linjc16/ctgov huggingface dataset:
Pneumococcal Vaccine in Untreated CLL Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine whether patients with chronic lymphocytic leukaemia (CLL) will benefit from vaccination with a 13-valent conjugated pneumococcal vaccine, Prevenar13, compared with a conventional 23-valent capsular polysaccharide vaccine in terms of immune response.

Official Title
-----------------
A Randomized Phase III Trial to Determine Whether Conjugated Pneumococcal Vaccine Can Improve the Immune Responsiveness Compared to Polyclonal Pneumococcal Vaccine in Patients With Untreated Chronic Lymphocytic Leukemia

Conditions
-----------------
Chronic Lymphocytic Leukemia

Intervention / Treatment
-----------------
* Drug: Prevenar 13
* Drug: Pneumovax


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Untreated CLL patients all Rai stages (0 to IV), as early as possible after diagnosis, always before any therapy with monoclonal antibodies and/or chemotherapy Exclusion Criteria: Immunosuppressive therapy planned to start within 1 month Other malignancies Corticosteroids or other immunosuppressive drugs Previous allergic reaction to any vaccination in the past Neutropenia (PMNs < 500 cells/mm3)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pneumovax<br>Pneumovax, 1x 0.5 ml injection | Drug: Pneumovax<br>* 23-valent pneumococcal polysaccharide vaccine<br>|
| Experimental: Prevenar 13<br>Prevenar 13, 1x 0.5 ml injection | Drug: Prevenar 13<br>* 13-valent pneumococcal conjugated vaccine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immune response to Pneumovax compared to immune response to Prevenar |  | 1 month post vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serotype-specific immunoglobulin G (IgG) antibody levels | Immune response to Pneumovax vs. Prevenar13 | 1 and 6 months post vaccination | 
| Levels of opsonophagocytic antibodies (OPA) | Immune response | 6 months post vaccination | 
| Serotype-specific IgG antibody levels by ELISA, geometric mean concentrations (GMCs)between arms |  | 1 and 6 months post vaccination |
Effect of Rivaroxaban on Coagulation Parameters- an ex Vivo Study

Study Overview
=================
Brief Summary
-----------------
Rivaroxaban represent a new class of anticoagulation agents. As an oral direct factor Xa inhibitor it has been effective in preventing venous thromboembolism in patients undergoing elective orthopaedic surgery. This ex vivo study is undertaken to investigate the ex-vivo effects of Xarelto® on different coagulation parameters.

Detailed Description
-----------------
To validate the effects of Rivaroxaban on coagulation parameters plasma samples of patients after hip or knee replacement surgery treated with Rivaroxaban 10 mg/d are investigated. Plasma samples are obtained by blood collection before, after 2 hours and after 12 hours after Rivaroxaban dosing in steady state (on 3rd - 5th day). Several techniques, including clot-based tests, chromogenic assays and ELISA´s are used for coagulation assays in our coagulation laboratory Frankfurt/Main. The influence of Rivaroxaban on different coagulation assays should be investigated in our coagulation laboratory.

Conditions
-----------------
Differences in Laboratory Coagulation Parameters

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients after hip or knee replacement surgery treated with Rivaroxaban 10 mg/d must be able to accept blood sampling

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Activated partial thromboplastin time, Thrombin clotting Time, Anti-Xa-activity, Factor X-activity, Factor XIII-activity, Antithrombin (based on factor II), Antithrombin (based on factor X<9
Management of Transitory Loss of Consciousness and Syncopes in the Emergency Department

Study Overview
=================
Brief Summary
-----------------
The goal of this observational study is to examine the clinical presentations, the diagnostic tests performed and the management of patients presenting with transient loss of consciousness (TLOC) The main questions it aims to answer are: prevalence of TLOC prevalence of different diagnoses leading to TLOC Demographic, clinical, paraclinical and biological data will be collected from the emergency medical file

Detailed Description
-----------------
Patients over the age of 18 presenting to the University Hospital of Clermont-Ferrand emergency department for transient loss of consciousness of syncopal or undifferentiated origin will be include. Their non-opposition will be sought. Demographic, clinical, paraclinical and biological data will be collected from the emergency medical file. No visit is planned after the passage to the emergency room.

