linjc16/ctgov huggingface dataset:
Aggressive Versus Moderate Glycemic Control in Diabetic Coronary Bypass Patients

Study Overview
=================
Brief Summary
-----------------
entGlycemic control has been found to improve clinical outcomes following Coronary Bypass Surgery. This study tests the hypothesis that obtaining tighter glycemic control(80-120mg/dl) as opposed to more moderate control (120-180mg/dl) will further improve outcomes.

Detailed Description
-----------------
150 diabetic patients will be randomized to achieve aggressive glycemic control (80-120mg/dl) vs moderate control (120-180mg/dl) using intravenous insulin infusions beginning at anesthetic induction and continuing for 18 hours following surgery.

Official Title
-----------------
Impact of Aggressive Versus Moderate Glycemic Control on Clinical Outcomes Following Coronary Artery Bypass Graft Surgery in Diabetic Patients

Conditions
-----------------
Glycemic Control

Intervention / Treatment
-----------------
* Drug: IV Insulin drip
* Drug: Insulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All diabetic patients undergoing Coronary Bypass Surgery Exclusion Criteria: Patients with hepatic and renal failure

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1Moderate Glycemic Control<br>Patients will receive an insulin drip to keep blood glucose levels between 120-180mg/dl | Drug: IV Insulin drip<br>* IV insulin drip at 100units insulin in 100ml saline designed to keep blood glucose between 120-180mg/dl<br>|
| Active Comparator: 2Aggressive Glycemic Control<br>Patients will receive an insulin drip designed to maintain serum glucose between 80-120mg/dl | Drug: Insulin<br>* IV insulin drip to keep serum glucose between 80-120mg/dl.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Hypoglycemia |  | 24 hours following surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| free fatty acid levels |  | 24 hours following surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glucose, Insulin
Routine Minimally Invasive Thoracic Surgery Without Aspirin Withdraw

Study Overview
=================
Brief Summary
-----------------
Surgeons are increasingly confronted by patients on long-term low-dose acetylsalicylic acid (ASA). However, the perioperative management of these patients undergo non-cardiac surgery has not yet been clear. This single- arm study was to evaluate the safety of continuous use of ASA in the perioperative period in routine minimally thoracic surgery.

Official Title
-----------------
Routine Minimally Invasive Thoracic Surgery Without Aspirin Withdraw Before Surgery

Conditions
-----------------
Aspirin Sensitivity, Surgery

Intervention / Treatment
-----------------
* Procedure: Surgery Without Aspirin Withdraw


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with stage I-IIIa Non-small-cell Lung Cancer underwent radical resection or other benign lung lesions need Minimally Invasive Thoracic Surgery; VATS and robotic surgery are both permitted; cardio-pulmonary function can tolerate surgery. Exclusion Criteria: cardio-pulmonary function couldn't tolerate surgery; high bleeding risk after the pre- operative evaluation.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Surgery Without Aspirin Withdraw<br>Routine Minimally Invasive Thoracic Surgery Without Aspirin Withdraw | Procedure: Surgery Without Aspirin Withdraw<br>* Routine Minimally Invasive Thoracic Surgery Without Aspirin Withdraw<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bleeding volume | bleeding volume during surgery | on the surgery day | 
| surgery time | total surgery time | on the surgery day | 
| postoperative drainage volume | chest drainage volume after surgery | within 7 days after surgery | 
| postoperative drainage duration | chest drainage duration after surgery | within 7 days after surgery | 
| postoperative hospitalization time | postoperative hospitalization time | within 7 days after surgery | 
| postoperative complication rate | postoperative complication rate | within 14 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression- free survival | progression- free survival | within 5 years after surgery | 
| overall survival | overall survival | within 10 years after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aspirin, Minimally Invasive Thoracic Surgery, Safety
Best Cutoff Value of Lactate Concentration in Vaginal Fluid to Predict Time of Spontaneous Onset of Labor in PPROM

Study Overview
=================
Brief Summary
-----------------
The present study is aimed to assess whether lactate determination in vaginal fluid is associated with and can predict onset of labor for women with suspected preterm prelabor rupture of membranes (PPROMs).

Detailed Description
-----------------
Study design: Prospective observational cohort

Official Title
-----------------
Best Cutoff Value of Lactate Concentration in Vaginal Fluid to Predict Time of Spontaneous Onset of Labor in PPROM

Conditions
-----------------
Aim is to Investigate Association Between Lactate Concentration in Vaginal Fluid and Time of Spontaneous Onset of Labor in PPROM

Intervention / Treatment
-----------------
* Diagnostic Test: Lactate concentration in vaginal fluid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 25-35 years old BMI 25-30 Singleton pregnancy in presentation with a history of suspected PPROM A live fetus with gestational age between 26+0 weeks and 34+0 weeks Exclusion Criteria: Abruption placenta Medical disorders and hypertensive disorders of pregnancy Intrauterine fetal death Known or suspected fetal anomalies Signs of infection (Fever, increase total leucocytic count) Multiple pregnancy. Regular uterine contractions. History of cervical insufficiency

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 35 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Lactate concentration in vaginal fluid|Lactate concentration in vaginal fluid|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from examination to spontaneous onset of labor | Time from examination to spontaneous onset of labor < or > 48 hours according to concentration of lactate in vaginal fluid | 48 hours |
A Study of Epoetin Beta (NeoRecormon) in Participants With Solid Tumors or Hematologic Malignancies

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the efficacy, safety, and pharmacoeconomics of treatment with subcutaneous (SC) epoetin beta (NeoRecormon) in participants with hematologic malignancies or solid tumors. The anticipated time on study treatment is 20 weeks, and the target sample size is 60 individuals.

