linjc16/ctgov huggingface dataset:
Study of Pancreatic Neuroendocrine Tumors and Carcinomas in Alsace Region

Study Overview
=================
Brief Summary
-----------------
Pancreatic Neuroendocrine tumors and carcinomas (pNET) see the last year their incidence and prevalence going up. On the basis of their grade of differentiation and proliferation ratio measured Ki67 staining, there are divided into 3 grade groups : Grade 1 with Ki67 between 1 and 3%, Grade 2 between 3 and 20% and well-differentiated neuroendocrine grade tumors 3 with KI67 greater than 20%, so undifferentiated carcinomas. pNET is a heterogenous group of tumors with variable prognosis. The aim of this study is to identify the prognostic factors in this population, as well the place of neutrophil-to-lymphocyte ratio as a prognostic marker. The primary endpoint is the description of clinic and pathological parameters of patients from Alsace. The secondary endpoints are the identification of prognostic factors in this population

Official Title
-----------------
Clinicopathological Assessment of Pancreatic Neuroendocrine Tumors and Carcinomas in Alsace Region

Conditions
-----------------
Pancreatic Neuroendocrine Tumor

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Major topic ((≥18 years) Subject with histologically confirmed pancreatic neuroendocrine tumor or carcinoma Subject with tumours or neuroendocrine carcinoma of the pancreas at any stage of the disease. Subject covered in one of the participating centres between 01/01/2008 and 01/01/2019 Have a pre-therapeutic biological check-up Subject who has not expressed opposition to the use of his or her data for research purposes Exclusion criteria: Subject who expressed opposition to participate in the study Lack of histological data Minor subject Patient under the protection of justice Subject under guardianship or trusteeship

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 |
| --- | --- | --- |
| The survival will be evaluated by Kaplan Meier Method. The prognostic factors will be evaluated with univariate and multivariate analysis by Cox regression model. |  | The participant will be followed-up for a maximum of 11 years, and 1 year at least. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pancreatic neuroendocrine tumors, Neutrophil-to-lymphocyte ratio
The Effect of Mild Traumatic Brain Injury on Recovery From Injury

Study Overview
=================
Brief Summary
-----------------
Mild traumatic brain injury (TBI) is a common injury that can produce significant functional sequelae and ongoing disabling symptoms. Predicting who will have an uncomplicated recovery and who will suffer ongoing symptoms is difficult. This protocol evaluates the use of neuropsychologic testing after mild TBI in injured patients to attempt to objectively establish predictors of long term disability and functional recovery.

Detailed Description
-----------------
Patients who are hospitalized and who have suffered mild TBI (loss of consciousness or post-traumatic amnesia; Glasgow Coma Score 13-15; admitted within 24 hours of injury; able to read, speak, and understand English) who do not have pre-injury dementia or significant cognitive impairment will undergo computerized neuropsychologic testing using a previously validated tool that has been effective in sports-related mild TBI. Sequential testing will be performed during recovery and patients who report disabling symptoms and/or functional impairment will be compared to patients who recover uneventfully. Goal is to identify those parameters that predict early who may suffer long term sequelae or functional impairment and therefore benefit from early cognitive rehabilitation. Secondary goals are to establish objective parameters for functional recovery after mild TBI.

Official Title
-----------------
The Effect of Mild Traumatic Brain Injury on Recovery From Injury

Conditions
-----------------
Traumatic Brain Injury, Trauma, Head Injury, Brain Concussion

Intervention / Treatment
-----------------
* Procedure: neuropsychologic testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mild TBI Admitted within 24 hours of injury Able to read, speak,and understand English Exclusion Criteria: Expected to die of their injuries Pre-existing dementia or significant cognitive impairment Neurologically impaired and incapable of completing testing Physically incapable of using arms/hands to complete computerized testing

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: neuropsychologic testing|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| functional outcome |  |  | 
| subjective symptoms |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
traumatic brain injury, head injury, concussion, neuropsychologic test
Intensive Care Unit (ICU) Diaries as a Therapeutic Intervention for Post Traumatic Stress Disorder (PTSD) Following Critical Illness

Study Overview
=================
Brief Summary
-----------------
The incidence of PTSD post ICU varies from unit to unit, however a significant number of patients have been shown to develop this disorder. Many patients do not recall their stay in ICU properly and yet can clearly recall nightmares, hallucinations or paranoid delusions, which may be very frightening for the patient to recall at a later stage. As yet, no interventional studies have had an impact on the development of PTSD in this population of patients. However, a recent observational multi-centre study suggested that those patients receiving a diary of their time in ICU had lower levels of symptoms of PTSD than those who did not. These results need to be verified in the form of a randomized study.

