linjc16/ctgov huggingface dataset:
Prediction of Delivery Mode by Ultrasound-assessed Fetal Position in Nulliparous Women With Prolonged First Stage of Labor.

Study Overview
=================
Brief Summary
-----------------
In the past years, numerous studies have been published on the use of ultrasound during labor, showing this is an effective, accurate and objective tool for the assessment of the fetal head position and station. Literature affirmed that traditional transvaginal digital examination is highly subjective and dependent on the operator's experience. On the contrary, the use of intrapartum suprapubic transabdominal ultrasound can improve accuracy in determination of fetal head position and the precise knowledge of the location of specific fetal head landmarks in relationship to maternal pelvis. Intrapartum ultrasound will assist obstetricians in the diagnosis of normal labor progression, suggesting when medical and or operative intervention should be taken in case of complications.

Official Title
-----------------
Prediction of Delivery Mode by Ultrasound-assessed Fetal Position in Nulliparous Women With Prolonged First Stage of Labor.

Conditions
-----------------
Prolonged Labor

Intervention / Treatment
-----------------
* Diagnostic Test: Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: nulliparous women Singleton pregnancy prolonged first stage of Labor average fetal weight gestational age at or beyond 37 weeks Exclusion Criteria: IUFD malpresentation
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Ultrasound|Fetal head position determination using ultrasound|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mode of delivery | Correlation between fetal head position and mode of delivery | 6 months |
Diabetes Mellitus - A Diagnosis Trial by Means of Non Invasive Measurements

Study Overview
=================
Brief Summary
-----------------
Vascular damage caused by diabetes mellitus, cigarette smoking, age and arterial hypertension theoretically changes pulse wave velocity.

Detailed Description
-----------------
Diabetes mellitus related vascular alterations are associated with an increased risk of hypertonia, atherosclerosis, neuropathy, diabetic retinopathy, and further more. Increased vascular rigidity, which is based on the increased stiffness of vessels caused by vascular damage leads to an increase of pulse wave velocity. This assumption is based on the Moens-Korteweg-equation which is calculated using the modus of arterial vessel elasticity, arterial vessel wall thickness, the arterial radius and blood viscosity.

Official Title
-----------------
Diabetes Mellitus - A Diagnosis Trial by Means of Non Invasive Measurements

Conditions
-----------------
Diabetes Mellitus Type II

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over 18 years Exclusion Criteria: Diabetic foot gangrene No possibility of pulse wave velocitiy measurement on the finger or toe

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 |
| --- | --- |
| Diabetes mellitus<br>All patients over 18 years with diagnosed diabetes mellitus type II. | |
| Non Diabetic<br>Patients over 18 years with no known diabetes mellitus or other known/diagnosed vascular diseases. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulse wave arrival time difference between finger and toe, duration of diabetes | The pulse wave is recorded by plethysmography using a pulse-oximeter and a continuous noninvasive arterial blood pressure measurement (CNAP-500) device, both on the finger and toe. The time between these 4 recorded waves is then calculated. The influence of age, duration of known arterial hypertension, cigarette smoking (pack-years) and diabetes mellitus. | 1 Minute data recording of the pulse waves at four sites. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulse walve arrival time differences
Do Self-Report and Physician Impressions of Adherence to Oral Antipsychotic Medication Agree With Objective Data?

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to prospectively examine adherence to oral atypical antipsychotics in patients with schizophrenia. We are psrticularly interested in examining the level of agreement among self-report, physician impressions and objective measures of adherence. We believe that physicians, casemanagers, and clients significantly overestimate the level of adherence.

Detailed Description
-----------------
Fifty schizophrenia patients will be recruited at the time of their clinic visit to Tri-County MHMR Services and the El Paso Community MHMR Center. Both physicians and patients will be asked to rate the patient's medication adherence on their index clinic visit. Initial ratings will also occur at this visit. After filling their medication prescription, all subjects will be given electronic medication caps that record each time and date their medication container is opened. Patients will then be followed in the community for the next 12 weeks to observe actual adherence to medication from the index visit to the next successive clinic visit. Every two weeks pills will be counted and data will be retrieved from the electronic medication caps. During the first and last two weeks of study, blood will be sampled on two randomly selected occasions approximately 72 hours apart. Self-report and physician assessment of adherence, symptom and attitudinal measures will be obtained a second time at the second clinic visit 12 weeks after the index visit.

Official Title
-----------------
Do Self-Report and Physician Impressions of Adherence to Oral Antipsychotic Medication Agree With Objective Data?

Conditions
-----------------
Schizophrenia, Schizoaffective

Intervention / Treatment
-----------------
* Device: MEMS caps


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Schizophrenia or Schizoaffective disorder Between the ages of 18-55 no documented history of head injury, mental retardation or neurological disorder

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: MEMS caps|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
-----------------
Schizophrenia, Schizoaffective, MEMS, adherence to antipsychotic medication
Metabolic Imaging Predict Histopathologic Response to Preop ChemoXRT for Locally Advanced Rectal CA

Study Overview
=================
Brief Summary
-----------------
In this research study of metabolic imaging in locally advanced rectal cancer, we hope to learn whether new medical imaging technology can help predict the response of rectal cancer to preoperative chemotherapy and radiation therapy. Ultimately we hope this information will in the future help us predict which patients will benefit from more or less aggressive initial therapy for their rectal cancer.

