linjc16/ctgov huggingface dataset:
Application of Cervical Elastography in Obstetrics

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to develop cervical elastography nomograms using Samsung's novel technology E-cervix and determine its ability to predict preterm birth. During each sonogram in which cervical lengths are measured, 5 additional cervical indices will be collected using Samsung's E-cervix technology. Each index will then be separated based on characteristics to create a nomogram for singletons, twins, and those with interventions already in place (i.e. cerclage and/or progesterone) at the time of their E-cervix assessment.

Official Title
-----------------
Application of Cervical Elastography in Obstetrics

Conditions
-----------------
Cervical Elastography

Intervention / Treatment
-----------------
* Device: Samsung's E-cervix technology


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women who present for early screening or level II ultrasound, aged 18 to 50 years, provides written Informed consent and is willing to comply with protocol requirements, and obtained cervical length and measurements using the E-cervix software/hardware Exclusion Criteria: >50 years old prior cervical surgical procedures (i.e. LEEP procedure, cold knife cone biopsy)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- |
| Cervical Elastography<br>During each sonogram in which cervical lengths are measured, 5 additional cervical indices will be collected using Samsung's E-cervix technology. Each index will then be separated based on characteristics to create a nomogram for singletons, twins, and those with interventions already in place (i.e. cerclage and/or progesterone) at the time of their E-cervix assessment. | Device: Samsung's E-cervix technology<br>* While patients are having their routine cervical ultrasound assessments which requires a 5 minute time period, we will use the built-in software to obtain additional E-cervix measurements to evaluate the consistency of the cervical os. This will be done within the standard 5 minute period which is typically done to observe for dynamic changes. The measurements will be obtained with the same sonogram machine, using updated software.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of preterm Births |  | 24 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| E-cervix indices | Pearson or Spearman correlation coefficients will be calculated to determine the association between the cervical length and each of the e-cervix parameters at the baseline assessment at 18-22 weeks. | 18 Weeks, 19 Weeks, 20 Weeks, 21 Weeks, 22 Weeks |
Voiding Log and Fluid Intake Habits

Study Overview
=================
Brief Summary
-----------------
Health practitioners usually instruct patients with complaints of urinary incontinence and urinary tract infection regarding voiding and fluid intake habits. However poor drinking habits develop early in life, even prior to the symptoms presentation. Little is known about the voiding habits and fluid intake routine among healthy young population. The current study aims to assess the habits of drinking and voiding log among such population.

Official Title
-----------------
Voiding Log and Fluid Intake Habits Among Young Healthy Population

Conditions
-----------------
Young Healthy Patients

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Both male and female Adolescent healthy population Exclusion Criteria: History of incontinence Symptoms of urinary tract infection History of any pelvic floor disorder

Ages Eligible for Study
-----------------
Minimum Age: 24 Years
Maximum Age: 38 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy young population<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluid intake | amount of cups taken per day | 1 month | 
| Voiding | voiding diary | 1 month |
IL-38 Evaluation as a Biomarker in Pediatric Asthma

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate the associations between serum IL-38 levels and different variables of asthma in children such as laboratory variables, pulmonary function test results, the diagnosis of asthma, and in correlation with disease severity.

Official Title
-----------------
Serum Human IL-38 Levels in Asthmatic Children

Conditions
-----------------
Bronchial Asthma

Intervention / Treatment
-----------------
* Diagnostic Test: Il-38 serum level


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients fulfilled the criteria of the Global Initiative for Asthma (GINA) Age group:6-14 years Exclusion Criteria: Malignancy Chronic inflammatory diseases

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 14 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: bronchial asthma patients<br>patients diagnosed with bronchial asthma | Diagnostic Test: Il-38 serum level<br>* measurement of serum levels of IL-38<br>|
| Active Comparator: healthy controls<br>healthy subjects with age and sex matched to bronchial asthma patients | Diagnostic Test: Il-38 serum level<br>* measurement of serum levels of IL-38<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum IL-38 levels | Measurement of Interleukin 38 in sera of all study subjects by ELISA | within 6 months |
Exercise Effect on Aerobic Capacity and QOL in Heart Failure

Study Overview
=================
Brief Summary
-----------------
Chronic heart failure (HF) is a syndrome of impaired ventricular function resulting in clinical symptoms of fatigue, dyspnea, and decreased exercise capacity. These symptoms lead to a cyclical pattern of an increasing sedentary lifestyle with accompanying deconditioning and deterioration of muscle function. Until recently, the prescription for individuals with HF was rest and minimization of physical exertion.

