linjc16/ctgov huggingface dataset:
The Predictive Value of TMPRSS2-ERG Fusion in High Risk Prostate Cancer Patient

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the predictive value of TMPRSS2-ERG gene fusion in patients with prostate cancer treated with radiation and hormonal therapy.

Detailed Description
-----------------
The objective of this study is to evaluate the predictive value of TMPRSS2-ERG gene fusion in prostate patients who have been treated with hormonal and radiation treatment after biochemical failure Original biopsy slides of 65 patients will be collected and reviewed. A tissue used to test and map DNA fragments will be constructed from patients who underwent radiation therapy. RNA and DNA will be extracted from each slide. This study, if positive, will establish the predictive value of TMPRSS2-ERG gene fusion in prostate cancer patients. It can lead to believe that high-risk prostate cancer patients will benefit from a more aggressive treatment. An endpoint of this study is to evaluate the relation between the Gleason score and the TMPRSS2-ERG gene fusion. Another is to evaluate the relation between the T-stage and TMPRSS2-ERG gene fusion.

Official Title
-----------------
The Predictive Value of TMPRSS2-ERG Fusion in High Risk Prostate Cancer Patient

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

Intervention / Treatment
-----------------
* Drug: LHRH therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: One of the following T3a + PSA > 20 Gleason 8 or higher Karnofsky performance status ≥ 70. Signed study-specific informed consent

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: LHRH therapy|These patients will be treated with LHRH agonist as standard therapy.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with biochemical failure showing presence of TMPRSS2-ERG gene fusion. | Biopsy samples of patients treated for high risk prostate cancer with radical radiation and hormonal therapy (LHRH) will be tested to evaluate the predictive value of the TMPRSS2-ERG gene fusionThe results between the two groups will be compared to see if either DNA changes are an indicator of LHRH refractoriness | recruitment over 4 years |
Cord Milking in Elective Cesarean Section

Study Overview
=================
Brief Summary
-----------------
The objective of the study was to investigate the efficacy and safety of umbilical cord milking as compared with immediate cord clamping on placental transfusion, estimated by Δ hematocrit between cord blood at birth and capillary heel hematocrit at 48 hours of age, in elective cesarean delivered neonates.

Official Title
-----------------
Efficacy of Umbilical Cord Milking in Elective Cesarean Section

Conditions
-----------------
Placental Transfusion

Intervention / Treatment
-----------------
* Procedure: Umbilical cord milking


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: singleton low risk pregnancy, gestational age of 39 to 40/0 weeks confirmed by a first trimester ultrasound, no evidence of active labor, 18 years of age, and (5) a written consent given by the woman. - Exclusion Criteria:maternal medical and obstetric complications, severe anemia, clotting disorders and suspected intrauterine growth restriction -

Ages Eligible for Study
-----------------
Minimum Age: 1 Minute
Maximum Age: 2 Days

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| immediate cord clamping<br>Tthe umbilical cord of neonates was cut and clamped. | Procedure: Umbilical cord milking<br>* The babies were held at the level of the placenta, while the umbilical cord was milked or cut and clamped.<br>* Other names: Immediate cord clamping;|
| umbilical cord milking.<br>Tthe umbilical cord of neonates was milked. | Procedure: Umbilical cord milking<br>* The babies were held at the level of the placenta, while the umbilical cord was milked or cut and clamped.<br>* Other names: Immediate cord clamping;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Placental transfusion | Δ hematocrit between cord blood at birth and capillary heel hematocrit at 48 hours of age | 48 hours |
Observation vs Progesterone Treatment for Management of Uterine Arteriovenous Malformation

Study Overview
=================
Brief Summary
-----------------
A randomized trial which compares conservative management to progesterone based treatment for arteriovenous malformation

Official Title
-----------------
Management of Uterine Arteriovenous Malformation- a Comparison of 2 Management Possibilities- Observation vs. Progesterone Treatment/ a Randomized Control Trial

Conditions
-----------------
Arteriovenous Malformations

Intervention / Treatment
-----------------
* Drug: MedroxyPROGESTERone Injection [Depo-Provera]
* Device: Other


