linjc16/ctgov huggingface dataset:
A Study Of Valsartan Used To Treat Hypertension For Up To 56 Weeks In Children Ages 1 - 5 Years Who Have Hypertension

Study Overview
=================
Brief Summary
-----------------
Drugs used to treat hypertension in adults should also be effective in treating high blood pressure in infants and children. This study will test the safety and efficacy of valsartan in lowering blood pressure in children 1 - 5 years old whose parents grant permission to participate.

Official Title
-----------------
A Double-Blind, Randomized, Multi-Center Study Followed By 12 Months Open-Label Treatment To Evaluate The Dose Response And Safety Of Valsartan In Pediatric Hypertension Patients 1 - 5 Years Of Age

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

Intervention / Treatment
-----------------
* Drug: valsartan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CHILDREN HAVE BLOOD PRESSURE LEVEL =>95TH PERCENTILE FOR AGE,GENDER & HEIGHT PARENTAL CONSENT MUST BE GRANTED Exclusion Criteria: BLOOD PESSURE IS =>25% HIGHER THAN 95TH PERCENTILE FOR AGE, GENDER & HEIGHT SERIOUS, CLINICALLY SIGNIFICANT FINDINGS UPON EXAMINATION AND LABORATORY OR OTHER ASSESSMENTS Other protocol-defined exclusion criteria will apply.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 5 Years

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

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: valsartan|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline systolic blood pressure after 2 and 4 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline systolic blood pressure after 4 weeks |  |  | 
| Change from baseline diastolic blood pressure after 2 weeks |  |  | 
| Change in 2 week diastolic blood pressure after 2 more weeks |  |  | 
| Change in baseline diastolic blood pressure after 4 weeks |  |  | 
| Adverse events, serious adverse events, and laboratory values during 4 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PEDIATRIC HYPERTENSION, PEDIATRIC, VALSARTAN
Effect of Early Enteral Tube Feeding Nutrition With an Immune Enhancing Diet in Severe Burn Patients

Study Overview
=================
Brief Summary
-----------------
Compare clinical and biological effects of two enteral tube feeding nutrition formula (immune enhancing diet versus polymeric diet)in severe burn hospitalized patients .

Official Title
-----------------
Effect of Early Enteral Tube Feeding Nutrition With an Immune Enhancing Diet in Severe Burn Patients

Conditions
-----------------
Infections on, Severe Burn Patients

Intervention / Treatment
-----------------
* Dietary Supplement: Crucial
* Dietary Supplement: Sondalis HP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Thermic burn from 20% to 80% 15 < age < 70 years written informed consent Exclusion Criteria: diabetes mellitus corticoid or immuno-suppressive therapy HIV evolutive cancers pregnancy abdominal lesion hepatic or renal failure

Ages Eligible for Study
-----------------
Minimum Age: 15 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I<br>Total enteral tube feeding | Dietary Supplement: Crucial<br>* Treatment between minimum 14 days and maximum 6 months. Apports depend on method of CURRERI.<br>|
| Active Comparator: II<br>Total enteral tube feeding | Dietary Supplement: Sondalis HP<br>* Treatment between minimum 14 days and maximum 6 months. Apports depend on method of CURRERI.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of infections and number of multiple organ failure |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| digestive tolerance and healing |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
infections
CRD007 for the Treatment of Duchenne Muscular Dystrophy, Becker Muscular Dystrophy and Symptomatic Carriers

Study Overview
=================
Brief Summary
-----------------
This is an investigation of the efficacy and safety of CRD007 in Duchenne Muscular Dystrophy (DMD), Becker Muscular Dystrophy (BMD) and symptomatic carriers.

