linjc16/ctgov huggingface dataset:
Registry to Collect Health Information Related to Fibrolamellar Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect information about people with fibrolamellar cancer (FLC). This study is a registry of people with FLC around the world. This study will involve collecting information about participants, their medical history and the regular medical care they receive for FLC. The study will not provide treatment for your cancer.

Official Title
-----------------
Fibrolamellar Carcinoma Global Dynamic Registry

Conditions
-----------------
FLC, Fibrolamellar Cancer, Liver Cancer

Intervention / Treatment
-----------------
* Behavioral: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 13 years or older. Personal history of histologically proven fibrolamellar carcinoma (clinical or radiographical suspicion of FLC must be confirmed at MSK or an external hospital) Participants must have access to electronic devices that meet the following minimum requirements: Ability to connect to the internet Capability of running modern internet browers (such as Google Chrome, Internet Explorer, Safari, or Mozilla Firefox). Participants must have a google account Exclusion Criteria: Participants residing in the European Union (EU).

Ages Eligible for Study
-----------------
Minimum Age: 13 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 |
| --- | --- |
| Participants with Fibrolamellar Carcinoma/FLC<br>Participants will have a personal history of histologically proven fibrolamellar carcinoma (clinical or radiographical suspicion of FLC must be confirmed at MSK or an external hospital) | Behavioral: Questionnaire<br>* The questionnaire will be completed at the time of enrollment, every month, and at the end of study. Regardless of current interventions or lack of, assessments will be completed at enrollment and then monthly for a total of 18 months. In order to provide reasonable flexibility to participants, physicians, and study teams, the assessments can be completed within 30 days of the last assessment. The next month will be recalculated based on last reporting date.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Build a Fibrolamellar Cancer/FLC registry | To build a registry of Fibrolamellar Cancer/FLC through patient reported information, that could be studied further in future studies. | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fibrolamellar cancer, liver cancer, 20-543, Memorial Sloan Kettering Cancer
Appendicitis With Medical Treatment

Study Overview
=================
Brief Summary
-----------------
prospective study to collect data of patients with appendicitis, not receiving operation

Detailed Description
-----------------
using ultrasound to follow up the resolution of acute appendicitis

Conditions
-----------------
Appendicitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:patients with appendicitis, not receiving operation - Exclusion Criteria:nil -

Ages Eligible for Study
-----------------
Minimum Age: 16 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
-----------------
appendicitis
The Role of Mucosal Microbiome in Recurrence of Clostridioides Difficile Infection

Study Overview
=================
Brief Summary
-----------------
The study is being done to identify types of bacteria associated with the lining of the large intestine in people who have recently been treated for C. difficile infection to determine if there are features associated with recurrent disease.

Detailed Description
-----------------
Patients who have recently been diagnosed with C. difficile infection and completed treatment will be enrolled to undergo evaluation of the colonic mucosa via sigmoid biopsies. Participants will also complete surveys, blood draw and stool collection. Overall goals are to identify whether C. difficile is persisting in the colon mucosa after treated infection, and whether this, and other clinical and microbiome factors may be playing a role in disease recurrence.

Official Title
-----------------
The Role of Mucosal Microbiome in Recurrence of Clostridioides Difficile Infection

Conditions
-----------------
Clostridioides Difficile Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Adults aged 18 and over Confirmed C. difficile infection based on positive C. difficile toxin PCR testing and clinical evidence of diarrhea Exclusion criteria: Known pregnancy Prior diagnosis of C. difficile infection within 2 months of this diagnosis Other known active gastrointestinal infectious process Known diagnosis of inflammatory bowel disease, microscopic colitis, celiac disease or other inflammatory conditions Vulnerable adults Any other disease(s), condition(s) or habit(s) that would interfere with completion of study, or in the judgment of the investigator would potentially interfere with compliance to this study or would adversely affect study outcomes.

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 |
| --- | --- | --- |
| Mucosal presence | Identification of C. difficile within the colonic mucosa on stained slides from biopsy samples | 1-14 days post C. Difficile treatment | 
| Disease recurrence | Determination of recurrent C. difficile infection based on symptoms and potential clinical testing | 8 weeks |
Comparation of Different Devices to Measure Corneal Thickness

Study Overview
=================
Brief Summary
-----------------
Comparison of different methods for measuring peoples corneal thickness

Detailed Description
-----------------
Volunteers with healthy corneas will be measured by different instruments to detect their corneal thickness. First interindividual difference between the instruments will be reviewed. People will be measured again two times on two different days to examine an interindividual difference in all instruments.

