linjc16/ctgov huggingface dataset:
A Clinical Study for Validating the Equivalence of Bloomlife MFM-Pro to Clinical Standard-of-care for Antepartum Fetal Monitoring

Study Overview
=================
Brief Summary
-----------------
Bloomlife has developed a wearable system (Bloomlife MFM-Pro) that can allow fetal monitoring to be conveniently performed in healthcare settings under supervision of a healthcare professional. Bloomlife MFM-Pro is a non-invasive, wireless, external monitoring system used to measure fetal heart rate, maternal heart rate, and uterine activity during antepartum (non-stress) testing on pregnant women with a singleton pregnancy. The purpose of this study is to validate that the Bloomlife MFM-Pro is equivalent to clinical standard-of-care for routine non-stress test (NST) performed at the hospital.

Official Title
-----------------
A Cross-sectional, Interventional, Single-arm Clinical Study for Validating the Equivalence of Bloomlife MFM-Pro to Clinical Standard-of-care for Antepartum Fetal Monitoring

Conditions
-----------------
Fetal Monitoring

Intervention / Treatment
-----------------
* Device: Bloomlife MFM-Pro


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant woman ≥ 18 years old Gestational age ≥ 32 weeks and 0 days Singleton pregnancy Ability to read and understand Dutch or English Willingness to participate in the study Exclusion Criteria: Implanted pacemaker or any other implanted electrical device Plurality higher than 1 History of allergies to skin adhesives Contraindication to the use of the CTG

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

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

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: Bloomlife MFM-Pro<br> | Device: Bloomlife MFM-Pro<br>* Bloomlife MFM-Pro is a non-invasive, wireless, external monitoring system used to measure fetal heart rate, maternal heart rate, and uterine activity during antepartum (non-stress) testing on pregnant women with a singleton pregnancy. The system acquires biopotential signals from abdominal surface electrodes and measures the fetal electrocardiography, maternal electrocardiography, electrohysterography, as well as accelerometer data.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extent of agreement between Bloomlife MFM-Pro and CTG in fetal heart rate | Bland-Altman analysis, based on a 95% limits of agreement | 1 hour | 
| Extent of agreement between Bloomlife MFM-Pro and CTG in maternal heart rate | Bland-Altman analysis, based on a 95% limits of agreement | 1 hour |
Additional Glucose Lowering and Anti-Inflammatory Effects by Acarbose and Alcohol in Subjects With Impaired Glucose Tolerance or Mild Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
To understand if acarbose, an alpha-glucosidase inhibitor usually for treating diabetes, will further lower post meal glucose and inflammatory state when taking together with moderate amount of alcohol during meal tolerance test in subjects with impaired glucose tolerance or mild diabetes.

Conditions
-----------------
Diabetes Mellitus, Impaired Glucose Tolerance

Intervention / Treatment
-----------------
* Drug: Acarbose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with mild diabetes without prior medications or impaired glucose tolerance Exclusion Criteria: Pregnancy Recent major cardiac, renal and hepatic disease Intolerance to alcohol Allergy to acarbose treatment

Ages Eligible for Study
-----------------
Minimum Age: 25 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: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Acarbose|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial hyperglycemia |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial inflammatory responses |  |  | 
| Postprandial oxidative stress |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetes, acarbose, alcohol, inflammation, oxidative stress, Mild diabetes mellitus
A Study of Juvenile Idiopathic Arthritis Patients Given Abatacept and the Number of Infections or Malignancies That Occur

Study Overview
=================
Brief Summary
-----------------
This study will determine the incidences of infections and malignancies among JIA patients treated with abatacept

Official Title
-----------------
Supplemental Data for the Juvenile Idiopathic Arthritis FDA Written Request

Conditions
-----------------
Juvenile Idiopathic Arthritis

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Two diagnoses of JIA (ICD-9 code 714.3x) within 90 days Age less than 18 years at the time of second of the two diagnoses Index date is the date of initiating treatment with abatacept Exclusion Criteria: Greater than or equal to 18 years of age