Official Title
-----------------
An Open-label, Un-controlled, Single-centre Trial Investigating the Efficacy and Safety of CRD007 in Children With Duchenne Muscular Dystrophy (DMD) or Becker Muscular Dystrophy (BMD) or Children Being Symptomatic Carriers for DMD or BMD

Conditions
-----------------
Duchenne Muscular Dystrophy, Becker Muscular Dystrophy

Intervention / Treatment
-----------------
* Drug: CRD007


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented diagnosis of dystrophinopathy Exclusion Criteria: Severe functional impairment

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 11 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CRD007 10 mg tablet<br> | Drug: CRD007<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DMD, BMD, symptomatic carriers
Oral Alfacalcidol and Coronary Artery Calcification in Predialysis Chronic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
Active vitamin D at therapeutic dose may prevent vascular calcification but in supraphysiologic dose may precipitate it.

Detailed Description
-----------------
Active vitamin D compound is used frequently in the treatment of hyperparathyroidism in chronic kidney disease. Recent evidence from animal studies suggested that low dose of active vitamin D may be protective against vascular calcification, whereas high dose could precipitate it. The present study will examine the effect of low dose oral alfacalcidol on coronary artery calcification in predialysis chronic kidney disease patients with hyperparathyroidism.

Official Title
-----------------
Randomized Control Trial of Oral Alfacalcidol and Coronary Artery Calcification in Predialysis Chronic Kidney Disease

Conditions
-----------------
Vascular Calcification

Intervention / Treatment
-----------------
* Drug: oral alfacalcidol
* Drug: no drug


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Predialysis chronic kidney disease with GFR < 90 mL/min/1.73m2 PTH above the upper limit of normal serum calcium and phosphate below the upper limit of normal Exclusion Criteria: changes in GFR>15% during the past 3 months receive elemental calcium>500 mg/day currently taking active vitamin D, oral calcium with elemental calcium>500 mg/day or bisphosphonate

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 |
| --- | --- |
| Experimental: Treatment<br>oral alfacalcidol | Drug: oral alfacalcidol<br>* Oral alfacalcidol 0.5 microgram per day<br>|
| No Intervention: Control<br>No drug | Drug: no drug<br>* no drug<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Coronary Artery Calcification |  | 6 months and 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
coronary calcification, vascular calcification, active vitamin D, alfacalcidol
HLA Sensitization in Severely Burned Patients

Study Overview
=================
Brief Summary
-----------------
Primary goal of this study is the analysis of HLA (Human leucocyte antigen) formation in severly burned patients. Potential HLA triggers in the treatment of severely burned patients are blood products, assist devices or temporary allogeneic skin. Besides that, inflammatory markers, such as WBC (white blood cell count), CRP (C-reactive protein), PCT (Procalcitonin) and two novel biomarkers (PSP (pancreatic stone protein), ST2) are to be investigated in severely burned patients.

Official Title
-----------------
HLA Sensitization in Severely Burned Patients

Conditions
-----------------
Severely Burned Patients

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: severely burned patients in need for hospitalization Exclusion Criteria: hematologic diseases Cancer

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 |
| --- | --- | --- |
| HLA antibody formation (HLA Sensitization) (Unit: PRA in %) | The degree of sensitization is reported as the percentage of CDC (Complement dependent Cytotoxicity) Panel Reactive Antibody (PRA). Unit is %. | Change from Baseline (admission) in HLA antibody count at 2 weeks, 4 weeks, 3 months and 6 months |
Safety and Efficacy Study of Vitrase for Clearance of Severe Vitreous Hemorrhage

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if intravitreal injection of Vitrase (ovine hyaluronidase) clears vitreous hemorrhage

Official Title
-----------------
Phase III Safety and Efficacy Study of Vitrase (Ovine Hyaluronidase) for Ophthalmic Intravitreal Injection for Clearance of Severe Vitreous Hemorrhage

