linjc16/ctgov huggingface dataset:
131I-MIBG With Myeloablative Chemotherapy and Autologous Stem Cell Transplantation for the Treatment of High-risk Neuroblastoma

Study Overview
=================
Brief Summary
-----------------
This trial is studying how well iodine I 131 metaiodobenzylguanidine together with combination chemotherapy works in treating patients who are undergoing an autologous peripheral stem cell for high risk or relapsed neuroblastoma.

Official Title
-----------------
Evaluation of Benefit and Side Effects of 131I-MIBG in Combination With Myeloablative Chemotherapy and Autologous Peripheral Blood Stem Cell Transplantation for the Treatment of High-risk Neuroblastoma

Conditions
-----------------
Neuroblastoma

Intervention / Treatment
-----------------
* Drug: 131I-MIBG , Etoposide, Melphalan, Carboplatin, Autologous Peripheral Stem Cell Transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed Neuroblastoma and/or demonstration of tumor cells in bone marrow with elevated urinary catecholamine metabolites High risk according COG (Children Oncology Group)OR Relapse OR Refractory As at least one I131-MIBG avid target lesion determined by diagnostic MIBG scan Glomerular filtration rate or creatinine clearance > 60 ml/min No tumor cell in Bone Marrow by routine morphology aspiration and biopsy before peripheral stem cell collection No active infection Exclusion Criteria: Impaired renal function No avid I131-MIBG lesion Active infection

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 14 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MIBG<br> | Drug: 131I-MIBG , Etoposide, Melphalan, Carboplatin, Autologous Peripheral Stem Cell Transplantation<br>* 131I-MIBG 12mci/kg CEM(Etoposide)=1200mg/m2 Melphalan=210mg/m2 Carboplatin=1500mg/m2 Autologous Peripheral Stem Cell Transplantation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response (complete response, very good partial response, and partial response) at one-years post stem cell transplantation |  | one-years post stem cell transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | one-year after stem cell tranplantation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neuroblastoma, MIBG, Autologous Peripheral Stem Cell Transplantation
Clinical Trial of Gene Therapy for the Treatment of Leber Congenital Amaurosis (LCA)

Study Overview
=================
Brief Summary
-----------------
A clinical trial of AAV2/5 vector for patients with Defects in RPE65

Detailed Description
-----------------
A dose escalation and dose expansion (Phase I/II) trial of adults and children with retinal dystrophy associated with defects in RPE65. ATIMP will be administered to one eye only in a single sub-retinal procedure

Official Title
-----------------
An Open-label, Multi-centre, Phase I/II Dose Escalation Trial of an Adeno Associated Virus Vector for Gene Therapy of Adults And Children With Retinal Dystrophy Associated With Defects in RPE65 (LCA)

Conditions
-----------------
Leber Congenital Amaurosis

Intervention / Treatment
-----------------
* Biological: AAV RPE65


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Aged 3 years or older Early-onset severe retinal dystrophy consistent with RPE65 deficiency Key Exclusion Criteria: Females who are pregnant or breastfeeding Have participated in another research study involving an investigational therapy for ocular disease within the last 6 months.

Ages Eligible for Study
-----------------
Minimum Age: 3 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: Sequential Assignment
Interventional Model Description: AAV2/5-OPTIRPE65
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low dose AAV-RPE65<br>Subretinal administration of a single low dose of range AAV-RPE65 | Biological: AAV RPE65<br>* Comparison of different dosages of AAV RPE65<br>|
| Experimental: Intermediate dose AAV-RPE65<br>Subretinal administration of a single intermediate dose of range AAV-RPE65 | Biological: AAV RPE65<br>* Comparison of different dosages of AAV RPE65<br>|
| Experimental: High dose AAV-RPE65<br>Subretinal administration of a single high dose of range AAV-RPE65 | Biological: AAV RPE65<br>* Comparison of different dosages of AAV RPE65<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Safety of Adeno-Associated Virus Vector (AAV-OPTIRPE65) - Number of Participants With a Safety Event | Safety was defined as an advanced therapy investigational medicinal product (ATIMP) related: Reduction in visual acuity by 15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters or more. Severe unresponsive inflammation. Infective endophthalmitis. Ocular malignancy. Grade III or above non-ocular suspected unexpected serious adverse reaction (SUSAR). | 6 months |
Troponin Leaks in Emergency Department Patients Presenting With Supraventricular Tachycardia (SVT)

Study Overview
=================
Brief Summary
-----------------
The goal of this study is twofold. First the investigators would like to determine the trajectory of troponin leaks; if it can be shown that the participants who have only minimal elevations of their repeat troponin universally decrease on the 3rd level then future patients may see significantly improved length of stay. Second, given conflicting results in the literature, the investigators would like to determine if elevated troponin levels correlate to later cardiovascular complications. These complications will be defined as Death, Myocardial Infarction, Cardiovascular intervention (such as coronary artery stenting or bypass). As the investigator is a single hospital system in this county it is uniquely positioned to be able to review this retrospectively.

