linjc16/ctgov huggingface dataset:
Nutritional Intervention Program in Malnourished Patients Admitted for Heart Failure

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether a modification of the diet of malnourished patients admitted for heart failure is beneficial in term of mortality,hospitalizations and quality of life.

Official Title
-----------------
Randomized Cotrolled Trial of Nutritional Intervention Program in Malnourished (Mini Nutritional Assessment < 17) Patients Admitted for Heart Failure

Conditions
-----------------
Heart Failure, Malnutrition, Nutritional Intervention, Mortality

Intervention / Treatment
-----------------
* Other: Nutritional intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients admitted for heart failure > 18 years old Malnutrition determined by MNA test (< 17 points) Exclusion Criteria: If is not possible to perform a nutritional assessment Planned PCI or CABG to correct heart failure etiology

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nutritional intervention<br>It will last 6 months. Will be conducted by a physician nutrition specialist assisted by a technician in diet and nutrition. The first visit will take place during admission. The patient receives dietary advice and a customized diet designed to optimize energy intake and macro/micro-nutrients needs. | Other: Nutritional intervention<br>* Modification of diet<br>|
| Placebo Comparator: Care as usual<br>The patients are referred to their cardiologyst and primary care physicians | Other: Nutritional intervention<br>* Modification of diet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality and heart failure hospitalizations |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  | 12 months |
A Comparison of the 15 and 30 Acquisition Angle Breast Tomosynthesis Mammography for Breast Abnormalities

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to conduct an initial investigation into whether an alternative method of using 3D imaging might offer accurate diagnostic performance at a reduced patient radiation exposure in comparison to conventional 2D screening and diagnostic mammography and conventional 2D + 3D imaging methods.

Official Title
-----------------
A Comparison of 15 and 30 Acquisition Angle Breast Tomosynthesis Mammography in the Visualization and Characterization of Breast Abnormalities

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

Intervention / Treatment
-----------------
* Device: 3D mammograpgy system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is female of any race and ethnicity Subject is at least 40 years old The screening and diagnostic mammograms were performed at the recruiting institution on a Hologic Selenia System Subject is categorized as BI-RADS 0 because if mass, density, or calcifications detected on the basis of screening or diagnostic mammography Subject will undergo study imaging within 30 days of standard of care imaging Exclusion Criteria: Patients who are pregnant or think they may be pregnant Patients who are breast feeding Subjects unable or unwilling to undergo informed consent Subjects with breast implants

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

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

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: 3D investigational imaging<br>patients returning with an area of interest will undergo 3D imaging in 2 modes of imaging to the breast of interest | Device: 3D mammograpgy system<br>* In addition to the standard care diagnostic imaging, all participants underwent two experimental acquisitions, in two projections (Cranio-Caudal and Mediolateral Oblique) on the breast of concern: one acquisition in Mode A (narrow angle acquisition) and one acquisition in Mode B (wide angle acquisition).<br>* Other names: Tomosynthesis;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| If the new imaging modes are successful, they will represent a method of reducing patient exposure for future imaging because they are designed to be used in 3D imaging only. |  | Fall 2010 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast cancer, Tomosynthesis, 3D Mammogram, Diagnostic mammogram
Derivation of An In-Hospital Cardiac Arrest Prediction Model for Patients in Intensive Care Unit

Study Overview
=================
Brief Summary
-----------------
Current studies have shown that hospitalized ICU patients have a high risk of IHCA, with an incidence of about 0.6-7.8%. Early prediction of the occurrence of IHCA in severe patients can provide early intervention, prevent the deterioration of the disease, and reduce the incidence of IHCA. Therefore, researchers wanted to verify the efficacy of MEWS, NEWS, and CART scores in predicting IHCA in ICU inpatients, and to establish an early-warning scoring model that could effectively predict the risk of IHCA occurrence in ICU inpatients during hospitalization.

