linjc16/ctgov huggingface dataset:
A Multicenter Study on the Diagnosis and Intervention of New Biomarkers on the Prodromal Stage of Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
The prevalence of Mild Cognitive Impairment (MCI) is about 15%-17%. 10%-15% of MCI progresses to Alzheimer's disease (AD) every year. The annual incidence of MCI in the normal elderly is about 1%. is the key and difficult points in AD research. Except expensive brain β amyloid plaque imaging, few breakthroughs of early diagnosis technology of MCI due to AD can be made to facilitate clinical application. The purpose of this program is to study the reliability and validity of plasma miRNAs for early diagnosis of MCI due to AD. The clinical diagnosis of AD and MCI due to AD are according to the National Institute of Aging and the Alzheimer's Disease Association (NIA-AA) diagnostic criteria in 2011. [18F]-AV-45 plaque imaging is used to be golden criteria for the diagnosis of AD and MCI due to AD. Next, a pilot intervention study on APP/PS1 transgenic mice will be promoted based on miRNAs gene regulation.

Official Title
-----------------
Shanghai Mental Health Center

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Diagnostic Test: MicRNAs battery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 2011 NIA-AA criteria of MCI due to AD or AD Exclusion Criteria: Non AD dementia

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 85 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: AD, MCI due to AD and Normal Control
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alzheimer's disease<br> | Diagnostic Test: MicRNAs battery<br>* for MCI due to AD diagnosis<br>|
| Experimental: MCI due to AD<br> | Diagnostic Test: MicRNAs battery<br>* for MCI due to AD diagnosis<br>|
| Experimental: Normal Elderly<br> | Diagnostic Test: MicRNAs battery<br>* for MCI due to AD diagnosis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the diagnostic accuracy of biomarkers for MCI due to AD | MicRNAs battery for diagnostic of MCI due to AD | 2 years | 
| Neropsychological test battery | MicRNAs for intervene of MCI due to AD | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Number of participants with treatment-related adverse events as assessed by MicRNAs. | 2 years |
Coronary Heart Disease Risk Factors in Blacks Vs Whites

Study Overview
=================
Brief Summary
-----------------
To use data from the Epidemiologic Follow-up Study of the National Health and Nutrition Examination Survey (NHANES) to develop models to predict morbidity and mortality as a function of risk factors for coronary artery disease. Bivariate dependent survival distributions were examined.

Detailed Description
-----------------
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Coronary Disease, Heart Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- | --- |
Comparative Treatment Study in Patients With Lower Ureteral Stones

Study Overview
=================
Brief Summary
-----------------
We wish to determine the best treatment for expulsion of lower ureteral stones. Which of the three major treatment protocols is the best treatment of conservative management of ureteral stones?

Detailed Description
-----------------
The study will include 60 patients with lower ureteral stones. The patients will be divided into three groups. The first group will be administered Alfuzosin (10 mg). The second group will be administered a combination of Alfuzosin (10 mg)and Rowatinex (Pinene 31%, Camphene 15%, Anetol 4%, Borneol 10%, Cineol 3%, Fenchenol 4%, Olive Oil 33%). The third group will be administered Rowatinex.

Official Title
-----------------
Comparative Study in Patients With Lower Ureteral Stones Treated With 10 MG Alfuzosin,10 MG Alfuzosin With Rowatinex, and Rowatinex Alone

Conditions
-----------------
Urinary Calculi

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of lower ureter (urinary calculi) up to 8mm Must be able to swallow tablets Exclusion Criteria: Sensitivity to Alfuzosin and Rowatinex Pregnant and breastfeeding women Single kidney Obstructing stone Renal failure creatinine up to 1.8 mg/dl Patients using various alpha blockers Liver failure Fever higher than 38 C UTI Syncope or hypotension Patients treated with PDE5 Patients treated with inhibitor CYP3A4 Patients refusing participation

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

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

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
-----------------
Urinary Calculi, Rowatinex, Alfuzosin, Drug Therapy
Evaluation of Safety and Effects of SLx-4090 After Dosing for 14 Days in Subjects With High Triglycerides

Study Overview
=================
Brief Summary
-----------------
The purpose is to investigate the effect of oral doses of SLx-4090 over 14 days on subjects with high triglycerides.

