linjc16/ctgov huggingface dataset:
Amyloid Beta-peptide 1-40 and Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
The combined measurement of Ab42 and tau protein (total and phosphorylated) in the spinal fluid has been shown to be promising in the diagnosis of Alzheimer's disease (AD), and has justified its inclusion new diagnostic criteria. However, it can sometimes yield discordant results that are not discriminant (isolated variation in Ab42 or P-181 Tau). To answer this challenge, a new marker has been developed in recent years, namely amyloid beta-peptide 1-40 (Aβ40). This marker reflects the patient's total amyloid deposits and is used to calculate the Aβ42/Aβ40 ratio. This ratio measures the relative variation of Aβ42 as compared to the total amyloid burden. Literature data on this topic are sparse and to date, no report has been published evaluating the utility of this marker in the diagnostic strategy for AD.

Official Title
-----------------
Utility of Amyloid Beta-peptide 1-40 Measurement in the Diagnosis of Alzheimer's Disease

Conditions
-----------------
Alzheimer Disease

Intervention / Treatment
-----------------
* Biological: spinal fluid collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients attending the Memory Clinic of Champagne-Ardennes for memory disorders, and Whose diagnostic work-up requires assessment of biomarkers present in the cerebrospinal fluid are considered eligible for inclusion in this study. Exclusion Criteria: Patients who do not have any social security coverage will not be included.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AD Patients<br> | Biological: spinal fluid collection<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of diagnostic certitude for AD (diagnosed cases) |  | six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dementia, biomarkers, cerebrospinal fluid
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for Autism

Study Overview
=================
Brief Summary
-----------------
This trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Autism

Detailed Description
-----------------
Studies have shown that stem cell treatment is safe and efficacious for the treatment of Autism. Patients with Autism will receive a single intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells. The total dose for the infusion will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy. For patients with more severe disease an autologous Effector cells (activated lymphocytes) treatment will be utilized created from the patient's own cells obtained by apheresis.

Official Title
-----------------
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Autism

Conditions
-----------------
Autism

Intervention / Treatment
-----------------
* Biological: AlloRx


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Autism Exclusion Criteria: Active infection Active cancer Chronic multisystem organ failure Pregnancy Clinically significant Abnormalities on pre-treatment laboratory evaluation Medical condition that would (based on the opinion of the investigator) compromise patient's safety Previous organ transplant Seizure disorder Hypersensitivity to sulfur
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: Treatment Group<br>One intravenous infusion of 100 million cells | Biological: AlloRx<br>* cultured allogeneic adult umbilical cord derived mesenchymal stem cells<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (adverse events) | Clinical monitoring of possible adverse events or complications | Four year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: Autism Treatment Evaluation Checklist (ATEC) | ATEC is a questionnaire to measure changes in severity in response to treatment. It will be completed for each follow up point. | Four year follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Autism, stem cell treatment
Models for Evaluate the Proximity of the Moon on the Frequency of Births

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to establish the relationship between moon and births through two analytic models.

Detailed Description
-----------------
Retrospective, descriptive and observational study. Classical model performs comparisons of births among lunar periods, lineal, cubical and exponential estimation was performed in the SPSS software and the inflection point of the curve was estimated using the formula x=[In (1/ebx)]/ebx in the Geogebra model. The significance was establish by a p value of ≤ 0.05 (95% IC). The second analysis was performed by the difference of media between all the stages of the moon cycle as in another trials. The difference was establish by the T-student test. The difference between groups was performed by the one way ANOVA test. This study had the review and approval from the Ethics Committee of the institution and according with Mexican regulation, and in adherence to the Helsinki declaration and International Conference for Harmonisation

Official Title
-----------------
Two Models for Evaluate the Effect of the Proximity of the Moon on the Frequency of Births. Study on Mexican Population

Conditions
-----------------
Establish the Relationship Between Moon and Births

Intervention / Treatment
-----------------
* Behavioral: pregnancy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women from January 2009 until June 2013 Exclusion Criteria: Pregnant women from any other period of time
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Treatment<br>Defined population (pregnant women) compared on a environmental moon luminosity influence | Behavioral: pregnancy<br>* Observational study in order to establish relationship between moon and births<br>* Other names: Statistics analysis;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First model of analysis (Classic model) | Initial association was tempted to be done based on previous analysis described. The Gibada moon phase showed a significant difference versus Full moon and new moon, due to average birth is increased in this phase | up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Second model of analysis. Luminosity - Births | For this analysis, the moon luminosity was estimated as percentage (%), as a measure of proximity between moon and the earth, and was correlated to number of births. More the percentage of light is, closest to the earth the moon is. | up to 34 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
moon, parturition, moon phases
Fluvastatin After Heart Transplantation