Detailed Description
-----------------
Background: Chronic heart failure (HF) is a syndrome of impaired ventricular function resulting in clinical symptoms of fatigue, dyspnea, and decreased exercise capacity. These symptoms lead to a cyclical pattern of an increasing sedentary lifestyle with accompanying deconditioning and deterioration of muscle function. Until recently, the prescription for individuals with HF was rest and minimization of physical exertion. Objectives: The primary objectives of this randomized clinical trial were to determine whether subjects, with moderate to severe chronic HF, who completed a 12-week individualized program of cardiopulmonary training (exercise group) would have significantly greater (i) quality of life, measured by the Rand Short Form-36, and (ii) aerobic fitness, measured by oxygen uptake during symptom limited maximal metabolic treadmill testing, than subjects who met weekly with an investigator and received vital sign measurements (non-exercise group). Methods: A randomized controlled clinical trial was utilized. Individuals who met the inclusion criteria were randomly assigned to either an exercise or control group. Individuals in the exercise group received 36 weeks of exercise training (primary outcome variables were measured at 12 weeks). Participants in the control group received weekly visits with a nurse for 12 weeks. Status: Ongoing data analysis for publication. Final report submitted.

Official Title
-----------------
Exercise Effect on Aerobic Capacity and QOL in Heart Failure

Conditions
-----------------
Heart Failure, Congestive

Intervention / Treatment
-----------------
* Behavioral: Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Left ventricular ejection fraction less than or equal to 40%. Stable heart failure. Exclusion 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?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arm 1<br> | Behavioral: Exercise<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Pharmacokinetic Study Of Tigecycline In Adult Subjects With Primary Biliary Cirrhosis

Study Overview
=================
Brief Summary
-----------------
Open label, single dose study of the pharmacokinetics of tigecycline in adult subjects with primary biliary cirrhosis (PBC)

Detailed Description
-----------------
pharmacokinetic study

Official Title
-----------------
Open Label, Single Dose Study Of The Pharmacokinetics Of Tigecycline In Adult Subjects With Primary Biliary Cirrhosis

Conditions
-----------------
Liver Cirrhosis, Biliary

Intervention / Treatment
-----------------
* Drug: tigecycline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and nonlactating and nonpregnant women greater than or equal to 18 years of age Subjects with biopsy proven primary biliary cirrhosis (PBC) disease in the asymptomatic or symptomatic phase of PBC. Otherwise healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results (other than those associated with PBC), vital signs, and 12-lead electrocardiogram (ECG). Exclusion Criteria: Subjects with a recent increase in bilirubin, bilirubin >15 mg/dL, presence of ascites, esophageal varices, or hepatic encephalopathy. Any major illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in the study Any malignancy including hepatocellular carcinoma.

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

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: tigecycline<br>* Single intravenous dose of tigecycline 50 mg, as a 30-minute infusion<br>* Other names: Tygacil, GAR-936;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the pharmacokinetics (PK) of tigecycline in subjects with cholestatic hepatic dysfunction. |  | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety and tolerability of single doses of tigecycline in subjects with cholestatic hepatic dysfunction. |  | 15 days |
Improvement After Physiotherapy for Low Back Pain: The Good Responders

Study Overview
=================
Brief Summary
-----------------
This is an observational study that aims to characterize individual response of patients getting physical therapy for chronic non-specific low back pain. Participants will be classified based on a questionnaire and motor tests to investigate whether individual improvement after physical therapy may be predicted. These observations may help to decide which should be the preferred treatment offered.

Official Title
-----------------
Improvement After Physiotherapy for Low Back Pain: The Good Responders. An Observational Study in Primary Care

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Behavioral: physiotherapy as usual in primary care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: low back pain receiving primary care physiotherapy Exclusion Criteria: - -

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- |
| low back pain<br> | Behavioral: physiotherapy as usual in primary care<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient-reported disability | questionnaire (Oswestry Disability Index) | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| self-efficacy | questionnaire and interview | 1 year | 
| global perceived effect | questionnaire | 1 year | 
| quality of life | questionnaire (EQ5D) | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prognosis, Physical Therapy Modalities, Patient Selection
Phase III Study of L-Cysteine in Patients With Erythropoietic Protoporphyria

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Determine the long-term efficacy and safety of L-cysteine in the prevention photosensitivity in patients with erythropoietic protoporphyria.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is a phase III study, lasting 3 years; 1996-1999. Patients are administered L-cysteine orally twice daily, 2 capsules with breakfast and 2 with lunch. Patients fill in questionnaires and diary sheets about their reaction to sunlight exposure, and have blood tested 3 times a year. Completion date provided represents the completion date of the grant per OOPD records