Official Title
-----------------
ICU Diaries as a Therapeutic Intervention for Post Traumatic Stress Disorder Following Critical Illness

Conditions
-----------------
Post-Traumatic Stress Disorder

Intervention / Treatment
-----------------
* Other: ICU Diary


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients staying on the ICU for at least 72 hours (with greater than 24 hours of artificial ventilation) Exclusion Criteria: ICU stay < 72 hours Too confused for informed consent Pre-existing psychotic illness

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Discussion with nurse<br>Brief discussion with ICU follow-up nurse about the patients' critical illness | |
| Experimental: ICU Diary<br>Receipt of ICU Diary at 1 month post critical illness | Other: ICU Diary<br>* ICU Diary containing daily information of patients condition and treatment with appropriate photographs<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis of Post Traumatic Stress Disorder |  | 3 months post critical illness | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Critical illness, ICU Diaries, Post Traumatic Stress Disorder, Incidence
Screening for Occult Malignancy in Idiopathic Venous Thromboembolism

Study Overview
=================
Brief Summary
-----------------
Prospective controlled randomized study. Aim of this study is to assess the feasibility and sensitivity of CT scanning of the thorax, abdomen and pelvis for the detection of occult cancer in patients with idiopathic venous thromboembolism. Patients presenting with acute idiopathic venous thromboembolism, free from already known cancer and in whom a routine battery screening has excluded the presence of cancer, are randomized to receive either a CT scanning of the thorax, abdomen and pelvis (completed by mammography if not already performed in the past year, and by gastroscopy and/or colonoscopy in patients with positive hemoccult) or a diagnostic programme freely decided by attending physicians. Patients of either group in whom the search for cancer is negative are followed-up for two years to register the development of clinically symptomatic malignant disease. The rate of cancer detection and that of cancer development are compared between the two study groups.

Conditions
-----------------
Venous Thromboembolism

Intervention / Treatment
-----------------
* Procedure: Diagnostic screening for occult malignancy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: idiopathic venous thromboembolism Exclusion Criteria: cancer already known or shown by routine battery tests previous venous thromboembolism geographic inaccessibility for long-term follow-up allergy to contrast medium refusal of informed consensus

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Diagnostic screening for occult malignancy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Association of PICP Serum Marker in Patients With LVSD

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if the carboxy-terminal of procollagen type I (PICP) can be a useful marker of different degrees of myocardial fibrosis.

Detailed Description
-----------------
Abnormality of diastolic function, particularly a more advanced form known as restrictive tilling pattern, has been correlated with worse outcome in patients with systolic dysfunction associated with chronic heart failure or following an acute myocardial infarction. Recently, the severity of diastolic dysfunction has also been shown to predict the response to cardiac synchronization therapy for refractory heart failure due to systolic dysfunction. Varying degree of diastolic dysfunction has been reported among patients with comparable severity of systolic dysfunction. The underlying mechanisms responsible for the observed discordance between systolic and diastolic dysfunction in these patients remains incompletely understood. The carboxy-terminal of procollagen type I (PICP), a peptide that is cleaved from procollagen type I during the synthesis of fibril-forming collagen type I, has been associated with myocardial fibrosis. Myocardial fibrosis is a major determinant of both systolic and diastolic function of the heart. We hypothesize that differential degrees of myocardial fibrosis may be responsible for these discrepancies.

Official Title
-----------------
Phase 1 Study of PICP Serum Marker of Myocardial Fibrosis and Diastolic Function in Patients With Systolic Dysfunction

Conditions
-----------------
Systolic Dysfunction

Intervention / Treatment
-----------------
* Procedure: Blood draw


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Evidence of left ventricular systolic dysfunction (measured LVEF% less than 35%) measured by echocardiography within the previous three months at the time of enrollment Greater than or equal to 18 years of age Greater than or equal to 110 pounds in weight Exclusion Criteria: 1.Non-sinus rhythm at the time of enrollment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Blood draw|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| There will be a significant relationship between the severity of diastolic dysfunction and PICP |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ejection Fraction <35%
Effect of Bariatric Surgery on Gut Hormones Production and Cure of Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
Type 2 diabetes mellitus (T2DM) is a relevant public health problem and obesity has been associated as the major risk factor. Roux-en-Y gastric bypass is an effective method to treat severe obesity, and its metabolic benefits can lead to early and complete remission of T2DM, even before a considerable weight loss. We have hypothesized that intestinal anatomic changes may change intestinal genes expression related to glycemic control. The knowledge of mechanisms mediating the glycemic control after Roux-en-Y gastric bypass and it site of action in bowel may eventually help to develop alternative, less invasive and safer surgery for the treatment of T2DM, as well as drug development for the newly targets identified.

Official Title
-----------------
Changes in Gene Expression of Intestinal Tissue From Type 2 Diabetes Patients Submitted to Roux-en-Y Gastric Bypass

Conditions
-----------------
Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes mellitus (T2DM) diagnosis Duration of T2DM >5 years Use of oral antidiabetic agents Body Mass Index >40 kg/m2 Candidates to Roux-en-Y gastric bypass Exclusion Criteria: Type 1 diabetes mellitus or non-diabetics Use of insulin Thyroid diseases Candidate to other surgery technique Body Mass Index <40 kg/m2 Presence of bacterium H. Pylori

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- | --- |
| Patient Selection | 10 patients fully completed with all biological samples colected in the preoperative and postoperative periods (gastrointestinal tissue). RNA extraction of gastrointestinal samples is being performed. | 2013 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 diabetes mellitus, Y-Roux gastric bypass, Gut hormones, Gene expression, Surgery
The Feasibility Study of Dual-Section Nasogastric Tube

Study Overview
=================
Brief Summary
-----------------
The purpose of this studyis to assess the feasibility and safety of novel designed two-piece nasogastric tube.