Official Title
-----------------
Management of Transitory Loss of Consciousness and Syncopes in the Emergency Department

Conditions
-----------------
Syncope, Unconscious State

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients over 18 presenting to the Clermont-Ferrand University Hospital emergency department for transient loss of consciousness of syncopal or undifferentiated origin 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence of transient loss of consciousness in emergency department | Percentage of TLOC in emergency department | through the study duration, an average of 6 months | 
| prevalence of different diagnoses leading to transient loss of consciousness | Percentage of different diagnoses leading to transient loss of consciousness | through the study duration, an average of 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence of different clinical presentations of loss of consciousness | Percentage of different clinical presentations of loss of consciousness | through the study duration, an average of 6 months | 
| Prevalence of the various diagnostic tests carried out and the treatment of patients presenting for transient loss of consciousness | Percentage of the various diagnostic tests carried out and the treatment of patients presenting for transient loss of consciousness | through the study duration, an average of 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
transient loss of consciousness, syncope, emergency department
Preferences of Parents for Pediatric Inpatient Ward Physicians' Attire

Study Overview
=================
Brief Summary
-----------------
Several studies have been conducted throughout the world to evaluate patients' and parents' preferences regarding physicians' attire. Most studies have shown that the attire influences their feelings trust and confidence regarding their care. In most countries the preference is for formal attire. In other places a more casual attire is generally accepted. Israel is a country where casual dress is acceptable in most settings. Israeli physician's dress code has been discussed in the past, but has never been systematically studied. The aim of this study is to systematically examine the attitudes of parents of children who have been admitted to the pediatric ward towards physicians' attire.

Conditions
-----------------
Parents, Physicians

Intervention / Treatment
-----------------
* Other: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parents whose children have been hospitalized Exclusion Criteria: All others
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 |
| --- | --- |
| Parents of Pediatric Inpatients<br> | Other: Questionnaire<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of parents preferring formal physician attire | Final analysis of survey will be processed and the total number of parents preferring formal physician attire will be determined. | Three years |
Impact of Gender on the Outcome of Liver Transplantation for Hepatocellular Carcinoma

Study Overview
=================
Brief Summary
-----------------
This is a large-scale study in China to provide evidence and insights in the role of gender in LT for HCC by analyzing the data of 3769 recipients with HCC registered in the China Liver Transplant Registry.

Official Title
-----------------
Impact of Gender on the Outcome of Liver Transplantation for Hepatocellular Carcinoma: A Multicenter Retrospective Study in China

Conditions
-----------------
Cancer of Liver

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients with liver transplants performed from January 2015 to December 2020, whose clinicopathological data were registered in the CLTR. Exclusion Criteria: Patients with following features were excluded: with concurrent other malignancies, pathologically-confirmed tumor types other than HCC, such as intrahepatic cholangiocarcinoma (ICC), combined hepatocellular cholangiocarcinoma (cHCC-CC), fibrolamellar hepatocellular carcinoma (FLC) or secondary metastatic tumor; without histological confirmation of HCC for transplantation. The patients who received living donor liver transplantation, split liver transplantation, reduced-size liver transplantation or simultaneous transplantation were also excluded. Next, pediatric patients (<18 years) or senile patients (>65 years) and those patients who died within six months after transplantation were also excluded. Finally, the patients with type-1 and type-2 portal vein tumor thrombus (PVTT), tumor metastasis, having doubtful or contradictory data or missing essential data for analysis, re-transplantation during follow-up time were excluded as well.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Male recipient<br> | Other: no intervention<br>* no intervention<br>|
| Female recipient<br> | Other: no intervention<br>* no intervention<br>|
| Male donor<br> | Other: no intervention<br>* no intervention<br>|
| Female donor<br> | Other: no intervention<br>* no intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | the overall survival of liver transplant recipient with HCC | January 2015 to December 2020 |
A Study to Assess Efficay and Safety of LC350189 Different Doses in Gout Patients With Hyperuricemia

Study Overview
=================
Brief Summary
-----------------
The aim of this 12-week randomized multicenter double-blind parallel group placebo-controlled dose finding study is to assess the efficacy and safety of three different doses of LC350189 in subjects with hyperuricemia and a diagnosis of gout.

Official Title
-----------------
A Randomized, Multicenter, Double-blind, Double-dummy, Parallel-group, Placebo and Active Comparator-controlled, Dose Finding, and Phase II Study to Assess Efficacy and Safety of LC350189 in Gout Patients With Hyperuricemia

Conditions
-----------------
Gout, Hyperuricemia

Intervention / Treatment
-----------------
* Drug: LC350189 formulated capsule
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects or the subject's legally acceptable representatives who sign a written informed consent form prior to the initiation of any study procedures. Subjects with hyperuricemia and a history or presence of gout per American College of Rheumatology (ACR) criteria. Exclusion Criteria: Subjects with secondary hyperuricemia (e.g., due to myeloproliferative disorder, or organ transplant). Subjects experiencing an active acute gout attack within 3 weeks prior to screening (Visit 1).

