linjc16/ctgov huggingface dataset:
Post-exercise Appetite Responses in Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesise that manipulating the glycaemic index of the meal after exercise will influence the acute appetite responses of Type 1 diabetes individuals

Official Title
-----------------
A Comparison of the Appetite Responses to High and Low Glycemic Index Post-exercise Meals Under Matched Insulinemia and Fibre in Type 1 Diabetes

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

Intervention / Treatment
-----------------
* Dietary Supplement: Meal composition - Low versus high GI.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged between 18-50 years old (male or female). Free from any diabetes related complications (apart from mild background diabetic retinopathy). HbA1c <8.5%. Not taking any prescribed medication other than insulin, and treated with a stable insulin regimen composed of a combination of slow/long acting insulin (glargine or detemir) and fast-acting insulin analogues (lispro or aspart), for a minimum of 6 months before the start of the study. Demonstrate normal cardiac function in response to exercise. Exclusion Criteria: Aged younger than 18, or older than 50 years. Suffering from, or diagnosed with a diabetes related complication (apart from mild background diabetic retinopathy). HbA1c >8.5%. Currently taking prescribed medication, and not currently treated with a stable basal bolus regimen composed of a combination glargine or detemir, and lispro or aspart for at least 6 months before the start of the study. Failure to demonstrate normal cardiopulmonary responses during exercise, or have a medical condition which could prevent completion of exercise or be exacerbated because of.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Meal composition - High GI<br>Changing the glycaemic index of the meal consumed after exercise (High GI versus Low GI). | Dietary Supplement: Meal composition - Low versus high GI.<br> <br> |
| Experimental: Meal composition - Low GI<br>Changing the glycaemic index of the meal consumed after exercise (High GI versus Low GI). | Dietary Supplement: Meal composition - Low versus high GI.<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute subjective appetite responses | Subjective appetite ratings via Visual Analogue Scales | 4 hours post-exercise | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 1 Diabetes Mellitus, Exercise, Appetite
Abdominal Exploration Without Incisions

Study Overview
=================
Brief Summary
-----------------
This study is being conducted to determine whether an endoscope, (a small, flexible tube with a camera mounted on the end) passed down through the throat, through the stomach, and into the abdomen can safely and accurately examine the organs and tissue of the abdomen and take biopsies if needed. We wish to determine if this endoscopic diagnostic route is as efficient as the laparoscopic diagnostic route, which is currently the standard of care.

Detailed Description
-----------------
We propose to investigate the efficacy of transgastric endoscopic peritoneoscopy with endoscopic biopsy in patients undergoing diagnostic laparoscopy and who will require a concurrent gastrotomy for placement of a PEG, gastrojejunostomy or gastric resection. We hypothesize that diagnostic endoscopic peritoneoscopy can be done safely with adequate visualization of the abdominal cavity to direct clinical treatment.

Official Title
-----------------
Diagnostic Transluminal Endoscopic Peritoneoscopy

Conditions
-----------------
Pancreatic Cancer

Intervention / Treatment
-----------------
* Procedure: Transgastric endoscopic peritoneoscopy.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pancreatic Cancer undergoing staging laparoscopy Staging or diagnostic laparoscopy in anyone needing enteral access Exclusion Criteria: Lack of consent Intra-abdominal adhesions precluding diagnostic laparoscopy

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Whipple<br>Patients with pancreatic cancer who will proceed to a Whipple procedure. | Procedure: Transgastric endoscopic peritoneoscopy.<br>* Exploration of the abdominal area<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1) That transgastric endoscopic peritoneoscopy is feasible. |  | 4/12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| That bacterial abdominal contamination is not clinically significant. |  | 04/11 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Transgastric, Endoluminal, Peritoneoscopy, Diagnostic, Feasibility
Continuous Glucose Monitoring Profile Description Under Alpelisib treAtment in Patients With Advanced bREast Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to describe the glycemic profile of postmenopausal women treated with alpelisib plus fulvestrant using a continuous blood sugar monitoring device (FreeStyle Libre Pro) over 14 days

Detailed Description
-----------------
AAREN is a monocentric prospective study monitoring glycemic profile in patients treated with alpelisib plus fulvestrant. Patients will wear a noninvasive glucose monitoring sensor, the Freestyle Libre Pro for a 14 day period. Forty patients will be enrolled.