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women between age of 18 to 50, diagnosed with AVM hemodynamically stable at clinical presentation Exclusion Criteria: unstable patients contraindication to treatment US examination not in the US department

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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 |
| --- | --- |
| No Intervention: Conservative management<br> | |
| Experimental: Progesterone treatment<br> | Drug: MedroxyPROGESTERone Injection [Depo-Provera]<br>* The drug-induced endometrial changes would likely to prevent the shedding of endometrium, in turn preventing the exposure of AVM.<br>Device: Other<br>* Follow up using US<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AVM regression | The time from diagnosis to regression | 3 weeks |
Evaluating the Efficacy of Opti-Speech for Speech Treatment

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if feedback from a three-dimensional real-time visualization of the tongue, a program called Opti-Speech, can be used to improve speech.

Detailed Description
-----------------
Participants will be asked to complete the Goldman Fristoe Test of Articulation along with several other assessment tests. Then speech treatment, guided by Opti-Speech, will be provided to the participant for up to 10 treatment sessions. The participant will be asked to come back after the final treatment for a 2-month follow-up assessment.

Official Title
-----------------
Evaluating the Efficacy of Opti-Speech, a 3D Visual Feedback System, for Speech Treatment

Conditions
-----------------
Articulation Disorder, Dysarthria, Prelingual Deafness

Intervention / Treatment
-----------------
* Device: Opti-Speech


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: English speaking individuals with speech errors resulting from persistent speech sound disorder, individuals with dysarthria resulting from neurological disorders and individuals with pre-lingual or congenital deafness. Exclusion Criteria: Cognitive impairments that affect their ability to understand and follow instructions by the treating speech language pathologists

Ages Eligible for Study
-----------------
Minimum Age: 12 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Opti-Speech<br>Speech treatment will be guided by Opti-Speech's visual feedback of tongue movement during speech | Device: Opti-Speech<br>* Uses visual feedback of the tongue's motion to guide speech sound production<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent articulatory accuracy | Sound probe lists will be administered within 30 minutes of treatment. Probe lists will be scored as correct or incorrect. The percentage of probes correct will be calculated | within 30 minutes of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Accuracy of Speech Sound Production from Pre-Treatment to Post-Treatment | The Goldman Fristoe Test of Articulation will be administered prior to any speech treatment with Opti-Speech and again 2 months after the final speech treatment session. The percentage of consonants correct (PCC) will be used to assess the change in accuracy of speech sound production from pre-treatment to post-treatment | Immediately prior to first speech treatment and 2 months after final treatment. |
HD16 for Early Stage Hodgkin Lymphoma

Study Overview
=================
Brief Summary
-----------------
This study is designed to test the non-inferiority of the experimental arm compared to the standard arm in terms of Progression free survival (PFS).

Official Title
-----------------
HD16 for Early Stages - Treatment Optimization Trial in the First-line Treatment of Early Stage Hodgkin Lymphoma; Treatment Stratification by Means of FDG-PET

Conditions
-----------------
Hodgkin Lymphoma

Intervention / Treatment
-----------------
* Drug: ABVD (Adriamycin, Bleomycin, Vincristine, Dacarbazine)
* Radiation: 20 Gy IFRT (Involved Field Radiotherapy)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hodgkin Lymphoma CS I, II without risk factors large mediastinal mass (> 1/3 of maximum transverse thorax diameter) extranodal involvement elevated ESR 3 or more involved nodal areas Written informed consent Exclusion Criteria: Leucocytes < 3000/µl Platelets < 100000/µl Hodgkin Lymphoma as composite lymphoma Activity index (WHO) > 2