Detailed Description
-----------------
Serum triglycerides Serum lipids and lipoproteins Safety and tolerability

Official Title
-----------------
A Randomised, Double-blind, Placebo Controlled Study to Evaluate the Pharmacodynamics, Safety, Tolerability and Pharmacokinetics Profile of SLx-4090 Over 14 Days Dosing in Subjects With High Triglyceride Values

Conditions
-----------------
Hypertriglyceridemia

Intervention / Treatment
-----------------
* Drug: SLx-4090
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subjects with high triglyceride levels Male or female subjects between age 18 and 65 years, inclusive Exclusion Criteria: History of drug abuse Any prescribed or over the counter medication taken within 2 weeks prior to administration of study drug or within 6 times the elimination half-life Blood donation of more than 500ml blood in the previous 3 months Any confirmed significant allergic reaction against any drug or multiple allergies

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: 1<br>SLx-4090 | Drug: SLx-4090<br> <br> |
| Placebo Comparator: 2<br>Matching Placebo Dose | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum triglycerides |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events and vital signs |  | 14 days |
HBOC-201 Expanded Access Protocol for Life-threatening Anemia for Whom Allogeneic Blood Transfusion is Not an Option

Study Overview
=================
Brief Summary
-----------------
The purpose of this protocol is to provide treatment with HBOC-201 to patients with life-threatening anemia for whom blood is not an option. Such patients may also be referred to in this document as patients who refuse blood transfusion (PWRBT). Other patients who potentially may require HBOC-201 treatment include those with red blood cell alloantibodies for whom immunologically compatible red blood cell units cannot be found, although these patients are less common than PWRBT.

Detailed Description
-----------------
This is an open label intermediate-size patient population expanded access IND protocol. Due to our experience with management of severely anemic patients for whom blood is not an option, we anticipate encountering future patients with life-threatening anemia for whom blood is not an option. Blood is not an option in the following circumstances: refusal of transfusion lack of compatible red blood cells due to alloimmunity All patients with life-threatening anemia for whom blood is not an option will be treated as per the standard procedure. If those measures are not successful and the life-threatening anemia persists, then at the investigator's discretion treatment with HBOC-201 will then be considered.

Official Title
-----------------
Expanded Access Protocol Using HBOC-201

Conditions
-----------------
Anemia

Intervention / Treatment
-----------------
* Drug: HBOC-201


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients ≥ 18 years of age Critically ill patients with hemoglobin < 5 g/dL (or 6-7 g/dL with significant active bleeding), and physiologic evidence of critical ischemia, for example: elevated troponins, altered mental status, acute renal failure, lactic acidosis or evidence of central nervous system acute deficits Patients or their Legally Authorized Representative who are able and willing to provide informed consent Blood is not an option due to: refusal of transfusion lack of compatible red blood cells Exclusion Criteria: Patients with known hypersensitivity or allergy to beef products Patients with pre-existing uncontrolled hypertension, heart failure, renal failure, circulatory hypervolemia or systemic mastocytosis* Patients who are eligible for blood transfusions Patients who are > 80 years old* Pregnant Lactating on a case by case and quality of life determination

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: HBOC-201|Hemoglobin Based Oxygen Carrier (HBOC)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
TacTIC- Trans-disciplinary Chronic Disease Continuity of Care Model

Study Overview
=================
Brief Summary
-----------------
The overall aim of this study is to create a trans-disciplinary chronic disease continuity of care model with health information technology, utilizing mobile devices such as tablets, iPads and smartphones.

Detailed Description
-----------------
This study aims to explore if a trans-disciplinary chronic disease continuity of care model with integrated technology (mobile devices such as tablets, iPads and smartphones) to standard practice (patient-centered, coordinated care model without the integration of technology) will results in a reduction in 30-day readmission rate in adult patients.

Official Title
-----------------
TacTIC- Trans-disciplinary Chronic Disease Continuity of Care Model

Conditions
-----------------
Chronic Disease, Geriatrics

Intervention / Treatment
-----------------
* Behavioral: TacTic care model
* Behavioral: Standard of care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients on a 43 bed medical surgical unit Adult patients on 44 bed geriatric unit Exclusion Criteria: Adult patients admitted and not diagnosed with chronic disease Patients who are transferred between Intervention and non-Intervention unit Patients who refuse Patients with delirium, dementia and altered mental status Patients who cannot read and write in any language Patients in the intervention group who cannot use mobile technology

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: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: TacTIC care model<br>Compare the 30-day readmission rate in adult patients who receive care in a trans-disciplinary chronic disease continuity of care model with integrated technology (mobile devices such as tablets, iPads and smartphones) | Behavioral: TacTic care model<br>* Patients receive care in a trans-disciplinary chronic disease continuity of care model integrated with technology (mobile devices such as tablets, iPads and smartphones<br>|
| Other: Standard of Care<br>Compare standard practice (patient-centered, coordinated care model without the integration of technology | Behavioral: Standard of care<br>* Patients receive care in a patient-centered, coordinated care model without the integration of technology<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in the 30-day readmission rates in adult patients who receive care in a trans-disciplinary chronic disease continuity of care model integrated with technology (mobile devices such as tablets, iPads and smartphones). |  | 30 days |
Adverse Event Data Collection From the EUHASS Registry on Turoctocog Alfa Pegol

Study Overview
=================
Brief Summary
-----------------
This non-interventional study concerns a safety data collection based on adverse event data from a third-party registry (European Haemophilia Safety Surveillance System, EUHASS) that includes information about adverse events from patients with haemophilia A treated with turoctocog alfa pegol. There is no extra burden to the patients by participating in this registry-based data collection.

