linjc16/ctgov huggingface dataset:
Assessment of Bleeding Symptoms in Normal Individuals Using a Comprehensive History Phenotyping Instrument

Study Overview
=================
Brief Summary
-----------------
A wide variety of individuals are at risk for bleeding, but even though bleeding symptoms are common it is difficult to compare different people's symptoms. Recent research has found that carefully designed surveys can be used to calculate a bleeding score that is useful for diagnosing bleeding disorders, but normal individuals have not been specifically studied in large numbers with a comprehensive survey. Whether factors like race, ethnicity, age, sex, aspirin use, and previous trauma and surgery influence bleeding scores is also unknown. The primary goal of this study is to use a comprehensive computerized questionnaire to record the bleeding symptoms of normal individuals and then assess the range and severity of bleeding symptoms in this normal population. Secondary goals include determining whether race, ethnicity, age, sex, aspirin use, and previous trauma and surgery correlate with bleeding symptoms.

Official Title
-----------------
Assessment of Bleeding Symptoms in Normal Individuals Using a Comprehensive History Phenotyping Instrument

Conditions
-----------------
Bleeding Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years of age. Self-assessed as being generally healthy. Self-assessed as being able to accurately read and answer questions in English about their past medical histories. Exclusion Criteria: A diagnosis of any disorder of hemostasis. A diagnosis of any condition associated with an increased risk of bleeding, namely, any current or previous diagnosis of liver or kidney disease, and malignancy requiring treatment within the past year. Use of heparin, low-molecular weight heparins, warfarin, clopidogrel, or other medications with known anticoagulant or anti-platelet properties in the past 30 days. History, physical, or known laboratory findings suggestive of any other medical or psychological condition that would impair the participant's ability to accurately respond to questions about bleeding symptoms.

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 |
| --- | --- | --- |
| Answers to bleeding history questions posed in the questionnaire and cofactors, such as participants' age, sex, history of prior hemostatic challenge, ASA use, ethnicity, and race. |  | During study visit |
Survey of Predictors of Human Papillomavirus (HPV) Vaccination Among Parents of Rural Adolescent Girls in Mysore, India

Study Overview
=================
Brief Summary
-----------------
To conduct a quantitative survey to measure knowledge about Human papillomavirus (HPV) and cervical cancer, and HPV vaccine acceptability among parents of rural adolescent girls in Mysore District, India. Hypothesis: General knowledge and attitudes about the severity and treat ability of cancer will predict acceptability of HPV vaccination among parents of rural adolescent girls in Mysore, India.

Official Title
-----------------
Survey of Predictors of HPV Vaccination Among Parents of Rural Adolescent Girls in Mysore, India

Conditions
-----------------
Human Papillomavirus, Cervical Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: over 18 years of age parent of an adolescent girl (10 -15 years of age) able to speak English or Kannada willing to undergo informed consent process Exclusion Criteria: Does not have the capacity to undergo informed consent process

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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 |
| --- | --- | --- |
| Parental Acceptability of HPV vaccine |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge about HPV and Cervical Cancer |  | One Year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
parental acceptability of HPV vaccine
Active vs Passive Distraction on Procedural Pain in the Pediatric Emergency Department

Study Overview
=================
Brief Summary
-----------------
The investigators proposed study will investigate the efficacy of tablet computer distraction as an analgesic for the pain associated with various painful procedures in the emergency department. Since prior studies have shown that distraction by a parent or nurse can be an effective analgesic, there is reason to believe that tablet computer distraction will similarly reduce pain. Participants in the control group will receive a cartoon on the TV monitor in the patient room, while participants in the study group will receive a more immersive distraction of playing a game or watching a cartoon (for children too young to play a game) on a tablet computer. Data from this study will help inform best practices for administering painful procedures in a way that minimizes pain.

