaluate the effects of different initial postoperative follow-up modalities. Given the nature of the study, it is not possible for either the surgeons or the subjects to be blinded. To reduce bias that may occur due to each surgeon's personal preference for postoperative follow-up modality, the surgeons (rather than individual subjects) will be randomized to one of two postoperative follow-up modality groups (traditional or virtual).

Official Title
-----------------
Patient Satisfaction With Virtual Postoperative Visit

Conditions
-----------------
Post-Op Complication

Intervention / Treatment
-----------------
* Behavioral: Traditional
* Behavioral: Virtual


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 18 years old < 60 years old Undergoing knee arthroscopy procedure Exclusion Criteria: < 18 years old > 60 years old

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Traditional<br> | Behavioral: Traditional<br>* Surgeons (rather than individual subjects) will be randomized to traditional Postoperative follow-up modality groups. They will adhere to this form of postoperative follow-up for all of their surgical patients (subjects) for one month.<br>|
| Experimental: Virtual<br> | Behavioral: Virtual<br>* Surgeons (rather than individual subjects) will be randomized to virtual postoperative follow-up modality group. They will adhere to that form of postoperative follow-up for all of their surgical patients (subjects) for one month.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction with their surgeon | Patients will report their satisfaction with their surgical experience 6 weeks after surgery using a 10-point Likert scale, 0-Completely Dissatisfied, 10-Completely Satisfied | 6 Months |
Autonomic Reflexes During Intra-arterial Chemotherapy for Retinoblastoma

Study Overview
=================
Brief Summary
-----------------
Prospective observational study in patients undergoing intra-arterial ophthalmic artery chemotherapy for the treatment of retinoblastoma. The main objective of the study is to evaluate the incidence of cardiorespiratory autonomic reflexes in these patients and to investigate the association between autonomic reflexes and perioperative clinical characteristics.

Official Title
-----------------
Cardiorespiratory Autonomic Reflexes During Superselective Ophthalmic Artery Chemotherapy for Retinoblastoma in Children: a Prospective Observational Study.

Conditions
-----------------
Retinoblastoma, Retinoblastoma Bilateral, Chemotherapy Effect

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients diagnosed with retinoblastoma and submitted to intra-arterial chemotherapy during the study period Informed consent form signed and dated by legal guardian and investigator Informed assent form signed by the patient if appropriate Exclusion Criteria: Refusal of the patient or guardian to participate in the research project

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- | --- |
| Cardiorespiratory autonomic reflexes incidence | To evaluate the incidence of cardiorespiratory autonomic reflexes during intra-arterial chemotherapy of the ophthalmic artery in a child cancer center. | from the admission of the patient in the operating room until the end of the procedure (intra-arterial chemotherapy) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical background and autonomic reflexes occurence | To evaluate the association between perioperative characteristics (both baseline and intraoperative characteristics) and the incidence of cardiorespiratory autonomic reflexes | from the admission of the patient in the operating room until the end of the procedure. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Retinoblastoma
A Study of MK0663 and an Approved Drug in the Treatment of Osteoarthritis (0663-076)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the safety and effectiveness of an investigational drug and an approved drug in the treatment of osteoarthritis of the knee and hip.

Detailed Description
-----------------
The duration of treatment is 26 weeks.

Official Title
-----------------
A 26-Week, Randomized, Placebo- and Active-Comparator-Controlled, Parallel-Group, Double-Blind, 2-Part Study to Assess the Safety and Efficacy of Etoricoxib 30 mg Versus Celecoxib 200 mg in Patients With Osteoarthritis (Study 1)

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Drug: MK0663, etoricoxib
* Drug: Comparator: celecoxib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Osteoarthritis of the knee or hip which requires treatment with a medication to obtain pain relief Exclusion Criteria: Any known allergy to the study drugs

Ages Eligible for Study
-----------------
Minimum Age: 40 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: MK0663, etoricoxib|nan|
|Drug: Comparator: celecoxib|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Osteoarthritis of the knee & hip as assessed by WOMAC VA 3.0 pain and physical function subscales, Patient/Investigator assessments of disease and response to therapy over 12 weeks of treatment. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maintenance of clinical efficacy as assessed by WOMAC subscales and Patient assessments over a 26-wks of treatment. Safety / tolerability over a 12-wk and 6-mo treatment period. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arcoxia
Outpatient Percutaneous Coronary Intervention

Study Overview
=================
Brief Summary
-----------------
To determine the safety and feasibility of same day discharge after elective coronary percutaneous intervention in a selected stable patient population. The hypothesis to be tested is that in an appropriately selected stable coronary artery disease population post percutaneous coronary intervention, early discharge is safe and feasible.