Official Title
-----------------
AAREN: Continuous Glucose Monitoring Profile Description Under Alpelisib treAtment in Patients With Advanced bREast Cancer

Conditions
-----------------
Breast Cancer, Diabetes

Intervention / Treatment
-----------------
* Device: FreeStyle Libre Pro


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women suffering breast cancer and eligible to treatment with Alpelisib Age ≥18 years Menopausal women (for at least 24 months) Informed Consent Form signed Exclusion Criteria: Men Pregnant ou child-bearing potential women

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continuous interstitial glucose measurements<br>Variations of interstitial glucose are measured during 14 days with FreeStyle Libre Pro | Device: FreeStyle Libre Pro<br>* Measurements of interstitial glucose variations with FreeStyle Libre Pro<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of hyperglycemia | In percentage, measured before breakfast and diner (fasting blood glucose). Hyperglycemia defined as follows: if diabetes de novo: capillar or interstitial fasting blood glucose ≥ 1,50 g/L, OR postprandial interstitial glucose ≥ 2 g/L OR glucose monitoring indicator ≥ 6,5% if worsening pre-existing diabetes: increased capillar or interstitial fasting blood glucose ≥ 0,50 g/L compared to average fasting blood glucose at J-3, J-2 and J-1 AND postprandial interstitial glucose ≥ + 1,00 g/L compared to average fasting blood glucose at J-3, J-2 et J-1 OR average blood glucose ≥ +0,50 g/L | Day 14 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast Cancer, Alpelisib, hyperglycemia
Impact of Systemic Manifestations/Comorbidities on Clinical State, Prognosis, Utilisation of Health Care Resources in Patients With COPD

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the prevalence and severity of extrapulmonary disorders and to quantify the impact of extrapulmonary organ manifestations on morbidity and mortality of COPD patients. Furthermore the investigators evaluate the relationship between systemic inflammation and organ involvement.

Detailed Description
-----------------
Chronic diseases and comorbidities have an increasing impact on individual life and health care use, as exemplified in chronic obstructive pulmonary disease (COPD). Currently, independent, comprehensive databases allowing for an integrated view are lacking. The study will for the first time establish a large, comprehensive longitudinal database covering a broad panel of comorbidities an markers of systemic alterations. These data will be of unique value in revealing specific phenotypes of COPD via patterns and risk profiles of comorbidities, enabling a more precise diagnosis and targeting of therapy, and an efficient allocation of resources.

Official Title
-----------------
Impact of Systemic Manifestations/Comorbidities on Clinical State, Prognosis and Utilisation of Health Care Resources in Patients With COPD

Conditions
-----------------
Chronic Obstructive Pulmonary Disease (COPD)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged 40 years and older diagnosis of COPD (GOLD-Criteria) or chronic bronchitis informed consent available for repeated study visits pver 18 months Exclusion Criteria: having undergone big lung surgery (e.g. lung reduction, lung transplant) Moderate or severe exacerbation within the last 4 weeks having a lung tumor Unable to walk or to understand the intention of the project

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- | --- |
| Change from baseline in BODE-Score at 18 months | The BODE-Score comprises BMI, airway obstruction, dyspnea and exercise capacity and is a good predictor for death in COPD patients. Progression is defined as a change in BODE-score by >=1 point over the observation period. | at initial visite, after 18, 36, 54, 72, 90 and 108 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COPD related mortality | The rate of mortality was elevated after 6, 18, 36, 54, 72, 90 and 108 months | after 18 months | 
| COPD related hospitalization | The rate of hospitalizations was elevated in every visit. | after 18, 36, 54, 72, 90 and 108 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, register, comorbidities, systemic inflammation
Influence of Kidney Performance and Magnesium on Formation of (OH)2-vitamin D3

Study Overview
=================
Brief Summary
-----------------
Retrospective database analysis. The target values are the serum values of 25(OH)D, of 1,25(OH)2D, of magnesium and creatinine as well as age and sex of the patients. The laboratory values of the years 2017 and 2018 are included. There are no additional measurements on patients.