Official Title
-----------------
Impact of Active vs Passive Distraction on Procedural Pain/Distress in the Pediatric Emergency

Conditions
-----------------
Pain Response

Intervention / Treatment
-----------------
* Behavioral: Active Distraction
* Behavioral: Passive Distraction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy pediatric patients in the University of Chicago emergency department who are undergoing insertion of a peripheral intravenous line, intramuscular injection, fingerstick, subcutaneous injection, laceration repair (sutures, tissue adhesive, and staples), nail avulsion, or abscess incision and drainage. Exclusion Criteria: Non-English speaking, over the age of 18 trauma, have come in for asthma-related complaints, are being resuscitated, are neurosurgical/neurology/seizure patients, or patients in whom use of distraction would interfere with the procedure

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active distraction<br>Child will use Ipad as active distraction | Behavioral: Active Distraction<br>* iPad will be used as active distraction<br>|
| Experimental: Passive Distraction<br>Child will watch movie as passive distraction (control) | Behavioral: Passive Distraction<br>* child will watch TV as passive distraction<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score on pain scale |  | after procedure |
Follicular Challenge Test to Predict Response to GnRH Agonist Triggering

Study Overview
=================
Brief Summary
-----------------
GnRH agonist triggering is used during ART in order to reduce the risk of OHSS. Some studies described that in up to 5% of the cycles triggered with GnRH agonist, a lack of respone or suboptimal response was displayed. The investigators aim to asses the possibility to predict the respone to ovulation triggering by the response to decapeptyl in the follicular phase of the same cycle.

Detailed Description
-----------------
The investigators will use Decapeptyl on day 2 of menstruation followed by antagonist protocol. Hormonal proflie including E2, P, LH, FSH will be measured. LH surge and the rest of the hormonal profile will be compared to day after ovulation triggering.

Official Title
-----------------
Follicular Challenge Test to Predict Response to GnRH Agonist Triggering

Conditions
-----------------
Infertility, Female

Intervention / Treatment
-----------------
* Other: Decapeptyl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients that undergo fertility preservation patients planned to freeze embryos due to PGT or surrogacy --patients at high risk for OHSS Exclusion Criteria: Poor ovarian response known hypothalamic- pituitary dysfunction

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 41 Years

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

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 |
| --- | --- |
| Other: study group<br>The participants will recieve decapeptyl 0.2 mg on day 2/3 of the follicular phase.At that day, and at the day after, hormonsl profile will be documented. The hormonal profile of the day after follicular decapeptyl administration will be compared to the hormonal profile to test the predictive value. | Other: Decapeptyl<br>* diagnosis of predictio value<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The response to GnRH triggering | LH levels 10-12 hours after decapeptyl trigger, number of mature oocytes | One treatment cycle (each cycle is 28 days) for each participant (up to 28 days). |
Taste Disorders and Their Relation to BMI, FFQ, and EORTC QLQ-BR23 in Breast Cancer Patients During Chemotherapy.

Study Overview
=================
Brief Summary
-----------------
Taste disorders in cancer patients during chemotherapy could be consider as multifactorial disease, it is related with changes of food consumption. Approximately 36-69% of the patients under chemotherapy suffer oral toxicity or dysgeusia A prospective case- only observational study was conducted in patients of the Hospital General de México for two years. A self-reported taste survey was used, and patients scored their results in a Likert scale.

Official Title
-----------------
Taste Disorders and Their Relation to Body Mass Index, Food Frequency Questionnaire and Quality of Life in Breast Cancer Patients During Chemotherapy.

Conditions
-----------------
Breast Cancer, Taste Disorders, Dysgeusia, Ageusia, Quality of Life

