linjc16/ctgov huggingface dataset:
Evaluate the Effect of Growth Hormone (GH) Treatment on Fibroblast Growth Factor 23, a Known Phosphaturic Agent

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of growth hormone treatment on phosphorus levels in the body. Phosphorus is an important mineral for bone growth. It is well known that growth hormone treatment improves bone density and bone mineral content. The amount of phosphorus is maintained by the kidneys. Fibroblast Growth Factor 23 has recently been recognized to help kidneys control phosphate levels.

Detailed Description
-----------------
This study will compare Fibroblast Growth Factor 23 levels in children with and without growth hormone deficiency. Children with growth hormone deficiency will have levels taken before starting growth hormone replacement and after it has been initiated.

Official Title
-----------------
Evaluate the Effect of Growth Hormone (GH) Treatment on Fibroblast Growth Factor 23 (a Known Phosphaturic Agent)

Conditions
-----------------
Growth Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Twenty children with significant short stature < 3rd percentile, ages 3-14 years, and referred to Children's Hospital of Alabama Normal healthy volunteer children 3-18 years with normal stature Exclusion Criteria: Patients on medication including GH Patients with concomitant hormonal abnormalities Patients with disorders of calcium and phosphate metabolism Active neoplasms Closed epiphysis Known bone disorders

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 14 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 |
| --- | --- |
| Growth Hormone<br>Patient ages 3-14 years receiving growth hormone for growth hormone deficiency or short stature | |
| Healthy Children<br>Children with normal stature ages 3-18 years. | |

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
-----------------
Fibroblast Growth Factors, Bone development
Study to Evaluate Drug-drug Interaction Between Valopicitabine and Ribavirin

Study Overview
=================
Brief Summary
-----------------
This study is being conducted to see if the investigational medication, valopicitabine, is safe to use in combination with ribavirin, a drug approved by the FDA for treating hepatitis C infection.

Official Title
-----------------
A Partially-blinded, Randomized, Parallel-group Study to Evaluate the Potential Pharmacokinetic and Pharmacodynamic Interactions Between Valopicitabine and Ribavirin When Administered in Combination With Pegylated Interferon Alfa-2a in Treatment-naive Patients With Chronic Hepatitis C

Conditions
-----------------
Chronic Hepatitis C

Intervention / Treatment
-----------------
* Drug: NM283 plus Peg-IFNα-2a


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented clinical history compatible with chronic hepatitis C and compensated liver disease Has not previously received anti-viral therapy for hepatitis C infection Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Patient is pregnant or breastfeeding Patient is co-infected with hepatitis B virus and/or HIV Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>NM283(200 mg QD)plus Peg-IFNα-2a (180 µg QW) | Drug: NM283 plus Peg-IFNα-2a<br>* 200 mg QD 180 µg QW<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
-----------------
treatment-naive
A Phase III Clinical Study to Compare the Efficacy and Safety of DA-3801 and That of Gonal-F®

Study Overview
=================
Brief Summary
-----------------
open label, active-controlled, randomized, parallel group, comparative study.

Detailed Description
-----------------
This is a phase III comparative study to evaluate the effectiveness and safety of DA-3801 in treatment of the patients with WHO Group II anovulatory infertility failing to clomiphene citrate treatment. The study is conducted with following methods: open label, active-controlled, randomized, parallel group, comparative.

Official Title
-----------------
A Phase III Clinical Study for the Comparison Evaluation of DA-3801 and Gonal-F® in Infertile Female Patients With Chronic Anovulation Syndrome

Conditions
-----------------
Infertility, Anovulation

Intervention / Treatment
-----------------
* Drug: DA-3801 Injection
* Drug: Gonal-F®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: WHO group II Clomiphene citrate resistance BMI: 17 29 kg/m^2 Irregular menstrual cycle Normal blood concentration of FSH, E2, prolactin and TSH Exclusion Criteria: Uncontrolled endocrine disease Ovarian cystic tumor which are NOT related to PCOS Severe endometriosis Chronic cardiovascular disease, liver complaint

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 38 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DA-3801 injection<br>Recominant human follicle stimulating hormone 75 IU/day is injected for 14 days | Drug: DA-3801 Injection<br> <br> |
| Active Comparator: Gonal-F®<br>75 IU/day is injected for 14 days | Drug: Gonal-F®<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The ovulation rate after 3 cycles of the injection |  | 5 weeks maximum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total dose used, IU (International Unit) |  | 5 weeks | 
| Duration of stimulation, days |  | 5 weeks | 
| Threshold dose, IU |  | 5 weeks | 
| Number of follicles | Counter the number of follicles which are 12 mm, 15 mm, 18 mm in diameter | 5 weeks |
Treatment of Binge Eating Disorder

Study Overview
=================
Brief Summary
-----------------
This is a study examining the use of different degrees of therapist involvement in the treatment of Binge Eating Disorder. The study will examine both which approaches work best for decreasing symptoms and which are most cost-effective.

