linjc16/ctgov huggingface dataset:
Continuous Endostar Infusion Combined With Radiotherapy in Patients With Brain Metastases

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the clinical efficacy and safety of continuous Endostar infusion combined with radiotherapy for treatment of brain metastases.

Official Title
-----------------
Phase II Study of Continuous Endostar Infusion Combined With Radiotherapy for the Treatment of Patients With Brain Metastases

Conditions
-----------------
Brain Metastases

Intervention / Treatment
-----------------
* Radiation: 6MV-X ray
* Drug: Endostar


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed malignancy with presence of intraparenchymal brain metastases Karnofsky performance status ≥ 40 Measurable disease according to RECIST criteria Hematologic function: WBC ≥ 4.0×109/L, PLT ≥ 80×109/L, Hb ≥ 90g/L Renal function: Cr ≤ 2.0×ULN Hepatic function: BIL ≤ 2.0×ULN, ALT/AST ≤ 5.0×ULN Adequate cardiac function Life expectancy ≥ 3 months Exclusion Criteria: Evidence of bleeding diathesis or serious infection Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension) Uncontrollable mental and nervous disorders Pregnant or lactating women

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 |
| --- | --- |
| Experimental: treatment<br>Radiotherapy plus Endostar | Radiation: 6MV-X ray<br>* 3Gy/time, 5 times/week, a total of 10 times<br>Drug: Endostar<br>* 7.5mg/m2/d, continuous infusion, in parallel with radiotherapy<br>|
| Active Comparator: control<br>Radiotherapy | Radiation: 6MV-X ray<br>* 3Gy/time, 5 times/week, a total of 10 times<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate (ORR) |  | 1 month after initial treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | 2 year | 
| Serum VEGF Levels |  | at baseline and 1 month after initial treatment | 
| VEGF levels in tumor tissue |  | at baseline and 1 month after initial treatment | 
| Incidence of Adverse Events |  | up to 1 month after last dose | 
| Cerebral Edema |  | 1 month after initial treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endostar, Radiotherapy, Brain Metastases
Sensitivity of Basic Taste in Elderly

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify the thresholds sensitivity of the five basic tastes in an elderly population and relate to food intake, nutritional status, age, gender and others variables.

Detailed Description
-----------------
The investigators propose a study of 300 elderly patients to characterize de sensitivity of the four basic tastes, according to the methodology of International Organization for Standardization (1985) and to identify umami taste (Mojet et al. 2001, 2003). This is a cross-sectional study. The length of the inclusion of the study will be 24 months. This study's general objective is: to characterize food intake, nutritional status and identify thresholds for the five basic tastes in an elderly population.

Official Title
-----------------
Thresholds Analysis of Five Basic Tastes in the Elderly Population

Conditions
-----------------
Taste Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 60 years old patient or older, who present oral feeding and the ability to express themselves to perform the sensory analysis tests will be included. Exclusion Criteria: Patient with fever, flu, cold or some complication in the oral cavity will be excluded, since these factors can interfere in the perception of the tastes and those that do not present conditions to express themselves or deficits of cognition, being excluded the elderly that present result of the application of the Mini Mental under 24. In addition to those who do not agree to sign the Term of Free and Informed Consent.

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterization of eldery according to sensitivity to basic tastes second age group and nutritional status | To identify the thresholds for detecting basic tastes in an elderly population and to relate to the age range and nutritional status. | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
elderly, taste, thresholds
Postoperative Delirium at Heidelberg's Intensive Care Unit -New Diagnostic Markers

Study Overview
=================
Brief Summary
-----------------
Summary: Postoperative delirium is a highly prevalent disease (10-30% prevalence) after surgery in intensive care unit, however, it is often misdiagnosed and mistreated. The aim of the present project is to investigate risk factors for postoperative delirium in more detail, to evaluate respective cognitive test systems and to measure EEG activity parallel to patients' serum anticholinergic activity. The pathophysiology of delirium is unknown up to now: a possible dysbalance between cerebral acetylcholine and dopamine concentrations is a likely hypothesis. Therefore, the measurement of peripheral serum anticholinergic activity could be a new prognostic factor for evaluation of delirium. Because delirium is also associated with higher postoperative mortality and morbidity, with delayed functional recovery, and postoperative delirium makes patient management much more difficult, increases costs, and, above all, causes severe discomfort to the patient new interdisciplinary diagnostic strategies are necessary to resolve this problem.

