linjc16/ctgov huggingface dataset:
Drug Biomarkers in Cell Samples From Patients With Acute Myeloid Leukemia

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Studying cell samples from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer PURPOSE: This research study is studying drug biomarkers in cell samples from patients with acute myeloid leukemia.

Detailed Description
-----------------
OBJECTIVES: To determine, in vitro, the cytotoxic activity of novel CD33-targeting immunoconjugate agents in cell samples from patients with acute myeloid leukemia (AML). To define the characteristics of AML cells responding to or resisting these agents. OUTLINE: Cell samples are thawed and used for in vitro studies to determine the cytotoxic activity of novel CD33-targeting immunoconjugate agents, including gemtuzumab ozogamicin, for genotyping characterization by flow cytometry-based assays and/or western blot, and colony-forming cell assays.

Official Title
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Preclinical Evaluation of Novel CD33-Targeting Therapeutics for Treatment of Acute Myeloid Leukemia (AML)

Conditions
-----------------
Leukemia

Intervention / Treatment
-----------------
* Genetic: western blotting
* Other: flow cytometry
* Other: laboratory biomarker analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Diagnosis of acute myeloid leukemia Cryopreserved samples available PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: Not specified

Ages Eligible for Study
-----------------
Maximum Age: 30 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: western blotting|nan|
|Other: flow cytometry|nan|
|Other: laboratory biomarker analysis|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activity of novel CD33-targeting immunoconjugate agents |  |  | 
| Genotypic characteristics of acute myeloid leukemia cells |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with del(5q), adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(15;17)(q22;q12), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), childhood acute myeloid leukemia/other myeloid malignancies, adult acute myeloid leukemia
Correlation Between Dehydroepiandrosterone Sulfate and Sebum Level in Adult Female Acne Vulgaris

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine the correlation between Dehydroepiandrosterone sulfate (DHEAS) and sebum level in adult female acne. A cross sectional study was conducted with 50 samples, in June to October 2017.

Detailed Description
-----------------
Epidemiological studies have shown that number of adult female acne vulgaris (AV) increases. Hormone, sebum production, Propionibacterium acne and inflammatory process are factors involved in AV development. The aim of this study is to determine the correlation between Dehydroepiandrosterone sulfate (DHEAS) and sebum level in adult female acne. This research used cross sectional study with 50 samples, aged 25-49 years by consecutive sampling. The degree of acne vulgaris was evaluated using Lehman criteria , and then the sebum level and DHEAS were measured objectively using sebumeter and serum, respectively.

Official Title
-----------------
Correlation Between Dehydroepiandrosterone Sulfate and Sebum Level in Adult Female Acne Vulgaris

Conditions
-----------------
Acne Vulgaris, Female

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female, age 25-29 years Diagnosed with mild to severe acne vulgaris Agree to participate Exclusion Criteria: History of taking antiandrogen drugs History of taking oral and topical antibiotics, using topical retinoid and BPO in the last 4 weeks History of taking oral isotretinoin in the last 6 months Pregnancy or breastfeeding

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 49 Years

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sebum level | Using sebumeter to evaluate the sebum level objectively | One day | 
| Dehydroepiandrosterone sulfate | Blood serum was used to evaluate Dehydroepiandrosterone sulfate level. | One day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acne vulgaris, Sebum level, Dehydroepiandrosterone Sulfate
Safety and Acceptability of Using a Rewetting Drop With Contact Lens Wear

Study Overview
=================
Brief Summary
-----------------
Testing the Safety and Acceptability of Using a Rewetting Drop with Contact Lenses

Official Title
-----------------
Safety and Acceptability of Using a Rewetting Drop With Contact Lens Wear

Conditions
-----------------
Ametropia

Intervention / Treatment
-----------------
* Device: Carboxymethylcellulose sodium and Glycerin
* Device: Carboxymethylcellulose sodium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adapted contact lens wearer Exclusion Criteria: Monovision lens wearer, ocular or systemic disease, pregnant or planning to become pregnant

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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carboxymethylcellulose sodium and Glycerin<br>Carboxymethylcellulose sodium and Glycerin based rewetting drop | Device: Carboxymethylcellulose sodium and Glycerin<br>* Eye drops used at least 4 times per day, 1-2 drops in each eye while wearing contact lenses.<br>* Other names: Optive™;|
| Active Comparator: Carboxymethylcellulose sodium<br>Carboxymethylcellulose sodium based rewetting drop | Device: Carboxymethylcellulose sodium<br>* Eye drops used at least 4 times per day, 1-2 drops in each eye while wearing contact lenses.<br>* Other names: Refresh Contacts®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best Corrected Visual Acuity | Percentage of Subjects Tabulated by Changes in Line Number at Day 90 from Baseline; Visual Acuity measured by LogMar reported as Snellen equivalents. Better: an increase of 2 lines or more in at least one eye; No Change: a change less than +/- 2 lines in both eyes; Worse: a decrease of 2 lines or more in at least one eye. | Change from Baseline at Day 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal Staining | Corneal staining of greater or equal to grade 2 at day 90. Grading scale: 0 = None Present; 1 = Trace Finding; 2 = Mild Finding; 3 = Moderate Finding; 4 = Severe Finding | Day 90 |
Sust-AIns: Sustainment of Suicide Prevention Programs in American Indian Settings

Study Overview
=================
Brief Summary
-----------------
The proposed study is part of the research project for a National Institute of Mental Health K01 grant to Dr. Haroz. The overall research project is focused on understanding how to sustain evidenced-based mental and behavioral health programs in tribal contexts. The aim of this study is to pilot test sustainment strategy interventions across tribal settings using mixed-methods.

