linjc16/ctgov huggingface dataset:
The Molecular Pathogenesis Study of Cataract

Study Overview
=================
Brief Summary
-----------------
To study the molecular pathogenesis of cataract and explore possible treatments，anterior lens capsules were collected from cataract patients

Detailed Description
-----------------
Anterior lens capsules were collected from the patients with DC and ARC, and transparent crystals of cadaveric eyes. M6A epitranscriptomic microarray was performed to investigate the altered m6A modifications and determine the differentially expressed mRNAs. The potential role of dysregulated m6A modification levels was predicted through Gene Ontology and Kyoto Encyclopedia of Genes and Genomes pathway enrichment analyses. Real-time polymerase chain reaction was performed to identify the dysregulated expression of RNA methyltransferases, demethylases, and readers.

Official Title
-----------------
The Molecular Pathogenesis Study of Cataract

Conditions
-----------------
Cataract, Pathogenesis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diabetic cataract underwent cataract surgery Exclusion Criteria: Combined with other eye diseases underwent other eye surgery

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 |
| --- | --- |
| DC group<br>Anterior lens capsule tissues from DC patients | |
| ARC group<br>Anterior lens capsule tissues from ARC patients | |
| NC group<br>anterior lens capsules collected from three age-matched transparent crystals of cadaveric eyes | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| m6A modification of mRNAs | Epitranscriptomic microarray analysis reveals the differential m6A modification of mRNAs in DC samples | 1 month | 
| expression level of mRNAs | the m6A microarray analyses provide data for mRNA expression levels | 1 month | 
| levels of methylated mRNA | in vitro validation of the diverse expression levels of methylated mRNA | 1 month | 
| levels of RNA methyltransferase | in vitro validation of the diverse expression levels of RNA methyltransferase | 1 month |
A Multicenter Treatment Protocol of Daclatasvir (BMS-790052) in Combination With Sofosbuvir for the Treatment of Post-Liver Transplant Subjects With Chronic Hepatitis C

Study Overview
=================
Brief Summary
-----------------
The primary objective of this program is to provide DCV for 24 weeks to be given in combination with SOF to subjects with chronic hepatitis C with decompensated cirrhosis or post-liver transplant subjects with chronic hepatitis C recurrence with either advanced fibrosis or fibrosing cholestatic hepatitis and who have a serious or immediately life-threatening condition or experienced an event that has decreased their life expectancy to <12 months, therefore, no research hypothesis will be tested and no specific endpoints are defined. However, safety data will be collected throughout the study as well as efficacy data

Official Title
-----------------
A Multicenter Treatment Protocol of Daclatasvir (BMS-790052) in Combination With Sofosbuvir for the Treatment of Subjects With Chronic Hepatitis C and Decompensated Cirrhosis or Post-Liver Transplant Subjects With Chronic Hepatitis C Recurrence

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

Intervention / Treatment
-----------------
* Drug: Daclatasvir (BMS-790052)
* Drug: Sofosbuvir


Participation Criteria
=================
Eligibility Criteria
-----------------
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Patients chronically infected with Hepatitis C Subjects who received a liver transplant, have chronic hepatitis C virus (HCV) recurrence and advanced fibrosis (Metavir F3-F4) or fibrosing cholestatic hepatitis Subjects with decompensated cirrhosis defined by Child-Pugh Class C Exclusion Criteria: Patients who are <18 years old Clinical or pathologic evidence of acute ongoing liver graft rejection Creatinine clearance (CrCl) ≤30 mL/min (as estimated by Cockcroft and Gault formula) Patients who have contraindications to either Daclatasvir (DCV) or Sofosbuvir (SOF) Patients who are pregnant or Women of Child Bearing Potential who are not using required contraception

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Daclatasvir (BMS-790052)|nan|
|Drug: Sofosbuvir|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Predictive Blood Tests for Severe Radiation Reactions in Breast Cancer Patients

Study Overview
=================
Brief Summary
-----------------
Some patients who undergo breast cancer treatment with lumpectomy followed by radiation therapy develop significant late skin and soft tissue changes, resulting in a poor cosmetic outcome. The goal of this study is to try to predict severe tissue reactions by using a combination of three of the latest blood tests, one of which we have developed ourselves.

Detailed Description
-----------------
Three tubes of blood will be drawn from each subject. Two members of the study team will also independently assess each subject for the degree to which various radiation-induced soft tissue changes are evident. Subjects will be put into three groups according to the severity of the soft tissue changes which are noted, and the results of the blood tests for members of each group will be analyzed to determine whether a correlation with cosmetic outcomes can be determined. If the results are promising, they will be studied further and used as the basis for future prospective clinical trials.