Detailed Description
-----------------
A select stable population of patients undergoing percutaneous coronary intervention are randomized to standard of care in-hospital stay for one night or early discharge to a nearby hotel. During PCI, patients receive bivalirudin as their anti-coagulant and also must be eligible for an angioseal closure device. Patients that stay overnight in the hotel must be accompanied by a family member. They return to the cath lab the next day for groin check and blood work. Satisfaction questionnaires are filled out by all patients.

Official Title
-----------------
Outpatient Percutaneous Coronary Intervention in a Selected, Stable Patient Population

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Procedure: Early discharge after percutaneous coronary intervenntion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with stable coronary artery disease scheduled for elective percutaneous coronary intervention Exclusion Criteria: Patients with acute coronary syndrome, patients with an MI within 30 days, an ejection fraction <30%, those with history of IV Dye allergy, creatinine level>2.2, those with increased risk of infection, those with history of bleeding diathesis or anemia (hemoglobin<11.0 g/dl, platelets <100,000 tho/ul)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
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 |
| --- | --- |
| 1 Control<br>Patients are discharged the day after PCI | Procedure: Early discharge after percutaneous coronary intervenntion<br>* Eligible patients receive Bivalirudin at the standard dose during PCI and all have to be eligible for femoral access seal.<br>|
| 2 Study group<br>Patients will be discharged 4-6 hrs after PCI | Procedure: Early discharge after percutaneous coronary intervenntion<br>* Eligible patients receive Bivalirudin at the standard dose during PCI and all have to be eligible for femoral access seal.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoints are patient satisfaction and safety. |  | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
percutaneous coronary intervention
AXIS 2: AX200 for the Treatment of Ischemic Stroke

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the efficacy of AX200 (filgrastim) in the treatment of acute ischemic stroke and to assess the safety and tolerability of AX200.

Official Title
-----------------
AXIS 2: AX200 for the Treatment of Ischemic Stroke - A Multinational, Multicenter, Randomized, Doubleblind, Placebo-controlled Phase II Trial

Conditions
-----------------
Acute Ischemic Stroke

Intervention / Treatment
-----------------
* Biological: Filgrastim
* Drug: Sodium chloride solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Major Inclusion Criteria: diagnosis of acute ischemic stroke with an onset within 9 hours prior to start of study agent administration ischemic stroke in the MCA territory confirmed by MRI (diffusion) age ≥18 years and ≤85 years lesion size on DWI ≥15 ccm written informed consent Major Exclusion Criteria: prior to current stroke: inability to walk or to lead an independent life life expectancy less or equal 6 months stupor or coma lacunar infarct any evidence of ICH malignant hypertension presence of history of active malignancies platelet count <100/nl at randomization leukocyte count >20/nl at randomization congenital neutropenia pregnant or lactating women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AX200<br> | Biological: Filgrastim<br>* 135 μg/kg body weight total dose Short term infusion (20 to 30 minutes) and continuous infusion over 3 days<br>|
| Placebo Comparator: Placebo<br> | Drug: Sodium chloride solution<br>* Short term infusion (20 to 30 minutes) and continuous infusion over 3 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement on mRS relative to placebo-treated patients |  | day 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement on NIHSS relative to placebo-treated patients |  | day 90 |
Study of HuMax-CD20, a New Drug to Treat Early Stage Non-Hodgkin´s Follicular Lymphoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to determine the safety and efficacy of HuMax-CD20 as a treatment for Follicular Lymphoma (FL).

Official Title
-----------------
An Open-label, International, Multicenter, Dose Escalating, Phase I/II Study of HuMax-CD20 in Patients With Relapsed or Refractory Follicular Lymphoma Grade I-II

