linjc16/ctgov huggingface dataset:
Chemotherapeutic Trial With Gemcitabine, Cisplatin, 5-FU and Folinic Acid in Esophageal Cancer

Study Overview
=================
Brief Summary
-----------------
This multicenter open labeled phase 2 trial examines the efficacy of a combination of Gemcitabine 1000 mg/m2 (30 min), Cisplatin 30 mg/m2 (90 min), Folinic Acid 200 mg/m2 (30 min) and 5-FU 750 mg/m2 (24h CI) all given day 1,8 q D22 in patients with inoperable esophageal cancer. The combination was considered to be suitable for further evaluation with a freedom of progression rate (PR+CR+SD) of more than 60% and not be be of further interest with a rate of less than 40%. Given an alpha error of 5% and an beta error of 10% at least 66 evaluable patients were needed based on a 2-Stage Simon design with a first evaluation after 25 evaluable patients.

Official Title
-----------------
An Open Labeled Phase 2 Study of Gemcitabine in Combination With Cisplatin, 5-FU (24h CI) and Folinic Acid in Patients With Inoperable Esophageal Cancer

Conditions
-----------------
Esophageal Cancer

Intervention / Treatment
-----------------
* Drug: Gemcitabine
* Drug: Cisplatin
* Drug: 5-FU
* Drug: Folinic Acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age>=18 Histologically proven inoperable esophageal cancer Karnofsky Performance status >=60% Estimated life expectancy of > 12 weeks Measurable disease No other oncologic therapy Measurable disease Adequate bone marrow function Geographic proximity and compliance Informed consent Negative pregnancy test and adequate contraception Exclusion Criteria: Insufficient hepatic or renal function Elevated serum calcium Pregnancy/breast feeding Active infection Other malignancies Systemic tumour complications requiring emergency interventions

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Gemcitabine|Gemcitabine 1000 mg/m2 (30 min)|
|Drug: Cisplatin|Cisplatin 30 mg/m2 (90 min)|
|Drug: 5-FU|5-FU 750 mg/m2 (24h CI)|
|Drug: Folinic Acid|Folinic Acid 200 mg/m2 (30 min)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary endpoint rate of freedom of progression (PR+CR+SD). |  | Max. 8 cycles of therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary endpoint median survival, progression free survival and toxicity. |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
esophageal cancer, Gemcitabine, Cisplatin, 5-FU, Folinic Acid, inoperable esophageal cancer
Standardized Management of Pregnancy Weight of Twin Pregnancy

Study Overview
=================
Brief Summary
-----------------
There are few studies on the optimal value of pregnancy weight gain for twin pregnancy in China.At present, China has not put forward guidelines for the appropriate value of weight gain in twin pregnancy, and the lack of standards for weight gain during pregnancy in clinical application or disease prevention and control seriously restricts the health management of pregnant women.In order to effectively control a series of adverse consequences caused by improper weight gain of women during twin pregnancy, it is urgent to establish the appropriate value of weight gain during twin pregnancy, which will also fill the gap in this field in China.

Official Title
-----------------
Standardized Management of Pregnancy Weight of Twin Pregnancy

Conditions
-----------------
Pregnancy Weight of Twin Pregnancy

Intervention / Treatment
-----------------
* Other: Standardized management of pregnancy weight of twin pregnancy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-45 years Twin pregnancy pregnancy weeks ≤ 6 weeks Exclusion Criteria: adverse pregnancy history kidney disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Standardized management of pregnancy weight of twin pregnancy|Standardized management of pregnancy weight of twin pregnancy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight gain of women during twin pregnancy |  | 1 year |
Kidney Disease After COVID-19

Study Overview
=================
Brief Summary
-----------------
To understand the long-term epidemiology, develop effective risk-prediction and stratification tools, and understand the pathobiology of kidney disease in COVID-19 survivors.

Official Title
-----------------
Multi-center Assessment of Survivors for Kidney Disease After COVID-19

Conditions
-----------------
COVID-19, Acute Kidney Injury, Chronic Kidney Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Criteria: Inclusion Criteria: Adults, age ≥18 years Confirmed diagnosis of COVID-19 Exclusion Criteria: • No confirmed diagnosis of COVID-19

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

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 |
| --- | --- |
| COVID<br>Patients who have had a confirmed diagnosis of COVID-19. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| estimated Glomerular Filtration Rate (eGFR) | Kidneys filter blood by removing waste and extra water to make urine. The kidney's filtration rate, called the glomerular filtration rate (GFR), shows how well the kidneys are filtering. A normal GFR is 60 or higher. | yearly for 4 years after COVID exposure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urine Albumin-to-Creatinine Ratio (UACR) | Albuminuria is present when UACR is greater than 30 mg/g and is a marker for chronic kidney disease. Albuminuria is used to diagnose and monitor kidney disease. | yearly for 4 years after COVID exposure | 
| Urine protein/creatinine ratio (UPCR) | Urine protein/creatinine ratio - Protein creatinine ratio in the urine quantifies the loss of the protein and helps in further evaluation of the kidney function. Normal ratio: < 0.20 | yearly for 4 years after COVID exposure |
Celecoxib as Adjuvant Therapy to Chemotherapy in Patients With Metastatic Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
The study aimed at evaluation of anticancer effect of celecoxib as adjuvant therapy to chemotherapy in patients with metastatic colorectal cancer