Official Title
-----------------
Optimizing Treatment of the Anaemia in Onco-Hematological Diseases With NeoRecormon 30,000 IU Once Weekly

Conditions
-----------------
Anemia

Intervention / Treatment
-----------------
* Drug: Epoetin beta


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults at least 18 years of age Multiple myeloma (MM), low-grade non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL), breast cancer, lung cancer, or ovarian cancer Anemia with low erythropoeitin (EPO) levels Exclusion Criteria: Poorly controlled hypertension Relevant acute or chronic bleeding requiring therapy within 3 months before study drug Treatment with EPO within the last 6 weeks Pregnant or breastfeeding females

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Epoetin beta<br>Participants with hematologic or solid malignancies will receive epoetin beta for a treatment period of approximately 20 weeks. | Drug: Epoetin beta<br>* Participants will receive SC epoetin beta as 30,000 international units (IU) once weekly for 20 weeks.<br>* Other names: NeoRecormon;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate according to hemoglobin level |  | At Week 4 | 
| Transfusion requirement rate |  | From Weeks 5 to 12 | 
| Predictive value of reticulocyte increase |  | At Week 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events (AEs) |  | Up to approximately 6 months |
Benefits of Pulmonary Rehabilitation in Patients With Severe Lymphangioleiomyomatosis (LAM)

Study Overview
=================
Brief Summary
-----------------
Data from patients with the orphan disease of lymphangioleiomyomatosis (LAM) which performed a pulmonary Rehabilitation program will be analyzed retrospectively. Data will be taken from the internal data base of the reference Center (Schoen Klinik Berchtesgadener Land, Schoenau, Germany) where These data were collected during clinical routine. Data will be included from the year 2000 until now. A retrospectively matched COPD cohort will be included for comparison.

Official Title
-----------------
Benefits of Pulmonary Rehabilitation in Patients With Severe Lymphangioleiomyomatosis (LAM) - a Retrospective Analysis

Conditions
-----------------
Lymphangioleiomyomatosis, LAM, Pulmonary Rehabilitation

Intervention / Treatment
-----------------
* Other: Pulmonary Rehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: confirmed diagnosis of Lymphangioleiomyomatosis performed a pulmonary Rehabilitation program at the reference center Exclusion Criteria: missing data repeated stay for pulmonary Rehabilitation at the reference center

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 |
| --- | --- |
| Pulmonary Rehabilitation<br> | Other: Pulmonary Rehabilitation<br>* Patients will perform a comprehensive, inpatient pulmonary rehabilitation program for 4 weeks duration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline 6 Minute walk distance at week 4 | the walked distance in meter will be the Primary outcome of the 6 Minute walk test | baseline and week 4 | 
| Change from baseline Quality of life at week 4 | the physical and mental health component summary score from the Short Form 36 Health Questionnaire will be recorded. Score range from 0 to 100 with lower scores indicating worse impairment | baseline and week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline lung function at week 4 | forced expiratory volume in 1 second and inspiratory vital capacity will be provided in Liter and percent predicted | baseline and week 4 |
Registry Study on Biological Disease Profile and Clinical Outcome in Patients With Newly Diagnosed or Existent Lung Cancer The LuCa Biology and Outcome (BiO)-Project

Study Overview
=================
Brief Summary
-----------------
Registry Study on Biological Disease Profile and Clinical Outcome in Patients with Newly Diagnosed or Existent Lung Cancer The LuCa Biology and Outcome (BiO)-Project

Official Title
-----------------
Registry Study on Biological Disease Profile and Clinical Outcome in Patients With Newly Diagnosed or Existent Lung Cancer The LuCa Biology and Outcome (BiO)-Project

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

Intervention / Treatment
-----------------
* Other: Registry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with suspected diagnosis of lung cancer, or previously diagnosed lung cancer Age ≥ 18 years. There is no upper age limit. Exclusion Criteria: Severe neurological or psychiatric disorder interfering with ability to give an informed consent No consent for registration, storage and processing of the individual disease characteristics and course as well as information of the family physician about study participation No consent for biobanking of patient's biological specimens and performance of analyses on stored material.