Official Title
-----------------
Metabolic Imaging: Predicting Histopathologic Response to Preoperative Chemoradiotherapy for Locally Advanced Rectal Cancer

Conditions
-----------------
Rectal Cancer

Intervention / Treatment
-----------------
* Procedure: Metabolic Imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:- You must be diagnosed with locally advanced rectal cancer and have chosen treatment with preoperative chemoradiotherapy followed by surgery, which is a standard treatment approach for this disease. Exclusion Criteria:- You are ineligible for this study if you are pregnant or under the age of 18 years old.

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Metabolic Imaging|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To learn whether new medical imaging technology can help predict the response of rectal cancer to preoperative chemotherapy and radiation therapy. |  |  |
18F-FDG Uptake Heterogeneity Predicts Pyrotinib Response

Study Overview
=================
Brief Summary
-----------------
Heterogeneity of 18F-fluorodeoxyglucose (FDG) uptake is a promising marker for predicting response to treatment. This study aimed to evaluate the ability of pretreatment positron emission tomography/computed tomography (PET/CT) 18F-FDG-based heterogeneity to predict the response to pyrotinib in patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC).

Official Title
-----------------
Pretreatment 18F-FDG Uptake Heterogeneity Predicts Response to Pyrotinib in Patients With Metastatic HER2-positive Breast Cancer

Conditions
-----------------
HER2-positive Breast Cancer

Intervention / Treatment
-----------------
* Drug: Pyrotinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pathologically confirmed HER2 positive breast cancer Treated with Pyrotinib in the metastatic settings Underwent whole-body FDG PET/CT within 4 weeks before the initiation of pyrotinib and capecitabine were included in this study Exclusion Criteria: Incomplete medical history Loss of follow up

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients cohort<br>Patients with HER2 positive MBC in the Fudan University Shanghai Cancer Center who underwent whole-body 18F-FDG PET/CT before the initiation of pyrotinib was included. | Drug: Pyrotinib<br>* Pyrotinib 400mg po qd<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS |  | Through study completion, an expected average of 12 months |
Validate the Dosimetric Parameters That Correlate With Acute Hematologic Toxicity (HT) in Patients With Rectal Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to validate the dosimetric parameters that correlate with acute hematologic toxicity (HT) in patients with rectal cancer treated with neoadjuvant chemoradiotherapy.

Detailed Description
-----------------
The investigators' ongoing retrospective study investigated the clinical and dosimetric parameter (dosimetry of pelvic bone marrow) which relate with acute hematologic toxicity in patient with rectal cancer treated with neoadjuvant chemoradiotherapy. In order to validate the dosimetric limitation of pelvic bone marrow in decreasing the intensity of HT, the investigators want to conduct a study to observe the acute HT without assigning any specific interventions to the subjects of the study, who will receive the standard treatment according to the multidisciplinary team's (MDT) decision and patient choice. Therefore, this study's type is observational.

Official Title
-----------------
Validate the Dosimetric Parameters That Correlate With Acute Hematologic Toxicity (HT) in Patients With Rectal Cancer Treated With Neoadjuvant Chemoradiotherapy

Conditions
-----------------
Rectal Neoplasm

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: rectal cancer receive neoadjuvant chemoradiotherapy Exclusion Criteria: hematological system disorders
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 |
| --- | --- | --- |
| the grade of acute hematologic toxicity | Hematologic Adverse Events That Are Related to Pelvic Bone Marrow Irradiation | 5-6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
radiotherapy hematologic toxicity pelvic bone marrow
Observational Study on Efficacy, Safety and Convenience of Using Mixtard® 30 NovoLet® Alone or Combined With OHA in Treatment of Type 2 Diabetes in Routine Clinical Practice

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Asia. The aim of this study is to assess the efficacy, safety and convenience of the use of Mixtard® 30 NovoLet® used alone or combined with oral hypoglycaemic agent (OHA) in the management of type 2 diabetes mellitus in an out-patient setting.

