linjc16/ctgov huggingface dataset:
Expanded Access for the Treatment of Cancers With Rearranged During Transfection (RET) Activation

Study Overview
=================
Brief Summary
-----------------
Expanded access for participants with cancer with RET activation who are ineligible for an ongoing selpercatinib (also known as LOXO-292) clinical trial or have other considerations that prevent access to selpercatinib through an existing clinical trial. The treating physician/investigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program.

Detailed Description
-----------------
N/A for expanded access

Official Title
-----------------
Expanded Access for the Treatment of Cancers With Rearranged During Transfection (RET) Activation

Conditions
-----------------
Non Small Cell Lung Cancer, Medullary Thyroid Cancer, Colon Cancer, Breast Cancer, Pancreatic Cancer, Papillary Thyroid Cancer, Other Solid Tumors With Evidence of Activating RET Alteration

Intervention / Treatment
-----------------
* Drug: Selpercatinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of cancer with RET activation, who are not eligible for an ongoing selpercatinib clinical trial and are medically suitable for treatment with selpercatinib Have progressed or are intolerant to standard therapy, or no standard therapy option exists, or in the opinion of the investigator, are unlikely to derive significant clinical benefit from standard therapy Have adequate organ function Exclusion Criteria: Currently enrolled in an ongoing clinical study of selpercatinib or another RET inhibitor Clinically significant active cardiovascular disease or history of myocardial infarction within 6 months prior to study treatment; ongoing cardiomyopathy; or current prolongation of the QT interval corrected for heart rate using Fridericia's formula (QTcF) interval greater than 470 milliseconds

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Selpercatinib|Open-label expanded access|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Evaluation of Nexfin During Anesthesia and in Intensive Care (NexfinEval)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the non invasive measurement of arterial pressure (Nexfin monitor)with the invasive measurement of arterial pressure (radial artery catheter) during induction of general anesthesia, during a leg raising test in the Intensive Care Unit

Official Title
-----------------
Evaluation of Nexfin During Induction of General Anesthesia and in Intensive Care During a Passive Legs Raising Test

Conditions
-----------------
Anesthesia

Intervention / Treatment
-----------------
* Device: arterial pressure measurement (Nexfin, a noninvasive finger cuff system)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 ASA II, III or IV weight between 40 and 180 kg; BMI < 35 normal Allen's test and/or hand Doppler examination. Exclusion Criteria: cardiac arrhythmias, history of vascular surgery or vascular implant in the upper limb Raynaud disease

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 |
| --- | --- |
| Anesthesia<br>Arterial pressure measurement using Nexfin (a noninvasive finger cuff system) during the induction of anesthesia | Device: arterial pressure measurement (Nexfin, a noninvasive finger cuff system)<br> <br> |
| Intensive Care Unit patients<br>Arterial pressure measurement using Nexfin (a noninvasive finger cuff system) during a passive legs raising test | Device: arterial pressure measurement (Nexfin, a noninvasive finger cuff system)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial pressure measurement |  | Blood pressure will be followed for the duration of induction of anesthesia, an expected average of 20 minutes, or for the passive legs raising test, an expected average of 20 minutes |
Serum Copeptin in Cirrhotic Patients With Spontaneous Bacterial Peritonitis

Study Overview
=================
Brief Summary
-----------------
Current reports have demonstrated that copeptin predicts disease progression and prognosis in cirrhotic patients, independent of liver-specific scoring systems. To the best of our knowledge, few studies have addressed the association between copeptin and sepsis in cirrhotic patients, however, they were performed on different types of infections. Therefore, we will conduct this study with a focus on it is possible role in patients with SBP.

Official Title
-----------------
Serum Copeptin in Cirrhotic Patients With Spontaneous Bacterial Peritonitis

Conditions
-----------------
Spontaneous Bacterial Peritonitis

Intervention / Treatment
-----------------
* Diagnostic Test: Serum copeptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The diagnosis of liver cirrhosis will be based on clinical data and findings on abdominal ultrasound. The diagnosis of SBP will be based on the presence of at least 250 cells/ml PMNLs in the ascitic fluid, with or without positive ascitic fluid culture in the absence of hemorrhagic ascites and secondary peritonitis Exclusion Criteria: Patients with heart failure, coronary insufficiency, advanced chronic respiratory disease, polyuria-polydipsia syndrome and hypotension or shock. Patients with chronic kidney disease treated with hemodialysis before admission. Patients with previous liver or kidney transplantation. Patients with intraabdominal malignancy. Patients with severe infection other than SBP. Patients who had received antibiotics before hospital admission.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ascites without SBP<br>Cirrhotic ascitic patients not diagnosed with SBP | Diagnostic Test: Serum copeptin<br>* Blood test<br>|
| Ascites with SBP<br>Cirrhotic ascitic patients diagnosed with SBP | Diagnostic Test: Serum copeptin<br>* Blood test<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| compare serum levels of copeptin in cirrhotic patients with and without SBP | compare serum levels of copeptin in cirrhotic patients with and without SBP | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assess serum copeptin levels in different stages of cirrhosis and its relationship with kidney and circulatory function | assess serum copeptin levels in different stages of cirrhosis and its relationship with kidney and circulatory function | 6 months |
Weekly Topotecan in the First-line Treatment of Elderly Patients With Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
In this phase II trial, we will evaluate the weekly schedule of topotecan in the first-line treatment of elderly and/or poor performance status patients with extensive stage small cell lung cancer. Patients eligible for this trial will be those considered poor candidates for standard combination chemotherapy or other investigational regimens

