linjc16/ctgov huggingface dataset:
Cervical Cancer Screening Strategies

Study Overview
=================
Brief Summary
-----------------
This study is to investigate retrospectively the results of cervical cytology and high-risk human papillomavirus in the past 20 years recorded in Peking Union Medical College Hospital. The histological findings after cervical cancer screening were reviewed. The diagnostic values of different screening strategies were compared based on the results of cervical histology. The primary endpoint is the diagnosis of grade 2 cervical intraepithelial neoplasia (CIN2) or more severe lesions (CIN2+). The secondary endpoints include following objectives: (1) the invasive procedures needed according to the screening results; (2) the diagnosis of vaginal and/or vulval intraepithelial neoplasia; (3) the persistence and recurrence of human papillomavirus infection; and (4) the cost-effectiveness of screening strategies for CIN2+.

Official Title
-----------------
A Retrospective Cohort Study on the Effectiveness of Various Screening Strategies for Uterine Cervical Cancer

Conditions
-----------------
Cervical Cancer, Cervical Intraepithelial Neoplasia, Human Papillomavirus Infection, Cervical Cytology, Cancer Screening

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18 years or older With definite cervical histology after cervical cancer screening, ore with at least one screening test after first testing Exclusion Criteria: - Not meeting all of the inclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| CIN2+ | CIN2+ detected by various screening methods | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Invasive procedures | Invasive procedures needed according to the screening results | One year | 
| Vaginal intraepithelial neoplasia (VaIN) | VaIN detected by various screening methods | One year | 
| Vulval intraepithelial neoplasia (VIN) | VIN detected by various screening methods | One year |
VX-950 and Peginterferon for Hepatitis C

Study Overview
=================
Brief Summary
-----------------
VX-950 is an investigational drug , which is being tested in combination with a known treatment for hepatitis C, peginterferon.

Official Title
-----------------
A Phase 1b Viral Kinetic Study of VX-950 and Peginterferon in Hepatitis C

Conditions
-----------------
Hepatitis C

Intervention / Treatment
-----------------
* Drug: VX-950
* Drug: peginterferon


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: infected with Hepatitis C virus Exclusion Criteria: contraindications to peginterferon therapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: VX-950|nan|
|Drug: peginterferon|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viral kinetics |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the safety of VX-950 in combination with peginterferon |  |  |
Estimation of Pulmonary Vascular Resistance by Contrast Echocardiography

Study Overview
=================
Brief Summary
-----------------
An echocardiogram using Definity contrast can provide the same information as the standard right heart catheterization.

Official Title
-----------------
Estimation of Pulmonary Vascular Resistance by Contrast Echocardiography

Conditions
-----------------
Pulmonary Arterial Hypertension

Intervention / Treatment
-----------------
* Procedure: 2D doppler echo with Definity solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients scheduled to undergo right heart catheterization at the George Washington University Hospital Exclusion Criteria: Patients with known or suspected right-to-left bi-directional or transient right-to-left shunts or pulmonary arteriovenous malformations, previously documented moderate to severe tricuspid regurgitation or moderate to severe pulmonary regurgitation, evidence of right ventricular hypokinesis, or prior adverse reaction to Definity or hypersensitivity to perflutren

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2D doppler echo with Definity solution<br>Study subjects will already be scheduled for right heart catheterization to diagnose pulmonary hypertension. Prior to the catheterization, each subject will have a 2D doppler echocardiogram with Definity solution as well. | Procedure: 2D doppler echo with Definity solution<br>* Correlate right heart catheterization results with results from 2D doppler echo with Definity Solution<br>* Other names: Definity solution;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure Pulmonary Vascular Resistance using 2D Doppler Echocardiogram w/Definity Solution | Correlation coefficients between the technique above the the gold standard right heart catheterization measures of pulmonary vascular resistance. | Two Years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulmonary Arterial Hypertension, Pulmonary Vascular Resistance, Right Heart Catheterization
Briagen Observational Study

Study Overview
=================
Brief Summary
-----------------
This research study is evaluating a study product called Briagen™ as a possible treatment for wound healing after Mohs procedure.

Detailed Description
-----------------
Briagen, the study product being used in this study, is a natural complex carbohydrate wound dressing for skin wounds created by Mohs surgery. Briagen was developed with the intent to improve healing time and reduce scarring of skin wounds. Briagen seeks to match the mechanical aspects of your skin (thickness, stiffness, hydration, pore size) to assist in the healing process. The purpose of this research study is to observe healing time of Briagen applied to wounds created as a result of Mohs surgery.

