linjc16/ctgov huggingface dataset:
Comparison Between Non-invasive Heat-flux and Invasive Core Temperature Monitoring

Study Overview
=================
Brief Summary
-----------------
The body core temperature drops during general anesthesia. To maintain homeostasis, patients require warming measures. Different methods to measure body core temperature exist, which are either highly accurate but invasive, or non-invasive but non-accurate. A new monitoring device, Tcore(TM), enables a non-invasive but accurate core temperature assessment. This study is performed to quantify accuracy and bias of the Tcore system in comparison with the blood temperature, which is the gold standard of core temperature measurement.

Official Title
-----------------
Comparison Between Tcore(TM) Temperature Monitoring System and Invasive Blood Temperature Measurements

Conditions
-----------------
Body Temperature Changes

Intervention / Treatment
-----------------
* Device: Tcore


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with invasive femoral artery temperature monitoring Exclusion Criteria: Pregnancy

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

| Intervention/Treatment |
| --- |
|Device: Tcore|Monitoring system to measure body temperature based on heat-flux technology|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bias of heat-flux temperature monitoring [%] | Over the time course of surgery, the body core temperature is actually measured in the bloodstream (Tbl) and estimated by the heat-flux thermometer (Thf). The bias or median prediction error (MPE) is calculated as median of PE, which is (Tbl-Thf)/Tbl. | from insertion of thermometers to end of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inaccuracy of heat-flux temperature monitoring [%] | Over the time course of surgery, the body core temperature is actually measured in the bloodstream (Tbl) and estimated by the heat-flux thermometer (Thf). The inaccuracy or median absolute prediction error (MAPE) is calculated as median of abs(PE), which is (Tbl-Thf)/Tbl. | from insertion of thermometers to end of surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
body core temperature
An Observational Study of Patients' Perception of Treatment With Erythropoiesis-Stimulating Agents in Patients With Chronic Kidney Disease Not on Dialysis (PERCEPOLIS)

Study Overview
=================
Brief Summary
-----------------
This observational study will evaluate patients' perception of treatment with erythropoiesis-stimulating agents in patients with chronic kidney disease not on dialysis. Eligible patients initiated on treatment with Mircera (methoxy polyethylene glycol-epoetin beta) will be followed for 6 months.

Conditions
-----------------
Anemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, >/= 18 years of age Patients with chronic kidney disease not on dialysis (with or without previous renal transplantation) Treated or not with ESA at time of visit Patients for whom the treating physician had decided to initiate Mircera for medical reasons before the commencement of the study Initiation of treatment with Mircera at the inclusion visit Accepting and able of completing the ESA preference questionnaire Exclusion Criteria: Participation in a clinical trial on anemia Treatment with Mircera during the 3 months before inclusion Dialysis planned in the next 6 months

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 |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative importance for patients of different attributes of ESA treatment, assessed by Choice Based Conjoint questionnaire at baseline and Month 6 |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biological parameters: hemoglobin concentration at each observation time point. |  | 6 months | 
| Adherence to Mircera treatment assessed by a questionnaire adapted from the Morisky scale at baseline and at Month 6 |  | 6 months | 
| Dose/schedule of Mircera treatment at each observation timepoint |  | 6 months | 
| Concomitant medication/treatments in the management of anemia |  | 6 months | 
| Proportion of patients with a hemoglobin level between 10 and 12 g/dL after 6 months of treatment with Mircera |  | Month 6 | 
| Change in hemoglobin level |  | from baseline to Month 6 | 
| Safety: Incidence of adverse events |  | 6 months |
MONOCENTRIC PERSPECTIVE STUDY: USE OF LIQUID BIOPSY WITH DIAGNOSTIC IMAGING

Study Overview
=================
Brief Summary
-----------------
Evaluation of the diagnostic accuracy of Mammography in the morpho-structural analysis of mammographic images in breast cancer-diagnosed patients or patients in follow-up for breast cancer by extracting a number of features describing the texture and morphology of the lesions reported in the form of a structured report explicitly developed for the study. Correlation of the data obtained from evaluating the primary endpoint with the genetic/molecular analysis on liquid biopsy.

Official Title
-----------------
PERSPECTIVE MONOCENTRIC STUDY: USE OF LIQUID BIOPSY AND DIAGNOSTIC IMAGING IN THE SEARCH FOR CIRCULATING TUMOR DNA IN PATIENTS WITH BREAST CANCER

Conditions
-----------------
Breast Cancer, Liquid Biopsy

Intervention / Treatment
-----------------
* Diagnostic Test: Liquid Biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: full information on the study and signature of the informed consent biopsy-proven breast cancer or previous surgery for breast cancer willingness of the patient to undergo liquid biopsy Exclusion Criteria: state of pregnancy or breastfeeding patients operated on for benign or inflammatory diseases