Detailed Description
-----------------
The investigators therefore propose retrospectively studying participants diagnosed with Supraventricular Tachycardia who had troponin(s) checked in the ED between January 1, 2012 and May 31, 2016 to allow a minimum of a year follow-up for our combined endpoint. The investigators will record the participants troponin value(s) in addition to the age, sex, race, heart rate, creatinine value. The investigators will compare the participants with positive troponins (and hopefully participants with strongly positive troponins) with those who are negative for troponin for presence of the combined end point via chart review.

Official Title
-----------------
Time Course and the Significance of Troponin Leaks in Emergency Department Patients Presenting With Supraventricular Tachycardia (SVT)

Conditions
-----------------
Supraventricular Tachycardia

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Supraventricular Tachycardia with troponin elevation Exclusion Criteria: Other cardiac arrhythmias or conditions with increased troponin
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No Intervention|No intervention was completed with this study.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Troponin-I Level | Measured in ng/ml | 6 hours after initial EKG | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death/ Need for Cardiac Stent Placement or Coronary Bypass Artery Graft |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Troponin
Clinical Implementation of TNM-immunoscore in Resected Non-small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to validate TNM-Immunoscore in resected non-small cell lung cancer.

Detailed Description
-----------------
The main aim is to validate the most promising T-cell marker candidates from earlier studies in a prospective multicenter study to establish a prognostic TNM-Immunoscore. The investigators will include around 1000 stage I-IIIA patients from various centers in Scandinavia. The investigators will also collect demographic and clinicopathological data, blood and tissues in a database and biobank. Candidate T-cell markers will be analyzed by immunohistochemistry for validation and by other methods for exploration of their impact on prognosis

Official Title
-----------------
Clinical Implementation of TNM-immunoscore in Resected Non-small Cell Lung Cancer

Conditions
-----------------
Non-Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Other: Will look for immune infiltration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: resectable NSCLC Age 18 and above no other malignancy last 5 years informed consent Exclusion Criteria: multiple tumor foci preoperative chemo- or radiotherapy non-NSCLC histology no tissue available for study metastasis

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 |
| --- | --- |
| NSCLC patients<br> | Other: Will look for immune infiltration<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Overall survival in the 1) overall population and in the 2) squamous cell carcinoma and 3) adenocarcinoma subgroups. | 5 year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TTR | Time to recurrence in the 1) overall population and in the 2) squamous cell carcinoma and 3) adenocarcinoma subgroups. | 5 year follow-up | 
| Disease-specific survival | Disease specific survival in the 1) overall population and in the 2) squamous cell carcinoma and 3) adenocarcinoma subgroups. | 5 year follow-up |
Serum Magnesium Levels in Desalination Tap Water and Outcomes in Acute Myocardial Infarction Patients

Study Overview
=================
Brief Summary
-----------------
Association between serum magnesium and clinical outcome in patients with acute MI (AMI) with 1 year follow-up in 300 patients in regions supplied by desalinated drinking water (DSW) (Sheba MC) and 150 patients in regions with non-desalinated drinking water (DW) (Nahariya MC).

Detailed Description
-----------------
Extensive seawater desalination in Israel may decrease magnesium in drinking water (DW), causing hypomagnesemia and adverse health effects. We study the association between consumption of desalinated drinking water (DSW) and serum magnesium in acute MI (AMI) patients, Subjects 35-75 years of age with the first AMI will be prospectively recruited during 1 year from 2 regions; the Departments of Cardiology at the Sheba Medical center (300 patients, predominantly served by DSW) and the Nahariya Medical Center (150 patients, served by non-DSW). Questionnaire will be developed to collect data on demographic variables (at home and work), water and beverages consumption habits (tap water, mineral water), dietary sources of Mg and Mg supplementations. Mg levels will be measured in DW from the patients' homes and in their serum on admission.

Official Title
-----------------
The Effect of Magnesium Serum Levels on Clinical Outcomes in Patients With Acute Myocardial Infarction by Considering Desalination Drinking Water Levels Patients Fed From.

Conditions
-----------------
Myocardial Infarction, Death, Congestive Heart Failure, Acute-MI, Cardiovascular Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with first AMI Age 35-75 Exclusion Criteria: 1. Patients > age 75

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 75 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 |
| --- | --- | --- |
| Number of Major Adverse Cardiovascular Events (MACE) | MACE including: acute infarct returns, revascularization, death within 30 days or one year, hospitalization for heart failure, hospitalization for angina pectoris and transient ischemic events. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Age | Age at the first Acute Myocardial Infraction | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Desalinated Sea Water, Magnesium, Drinking Water
Robotic-assisted Versus Laparoscopic Sigmoid Resection

Study Overview
=================
Brief Summary
-----------------
Retrospective multi-center comparative chart review of robotic-assisted versus laparoscopic sigmoid resection for both benign and malignant disease

Detailed Description
-----------------
The goal is to establish safety and effectiveness of robotic-assisted surgery in sigmoid resection for both benign and malignant disease by evaluation of short-term clinical outcomes through 30 days post index procedure.

