linjc16/ctgov huggingface dataset:
Cytomegalovirus (CMV) Infection in Amniotic Fluid

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if detection of cytomegalovirus (CMV) in amniotic fluid collected in the second trimester of pregnancy is associated with pregnancy complications such as preterm delivery or severe preeclampsia.

Detailed Description
-----------------
CMV infection in adults with a normal immune system is rarely a serious event. Once a person has been infected with CMV, they may have recurrences (relapses) of the infection. If a mother is infected with the virus or relapses during pregnancy, her fetus may be at risk for infection. Unlike infection in adults, congenital infection may result in serious complications (congenital infection). The effects of fetal infection with CMV are well understood and many efforts have been made to potentially reduce the risk of congenital infection. However, the effect of CMV infection on the pregnancy itself (when the fetus is not affected by CMV) is less understood. The incidence of CMV detection in amniotic fluid collected in the second trimester is thought to be low. However, the association between detection of CMV infection in the second trimester and ultimate pregnancy outcome is poorly described. In this study, we plan to determine if CMV detection in amniotic fluid collected in the second trimester is associated with pregnancy complications.

Conditions
-----------------
Pregnancy Complications, Cytomegalovirus Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women who deliver at term without pregnancy complications Women who deliver (preterm, less than 37 weeks of gestation) as a result of spontaneous preterm labor Women whose pregnancies are complicated by severe preeclampsia Exclusion Criteria: Women with multi-gestational pregnancies, or whose pregnancies are complicated by a congenital malformation or chromosomal abnormality Women who have a medical history of hypertension (high blood pressure), diabetes, or severe renal (kidney) disease

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 45 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pregnancy, Cytomegalovirus
Study on Intraocular Structural Parameters and Surgical Effect Before and After the Onset of Malignant Glaucoma

Study Overview
=================
Brief Summary
-----------------
In this retrospective observational study, we collected intraocular structure parameters of malignant glaucoma and primary angle closure glaucoma. Anterior chamber depth (ACD) and width (ACW), lens vault (LV), ciliary process-ciliary process distance(CCD), trabecular-ciliary processes distance (TCPD), ciliary body max thickness (CBMT), peripheral iris thickness (PIT), trabecular ciliary process angle (TCPA), and anterior vault (AV), were measured by ultrasound biomicroscopy. Other parameters measured by A-scan ultrasonography and optical coherence tomography. To analyze the high risk factors and the possible pathogenesis of the disease and discuss the long-term effect of different treatment methods.

Detailed Description
-----------------
Outcome Measures: Anterior chamber depth (ACD) and width (ACW), lens vault (LV), ciliary process-ciliary process distance(CCD), trabecular-ciliary processes distance (TCPD), ciliary body max thickness (CBMT), peripheral iris thickness (PIT), trabecular ciliary process angle (TCPA), and anterior vault (AV), were measured by ultrasound biomicroscopy. Other parameters measured by A-scan ultrasonography and optical coherence tomography.

Official Title
-----------------
Study on Intraocular Structural Parameters and Surgical Effect Before and After the Onset of Malignant Glaucoma

Conditions
-----------------
Glaucoma, Malignant Glaucoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (1) history of operation, (2) diagnosis of MG, and (3) eyes with clear optical media. Exclusion Criteria:(1)hypertension or diabetes and (2) diagnosis of ocular fundus diseases.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Malignant Glaucoma<br>To determine the biometric measurements. | |
| Fellow Eyes<br>To determine the biometric measurements. | |
| Matched Eyes<br>To determine the biometric measurements. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trabecular ciliary process angle | TCPA is measured with its apex at the scleral spur, one arm along the posterior corneal surface, and another arm along the most anterior surface of the ciliary body | baseline | 
| Choroidal vascularity parameter | Choroidal vascularity parameter is a vessel ratio measured by optical coherence tomographic images | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Malignant Glaucoma, Biometric Measurements
Screening for Hypoglycemia in an Institutionalized Elderly Diabetic Population.