Study Overview
=================
Brief Summary
-----------------
Statin therapy is a treatment with a proven positive impact on survival after heart transplantation. However, it is unclear whether the beneficial effect of this class of drugs depends solely on their LDL-lowering properties or on anti-inflammatory and immuno-modulatory properties. Thus, this study was designed to compare safety and efficacy of two different strategies: 1. high fixed statin dose vs. 2. low starting dose with LDL-driven doses adjustments.

Official Title
-----------------
Safety and Efficacy of Fluvastatin in Heart Transplant Recipients

Conditions
-----------------
Heart Transplantation, Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: fluvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: De novo heart transplantation Exclusion Criteria: Known allergy/intolerance to fluvastatin; Preexisting neuromuscular disorders; Significant liver disease and/or elevation of transaminase exceeding 3 times the ULN Severe renal impairment : creatinine > 3 mg/dL Intellectual/cognitive impairment likely to compromise informed consent or adherence to protocol or age <18 years. Patients refusal 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Fluvastatin 80mg | Drug: fluvastatin<br>* Fluvastatin 80 mg (Arm 1) vs. Fluvastatin 20 mg (Arm 2) increased according with LDL concentrations<br>* Other names: Lescol;|
| Active Comparator: 2<br>Fluvastatin 20, tapered up according to LDL concentration | Drug: fluvastatin<br>* Fluvastatin 80 mg (Arm 1) vs. Fluvastatin 20 mg (Arm 2) increased according with LDL concentrations<br>* Other names: Lescol;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Safety And Efficacy Of Bosutinib

Study Overview
=================
Brief Summary
-----------------
The objective of this surveillance is to collect information about adverse drug reaction not expected from the LPD (unknown adverse drug reaction) the incidence of adverse drug reactions in this surveillance factors considered to affect the safety and/or efficacy of this drug.

Detailed Description
-----------------
The patients should be registered by central registration system.

Official Title
-----------------
DRUG USE INVESTIGATION OF BOSUTINIB FOR CML (POST MARKETING COMMITMENT PLAN)

Conditions
-----------------
Chronic Myelogenous Leukemia

Intervention / Treatment
-----------------
* Drug: Bosutinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic myelogenous leukemia patients resistant or intolerant to prior treatment there is no experience with this drug Newly-diagnosed chronic phase Chronic myelogenous leukemia patients there is no experience with this drug Exclusion Criteria: Patients with a history of hypersensitivity Women who may possibly be pregnant or become pregnant

Ages Eligible for Study
-----------------
Minimum Age: 0 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 |
| --- | --- |
| Bosutinib<br> | Drug: Bosutinib<br>* The recommended adult dose of bosutinib is 500 mg orally once daily with food. For newly-diagnosed chronic phase CML, the recommended dose is 400 mg. The dose may be adjusted appropriately according to the patient's condition; however, the maximum dose is 600 mg once daily.<br>* Other names: BOSULIF;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of adverse drug reactions |  | 24 weeks | 
| Cytogenetic response |  | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Drug use investigation in Japan
Prosthetic and Biological Complications of Implant Supported Prostheses

Study Overview
=================
Brief Summary
-----------------
complications of implant retained prostheses

Detailed Description
-----------------
counting and analyzing the prosthetic and biological complications of the fixed and removable implant retained prostheses in the completely edentulous patients

Official Title
-----------------
Prosthetic and Biological Complications of Implant Retained Fixed Versus Removable Telescopic Overdentures

Conditions
-----------------
Implant Complication

Intervention / Treatment
-----------------
* Device: telescopic overdenture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: completely edentulous patients Exclusion Criteria: medically free adequate bone quality and quantity
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 |
| --- | --- |
| telescopic overdenture group<br>patients receiving implant retained telescopic overdentures | |
| fixed group<br>patients receiving fixed implant prostheses | Device: telescopic overdenture<br>* fixed implant retained prostheses<br>* Other names: fixed implant prosthses;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| biological complications | biological complications of implant retained prostheses | one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prosthetic complications | prosthetic complications of implant retained prostheses | three months after delivery of the prostheses | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dental implant prosthesis, completely edentulous
Phase II Study of Lactulose and Circadian Rhythms in Patients With Cirrhosis

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Assess the effect of lactulose on the circadian rhythm of plasma melatonin in patients with subclinical hepatic encephalopathy. II. Assess the intrasubject variability of circadian melatonin levels and neuropsychological tests. III. Assess which elements of the neuropsychological test battery show the response to lactulose.