Detailed Description
-----------------
Upon determination of eligibility, all patients will be receive: Topotecan

Official Title
-----------------
Phase II Trial of Weekly Topotecan in the First-line Treatment of Elderly Patients With Small Cell Lung Cancer

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Drug: Topotecan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: To be included in this study, you must meet the following criteria: Biopsy-proven small cell lung cancer, extensive stage disease Age > 65 years No previous chemotherapy or radiation therapy. Measurable or evaluable disease. Adequate bone marrow, liver and kidney function. Must be > 4 weeks from previous major surgery Must give written informed consent prior to study entry. Exclusion Criteria: You cannot participate in this study if any of the following apply to you: Meningeal involvement Serious active infections Serious underlying medical conditions Other active neoplasms Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Topotecan|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median survival |  |  | 
| 1 year and 2 year survival |  |  | 
| Overall toxicity |  |  |
Phase III rhu_GM-CSF + 3 Induction Regimens in Adults With Acute Non-Lymphocytic Leukemia

Study Overview
=================
Brief Summary
-----------------
Phase III Study of Priming with Granulocyte-Macrophage Colony Stimulating Factor (rhu-GM-CSF) and ofThree Induction Regimens in Adult Patients (Over 55) with Acute Non-Lymphocytic Leukemia

Official Title
-----------------
Phase III Study Priming With rhu_GM-CSF and of Three Induction Regimens in Adult Patients (55 and Over) With Acute Non-Lymphocytic Leukemia

Conditions
-----------------
Adult Patients (Over 55) With Acute Non-Lymphocytic Leukemia

Intervention / Treatment
-----------------
* Drug: GM-CSF priming
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with acute non-lymphocytic leukemia are eligible for the study. Exclusion Criteria: N/A

Ages Eligible for Study
-----------------
Minimum Age: 56 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo<br>|
| Active Comparator: GM-CSF priming<br> | Drug: GM-CSF priming<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete remission rates |  | 3 years |
A Study to Assess the Pharmacokinetics and Safety of Recombinant Human Murine Chimeric Anti CD20 Monoclonal Antibody Injection (IBI301) Compared to Rituximab Injection in CD20 Positive B Cell Lymphoma Patients

Study Overview
=================
Brief Summary
-----------------
Randomised, double-blind, parallel group study to compare PK and PD profiles between IBI301 and rituximab in patients with CD20+ B-cell Lymphoma

Official Title
-----------------
A Multicenter, Randomized, Double-blinded, Parallel Controlled Study to Assess the Pharmacokinetics and Safety of Recombinant Human Murine Chimeric Anti CD20 Monoclonal Antibody Injection (IBI301) Compared to Rituximab Injection in CD20 Positive B Cell Lymphoma Patients

Conditions
-----------------
B-Cell Lymphoma

Intervention / Treatment
-----------------
* Drug: IBI301
* Drug: Rituximab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CD20-positive B-cell lymphoma. 18 years to 65 years. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Signed an informed consent. Obtained CR (complete remission) or CRu (uncertain complete remission) after the prior therapy. Exclusion Criteria: Participation in another interventional clinical trial in the past 28 days. Known allergic reactions against monoclonal antibody or rituximab. Rituximab and other anti-CD20 monoclonal antibody used in the past 4 months. Blood concentration of Rituximab>24ug/ml. HIV positive patients. HCV antigen and antibody positive. Acute and chronic hepatitis B virus infection.

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IBI301<br> | Drug: IBI301<br>* IBI301 375mg/㎡<br>|
| Active Comparator: Rituximab<br> | Drug: Rituximab<br>* Rituximab 375mg/㎡<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0-inf of IBI301 and rituximab |  | 91 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Plasma Concentration (Cmax) |  | 91 days | 
| Percentage and absolute value of CD19+ |  | 91 days | 
| Percentage and absolute value of CD20+ B-cell |  | 91 days | 
| Positive rate of ADA |  | 91 days | 
| Positive rate of NAb |  | 91 days | 
| Safety profiles | Including AE type、incidence rate、severity and drug- related | up to 1 year | 
| Area under the plasma concentration versus time curve (AUC) |  | 91days | 
| AUC（0-t） of IBI301 and rituximab |  | 91 days |
Does Gloved Medical Personnel Scratch Less Often?