Conditions
-----------------
Vitreous Hemorrhage, Diabetic Retinopathy

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: Vitrase
* Drug: Vitrase


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Severe vitreous hemorrhage that obscures visualization of the fundus on indirect ophthalmoscopy, that has been present >/= 1 month by history or exam BCVA is worse than 20/200 at time of screening Exclusion Criteria: Corneal or lenticular abnormalities that preclude fundus observation Ongoing ocular infection, inflammation or history of herpetic corneal lesion Current or prior retinal detachment or retinal tears or breaks or intraocular tumor More than 1 severe vitreous hemorrhage within 6 months Previous vitrectomy for any reason Hemorrhage is exclusively pre-retinal, or old & organized Prior Vitrase for intravitreal injection in either eye No light perception in either eye at any time Known contraindications to study medication Sickle cell disease

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitrase<br>Single Hyaluronidase ophthalmic intravitreal injection | Drug: Vitrase<br>* Hyaluronidase 55 IU in saline solution<br>* Other names: Hyaluronidase;Drug: Vitrase<br>* Hyaluronidase 75 IU in saline solution<br>* Other names: Hyaluronidase;|
| Placebo Comparator: Placebo<br>Single Saline solution intravitreal injection | Drug: Placebo<br> <br> * Other names: Saline solution;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vitreous hemorrhage resolution | laser treatment of underlying cause of vitreous hemorrhage, or other surgical treatment, or documented evidence of macula & at least 180 degrees of vitreous base, that vitreous hemorrhage cause is resolved | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events |  | 12 months | 
| Visual Acuity |  | 3 months, 6 months and 12 months |
Neural Circuits for Action Perception

Study Overview
=================
Brief Summary
-----------------
Study the mechanisms underlying action recognition and execution

Detailed Description
-----------------
Subjects will participate in a task where they have to either Perform a movement Observe an actor performing a movement There are three types of actions including different kinematics and grip types The goal is to compare the neural circuits activated by action execution versus action observation.

Official Title
-----------------
Neural Circuits for Action Perception

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

Intervention / Treatment
-----------------
* Behavioral: Mechanisms of action perception and execution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with pharmacologically intractable epilepsy Exclusion Criteria: Any situation that may put the patient at risk

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Mechanisms of action perception and execution|Study the mechanisms of action perception and execution|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Selectivity for kinematics and movement type in neurophysiological responses | Measure intracranial field potentials (in microvolts) in the gamma frequency band through neurophysiological responses comparing neural responses during action perception versus execution. We will assess selectivity for kinematics for each movement type | Through study completion, an average of 2 years. | 
| Evoked responses by action execution | Measure intracranial field potentials (in microvolts) in the gamma frequency band through neurophysiological responses comparing neural responses during action perception versus execution. We will quantify responses evoked by action execution | Through study completion, an average of 2 years. | 
| Evoked responses by action observation | Measure intracranial field potentials (in microvolts) in the gamma frequency band through neurophysiological responses comparing neural responses during action perception versus execution. We will quantify responses evoked by action observation | Through study completion, an average of 2 years. |
Pelvic Sentinel Node Detection Using Indocyanine Green Learning Curve

Study Overview
=================
Brief Summary
-----------------
According to ESGO-ESTRO-ESMO guidelines, pelvic Sentinel lymph node detection is suitable for lymph node staging in endometrial carcinoma of the uteri. Nonetheless, a learning curve is mandatory to ensure the surgical quality of the sampling. The aim of the study is to assess the success of sentinel lymph node detection according to SHREC-Trial surgical strategy.

Detailed Description
-----------------
Introduction: According to ESGO-ESTRO-ESMO guidelines, pelvic Sentinel lymph node detection is suitable for lymph node staging in endometrial carcinoma of the uteri. The aim of the study is to assess the success of sentinel lymph node detection according to SHREC-Trial surgical strategy. Patients and Method: All patients presenting with early FIGO stage and low, intermediate, high intermediate or high risk endometrial carcinoma will be prospectively enrolled. Sentinel lymph node mapping will be performed using laparoscopic approach and cervical Indocyanine Green injection. Based on the surgical algorithm for detection of pelvic sentinel lymph node in endometrial cancer from Persson and coll., we designed a study with a target of 70% to 90% of bilateral detection rate . Thirty patients will be included over 18 months.