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LC350189 50mg<br>LC350189 50mg, Once a day (QD) | Drug: LC350189 formulated capsule<br>* Xanthine Oxidase Inhibitor<br>|
| Experimental: LC350189 100mg<br>LC350189 100mg, QD | Drug: LC350189 formulated capsule<br>* Xanthine Oxidase Inhibitor<br>|
| Experimental: LC350189 200mg<br>LC350189 200mg, QD | Drug: LC350189 formulated capsule<br>* Xanthine Oxidase Inhibitor<br>|
| Placebo Comparator: Placebo<br>Placebo, QD | Drug: Placebo<br>* Matching placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sUA level | Proportion of subjects with sUA <5.0 mg/dL | Day 84 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sUA level | Proportion of subjects with sUA <6.0 mg/dL | Day 84 | 
| Pharmacokinetic | Ctrough,ss | baseline, Day 7, Day 28 and Day 56 | 
| Pharmacodynamic | Change and percent change in sUA levels | Up to Day 84 | 
| Pharmacodynamic | Maximum percent reduction in sUA level | Up to Day 84 | 
| Antiflare activity | Gout flare rate in subjects | Up to Day 84 |
Improving Management of Patients at High Risk for Osteoporotic Fractures (0000-038)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the impact of disease management interventions on percent receiving a bone densitometry test and percent appropriately prescribed a medication for osteoporosis.

Official Title
-----------------
Improving Management of Patients at High Risk for Osteoporotic Fractures

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Behavioral: Disease Management Assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Members of the Horizon Blue Cross Blue Shield of New Jersey who are at risk for osteoporosis based on age (women age 65 or older, men and women age 45 or older who have a history of fragility fracture or have a history of taking oral glucocorticoids over 3 months). Exclusion Criteria: Individuals who are not members of Horizon Blue Cross Blue Shield of New Jersey and who otherwise do not meet the inclusion criteria.

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Disease Management Assessment|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A composite measure of bone mineral density (BMD) testing and/or osteoporosis medications prescriptions. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMD testing, osteoporosis medication prescriptions, fracture |  |  |
Sbrt±sTad for Unfavorable iNtermediate rIsk/High Risk Prostate caNcer

Study Overview
=================
Brief Summary
-----------------
This is a prospective, open, randomized phase II trial.

Detailed Description
-----------------
Patients will be randomized between SBRT alone (38 Gy in 4 fractions) or SBRT (same schedule) along with short course (6 months) androgen deprivation (STAD). All patients will be treated by intensity modulated radiotherapy. Regarding the combined modality approach, SBRT has to start within 3 months from the first injection of LHRH analogue.

Official Title
-----------------
Sbrt±sTad for Unfavorable iNtermediate rIsk/High Risk Prostate caNcer (STUNNIN): A Randomized Phase II Study

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: Decapeptyl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically proven prostate adenocarcinoma IR or HR in the NCCN definition N0M0 at staging with choline or (preferably) PSMA PET-CT; ECOG performance status between 0 and 2; Exclusion Criteria: Previous local treatment of the prostate with surgery (radical prostatectomy or cryotherapy) Previous radiotherapy to the pelvis Previous chemotherapy for malignancy in past 5 years Impossibility to implant fiducials for tracking purposes Impossibility to undergo MRI of the prostate Contraindication to short term AD Prostate volume >90cc

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

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective, open, randomized phase 2 trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: arm 1<br>SBRT alone 38 GY in 4 fractions | |
| Experimental: arm 2<br>SBRT along with short course (6 months) androgen deprivation (STAD) | Drug: Decapeptyl<br>* STAD androgen deprivation<br>* Other names: Enantone;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-yr bNED survival | The primary objective of the study is 3-yr bNED survival. If bNED survival is not significantly different between the two experimental arms, the one without AD will be chosen in a future comparison with the standard of care. | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neoplasm, prostate cancer,
Safety of Therapeutic Step-down in Neuromyelitis Optica

Study Overview
=================
Brief Summary
-----------------
Neuromyelitis Optica (NMO) is a neuroinflammatory disease related to multiple sclerosis (MS). It affects young subjects and causes a lot of handicap without treatment. Thus, aggressive treatments are frequently introduced early in the life of patients and maintained over the long term. A long duration of treatment exposes to iatrogenism. Therapeutic de-escalation trials in MS or other autoimmune diseases show rebound phenomena. In the NMO, there are no published data on the tolerance of desescalations to guide such strategies.

Official Title
-----------------
Safety of Therapeutic Step-down in Neuromyelitis Optica

Conditions
-----------------
Neuromyelitis Optica

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Major patients who have received long-term treatment for NMO Patients with a prospectively diagnosed NMO using the 2015 NMO classification criteria (IPND) Patients who retrospectively meet the classification criteria of the 2015 NMO (IPND) Patients who have not expressed their opposition, after information, to the reuse of their data for research purposes. Exclusion criteria: Patient who expressed his opposition to participating in the study Lack of data on the assay of anti-AQP4 and anti-MOG antibodies Less than a year of taking a second-line treatment before the relay End of follow-up <1 year following the transfer, this therefore includes patients whose transfer took place less than one year before the date of data extraction

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

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 |
| --- | --- | --- |
| Retrospective evaluation of the risk of rebound during therapeutic escalations in neuromyelitis optica (NMO) |  | Files analysed retrospectively from January 01, 2000 to December 31, 2020 will be examined] | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neuromyelitis Optica, NMO, multiple sclerosis (MS), Iatrogeny., Autoimmune diseases