Intervention / Treatment
-----------------
* Other: Taste disorder´s test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Chemotherapy with Doxorubicin + Cyclophosphamide (DC) or Paclitaxel + Carboplatin (PC) or Docetaxel. Exclusión Criteria: No smokers Infections in oral cavity Acute respiratory diseases Gastro- oesophageal reflux disease Other types of cancer.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 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 |
| --- | --- |
| Chemotherapy breast cancer patients<br>Newly diagnosed breast cancer patients (clinical stages IA, IIA, IIB, IIIA and IIIB) before and after chemotherapy with the following drugs (Doxorubicin + Cyclophosphamide (DC) or Paclitaxel + Carboplatin (PC) or Docetaxel were followed until they complete four cycles of chemotherapy. | Other: Taste disorder´s test<br>* Each patient performed their own test placing three drops with a disposable dropper from each bottle into the center of the tongue for whole-mouth testing.<br>* Other names: Taste disorders;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of taste disorders and perception of the four basic flavors | to assess the prevalence of taste alterations perception of the four basic flavors (sweet, salty, bitter and acidic) in newly diagnosed breast cancer patients (clinical stages IA, IIA, IIB, IIIA and IIIB) before and after chemotherapy | 21 days |
Tolerability and Pharmacokinetics of Metformin and Metformin Extended Release (ER)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the gastric tolerability and the pharmacokinetics of an extended release metformin compared with an immediate release metformin in healthy subjects.

Official Title
-----------------
Gastric Tolerability and Pharmacokinetics of an Extended Release Metformin and an Immediate Release Metformin

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: metformin ER
* Drug: metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mexican healthy subjects with normal clinical laboratory test results and imaging (hematology, blood chemistry, urine test, VDRL, Hepatitis B, HIV, chest radiography and electrocardiogram) Exclusion Criteria: Familiar or personal history of diabetes History of drug or alcohol abuse within the 2 years prior to the study A smoking habit greater than 10 cigarettes per day History of allergy to the study drugs Intercurrent disease Intercurrent treatment with any drug

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: metformin ER<br>Extended Release Metformin | Drug: metformin ER<br>* 850mg daily for 30 days<br>* Other names: predial plus;|
| Active Comparator: metformin<br>Immediate release metformin | Drug: metformin<br>* 850 mg daily for 30 days<br>* Other names: extended release predial plus;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasmatic drug concentration |  | 48 hours (7.5, 15,30,45,60,75,90,120,150,180,205,240,360,480,600,720,1440,2880 min and days : 3,5,7,14,21,28,30,35) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lanza score |  | 30 days (0 and 30) | 
| plasmatic glucose |  | 30 days (0, 6, 12 and 18 hours and days: 2,5,7,14,21,28,30 and 35) | 
| Glycated hemoglobin |  | 30 days (days: 0, 14 and 30) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metformin ER, Pharmacokinetics, Tolerability, Healthy volunteers
Endostar Plus EGFR-TKI（Epidermal Growth Factor Receptor-Tyrosine-Kinase Inhibitor） as a Treatment of EGFR Mutation-positive NSCLC

Study Overview
=================
Brief Summary
-----------------
EGFR Tyrosine-Kinase Inhibitor monotherapy is widely used in treatment of patients with EGFR mutation-positive Non-small cell lung cancer(NSCLC), In despite of the benefit of PFS （progression-free survival） , the OS （ overall survival） is limited extended. This study is aim to observe the safety and efficacy of the combination of an anti-angiogenic drug recombinant human-endostatin with EGFR TKI ,to find out a new strategy which may further extend the PFS and OS with a tolerated toxicity.

Official Title
-----------------
Short-term Injection of Recombinant Human Endostatin Plus EGFR-TKI as a Treatment of EGFR Mutation-positive Advanced Non-small Cell Lung Cancer

Conditions
-----------------
Advanced Cancer, Lung Cancer, Nonsmall Cell

Intervention / Treatment
-----------------
* Drug: EGFR-TK Inhibitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Advanced NSCLC,EGFR mutation positive,PS（performance status） 0-2,Patients were required to have one or more measurable lesions 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EGFR-TK inhibitor plus RH-endostatin<br>EGFR-TKI icotinib:125mg Tid RH-endostatin:15mg/m2 ,d1-7 | Drug: EGFR-TK Inhibitor<br> <br> * Other names: Recombinant human endostatin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival |  | 18 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
EGFR-TKI, Recombinant human endostatin
Comparison of 18F-fluorodeoxyglucose Positron Emission Tomography and Coronary Computed Tomography in Assessing Vascular Inflammation

Study Overview
=================
Brief Summary
-----------------
Vascular inflammation is a key factor in both the pathogenesis and outcome of atherosclerosis. 18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) is a promising tool for identifying and quantifying vascular inflammation within atherosclerotic plaques.cardiac multidetector-row CT can provide measurements of coronary artery calcium (CAC), the degree of stenosis, and the characteristics of plaque including its potential vulnerability. Therefore, the purpose of the investigators study is to compare the usefulness of 18 FDG-PET and MDCT in assessing the vascular inflammatory status and vulnerability.