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Liquid Biopsy|Venous blood sampling for liquid biopsy in breast cancer patients after segmentation of the lesion on mammography|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiomic of breast cancers and liquid biopsy | Detect possible relationships between breast cancers radiomic feature and genetic mutations on liquid biopsy | 36 months |
Clinical Evaluation of the Efficacity of Epilepsy Surgery in Infants and Children

Study Overview
=================
Brief Summary
-----------------
The Pediatric Neurosurgery Service of the Rothschild Foundation (Paris) is the French leader center for surgery of epilepsy in infants and children. Postoperative follow-up of these children is performed during medical and neurosurgical consultations in order to assess the frequency of attacks and to reduce medication. On average, two postoperative consultations are carried out between 3 and 5 months and between 12 and 18 months. Beyond 18 months, some children may benefit from long-term monitoring at this center, but most children are followed by their neurologist . Therefore, the center has no rigorous and systematic collection of standardized data on the outcome of these patients. The purpose of this study is to evaluate the efficacy of the epilepsy surgery in children with a monitoring of 3 years.

Official Title
-----------------
Clinical Evaluation of the Efficacity of Epilepsy Surgery in Infants and Children

Conditions
-----------------
Epilepsy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Child treated surgically for epilepsy at the Rothschild Foundation (Paris, France) Exclusion Criteria: Parental opposition to the participation of their child to the study

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- | --- |
| Number of seizures |  | Three years |
Masked Comparison of a New PEG Based Artificial Tear and Optive for Comfort, Vision & Wear Time in Patients Wearing Contact Lenses

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the effect of a new PEG based artificial tear as compared to Optive on comfort, wear time, and vision in patients wearing contact lenses.

Official Title
-----------------
Phase 4 Masked Comparison of a New PEG Based Artificial Tear and Optive for Comfort, Vision & Wear Time in Patients Wearing Contact Lenses

Conditions
-----------------
Comfort, Vision and Wear Time

Intervention / Treatment
-----------------
* Drug: New PEG based artificial tear
* Drug: Optive


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Use of soft contact lenses (e.g. silicone hydrogel lenses, daily disposables etc.) and multipurpose solution for cleaning, including enzyme-based cleaners (ClearCare etc.) Able to wear contact lenses for approximately 10-12 hours/day Willingness to complete entire length of trial and comply with subjective questionnaire. Exclusion Criteria: Patients taking topical cyclosporine (Restasis) Patients currently using Optive for dryness relief. Patients wearing hard or rigid gas permeable lenses Patients with uncontrolled systemic disease which may confound the results of the trial.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1.<br> | Drug: New PEG based artificial tear<br>* 1, 2, (in the eye) Instill one drop in the left eye or right eye four times daily (can be used more frequently if needed)<br>|
| Placebo Comparator: 2.<br> | Drug: Optive<br>* 1, 2, (in the eye) Instill one drop in the left eye or right eye four times daily (can be used more frequently if needed)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vision and wear time |  | 1 month |
Three-dimensional Analysis of EMMPRIN on Conjunctival Epithelial Cells Surface in Severe Dry Eye Syndrome (ALTESSE)

Study Overview
=================
Brief Summary
-----------------
Modifications of cell surface markers (including EMMPRIN) were observed in conjunctival epithelial cells during dry eye syndrome ; this study aims to describe the modifications of the repartition of these cell surface markers before and after initiation of a treatment.

Official Title
-----------------
Three-dimensional Analysis of EMMPRIN on Conjunctival Epithelial Cells Surface in Severe Dry Eye Syndrome (ALTESSE)

Conditions
-----------------
Conjunctival Diseases, Dry Eye Syndromes

Participation Criteria
=================
Eligibility Criteria
-----------------
Patients: Inclusion criteria 18 years and over Severe eye dryness (grade 3 or 4) as defined by the International Dry Eye Work Shop (2007): Frequent symptoms, Impregnation of fluorescein at the conjunctival level, marked fluorescein staining at the corneal level, Tear Break Up Time ≤ 5 seconds (fluorescein test) Schirmer's test score without anesthesia ≤ 5mm at 5 minutes Exclusion criteria Treatment with topical ciclosporin Autologous serum treatment Wearer of scleral lenses Known pregnancy or breastfeeding Control subjects: Inclusion criteria 18 years and over Tear Break Up Time > 5 seconds (fluorescein test) Exclusion criteria Wearer of contact lenses Functional ocular signs Anomalies of the ocular surface observed during examination with the slit lamp Fluorescein staining of the ocular surface (cornea, conjunctiva) Topical ocular treatment Known pregnancy or breastfeeding

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 |
| --- | --- |
| Severe eye dryness<br> | |
| absence of eye dryness<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparison of surface area of cell markers measured on conjunctival epithelial cells, in persons with and without severe eye dryness. | Comparison of the mean surface in patients before treatment for eye dryness versus in persons with no eye dryness. Immunofluorescence analysed in confocal microscopy on conjunctival impression cytology. | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Conjunctival Diseases, Dry Eye Syndromes, Antigens, CD147
Continuous Pre-peritoneal Wound Infiltration Versus Epidural Analgesia in Cancer Surgery

