linjc16/ctgov huggingface dataset:
Clinical Evaluation of an Investigational Blood Creatinine Point-of-Care Test Device

Study Overview
=================
Brief Summary
-----------------
This study is being done to see if the Nova Creatinine Meter can give a correct measure of creatinine (a blood test used to measure kidney function) when the blood is taken from a capillary (smallest type of blood vessels). The Nova Creatinine Meter is a hand held device that can be used in a clinic to measure creatinine in about 50 seconds. Current laboratory creatinine testing can take up to an hour. Since chemotherapy patients need to have their creatinine measured prior to treatment, this meter could make testing easier and faster.

Official Title
-----------------
Clinical Evaluation of an Investigational Blood Creatinine Point-of-Care Test Device

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Other: hand-held POC creatinine analyzer-blood test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written Informed Consent Must have a creatinine > or = to than 3.5 mg/dl Exclusion Criteria: Patients who are less than 18 years of age

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 |
| --- | --- |
| 1<br>Patients having a creatinine drawn | Other: hand-held POC creatinine analyzer-blood test<br>* This study will require the collection of a finger-puncture capillary blood specimen in addition to one green stoppered heparin containing collection tube. This is taken pre-therapy. The capillary whole blood specimen will be used to perform a creatinine determination on the investigational hand-held creatinine analyzer using special test strips for the analysis.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcomes would be, reduced wait time and increased patient satisfaction. |  | conclusion of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduced blood loss |  | conclusion of the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple Diseases
Quetiapine Augmentation in Severe Obsessive Compulsive Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the efficacy of quetiapine or placebo added to baseline treatment of SSRI/clomipramine for the treatment of OCD in adult subjects.

Official Title
-----------------
Quetiapine Augmentation in Severe Obsessive Compulsive Disorder (OCD) - Pilot Study

Conditions
-----------------
Obsessive Compulsive Disorder

Intervention / Treatment
-----------------
* Drug: quetiapine fumarate
* Drug: SSRI/Clomipramine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent, men and women aged ³18 to £65 years with diagnosis of OCD, at least 12 weeks of treatment with SSRI or clomipramine Exclusion Criteria: Substance abuse or dependence, female patients who are pregnant, lactating or at risk of pregnancy, known intolerance or lack of response to quetiapine, use of antihypertensive medication with changing doses

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

| Intervention/Treatment |
| --- |
|Drug: quetiapine fumarate|nan|
|Drug: SSRI/Clomipramine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change of OCD symptoms from baseline to endpoint on the total Y-BOCS score. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of comorbid psychiatric symptoms and measures of quality of life from baseline to endpoint documented by different scales. |  |  | 
| Evaluation of the safety and tolerability profile of quetiapine compared to placebo added to a baseline medication of SSRI/clomipramine. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obsessive Compulsive Disorder (OCD)
A Study to Assess the Disturbances in Calcitonin Gene in Patients With Gum Disease and Osteoporosis

Study Overview
=================
Brief Summary
-----------------
Osteoporosis and Periodontitis are multifactorial diseases which share common risk factors.The aim of the present study is to ellucidate polymorphisms in Calcitonin receptor gene? in patients with Osteoporosis and Periodontitis.

Detailed Description
-----------------
Periodontitis is a polymicrobial inflammatory disease which includes various modifiable and nonmodifiable risk factors. The non modifiable risk factors include genetic polymorphisms like metabolism associated genetic polymorphisms ( Vitamin D and Calcitonin). Osteoporosis is a systemic skeletal disease characterized by low bone mass and micro-architectural deterioration of bone tissue with consequent increase in bone fragility and susceptibility to fractures. Bone loss is a common feature shared between periodontal disease and osteoporosis. Out of all genetic factors Calcitonin gene polymorphism contributes to the development of both osteoporosis and chronic periodontitis.

Official Title
-----------------
Calcitonin Receptor Gene Polymorphisms in Patients With Osteoporosis and Chronic Periodontitis-An Observational Study

Conditions
-----------------
Generalized Chronic Periodontitis, Osteoporosis

Intervention / Treatment
-----------------
* Genetic: CTR Gene


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and Female Patients aged between 35.00 Year(s) to 60.00 Year(s) diagnosed with Osteoporosis and Chronic Periodontitis who are willing to participate in the study Exclusion Criteria: Patients who are Systemically compromised and under medications such as steroids. Patients who smoke.Pregnant and lactating mothers are excluded from the study

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 60 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 |
| --- | --- |
| CTR Gene in Osteoporosis and Periodontitis<br>Patients aged between 35 - 60 yrs with Osteoporosis (BMD>-2.5) and Chronic Periodontitis (>3mm Pocket Probing Depth) | Genetic: CTR Gene<br>* 2ml blood sample collected from patients to extract DNA for Assessment of CTR Gene polymorphism<br>* Other names: Calcitonin Gene, Hypocalcaemic agent;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calcitonin gene polymorphism | Collection of blood samples and running the samples by PCR | 5 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoporosis, Chronic Periodontitis, Calcitonin gene Polymorphism
Evaluation of Wear Experience With Daily Disposable and Monthly Replacement Toric Contact Lenses

Study Overview
=================
Brief Summary
-----------------
Comparison of wear experience with daily disposable and monthly replacement soft contact lenses in contact lens wearers who have astigmatism.