Official Title
-----------------
Comparison of 18F-fluorodeoxyglucose Positron Emission Tomography and Coronary Computed Tomography in Assessing Vascular Inflammation in Healthy Population

Conditions
-----------------
Atherosclerosis

Intervention / Treatment
-----------------
* Other: Cross section study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy patients for visiting routine medical check in our clinic Exclusion Criteria: History of cardiovascular disease (myocardial infarction, unstable angina, stroke, or cardiovascular revascularization) Diabetes Stage 2 hypertension (resting blood pressure, ≥ 160/100 mmHg) Malignancy Severe renal or hepatic disease Subjects taking medications that might affect inflammation such as NSIAD and statin

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy patients<br> | Other: Cross section study<br>* This is not intervention study. The purpose of the study is to examine the relationship of vascular inflammation assessed by 18FDG-PET and MDCT at the cross section setting<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between vascular inflammatory status measured by 18FDG PET and MDCT |  | 20weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison the correlation with inflammatory marker and vascular inflammatory status assessed by 18FDG PET and MDCT |  | 20 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
atherosclerosis, vascular inflammation, MDCT, 18FDG-PET
Prevention of Neonatal Respiratory Distress Syndrome With Antenatal Steroid Administration

Study Overview
=================
Brief Summary
-----------------
To determine the effect of corticosteroids, administered 24 to 48 hours before parturition, on the incidence of neonatal respiratory distress syndrome (RDS) and to determine whether the therapy has any adverse short- or long-term (up to 36 months) effects on the infant. Secondarily, to determine whether the therapy has any adverse short-term effects on the mother and to determine whether morbidity rates for neonatal respiratory distress syndrome as well as total and cause-specific infant mortality rates differ between mothers who received antenatal steroids and those who received conventional medical care.

Detailed Description
-----------------
BACKGROUND: Neonatal respiratory distress syndrome is one of the leading causes of disability and death in the newborn. In the United States, approximately 10 percent of all infants are premature, and each year about 50,000 cases of neonatal respiratory distress syndrome occur. Extensive studies in animal models on respiratory distress syndrome have demonstrated that antenatal administration of synthetic (dexamethasone) and natural (cortisol) corticosteroids accelerates lung maturation and significantly diminishes the occurrence of RDS. Although a variety of conditions in newborn infants have been treated with steroids over the past 20 years without adverse effects, investigations have been needed on the short-term effects of corticosteroids administered antenatally on neonate and mother and on the long-term effects on the infant. The Planning Phase of this trial was completed in March 1977, with formulation of a common protocol and manual of operations. Patient screening and enrollment began in August 1977 and ended on March 1, 1980. Follow-up ended in August 1983 and data analysis was completed October 31, 1983. DESIGN NARRATIVE: Randomized, double-blind, fixed sample. Six hundred and ninety-six pregnant women were randomized to four doses of dexamethasone every 12 hours or to placebo. Endpoints were the incidence of respiratory distress syndrome and abnormality of motor-neuro-intellectual development in their infants.

Conditions
-----------------
Lung Diseases, Respiratory Distress Syndrome

Intervention / Treatment
-----------------
* Drug: dexamethasone


Participation Criteria
=================
Eligibility Criteria
-----------------
Male and female fetuses and infants; pregnant women with anticipated premature delivery and gestational age between 26 and 37 weeks.

Ages Eligible for Study
-----------------
Maximum Age: 1 Year

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |