linjc16/ctgov huggingface dataset:
Twelve Month Clinical Evaluation of KeraSoft IC Soft Contact Lenses

Study Overview
=================
Brief Summary
-----------------
The objective of this twelve month dispensing study is to evaluate the clinical performance, particularly comfort and vision, of KeraSoft IC Soft Contact Lenses.

Official Title
-----------------
Twelve Month Clinical Evaluation of KeraSoft IC Soft Contact Lenses

Conditions
-----------------
Keratoconus

Intervention / Treatment
-----------------
* Device: KeraSoft IC Soft Contact Lenses


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have participated and completed a previous study (ROC2-10-078). Is Keratoconic Exclusion Criteria: Has any systemic disease affecting ocular health. Is using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance. Is not correctable to 20/50 or better in each eye with contact lenses. Has greater than Grade 2 slit lamp exam findings. Has any atypical scar for a keratoconic or neovascularization within the central 4mm of the cornea. Subjects with minor peripheral corneal scarring that, in the Investigator's judgment, does not interfere with contact lens wear are eligible for this study. Has any neovascularization within the central 4mm of the cornea.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KeraSoft IC Soft Contact Lenses<br>KeraSoft IC Soft Contact Lenses, with CIBA Clear Care solution provided for lens care | Device: KeraSoft IC Soft Contact Lenses<br>* Lenses will be worn between 8 and 16 hrs each day, for 12 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort | Symptoms and complaints measured on an analog scale | 4 visits over 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity - Low Contrast | Low contrast visual acuity measured with high ambient illumination (LCHI) | 4 visits over 1 year | 
| Visual Acuity - High Contrast | High contrast visual acuity measured with high ambient illumination (HCHI) | 4 visits over 1 year |
Prediction of Chronic Kidney Disease Following Pre-eclampsia: Diagnosis and Early Care

Study Overview
=================
Brief Summary
-----------------
Pre-eclampsia (PE) is a pregnancy-associated syndrome of variable severity, classically defined by the combination of hypertension and proteinuria in a previously non-hypertensive or proteinuric patient. These symptoms normally resolve within 2-3 months after delivery regardless of the severity of the pre-eclampsia. Regardless of its definition, preeclampsia is associated with an increased risk of obstetric events and, for the mother, an increased risk of developing chronic kidney disease (CKD), hypertension, diabetes and cardiovascular disease in the broad sense. The relationship between preeclampsia and Chronic Kidney Disease is, however, complex and not fully understood. Investigator proposes an interventional study to identify the diagnosis of Chronic Kidney Disease in patients who have developed an episode of Preeclampsia.

Official Title
-----------------
Prediction of Chronic Kidney Disease Following Pre-eclampsia: Diagnosis and Early Care

Conditions
-----------------
Preeclampsia

Intervention / Treatment
-----------------
* Other: annual follow-up during 10 years


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meeting the preeclampsia criteria according to the ISSHP 2018 definitions Having signed the informed consent Exclusion Criteria: Patient with mental disability or language barrier preventing understanding of the study or consent Person deprived of liberty by judicial or administrative decision Person under forced psychiatric care Person subject to a legal protection measure

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patient with preeclampsia<br>Patient meeting preeclampsia criteria according to International Society for the Study of Hypertension in Pregnancy (ISSHP) 2018 definitions | Other: annual follow-up during 10 years<br>* an annual follow-up is carried out systematically for a total of 10 years in order to detect the subsequent occurrence of CKD<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence of the Chronic Kidney Disease (CKD) | prevalence of the CKD is measured by the the rate of new CKD Diagnoses (according to the standard definitions) | until 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic kidney disease (CKD), preeclampsia
Efficacy and Safety on the Use of Bisphosphonates in Paediatrics

Study Overview
=================
Brief Summary
-----------------
The investigators suppose that the impact of bisphosphonate therapy is beneficial on the bone during the growth period with few adverse events.

Official Title
-----------------
Efficacy and Safety on the Use of Bisphosphonates in Paediatrics

Conditions
-----------------
Bone Fragile, Bisphosphonate-Associated Osteonecrosis, Children, Adverse Events

Intervention / Treatment
-----------------
* Other: No intervention, observational study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: be under 18 years of age have been treated by intravenous bisphosphonates for primary or secondary osteoporosis Exclusion Criteria: be over 18 years of age

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pamidronate therapy<br> | Other: No intervention, observational study<br>* No intervention, observational study<br>|
| Zoledronate therapy<br> | Other: No intervention, observational study<br>* No intervention, observational study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fracture rates | (numbers) | 2 years | 
| bone mineral density | (Z-score) | 2 years | 
| pain frequency | (never, occasional, regular) | 2 years |
Comparison of Initial Treatment in With Laser Grid in Diabetic Macular Edema to Intra Vitreal Avastin Injections

Study Overview
=================
Brief Summary
-----------------
there is no yet agreement about the best way to treat Diabetic Macular Edema (DME) the two options up to day are using Grid laser treatment Vs. Avastin injections or a combination of both in this study we want to compare the two attitudes.

