linjc16/ctgov huggingface dataset:
Resident Observed Burnout After Daily Supplementation With Coffee

Study Overview
=================
Brief Summary
-----------------
Coffee drinking is frequently reported as a negative outcome in studies on burnout, but the effect of an increased coffee intake on resident burnout has not been reported in the literature. This study is a prospective, interventional cohort study enrolling up to 50 residents from the Internal Medicine Residency Program to look at the relationship between coffee and resident burnout.

Detailed Description
-----------------
Resident burnout is increasingly being recognized as detrimental to both physician well being and patient care. It has been linked to an increased rate of medical errors and a reduced quality of patient care. In addition, there have been multiple high-profile physician suicides in the past years. This has resulted in a renewed focus on physician mental health and workload.

Official Title
-----------------
Resident Observed Burnout After Daily Supplementation With Coffee

Conditions
-----------------
Burnout, Professional

Intervention / Treatment
-----------------
* Dietary Supplement: Daily Supplementation with Coffee


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A resident in the NYU Internal Medicine residency program Exclusion Criteria: Allergy or intolerance to coffee or caffeine Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Internal Medicine residents at NYU<br>effect of supplying Internal Medicine residents at NYU with free coffee on self reported features of psychological health, energy and burnout | Dietary Supplement: Daily Supplementation with Coffee<br>* At the beginning of study week 2 (study day 8), two coffee machines (one Nespresso Inissia and one Hamilton Beach 46205 12 Cup Programmable Coffee Maker) will be installed in the resident work rooms at each site. Subjects will be provided with free coffee beans, milk, cream, sugar and sweetener<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self reported feelings of burnout | 14 question survey measuring number of cups of coffee and level of exhaustion | 1 Month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coffee consumption measured by self reporting questionaire | Measured by self reporting questionnaire | 1 Month | 
| Self reported emotional well being | 14 question survey with questions measuring emotional wellbeing | 1 Month | 
| Self reported feelings of value | 14 question survey with questions measuring feelings of self value | 1 Month |
Trametinib Combined With Everolimus and Lenvatinib for Recurrent/Refractory Advanced Solid Tumors

Study Overview
=================
Brief Summary
-----------------
To study the clinical effect of Trametinib combined with Everolimus and Lenvatinib in the treatment of Recurrent/Refractory advanced solid tumors.

Detailed Description
-----------------
The tumor diameter was measured and the efficacy was evaluated after treatment with Trametinib combined with Everolimus and Lenvatinib.

Official Title
-----------------
Trametinib Combined With Everolimus and Lenvatinib in the Treatment of Recurrent/Refractory Advanced Solid Tumors: a Phase II Clinical Trial

Conditions
-----------------
Solid Tumor, Adult, Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Drug: Combination of three inhibitors Trametinib, Everolimus and Lenvatinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recurrent/Refractory advanced solid tumors Age between 18 and 85 years Expected life expectancy is greater than three months Exclusion Criteria: Benign tumor Life expectancy is less than three months Serious medical commodities others

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
Interventional Model Description: To treat recurrent or refractory advanced solid tumors with multiple targeting drugs that inhibit several critical signaling pathways in cancer cells.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combination treatment of 3 inhibitors<br>Oral administration of 3 signaling pathways inhibitors: Mek inhibitor Trametinib, mTOR inhibitor Everolimus, and angiogenesis inhibitor Lenvatinib on refractory advanced solid tumors. | Drug: Combination of three inhibitors Trametinib, Everolimus and Lenvatinib<br>* Oral administration of three inhibitors including Trametinib, Everolimus and Lenvatinib.<br>* Other names: Combination of 3 signaling pathway inhibitors specific to MEK, mTOR, and angiogenesis.;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessing Incidence of Treatment-Emergent Adverse Events during the treatment and various responses to the treatment. |  | up to 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessing progress free survival |  | 48 months | 
| Assessing overall survival | Assessing overall time to survival. | 48 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Trametinib, Hepatocellular Carcinoma;Lung Cancer, Everolimus, Lenvatinib
Study of PIVKA-II and AFP Measurement in Surveillance Program for Early Detection of Hepatocellular Carcinoma

Study Overview
=================
Brief Summary
-----------------
There is no prospective study on the test intervals of alpha-fetoprotein (AFP) or on the role of prothrombin induced vitamin K absence or antagonist-II (PIVKA-II) in surveillance program for early detection of hepatocellular carcinoma(HCC). The goal of this study is to compare if the testing of AFP + PIVKA-II in intervals of 3 months is more effective in diagnosing early stages of HCC than the 6 month interval of AFP that is commonly used

