linjc16/ctgov huggingface dataset:
Effects of Cyclosporine A on Pancreatic Insulin Secretion

Study Overview
=================
Brief Summary
-----------------
Our primary aim is to investigate if cyclosporine A reduces insulin secretion.

Detailed Description
-----------------
Our primary aim is to investigate if cyclosporine A may reduce insulin secretion by 20% or more. In order to get cyclosporine A naïve patients we will perform this investigation in dialysis patients on the waiting list for a renal transplantation. In addition we will investigate if also the peripheral insulin sensitivity and endothelia function is affected by cyclosporine A treatment in these patients. Since these patients will be treated with cyclosporine A we will also measure cyclosporine pharmacokinetics at the time of investigation and repeat this investigation at the time of the first week following transplantation in order to evaluate if a pretransplant cyclosporine dose can be of value in predefining the dose to be used at the time of transplantation.

Official Title
-----------------
Effects of Cyclosporine A on Pancreatic Insulin Secretion

Conditions
-----------------
Chronic Renal Failure

Intervention / Treatment
-----------------
* Drug: cyclosporine A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Renal failure patients on dialysis which is planned to receive a renal transplant Exclusion Criteria: Age below 18 years or above 75 years Pregnancy Breast feeding mothers Diabetes mellitus /WHO criteria) Dialysis treatment less than 2 months Serious coronary heart disease Unstable angina pectoris Recent acute infarction (less than 3 months) Non-compensated heart failure Simultaneous treatment with glucocorticosteroids (e.g. prednisolone, dexamethasone), diltiazem, verapamil, erythromycin, clarithromycin, telithromycin, rifampicin, fluconazole, itraconazole, ketoconazole, voriconazole, indinavir, nelfinavir, ritonavir, nefazodone, bosentan, carbamazepine, St. John's worth, grapefruit.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: cyclosporine A|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin secretion |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peripheral insulin sensitivity |  |  | 
| Endothelial function |  |  | 
| Pharmacokinetics |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
glucose intolerance, insulin, microvascular function, genotyping, CYP3A5, pharmacokinetics, renal transplantation
A Study to Identify Markers in Blood and Tissue of HPV Clearance

Study Overview
=================
Brief Summary
-----------------
This is a research study looking at gene characteristics in blood and Pap smear samples in hopes of identifying markers that will predict if the HPV infection is present or not.

Detailed Description
-----------------
Because infection with high-risk human papillomavirus is a necessary cause of cervical cancer, HPV testing has many potential uses in cervical cancer screening. Unfortunately, like cytology, it suffers from a lack of specificity when used for population-based screening. Given that HPV testing detects more cases of CIN3+ than cytology and that it would probably be more practical in developing regions, finding a biomarker that would increase specificity has been the goal for much research on HPV and cervical cancer. The goal of this study is to explore potential predictors of viral clearance, specifically RNA levels of candidate genes in cervical swabs and host genetic polymorphisms, in the context of genotype-specific infection data.

Official Title
-----------------
Biomarkers of HPV Clearance: A Prospective Study

Conditions
-----------------
HPV Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HPV positive Exclusion Criteria: Negative for HPV

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| UA<br>HPV positive | |

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
-----------------
HPV, Women of the state of Alabama, CIN 1, negative biopsy, normal colposcopy
Investigation of the Effect of Scan Delay on the Measurement of Dental Prescale II

Study Overview
=================
Brief Summary
-----------------
Dental Prescale II (GC Corp., Tokyo) is a pressure sensitive sheet for occlusal force measurement. According to the instruction, the patient need to bite the sheet for about 3 seconds and then the sheet will be scanned. But the delay response of coloring agent will influence the data collected and was noticed in vitro. To have a standard procedure, we need to know the time for scanning. This study will scan the sheet up to 2 hours and try to find the relation between the time the sheet scanned and the data collected.

Official Title
-----------------
Investigation of the Effect of Scan Delay on the Measurement of Dental Prescale II

Conditions
-----------------
Bite Force, Scan Delay

Intervention / Treatment
-----------------
* Device: Dental Prescale II


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusive criteria: full dentition except third molar healthy periodontal condition can sign consent Exclusive criteria: history of temporomandibular disorders

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dental Prescale II used<br> | Device: Dental Prescale II<br>* The participant will bite Dental Prescale II for about 3 seconds, using a force for  chewing beef . And the Dental Prescale II will be taken out from the mouth. Then the trial is end.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The relation between occlusal force and scanning time | After Dental Prescale II is used and cleaned, the first time of scanning will be defined as 0 min. The pressure sensitive sheet will be scanned every minute during 0 15 minutes, and at 30, 60, 90 and 120 minutes. | immediately after the intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dental Prescale II,Scan Delay
Effects of Advertising on Young Children's Perception of Taste

Study Overview
=================
Brief Summary
-----------------
To test whether young children's actual taste preferences are influenced by the natural marketing environment in which they live. To do so, we tested whether preschool children would like the taste of a food more if they thought it was from a heavily marketed source. We asked preschool children to taste identical foods in packaging from this heavily marketed source and plain packaging, and to tell us if they tasted the same or if one tasted better. We hypothesized that, even among a sample of 3-5 year olds participating in Head Start, a federally-sponsored preschool program for low-income families, young children would prefer the taste of foods perceived to be from the heavily marketed source.