Detailed Description
-----------------
The laboratory values of the years 2017 and 2018 are included. All laboratory results to be evaluated originate from Medics Labor in Bern. We expect about 50'000 data sets. It is impossible for the study team to draw conclusions about the patients or the senders.

Official Title
-----------------
Influence of Kidney Performance and Magnesium on the Biomarkers of Vitamin D

Conditions
-----------------
Hydroxylase Deficiency

Intervention / Treatment
-----------------
* Diagnostic Test: serum value 1,25(OH)2 vitamin D


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all data sets available Exclusion Criteria: a declaration from the patient that his laboratory values may not be included in an evaluation.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: serum value 1,25(OH)2 vitamin D|statistical evaluation of the serum values|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation of serum values of 1,25(OH)2 vitamin D with estimated glomerular filtration rate | statistical evaluation of serum values | 2017 - 2018 | 
| correlation of serum values of 1,25(OH)2 vitamin D with magnesium | statistical evaluation of serum values | 2017 - 2018 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vitamin D, 1-alpha hydroxylase, magnesium, renal insufficiency
Validation of CAGIB Score for In-hospital Mortality of Cirrhotic Patients With Acute Gastrointestinal Bleeding

Study Overview
=================
Brief Summary
-----------------
Acute gastrointestinal bleeding is potentially lethal in liver cirrhosis. Accurate assessment of prognosis is critical in a timely fashion. A novel model, CAGIB score, has been developed based on our Chinese multicenter retrospective study. Now, a prospective, international multicenter, observational study will be performed to further compare the performance of CAGIB versus Child-Pugh and MELD scores for evaluating the in-hospital mortality of patients with liver cirrhosis and acute gastrointestinal bleeding.

Official Title
-----------------
Validation of CAGIB Score for In-hospital Mortality of Cirrhotic Patients With Acute Gastrointestinal Bleeding: A Prospective, International Multicenter, Observational Study

Conditions
-----------------
GastroIntestinal Bleeding

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with liver cirrhosis; Patients with acute gastrointestinal bleeding presenting with hematemesis, melena, and/or hematochezia; Adults (age≥18 years old). Exclusion Criteria: Components of Child-Pugh, MELD, and CAGIB scores are not available; In-hospital outcomes are not evaluable.

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 |
| --- | --- | --- |
| Mortality | Death caused by any events during hospitalizations. | An average of 1-6 weeks, from admission to discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Failure to control bleeding within 5 days | Failure is defined as death or need to change therapy defined by one of the following criteria within 5 days: 1) Fresh hematemesis or nasogastric aspiration of ≥100 ml of fresh blood ≥2 h after the start of a specific drug treatment or therapeutic endoscopy; 2) Development of hypovolaemic shock; 3) 3g drop in hemoglobin (9% drop of hematocrit) within any 24 hours period if no transfusion is administered. | 5 days |
Docetaxel+Carboplatin vs Epirubicin+Cyclophosphamide Followed by Docetaxel as Adjuvant Treatment in Triple-negative Breast Cancer

Study Overview
=================
Brief Summary
-----------------
Triple-negative breast cancer (TNBC) has a relatively bad prognosis whereas there is no standard regimen. Some data showed that platins could improve the efficacy of advance TNBC. In this trial, it is the hypothesis that TP (docetaxel plus carboplatin) has a better efficacy than EC-T (epirubicin plus cyclophosphamide followed by docetaxel).

