linjc16/ctgov huggingface dataset:
Hiperemezis and Serotonin Elevated Serum Serotonin Levels in Hyperemesis

Study Overview
=================
Brief Summary
-----------------
Serotonin excretion was investigated in the nausea and vomiting associated with hiperemezis gravid arum.

Detailed Description
-----------------
The occurrence of severe nausea and vomiting of early pregnancy (hiperemezis gravid arum) is estimated between 0.3% to 1% of all pregnancies. Although hiperemezis gravid arum has been recognized for a long time, its pathophysiologic mechanisms are still poorly understood. Many theories have been advocated, but to date none of these have been convincing. It has been demonstrated that the nausea and vomiting associated with increased in serotonin liberation. This has provided a rationale for the treatment of these symptoms with specific serotonin antagonists. The aim of this trial was to investigate the possible relationship between hiperemezis gravid arum and serotonin liberation.

Official Title
-----------------
Relationship Between Elevated Serum Serotonin Levels in Symptomatic Patients With Hyperemezis

Conditions
-----------------
Nausea, Vomiting, Markedly Reduced Food Intake, Severe Dehydration

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 6-14 week pregnant women nausea protracted vomiting inability to tolerate food intake accompanied by obvious dehydration severe enough to justify hospitalisation at least 2+ ketonuria on dipstick urinanalysis. Exclusion Criteria: with metabolic disorders such as diabet, thyroid

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 50 Years

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

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 |
| --- | --- | --- |
| serum serotonin levels in hiperemezis gravidarum |  | 6-14week pregnancy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ıs there any assosiation between serotonin levels and severity of symptoms in pregnant women with hiperemezis |  | 6-14week pregnancy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hiperemesis gravidarum,vomiting,serotonin levels,ketonuria
Visual Maturation in Premature Newborns According to Factors Influencing Its Development

Study Overview
=================
Brief Summary
-----------------
The purpose is to describe the level of visual maturation of premature newborns at term equivalent age. The secondary purpose is to determine factors associated to an altered level of visual maturation, through an exploratory approach.

Official Title
-----------------
Visual Maturation in Premature Newborns According to Factors Influencing Its Development

Conditions
-----------------
Delayed Visual Maturation

Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Infants born before 33 weeks of amenorrhea and hospitalized at CHRU Nancy Exclusion Criteria: Parental opposition Ocular malformation Face malformation Cranial stenosis Chromosomal abnormality

Ages Eligible for Study
-----------------
Minimum Age: 6 Weeks
Maximum Age: 10 Weeks

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 |
| --- | --- | --- |
| Measurement of Visual Acuity by Baby Vision Cards | Baby Vision cards are the French equivalent of Teller Cards - The measurement will be done at the term equivalent age : at the inclusion | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Control of the Retina by Retinal Camera | Use of Retcam to diagnose Retinopathy of Prematurity - The measurement will be done at the term equivalent age : at the inclusion | Baseline | 
| Measurement of cycloplegic refraction by mydriaticum 0.5% | The measurement will be done at the term equivalent age : at the inclusion | Baseline | 
| Presence, absence of light reflex by clinical evaluation | The measurement will be done at the term equivalent age : at the inclusion | Baseline | 
| Presence, absence or abnormality of visual fixation by clinical observation | The measurement will be done at the term equivalent age : at the inclusion | Baseline | 
| Analysis of visual cortex with MRI | Determinants of indices of cerebral volume in former very premature infants and their relation to visual maturation. The measurement will be done at the term equivalent age : at the inclusion | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Infant, Premature, Diseases
Impact of Cytomegalovirus (CMV) Replication Over Hepatitis C Recurrence in Liver Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
The relationship between cytomegalovirus infection and recurrence of hepatitis C in liver transplant recipients remains controversial. Although some studies (Teixeira et al., 2000; Singh et al., 2005)have not found an association between recurrence of hepatitis C and CMV infection, studies such as Rosen et al. show that 50% of patients with CMV infection suffered cirrhosis durig follow-up period, while between not-infected patients the rate was 11%. To clarify this question, a non-interventional study will be carried out in order to assess if CMV replication is a risk factor for graft dysfunction in liver transplant recipients.