Detailed Description
-----------------
Among the most pressing issues in mental health Dissemination and Implementation research (D&I) is the lack of knowledge about how to sustain mental health prevention and treatment services for which there is substantial evidence of impact. Most D&I studies focus on adoption and initial implementation, with few studies (<20) rigorously exploring sustainment. The sustainment of services has been described as one of the greatest, yet least understood, challenges in the field of implementation science. The gap in knowledge is even greater for low-resource contexts, as few studies have focused on these settings. This project aims to address this gap by developing and testing sustainment strategies for an evidenced-based youth suicide prevention program in a low-resource, American Indian (AI) contexts.

Official Title
-----------------
Sust-AIns: Sustainment of Suicide Prevention Programs in American Indian Settings

Conditions
-----------------
Program Sustainability

Intervention / Treatment
-----------------
* Other: Sustainability strategies


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Knowledgeable about the implementation of the suicide prevention program Over the age of 18 Available to participate in required study meetings and assessments Fluent in English Exclusion Criteria: Factors identified at baseline that preclude full participation including: being under the influence of a substance; active psychosis or mania; any other condition that makes an individual lack capacity to give consent.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intervention<br>Interrupted time series design | Other: Sustainability strategies<br>* The investigators will work with each site to determine strategies that are relevant locally to help promote sustainability of the suicide prevention program.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Program Sustainability Assessment Tool | Tool that assess domains of capacity for sustainability | up to 5 years |
Studying Biomarkers in Cell Samples From Patients With Acute Myeloid Leukemia

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Studying samples of 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. PURPOSE: This research study is looking at biomarkers in cell samples from patients with acute myeloid leukemia.

Detailed Description
-----------------
OBJECTIVES: To determine the significance of regulation of microRNA-34a and microRNA-194 by C/EBPα during granulopoiesis in patients with acute myeloid leukemia with CEBPA mutations. To determine whether overexpression of micro RNA-34a and microRNA-194 in myeloid progenitors with C/EBPα mutations leads to granulocytic differentiation. To examine how microRNA-34a and microRNA-194 downregulate E2F3 during granulopoiesis. To determine the role of microRNA-34a and microRNA-194 in myeloid cell proliferation. OUTLINE: Cryopreserved cell samples are collected for laboratory analysis, including mutation analysis, gene expression analysis, RNA analysis, and fluorescence-activated cell sorting (FACS) analysis.

Official Title
-----------------
Critical Role of MicroRNA-34a and MicroRNA-194 in Acute Myeloid Leukemia With CEBPA Mutations

Conditions
-----------------
Leukemia

Intervention / Treatment
-----------------
* Genetic: RNA analysis
* Genetic: gene expression analysis
* Genetic: mutation analysis
* Genetic: protein expression analysis
* Other: fluorescence activated cell sorting
* Other: laboratory biomarker analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Diagnosis of acute myeloid leukemia with CEBPA mutations PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: Not specified
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: RNA analysis|nan|
|Genetic: gene expression analysis|nan|
|Genetic: mutation analysis|nan|
|Genetic: protein expression analysis|nan|
|Other: fluorescence activated cell sorting|nan|
|Other: laboratory biomarker analysis|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Significance of regulation of microRNA-34a and microRNA-194 by C/EBPα during granulopoiesis |  |  | 
| Relationship between overexpression of microRNA-34a and microRNA-194 in myeloid progenitors with C/EBPα mutations and granulocytic differentiation |  |  | 
| Downregulation of E2F3 by microRNA-34a and microRNA-194 during granulopoiesis |  |  | 
| Role of microRNA-34a and microRNA-194 in myeloid cell proliferation |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adult acute myeloid leukemia, childhood acute myeloid leukemia/other myeloid malignancies
Clinical Study of the Topcon Tonometer TRK-3

Study Overview
=================
Brief Summary
-----------------
The study will assess the TRK-3 for conformity to ISO 8612:2009, JIS T7312:2015, and ANSI Z80.10-2014 Ophthalmic Instruments - Tonometers, to the FDA Guidance for Industry and FDA Staff, Tonometer-Premarket Notification [510(k)] Submissions, and the applicable Supplemental Information Sheet.