Conditions
-----------------
Erythropoietic Protoporphyria

Intervention / Treatment
-----------------
* Drug: cysteine hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Erythropoietic protoporphyria RBC protoporphyrin greater than 50 micrograms/100 dL --Prior/Concurrent Therapy-- At least 3 months since prior betacarotene or L-cysteine No concurrent betacarotene --Patient Characteristics-- Fertile female patients must use effective contraception for duration of trial and for 3 weeks thereafter Not pregnant or nursing

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: cysteine hydrochloride|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
-----------------
erythropoietic protoporphyria, inborn errors of metabolism, porphyria, rare disease
Clinical Study of Peripheral Capillary Oxygen Saturation (SpO2): Vital Signs Patch (VSP)

Study Overview
=================
Brief Summary
-----------------
A clinical study designed to determine the accuracy of the peripheral capillary oxygen saturation (SpO2) function of the Vital Signs Patch (VSP) device for measuring blood saturation level.

Detailed Description
-----------------
The clinical study protocol was designed for determining the accuracy of the SpO2 function of the Vital Signs Patch device for measuring blood oxygen saturation level, according to the guidelines for evaluating and documenting SpO2 accuracy in human subjects as set out in Annex EE of ISO 80601-2-61. Section 4.

Official Title
-----------------
Pulse Oximeter Response TO Multiple Levels Of Stable Hypoxia

Conditions
-----------------
Desaturation of Blood

Intervention / Treatment
-----------------
* Device: Vital Signs Patch (VSP)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 23 to 33. Skin tone varied from light to dark. Exclusion Criteria: Smokers Anemic

Ages Eligible for Study
-----------------
Minimum Age: 23 Years
Maximum Age: 33 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vital Signs Patch (VSP)<br>Infrared and Red absorbance measurement on chest | Device: Vital Signs Patch (VSP)<br>* Infrared and red absorbance measurement<br>* Other names: VSP;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite Outcome Measure: Successful Capture of Peripheral Capillary Oxygen Saturation (SpO2) Level | Successful capture of SpO2 levels - Infrared and red light absorbency was measured and used for SpO2 percentage calculation from both the Vital Signs Patch (VSP) study device and an invasive Blood Arterial Hemoximeter (standard method) to determine the level of accuracy of data obtained from the VSP device when compared data taken from the Arterial Hemoximeter. A comparison was made by calculating the Average Root Mean Square (Arms) and comparing against the Arms error rate limit of less than or equal to 3.5% at a 95% confidence level. The outcome is either positive or negative - this is a composite outcome measure. | within 24 hrs |
Clinical Study to Test the Efficacy and Safety of ACYC to Treat Moderate to Severe Acne

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to compare the efficacy and safety and tolerability of ACYC Gel and vehicle in the treatment of subjects with Acne Vulgaris.

Detailed Description
-----------------
The primary objective of this study is to compare the efficacy and safety and tolerability of ACYC Gel and vehicle in the treatment of subjects with Acne Vulgaris

Official Title
-----------------
A Phase 3, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, 2-Arm, Parallel Group Comparison Study Comparing the Efficacy and Safety of ACYC and ACYC Vehicle Gel in the Treatment of Acne Vulgaris

Conditions
-----------------
Acne

Intervention / Treatment
-----------------
* Drug: ACYC
* Drug: ACYC vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Male or female between the ages of 12 and 40 (inclusive) Written and verbal informed consent must be obtained. Subjects less than 18 years of age must sign an assent for the study and a parent or a legal guardian must sign the informed consent Subject must have moderate to severe acne at the baseline visit Women of childbearing potential must be willing to practice effective contraception for the duration of the study Key Exclusion Criteria: Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study Dermatological conditions on the face that could interfere with clinical evaluations

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 40 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 |
| --- | --- |
| Active Comparator: ACYC<br>ACYC active, topically applied to the face for 12 weeks | Drug: ACYC<br>* ACYC active, topically applied to the face for 12 weeks<br>|
| Placebo Comparator: ACYC vehicle<br>ACYC vehicle (placebo), topically applied to the face for 12 weeks | Drug: ACYC vehicle<br>* ACYC vehicle (placebo), topically applied to the face for 12 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute Change in Inflammatory Lesion Count |  | Baseline and 12 Weeks | 
| Absolute Change in Non-inflammatory Lesion Count |  | Baseline and 12 Weeks | 
| Percent of Subjects Who Have a Least a 2 Grade Reduction |  | Baseline and 12 Weeks | 
| Percent of Subjects With Two Grade Reduction From Baseline and Achieving Clear or Almost Clear |  | Baseline and 12 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acne