Official Title
-----------------
Effects of Advertising on Young Children's Perception of Taste

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Behavioral: Packaging and identification of source


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: enrolled at participating head start sites Exclusion Criteria: unable to complete the study procedures

Ages Eligible for Study
-----------------
Minimum Age: 0 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Packaging and identification of source|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
-----------------
Taste, preschool children, fast food
AL-15469A for the Treatment of Bacterial Conjunctivitis

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine whether AL-15469A is safe and effective in the treatment of bacterial conjunctivitis.

Official Title
-----------------
An Evaluation of the Safety and Efficacy of Moxifloxacin AF Ophthalmic Solution 0.5% for the Treatment of Bacterial Conjunctivitis in India

Conditions
-----------------
Bacterial Conjunctivitis

Intervention / Treatment
-----------------
* Drug: Moxifloxacin Alternative Formulation Ophthalmic Solution 0.5%
* Drug: Moxifloxacin hydrochloride ophthalmic solution 0.5% as base


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: signs and symptoms of bacterial conjunctivitis Other protocol-defined inclusion criteria may apply Exclusion Criteria: under 1 mo. age Other protocol-defined exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum 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
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moxifloxacin<br> | Drug: Moxifloxacin Alternative Formulation Ophthalmic Solution 0.5%<br>* 1 drop into the conjunctival sac of both eyes 3 times a day for 3 days<br>|
| Active Comparator: VIGAMOX<br> | Drug: Moxifloxacin hydrochloride ophthalmic solution 0.5% as base<br>* 1 drop into the conjunctival sac of both eyes 3 times a day for 3 days<br>* Other names: VIGAMOX;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical cure and microbiological success |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Individual signs and symptoms of bacterial conjunctivitis at each visit |  |  |
Natural History Study of MNGIE

Study Overview
=================
Brief Summary
-----------------
Non-interventional, prospective, multicenter, natural history study of patients with mitochondrial neurogastrointestinal encephalomyopathy (MNGIE)

Official Title
-----------------
Natural History Study of Mitochondrial Neurogastrointestinal Encephalomyopathy

Conditions
-----------------
Mitochondrial Neurogastrointestinal Encephalomyopathy

Intervention / Treatment
-----------------
* Other: Non-interventional


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Has MNGIE Exclusion Criteria: Substance abuser

Ages Eligible for Study
-----------------
Minimum Age: 5 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 |
| --- | --- |
| MNGIE Patients<br>Patients with mitochondrial neurogastrointestinal encephalomyopathy | Other: Non-interventional<br>* Non-interventional natural history study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MNGIE Clinical Course | To evaluate the clinical course of MNGIE patients | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MNGIE
The Efficacy and Safety of Qizhiweitong Granule on Patients With Functional Dyspepsia in a Multi-center Clinical Study

Study Overview
=================
Brief Summary
-----------------
The study aims to verify the efficacy and safety of Qizhiweitong granule on Chinese patients with functional dyspepsia diagnosed by the Rome III criteria. It includes two subtypes of functional dyspepsia, postprandial distress syndrome or abdominal pain syndrome.

Conditions
-----------------
Functional Dyspepsia

Intervention / Treatment
-----------------
* Drug: Qizhiweitong granule


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient with written ICF signed patient with functional dyspepsia diagnosed by the Rome III criteria age between 18y and 65y;male or female. patient without gastric ulcers, erosive gastritis or other gastric organic diseases according to the endoscopy in the past one year in the hospital patient without hepatobiliary and pancreatic diseases according to B-ultrasoundin the past one year in the hospital patient with normal ECG (QT interval in the normal range) within one month prior to enrollment in this center patient with symptoms of only one subtype of functional dyspepsia Exclusion Criteria: history of abdominal surgery; take drugs related to gastrointestinal motility or gastric acid secretion and gastric acid drugs, anti-Helicobacter pylori drugs within 5 days of inclusion suffering from hepatobiliary and pancreatic diseases with B ultrasound suffering from high blood pressure and uncontroled hypertension diabetes mellitus have history of thyroid disease, systemic sclerosis, systemic lupus erythematosus severe mental disorders pregnant women, breastfeeding women or those who plan to become pregnant allergy to Qizhiweitong particle have symptoms of both subtypes of functional dyspepsia

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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Qizhiweitong granule<br>2.5g/time,tid,oral administration,6 weeks | Drug: Qizhiweitong granule<br> <br> |
| Placebo Comparator: Placebo<br>2.5g/time,tid,oral administration,6 weeks | Drug: Qizhiweitong granule<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| symptom severity score |  | 3 days |
MEDCEM PC and MTA in Pulpotomies of Primary Molars

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to evaluate and compare, clinically and radiographically,the effects of MEDCEM PC and MTA when used as pulp dressings following pulpotomy in human primary molars.