Official Title
-----------------
Clinical Study of the Topcon Tonometer TRK-3 to Demonstrate Conformance to ISO 8612, JIS T7312, and ANSI Z80.10-2014 Ophthalmic Instruments - Tonometers

Conditions
-----------------
Intraocular Pressure

Intervention / Treatment
-----------------
* Device: tonometer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be 18 years of age or older at the time of informed consent Irrespective of sex Irrespective of race or ethnicity Be willing and able to provide written informed consent by subject or legally designated representative prior to any study procedures Exclusion Criteria: Have only one functional eye Have one eye with poor or eccentric fixation Have corneal scarring or have had corneal surgery, including corneal laser surgery in either eye Have microphthalmos in either eye Have buphthalmos in either eye Be a contact lens wearer (persons wearing soft contact lenses within the past 3 months and/or hard contact lenses within the past 6 months) Have dry eyes (persons who have been diagnosed by a physician and are currently using prescription drugs or routinely using artificial tears) Uncontrollably blink, squint, wink, twitch or squeeze eye(s) - blepharospasm Have nystagmus in either eye Have keratoconus in either eye Have any other corneal or conjunctival pathology or infection in either eye Have central corneal thickness is less than 500μm or more than 600μm Be allergic to eye drop anesthetics Be allergic to sodium fluorescein

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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: tonometer|A subject undergoes intraocular pressure measurement with tonometer|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fluid pressure inside the eye (intraocular pressure) measured in millimeters of mercury (mm Hg) | Intraocular Pressure (IOP) measurements acquired with the study tonometer are compared to the reference tonometer IOP measurements to demonstrate that they meet the requirement specified in the tonometer standards (ISO 8612:2009, JIS T7312:2015 and ANSI Z80.10-2014) | 1 day |
Non-invasive Sensor for Core Temperature Measurement

Study Overview
=================
Brief Summary
-----------------
Soldiers are required to perform and maintain alertness in difficult environmental conditions. The sensor examined in this trail may indicate body core temperature elevation during exertion. 12 male volunteers will arrive to our lab and perform a protocol of sitting and walking in thermoneutral and hot environments with two core temperature sensors. The results obtained from them will be compared.

Detailed Description
-----------------
During the protocol the volunteers will sit in thermoneutral condition for 30 minutes, than they will sit in hot chamber (40 celsius and 40% relative humidity). Afterwards, the participants will walk on a treadmill in 5 km/hr and 4% incline for one hour. The participants will be connected to rectal thermistor which is considered the gold standard and to the new noninvasive sensor which is attached to the skin surface.

Official Title
-----------------
Non-invasive Sensor for Core Temperature Measurement

Conditions
-----------------
Body Temperature Regulation

Intervention / Treatment
-----------------
* Biological: Noninvasive core temperature thermistor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-25 - healthy after medical checkup after signing concent form with no heat stroke medical history Exclusion Criteria: heat stroke medical history heart disease diabetes obesity

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 25 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Research arm<br>This trial contains one group which will undergo the described protocol while connected to both sensors: a rectal thermistor and a non invasive thermistor. | Biological: Noninvasive core temperature thermistor<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rectal temperature | The participants will undergo the described protocol and their rectal temperature will be measured by rectal thermistor and the new noninvasive thermistor and will be monitored continuously and viewed by the attending medical staff. Automatically all data will be recorded by the monitoring Biopac system. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Body Temperature Regulation Sensor Noninvasive
Nutritional Deficiency and Recurrent Miscarriage

Study Overview
=================
Brief Summary
-----------------
This prospective cohort study primarily aims to examine the association between blood niacin levels and recurrent miscarriage.

Detailed Description
-----------------
Recurrent miscarriage is affecting around 5% women at reproductive age. And the underlying causes remain undetermined in 50%-70% of cases. Although animal models and linkage analysis according to family studies have identified that niacin deficiency can lead to congenital malformations and recurrent miscarriage. Evidence based on population is lacking with regard to the effect of blood niacin levels on recurrent miscarriage. We intend to enroll 499 pregnant women confirmed by a positive blood human chorionic gonadotropin test and with history of unexplained recurrent miscarriage. By testing their blood niacin levels and following up to the end of first-trimester pregnancy, this study aims to examine the role of niacin levels in preventing miscarriages among women with history of recurrent miscarriage.

Official Title
-----------------
A Cohort Study Investigating Nutritional Deficiency Among Pregnant Women With History of Recurrent Miscarriage

Conditions
-----------------
Recurrent Miscarriage

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-40years old, female Positive blood human chorionic gonadotropin test Naturally pregnant History of recurrent miscarriage (2 or more consecutive spontaneous miscarriage within 28 weeks of gestation) Willing to participate in this study with informed consent Exclusion Criteria: Women whose confirmed cause of recurrent miscarriage has nothing to do with nutritional deficiencies, including chromosomal abnormalities, abnormal uterine anatomy, immune system diseases, blood diseases, etc. Women with Hepatitis B, syphilis, HIV/AIDS and other infectious diseases. Women with serious conditions, such as schizophrenia, tumors, heart failure

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant women with history of recurrent miscarriage<br> | Other: No intervention<br>* This is an observational study without any intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with miscarriage | pregnancy outcomes are confirmed by electronic hospital records or self-reported by participants | 6-13(+6) weeks of gestation | 
| Gestation week at miscarriage | pregnancy outcomes are confirmed by electronic hospital records or self-reported by participants | 6-13(+6) weeks of gestation |