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>2 cycles ABVD followed by 20 Gy IF-RT irrespective of FDG-PET results after chemotherapy | Drug: ABVD (Adriamycin, Bleomycin, Vincristine, Dacarbazine)<br>* chemotherapy with 2 cycles of ABVD (day 1 + 15)<br>Radiation: 20 Gy IFRT (Involved Field Radiotherapy)<br>* 20 Gy Involved Field Radiotherapy<br>|
| Experimental: B<br>2 cycles ABVD followed by 20 Gy IF-RT if FDG-PET is positive after chemotherapy; 2 cycles ABVD and treatment stop if FDG-PET is negative after chemotherapy | Drug: ABVD (Adriamycin, Bleomycin, Vincristine, Dacarbazine)<br>* chemotherapy with 2 cycles of ABVD (day 1 + 15)<br>Radiation: 20 Gy IFRT (Involved Field Radiotherapy)<br>* 20 Gy Involved Field Radiotherapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 5 years | 
| acute toxicity |  | 5 years | 
| late toxicity |  | 5 years | 
| CR rate |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hodgkin Lymphoma, early stage, PET
Immunodeficiency in MS

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify if there is a relationship between multiple sclerosis disease-modifying therapy exposure, immunodeficiencies, and infection risk in subjects living with MS.

Detailed Description
-----------------
The purpose of this study is to identify if there is a relationship between multiple sclerosis disease-modifying therapy exposure, immunodeficiencies, and infection risk in subjects living with MS. By understanding this relationship future studies can be designed to create a model of immunosenescence in multiple sclerosis, which could help healthcare providers to predict and assess health risks. Preventative strategies can then be tested to look for ways to prevent these immune-related risks.

Official Title
-----------------
Analysis of Medical Therapy and History as Risks of Immunodeficiency in Multiple Sclerosis Patients

Conditions
-----------------
Multiple Sclerosis, Hypogammaglobulinemia, Immunodeficiency, Infection, Bacterial

Intervention / Treatment
-----------------
* Other: No Interventions


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria One or more immunoglobulin level results and medical history available 18 years of age or older at the time of data collection Patients with first symptom MS or other isolated demyelinating syndromes, neuromyelitis optica, or rheumatic-associated CNS inflammation Exclusion Criteria: No evidence of CNS autoimmune disease Less than 18 years of age at the time of data abstraction Undergoing plasma exchange at the time of any lab tests drawn

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 |
| --- | --- |
| Multiple Sclerosis and Related Diseases<br>Individuals with one or more immunoglobulin level results and medical histories available for data collection will be included. Subjects will be 18 years of age or older at the time of data collection. | Other: No Interventions<br>* There are no interventions associated with the study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunoglobulin Levels | IgG, IgA, IgM | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infections | Serious and non-serious | 1 year | 
| Immune-mediated conditions | Serious and non-serious | 1 year | 
| Malignant and pre-malignant conditions | Serious and non-serious | 1 year |
Study of Denufosol Tetrasodium Inhalation Solution in Patients With Cystic Fibrosis (CF) Lung Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to evaluate the safety and effectiveness of one dose strength of Denufosol compared to placebo in patients with CF and a predicted FEV1 of greater than or equal to 75% but less than or equal to 110% predicted.

Official Title
-----------------
A Phase 3, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Study of Denufosol Tetrasodium Inhalation Solution in Patients With Cystic Fibrosis Lung Disease and FEV1 Greater Than or Equal to 75% Predicted But Less Than or Equal to 110% Predicted

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Drug: Denufosol Tetrasodium (INS37217) Inhalation Solution
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have confirmed diagnosis of cystic fibrosis Have FEV1 of greater than or equal to 75% but less than or equal to 110%predicted normal for age, gender and height Be able to reproducibly perform spirometry Be clinically stable for at least 4 weeks before screening Exclusion Criteria: Have abnormal renal or liver function Have lung transplant Unable to discontinue use of hypertonic saline Participated in Inspire trial 08-108

Ages Eligible for Study
-----------------
Minimum Age: 5 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 |
| --- | --- |
| Placebo Comparator: 2<br> | Drug: Placebo<br>* Placebo - 0.9% w/v sodium chloride solution, three times daily for twelve months.<br>|
| Experimental: 1<br>Denufosol Tetrasodium (INS37217) Inhalation Solution | Drug: Denufosol Tetrasodium (INS37217) Inhalation Solution<br>* Drug: Denufosol Tetrasodium (INS37217) Inhalation Solution, Denufosol 60 mg is administered as an inhalation solution, three times daily for twelve months.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in lung function |  | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary Exacerbation, Antibiotic Use, Incidence of Hospitalization/ER visits, Health resource utilization, Quality of Life |  | 48 weeks |
The Detection of Early Dementia With the Digital Game Memory