Official Title
-----------------
Non-interventional, Prospective Study to Evaluate the Impact of CMV Replication Over Hepatitis C Recurrence in Liver Transplant Recipients

Conditions
-----------------
Cytomegalovirus Infection, Hepatitis C

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men or women who underwent liver transplantation after hepatopathy caused by HCV, confirmed by pre-transplantation detection of HCV RNA Age > 18 years old Exclusion Criteria: Patients co-infected with HBV or HIV Patients who show other causes of liver 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of CMV replication over hepatitis C recurrence | viral charge of HCV will be assessed 48 weeks after transplantation | 48 weeks after transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of CMV replication over fibrosis in graft after Hepatitis C recurrence after transplantation |  | 1 year | 
| Effect of CMV recurrence over graft and patient survival |  | 1 year | 
| Relationship between viral charge of CMV and HCV during study period |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cytomegalovirus, Liver transplantation, Hepatitis C virus, Patients who underwent first liver transplantation due to hepatopathy caused by HCV,confirmed by detection of HCV RNA previously to transplantation
Extravalvular Procedure for Surgical Treatment of Ascending Aorta Aneurism

Study Overview
=================
Brief Summary
-----------------
The investigators expect that the using of prothesis with sinuses has more benefits for long term competence and condition of aortic valve than the using of straight prothesis.

Official Title
-----------------
Reimplantation Procedure for Surgical Treatment of Ascending Aorta Aneurism With Concomitant Aortic Valve Insufficiency

Conditions
-----------------
Ascending Aorta Aneurism, Aortic Insufficiency

Intervention / Treatment
-----------------
* Procedure: Aortic valve reimplantation using Valsalva prosthesis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aortic insufficiency 2+ Ascending aorta size more than 5 cm Ascending aorta size more than 4,5 cm (Marfan syndrome) Good conditions of aortic cusps Exclusion Criteria: Aortic annulus more than 30 mm Aortic cusps destruction Critical aortic cusps elongation Aortic root dissection

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Valsalva<br>Reimplantation procedure using Valsalva prosthesis | Procedure: Aortic valve reimplantation using Valsalva prosthesis<br>* Aortic valve reimplantation (David procedure)using Valsalva prosthesis<br>* Other names: Gelweave Vascutek Valsalva;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all causes of aortic valve replacement | Aortic insufficiency (AI) measured by echocardiography. If AI more than 2+, aortic valve replacement performed | before discharging (average of 2 weeks after surgery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all causes of death after procedure | Aortic insufficiency (AI) measured by echocardiography. If AI more than 2+, aortic valve replacement performed | 6, 12, 24,36,48,60,72, 84, 96 months after procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aortic insufficiency, Ascending aorta aneurism
Clinical Evaluation of FreeO2 (Version 4) in All Patients Receiving Oxygen

Study Overview
=================
Brief Summary
-----------------
Evaluation of automatic titration of oxygen with a new version of FreeO2 (V4)

Detailed Description
-----------------
In the previous studies, the investigators used many times automatic titration of oxygen on spontanous breathing patient (FreeO2 device) with a prototype develop in our lab in collaboration with Laval university. In this study, we want to evaluate the new version of the FreeO2 device (V4)

Official Title
-----------------
Clinical Evaluation of the Automatic Oxygen Adjustment by FreeO2 in a Medical Population in Hospital

Conditions
-----------------
Respiratory Failure, COPD Exacerbation, Asthma, Pneumonia, Respiratory Disease

Intervention / Treatment
-----------------
* Device: FreeO2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > or = 18 years old Patient receiving oxygen between 1 to 6 lpm for medical pathology Admitted to a medical service for less than 72 hours (emergency room not included) Exclusion Criteria: Unreliable SpO2 signal Emergency or intensive care hospitalization Absence of NIV or intubation criteria at baseline Sleep apnea not paired Long-term Oxygen Therapy Active delirium and cognitive impairment preventing informed consent