Official Title
-----------------
Briagen™ Case Study and Observation of Skin Excision Healing in Mohs and Other Dermatological Procedures

Conditions
-----------------
Mohs Surgery

Intervention / Treatment
-----------------
* Device: Briagen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient seeking treatment for wound created by Mohs or other full thickness skin excisions Over 18 years of age English-speaking Presents for treatment within 24 hours of initial Mohs skin excision procedure. Exclusion Criteria: History of significant wound complications and non-compliance on wound maintenance instructions (infections, disturbing the wound during the healing process, etc.) Known diagnosis of Diabetes Active infection in the wound bed Under 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

| Intervention/Treatment |
| --- |
|Device: Briagen|Natural complex carbohydrate wound dressing for skin wounds|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healing Time |  | 28 days |
Roflumilast In-Vitro Basophil Release

Study Overview
=================
Brief Summary
-----------------
This study is looking for allergic asthmatics. Lung and allergy testing will be done to verify. If qualified, blood will be drawn for laboratory studies.

Detailed Description
-----------------
Non-smoking allergic asthmatics will be verified using pulmonary function, skin prick testing, exhaled nitric oxide and serum IgE. If qualified, blood will be drawn, treated with study medication and then stimulated with the allergen to which the subject is allergic. Mediators including Histamine, IL-13, IL-4, and leukotrienes will be measured.

Official Title
-----------------
Effect of Roflumilast In-Vitro on Basophil Histamine, Leukotriene, IL-4 and IL13-release.

Conditions
-----------------
Allergy, Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 19 and above Allergic Asthma Serum IgE greater than 30iu/ml Exhaled Nitric Oxide greater than 17ppb Exclusion Criteria: smoking history

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 65 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Interleukin 13, Interleukin 4, Leukotrienes, Basophil Histamine Release
Pemetrexed and Gemcitabine in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

Study Overview
=================
Brief Summary
-----------------
This is a Phase 2 study of pemetrexed and gemcitabine chemotherapy given once every 14 days to patients with advanced stage non-small cell lung cancer. This treatment is for patients that have not received any prior chemotherapy treatment for lung cancer. The primary goal is to find out if the tumor gets smaller or disappears with this treatment.

Official Title
-----------------
Phase 1/2 Dose-Escalating Study of Biweekly Alimta and Gemcitabine in Patients With Advanced Cancer

Conditions
-----------------
Lung Neoplasms

Intervention / Treatment
-----------------
* Drug: pemetrexed
* Drug: gemcitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have a diagnosis of advanced stage non-small cell lung cancer. Are able to be active at home and/or work. Have not received chemotherapy for this cancer disease. Have good organ function (for example, most blood work is normal). Have completed any prior radiation treatment at least 4 weeks ago. Exclusion Criteria: Have been treated with an investigational/research drug within the last month. Have cancer that has spread to the brain and is causing symptoms. Have an active infection or other serious medical condition. Have a second cancer in addition to non-small cell lung cancer. Can not stop taking aspirin or other anti-inflammatory agents for 5-8 days.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: pemetrexed|nan|
|Drug: gemcitabine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To find out how often tumors become smaller or disappear in patients with advanced NSCLC treated with gemcitabine followed by pemetrexed once every 14 days. Chemotherapy treatment will be given for up to 12 times or until the cancer disease increases. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure the effects of chemotherapy treatment on: |  |  | 
| time until the cancer becomes less;time to cancer re-appears or becomes larger;length of time there is no increase in the amount of cancer;length of time patients survive; |  |  | 
| To measure the side-effects from this chemotherapy as given once every 14 days. |  |  |
Supplementary Food for Moderate Acute Malnutrition in Children

Study Overview
=================
Brief Summary
-----------------
Children with moderate acute malnutrition will be recruited in order to receive an intervention which consists in the consumption of a single serving of SF-cookies daily, 7-days a week for 12 months and 12 educational sessions on health and nutrition.

Official Title
-----------------
The Effect of Supplementary Food on Recovery From Moderate Acute Malnutrition in Pre-school Children in Rural Mexico

Conditions
-----------------
Moderate Acute Malnutrition

Intervention / Treatment
-----------------
* Other: Nutritional Oats Cookie


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children (2-5 years old), who are from low socioeconomic classes (E and D classes), reside in rural areas, and with WHZ- between > -3 and ≤ -2, and informed consent given by the subject's mother or caregiver Exclusion Criteria: Severe acute malnutrition (HAZ, WAZ and WHZ-scores ≤-3) based on the 2006 World Health Organization (WHO) reference values (24) Vitamin A deficiency (softening, ulceration, cloudiness of the cornea, and dryness of the conjunctivitis), and iodine deficiency (visible goiter) (3 or more episodes of loose/liquid stools/per day and lasted more than 24-hours), fever (high temperature that lasted more than 24 hours as reported by the mother/caregiver), and respiratory infections (coughing and/or runny nose that last more than 24 hours). Current consumption of other supplementary foods. Peanut or other ingredient allergy based on prior report. If some direct family member is allergic to peanuts, child would not be enrolled.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 5 Years