Detailed Description
-----------------
There is no prospective study on the test intervals of alpha-fetoprotein (AFP) or on the role of prothrombin induced vitamin K absence or antagonist-II (PIVKA-II) in surveillance program for early detection of hepatocellular carcinoma(HCC). The goal of this study is to compare if the testing of AFP + PIVKA-II in intervals of 3 months is more effective in diagnosing early stages of HCC than the 6 month interval of AFP that is commonly used

Official Title
-----------------
Prospective, Randomized Study of PIVKA-II and AFP Measurement Every 3 Months Compared to AFP Every 6 Months in Surveillance Program for Early Detection of Hepatocellular Carcinoma

Conditions
-----------------
Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Device: tumor maker interval shortly


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: LC Exclusion Criteria: previous HCC

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 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 |
| --- | --- |
| PIVKA-II and AFP 6 months<br>PIVKA-II and AFP measurement every 6 months | |
| tumor maker interval every 6 month<br>tumor maker interval every 6 month | Device: tumor maker interval shortly<br>* tumor maker interval every 3 month<br>* Other names: tumor maker interval every 3 month;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the difference of curative treatments & survival rates |  | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the difference of early detection rates of HCC between both groups |  | 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatocellular carcinoma
Cognitive Impairment and Cardiovascular Risk in Older

Study Overview
=================
Brief Summary
-----------------
The objective of this project is to study cognitive yields in people of the town of Salamanca over 65, with particular emphasis on the acquisition of the initial symptoms of cognitive impairment in order to detect mild cognitive impairment and study the relationship between the clinical situation and cardiovascular risk factors. It will depart from a reference population of 420 people older than 65 years living in the municipality of Salamanca which took part in a survey prior to partner health needs of the elderly of 65 years in the municipality of Salamanca. This was a stratified sampling as stratum considering the area of health. The results of this study are expected to evidence the extent of the problem of cognitive decline in the population over 65 years. It is also expected to determine the relationship between the co-morbidity in this problem and specific factors of cardiovascular risk in this group of population.

Detailed Description
-----------------
A random sample population, the information obtained has a validity superior to other studies in which the sample has not followed very strict criteria of selection. Protocol for measurement: variable demographic partner vascular risk factors co-morbidity functional level for the activities of daily life cognitive performance in attention, memory, language, praxias, gnosias (abbreviated neuropsychological battery) Through a battery short neuropsychological specially adapted for the study of older people will carry out a study of the cognitive performance in people older than 65 years of age and will try to establish how much influence the controlled variables of cardiovascular risk.

Official Title
-----------------
Detection of Mild Cognitive Impairment in People Older Than 65 Years of Age and Its Relationship to Cardiovascular Risk Factors (DECRIVAM)

Conditions
-----------------
Cognitive Impairment, Cardiovascular Risk Factor

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: lives in the municipality of Salamanca over 65 years of age

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- | --- |
| Prevalence of risk factors cardiovascular |  | Prevalence of risk factors cardiovascular | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neuropsychological assessment |  | neuropsychological assessment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dementia, cardiovascular risk, elderly, aging, older 65-100 years
Cough Monitoring Study

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to establish the accuracy of a new device designed specifically to record and detect cough episodes. Cough is an important defense mechanism of the respiratory tract. The presence of chronic cough may indicate the presence of underlying diseases, including reflux. Despite the increased number of patients suffering from cough in the ENT and GI practice, to date, there has been no method/device to objectively assess the frequency of cough episodes in a given patient. PULMOTRACK-CC, manufactured by KarmelSonix (Haifa, Israel), has recently introduced an innovative device that is able to record cough episodes and then automatically detect and count them with the help of a specific software program. This study will assess the accuracy of this novel cough monitoring and counting technology and validate potential clinical use in patients with chronic cough.

Official Title
-----------------
Monitoring Cough Device - Step 1 and 2

Conditions
-----------------
Cough, Reflux

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Arm 1: healthy volunteers: Male and female volunteers 18 years of age and older No history of chronic or acute cough and throat clearing Ability to read a 5th grade script written in English for approximately 20 minutes Arm 2: patients: Male and female volunteers 18 years of age and older Cough as chief complaint Referred to the GI clinic to evaluate if reflux is the cause of their chief complaint pH testing for standard of care purposes Exclusion Criteria: Subjects who are not able to give informed consent

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 |
| --- | --- |
| Cough as Primary Complaint<br>Male and female volunteers 18 years of age and older Cough as chief complaint Referred to the GI clinic to evaluate if reflux is the cause of their chief complaint pH testing for standard of care purposes | |
| Healthy Volunteers<br>Male and female volunteers 18 years of age and older No history of chronic or acute cough and throat clearing Ability to read a 5th grade script written in English for approximately 20 minutes | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of Cough Device | The aim of the study is to establish the accuracy of a new device designed specifically to record and detect cough episodes. | 24 hours post device placement | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cough, Chronic Cough, Reflux
Pemoline for Cocaine Abuse - 7

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the treatment of pemoline for cocaine abuse.