Ages Eligible for Study
-----------------
Minimum Age: 12 Months

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| JIA patients prescribed abatacept<br> | Other: Non-Interventional<br>* Non-Interventional<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of infections |  | 110 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of malignancies |  | 110 months |
Relationship Between Academic Achievement, Musculoskeletal System, Quality of Life and Technology Addiction

Study Overview
=================
Brief Summary
-----------------
The increasing use of technological devices such as mobile phones and computers has become indispensable elements of daily life. Especially students are one of the groups that use communication tools most with the developing technology. This study was conducted to investigate the effect of technology addiction on academic achievement, musculoskeletal system and quality of life in young people.

Official Title
-----------------
How Much Does Technology Addiction in Youth Affect Academic Achievement, Musculoskeletal System and Quality of Life?

Conditions
-----------------
Technology Addiction, Musculoskeletal System, Quality of Life, Youth

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals between the ages of 20-30, using smartphones and/or computers were included in the study. Exclusion Criteria: Individuals who did not meet the inclusion criteria and had a physical-psycho-social condition that could affect the study were excluded from the study.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 30 Years

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smartphone Addiction Scale-Short Form | It is a 10-item scale assessed with a six-point Likert rating developed by Kwon et al. to measure the risk of smartphone addiction in adolescents. | 5 minutes | 
| Young Internet Addiction Test Short Form | Developed by Young and converted into short form by Pawlikowski et al., IAT-SF consists of 12 items (13,14). IAT-SF, for which Turkish validity and reliability study has also been carried out, is a five-point Likert (1 = Never, 5 = Very often) type scale. High scores on the scale indicate a high level of internet addiction | 5 minutes | 
| Cornell Musculoskeletal Discomfort Questionnaire | The survey indicates whether the pain or discomfort has affected the frequency of 11 different body regions (neck, shoulder, back, upper arm, waist, forearm, hip, upper leg, knee and lower leg) in the last 7 days, the severity of this situation and the ability to work. evaluates. | 5 minutes | 
| Short Form-36 | SF-36 Quality of life questionnaire was used as the general health questionnaire. SF-36, for which Turkish validity-reliability study was conducted, consists of eight subsections (general health perception, physical function, physical role limitation, emotional role limitation, social function, pain, energy, mental health) each varying between 2-10 questions. | 5 minutes | 
| Meaning of Life Questionnaire | Each item is evaluated according to a 7-graded response system (1: Strongly Disagree, 7: Strongly Agree). It is stated that as the score obtained from the questionnaire increases, life satisfaction increases. | 2 minutes |
Multiparametric MRI for Prostate Cancer Localization and Characterization: New Methods

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the ability of several new MRI techniques (MR elastography, dynamic contrast-enhanced MRI with gadofosveset, and oscillating gradient diffusion) to determine the location, size, and grade of prostate carcinoma. Thirty patients with biopsy proven carcinoma awaiting prostatectomy will be included in the study. Ex-vivo MRI will also be conducted on the prostate specimen to obtain high resolution imaging correlates to both in-vivo MRI and whole mount prostatectomy specimens. The investigators hypothesize that the addition of these three techniques will increase the accuracy, sensitivity, and specificity of MRI for detecting clinically significant prostate cancer.

Official Title
-----------------
Determining the Extent and Grade of Prostate Cancer Using MR Elastography, Diffusion Weighted Imaging, and Dynamic Contrast Enhanced MRI With Gadofosveset

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Other: MRI with gadofosveset and MR elastography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male patients diagnosed with T1C or T2 prostate cancer, awaiting prostatectomy Exclusion Criteria: unable to give informed consent contraindication to MRI or MRI contrast agent claustrophobia renal impairment prior hormonal or radiation therapy for prostate cancer active prostatitis moderate to severe rectal inflammation previous rectal surgery prostate biopsy within 4 weeks of planned MRI