Official Title
-----------------
Predictive Blood Tests for Severe Radiation Reactions in Breast Cancer Patients

Conditions
-----------------
Abnormalities, Radiation-Induced

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Breast cancer treatment: lumpectomy followed by external beam XRT to breast Age at the time of radiotherapy treatment: 45-65 years old XRT dose to breast: >/= 4500 and </= 5200 cGy, fraction size 180 or 200 cGy Dose distribution: no area receiving >/= 112% of prescribed dose Follow-ups: patients must be >/= 2.5 years post-treatment Exclusion Criteria: Reconstructive surgery to involved breast

Ages Eligible for Study
-----------------
Minimum Age: 48 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 |
| --- | --- | --- |
| correlation of the results obtained from the three blood tests with the clinical assessments of cosmetic outcome for each subject |  | at least 2.5 years following lumpectomy and radiation therapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast cancer, Radiation effects
Blephacura Versus Baby Shampoo to Treat Blepharitis

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to compare the effectiveness in treatment of chronic blepharitis either with a phospholipid liposome suspension compared to a conventional therapy recommendation using diluted baby shampoo.

Official Title
-----------------
Blephacura Versus Baby Shampoo to Treat Blepharitis

Conditions
-----------------
Blepharitis

Intervention / Treatment
-----------------
* Procedure: Group A
* Procedure: Group B


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with blepharitis 100 eyes of 100 patients (50 patients treated with Blephacura, 50 patients treated with diluted baby shampoo) The ratio of female / male is not involved. Exclusion Criteria: all patients that are not included in the group of inclusion criteria
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Patients with chronic blepharitis, that will be treated with blephacura | Procedure: Group A<br>* Blephacura is a solution with liposomes and used for cleaning of the eye lid to treat blepharitis<br>|
| Experimental: Group B<br>Patients with chronic blepharitis that will be treated with diluted baby shampoo | Procedure: Group B<br>* Diluted Baby Shampoo is used for cleaning of the eye lid to treat blepharitis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Non-investigational Study to Evaluate Adenovirus Serotype 5 (Ad5) Neutralizing Antibodies (nAb) in Patients With Chronic Hepatitis B Virus (HBV) Mono-infection

Study Overview
=================
Brief Summary
-----------------
Objectives: Primary Objective: To identify and preselect patients with chronic HBV mono infection, who are undetectable for anti-Ad5 nAb, currently being treated with nucleo(t)sides, for participation in the TG1050.02 Phase1/1b First in Man (FIM) study. Secondary Objectives: To assess the prevalence of undetectable anti-Ad5 nAb in chronic HBV mono-infected patients. Methodology: Patients with chronic HBV mono-infection, who are currently being treated with nucleo(t)sides for their HBV infection, will be enrolled in this study to measure Ad5 nAb levels. A single peripheral blood collection (4 mL) will be obtained and Ad5 nAb titers will be measured by a central laboratory using a newly validated assay.

Conditions
-----------------
Chronic Hepatitis B

Intervention / Treatment
-----------------
* Other: blood draw


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 through 65 years of age, inclusive Patients mono-infected with HBV and currently on HBV treatment for at least 2 years with either the nucleos(t)ide tenofovir (TDF) or entecavir (ENT) HBV DNA < lower limit of quantification (LLOQ) (eg, HBV deoxyribonucleic acid (DNA) < 20 IU/mL using the Roche COBAS TaqMan assay) within 6 last months Signed, written Independent Ethics Committee (IEC)-approved informed consent Exclusion Criteria: Patients with either medical history or evidence of cirrhosis, as documented in the medical source, who had: a) any biopsy showing cirrhosis; or b) any transient elastography score of ≥ 10.5 kPa or Fibrosure® / FibroTest ® score of ≥ 0.48 with either test result within past 2 years.

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: Screening


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: blood draw|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunology analysis: Serum titers of Adenovirus serotypes 5 (Ad5) neutralizing antibodies (nAb) |  | Day 1 |
Use of a Fabric Mattress Cover for Patient Comfort

Study Overview
=================
Brief Summary
-----------------
The main objective of this research project is to measure the impact on patient satisfaction of the use of a fabric mattress cover fabric on a bedsheet protecting a plastic mattress.

Official Title
-----------------
Use of a Fabric Mattress Cover for Patient Comfort

Conditions
-----------------
Patient Comfort

Intervention / Treatment
-----------------
* Other: Mattress protector for days 1 and 2
* Other: Mattress protector for days 3 and 4


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient must have given his/her informed and signed consent The patient must be insured or beneficiary of a health insurance plan The patient has a planned hospitalization > 4 days The patient is movable within 48 hours Exclusion Criteria: The patient is participating in another study The patient is in an exclusion period determined by a previous study The patient is under judicial protection, under tutorship or curatorship The patient refuses to sign the consent It is impossible to correctly inform the patient The patient is pregnant The patient is breastfeeding

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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mattress protector days 1,2<br>A mattress protector is placed in the bed for the first two days and then removed for days 3 and 4. | Other: Mattress protector for days 1 and 2<br>* A mattress protector is placed in the bed for the first two days and then removed for days 3 and 4.<br>|
| Experimental: Mattress protector days 3,4<br>A mattress protector is not placed in the bed for the first two days and then added to the bed for days 3 and 4. | Other: Mattress protector for days 3 and 4<br>* A mattress protector is not placed in the bed for the first two days and then added to the bed for days 3 and 4.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog scale for patient comfort | score ranging from 0 to 10 | 2 days | 
| Visual analog scale for patient comfort | score ranging from 0 to 10 | 4 days |
Effect of Pasta on Blood Glucose Response in Normal Subjects

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to determine whether ingestion of modified pasta products (Dreamfields, Miracle Noodles) result in an improvement in blood glucose concentration when compared with a traditional pasta.