Detailed Description
-----------------
PROTOCOL OUTLINE: Patients are alternately assigned to 1 of 2 treatment groups: no therapy for 3 weeks followed by lactulose for 3 weeks versus lactulose for 3 weeks followed by no therapy for 3 weeks. A dietician advises patients on a 1 g/kg per day protein diet. The lactulose dose is adjusted to result in 2 or 3 loose bowel movements per day.

Conditions
-----------------
Portal Hypertension, Hepatic Encephalopathy, Cirrhosis

Intervention / Treatment
-----------------
* Drug: lactulose


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Clinical diagnosis of cirrhosis with portal hypertension or portal-systemic shunting --Prior/Concurrent Therapy-- No concurrent therapy for hepatic encephalopathy --Patient Characteristics-- Age: Under 65 Performance status: Not specified Hematopoietic: Not specified Hepatic: See Disease Characteristics Renal: Not specified Other: No alcohol intake within 1 month prior to entry No requirement for beta blockers No requirement for corticosteroids Not in intercontinental travel

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 64 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: lactulose|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
-----------------
cardiovascular and respiratory diseases, cirrhosis, gastrointestinal disorders, hypertensive disorder, portal hypertension, rare disease
Prophylactic Treatment With Oseltamivir

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the efficacy of 5-day versus 10-day oseltamivir prophylactic treatment in patients who had been exposed to influenza.

Official Title
-----------------
Duration of Prophylactic Treatment With Oseltamivir: A Randomized Clinical Trial

Conditions
-----------------
Influenza, Human

Intervention / Treatment
-----------------
* Drug: Oseltamivir Oral Capsule for 5 days post-exposure
* Drug: Oseltamivir Oral Capsule for 10 days post-exposure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older exposure to influenza during hospitalization risk factors for influenza complications consent for participation obtained Exclusion Criteria: younger than 18 years hematological malignancy hospitalized in intensive care unit refusal to participate

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 5 days<br>oral oseltamivir 75 mg once daily for 5 days post-exposure | Drug: Oseltamivir Oral Capsule for 5 days post-exposure<br>* Patients will receive oseltamivir for 5 days after last influenza exposure.<br>|
| Active Comparator: 10 days<br>oral oseltamivir 75 mg once daily for 10 days post-exposure | Drug: Oseltamivir Oral Capsule for 10 days post-exposure<br>* Patients will receive oseltamivir for 10 days after last influenza exposure.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of influenza like illness 10 days after oseltamivir prophylactic therapy | Experiencing influenza like illness as self assessed by a patient and/or as assessed by a medical doctor while on prophylaxis with oseltamivir and during the following 10 days. | 10 days after oseltamivir prophylactic therapy |
Home Screening for Chlamydia Surveillance

Study Overview
=================
Brief Summary
-----------------
This is a randomized controlled trial to determine whether a home screening test for chlamydia and gonorrhea will lead to increased use of screening tests and increased detection of sexually transmitted diseases.

Detailed Description
-----------------
This is a phase III randomized controlled trial. We enrolled 403 young women from a variety of clinical settings and neighborhoods in the Pittsburgh, PA region. Women completed a baseline questionnaire and then were randomized to either an intervention group (receive home testing kit every six months) or to a control group (receive a letter suggesting a clinic visit for screening). Participants were followed for 2 years, and medical chart abstraction was done to document tests done in clinical settings. The final study end points were number of tests completed, number of screening tests completed, number of STDs detected, and incident cases of pelvic inflammatory disease.

Official Title
-----------------
Home Screening for Chlamydia Surveillance

Conditions
-----------------
Chlamydia Trachomatis, Gonorrhea

Intervention / Treatment
-----------------
* Behavioral: home testing kit


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 15 to 29, 2 or more risk factors for STDs, sexually active - Exclusion Criteria: currently pregnant, homeless -

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 29 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: home testing kit|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| chlamydia and gonorrhea tests completed |  |  | 
| chlamydia and gonorrhea infections detected |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pelvic inflammatory disease cases detected |  |  |