Official Title
-----------------
Evaluation of Wear Experience With Daily Disposable and Monthly Replacement Toric

Conditions
-----------------
Astigmatism Bilateral

Intervention / Treatment
-----------------
* Device: Daily disposable toric soft contact lens
* Device: Monthly replacement toric daily wear soft contact lens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must be current soft lens wearers in both eyes. Subjects must have 20/25 or better distance visual acuity with current lenses (entering acuity). Good general health (defined by medication use that has not changed within the last month and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the PI) Ability to give informed consent Willing to spend time for the study. Subjects will be required to attend two study visits and wear contact lenses on days between study visits. Either gender Any racial or ethnic origin Exclusion Criteria: Participants cannot be pregnant or lactating. Participants cannot be current wearers of the study lenses No current ocular inflammation or infection as assessed by the study investigator

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: First lens wear experience<br>Subject will wear contact lenses for 30 days during the day only. | Device: Daily disposable toric soft contact lens<br>* Daily disposable toric soft contact lens<br>Device: Monthly replacement toric daily wear soft contact lens<br>* Monthly replacement toric daily wear soft contact lens<br>|
| Experimental: Second lens wear experience<br>Subject will wear contact lenses for 30 days during the day only. | Device: Daily disposable toric soft contact lens<br>* Daily disposable toric soft contact lens<br>Device: Monthly replacement toric daily wear soft contact lens<br>* Monthly replacement toric daily wear soft contact lens<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog scale survey of overall comfort | Visual analog scale survey of comfort from 0 to 100, with 0 anchored as poor and 100 as excellent | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
contact lenses, astigmatism
INVSENSOR00027 Fall Detection Clinical Performance Study

Study Overview
=================
Brief Summary
-----------------
This study assesses INVSENSOR00027's clinical performance for fall detection.

Official Title
-----------------
INVSENSOR00027 Fall Detection Clinical Performance Study

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Device: INVSENSOR00027


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 to 45 years old Physical status of ASA I or II Subjects must be able to read and communicate in English Has signed all necessary related documents, e.g. written informed consent, volunteer payment form, confidentiality agreement Has completed Health Assessment Questionnaire and passed health assessment screening Exclusion Criteria: Subject has any medical condition which in the judgment of the investigator, renders them inappropriate for participation in this study Inability to tolerate physical activities including jumping and fall simulation Nursing female volunteers Excluded at the Principal Investigator's discretion Refusal to take the pregnancy test (for female subjects) Positive pregnancy test for female subjects of child bearing potential. This is done for the safety of this population. Refusal to shave hair (chest) off areas where sensors will be applied (male subjects)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: INVSENSOR00027 Test group<br>The subjects will be enrolled into the test group and will receive the INVSENSOR00027 investigational sensor. | Device: INVSENSOR00027<br>* Investigational, noninvasive sensor that will be placed on the subject's chest. INVSENSOR00027 detects falls for each subject.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of INVSENSOR00027's Fall Detection. | For each subject's fall simulation, INVSENSOR00027 output will be computed. In order to calculate sensitivity of the device, true positives and false negatives need to be accounted for. For each event of fall, the sensor's output is observed. Fall that is correctly identified is marked as true positive (TP), whereas a missed detection is marked as false negative (FN). Combining the two, test sensitivity is computed by multiplying TP by 100 and dividing that over the sum of TP and FN. | 1-5 hours |
The Construction of a Chinese Picture Naming Test and Its Preliminary Normative Data

Study Overview
=================
Brief Summary
-----------------
We will construct a Chinese Picture Naming test which include 60 items with various word frequency and familiarity and is arranged by their familiarity in daily life. Then we will collect the normative data for this test using normal subjects of various age and educational level.

Detailed Description
-----------------
In this study, we will first construct a Chinese Picture Naming Testing following the format of Boston Naming test. We will use the original 60 items from BNT and also choose another 100 items of objects with various frequency using the word frequency data from the Linguistic Corpus of the Academia Sinica. Colored pictures will be constructed accordingly. University students will be recruited to name the pictures and to judge the familiarity and image agreement for these pictures. Then, we will choose 60 pictures of according to the principles of 1. high image agreement 2. high naming agreement 3. including items of various familiarity and word frequency 4. double or triple phoneme words 5. including the original BNT items as possible. The 60 pictures will be arranged by their familiarity to construct the Chinese Picture Naming Test. Then, we will recruit normal subjects of various age group and educational level to to the Naming test and to construct the preliminary norm.