Study Overview
=================
Brief Summary
-----------------
Unconscious touching of a person's own head or neck (for example by scratching) is a frequently observed and completely normal physiological movement pattern in humans, which when done by medical personnel attending a patient poses a high risk of unconscious self-contamination, even of an already disinfected hand, and of subsequent contamination of the patient. However, as compared to an ungloved hand, a gloved hand is felt to be foreign, which could reduce the frequency of self-contact and thus the contamination rate. Wearing protective gloves is highly recommended in medical practice. The purpose of this study is to explore how wearing, or not wearing, protective gloves affects the frequency of unconscious self-contact contamination of the gloved/ungloved hand

Conditions
-----------------
Hygiene, Equipment Contamination, Health Education

Intervention / Treatment
-----------------
* Procedure: wearing gloves


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Medical students working in a simulated OR environment

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: wearing gloves|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Post-Approval Study With the KAMRA Inlay

Study Overview
=================
Brief Summary
-----------------
KAMRA inlay, to be unilaterally implanted into the cornea of a subject's non-dominant eye. The inlay is to be inserted into a stromal pocket created with a surgical femtosecond laser.

Detailed Description
-----------------
This is a post-approval study of the KAMRA inlay performance and potential device-related issues in a broader population over an extended period of time after pre-market establishment of reasonable safety and effectiveness. Study objectives include: Evaluate the long-term performance (effectiveness) and safety of the device; Evaluate real-world performance of the device in subjects treated by refractive surgeons with a range of experience levels; Evaluate the performance of the device in racial/ethnic subgroups representative of the population for which the device is intended. In addition, the data from a subset of the first 105 subjects who have been enrolled in this study will be used to validate the KAMRA Inlay Patient Questionnaire (KIPQ) for the assessment of patients who have received the KAMRA inlay for the treatment of presbyopia.

Official Title
-----------------
Post-Approval Study of Clinical Outcomes and Visual Symptoms With the KAMRA Inlay

Conditions
-----------------
Presbyopia

Intervention / Treatment
-----------------
* Device: KAMRA Inlay


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meet the indications for use for this device; Do not have any of the conditions described in the contraindications in the labeling of the device; Are willing and able to provide informed consent; Are not participating in any other clinical studies during the course of the study. Exclusion Criteria: Subject has insufficient ability to read or write that would prevent them from completing a questionnaire without help; or Subject is not a fluent speaker of U.S. English.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 60 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: KAMRA Inlay|Unilateral implantation of the KAMRA inlay in the corneal stroma.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monocular Near Visual Acuity | Percentage of implanted eyes with monocular near visual acuity of 20/40 or better is greater than or equal to 75% of implanted eyes. | Five years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best-corrected distance visual acuity | Percentage of implanted eyes with a persistent loss of two or more lines of best-corrected distance visual acuity from baseline at the subject's last study visit is less than 5%. | Five years |
Investigation of the Immuno-regulation and Viral Hepatitis Among Patients With or After Dengue Fever Infection

Study Overview
=================
Brief Summary
-----------------
The study will collect the blood samples from 350 healthy persons and 350 persons infected with dengue fever.

Detailed Description
-----------------
Research has showed that CLEC5A interacts with dengue virion directly, and is responsible for dengue virus (DV)-induced DAP12 phosphorylation. Data suggests that CLEC5A is a potential therapeutic target for dengue hemorrhagic fever (DHF)/dengue shock syndrome (DSS). This project will study the genes of CLEC5A, Mannose receptor, DC-SIGN, NALP, decoy receptor 3 (DcR3), Toll-like receptors(TLRs), and (Nod)-like receptors (NLRs) for both DF and DHF groups. In addition, serum level of decoy receptor 3 (DcR3) will be tested. The study will collect the blood samples from 350 healthy persons and 350 persons infected with dengue fever.

Official Title
-----------------
Follow-up the Health Condition , Investigation of the Immuno-regulation , and the Study for Interaction of Viral Hepatitis--- Among Patients With or After Dengue Fever Infection

Conditions
-----------------
Dengue Fever

Intervention / Treatment
-----------------
* Other: case/control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of Dengue fever Exclusion Criteria: none
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<br> | Other: case/control<br>* case: infected dengue fever people control:healthy people<br>|
| DF<br> | Other: case/control<br>* case: infected dengue fever people control:healthy people<br>|
| DHF<br> | Other: case/control<br>* case: infected dengue fever people control:healthy people<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 檢查肝臟、腎臟及其他生化功能，並分析宿主免疫調控及血小板變化機致 | 抽血20 c.c 檢查肝臟、腎臟及其他生化功能，並分析宿主免疫調控及血小板變化機致 | 2007/7/1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dengue fever, CLEC5A, Mannose receptor, DC-SIGN, NALP,, decoy receptor 3 (DcR3), Toll-like receptors(TLRs),, (Nod)-like receptors (NLRs)