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

| Intervention/Treatment |
| --- |
|Other: Registry|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | maximally 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lung cancer, registry study, Biological Disease Profile
Recovering From COVID

Study Overview
=================
Brief Summary
-----------------
Following the success of pilot data trialling a virtual community-based remote monitoring model, using Bluetooth enabled pulse oximeters, which demonstrated a saving of 300 bed spaces over a three week period,9 a nationwide expansion is set to be implemented through NHS Digital. Participants who were on the virtual wards approximately 12 weeks after their admission and those referred to long-COVID outpatient clinics will be approached. There is a particular lack of understanding as to whether post-COVID syndrome constitutes a singular disease process. It has been suggested that the post-COVID syndrome may be characterised into either an acute or chronic subtype, depending on whether symptoms extend beyond 12 weeks following initial diagnosis.7,10 However, it is not currently understood as to whether chronic post-COVID is either an extension of acute post-COVID or is a separate disease subtype that carries a distinct risk profile. However, there remains a paucity in the literature depicting the recovery experience, risk factors for the development of post-COVID syndrome, management strategies, and qualitative experiences. This study aims to address these gaps

Official Title
-----------------
Recovering From COVID: Community-based Remote Monitoring in COVID-19 (SARS-CoV 2) Cases: The OVER-COVID Study

Conditions
-----------------
SARS CoV 2 Infection

Intervention / Treatment
-----------------
* Device: Fitbit


Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA Aged 18 years or over. Able to provide written consent. EXCLUSION CRITERIA Any participants that withdraw their consent. Any form of psychiatric disorder or a condition that, in the opinion of the investigator, may hinder communication with the research team. Inability to cooperate or communicate with the research team.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Fitbit|The use of Fitbit sensors to see if activity levels can be improved to track recovery from COVID|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Step count | step count recorded from Fitbit devices | up to 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
monitoring, ambulatory, vital signs, remote monitoring
Single-blind, Dose-ranging Study of Novel Swine Influenza Virus Vaccine in Japanese Adult Subjects

Study Overview
=================
Brief Summary
-----------------
This study is to identify the preferred vaccine dosage (of antigen and adjuvant) and schedule (one or two administrations) of the cell-derived H1N1sw monovalent vaccine in healthy adults based on EMEA/CHMP criteria, and safety & tolerability.

Official Title
-----------------
A Multi-center, Randomized, Single-blind, Dose-Ranging Study to Evaluate Immunogenicity, Safety and Tolerability of Different Doses of Adjuvanted Cell-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Japanese Adult Subjects

Conditions
-----------------
Influenza

Intervention / Treatment
-----------------
* Biological: Adjuvanted cell-derived, inactivated novel swine origin A/H1N1 monovalent subunit influenza virus vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Japanese adults aged 20 to 60 years Exclusion Criteria: History of anaphylaxis, serious vaccine reactions, hypersensitivity to vaccine viral proteins or excipients Administration of adjuvanted influenza vaccine or suspected influenza disease within 3 month prior to study start Administration of any other vaccines within 4 weeks prior to enrollment expect for seasonal influenza vaccines within 1 week History of progressive or severe neurological disorders

Ages Eligible for Study
-----------------
Minimum Age: 29 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arm 1<br>Dose ranging | Biological: Adjuvanted cell-derived, inactivated novel swine origin A/H1N1 monovalent subunit influenza virus vaccine<br>* High dose group and low dose group of adjuvanted vaccines<br>|
| Other: Arm 2<br>Dose ranging | Biological: Adjuvanted cell-derived, inactivated novel swine origin A/H1N1 monovalent subunit influenza virus vaccine<br>* High dose group and low dose group of adjuvanted vaccines<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroprotection, GMRs and Seroconversion rate at Weeks 0, 3 and 6 |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AEs, vital signs, laboratory tests |  | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Influenza A, H1N1 subtype, Adult, Vaccine, Adjuvant, Swine-Origin Influenza A H1N1 Virus
DNA Analysis of Discarded Media Drops From the Clinical IVF Cycles

Study Overview
=================
Brief Summary
-----------------
Performing DNA analysis of discarded media drops from the clinical IVF cycles completed in our Center

Detailed Description
-----------------
The purpose of this research study is to investigate for the presence of DNA in the surrounding media that is remaining after human clinical IVF cycles, to have a non-invasive way of obtaining markers of embryo chromosome numeration. Media recovered from the clinical IVF laboratory is typically discarded during an IVF cycle. Genomic technologies will be used to analyze the otherwise discarded media drop for chromosome counting.

Official Title
-----------------
DNA Analysis of Discarded Media Drops From the Clinical IVF Cycles

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Diagnostic Test: chromosome numeration of embryos


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any women undergoing an In Vitro Fertilization cycle (IVF) at the Colorado Center for Reproductive Medicine that is also having Comprehensive Chromosomal Screening (CCS) of embryos Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 44 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: chromosome numeration of embryos|Use genomic technologies to analyze the discarded media drop for chromosome counting|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DNA Analysis of discarded media drops form the clinical IVF Cycles | Analyze media drop for presence of DNA to obtain embryo chromosome numeration | 1 day |