Study Overview
=================
Brief Summary
-----------------
Diabetes is a major public health problem that has been growing steadily in recent years. Its prevalence is very high in the elderly, in whom there is an increased risk of hypoglycemia. Hypoglycaemia in elderly diabetics has serious consequences: increased mortality, increased cardiovascular morbidity, increased risk of falling, impairment of quality of life. Hypoglycaemia is also a risk factor for dementia in type 2 diabetes. The frequency of asymptomatic and atypical hypoglycemia has been shown to be greater in the elderly, but the exact prevalence of hypoglycemia in the elderly remains unknown. Elderly diabetic patients in institutions are particularly fragile and have more frequent cognitive problems than non-diabetic subjects. A study conducted in this population of patients showed that a third of them had HbA1C <6.5%, which suggests a higher frequency of hypoglycemia though the figures were not available. We therefore decided to conduct a study to assess the frequency of hypoglycemia in order to better understand the contributing factors and to improve the management of this fragile population.

Official Title
-----------------
Screening for Hypoglycemia in an Institutionalized Elderly Diabetic Population.

Conditions
-----------------
Diabetes, Old Age, Institutionalized in EHPAD (French Nursing Home), Hypoglycemic Syndrome

Intervention / Treatment
-----------------
* Device: Continuous interstitial glucose sensor
* Other: Sensor Scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: written consent diabetic patient receiving treatment which could result in hypoglycemia: insulin and/or sulfonamide and/or glinides institutionalized patient in an EHPAD patient over 60 years of age Exclusion Criteria: - person not affiliated to a national health insurance

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Continuous interstitial glucose sensor|Installing and removing the sensor|
|Other: Sensor Scan|Scan of the sensor, using the Freestyle Pro free version reader, at installation then before removal after 14 days.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of hypoglycemic events (<70 mg/dl) demonstrated by continuous interstitial glucose monitoring over the study period. |  | Day 14 | 
| Number of hypoglycemic events (<70 mg/dl) detected by capillary blood glucose measurement or clinical signs suggestive of hypoglycemia. |  | Day 14 |
Home-Administered Trial of Direct Current Stimulation

Study Overview
=================
Brief Summary
-----------------
Transcranial Direct Current Stimulation (tDCS) is a novel non-invasive brain stimulation treatment that is effective with no significant side effects. It can potentially be self-administered by patients in their own homes with remote monitoring, substantially reducing treatment costs and increasing accessibility, including to remote areas. This study will evaluate the feasibility and efficacy of home-administered tDCS treatment for depression.

Official Title
-----------------
Home-administered Transcranial Direct Current Stimulation (tDCS) Treatment for Depression

Conditions
-----------------
Major Depression

Intervention / Treatment
-----------------
* Device: Soterix tDCS machine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject meets criteria for a DSM-IV Major Depressive Episode, lasting more than 4 weeks Total MADRS score ≥ 20 Exclusion Criteria: Diagnosis of any DSM-IV psychotic disorder History of drug or alcohol abuse or dependence in the preceding 3 months High suicide risk Clinically defined neurological disorder or insult Metal in the cranium or skull defects Skin lesions on the scalp (e.g. cuts, abrasions, rashes) at the proposed electrode sites 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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active tDCS<br>Soterix tDCS machine is used to administer active stimulation | Device: Soterix tDCS machine<br>* Soterix tDCS machine - miniCT supervised neuromodulation system<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montgomery Asberg Depression Rating Scale for Depression (MADRS) |  | 6 months |
Tolerability, Safety and Efficacy of SAD448 in Subjects With Ocular Hypertension

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the tolerability and safety of SAD448 and explore the compound's effect on intraocular pressure in subjects with ocular hypertension.