Official Title
-----------------
Treatment of Binge Eating Disorder

Conditions
-----------------
Binge Eating Disorder

Intervention / Treatment
-----------------
* Behavioral: Group Cognitive Behavioral Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Binge Eating Disorder Age 18-65, Male or Female Not Currently receiving psychotherapy Not currently in Formal weight loss treatment No current unstable medical problems No history of Bipolar illness or Schizophrenia Overweight or Obese (body mass index 25-45)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Group Cognitive Behavioral Therapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Does the Use of Ropivacaine Facilitates Cholecystectomy by Laparoscopy in Ambulatory Surgery?

Study Overview
=================
Brief Summary
-----------------
Since the recommendations of the French Society of Digestive Surgery 2010, cholecystectomy can be performed as outpatient surgery. This approach is difficult in many centers because of post operative pain and nausea/vomiting. The use of postoperative morphine may be responsible for the state of nausea. The use of ropivacaine allows a reduction of the morphine consumption and thus may allow the patient to have their surgery as an outpatient. Currently, ropivacaine is used randomly during the investigators surgeries. Initially, it was used for the infiltration holes trocar. In recent years, ropivacaine is used for the reduction of intra-abdominal postoperative pain. Its use is made of parietal surgery ( hernia ) in cholecystectomy and colonic surgery. This mode of administration is allowed to view the many publications made on this subject. Its use in the investigators daily surgery, however, has not been evaluated in ambulatory surgery.

Official Title
-----------------
Does the Use of Ropivacaine Facilitates Cholecystectomy by Laparoscopy in Ambulatory Surgery?

Conditions
-----------------
Cholecystectomy, Laparoscopy

Intervention / Treatment
-----------------
* Drug: Ropivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Programmed Cholecystectomy Laparoscopy Man and woman ≥ 18 ASA 1 or 2 Not living alone Patient receiving social security coverage Signature of Informed Consent Form Exclusion Criteria: Cholecystectomy emergency Patient minor Pregnant woman (pregnancy test) or during breastfeeding Conversion to laparotomy Patient anticoagulant curative dose Living alone Patient addict Peptic Ulcer Refusal to enter the protocol Chronic requiring analgesics long-term Immunosuppression Long-term Treatment with corticosteroids Discovery intraoperative calculation in the bile duct Contraindication to ropivacaine (see cons-indications to ropivacaine) Hypersensitivity to study treatment or concomitant medications anesthesia Cardiac or unbalanced epileptic patients (due to the risk of cardiovascular and neurological local anesthetics) Patients ASA ≥ 3 Patient <50 kg

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: standard anesthesia<br> | |
| Experimental: standard anesthesia with ropivacaine<br>ropivacaine | Drug: Ropivacaine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to discharge patient after surgery |  | 6 hours postoperative |
ENTegral Artificial Larynx Clinical Trial

Study Overview
=================
Brief Summary
-----------------
The objective of this clinical study is to evaluate the feasibility, safety and efficacy of the ENTegral Artificial Larynx (AL) in patients indicated for total laryngectomy.

Official Title
-----------------
An Evaluation of the ENTegral Artificial Larynx (AL) in Patients Indicated for Total Laryngectomy

Conditions
-----------------
Total Laryngectomy

Intervention / Treatment
-----------------
* Device: ENTegral Artificial Larynx implant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age more than or equal to 18 years old Is indicated for total laryngectomy (first intention) Must be able to comply with study requirements Must be able to understand and be willing to provide written informed consent Exclusion Criteria: Any condition that precludes the implantation of the ENTegral AL Existing coagulation disorder Contraindication for general anesthesia Tumoral extension outside of the larynx invading through extra-laryngeal structures Previous radiotherapy Life-expectancy < 12 months Be pregnant of breastfeeding or intention to becoming pregnant during study

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ENTegral Artificial Larynx implant<br>ENTegral Artificial Larynx implantation | Device: ENTegral Artificial Larynx implant<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of device implant procedure | Number of patients with adverse event associated with device implantation procedure | 1 year |
LiDCO Monitor Study

Study Overview
=================
Brief Summary
-----------------
This is a study to validate the utility and accuracy of the non-invasive device (LiDCOrapid monitor) during a period of phlebotomy and graded blood loss in patients who are having cardiac surgery.

Official Title
-----------------
Use of the LiDCORapid Monitor in Patients During Graded Phlebotomy and the Removal of Autologous Blood

Conditions
-----------------
Cardiac Surgery

Intervention / Treatment
-----------------
* Device: LiDCO rapid monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled for intraoperative phlebotomy following anesthetic induction to obtain autologous blood for use following cardiopulmonary bypass and cardiac surgery.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LiDCO rapid monitor<br> | Device: LiDCO rapid monitor<br>* Technology which provides a continuous means of monitoring various hemodynamic parameters including cardiac output and pulse pressure variability.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Pulse Pressure Variability From Baseline to Post-ANH | The difference in pulse pressure variability during a period of phlebotomy and graded blood loss, measured before phlebotomy or acute normovolemic hemodilution (ANH) and immediately after. | 1 Day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Stroke Volume Variability From Baseline to Post ANH. | The difference in stroke volume variability during a period of phlebotomy and graded blood loss, measured before phlebotomy or acute normovolemic hemodilution (ANH) and immediately after. | 1 Day |
Role of Deep Brain Stimulation on Social Cognition in Parkinsonian Patients