Official Title
-----------------
Robotic-assisted Versus Laparoscopic Sigmoid Resection: a Retrospective Chart Review of Benign and Malignant Sigmoid Disease

Conditions
-----------------
Sigmoid Diseases

Intervention / Treatment
-----------------
* Procedure: Sigmoid Resection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients that have undergone sigmoid resection for benign or malignant disease Exclusion Criteria: Emergency Procedures

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 |
| --- | --- |
| Robotic-assisted sigmoid resection<br>Patient that have undergone robotic-assisted sigmoid resection for benign or malignant disease between 2010 and 2015 | Procedure: Sigmoid Resection<br> <br> |
| Laparoscopic sigmoid resection<br>Patient that have undergone laparoscopic sigmoid resection for benign or malignant disease between 2010 and 2015 | Procedure: Sigmoid Resection<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of complications observed intraoperatively through 30-days | Number of complications observed intraoperatively through 30-days | Intraoperative through 30-days follow-up |
Pregnancy Rate in Direct Versus Afterload Technique of Embryo Transfer

Study Overview
=================
Brief Summary
-----------------
The primary outcome of the study is to determine if a difference in terms of pregnancy rate exists between direct and afterload embryo transfer (ET) techniques. The secondary end points include the evaluation of the difficult transfer rates.

Detailed Description
-----------------
The study database includes all the single fresh and frozen (G5-G6) blastocyst transfers performed at Humanitas Fertility Centre between 1st January 2016 and 31th December 2021 by using the direct and afterload protocols. Any blastocysts that underwent preimplantation genetic testing will be excluded from the analysis, as well as embryos derived from gamete donation or those imported from other centers. Data are gathered using a specific internal web-based database, which allows to organize, store and readily retrieve information about patients and IVF cycle.

Official Title
-----------------
Pregnancy Rate in Single Step Versus After Load Technique of Embryo Transfer: a Retrospective Analysis

Conditions
-----------------
Fertility Issues, IVF, Embryo Transfer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: IVF procedure Fresh and frozen single blastocyst transfer Exclusion Criteria: Any blastocysts that underwent PGS testing Embryos derived from gamete donation Embryos imported from other centers

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 43 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| clinical pregnancies with direct catheter<br>Clinical pregnancies occurred after fresh and frozen blastocyst transfers using direct technique. | |
| clinical pregnancies with afterload catheter<br>Clinical pregnancies occurred after fresh and frozen blastocyst transfers using afterload technique. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical pregnancy rate | number of pregnancies diagnosed by ultrasonographic visualization of one or more gestational sacs x 100 divided by the number of embryo transfer cycles | 6 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difficult transfer rate | advancement of the outer sheath, multiple attempts, force, required manipulation, use of a stylet or tenaculum, dilatation, use of a different catheter | 6 years |
DPPE in Combination With Epirubicin and Cyclophosphamide in the Treatment of Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to study DPPE combined with epirubicin and cyclophosphamide in patients with metastatic and/or recurrent breast cancer who may have received previous hormone treatment but have not had exposure to anthracycline treatment. Stratification allocation will be within the following subgroups: Prior cytotoxic treatment; Estrogen receptor status; ECOG performance status; Number of cycles of chemotherapy.

Detailed Description
-----------------
Endpoints of the trial are as follows: primary: overall survival; secondary: response rate, progression free survival, toxicity, neurocognitive function.

Official Title
-----------------
A Phase III Study of DPPE Combined With Epirubicin and Cyclophosphamide vs Epirubicin and Cyclophosphamide Alone as First Line Treatment in Metastatic/Recurrent Breast Cancer

Conditions
-----------------
Breast Cancer, Metastases

Intervention / Treatment
-----------------
* Drug: YMB 1002


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histological proof of breast cancer Documented evidence of metastatic and/or recurrent breast cancer Presence of at least one bi-dimensional or uni-dimensional lesion ECOG status 0, 1 or 2 Quality of life

Ages Eligible for Study
-----------------
Minimum Age: 16 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

| Intervention/Treatment |
| --- |
|Drug: YMB 1002|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  |  | 
| Progression-free survival |  |  | 
| Toxicity |  |  | 
| Neurocognitive function |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metastatic breast cancer
Treatment of TNNT1-Myopathy With L-Tyrosine.

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to investigate if treatment with L-Tyrosine improves selected outcome measures of TNNT1 myopathy.

Official Title
-----------------
Treatment of TNNT1-Myopathy With L-Tyrosine. A Double-blind, Placebo-controlled Crossover Trial.

Conditions
-----------------
Nemaline Myopathy

Intervention / Treatment
-----------------
* Drug: L-Tyrosine
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients any age with TNNT1-related myopathy Exclusion Criteria: Patients who are non-cooperative or parents/ legal guardians who are unwilling to sign consent form

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: L-Tyrosine<br> | Drug: L-Tyrosine<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. goal attainment score |  | 3 month |