Official Title
-----------------
A Multicenter, Randomized, Placebo-Controlled, Double-Masked, 4-Arm Parallel Group Study to Assess the Tolerability, Safety and Efficacy of Two Doses of SAD448 in Subjects With Ocular Hypertension

Conditions
-----------------
Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: SAD448


Participation Criteria
=================
Eligibility Criteria
-----------------
Key inclusion criteria: Males and females, 18 - 65 years of age, with ocular hypertension Females must be post-menopausal or surgically sterile Key exclusion criteria: Diagnosis of glaucoma in either eye A history of or current eye conditions or medical problems that would prohibit the use of an investigational drug

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SAD448|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of adverse events and serious adverse events, as well as changes in ophthalmic evaluations, laboratory values, ECGs and vital signs from baseline up to 24 hours post-dosing. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ocular hypertension from baseline up to 24 hours post-dosing. Systemic exposure to SAD448 following the administration of two doses. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ocular Hypertension, SAD448
Effects of Oxytocin and Vasopressin on Moral Decision Making

Study Overview
=================
Brief Summary
-----------------
To determine whether the neuropeptide oxytocin (OXT) and vassopressin (AVP) influence moral decision making

Detailed Description
-----------------
In a double-blind, between- subject placebo (PLC) controlled design, subjects will first complete a series of questionnaires in terms of mood, clinical symptoms, and traits. After that their moral judgment and emotion towards both verbal descriptions of moral dilemma scenarios and pictures of specific interpersonal ones will be assessed and the effect of intranasal OXT and AVP between both male and female healthy subjects will be investigated.

Official Title
-----------------
Effects of Oxytocin and Vasopressin on Moral Decision Making

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Oxytocin
* Drug: Vasopressin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy subjects without past or current psychiatric or neurological disorders Exclusion Criteria: pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: oxytocin group<br>subjects with oxytocin treatment | Drug: Oxytocin<br>* intranasal administration of oxytocin (24 IU)<br>|
| Experimental: vasopressin group<br>subjects with vasopressin treatment | Drug: Vasopressin<br>* intranasal administration of vasopressin (20 IU)<br>|
| Placebo Comparator: placebo group<br>subjects with placebo treatment | Drug: Placebo<br>* intranasal administration of placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of OXT and AVP on behavioral index of moral decision task | intensity of feelings | 45 mins - 105 mins | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
moral decision making, oxytocin, vasopressin
Does the Optic Disc Grading Done Visually by Your Doctor Agree With Optic Nerve Testing Which is Done by Machines?

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine how well the DDLS (Disc Damage Likelihood Scale) (which is a method used by the eye doctor to evaluate how healthy the optic nerve is) measures up to the standard glaucoma tests: OCT (Optical Coherence Tomography), the HRT (Heidelberg Retinal Tomography) and the HVF (Humphrey Visual Field).

Detailed Description
-----------------
The Disc Damage Likelihood Scale (DDLS) has been shown to be a reproducible method for clinicians to evaluate the optic nerve for glaucomatous damage and is highly correlated to diagnosis of glaucoma, severity of glaucoma as evidenced by visual field loss and Heidelberg Retina Tomography (HRT) evaluation. In comparison with the commonly used cup-disc ratio, the DDLS has less inter-observer variation and captures glaucomatous aspects of the optic nerve not assessed by the cup-disc ratio. The optic nerve imagers do not have the potential to completely replace the clinical examination of the optic nerve since they do not assess many critical features such as optic nerve pallor, hemorrhages, asymmetry of disc size, edema, etc. The DDLS presents the opportunity to provide a system to clinicians to increase the quality and objectivity of clinical optic nerve evaluation. The purpose of this study is to investigate the correlation of the DDLS grading to OCT, HRT and HVF testing of glaucomatous and normal optic nerves.