Official Title
-----------------
Derivation of An In-Hospital Cardiac Arrest Prediction Model for Patients in Intensive Care Unit

Conditions
-----------------
In-Hospital Cardiac Arrest

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


Participation Criteria
=================
Eligibility Criteria
-----------------
CA group Inclusion Criteria: Occurrence of IHCA Hospital stay ≥48h. Exclusion Criteria: <14 years Do Not Resuscitat Patients hospitalized due to out-of-hospital cardiac arrest Cardiac arrest occurs during the operation The patients with implanted cardiac pacemaker suffered cardiac arrest due to instrument malfunction. CONTROL group Inclusion Criteria: Without IHCA Hospital stay ≥48h Exclusion Criteria: <14 years Leave hospital without medical advice

Ages Eligible for Study
-----------------
Minimum Age: 14 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 |
| --- | --- |
| CA group<br>Patients with In-Hospital Cardiac Arrest | Other: no intervention<br>* no intervention<br>|
| CONTROL group<br>Patients without In-Hospital Cardiac Arrest | Other: no intervention<br>* no intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-Hospital Cardiac Arrest | Cardiac arrest occurs during hospitalization | Day 2 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Critically ill patients, In-Hospital Cardiac Arrest, Early recognition, Early warning score
Growth Hormone For Poor Ovarian Reserve Patients in ICSI Trials

Study Overview
=================
Brief Summary
-----------------
Effect of Growth Hormone Adjuvant Therapy on ICSI Trials For Poor ovarian Reserve Patients

Detailed Description
-----------------
To study the effect of growth hormone as adjuvant treatment on the outcomes of ICSI trials in poor ovarian reserve patients.

Official Title
-----------------
Effect of Growth Hormone Adjuvant Therapy on ICSI Trials For Poor Ovarian Reserve Patients

Conditions
-----------------
Poor Ovarian Reserve

Intervention / Treatment
-----------------
* Drug: 4 IU of recombinant GH (Somatotropin )


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: According to Bologna criteria (((at least two )))of the following features must be present: Advanced maternal age (40years). A previous poor ovarian response with 3 oocytes retrieved after conventional stimulation An abnormal ovarian reserve test (ORT) antral follicle count (AFC)<7 or anti-Müllerian hormone (AMH)<1.1ng/ml. Exclusion Criteria: Any known contraindications to the approved fertility drugs. Any contraindications to growth hormone, pregnancy (to be ruled out and documented before GH treatment) 4- Hydrosalpinx 5- Uterine malformations or abnormal uterine cavity. 6- Basal FSH more than 17 IU. 7- Abnormal karyotyping 8- Partner with severe male factor 9- Uncontrolled endocrinopathies: DM, hyperthyroidism, hypothyroidism.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Growth Hormone adjuvant treatment<br>Growth hormone in this trial will use 4 IU of recombinant GH (Somatotropin, ) by day after day subcutaneous injection for 6 weeks before starting cycle. And on start day of induction ( Day 2 to 3) until the day of the human chorionic gonadotropin (hCG) trigger. | Drug: 4 IU of recombinant GH (Somatotropin )<br>* 4 IU of recombinant GH<br>* Other names: (Somatotropin );|
| No Intervention: control<br>standard controlled ovarian stimulation | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pregnancy rate | HCG positive | ICSI trial (1month) |
Molecular Analysis of 150 Lung Adenocarcinoma

Study Overview
=================
Brief Summary
-----------------
LUNG-EST is a retrospective study including 152 patients who benefit from lung surgery during the years 2012 to 2013 at Hospices civils de Lyon and with a diagnosis of lung adenocarcinomas. For all patients, clinical data and histopathological data are available. The objective of this study is to characterize these lung adenocarcinomas by the LungCarta Panel using the mass spectrometry array Sequenom. This panel could identify 214 DNA mutations and/or frameshift insert/deletion among 26 oncogenes. Once included in the study, the adenocarcinomas are also included in a Tissue MicroArray (TMA) in order to perform immunohistochemical analysis. Immunohistochemical staining with innovative antibodies are correlated with clinical, histopathological and molecular data. Our hypothesis is that this TMA could constitute a good tool to screen interesting protein's expression.