Detailed Description
-----------------
The primary aim of the study is to evaluate the anticancer effect of celecoxib as adjuvant therapy to chemotherapy in patients with metastatic colorectal cancer

Official Title
-----------------
Evaluation of Anticancer Effect of Celecoxib as Adjuvant Therapy to Chemotherapy in Patients With Metastatic Colorectal Cancer

Conditions
-----------------
Colon Cancer Stage

Intervention / Treatment
-----------------
* Drug: FOLFERI
* Drug: Folferi and celecoxib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: advanced colorectal cancer Exclusion Criteria: cerebral metastases other malignancy H pylori infection thromboembolism

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

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: FOLFERI<br>FOLFERI regien | Drug: FOLFERI<br>* FOLFERI regimen<br>|
| Active Comparator: FOLFERI and celecoxib<br>FOLFERI and celecoxib | Drug: Folferi and celecoxib<br>* Folferi regimen and celecoxib<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients with improved radiology | number of patients with improved radiology | 6 months |
Reversal of General Anesthesia With Methylphenidate

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate whether methylphenidate (Ritalin) can actively induce emergence from general anesthesia in patients having a pancreaticoduodenectomy (Whipple procedure), a pancreatectomy, or a prostatectomy.

Official Title
-----------------
Reversal of General Anesthesia With Intravenous Methylphenidate

Conditions
-----------------
Post Operative Cognitive Dysfunction, Emergence From Anesthesia

Intervention / Treatment
-----------------
* Drug: Methylphenidate
* Other: Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-75 years American Society of Anesthesiologists classification 1 or 2 Scheduled to undergo a pancreaticoduodenectomy or distal pancreatectomy at Massachusetts General Hospital Exclusion Criteria: American Society of Anesthesiologists physical status classification of 3 or beyond.

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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Methylphenidate<br>Methylphenidate | Drug: Methylphenidate<br> <br> * Other names: ritalin;|
| Placebo Comparator: placebo<br>Saline | Other: Saline<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events | Recorded as a measure of safety and tolerability | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Emergence From General Anesthesia | Measured as the time from drug (MPH or saline placebo) administration to extubation | 1-4 hours |
Comparing a Closing System Without a Needle With Positive Pressure to a Heparin Lock With Positive Pressure

Study Overview
=================
Brief Summary
-----------------
A prospective randomized study to compare 2 groups: heparine lock with positive pressure lock without a needle with positive pressure

Official Title
-----------------
Prospective Study Which Compares the Use of a Closing System Without a Needle and With Positive Pressure to a Heparin Lock With Positive Pressure for Patients With a Catheter for Chemotherapy

Conditions
-----------------
Neoplasms

Intervention / Treatment
-----------------
* Device: Catheter locking systems


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Oncological patients who require intravenous chemotherapy

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: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Catheter locking systems|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical evaluation |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intravenous chemotherapy
The Use of the EXCOR Active Driving Unit for Mobilization of Pediatric Patients With Ventricular Assist Device Support

Study Overview
=================
Brief Summary
-----------------
The purpose of this observational study is to evaluate the performance of the Berlin Heart EXCOR Active driving unit while being used with the approved EXCOR ventricular assist device system.

Detailed Description
-----------------
The study has a prospective, multicenter, international, single arm, observational design. Study enrollment is expected to take 18 months and subjects will be followed until they reach an outcome or for 45 days on the EXCOR Active driving unit. The overall study duration is expected to be approximately 20 months.

Official Title
-----------------
The Use of the EXCOR Active Driving Unit for Mobilization of Pediatric Patients With Ventricular Assist Device Support

Conditions
-----------------
Heart Failure, Cardiomyopathies, Ventricular Dysfunction, Heart Diseases, Cardiovascular Diseases

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric patients meeting all indications as specified in the current version of the instructions for use (IFU) of the EXCOR® Active system, Age < 18 years, Patient and legal guardian has consented via signature on the study informed consent form, Patient is able to get mobilized according to hospital standard and is currently supported with the Ikus driving unit. The decision if a patient is able to get mobilized is at the discretion of the investigator. Exclusion Criteria: Patient has any contraindication as specified in the current version of the IFU of the EXCOR® Active system, Patient and/or legal representative has not given written consent to participate in the study (non-consent), Females of childbearing age who are not on contraceptives or surgically sterile or who are pregnant.