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

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

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: Nutritional Oats Cookie<br> | Other: Nutritional Oats Cookie<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight (kg) for height (cm) Z-score |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight (kg) gains |  | 12 months | 
| height (cm) for age (months) Z-score |  | 12 months | 
| weight (kg) for age (months) Z-score |  | 12 months | 
| Mid-upper arm circumference (cm) (MUAC) |  | 12 hours | 
| height (cm) gain |  | 12 months |
Fluid Optimization in Liver Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to analyze hemodynamic changes, in patients undergoing liver resection, through the Vigileo/FloTrac system.

Detailed Description
-----------------
To reduce bleeding, hepatectomies are performed with low central pressure (CVP) combined with extrahepatic control flow. This management can lead hemodynamic instability and reduction in oxygen delivery so an advanced monitoring should be used. This study analyzes hemodynamic changes, in patients undergoing liver resection, through the Vigileo/FloTrac system.

Official Title
-----------------
Study on Fluid Optimization in Liver Surgery Trough Vigileo/FloTac System Associated to Traditional Monitoring.

Conditions
-----------------
Cancer of Liver

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I-III Exclusion Criteria: Cirrhosis systolic ventricular contractility or diastolic relaxation alterations ischemic or valvular diseases absence of sinusal rhythm impaired renal function

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 70 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 |
| --- | --- | --- |
| Stroke volume variation | Evaluation of changes in Stroke Volume Variation from Vigileo/FloTrac system during liver resection. | at time of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke volume variation | Evaluation of changes in Stroke Volume Variation at the end of liver resection, during fluid optimization. | at the end of surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intraoperative monitoring, fluid management
Qualitative Validation of Patient-Reported Outcomes (PRO) Instrument

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to conduct concept elicitation and cognitive debriefing interviews with patients who have been implanted with the KAMRA inlay in order to assess the content validity of a PRO instrument

Official Title
-----------------
Qualitative Patient Interviews to Develop a Patient-Reported Outcomes (PRO) Instrument to Assess Visual Symptoms in KAMRA® Inlay Patients

Conditions
-----------------
Patient-Reported Outcomes (PRO)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Minimum 45 years of age, maximum age 60 years; Subject has been implanted with the KAMRA inlay; Subject is in good general health, as evidenced by medical history; Subject is willing and able to attend and participate in the interviews and demographic questionnaire (fluent in U.S. English); and Signed informed consent document. Exclusion Criteria: Subject has severe neurological or cognitive deficits or an uncontrolled psychiatric condition that might affect their ability to participate in the interview; Subject has insufficient ability to read or write that would prevent them from completing a questionnaire without help; Subject is not a fluent speaker of U.S. English; or Subject is unable to attend the interview.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 60 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 |
| --- | --- | --- |
| PRO instrument | Develop PRO instrument that will assess KAMRA inlay-related visual symptoms and to establish the content validity of that PRO instrument. | 6 months |
A Cohort Study of Uterine Malignancies

Study Overview
=================
Brief Summary
-----------------
The purposes of current study were to explore the relationship between cervical cancer/endometrial cancer and demographic information, behavior and life style, pregnancy-related factors, and disease history, and to study the factors affecting the prognosis of cancers. In addition, omics tests were performed on the biological specimens to identify the diagnostic markers and prognostic biomarkers.

Detailed Description
-----------------
After being informed about the study and potential risks, all patients who meet the eligibility requirements will be enrolled.

Official Title
-----------------
A Cohort Study of Uterine Malignancies

Conditions
-----------------
Cervical Cancer, Endometrial Cancer

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 20-75 years; Women with cervical cancer or endometrial cancer with a definite pathological diagnosis for the first time; Women attending a health check-up; Obtain informed consent and sign an informed consent form. Exclusion Criteria: Patients who are unable to cooperate with the investigations such as mental disorders or cognitive impairment； Patients with cancer other than cervical cancer or endometrial cancer; Women who have received hysterectomy or pelvic radiation therapy previously.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No intervention|This is a prospective observational study with no intervention.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival (PFS) | progression free survival for patients with cervical cancer or endometrial cancer | 60 months |