Official Title
-----------------
The Construction of a Chinese Picture Naming Test and Its Preliminary Normative Data

Conditions
-----------------
Normality

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: living in Taiwan for more than 5 years fluent in Chinese Exclusion Criteria: previous neurological, psychiatric or speech language disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| test construction<br>university student living in Taiwan for more than 5 years No known neurological, psychiatric or speech language disorders | |
| normative data<br>normal subjects 20-80 y/o Living in Taiwan for at least 5 years No know neurological, psychiatric and speech-language disorders | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| naming accuracy |  | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| naming agreement |  | 10 min | 
| image agreement |  | 10 min | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
naming test
Calcinosis Reduction by Pyrophosphate in SSC

Study Overview
=================
Brief Summary
-----------------
Calcinosis, i.e. crystal-like nodules are troublesome complication of systemic sclerosis, an autoimmune disease. Pyrophosphate inhibits its formation is laborytory. We would like to test if orally administered pyrophosphate prevents calcinosis formation.

Detailed Description
-----------------
Calcinosis, the formation of hydroxyapatite subcutaneous nodules, often complicates systemic sclerosis. There is no standard treatment for it. Based upon our preclinical experienc, we would like to test it orally administered pyrophosphate inhibits calciosis.

Official Title
-----------------
The Effect of Orally Administered Pyrophosphate on Calcinosis Formation in Systematic Sclerosis

Conditions
-----------------
Systemic Sclerosis, Scleroderma

Intervention / Treatment
-----------------
* Dietary Supplement: Pyrophosphate
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: to meet ACR/ EULAR classification criteria Exclusion Criteria: severe upper minfestation of SSC hypo- or hyperthyreoidism QT prolongation on ECG

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pyrophosphate<br>Disodium pyrophosphate | Dietary Supplement: Pyrophosphate<br>* 50 mg/kg bwt once daily in gelatine capsules.<br>|
| Placebo Comparator: Placebo<br>Glucose | Dietary Supplement: Placebo<br>* Glucose in gelatine capsules.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the size of calcinosis nodues. | Volumetric assessment with low energy CT | 52 weeks+ 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the severity of sympthoms caused by calcinosis | Visual analogue scale (0-100) | 52 weeks+ 16 weeks | 
| Change of the activity of calcinosis | Visual analogue scale (0-100) | 52 weeks+ 16 weeks | 
| Change of the size of calcinosis by ultrasound | Volumetric assessment by ultrasound | 52 weeks+ 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
calcinosis, pyrophosphate
Tumor Bed Hypofractionated IMRT After Surgery for Patients With Single,Large Brain Metastases From Solid Tumor

Study Overview
=================
Brief Summary
-----------------
Investigators designed a study of a multimodality approach: surgery followed by hypofractionated intensity modulated radiation therapy (IMRT) using VMAT approach for patients with single, large brain metastases from solid primary tumor

Detailed Description
-----------------
Investigators designed a study to recruit patients with single, large brain metastases from solid primary tumor for a multimodality approach: surgery followed by hypofractionated intensity modulated radiation therapy (IMRT) using VMAT approach. The potential advantage of this treatment is to improve local control and to reduce toxicity compared with WBRT or SRS after surgical resection.

Official Title
-----------------
Tumor Bed Hypofractionated IMRT (VMAT-RA) After Surgical Resection for Patients With Single, Large (≥2.1 cm) Brain Metastases From Solid Tumor

Conditions
-----------------
Brain Metastases

Intervention / Treatment
-----------------
* Radiation: brain metastatic patients


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years Karnosky performance status (KPS) ≥70 All Solid tumor (esclusion SCLC and Germinal tumors) Controlled primary tumor Controlled other metastatic site Single metastatic lesion at diagnosis Lesions ≥ 2.1 cm in maximum diameter (4 cm3), < 3 cm conditioning mass effect or neurological deficits or massive aedema, unknown primary tumor Estimated survival ≥ 3 months. Written informed consent Exclusion Criteria: Prior WBRT KPS ≤ 70 Other primary cancer Pregnant women

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: brain metastatic patients<br>Patients with single, large brain metastases from solid tumors | Radiation: brain metastatic patients<br>* Surgery followed by hypofractionated intensity modulated radiation therapy (IMRT) using VMAT approach<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local control rate |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distant brain failure |  | 6 months | 
| Overall survival, statistical |  | 6 months | 
| Morbidity/mortality after surgery |  | 1 month | 
| Radionecrosis after treatments |  | 6 months | 
| Neuropsycological alterations after treatments, questionnaire |  | 6 months |