Official Title
-----------------
Correlation of DDLS Grading to OCT, HRT, and HVF

Conditions
-----------------
Open Angle Glaucoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Vision 20/50 or better Less than 3 diopters of astigmatism 3 diopters or less of myopia or hyperopia Pattern Standard Deviation on HVF less than 2.5dB in normals Pattern Standard Deviation on HVF greater than 2.5 db in glaucoma patients Exclusion Criteria: Abnormalities of cornea or ocular media Significant ocular pathologies affecting visual field History of hypotony Ocular surgery within 6 months Nystagmus Unreliable visual fields OCT signal strength scan less than 6

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 85 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 |
| --- | --- |
| 1: Primary open angle glaucoma<br>Patients with a form of primary open angle glaucoma | |
| 2: No known eye disease (controls)<br>Patients with no known eye disease (controls) | |

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
-----------------
primary open angle glaucoma, low tension glaucoma, pigmentary glaucoma, exfoliative glaucoma
A Long-term Safety Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to assess the long-term safety of Olumacostat Glasaretil gel, 5.0% in patients with acne vulgaris

Official Title
-----------------
An Open-Label Study Assessing Long-Term Safety of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris

Conditions
-----------------
Acne Vulgaris

Intervention / Treatment
-----------------
* Drug: Olumacostat Glasaretil Gel, 5.0%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent or assent (for subjects under legal adult age) Completed Week 12 visit of either DRM01B-ACN03 or DRM01B-ACN04 studies. Willing to comply with the protocol. Subjects under legal adult age will be assessed by the investigator as to their ability to comply with the protocol Willing to refrain from using any treatments on the face for acne vulgaris, other than the investigational product, including topical or systemic antibiotics. Exclusion Criteria: Abnormal clinically significant findings on physical exam, vital signs or ECG at Week 12 visit of either the DRM01-ACN03 or DMR01-ACN04 studies that would make further treatment with Olumacostat Glasaretil Gel contraindicated, as determined by the Investigator Any other condition which, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study

Ages Eligible for Study
-----------------
Minimum Age: 9 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: Olumacostat Glasaretil Gel, 5.0%<br>Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face | Drug: Olumacostat Glasaretil Gel, 5.0%<br>* Gel containing Olumacostat Glasaretil<br>* Other names: DRM01B;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions | Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions | Day 1 - Week 36 |
Biodistribution of Neutrophile Proteases in the Sputum of Patients Affected by Cystic Fibrosis

Study Overview
=================
Brief Summary
-----------------
The purpose of the proposed project is to characterize the neutrophile proteases which participate in the chronic inflammatory phenomenon associated with the cystic fibrosis and which are responsible for the degradation of the lung tissue. The respiratory failure which results from it is one of main causes of the fatal evolution of this pathology but the anti-inflammatory therapies based on the use of antiproteases targeting specifically the soluble elastase did not end, until now, in the hoped results. The identification of the other noxious targets is a crucial element to give new orientations to the anti-inflammatory strategies based on the administration of antiproteases which remain a promising way.

Official Title
-----------------
Study of the Biodistribution of PMN Serine Proteases in Sputum of Patients Affected by Cystic Fibrosis: Towards New Anti-inflammatory Therapies

Conditions
-----------------
Cystic Fibrosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Man /woman older than 18 years (for adult and group) Child aged 6 to 18 years (for child group) Suffering from cystic fibrosis in stable condition, ie not having presented thrust acute attack of the broncho-pulmonary or hospitalization for treatment of his illness during the previous 2 weeks Exclusion Criteria: colonized by Burkholderia cepacia ou Stenotrophomonas maltophilia non smoker (control group) Without history or respiratory respiratory disease known (control group) Antibiotic treatment and / or anti-inflammatory drug (NSAID or corticosteroids) in the 2 weeks prior to the inclusion in the study (control group)

Ages Eligible for Study
-----------------
Minimum Age: 6 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 |
| --- | --- |
| T<br>Control | |
| M<br>Minor with cystic fibrosis | |
| A<br>Adult with cystic fibrosis | |

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

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