Official Title
-----------------
The Feasibility Study of Dual-Section Nasogastric Tube in Dysphagia Patients

Conditions
-----------------
Stroke, Mouth Neoplasms

Intervention / Treatment
-----------------
* Device: two-piece nasogastric tube


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: dysphagia mouth neoplasms stroke already use conventional nasogastric tube for at least 2 weeks Exclusion Criteria: unconsciousness patient unstable medical condition with needs of closely medical care unable to fill in inform consent the fixed length was less than 50 or more than 60 centimeter when using conventional nasogastric tube

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: two-piece nasogastric tube|one week period|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events | monitor the adverse events like pressure sore, numbers of self-extubation, dislocation of tube, or other unpredictable events. | participants will be followed for the duration of hospital stay, an expected average of 1 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| satisfaction of Dual-Section Nasogastric Tube | using Likert scale for overall satisfaction | participants will be followed for the duration of hospital stay, an expected average of 1 weeks |
Early Exposure to OMT Prevents Long LOS

Study Overview
=================
Brief Summary
-----------------
The application of osteopathic manipulative treatment (OMT) in preterm infants has been demonstrated to be effective in reducing length of stay (LOS). The scope of the present study is to investigate the association between earlier exposure to OMT and reduction of LOS in premature infants

Conditions
-----------------
Prematurity

Intervention / Treatment
-----------------
* Other: osteopathic manipulative treatment
* Other: Usual care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: preterm infants born at age between 29 and 37 weeks osteopathic treatment performed < 14 days after birth preterms born in the same hospital Exclusion Criteria: Gestational age < 29 weeks Gestational age > 37 weeks First OMT performed after 14 days from birth genetic disorders congenital disorders cardiovascular abnormalities proven or suspected necrotized enterocolitis with or without gastrointestinal perforation proven or suspected abdominal obstruction pre/post surgery patients pneumoperitoneum atelectasis Newborn from an HIV seropositive/drug addicted mother respiratory disorders transferred to/from other hospital admitted for preterminal comfort care (defined as neither intubation nor cardio-respiratory resuscitation)

Ages Eligible for Study
-----------------
Minimum Age: 32 Weeks
Maximum Age: 37 Weeks

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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: control<br>patients under standard medical care | Other: Usual care<br>* Patients from control group received standard care plus osteopathic evaluation only, according to the same schedule as the study group.<br>|
| Experimental: OMT<br>patients under usual medical care plus osteopathic treatment | Other: osteopathic manipulative treatment<br>* Patients from this group received osteopathic treatments twice a week for the entire length of stay in the unit.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days of LOS |  | participants will be followed for the duration of hospital stay, an expected average of 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effectiveness of OMT considering different lag time between birth and the first OMT |  | participants will be followed for the duration of hospital stay, an expected average of 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteopathic manipulative treatment, neonatology, neonatal care, prematurity, complementary and alternative medicine, length of stay
Inter-observer and Intra-observer Variability of the Wrinkle Test

Study Overview
=================
Brief Summary
-----------------
Skin wrinkling of the fingers following immersion in warm water depends on intact sympathetic innervation. It is abolished by lesions affecting both central and peripheral sympathetic pathways. It affords a simple and reliable clinical test of sympathetic function.

Detailed Description
-----------------
Fingertip skin wrinkling after prolonged immersion in water is a well-recognized phenomenon, whereas a denervated digit does not exhibit normal skin wrinkling while a finger with a regenerated or repaired nerve shows at least partial reappearance of wrinkling. This is the basis for the bedside immersion-wrinkling test of autonomic digital nerve function. The exact mechanism of fingertip skin wrinkling is still subject to controversy. the purpose of this study is to examine the Inter-observer and Intra-observer Variability of the Wrinkle Test.

Official Title
-----------------
Inter-observer and Intra-observer Variability of the Wrinkle Test and the Optimum Time Need for the Test. Pilot Study

Conditions
-----------------
Wrinkle Test

Intervention / Treatment
-----------------
* Diagnostic Test: wrinkle test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients after suture of full cut of digital nerve Exclusion Criteria: other nerve injury

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 100 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 |
| --- | --- |
| finger after digital nerve cut<br> | Diagnostic Test: wrinkle test<br>* soaking in 40 deg water for 40 min. every 10 min the hand will be photo<br>|
| healthy finger<br> | Diagnostic Test: wrinkle test<br>* soaking in 40 deg water for 40 min. every 10 min the hand will be photo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| wrinkle test | wrinkle of the skin in the finger compaared to the finger witout digital nerve injury | 40 min |