Official Title
-----------------
Pemoline for Cocaine Abuse

Conditions
-----------------
Cocaine-Related Disorders

Intervention / Treatment
-----------------
* Drug: Pemoline


Participation Criteria
=================
Eligibility Criteria
-----------------
Please contact site for information.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pemoline|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects |  |  | 
| Drug use |  |  | 
| Retention |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pemoline
Evaluation of Surgical Complications

Study Overview
=================
Brief Summary
-----------------
Surgical complications may be very serious and are often under-reported. The aim of this study it to document and study all the postoperative complications at our department during one year using a novel grading system.

Official Title
-----------------
Evaluation of Surgical Complications Using a Novel Grading System - A Prospective Single Arm Study

Conditions
-----------------
Post Operative Complications

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients undergoing surgery at our department. No gender difference. Exclusion Criteria: Age - less than 18.

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients that underwent surgery<br>Single arm | Other: No intervention<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of complications | all post operative complications will be included | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
surgery, post operative, complications, length of stay
A Single Center Real-world Study of Donafenib in the Treatment of Hepatocellular Carcinoma in Routine Clinical Practice

Study Overview
=================
Brief Summary
-----------------
This trial is a single center observational real-world study. It is planned to include 300 patients with unresectable hepatocellular carcinoma (uHCC) treated with Donafenib. The purpose of the study was to observe the effectiveness and safety of Donafenib in the real world.

Official Title
-----------------
A Single Center Real-world Study of Donafenib in the Treatment of Hepatocellular Carcinoma (HCC) in Routine Clinical Practice

Conditions
-----------------
Donafenib, Hepatocellular Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years old; Histologically confirmed HCC or meet the clinical diagnostic criteria of HCC; Unresectable HCC; The doctor decided to use donafenib before the patient was enrolled in the study； Informed consent and willing to complete the study according to the protocol. Exclusion Criteria: Those who are participating in clinical trials of other antitumor drugs; Allergic to any component of Donafenib tablets; Patients with active bleeding, active peptic ulcer, drug uncontrollable hypertension or severe liver dysfunction; Pregnant or lactating women.

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 |
| --- | --- |
| Donafenib<br>Patients with uHCC taking donafenib in clinical treatment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events and serious adverse events. | Incidence of adverse events and serious adverse events. | an average of 1.5 year. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (ORR) | According to RECIST v1.1 and mRECIST to evaluate the proportion of patients with complete response(CR) and partial response(PR) in the total number of patients. | an average of 1 year. | 
| Duration of remission (DoR) | Time from the date of first confirmed CR or PR to the occurrence of disease progression. | an average of 1 year. | 
| Disease control rate (DCR) | According to RECIST v1.1 and mRECIST to evaluate the proportion of patients with CR, PR and stable disease(SD) in the total number of patients. | an average of 1 year | 
| Progression-free survival(PFS) | PFS refers to the time from the date of enrollment to tumor progression or death from any cause. | an average of 1 year | 
| overall survival(OS) | The time from the date of enrollment to the date of death from any cause. | an average of 1 year |
Pathogenesis and Cerebrovascular Manifestations of Septic Encephalopathy

Study Overview
=================
Brief Summary
-----------------
Septic encephalopathy is an important complication of sepsis. Why some patients with sepsis develop septic encephalopathy is unknown. We will investigate whether patients who develop this condition have different patterns of cerebrovascular reactivity and whether it is possible to predict the development of septic encephalopathy from early measurements of cerebral perfusion or from the EEG. We will specifically test the hypotheses that septic encephalopathy may not be predicted by changes in the EEG, and that cerebrovascular autoregulation is not dysfunctional in septic encephalopathy.

Official Title
-----------------
A Pilotstudy on Pathogenesis and Cerebrovascular Manifestations of Septic Encephalopathy

Conditions
-----------------
Sepsis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sepsis Admission to ICU Exclusion Criteria: CNS infection History of cerebrovascular disease

Ages Eligible for Study
-----------------
Minimum Age: 16 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
-----------------
sepsis, encephalopathy, cerebral perfusion, electroencephalogram