linjc16/ctgov huggingface dataset:
The Effects of Potassium on Physiological and Cardiovascular Variables in Healthy Persons

Study Overview
=================
Brief Summary
-----------------
In humans living of fruit and vegetables, hypertension is rarely seen. We wish to study if the development of hypertension has a connection to our intake of potassium. We know that fruit and vegetables contain a lot of potassium and we will simulate this intake by giving healthy subjects potassium as tablets.

Official Title
-----------------
The Effects of Potassium on Physiological Variables in the Kidney and Cardiovascular Variables in Healthy Persons in a Double-blinded, Randomised, Placebo-controlled, Cross-over Study

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Calcium
* Drug: Potassium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy age 18-40 years old BMI 18, 5-30 non-smoker Exclusion Criteria: daily use of medicine alcohol or drugs desire to become pregnant not using safe anti-contraceptive abnormal results in the initial testing

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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 |
| --- | --- |
| Placebo Comparator: 1<br>Calcium tablets | Drug: Calcium<br>* tablets, 1 tablet 2 times per day in 28 days<br>|
| Active Comparator: 2<br>Potassium tablets | Drug: Potassium<br>* Tablets, 5 tablets 2 times per day for 28 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on blood pressure |  | three months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypertension, potassium, blood pressure
Leptin, IGF1 and the Refeeding Index

Study Overview
=================
Brief Summary
-----------------
Background and study hypothesis: Refeeding syndrome is a dangerous condition which could arise if patients who have had little or no food for many days, are started on any form of feeding. The metabolic consequences of this condition could affect the heart, lungs and nervous system of the patient and cause serious imbalance in the level of salts in the body. The available guidelines for predicting that refeeding syndrome may occur are very subjective since they depend mainly on a history which is sometimes difficult to obtain from the patient. The main biochemical landmark that refeeding syndrome has occurred is a fall in the phosphate levels once feeding has been started. There are currently no biochemical markers that can identify patients at risk of developing refeeding syndrome. Leptin and IGF1 are hormones which have been observed to go down if someone has had little or no food for a while. The investigators therefore hypothesized that using a combination of leptin and IGF1 values in a 'Refeeding Index' would make the latter a useful biochemical marker to predict that refeeding may occur, hence take the precautionary measures to avoid its occurrence before starting feeding. Design: Thirty five consecutive patients referred for commencement of parenteral nutrition (PN) were included. Serum leptin and IGF1 were measured prior to starting PN. Electrolytes, liver and renal function tests were measured before and daily for one week after initiating PN. The primary outcome was a decrease in phosphate on day two or three after initiating PN. A 'Refeeding Index' (RI) was defined as leptin x IGF1 divided by 2800 to produce a ratio of 1.0 in patients who are well nourished.

Official Title
-----------------
Leptin and IGF1; Diagnostic Markers of Refeeding Syndrome and Mortality

Conditions
-----------------
Refeeding Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients referred for parenteral nutrition at King's College Hospital between January and April 2009. Exclusion Criteria: Non adult patients (less than 18 years of age).

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 |
| --- | --- |
| Parenteral nutrition patients.<br> | |

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
-----------------
Leptin, IGF1, Refeeding Index, Hypophosphataemia, Primary focus of the study was to detemine whether the 'Refeeding Index', could reliably predict,that the refeeding syndrome would occur
French Database of Occipital Nerves Stimulation in the Treatment of Refractory Chronic Headache Disorders

Study Overview
=================
Brief Summary
-----------------
The purpose of this non interventional research is to set up a French database, initially for 3 years, of patients suffering from refractory chronic headache disorders (chronic migraine, cluster headache, chronic paroxysmal hemicranias, SUNCT syndrome, hemicrania continua, cervicogenic headache disorders), and treated by occipital nerves stimulation. Every team using this neuromodulation approach in France is likely to participate in the network. Fifty patients a year are expected. They will be informed about data which are collected and why they are collected. The data will come from medical files and questionnaires filling out by the patients. The data will be collected on a case report form adapted to each refractory chronic headache disorder. The case report form pages will be faxed to the coordinating team who will enter the data in the database and analyse the data in a descriptive manner. These data are social and demographic data, medical data (headache features, headache functional and emotional impact, medications, and concomitant medical conditions), technical data (kind of electrodes and implantable pulse generator used, stimulation parameters chosen), and safety data. This research should provide an update on practices, an evaluation of the efficacy and long term safety of occipital nerves stimulation, and perhaps help in identifying response predictive factors to this neuromodulation approach.