Official Title
-----------------
Pelvic Sentinel Node According to SHREC-trial for the Application of the 2021 European Recommendations for Lymph Node Staging Strategy in Endometrial Cancer

Conditions
-----------------
Endometrial Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Letter of non objection Endometrial carcinoma Stage FIGO I-II whatever the histological subtype. ESGO-ESMO-ESTRO 2021 risk classification : low, intermediate, high intermediate, high Laparoscopic approach. Exclusion Criteria: Participation refusal Medical contraindication to laparoscopic approach. Stage FIGO > II Suspected Indocyanine Green allergy

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bilateral node detection rates | target = 70% to 90% | Day 0 (during surgery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sentinel nodes | number of sentinel nodes collected | Day 0 (during surgery) | 
| Salvage operations in case of GS failure | Number of salvage operations | Day 0 (during surgery) | 
| adverse events | Per and post operative adverse events according to Clavine Dindo Classification | Day 30 | 
| factors for detection failure |  | Day 0 (during surgery) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endometrial cancer
The Impact of Post-tetanic Count on Subsequent Train-of-four During Recovery From Rocuronium

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see how long does the effect of a post-tetanic facilitation last on subsequent train-of-four. The investigators hypothesis is that the effect last at least 30 minutes.

Conditions
-----------------
Post-tetanic Count on One Arm, the Other Arm is the Control

Intervention / Treatment
-----------------
* Device: NMT (a device that can do neurostimulation and can record the response on the stimulation by Datex)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient having general anesthesia in dorsal decubitus with both arm available for at least an hour and a half Exclusion Criteria: Age >75 or <18 Neuromuscular disease difficult laryngoscopy predicted Allergy to rocuronium Malignant hyperthermia Full stomach Drugs the influence neuromuscular blockers Decision of the clinician to exclude his patient

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Patient-control<br> | Device: NMT (a device that can do neurostimulation and can record the response on the stimulation by Datex)<br>* on one side, we do a post-tetanic count, on the other side we don't, after, we do train-of-four on both sides and check the difference<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference at 30 minutes after the post-tetanic count between the TOF% in both arms, we expect a difference of more than 10% |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference at 30 minutes after the post-tetanic count on the T1% (of the calibrated T1) in both arms, we expect a difference of more than 10% |  |  | 
| The difference of the slope of recuperation on TOF and T1% after a post-tetanic count vs the control arm that had no tetanic stimulation |  |  |
Molecular Diagnosis on Circulating Tumor DNA of Non-Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to develop an ultra sensitive assay of mutation detection on circulating tumor DNA (ctDNA) for treatment, diagnosis and monitoring disease progression of Non-Small Cell Lung Cancer (NSCLC).

Official Title
-----------------
Advancing Monitoring of NSCLC Treated With Epidermal Growth Factor Receptor (EGFR)-Tyrosine Kinase Inhibitor (TKI) - Molecular Diagnosis on Circulating Tumor DNA

Conditions
-----------------
Stage IIIb and IV Non Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Other: laboratory biomarker analysis
* Other: Next Generation Sequencing
* Genetic: DNA Analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed written informed consent Male or female aged >= 18 years Stage IIIb and IV Non Small Cell Lung Cancer histologically confirmed Exclusion Criteria: Tissue and plasma samples can not be provided for mutation analysis Unwilling or unable to provide informed consent Any serious medical condition that would interfere with the subject's safety

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 |
| --- |
|Other: laboratory biomarker analysis|nan|
|Other: Next Generation Sequencing|nan|
|Genetic: DNA Analysis|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mutation profiling of circulating tumor DNA from plasma samples. | To evaluate the sensitivity of NGS to detect the genetic alterations in plasma tumor DNA. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantity of circulating tumor DNA in serially collected plasma specimens. | To evaluate the change of quantity of circulating tumor DNA during treatment. | 1 year |