Conditions
-----------------
Diabetic Macular Edema, Diabetus Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetic patients with macular edema age 30 to 80 Yrs. old no previous ocular treatment patiens with macular edema that was shown by OCT or FA patients with at least 6 months follow-up after the last treatment Exclusion Criteria: patients with other ocular disease (such as glaucoma etc.) patients with previous ocular surgery patiens with eye trauma patiens with macular edema not from DM

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Grid Treatment<br>30 patients that were treated with laser grid treatment | |
| Avastin Treatment<br>patients that were treated with Avastin injections | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Macular thickness | by measuring the retinal thickness and comparing in both aproaches. and see if there is any difference. | 36 months |
Phase III Randomized, Controlled Study of Ganciclovir for Symptomatic Congenital Cytomegalovirus Infection

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Evaluate the efficacy of ganciclovir (12 mg/kg per day) versus no treatment in neonates with symptomatic congenital cytomegalovirus infection with central nervous system disease.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is a randomized study. Patients are stratified by participating institution. Patients are randomly assigned to no antiviral therapy or intravenous ganciclovir every 12 hours for 6 weeks. Patients are followed at weeks 1-4 and 12, months 6, 12, 24, 36, 48, and 60, and yearly thereafter until puberty (when possible).

Conditions
-----------------
Cytomegalovirus Infections

Intervention / Treatment
-----------------
* Drug: ganciclovir


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Symptomatic cytomegalovirus (CMV) infection: Central nervous system disease, with or without other organ system involvement, e.g.: Microcephaly, i.e., less than 5% for age Radiologic changes indicating brain disease Cerebrospinal fluid exam abnormal for age Chorioretinitis Hearing defects CMV confirmed by urine, throat, buffy coat, and/or conjunctiva culture No hydroencephalopathy or other devastating brain involvement --Prior/Concurrent Therapy-- No concurrent antiviral agent No concurrent immune globulin --Patient Characteristics-- Age: Under 1 month (preferably under 2 weeks) Life expectancy: No imminent demise Renal: Creatinine no greater than 1.5 mg/dL Other: Birth weight at least 1200 g Gestational age at least 32 weeks No HIV infection No concurrent bacterial infection Eligible if resolved following 2-week treatment and CMV symptoms persist

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 1 Month

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

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

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
-----------------
congenital cytomegalovirus infection, cytomegalovirus infection, herpesvirus infection, immunologic disorders and infectious disorders, neonatal disorders, rare disease, viral infection
Salivary Interleukin-32, Interleukin-10, Interleukin-6 and Tumor Necrosis Factor-alpha Levels in Children

Study Overview
=================
Brief Summary
-----------------
This study aimed to evaluate the levels of interleukin 10, interleukin 6, interleukin 32 and tumor necrosis factor-alpha (TNF-α) in saliva of children with early childhood caries.

Detailed Description
-----------------
Fifty six children ( 28 with early childhood caries and 28 without early childhood caries ; age range 3-6 years) will be recruited for the study. Probing pocket depth (PPD), gingival index (GI) and plaque index (PI) will be recorded and saliva samples will be collected. Interleukin-32, Interleukin-10, Interleukin-6 and TNF-α will be analyzed in saliva samples by ELISA.

Official Title
-----------------
Evaluation of Salivary Interleukin-32, Interleukin-10, Interleukin-6 and Tumor Necrosis Factor-alpha Levels in Children With Early Childhood Caries.

Conditions
-----------------
Early Childhood Caries

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children with untreated early chilhood caries Age between 3 and 6 years Exclusion Criteria: Having a systemic problem or mental retardation Children with treated caries

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 70 Months

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children with early chilhood caries<br>Early chilhood caries group | Diagnostic Test: ELISA<br>* Enzim linked immunoabsorbant assay<br>|
| Without early chilhood caries<br>Control group | Diagnostic Test: ELISA<br>* Enzim linked immunoabsorbant assay<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IL-32 | Interleukin- 32 level | Baseline | 
| IL-10 | Interleukin- 10 level | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IL-6 | Interleukin- 6 level | Baseline | 
| Tnf-Alpha | Tnf-alpha level | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
early childhood caries
Schizophrenia and the Gut Microbiome