Official Title
-----------------
Molecular Analysis of 150 Lung Adenocarcinoma With Corresponding Histopathological and Clinical Data Available

Conditions
-----------------
Lung Adenocarcinoma

Intervention / Treatment
-----------------
* Genetic: Sequencing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults lung adenocarcinoma Surgical specimen Exclusion Criteria: not adenocarcinoma subtype of lung cancer Tumour biopsy insufficient material for DNA extraction

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| Adenocarcinoma<br>Tumour samples coming from patients harboring a lung adenocarcinoma diagnosed at the Hospices Civils de Lyon. Tumour samples are coming from lung surgery. | Genetic: Sequencing<br>* Tumour samples are coming from routine histopathological procedure. They are used with consent of the patients. Genomic DNA extraction is performed from paraffin-embedded formalin-fixed (FFPE) tumour samples of lung adenocarcinoma. The genomic DNA mutations are identified by mass spectrometry array (Sequenom) using the LungCarta Panel. This panel could identify 214 mutations among 26 oncogenes.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genomic DNA Mutation | Mutations identified by the LungCarta Panel (Sequenom) at the time of diagnosis. DNA was extracted from the lung surgical specimen. | at diagnosis (Day 0) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lungcarta Panel, lung adenocarcinoma
Assessment of Severity and Prognosis for Patients With Status Epileptics(SE)

Study Overview
=================
Brief Summary
-----------------
To characterize the functional outcomes and prognostic factors for convulsive status epilepticus (SE) and to further develop and validate a simple and practicable scoring system for outcome prediction.

Detailed Description
-----------------
Retrospectively study all patients with convulsive SE treated between March, 2008, and November, 2014. Develop a scoring system for outcome prediction. Prospectively validate the predictive accuracy of the scoring system

Official Title
-----------------
Assessment of Severity and Prognosis for Patients With Status Epileptics

Conditions
-----------------
Status Epileptics

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 30 min or more of (1) continuous clinical seizure activities or (2) recurrent seizure activities without recovery(returning to baseline)between seizures; clinical data is complete. Exclusion Criteria: hypoglycemia SE;psychogenic SE;any other pseudo-SE
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 modified Rankin scale |  | 3 months after discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The modified Rankin scale |  | on discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
status epileptics, prognosis, risk factor, outcome
Iatrogenic Withdrawal Symptoms in Severe Traumatic Brain Injury

Study Overview
=================
Brief Summary
-----------------
Iatrogenic withdrawal symptomes has been associated with prolonged mechanical ventilation and the and the derived symptoms such as fever and agitation has been shown to cause significantly prolonged ICU and hospital length of stay. The incidence of IWS in the adult general ICU ranges from 16,7-55%. To this date, the incidence of IWS has not been studied in patients with TBI.

Official Title
-----------------
Iatrogenic Withdrawal Symptoms in Severe Traumatic Brain Injury

Conditions
-----------------
Iatrogenic Withdrawal Symptomes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients suffering from severe TBI and were mechanical ventilated and received continuous infusions of opioids, benzodiazepines and neuromuscular blocking agents for 72ours or more Exclusion Criteria: age <18 years, patients who died before discharge, chronic alcohol abuse, regular use of heroin, cocaine and amphetamines, chronic use of opioids, patient that were primary admitted to other ICUs and patients that were moved to other ICUs with ongoing infusions.