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

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

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

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: Single arm study<br> | Other: MRI with gadofosveset and MR elastography<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation coefficient | Correlation coefficient between the expected location and grade of prostate cancer as determined by each new MRI method compared with whole mount histological specimen using a 5 mm grid for spatial reference. | This outcome measure will be assessed approximately 4 weeks following prostatectomy (an average of 8 weeks from time of enrolment). | 
| Receiver operator characteristic curve for the prediction of prostate cancer for each new MRI method |  | This outcome measure will be assessed approximately 4 weeks following prostatectomy (an average of 8 weeks from time of enrolment). | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostate cancer, MRI, Elastography, Gadofosveset
Primary Antimicrobial Resistance Patterns of Austrian Helicobacter Pylori Clinical Isolates

Study Overview
=================
Brief Summary
-----------------
Helicobacter pylori infects   50% of the world's population and a quarter of the European population. H. pylori is responsible for a large proportion of gastric and duodenal ulcers and gastritis. Chronic infection with H. pylori is a risk factor for the development of stomach cancer and MALT (mucosa-associated lymphoid tissue) Lymphoma. The prospects of success for an antimicrobial eradication therapy is drastically reduced by the significant increase in antibiotic resistance in Austrian H. pylori isolates. The currently available data were obtained however from narrowly defined geographical regions and the clinical routine without information on patient selection. We suspect a considerable geographical variability of resistance patterns and a clinical bias for a preferential investigation of patients with unsuccessful, empirical eradication therapy. The objective of the proposed study is therefore an Austria-wide collection of data on H. pylori resistance in a prospective clinical study. The data thus collected will enable a significant improvement in current treatment recommendations.

Conditions
-----------------
Helicobacter Pylori Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undergoing a diagnostic gastroscopy for the first time in their lives or had a diagnostic gastroscopy for any reason >10 years ago Older than 18 years of age Written informed consent Exclusion Criteria: Previous H. pylori eradication therapies Antimicrobial treatment for other reasons than H. pylori eradication within 3 months prior to gastroscopy

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 |
| --- | --- | --- |
| Antimicrobial resistance of H. pylori isolate |  | 1 day (Once) |
Alcohol Consumption and Type 2 Diabetes Mellitus Risk in Nonalcoholic Fatty Liver Disease

Study Overview
=================
Brief Summary
-----------------
This study explored the cross-sectional and prospective associations between light-to-moderate alcohol consumption (LMAC) and risk of type 2 diabetes mellitus (T2DM) in individuals with nonalcoholic fatty liver disease (NAFLD).

Official Title
-----------------
Association of Light-to-moderate Alcohol Consumption With Risk of Type 2 Diabetes Mellitus in Individuals With Nonalcoholic Fatty Liver Disease

Conditions
-----------------
Nonalcoholic Fatty Liver Disease, Light-to-moderate Alcohol Consumption, Type2 Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged 18 years or above undergoing annual health examinations in 2009 in Zhenhai Lianhua Hospital, Ningbo, China. informed about the study Exclusion Criteria: female participants; missing data on ultrasound, alcohol consumption, and T2DM status; alcohol consumption > 210 g per week, and binge drinkers; with evidence of other liver diseases including viral hepatitis, autoimmune hepatitis, and drug-induced liver disease.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Light-to-moderate alcohol consumption (LMAC) and risk of prevalent type 2 diabetes mellitus (T2DM) | Fatty liver was assessed by ultrasound. T2DM was defined as the presence of any of the following conditions based on American Diabetes Association criteria: (1) fasting plasma glucose (FPG) ≥ 7.0 mmol/L; (2) hemoglobin A1c (HbA1c) ≥ 6.5%; (3) self-reported clinician-diagnosed T2DM. | cross-sectional analyses in 2009 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LMAC and incident risk of T2DM | Fatty liver was assessed by ultrasound. T2DM was defined as the presence of any of the following conditions based on American Diabetes Association criteria: (1) fasting plasma glucose (FPG) ≥ 7.0 mmol/L; (2) hemoglobin A1c (HbA1c) ≥ 6.5%; (3) self-reported clinician-diagnosed T2DM. | 9-year cohort observation |
Genetic and Molecular Characteristics of Mexican Adults With Acute Myeloid Leukemia: a Prospective Multicentric Study.