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Automated oxygen adjustment<br>All patient in this study have automatic oxygen titration and automatic oxygen weanning | Device: FreeO2<br>* All include patients will have automatic administration of oxygen by FreeO2 up to 3 day or until weaning of oxygen adminisatrion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % of time in the set SpO2 target | Continuous SpO2 monitoring (1 data each second) will be recorded, the % of time within the SpO2 target±2% set by the physician will be considered (Time in the target±2/Total recording time) | During 3 days of hospitalization or until Oxygen weaning | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygenation data | the % of time with hyperoxia (SpO2 >= SpO2 target+4%), the % of time with severe hypoxemia (SpO2 <85%) the % of time without SpO2 signal, the % of time with oscillations of SpO2 values, comparison of Wired SpO2 vs Bluetooth SpO2, Daily variations of oxygen flows J1, J2 and J3 % Weaning> 50% relative baseline,% complete weaning of O2 | 3 hospitalisations day or until Oxygen weaning |
The Extreme Significance of Bilateral Embolic Retinal Phenomena That Can be Life Saving

Study Overview
=================
Brief Summary
-----------------
This study shows how careful ophthalmic examination of two patients showed signs of simultaneous bilateral retinal emboli. Starting from this point significant, life threatening, underlying reasons were found and treated.

Detailed Description
-----------------
Two patients were found to have signs of simultaneous bilateral retinal emboli. One patient was asymptomatic and routine ophthalmic examination showed bilateral retinal hemorrhages and exudates close to both optic discs. This patient was on anti-coagulant treatment for atrial fibrillation. The finding of bilateral signs of retinal emboli necessitated immediate blood tests and dose adjustments of her medication. The second case did not have general symptoms other than mild evening chills and her eye examination again was the start point of intensive investigation to find the reason of her bilateral retinal emboli. Ultrasound studies revealed a life threatening reason that was urgently treated.

Official Title
-----------------
Bilateral Retinal Embolic Phenomena Always Necessitates Immediate and Intensive Investigation. Careful, Documented, Ophthalmic Examination is All we Require to Initiate Life Saving Investigations.

Conditions
-----------------
Life Threatening Diseases, Embolic Shower

Intervention / Treatment
-----------------
* Diagnostic Test: imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: any patient who is found to have sure signs of bilateral retinal emboli. Exclusion Criteria: all other bilateral retinal diseases.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: imaging|imaging before and after treatment|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The extreme significance of immediate investigation of cases of bilateral retinal emboli (non-diabetic bilateral posterior pole retinal nerve fiber or pre-retinal hemorrhages). | Patients that are noticed to have signs of bilateral retinal emboli (bilateral retinal nerve fiber layer hemorrhages or bilateral pre-retinal hemorrhages and sometimes bilateral soft exudates) may be asymptomatic or have very mild symptoms. However these patients must be immediately and, if needed, intensively investigated to find the source of these emboli. The extremely important point of this study is these patients usually have life threatening conditions that should be found out and treated in time. | through study completion, an average of one year |
Evaluating the Role of Immune Responses in the Emergence of Protease Inhibitor Mutations

Study Overview
=================
Brief Summary
-----------------
The major goal of this project is to identify the role of the immune responses in the emergence of protease inhibitor mutants during therapy.

Detailed Description
-----------------
Objective 1: Evaluate the role of the immune responses in determining the emergence of HCV NS3 resistance mutation during protease inhibitor therapy Hypothesis 1 (HT 1): Low HLA binding to peptides containing protease inhibitor resistance mutations is associated with the emergence of protease inhibitor mutants during therapy and failure of the treatment. Hypothesis 2 (HT 2): A hole in T cell repertoire may allow emergence of protease inhibitor mutants during protease inhibitor therapy which leads to loss of the immune responses to these mutants and failure of treatment.