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 |
| --- | --- | --- |
| proportion of patients with positive IWS diagnosis |  | 20-6-2019 |
Single Ascending Dose Study With 5-MeO-DMT in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The study will evaluate safety, tolerability and PK profile of 5-MeO-DMT in healthy subjects

Official Title
-----------------
A Double-Blind, Randomized, Phase 1, First-in-Human, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of Intranasal 5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT) in Healthy Subjects

Conditions
-----------------
Pharmacokinetics in Healthy Adults

Intervention / Treatment
-----------------
* Drug: 5-MeO-DMT
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: * Medically healthy based on medical records and study specific assessments Exclusion Criteria: * Presence or history of severe adverse reaction to any drug or drug excipient

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 55 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: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 5-MeO-DMT arm<br> | Drug: 5-MeO-DMT<br>* A single dose of 5-MeO-DMT will be administered intranasally<br>|
| Placebo Comparator: Placebo arm<br> | Other: Placebo<br>* A single dose of placebo will be administered intranasally<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects with treatment emergent AEs (TEAES) |  | From screening through to the follow up visit, up to 65 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak plasma concentration (Cmax) |  | Day 1 (dosing day) and Day 2 | 
| Time to reach Cmax (tmax) |  | Day 1 (dosing day) and Day 2 | 
| Area under the plasma concentration- time curve |  | Day 1 (dosing day) and Day 2 |
Depakote-ER for Depressive and Bipolar Depression

Study Overview
=================
Brief Summary
-----------------
Obtain information using a randomized treatment to assess the antidepressant and anxiolytic efficacy of divalproex vs. placebo for nonrefractory bipolar patients with major depressive episodes.

Detailed Description
-----------------
Study is 6 weeks long, with 7 clinical visits.

Official Title
-----------------
Phase 4 Study: Double-blind Placebo-controlled Trial of Depakote-ER for Depressive and Anxiety Symptoms in Non-refractory Bipolar Depression

Conditions
-----------------
Bipolar Disorder

Intervention / Treatment
-----------------
* Drug: Depakote-ER


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: DSM-IV diagnosis of bipolar disorder type I or II, non refractory, non-psychotic; females must be nonpregnant/nonlactating; sexually active females must use adequate contraception; MRS < 12; MADRS > 17; no other baseline mood stabilizing drugs, antidepressants or antipsychotics Exclusion Criteria: Active substance abuse or dependence in the past month; medically unstable condition; previously intolerance to valproate; past hepatitis B or C, or serious liver disease; serious suicidality

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Depakote-ER|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety and Depressive Symptom severity |  |  |
Appropriation and Impact of the Introduction of Naps During Night Work by Intensive Care Caregiver - One Year Review

Study Overview
=================
Brief Summary
-----------------
MARIENAIE study is a pilot study on the feasibility and appropriation of nocturnal naps by a team of paramedical caregivers alternating a 12-hour day/night work rhythm for a period of 1 year. To date no study on the impact of nap in ICU on a long period was published. This study will also explore : the factors favouring or hindering the implementation of this strategy and its maintenance over time through a concomitant sociological qualitative study, the evolution over time of the parameters of perceived nocturnal sleepiness and the immediate impact of the realization of naps on this sleepiness and the evolution over time of the medium-term impact with the help of questionnaires exploring various dimensions concerning the working conditions and health (somatic health, stress, psychosocial risks, evaluation of the working environment).

Official Title
-----------------
Appropriation and Impact of the Introduction of Naps During Night Work by Intensive Care Caregiver - One Year Review

Conditions
-----------------
Nap

Intervention / Treatment
-----------------
* Procedure: Nap


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Paramedic working 12 hours alternating day and night in the ICU department of the Vendee departmental hospital center. Exclusion Criteria: Pregnant woman. Caregiver with knowledge of a scheduled departure from the ICU within 2 months after the start of the project. Caregiver refusing to participate in the project.

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 20-min nap<br>ICU nurses can take a 20-minute nap between 2 and 5 am according to a rotation of personal. Naps will be carried out with the help of a Nap and Up ® cocoon deckchair. | Procedure: Nap<br>* ICU nurses can take a 20-mn nap between 2 and 5 am according to a rotation of personal. Naps will be carried out with the help of a Nap and Up ® cocoon deckchair.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nap appropriation | Proportion of the number of nights worked with micro-naps to the number of nights worked by a caregiver over a year. | 12 months after baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nap; ICU; nurse; Shift work