Official Title
-----------------
A Multi-center, Prospective, Non-interventional Evaluation of Efficacy, Safety and Convenience of Mixtard® 30 NovoLet® as Monotherapy, or in Combination With Oral Hypoglycaemic Agent ( OHA ), in Treatment of Subjects With Type 2 Diabetes in Routine Clinical Practice

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: biphasic human insulin 30


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes Not adequately controlled on their current therapy
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Novolet®<br> | Drug: biphasic human insulin 30<br>* Dose and timing of dose for each subject was at the discretion of the attending physicians based on current clinical practice guidelines<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fasting blood glucose (FBG) |  |  | 
| Change in 2-hour post prandial blood glucose |  |  | 
| Change in HbA1c (glycosylated haemoglobin) |  |  | 
| Change in prandial glucose increment (PGI) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of minor and major hypoglycaemia |  |  | 
| Occurrence of Adverse Drug Reactions (ADR) |  |  |
A Study to Evaluate Subjects With Turner Syndrome Treated With Growth Hormone

Study Overview
=================
Brief Summary
-----------------
This study is a multicenter, open-label, observational, postmarketing surveillance study of Genentech growth hormone (GH) products in the treatment of girls with Turner syndrome in the United States and Canada.

Official Title
-----------------
Characterization of Subjects With Turner Syndrome Treated With Growth Hormone in the National Cooperative Growth Study (NCGS)

Conditions
-----------------
Turner Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Are girls with Turner syndrome who are being or will be treated with Nutropin, Nutropin AQ, or Protropin Are willing to keep follow-up appointments throughout study participation Are girls with Turner syndrome who have submitted Form 4 upon discontinuation and may also submit Form 9 Exclusion Criteria: Have Noonan syndrome Subjects treated within the last 6 months with a non-Genentech GH preparation Have closed epiphyses prior to NCGS enrollment Have active neoplasia

Ages Eligible for Study
-----------------
Maximum Age: 17 Years

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

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 |
| --- | --- | --- |
Intraocular Pressure Accuracy and Variability of the Barraquer Tonometer

Study Overview
=================
Brief Summary
-----------------
To determine if the Barraquer tonometer provides an accurate and reliable measurement of intraocular pressure. The Barraquer tonometer is a device used to safely and painlessly measure intraocular pressure.

Detailed Description
-----------------
Intraocular pressure will be checked using four different methods of tonometry. These four methods will include Tonopen, Goldmann applanation tonometry, Schiotz tonometry, and Barraquer tonometer. The data will then be compared to determine the reliability and accuracy of the Barraquer tonometer.

Official Title
-----------------
Study to Compare the Accuracy and Variability of the Barraquer Tonometer With Other Methods of Tonometry

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients of Barnes Retina Institute who are scheduled to undergo vitreoretinal surgery. All patients scheduled for routine eye examination at the Washington University Eye Clinic or Barnes Jewish Eye Clinic. All ages (patients seen at these locations are adult patients >18 years of age). Exclusion Criteria: Any patient who is seen in the outpatient clinics for an urgent or emergency ophthalmological issue. Any patient who has a contraindication to routine, noninvasive methods of tonometry and/or pachymetry (ie corneal ulcer).

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Barraquer tonometer|barraquer tonometer|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central corneal thickness as measured by pachymetry |  | at time of measurement | 
| Intraocular pressure as measured by Schiotz tonometer |  | at time of measurement | 
| Tonopen |  | at time of measurement | 
| Barraquer tonometer |  | at time of measurement | 
| and Perkins tonometer |  | at time of measurement | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Barraquer tonometer, Intraocular pressure, Tonometry
Nutrition, Overgrowth, and Vaccine Efficacy in Low-income Settings

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the impact of small intestine bacterial overgrowth (SIBO) on childhood nutritional status, growth, and oral vaccine efficacy.

Official Title
-----------------
A Longitudinal Study of Childhood Intestinal Bacterial Overgrowth, Vaccine Underperformance, and Malnutrition

Conditions
-----------------
Small Intestine Bacterial Overgrowth

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Child previously enrolled in the FIELD STUDIES protocol (enrollments in both studies may occur simultaneously) Mother willing to sign informed consent form. Healthy infant aged less than 7 days old Exclusion Criteria: Parents are not willing to have child's blood drawn, oral fluid collected, urine collected, or breath testing performed. History of seizures, other apparent neurologic disorders, or other congenital abnormalities involving major organ systems.

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 7 Days

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 |
| --- | --- | --- |
| Glucose-Hydrogen Breath Test | Test for Small Intestine Bacterial Overgrowth | Birth to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fecal Regenerating Islet-Derived 1 Beta (Reg 1B) |  | Birth to 2 years | 
| Fecal Myeloperoxidase |  | Birth to 2 years | 
| Serum 25-OH vitamin D |  | Birth to 2 years | 
| Serum Zinc |  | Birth to 2 years | 
| Serum Retinol Binding Protein |  | Birth to 2 years | 
| Serum Cobalamin |  | Birth to 2 years | 
| Serum Albumin |  | Birth to 2 years | 
| Lactulose mannitol ratio |  | 12 weeks of age | 
| Serum Tetanus antibody titers |  | Birth to 2 years | 
| Serum Polio antibody titers to sabin strains |  | Birth to 2 years | 
| Oral fluid Tetanus antibody titers |  | Birth to 2 years | 
| Height |  | Birth to 2 years | 
| Weight |  | Birth to 2 years | 
| Head circumference |  | Birth to 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oral vaccination, nutrition