Conditions
-----------------
Postoperative Delirium

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients at Intensive Care Unit over a defined time period Over 18 years old Exclusion Criteria: Elective heart and vascular patients

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
EEG, postoperative delirium, psychometric testing, serum markers
Risk Factors for Progressive Supranuclear Palsy (PSP)

Study Overview
=================
Brief Summary
-----------------
Progressive supranuclear palsy (PSP) is the most common atypical parkinsonian movement disorder. This study will determine the role of specific genetic, occupational and environmental components in the development of PSP by evaluating patients with this disorder and age and gender matched controls.

Detailed Description
-----------------
This proposal will determine: (1) if there is an association between PSP and specific genes of interest; (2) if there is an association between PSP and occupational and/or environmental chemical exposures functionally or structurally similar to known parkinsonian toxicants; and (3) if hypertension or traumatic brain injury prior to symptom-onset is associated with PSP. To disentangle the complex etiology of PSP, this case-control multicenter study involves 500 PSP cases, 500 age/gender matched primary controls, and 500 secondary controls for genetic confirmation. Understanding the etiology of PSP may also help explain the causes of other related diseases such as Alzheimer's disease. This multidisciplinary team of movement disorder specialists, epidemiologists, geneticists, biostatisticians, industrial hygienist and toxicologist is well suited to unravel the etiology of PSP.

Official Title
-----------------
Genetic and Environmental Risk Factors for PSP

Conditions
-----------------
Progressive Supranuclear Palsy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PSP patients able to visit one of the screening sites for diagnostic confirmation and able to participate in a one hour telephone interview Exclusion Criteria: No other major neurological disorders Unable to communicate by telephone

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| Case<br>PSP Cases | |
| Control<br>Healthy Controls | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PSP, Progressive Supranuclear Palsy, Epidemiology, Case-Control, Genetic, Environmental, Neurodegenerative Disease, Movement Disorders, Atypical Parkinsonism, Parkinson Plus, Steele-Richardson-Olszewski
Spinal Morphine in Robotic Assisted Radical Prostatectomy

Study Overview
=================
Brief Summary
-----------------
This study will investigate if a single shot of spinal morphine will increase patient satisfaction when compared to intravenous morphine in Robot-Assisted Radical Prostatectomy

Detailed Description
-----------------
This study is a randomized controlled trial. It will randomize 160 patients who are scheduled for Robot-Assisted Radical Prostatectomy. The intervention group will receive a single spinal injection of a bupivacaine (12,5 mg)/morphine(300 mcg) mixture. Controlgroup will receive a subcutaneous injection of lidocaïne for placebo purposes and an intravenous loading dose of morphine at the end of surgery. Both groups will receive general anesthesia during surgery in a standardized fashion. After the surgery, both groups will receive a Patient-Controlled Analgesia pump for post-operative pain control. Primary outcome is patient satisfaction as measured by the Quality-of-Recovery-15 questionnaire. This questionnaire will be taken at baseline, day 2 and 1 week after surgery. Secundary outcomes are morphine use per PCA, duration of hospital stay, side-effects and ease of surgery.

Official Title
-----------------
Spinal Morphine in Robotic Assisted Radical Prostatectomy

Conditions
-----------------
Prostatectomy, Morphine, Injections, Spinal, Patient Satisfaction

Intervention / Treatment
-----------------
* Drug: Morphine
* Drug: Lidocaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Scheduled for Robot-Assisted Radical Prostatectomy Exclusion Criteria: Contra-indications to spinal anesthesia (severe aortic stenosis, coagulation disorders) Contra-indications to study medication (local anesthetics, morphine, paracetamol, metamizol) Conversion to an open procedure Post-operative ICU-admission

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Control<br>subcutaneous lidocaïne and intravenous loading dose of morphine | Drug: Lidocaine<br>* sham procedure (s.c. lidocaïne)<br>|
| Experimental: Intervention<br>Spinal injection of 4 or 5 ml of bupivacaine/morphine 2,5 mg/ml/60mcg/ml. The reduction to 4 ml is for patients over 75 years of age | Drug: Morphine<br>* mixed with bupivacaine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction | Quality of Recovery-15 questionnaire | day 1 |
Physical Fitness and Cardiovascular Mortality in Firefighters

Study Overview
=================
Brief Summary
-----------------
To study prospectively the interrelationships among physical fitness, activity, other measured risk factors, coronary heart disease (CHD) and all-cause mortality in a cohort of 3,403 firefighters.