Conditions
-----------------
Lymphoma, Follicular

Intervention / Treatment
-----------------
* Drug: HuMax-CD20


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Relapsed or refractory follicular lymphoma grade I-II Tumor verified to be CD20 positive CT scan showing demarcated lesions Exclusion Criteria: Previous treatment with rituximab resulting in less than partial response Previous radioimmunotherapy Previous stem cell transplantation Received the following treatments within 4 weeks prior to entering this study: Anti-cancer therapy Glucocorticosteroids unless less than 10 mg prednisolone/day Radiotherapy Received Mitomycin C or Nitrosoureas within 6 weeks prior to entering this trial HIV positivity Hepatitis B or hepatitis C Uncontrolled or chronic bacterial, fungal or viral infection Other cancer diseases, except certain skin cancers, cervix cancer and breast cancer Certain serious medical conditions, including kidney or liver disease, some psychiatric illnesses, and stomach, lung, heart, hormonal, nerve or blood diseases WHO performance status of 3 or 4 If you are participating in another trial with a different new drug 4 weeks before you enter this trial Current participation in any other clinical study Pregnant or breast-feeding women Women of childbearing age who are unable or unwilling to use an IUD or hormonal birth control during the whole 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?
-----------------

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: HuMax-CD20|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
-----------------
Follicular Lymphoma, Non Hodgkin´s Lymphoma
Neurobehavioral Moderators of Post-traumatic Disease Trajectories

Study Overview
=================
Brief Summary
-----------------
The research goal is to uncover the neurocognitive moderators of PTSD trajectories, by documenting clinical symptoms, cognitive functioning, and brain structure and function, one-, six- and fourteen months following a traumatic event, in a large population of survivors at initial high risk for PTSD.

Official Title
-----------------
Neurobehavioral Moderators of Post-traumatic Disease Trajectories: Prospective MRI Study of Recent Trauma Survivors

Conditions
-----------------
PTSD, Trauma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 - 65 years Able to read and comprehend Hebrew Arrived in the ER because of one of the following: car accidents, terrorist attacks, work accidents, home accidents, burns, physical assault, large-scale disaster. Exclusion Criteria: Individuals with known claustrophobia Individuals with history of substance abuse Individuals with current or past psychotic or bipolar I disorder Individuals with chronic PTSD at the time of the current trauma Individuals on psychotropic medication or recreational drugs in the week that precedes the MRI Individuals with hearing problems Individuals with head trauma with coma exceeding 30 minutes Individuals which can't perform MRI due to safety reasons (e.g. irremovable metals in their body)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- | --- |
| Change in CAPS Total Scores | The Clinician-Administered PTSD Scale, used to assess PTSD diagnostic status and symptom severity. CAPS total symptom severity score is calculated by summing severity scores for all PTSD symptoms. We use both CAPS-V (according to DSM-4) and CAPS-5 (according to DSM-5). | one-, six- and fourteen months following a traumatic event |
CT and Clinical Features of Internal Hernia

Study Overview
=================
Brief Summary
-----------------
Researchers retrospectively reviewed patients with internal hernia that confirmed by surgical exploration between Feb. 2012 and Feb. 2018. and analysis the Medical records and MDCT images to investigate the clinical and radiological features of internal hernia.

Detailed Description
-----------------
51 Patients with definite diagnosis of IH during surgical exploration from Feb. 2012 to Feb. 2018 in our hospital were included in this research. Medical records including MDCT images and intra-operative findings were collected retrospectively. The CT features of different subgroups were also evaluated.

Official Title
-----------------
CT Images and Clinical Relevance of Internal Hernia

Conditions
-----------------
CT Images of Internal Hernia, Clinical Outcomes

Intervention / Treatment
-----------------
* Diagnostic Test: Multi-detector CT scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: IH confirmed by surgical exploration Exclusion Criteria: diaphragmatic hernia and traumatic IH

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Adhesive IH<br>Adhesive IH can further be divided into primary or secondary groups according to the history of abdominal and(or) pelvic surgery | Diagnostic Test: Multi-detector CT scan<br>* This is a diagnostic radiological test to diagnose the IH and evaluate the clinical condition of IH<br>|
| non-adhesive IH<br>Non-adhesive IH means the IH resulting from the abnormality of peritoneal structure. | Diagnostic Test: Multi-detector CT scan<br>* This is a diagnostic radiological test to diagnose the IH and evaluate the clinical condition of IH<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CT features | MDCT features of IH were assessed for the following findings: (1) Demonstration of bowels dislocation in IH: dislocated cluster of the intestinal segments; crowding or convergence of mesenteric vessels; (2) Demonstration of obstruction or ischemia: bowel wall thickening or abnormal enhancement; dilated bowels with abnormal free fluid; twisted bowels with swirl sign of vessels. (3) Demonstration of specific signs: hernial orifice and closed-loop of intestine; fat notch sign. | 2 weeks |