Study Overview
=================
Brief Summary
-----------------
Newly diagnosed adults patients with Acute Myeloid Leukemia will be assessed as traditionally by the treating institution using classic clinical, demographic and cytogenetic variables. Complementary molecular tests will be performed in the patients included in the study using PCR to detect classic CBF (Core Binding Factor) rearrangements: CBFB-MYH11 [inv(16)(p13;q22), isoforms A, E and D; AML-ETO (RUNX1-RUNX1T1) (t8;21)(q22;q22). NGS (Next Generation Sequencing) to detect mutations in: FLT3-ITD and TKD, NPM1, CEBPA, RUNX1, TP53, ASXL1, IDH1, IDH2 and KIT

Official Title
-----------------
Genetic and Molecular Characteristics of Mexican Adults With Acute Myeloid Leukemia: a Prospective Multicenter Study

Conditions
-----------------
Acute Myeloid Leukemia

Intervention / Treatment
-----------------
* Diagnostic Test: Molecular panel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed AML Over 15 years of age Flow cytometry confirmation Candidate for treatment (intensive or not intensive) Exclusion Criteria: Acute Promyelocytic Leukemia Mixed phenotype leukemias Isolated myeloid sarcoma Blastic plasmacytoid dendritic cell neoplasm

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Molecular panel|Detection of CBF rearrangements using PCR: CBFB-MYH11 [inv(16)(p13;q22), isoforms A, E and D; AML-ETO (RUNX1-RUNX1T1) (t8;21)(q22;q22). NGS panel to detect classic mutations in: FLT3-ITD and TKD, NPM1, CEBPA, RUNX1, TP53, ASXL1, IDH1, IDH2 and KIT|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 3 year |
COMT Polymorphism and Entacapone Efficacy

Study Overview
=================
Brief Summary
-----------------
Entacapone is an antiparkinsonian drug which block L-dopa metabolism, inhibiting the C-O-methyltransferase (COMT) enzyme. There is an individual variability of the COMT activity determined by a genetic polymorphism. The aim of this study is to investigate whether the genetic variability influences entacapone efficacy in Parkinson's disease.

Detailed Description
-----------------
COMT protein is dependent of a single autosomal locus with two co-dominant alleles with a high activity (allele H) and a low activity (allele L) form of the enzyme. L and H allele frequency in the Caucasian population is around 50%. This is a monocentric randomized blinded cross-over study comparing acute challenge of L-dopa + placebo versus L-dopa + 200 mg entacapone, in Parkinson's disease patients with HH and LL genotypes.

Official Title
-----------------
Influence of Catechol-O-methyltransferase Polymorphism on Entacapone Efficacy in Parkinson's Disease

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Drug: entacapone
* Drug: l dopa versus placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parkinson's disease wearing off Exclusion Criteria: atypical parkinsonism neuroleptic use

Ages Eligible for Study
-----------------
Minimum Age: 30 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: L-dopa + entacapone<br>L-dopa + entacapone | Drug: entacapone<br>* entacapone<br>|
| Experimental: L dopa / placebo<br>L dopa / placebo | Drug: l dopa versus placebo<br>* l dopa versus placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| L-dopa efficacy duration on UPDRS motor scale during an acute L-dopa test | L-dopa efficacy duration on UPDRS motor scale during an acute L-dopa test | during the hospitalization in 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of L-dopa and its metabolites | Pharmacokinetics of L-dopa and its metabolites | at the end of the study during the last hospitalization | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinson's disease, Catechol O-methyltransferase, Entacapone, pharmacogenetic