Detailed Description
-----------------
BACKGROUND: From 1971-1991 the Occupational Health Service of Los Angeles Country measured physical fitness and other CHD risk factors (including physical activity, anthropometric measures, blood pressure, smoking, family history of CHD, and levels of total cholesterol, uric acid, and glucose) in Los Angeles County firefighters at application and routine intervals (approximately every three years). The entire cohort of 3403 firefighters is now followed for mortality up to 1996. DESIGN NARRATIVE: The entire cohort of 3,403 firefighers is followed up to 1996 in this longitudinal study. The investigators are using a variety of tracing sources, including the National Death Index, and obtaining death certificates to determine date and cause of death. Cohort data will be analyzed to address the following aims: (1) To provide a longitudinal description of and determine the interrelationships among physical fitness, physical activity, and other measured risk factors; (2) to determine whether levels of physical fitness are related, independently of other known and measured risk factors, CHD and all-cause mortality; (3) To determine whether there is a gradient of decreasing CHD risk with increasing levels of physical fitness, or whether there appears to be some threshold of physical fitness, above which CHD risk stabilizes; (4) To determine whether the relationship between physical fitness and CHD and all-cause mortality varies by such cardiovascular risk factors as age, cholesterol levels, blood pressure, smoking, and obesity.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Coronary Disease, Hypertension, Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |
Immediate Effect of Light on Reproductive Hormones in Women: a Role of the Spectrum

Study Overview
=================
Brief Summary
-----------------
The study investigates an acute effect of white-appearing LED light (with a peak in blue portion) vs. red LED light of similar irradiance on reproductive hormones in healthy women.

Detailed Description
-----------------
Sixteen healthy women came to the laboratory at 7:30 (wearing dark goggles) at two occasions (separated by 2-3 days, first time - at the 3rd-8th day of their menstrual cycle) to be exposed for 45' to white-appearing or red LED light (sequential allocation). The white light has a distinct peak at 460 nm, the narrow-band red light peaked at 651 nm. The LED devices were positioned at the distance of 50 cm (white) and 45 cm (red) from the eyes to be matched by irradiance (approximately 7.0 microWt/m2); background light in direction of gaze was 5-10 lux. Blood and saliva samples were collected before, in the middle, and during the last minutes of the 45' exposure to be measured later for concentration of luteinizing hormone, follicle-stimulating hormone, prolactin, estrogen, progesterone, and also - for cortisol and melatonin (the last one - in saliva) as well-studied indicators of the direct effect of light.

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Procedure: Light therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-45 y normal (21-35 days) menstrual cycle good and stable general health normal body weight index 18.5-29.9 normal sleep-wake regimen living close to the laboratory (<7' by walk) goodcubital veins Exclusion Criteria: difficulty to contact travel over several time zones during last month medications known to interfere with hormone release

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: Basic Science
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Light therapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reproductive hormones concentration |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Light exposure, light spectrum, reproductive hormones, women
Sensor-augmented Pump Versus Multiple Daily Injections With Degludec as Basal Insulin for Insulin Therapy in Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
Several studies have shown that Continuous Subcutaneous Insulin Infusion together with Continuous Glucose Monitoring improves glycemic control in type 1 diabetes when compared to more traditional approaches; however, in available trials the basal insulin used in multi-injection therapy is typically glargine, which is associated with a higher hypoglycemic risk than degludec. This study will assess the efficacy and safety of Continuous Subcutaneous Insulin infusion (CSII) combined with Continuous Glucose Monitoring (CGM), as compared to Multiple Daily Injections (MDI) of insulin analogues, using degludec as basal insulin, associated with traditional self-monitoring of capillary blood glucose (SMBG) in patients with type 1 diabetes. A crossover design was chosen in order to minimize study sample improving statistical power.

Official Title
-----------------
Continuous Subcutaneous Insulin Infusion Associated With Continuous Glucose Monitoring in Comparison With Subcutaneous Multi-injection Insulin Therapy Using Degludec as Basal Insulin: a Randomized Crossover Trial in Type 1 Diabetes

Conditions
-----------------
Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Device: CGM+CSII
* Device: MDI with degludec


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 diabetes Duration of diabetes > 2 years Current treatment with MDI, using insulin analogues as bolus and basal insulin HbA1c<64 mmol/mol Exclusion Criteria: HbA1c>64 mmol/mol Pregnancy or lactation

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CSII+CGM<br> | Device: CGM+CSII<br>* Animas Vibe Platinum insulin pump and Dexcom G4 CGM<br>|
| Active Comparator: MDI with degludec<br> | Device: MDI with degludec<br>* Multiple injection therapy with any short-acting analogue as bolus insulin and degludec as basal insulin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | Variation of HbA1c in each treatment phase (difference between end-of-treatment and baseline for each treatment phase) | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severe Hypoglycemia | Number of subjects with at least one episode of severe hypoglycemia, for each treatment phase | 4 months | 
| Local Reactions | Number of participants with local reactions at infusion/glucose monitoring site | 4 months |