Study Overview
=================
Brief Summary
-----------------
The investigators are going to test if it is possible to detect early dementia with the digital game memory. The investigators are going to test 15 healthy people and 15 patients with early dementia. The test consists of playing the game memory several times. While playing, several parameters are stored. The investigators are going to test if any correlation can be found between these parameters and the cognitive state of the person as tested by the Mini-Mental status examination.

Conditions
-----------------
Alzheimer's Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy 75-plusser 75-plusser with early dementia Exclusion Criteria: younger than 75 patient with other cognitive impairments than dementia

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association of cognitive status with failures in a computerised memory game | Failure is defined as the number of trials for the memory task | The game will be played once during 10-30 minutes. |
EUS-FNA for Patients Taking Anticoagulants Without Heparin Bridge

Study Overview
=================
Brief Summary
-----------------
To evaluate the feasibility of EUS-FNA for patients taking anticoagulants without heparin bridge.

Official Title
-----------------
EUS-FNA for Patients Taking Anticoagulants Without Heparin Bridge

Conditions
-----------------
Endoscopic Ultrasonography-guided Fine Needle Aspiration

Intervention / Treatment
-----------------
* Procedure: Endoscopic ultrasonography-guided fine needle aspiration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Taking anticoagulants Written informed consent Exclusion Criteria: Platelets count less than 50000/μl PT-INR more than 2.6 ASA more than 3 Severe bleeding tendency

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Endoscopic ultrasonography-guided fine needle aspiration|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of bleeding adverse events |  | Within 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of thromboembolic events |  | Within 2 weeks | 
| The rate of other adverse events |  | Within 2 weeks |
Long Term Follow-up on Menkes Disease Patients

Study Overview
=================
Brief Summary
-----------------
This study will collect long term follow-up data regarding overall survival and neurological parameters from patients previously identified and/or enrolled in Protocols 09-CH-0059 and 90-CH0149 and Historical Control data on Menkes disease patients.

Detailed Description
-----------------
Primary Objective: To provide additional clinical and safety data on long term following administration of Copper Histidinate treatment in patients treated with Copper Histidinate under Protocols 09-CH-0059 and 90-CH0149 and untreated patients previously identified and/or enrolled in Protocol 09-CH-0059. To provide additional Historical Control data on Menkes disease patients.

Official Title
-----------------
Long Term Follow-Up and Collection of Historical Control Data on Menkes Disease Patients

Conditions
-----------------
Menkes Disease

Intervention / Treatment
-----------------
* Drug: Long Term Follow-Up


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject must have been previously identified and/or enrolled under Protocols 09-CH-0059 or 90-CH-0149; or An untreated Menkes disease patients for whom data collection is incomplete under Protocols 09-CH-0059 (Amendment M); or Other untreated Menkes disease patients. Must sign and date an informed consent form by parent or legal guardian for this study prior to any assessment being done in this study. If the patient is > 18 years of age, the patient must sign the informed consent. Male or female, aged 0 to < 65 years of age. Exclusion Criteria: - Unwillingness/unable to participate in the study.
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Historical Control<br> | |
| Treated with Copper Histidinate<br> | Drug: Long Term Follow-Up<br>* Menkes disease is a form of inherited copper deficiency associated with neurodevelopmental delays and neurological problems. Copper Histidinate is being evaluated for efficacy and safety in patients with Menkes disease. The purpose of this protocol is to collect long term follow-up data. During the study, patients and/or parent/legal guardian will be contacted by the investigator by either telephone or an in-person visit to assess long term follow-up.<br>* Other names: CUTX-101;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long Term Follow-Up on Survival | The primary outcome measure will be overall survival. | 12/01/2019 - 12/31/2022 |