Official Title
-----------------
Adverse Event Data Collection From the EUHASS Registry on Turoctocog Alfa Pegol

Conditions
-----------------
Haemophilia A

Intervention / Treatment
-----------------
* Drug: Turoctocog alfa pegol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participation in the European Haemophilia Safety Surveillance System (EUHASS). Exclusion Criteria: N/A
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Haemophilia A patients<br>All patients with haemophilia A treated with turoctocog alfa pegol and reporting adverse events to EUHASS. | Drug: Turoctocog alfa pegol<br>* Patients will be treated with commercially available turoctocog alfa pegol according to routine clinical practice at the discretion of the treating physician. A decision to initiate treatment with commercially available turoctocog alfa pegol has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in the registry in scope.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events (AEs) reported to the registry with suspected relation to turoctocog alfa pegol, Adverse Drug Reactions (ADRs), in patients with haemophilia A for renal, hepatic and neurological events. | Count | From start to end of data collection (December 2019 to January 2025) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other AEs reported to the registry during the study period with suspected relation to turoctocog alfa pegol in patients with haemophilia A | Count. Includes ADRs of special interest (de novo FVIII inhibitors equal to or above 0.6 Bethesda Units (BU)); anaphylaxis and other allergic reactions; thromboembolic events). | From start to end of data collection (December 2019 to January 2025) |
Efficacy Comparative Study Between Tears Again®, Opticol® and Optive®

Study Overview
=================
Brief Summary
-----------------
Primary Purpose: To compare the efficacy in treating dry eye syndrome in contact lens wearers or computer users of Tears Again® versus Opticol® versus Optive® Secondary Purpose: Subjective evaluation of symptomatology Evaluation of preference in different kind of administration - spray versus monodoses versus multi-doses

Official Title
-----------------
Efficacy Comparative Study Between Tears Again®, o Opticol® e o Optive® in Clinical and Symptomatology Treatment of Dry Eye Syndrome in Contact Lens Wearers and/or Computers Users

Conditions
-----------------
Dry Eye Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed Consent signed Age >18 years and < 55 years Daily wearer of soft contact lens and/or daily (> 4 hours/day) computer user Exclusion Criteria: Dry eye Syndrome other than of evaporative etiology, according to DEWS Ocular or systemic disease that can affect the normal tear film Pregnancy or pregnancy risk (no contraceptive method), lactation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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 |
| --- | --- |
| 1Tears Again/Control<br> | |
| 2Opticol/Control<br> | |
| 3Optive/Control<br> | |
| 4Tears Again/Opticol<br> | |
| 5Tears Again/Optive<br> | |
| 6Opticol/Optive<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
The EXPLORE MG Registry for Myasthenia Gravis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to create a Yale University Department of Neurology Myasthenia Gravis (MG) registry that will be used for current and future research projects involving the study of Myasthenia Gravis.

Detailed Description
-----------------
This registry will allow for the research of several mechanisms of Myasthenia Gravis (MG) by studying peripheral blood, stool, disease status and course, and treatment of subjects with MG. The EXPLORE-MG Registry focuses on varied aspects of MG such as disease management, health care utilization, health costs, disease characteristics, and diagnostic tools. As such, it will aid in a broader understanding of MG, while providing a registry from which questions about the disease may be better answered.

Official Title
-----------------
Exploring Outcomes and Characteristics of Myasthenia Gravis: The EXPLORE MG Registry

Conditions
-----------------
Myasthenia Gravis

Intervention / Treatment
-----------------
* Other: Blood Sample Draw


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients diagnosed with Myasthenia Gravis presenting to the Yale Department of Neurology for clinical care or research interventions will be invited to donate their biological specimens/clinical data. Exclusion Criteria: Failure to meet the Inclusion Criteria.

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- |
| Neurological Outpatients<br>Participants in this group will be recruited from the outpatient clinical population at the Yale University Department of Neurology. Treating physicians will make the initial determination of patients' potential eligibility to participate in the study. | Other: Blood Sample Draw<br>* Approximately 100 cc (less than 1/2 cup) of blood will be drawn from both groups.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of successful blood draws will be reported at the conclusion of the sample collection | Successful Collection of Blood | 8 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of stool samples collected will be reported at the conclusion of the sample | Count of Stool Samples | 8 years |