Official Title
-----------------
Evaluating the Role of the Immune Responses in the Emergence of HCV NS3 Resistance Mutations During Protease Inhibitor Therapy

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All chronically HCV-infected patients who fail peg-IFN and RBV therapy and are eligible for combined treatment with PI therapy will be enrolled. Briefly, this includes: Male or female Age 18 to 65 Chronic HCV infection evidenced by liver biopsy or persistent HCV viremia for >6 months Treatment experienced and classified as non-responder or relapser to prior interferon-based therapy. Exclusion criteria: Treatment naïve chronically HCV-infected patients. Patients with a history of inflammatory bowel diseases (IBD) or suspected IBD, autoimmune diseases, including rheumatoid arthritis, and any patients on systemic immunomodulators. Pregnancy HIV

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 10 Hepatitis C infected subjects<br>10 chronically HCV-infected patients who fail the standard peg-IFN and Ribavirin therapy (NR) and are therefore eligible for combined treatment with Protease Inhibitor therapy. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Completed Standard Treatment | Blood samples will be drawn while the subject is on treatment to measure viral load and HCV-specific immune responses. | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Cleared the Virus | Blood samples will be drawn while the subject is on treatment to measure viral load and HCV-specific immune responses | 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatitis C, HCV
Phase 3 Study to Evaluate the Efficacy and Safety of the DW0929 in Patients With Primary Hypercholesterolemia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of the DW0929 in patients with primary hypercholesterolemia

Conditions
-----------------
Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: DW-0929
* Drug: DW-0929
* Drug: DW-0929
* Drug: Rosuvastatin
* Drug: Rosuvastatin
* Drug: Rosuvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult over 19years Patients with primary hypercholesterolemia whose LDL-C level is below 250mg/dL and TG level is below 350mg/dL Patients whose LDL-C level is under 'Anti- dyslipidemia drug administration considered standard' of NCEP ATP III(2004) Those who voluntarily written consent to participate in this clinical trial Exclusion Criteria: Uncontrolled hypertension Severe renal impairment(CrCl<30mL/min) Those who have active liver disease and whose ALT, AST levels greater than twice the upper limit of normal Serum creatinine > 2.0mg/dL Those who have been geunyukbyeong or rhabdomyolysis caused by using statin or have hypersensitivity to ezetimibe Combined cyclosporine -treated patients HbA1c ≥ 9% TSH ≥ 1.5 X ULN HIV-positive person Congestive heart failure patients classified as NYHA Class III or IV Patients with uncontrolled arrhythmias Patients who have malignant tumors needed chemotherapy, radiation therapy, etc. Blood clotting disorders Patients who had a myocardial infarction within 6 months or cardiovascular bypass surgery, patients who have underwent angioplasty Patients who had a history of anxiety or severe typical peripheral arterial disease within three months Women of childbearing age who don't agree with contraception during this clinical trials Pregnant women or nursing mothers Those who take the drug in combination taboo Who have been treated for another investigational drug within 30 days Unsuitable characters in a clinical trial to test self- determination

Ages Eligible for Study
-----------------
Minimum Age: 19 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: A<br>DW-0929 | Drug: DW-0929<br>* 5/10mg<br>Drug: DW-0929<br>* 10/10mg<br>Drug: DW-0929<br>* 20/10mg<br>|
| Active Comparator: B<br>Rosuvastatin | Drug: DW-0929<br>* 5/10mg<br>Drug: DW-0929<br>* 10/10mg<br>Drug: DW-0929<br>* 20/10mg<br>Drug: Rosuvastatin<br>* 5mg F/U study: DW-0929 5/10mg<br>Drug: Rosuvastatin<br>* 10mg F/U study: DW-0929 10/10mg<br>Drug: Rosuvastatin<br>* 20mg F/U study: DW-0929 20/10mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL-C level |  | 8 weeks |