Study Overview
=================
Brief Summary
-----------------
the investigators aim is to investigate the effect of continuous preperitoneal bupivacaine wound infiltration versus epidural analgesia on the inflammatory cytokines response following radical cytectomy

Official Title
-----------------
Effect of Continuous Pre-peritoneal Wound Infiltration Versus Epidural Analgesia on Inflammatory Response and Pain Following Radical Cytsectomy

Conditions
-----------------
Abdominal Neoplasms

Intervention / Treatment
-----------------
* Device: epidural catheter
* Device: preperitoneal catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I-III patients aged 18-60 yr undergo open abdominal cancer surgery Exclusion Criteria: general contraindications for epidural analgesia, recent history (8 weeks) of, chemotherapy or radiation, chronic opioid use

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: epidural group<br>an epidural catheter will be inserted under sterile conditions through the T9- 12 interspace using the 'loss-of-resistance' technique. The catheter will be advanced 4 cm cephalad. . | Device: epidural catheter<br> <br> * Other names: PEA block;|
| Active Comparator: preperitoneal group<br>preperitoneal catheters will be placed in the subfascial (ie, pre-peritoneal) space under direct vision. | Device: preperitoneal catheter<br> <br> * Other names: preperitoneal infusion;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in the level of inflammatory cytokines in pg /ml | Blood samples taken all over the 24-hr. period were collected in plasma tubes containing ethyl-enediamine-tetra-acectic (EDTA), centrifuged and stored at 20○c for assessment of Plasma concentrations plasma IL 1, IL 6, IL10 and TNF to assess inflammatory cytokines | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale at rest and on coughing | pain intensity was assessed using a 10-cm VAS (0 = no pain and 10 = worst imaginable pain) | 24 hours | 
| opioid side-effects | observation of side effects and record incidence as nausea, vomiting and itching | 24 hours | 
| patient satisfaction | scale ranging 1-4 :unsatisfactory, regular, satisfactory and excellent) | 24 hours |
A 10-Week Efficacy and Safety Study for of Gabitril in the Treatment of Adults With Generalized Anxiety Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of an investigational anti-anxiety medication relative to placebo in patients with generalized anxiety disorder (GAD)

Official Title
-----------------
A 10-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Flexible-Dosage Study to Evaluate the Efficacy and Safety of Gabitril (up to 16 mg/Day) in the Treatment of Adults With Generalized Anxiety Disorder

Conditions
-----------------
Generalized Anxiety Disorder

Intervention / Treatment
-----------------
* Drug: Gabitril


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects 18 to 64 years of age (inclusive) will be eligible to participate if they satisfy the DSM-IV-TR criteria for GAD, as well as meeting the required screening and baseline visit scores for a series of psychiatric evaluations (i.e., HAM-A, HADS, MADRS and CGI-S). Exclusion Criteria: Have been previously unresponsive to two or more adequate courses of pharmacological treatment for GAD Have been diagnosed with any other psychiatric Axis I disorder (except GAD) as a principal diagnosis within the past six months Have been diagnosed with any eating disorder within the past six months Have any history of OCD, psychotic disorder, bipolar disorder or antisocial personality disorder Have any history of alcohol or substance abuse within the past 3 months Have any history of seizures, including febrile seizures Have any history of head trauma associated with loss of consciousness within the past 15 years

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 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: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of symptomatology associated with Generalized Anxiety Disorder as assessed by the change from baseline to endpoint in the total score of the HAM-A scale. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of proportion of responders and |  |  | 
| patients in remission according to HAM-A scores and CGI ratings by |  |  | 
| visit, assessment of the safety and tolerability in patients with GAD |  |  |
Phase 2 Study of NGM282 in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety, tolerability, and activity of NGM282 in patients with Type 2 Diabetes.

Official Title
-----------------
A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multiple Center Study to Evaluate the Safety, Tolerability, and Activity of NGM282 Administered for 28 Days to Patients With Type 2 Diabetes Mellitus

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Biological: NGM282
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females, between 18 and 70 years of age, inclusive BMI range of 24-40 kg/m2, inclusive No active coronary artery disease Resting heart rate in the range of 40-100 bpm Exclusion Criteria: Diagnosis of Type 1 diabetes History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NGM282 Dose 1<br>NGM Dose 1 | Biological: NGM282<br> <br> |
| Experimental: NGM282 Dose 2<br>NGM Dose 2 | Biological: NGM282<br> <br> |
| Experimental: NGM282 Dose 3<br>NGM Dose 3 | Biological: NGM282<br> <br> |
| Placebo Comparator: Placebo<br>Placebo | Other: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting Plasma Glucose |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | 28 days | 
| Lipids |  | 28 days |