Conditions
-----------------
Evaluate the Effects of MEDCEM PC and MTA in Pulpotomies of Primary Molars.

Intervention / Treatment
-----------------
* Procedure: Pulpotomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy children molars showing: symptomless exposure of vital pulp by caries no clinical or radiographic evidence of pulp degeneration (excessive bleeding from the root canal, internal root resorption, inter-radicular and/or furcal bone destruction) the possibility of proper restoration of the teeth no physiological resorption of more than one-third of the root Exclusion Criteria: presence of systemic pathology history of allergic reaction to latex, local anaesthetics or to the constituents of the test pulp dressing agents

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 10 Years

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

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

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 |
| --- | --- |
| Active Comparator: MTA<br>ProRoot® MTA is a root canal repair material that is a unique improvement over other materials used for root canal repair. Made up of fine hydrophilic particles that set in the presence of water, ProRoot® MTA seals off all pathways between the root canal system and surrounding tissues, significantly reducing bacterial migration. Its excellent compatibility with the dentinal wall allows for a predictable clinical healing response. | Procedure: Pulpotomy<br> <br> |
| Experimental: MedCem Portland Cement (PC)<br>MedCem PC is an excellent capping material for cariology on permanent teeth (direct and indirect capping) and in milk tooth endodontics (milk tooth amputation). Is characterized by excellent colour stability and neutrality and does not contain any additional ingredients | Procedure: Pulpotomy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical success | No pain, no swelling, no fistula or sinus tract, no pathologic mobility | 24 months | 
| Radiographic success | No internal root resorption progressing into the bone, no external root resorption, no furcation and/or periapical bone destruction | 24 months |
Colon Cancer Risk-stratification Via Optical Analysis of Rectal Ultrastructure

Study Overview
=================
Brief Summary
-----------------
This is a study whose focus is on understanding the clinical utility of rectal ultrastructure in detecting colonic neoplasm. The method uses Low-coherence Enhanced Backscattering Spectroscopy (LEBS).

Detailed Description
-----------------
The investigators use an optic probe which is a small device that uses light to assess the colon tissue. This probe will be used to identify subjects who do and do not have precancerous changes in the colon by capturing the light reflected back from the rectal wall and that will be assessed without the need for colonoscopy and bowel preparation (i.e unprepped). This device may detect early cancerous changes in colon tissue with higher accuracy than current tests.

Official Title
-----------------
Colon Cancer Risk-stratification Via Optical Analysis of Rectal Ultrastructure

Conditions
-----------------
Colon Cancer

Intervention / Treatment
-----------------
* Device: LEBS - Low coherence enhanced backscattering


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Subjects are eligible if they were scheduled for colonoscopy for colon cancer screening or surveillance Exclusion Criteria: age <50 personal/family history of colonic neoplasia personal history of coagulopathy (retrospectively) failure to complete or inadequate colonoscopy any patients harboring non-pathoglocially normal rectum (i.e. presence of lesion, inflammation, polyp, adenomas at rectum)

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: LEBS - Low coherence enhanced backscattering|Unprepped patients will have the LEBS probe brought into contact with the rectal mucosa, upon which 10 random readings will be obtained.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Whether rectal LEBS readings can predict the presence of advanced adenomas in the colon. |  | Through study completion, an average of 1 year |
Biomarkers in Tumor Tissue Samples From Younger Patients With Rhabdomyosarcoma

Study Overview
=================
Brief Summary
-----------------
This research trial studies biomarkers in tumor tissue samples from younger patients with rhabdomyosarcoma. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer

Detailed Description
-----------------
PRIMARY OBJECTIVES: I. To demonstrate CRKL expression at the protein level in rhabdomyosarcoma tumors by tissue microarray (TMA). OUTLINE: Archived tumor tissue samples are analyzed for CRKL expression.

Official Title
-----------------
Observational - CRKL Expression at the Protein Level in Rhabdomyosarcoma Tumors by Tissue Microarray (TMA)

Conditions
-----------------
Alveolar Childhood Rhabdomyosarcoma, Childhood Rhabdomyosarcoma, Embryonal Childhood Rhabdomyosarcoma

Intervention / Treatment
-----------------
* Other: laboratory biomarker analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Alveolar rhabdomyosarcoma and embryonal rhabdomyosarcoma specimens from the Children Oncology Group (COG) tumor microarrays (TMAs)
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Basic science (biomarker analysis)<br>Archived tumor tissue samples are analyzed for CRKL expression. | Other: laboratory biomarker analysis<br>* Correlative studies<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CRKL expression at the protein level |  | 1 month |