Official Title
-----------------
French Database of Occipital Nerves Stimulation in the Treatment of Refractory Chronic Headache Disorders

Conditions
-----------------
Refractory Chronic Headache Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients suffering from refractory chronic headache disorders and treated by occipital nerves stimulation Exclusion Criteria: patients who don't agree with participating in the study because the ending of professional confidentiality is required for setting up the database
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 |
| --- | --- | --- |
| observation of a disease or medical condition under normal conditions | social and demographic data, medical data (headache features, headache functional and emotional impact, medications, and concomitant medical conditions), technical data (kind of electrodes and implantable pulse generator used, stimulation parameters chosen), and safety data. | at each visit (up to 4 years) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic daily headache, treated by occipital nerves stimulation, peripheral neuromodulation, occipital nerves, network, database
Study Evaluating the Tolerance of Conjugate Meningococcal C Vaccine in Infants

Study Overview
=================
Brief Summary
-----------------
Infant phase: To determine the safety of and production of antibodies by a group C meningococcal conjugate vaccine (MnCC), when given at 2, 3, and 4 months of age with routine vaccines. Booster phase: To compare the safety of and production of antibodies by MnCC with and without MMR and to compare the antibody response to that produced by a low dose of plain polysaccharide vaccine as a way of investigating immune memory

Official Title
-----------------
A Randomized, Double-blind, Controlled, Active Comparator, Phase II Study to Assess the Tolerance and Immunogenicity of Conjugate Meningococcal C (MnCC) Vaccine in Infants When Administered in Conjunction With Primary DTP/Hib Vaccination at 2, 3, and 4 Months of Age.

Conditions
-----------------
Meningitis, Meningococcal

Intervention / Treatment
-----------------
* Biological: Meningococcal C
* Biological: DTP/Hib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy infants 7-10 weeks of age eligible to receive routine immunization

Ages Eligible for Study
-----------------
Minimum Age: 7 Weeks
Maximum Age: 10 Weeks

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Meningococcal C|nan|
|Biological: DTP/Hib|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody responses to MnCC and concomitant vaccines |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and reactogenicity |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Infant, Conjugate vaccine, Meningococcal, Antibody, Immune memory, Health, Meningococcal Vaccines
Symptoms Experienced and Quality of Life in Breast Cancer Receiving Radiotherapy

Study Overview
=================
Brief Summary
-----------------
EORTC-QLQ-30 questionnaire filled in by participants 6 times

Detailed Description
-----------------
EORTC-QLQ-30 questionnaire filled in by participants 6 times 1st before receive radiotherapy 2nd after receive radiotherapy 3th 1 month after receive radiotherapy 4th 3 month after receive radiotherapy 5th 6 month after receive radiotherapy 6th 1 year after receive radiotherapy

Official Title
-----------------
Symptoms Experienced and Quality of Life in Patients With Breast Cancer Receiving Radiotherapy Across One Year

Conditions
-----------------
Quality of Life

Intervention / Treatment
-----------------
* Other: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: good consciousness ability to understand and provide information no hearing impairment Eastern Cooperative Oncology Group performance level of 0 to 2 Exclusion Criteria: prior radiotherapy

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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 |
| --- | --- |
| questionnaire<br>EORTC-QLQ-30 questionnaire | Other: Questionnaire<br>* The EORTC QLQ-C30 is a questionnaire developed to assess the quality of life of cancer patients. It is a copyrighted instrument, which has been translated and validated in over 100 languages and is used in more than 3,000 studies worldwide.<br>* Other names: EORTC-QLQ-30 Questionnaire;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| symptoms experienced | symptoms experienced collected by EORTC-QLQ-30 | Change from Baseline symptoms experienced at 1 month,3 month,6 month,1 year after radiotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life | quality of life collected by EORTC-QLQ-30 | Change from Baseline quality of life at 1 month,3 month,6 month,1 year after radiotherapy |
Complications in Central American Diabetic Patients: Historic Cohort

Study Overview
=================
Brief Summary
-----------------
Retrospective, observational study to determine the prevalence of complications in Central American diabetic patients.

Detailed Description
-----------------
This is retrospective observational study aimed to determine the prevalence of complications in Central American diabetic patients. Patients included are treated in the usual outpatient practice setting and we will try to determine the prevalence of diabetic complications in these patients.