Study Overview
=================
Brief Summary
-----------------
Parkinson's disease (PD) is usually responsible of cognitive and behavioral non-motor signs with a major impact on the quality of life. Social cognition is a complex system relying on emotion recognition (neurons mirror system, NMS), the theory of mind (with its two parts: emotional and cognitive), but also on the social and cultural environment and the personal history. The first step in this model is represented by the NMS, which seems to be altered in PD patients for both positive and negative emotions as shown in our preliminary study. The investigator purpose is to investigate the role of the treatment (levodopa and deep brain stimulation) on the functioning of the NMS.

Official Title
-----------------
Functioning of the Mirror Neurons System in Parkinson's Disease and Its Impact on the Social Cognition

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Other: Neuropsychological detailed tests with focus on social cognition


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parkinson's disease with motor fluctuations and dyskinesias receiving deep-brain stimulation Social insurance Exclusion Criteria: No affiliation to the social insurance Patients under guardianship

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Deep brain stimulation<br> | Other: Neuropsychological detailed tests with focus on social cognition<br>* MATTIS, MOCA, BREF, Light points test, PDQ39<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| variation of the emotional recognition score (point lights test) before deep brain surgery |  | Baseline | 
| variation of the emotional recognition score (point lights test) after deep brain surgery |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PDQ39 score (Parkinson's Disease Questionnaire) | Quality of Life | 1 year | 
| MATTIS (dementia rating scale) score | Global cognition. The Clinical Dementia Rating or CDR is a numeric scale used to quantify the severity of symptoms of dementia | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinson Disease, emotional recognition, Deep Brain Stimulation
The Impact of Medical Clowning on Pain and Stress Level in Pediatric Patients Undergoing Hernia Repair Surgery LAUGH Study.

Study Overview
=================
Brief Summary
-----------------
The purpose of our study to quantitatively examine the stress levels prior to surgery and the use of analgesics post surgery in both children and their parents following a preoperative intervention with a medical clown compared to children that were not exposed to this intervention.

Official Title
-----------------
The Impact of Medical Clowning on Pain and Stress Level in Pediatric Patients Undergoing Hernia Repair Surgery LAUGH Study

Conditions
-----------------
Umbilical Hernia, Inguinal Hernia

Intervention / Treatment
-----------------
* Behavioral: Medical Clown


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ages 4-10 years old undergoing elective umbilical or inguinal hernia repair surgery ASA Physical Status = 1 Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 10 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medical Clown<br>Presence of clowns on child's postoperative pain levels, anxiety levels of the child and the accompanying parent and the effect of the intervention on the total consumption of analgesics and on the post- surgery inflammatory markers. | Behavioral: Medical Clown<br>* Presence of clowns on child's postoperative pain levels, anxiety levels of the child and the accompanying parent and the effect of the intervention on the total consumption of analgesics and on the post- surgery inflammatory markers<br>|
| No Intervention: Control<br>Assessment of child's postoperative pain levels, anxiety levels of the child and the accompanying parent and the effect on the total consumption of analgesics and on the post- surgery inflammatory markers. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Children: WBS (Wong Baker Faces Pain Rating Scale) | measure at 4 time points (repeated measures) - at admission, discharge, 12 and 24 hours. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of analgesics | Total dose of analgesics over 24 periods per kg. | During the 24 hours following the surgery | 
| Cytokines levels | Cytokined levels at the end of the surgery (end of precedure, before waking up)(IL-1b, IL-2,IL-6, IL-8, IL-10,TNF-α and VEGF) | End of precedure, before waking up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Medical clown
The Effect of Bifidobacterium Lactis and Inulin on Functional Constipation

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to asses the effect of Bifidobacterium lactis and Inulin on functional constipation in children

Official Title
-----------------
The Effect of Bifidobacterium Lactis and Inulin on Functional Constipation

Conditions
-----------------
Functional Constipation

Intervention / Treatment
-----------------
* Other: B.lactis
* Other: Inulin
* Other: B.Lactis +Inulin
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children with functional constipation over 3 years age below 18 years of age Exclusion Criteria: Chronic gastrointestinal disease, hirschsprung disease, celiac disease, hypothyroids, neurological deficit, constipation treatment receiving children will be excluded

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: B.Lactis<br>children with functional constipation | Other: B.lactis<br> <br> |
| Active Comparator: Inulin<br>children with functional constipation | Other: Inulin<br> <br> |
| Active Comparator: B.Lactis+ınulin<br>children with functional constipation | Other: B.Lactis +Inulin<br> <br> |
| Placebo Comparator: plasebo<br>children with functional constipation | Other: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to compare defecation frequency between baseline and 4 th week of treatment |  | baseline and 4th week of intervention |