Detailed Description
-----------------
On one occasion the pasta will be a traditionally available pasta; on another occasion, approximately 1 week later a modified pasta, advertised to contain   5 grams of digestible carbohydrate, or to be low in digestible starch, will be studied.

Official Title
-----------------
Effect of Pasta on Blood Glucose Response in Normal Subjects

Conditions
-----------------
Blood Glucose Concentration, Type 2 Diabetes, Metabolic Syndrome

Intervention / Treatment
-----------------
* Other: modified pasta


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal blood glucose concentration

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>The control arm consists of the traditional pasta. | Other: modified pasta<br>* 50 grams carbohydrate as a single breakfast meal<br>* Other names: Dreamfields Pasta, Miracle Noodles;|
| Active Comparator: Modified pasta<br>Dreamfields, Miracle Noodles | Other: modified pasta<br>* 50 grams carbohydrate as a single breakfast meal<br>* Other names: Dreamfields Pasta, Miracle Noodles;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Blood Glucose | Blood glucose will be determined by finger stick. | 0, 30, 60, 90, 120, and 180 minutes after ingestion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Low Biologically Available Glucose Diet (LoBAG diet), Diabetes, Glycemic Index
A Clinical Study of the Efficacy of Idebenone in the Treatment of iRBD Into Synucleinopathies

Study Overview
=================
Brief Summary
-----------------
142 cases of patients with iRBD will be recruited from the neurology department of Ruijin Hospital, th second Affiliated Hospital of Soochow University and wuhan Union Hospital. After the informed consent was signed, they were divided into a trial group and a control group randomly. Each group contains 71 cases. The patients in the trial group will be treated with Idebenone, while the patients in the control group was treated with placebo. Both groups of subjects will be treated for 5 years, and patients will be followed-up and evaluated in the first year, 3 years and 5 years after treatment. The observations include the MDS-UPDRS questionnaires evaluation, blood biomarker measurements and fMRI or PET-MR examination to make sure whether the patients has converted to synucleinopathies. Study hypothesis: Idebenone therapy for patients with iRBD is safe and effective in delaying disease progression into synucleinopathies.

Official Title
-----------------
A Randomized, Double-blind, Multi-center Clinical Study of the Efficacy of Idebenone in the Treatment of Primary Rapid Eye Movement Sleep Behavior Disorder Into Synucleinopathies

Conditions
-----------------
Rapid Eye Movement Sleep Behavior Disorder, Synucleinopathy

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosed of iRBD. Age between 40 and 75. Be voluntarily to participate in the experiment by signing an informed consent form. Exclusion Criteria: Sleep apnea hypopnea syndrome Slow movement, muscle rigidity, tremor or postural instability. Neurological diseases such as cerebral hemorrhage, cerebral infarction, brain trauma, brain tumor or central nervous system infection. Other sleep disorders or seizures. Alcoholism or drug addiction patients.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 75 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: trial group<br> | Drug: Idebenone<br>* trial group<br>|
| Placebo Comparator: control group<br> | Drug: Placebo<br>* control group<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effective | 5-year conversion rate of iRBD patients to synucleinopathies decreased | 5 years | 
| Ineffective | 5-year conversion rate of iRBD patients to synucleinopathies remained unchanged or increased. | 5 years |
An Intervention to Preserve Functional Status and Independence Among Community Dwelling Elderly

Study Overview
=================
Brief Summary
-----------------
This is a study aimed at identifying Olmsted County senior citizens who are at risk for vulnerability. Those elders who screen affirmatively for vulnerability will be offered participation in a pilot intervention aimed at keeping seniors independent in the community. This intervention consists of a comprehensive geriatric home visit and the development of an individualized action plan aimed at preservation of function and independence. Participants will be followed for several months after their baseline assessment to evaluate implementation of recommendations.

Official Title
-----------------
An Intervention to Preserve Functional Status and Independence Among Community Dwelling Elderly

Conditions
-----------------
Elderly

Intervention / Treatment
-----------------
* Behavioral: Geriatric home visit and Action Plan


Participation Criteria
=================
Eligibility Criteria
-----------------
Age 65 or older Olmsted County Resident Able to provide own consent English speaking or with available translator

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Geriatric home visit and Action Plan|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in VES-13 score (Pre/Post) |  |  | 
| Implementation of Action Plan Recommendations |  |  | 
| Frailty Domain Scores |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalization and Nursing home admissions |  |  |