Study Overview
=================
Brief Summary
-----------------
In a sample of 20 inpatients with a DSM-IV-TR/DSM 5 diagnosis of schizophrenia or schizoaffective disorder, investigators propose to conduct a prospective, 2 week observational trial to collect gastrointestinal stool samples in order to characterize the microbiota in people with schizophrenia and examine its variability over time. Participants may elect to participate for an additional two weeks, during which they will receive the prebiotic, oligofructose-enriched inulin (FOS), in order to examine its effects on the relative preponderance of butyrate-producing bacteria in the gut microbiome. Investigators will use an inpatient sample in order to standardize meals, exercise and environmental mediators. This is considered a feasibility, pilot study in order to apply for future grant funding. Investigators will recruit patients from the Treatment Research Program inpatient unit, Maryland Psychiatric Research Center, University of Maryland School of Medicine.

Official Title
-----------------
Schizophrenia and the Gut Microbiome

Conditions
-----------------
Schizophrenia, Schizoaffective Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: DSM-IV-TR /DSM 5 diagnosis of schizophrenia or schizoaffective disorder; Age 18-64 years; currently hospitalized for at least 7 days currently treated with an antipsychotic, with no dose changes in last 14 days ability to participate in the informed consent process, as determined by a score of 10 or greater on the Evaluation to Sign Consent Exclusion Criteria: Gastrointestinal disorders, including, but not limited to Crohn's Disease, Irritable Bowel Syndrome, Celiac Disease, Organic brain disorder, including cerebrovascular accident; epilepsy; traumatic brain injury, Loss of consciousness (LOC) for more than 30 minutes Mental retardation Antibiotic or immune therapy within the last three months Prebiotic or probiotic treatment within the last three months Inability to understand English Inability to cooperate with study procedures Pregnant women Prisoner status For MRI ONLY Contraindication for MRI scanning (e.g. metal in body, pacemaker).

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Stool Sample Collection<br> | |
| Prebiotic<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 16S rRNA gene amplicons from stool samples | The 16S rRNA gene amplicon data will be used to examine the relative preponderance of butyrate-producing bacteria in the gut microbiota of people with schizophrenia. | 4 weeks |
Effects of Thai Massage on EMG

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effect of Thai massage on electromyogram in patients with chronic upper back pain associated with myofascial trigger points.

Official Title
-----------------
Effects of Thai Massage on EMG

Conditions
-----------------
Myofascial Pain Syndrome

Intervention / Treatment
-----------------
* Other: Thai massage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female Age between 18 - 50 years old The participants have experienced spontaneous upper pain for longer than 12 weeks (chronic) and that at least one trigger point will be present in the s trapezius muscles. Trigger points will be diagnosed as the presence of focal tenderness in a taut band and with pain recognition. The participants will be able to follow instructions. Good communication and cooperation. Exclusion Criteria: A history of the following diseases or disorders: Cervical radiculopathy Contraindications of traditional Thai massage Contagious skin disease Injury or inflammation of muscle Bone fracture and/or joint dislocation Open wound Uncontrolled hypertension Drug and/or alcohol intoxication

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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: Thai massage<br>The participants will receive thirty minutes session of Thai massage onto the trapezius muscle for 1 sessions | Other: Thai massage<br> <br> |
| Sham Comparator: Sham Microwave diathermy<br>The participants will receive thirty minutes session of Sham Microwave diathermy onto the trapezius muscle for 1 sessions | Other: Thai massage<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle activity as a Measure of Electromyogram |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scores on Visual Analog Scale |  | 1 day | 
| Muscle tension on Visual Analog Scale |  | 1 days |
Choice of Valve Substitute in the Era of Oral Anticoagulation Self-Management

Study Overview
=================
Brief Summary
-----------------
The optimal valve substitute for patients between 60-70 years is controversial. We compared anticoagulation-related adverse events (ARAE) in patients receiving mechanical heart valve replacement (MHVR) on INR self-management vs. stentless bioprosthesis, to assess whether the risk of structural valve deterioration (SVD) is still out-weighted by the benefit of not requiring permanent anticoagulation.

Conditions
-----------------
Anticoagulation, Mechanical Heart Valve Replacement

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: heart valve replacement Exclusion Criteria: CABG Afib

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Group A<br>Group A patients received mechanical heart valve replacement MHVR (and were educated in INR self-management using the Coagu-Check monitor. | |
| Group B<br>Group B patients received MHVR and their anticoagulation was managed by their general practitioners. | |
| Group C<br>Group C patients received stentless bioprosthesis, with initial 6 weeks on oral anticoagulation managed by their general practitioners. | |

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

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