Official Title
-----------------
Docetaxel Plus Carboplatin Versus Epirubicin Plus Cyclophosphamide Followed by Docetaxel as Adjuvant Treatment in Triple-negative Breast Cancer

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Drug: EC-T
* Drug: TP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Triple-negative breast cancer Older than 18 years old Have tumor resection surgery Sufficient organ function (marrow, heart, liver) Exclusion Criteria: Other malignancy Other serious disease( marrow, heart, liver)

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

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

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: EC-T<br> | Drug: EC-T<br>* four cycles of EC (epirubicin: 90 mg/m2; cyclophosphamide :600 mg/m2, day 1) followed by four cycles of T (docetaxel : 75 mg/m2 or paclitaxel 175 mg/m2, day 1)<br>|
| Experimental: TP<br> | Drug: TP<br>* six cycles of TP (docetaxel: 75 mg/m2 or paclitaxel 175 mg/m2 d1; carboplatin AUC=5, day 1)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Free Survival (DFS) of 3 years | local recurrence, distant metastasis, the secondary primary malignancy | 3 years after mastectomy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Profiles | All adverse events occurring during chemotherapy are to be recorded in the case report form, including hemotologic and nonhemotologic toxicities. | Up to 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TRIPLE-NEGATIVE, BREAST CANCER
Photometric Stereo Endoscopy (PSE) as a Tool for Imaging the Rectum and Colon

Study Overview
=================
Brief Summary
-----------------
The goal of this research is to assess photometric stereo endoscopy (PSE) as an endoscopic imaging technique. Specifically, topographical surface contrast reconstructed from the PSE data will be compared to conventional imaging contrast to assess if PSE provides enhanced contrast of abnormal tissue.

Official Title
-----------------
Pilot Study to Evaluate Photometric Stereo Endoscopy (PSE) as a Tool for Imaging the Rectum and Colon

Conditions
-----------------
Colonic Polyps

Intervention / Treatment
-----------------
* Device: PSE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing a routine colonoscopy screening Patients must be over the age of 18 Patients must be able to give informed consent Exclusion Criteria: Patients with bleeding/hemostasis disorders Patients that are pregnant Patients taking any anti-coagulants that would preclude them from undergoing a standard of care colonoscopy, such as Coumadin and Plavix, at the time of the study Patients with known colitis or active bleeding will be excluded

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PSE<br>Patients whose distal colon is imaged using the PSE device. This is a pilot trial of 30 patients. | Device: PSE<br> <br> * Other names: photometric stereo endoscopy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Image Contrast | Comparison of image contrast obtained using standard colonoscopy and PSE. | Immediate | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colonoscopy
The Absorption of Vitamin B12 Among Healthy Pregnant Women

Study Overview
=================
Brief Summary
-----------------
During pregnancy the woman uses more vitamin B12, but we do not know, whether it is through increased absorption or it eats into the womans vitamin B12 deposit . Sufficient B-vitamin is crucial for the normal development af foetus during pregnancy. In Denmark the National Board of Health recommend an intake of Folic Acid, from the day the woman wishes to be pregnant and to the 12. week of gestation, but there is no recommendation for vitamin B12. We will measure the vitamin B12 absorption with a new non-radioactive test, CobaSorb. .

Official Title
-----------------
The Absorption of Vitamin B12 Among Healthy Pregnant Women

Conditions
-----------------
Pregnancy

Intervention / Treatment
-----------------
* Dietary Supplement: B12 vitamin (Cyanocobalamin)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: the 13 week of gestation +/- 1 week (only fore pregnant women) Between 20- 40 years Northern European abel to read and understand danish Exclusion Criteria: treatment with vitamin B12 within the last 5 years daily intake of vitamins that contain more than 1µg vitamin B12 infectious disease systemic disease daily use of medicine that interferes with vitamin B12

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: A<br> | Dietary Supplement: B12 vitamin (Cyanocobalamin)<br>* Arm A: B12 vitamin (Cyanocobalamin)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in vitamin B12 absorption during pregnancy, measured with CobaSorb. |  | 9 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vitamin B12 absorption, Pregnancy