Ages Eligible for Study
-----------------
Maximum Age: 17 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 |
| --- | --- |
| Pediatric patients on EXCOR VAD support<br> | Other: No intervention<br>* No intervention due to observational design<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EXCOR Active device performance |  | 52 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful patient outcome rates | Successful outcome is defined as: survival to transplant, or survival to recovery/successful weaning, or survival on EXCOR Pediatric at 45 days post-switch to EXCOR Active. | Whenever it happens or 52 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
EXCOR Ventricular Assist Device, EXCOR Active, Mobilization, Pediatric
Adverse Effects of Ivermectin Used in Egypt During COVID-19

Study Overview
=================
Brief Summary
-----------------
retrograde study of common and rare adverse effects of multiple doses of ivermectin used during the coivd 19 pandemic in egypt

Detailed Description
-----------------
ivermectin was used in Egypt during the pandemic of covid-19 and it was registered in the MOH protocol that has been published in November 2020 the study will document the adverse effects of many patients used ivermectin as aprophylaxis and as a treatment with multiple dose regimens

Official Title
-----------------
Tolerability and Adverse Effects of Using Multiple Doses of Ivermectin in Egypt During Covid 19 Pandemic

Conditions
-----------------
Covid19, Ivermectin Poisoning, Drug Toxicity, Drug Side Effect

Intervention / Treatment
-----------------
* Drug: Ivermectin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all people used ivermectin as a treatment or as a prophylactic in covid 19 pandemic in egypt with explained dose Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 80 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ivermectin|retrograde study of common and rare adverse effects of multiple doses of ivermectin used during the coivd 19 pandemic in egypt|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all adverse effects will be collected from people used Ivermectin in between September 2020 to December 2020 | all data will be collected from retrospective manner as a retrospective study | the data will be collected from February 2021 to march 2021 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all data will be arranged according to time and dose manner | data for each dose will be identified together | February to match 2021 |
GORE EXCLUDER® Endoprosthesis - Low Permeability in Treatment of Abdominal Aortic Aneurysms

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the performance of the GORE EXCLUDER® Bifurcated Endoprosthesis-Low Permeability in the primary treatment of infrarenal abdominal aortic aneurysms.

Official Title
-----------------
A Clinical Evaluation of the GORE EXCLUDER® Bifurcated Endoprosthesis - Low Permeability in the Primary Treatment of Infrarenal Abdominal Aortic Aneurysms

Conditions
-----------------
Aortic Aneurysm, Abdominal

Intervention / Treatment
-----------------
* Device: GORE EXCLUDER® Bifurcated Endoprosthesis-Low Permeability


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infrarenal Abdominal Aortic Aneurysms less than 4.5 cm in diameter Anatomy meets EXCLUDER Bifurcated Endoprosthesis - Low Permeability specification criteria per Instructions for Use Access vessel able to receive 18 French introducer sheath Life expectancy > 2 years Appropriate candidate for endovascular repair Ability to comply with protocol requirements including follow-up 21 years of age or older, male or infertile female** Exclusion Criteria: Mycotic or ruptured aneurysm Participating in another investigational device or drug study within one year Documented history of drug abuse within six months Myocardial infarction or cerebral vascular accident within six weeks Pulmonary insufficiency requiring chronic home oxygen or inability to ambulate due to pulmonary function Iliac anatomy that would require occlusion of both internal iliac arteries Planned occlusion or reimplantation of significant mesenteric or renal arteries Planned concomitant surgical procedure or previous major surgery within 30 days Previous prosthesis placement in the aorta or iliac arteries Degenerative connective tissue disease (e.g., Marfan's and Ehlers Danlos Syndrome)

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: GORE EXCLUDER® Bifurcated Endoprosthesis-Low Permeability|Implant|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Aneurysm Volume Increase Greater Than 10% at 2 Years Post-procedure |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Device Efficacy Events |  | 2 years |
A Study to Determine the Feasibility of Wireless Electrocardiography

Study Overview
=================
Brief Summary
-----------------
The investigators are conducting a prospective, observational study to examine the ECG waveforms captured by the new medical device as compared to a traditional Holter monitor for subsequent use in visual diagnoses of atrial and ventricular arrhythmias as well as cardiac impulse and/or conduction disorders by qualified clinicians. The hypothesis is that this new medical device prototype is non-inferior to traditional Holter monitoring for capturing ECG waveforms that can be visually assessed for atrial and ventricular arrhythmias as well as disorders of cardiac impulse formation and/or conduction.

Official Title
-----------------
Study to Determine the Feasibility of Wireless Electrocardiography

Conditions
-----------------
Atrial Fibrillation, Premature Atrial and Ventricular Beats, Conduction Defects, Normal Sinus Rhythm

Intervention / Treatment
-----------------
* Device: Observational ambulatory ECG monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must be at least 18 years of age Patients must have a medical indication to wear a Holter monitor Patients must not be pregnant Patients must be able to comply with the study procedures Patients must be willing to participate and able to provide informed consent Patients must be willing to wear both devices (Holter and the wireless device prototype) simultaneously and continuously for a 2 to 3 hr period Exclusion Criteria: Patients who are not able or willing to comply with study procedures Patients with an existing implanted cardioverter-defibrillator and/or pacemaker Patients with a known life threatening arrhythmia Patients who manifest low voltage on their electrocardiogram Patients affected by inflammatory and/or infectious skin disorders

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 |
| --- | --- |
| Referred for Holter monitoring<br> | Device: Observational ambulatory ECG monitoring<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of 8 second ECG strips of sufficient quality for visual diagnosis |  | 3 hours |