Official Title
-----------------
Complications in Central American Diabetic Patients: Historic Cohort

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Other: None, observational study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: type 2 diabetes mellitus diagnosed between 2004 and 2009 seen by the attending physician for the first time between January and December 2009. male or female patients between 18 and 80 years Exclusion Criteria: none

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Type 2 diabetes mellitus<br>Type 2 diabetes mellitus patients, no intervention is performed besides usual clinical practice | Other: None, observational study<br>* None, it is an observational study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with microvascular and cardiovascular complications |  | up to 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with at least one episode of hypoglycemia |  | up to 10 years | 
| Number of patients with microvascular and cardiovascular complications stratified by their glucose control |  | up to 10 years | 
| Number of patients with microvascular and cardiovascular complications stratified by blood pressure control |  | up to 10 years | 
| Number of patients with microvascular and cardiovascular complications stratified by cholesterol levels |  | up to 10 years | 
| Number of patients with microvascular and cardiovascular complications stratified by diabetes pharmacologic treatment |  | up to 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetes mellitus, complications, prevalence
Myocilin Variations and Familial Glaucoma in Taxiarchis

Study Overview
=================
Brief Summary
-----------------
Taxiarchis, a small village in Northern Greece with 1060 inhabitants, was considered to have a surprisingly high incidence of glaucoma. This isolated population located on Mount Holomondas appeared to be enriched for familial glaucoma. Based upon the high reported incidence of glaucoma in Taxiarchis and previous findings of the Thr377Met myocilin mutation in the Greek population,the investigators undertook a community-based study to determine if this variant was present in this village.

Official Title
-----------------
Myocilin Variations and Familial Glaucoma in Taxiarchis, A Small Greek Village.

Conditions
-----------------
Glaucoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals born in Taxiarchis Exclusion Criteria: Individuals that have not been born in Taxiarchis

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 90 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 |
| --- | --- |
| Villagers in Taxiarchis<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Examining all of the villagers to determine the actual incidence of glaucoma in Taxiarchis and identify the Thr377Met myocilin mutation in glaucoma patients. |  | 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
glaucoma, myocilin
Device-based QRS Evaluation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect simultaneous surface electrocardiogram (ECG) recordings and Cardiac Resynchronization Therapy (CRT) intracardiac electrogram (IEGM) recordings of variations in electrical synchrony.

Official Title
-----------------
Device-based QRS Evaluation

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Device: ECG+IEGM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Already implanted with SJM Quadripolar CRT Pacing System Ability to provide informed consent for study participation Willing to comply with the study evaluation requirements At least 18 years of age Exclusion Criteria: Resting ventricular rate >100 bpm Intrinsic PR interval > 300 ms Paroxysmal or persistent atrial tachycardia or atrial fibrillation documented Pregnant or plans to become pregnant during the study

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 |
| --- | --- |
| ECG+IEGM<br>Surface ECG and intracardiac electrogram recordings will be taken during the adjustment of programmable Cardiac Resynchronization Therapy settings | Device: ECG+IEGM<br>* Cardiac Resynchronization Therapy programming adjustments<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterize CRT IEGM-based estimations of QRS duration |  | Acute (1 day) |
The Comparison of Pulse Oximetry, End-tidal Capnometry, and Integrated Pulmonary Index (IPI)

Study Overview
=================
Brief Summary
-----------------
To compare two ways to test breathing after surgery in acute care setting. One method tests oxygen level of the blood, and one method will test oxygen and the carbon dioxide that is breathed out.

Detailed Description
-----------------
A simple comparison design will be used to compare pulse SpO2 monitoring of respiratory status to a combination of pulse SpO2 monitoring and EtCO2 nasal cannula monitoring with Integrated Pulmonary Index (IPI). Using combination monitor, each subject will serve as their own control with repeated measurements of respiratory rate, SpO2, EtCO2 and IPI at 5 second intervals. Patients will be monitored for a minimum of 8 hours after admission to the acute care unit and through the first night. Subjects for this study will be a convenience sample post-operative in-patients admitted to 2 East after surgery at Allenmore Hospital/Multicare Health System a 75 bed community facility.

Official Title
-----------------
The Comparison of Pulse Oximetry, End-tidal Capnometry, and Integrated Pulmonary Index in Adult Post-operative Patients

Conditions
-----------------
Postoperative Care

Intervention / Treatment
-----------------
* Device: capnostream 20, Oridian Medical 1987 ltd, Needham MA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Age greater than 18 Increased Body Mass Index (BMI) > 31 History of chronic obstructive pulmonary disease (COPD) History of Sleep Apnea Exclusion criteria: Respiratory failure Isolation requirements Surgical patients admitted to 2 West or ICU

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

| Intervention/Treatment |
| --- |
|Device: capnostream 20, Oridian Medical 1987 ltd, Needham MA|Oxygen blood saturation measured by a s sensor that reflects infrared light on oxygenated and deoxygenated arterial blood via a noninvasive, clip on digit sensor connected to a combination capnometer and pulse oximeter monitor. End-tidal Carbon dioxide (EtCO2) is measured with a noninvasive nasal cannula sampling line which calculates the EtCO2 from exhaled air. Measurements recorded at 5 second intervals.|

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
-----------------
Adult, Post, operative, oximetry, capnometry, Integrated, Pulmonary, Index, End-tidal, Monitoring Respiratory status, post-operative