Official Title
-----------------
Comparation of Different Devices to Measure Corneal Thickness

Conditions
-----------------
Corneal Thickness

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy cornea Exclusion Criteria: myopia or astigmatism over 1,5 dpt corneal surgery acute ocular inflammation lost of vision

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cornea, SL OCT, Spectral OCT Cornea modul, ultrasound pachymetry, Pentacam
LMA Cuff Pressure and LMA-induced Complications

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if using 20 mL B.Braun syringes to inflate LMAs and allowing them to recoil will put the pressure of the LMA cuff within the safety range. It will also determine if remaining within this safety range has an effect on complications after surgery..

Official Title
-----------------
Using the Natural Recoil of the Inflating Syringe as a Safety Valve to Limit LMA Cuff Pressure and Decrease LMA-Induced Complications

Conditions
-----------------
Sore Throat, Dysphagia, Dysphonia

Intervention / Treatment
-----------------
* Device: Standard inflation of LMA cuff
* Device: Pressure check with syringe recoil
* Device: Pressure check by pressure transducer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Registered Mayo Clinic in Florida patients scheduled to undergo a surgery Planned use of LMA during surgery between the ages of 18-99 short duration (<2 hours elective surgery) Exclusion Criteria: recent history of upper respiratory tract infection intra-cavitary or laparoscopic procedure risk of pulmonary aspiration known difficult airway history of gastric reflux BMI > 40 lateral or prone positions oral or nasal surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| Standard Practice<br> | Device: Standard inflation of LMA cuff<br>* LMA cuff will be inflated per standard practice with a syringe and resulting cuff pressure will be measured by manual palpation of the cuff per standard practice.<br>* Other names: LMA inflation routine clinical practice;|
| Syringe recoil<br> | Device: Pressure check with syringe recoil<br>* LMA cuff will be inflated per standard practice with a syringe and resulting cuff pressure will be measured by syringe recoil<br>* Other names: LMA cuff pressure by syringe recoil;|
| Pressure Transducer<br> | Device: Pressure check by pressure transducer<br>* LMA cuff will be inflated per standard practice with a syringe and resulting cuff pressure will be measured by pressure transducer.<br>* Other names: LMA cuff pressure checked by pressure transducer;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pressure of the syringe after inflation of the LMA cuff |  | after inflation, 1 hour into surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with dysphagia and/or dysphonia |  | 1, 2, and 24 hours after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
overinflation of LMAs
Effect of Epinephrine/ Phenylephrine for Preventing the Postreperfusion Syndrome During Reperfusion in Liver Transplantation

Study Overview
=================
Brief Summary
-----------------
Postreperfusion syndrome (PRS) is a relatively common phenomenon in patients undergoing liver transplantation which is characterized by an acute drop in blood pressure immediately after the prefusion is restored to the transplanted liver. We hypothesized that PRS would be prevented when phenylephrine or epinephrine is administered immediately prior to reperfusion in liver transplantation.

Official Title
-----------------
Effect of Preventive Medicine on the Postreperfusion Syndrome

Conditions
-----------------
Hypotension After Reperfusion in Liver Transplantation

Intervention / Treatment
-----------------
* Drug: phenylephrine
* Drug: epinephrine
* Drug: placebo control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - adults scheduled to undergo liver transplantation Exclusion Criteria: - pediatric liver transplantation

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: phenylephrine<br>100 mcg of phenylephrine is administered at the time of reperfusion | Drug: phenylephrine<br>* 100 mcg of phenylephrine (volume 10 ml) iv at the time of reperfusion<br>|
| Experimental: epinephrine<br>10 mcg of epinephrine is administered iv at the time of reperfusion | Drug: epinephrine<br>* 10mcg of epinephrine (volume 10 ml) is administered iv at the time of reperfusion<br>|
| Placebo Comparator: control<br>10 ml of normal saline is administered at the time of reperfusion | Drug: placebo control<br>* 10ml of normal saline is administered at the time of reperfusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of Postreperfusion Syndrome (PRS) | the number of patients who showed PRS (hypotension defined as < 30% of baseline mean arterial pressure [MAP] lasting over 1 min immediately after reperfusion of liver graft) was divided by the total number of patients enrolled for each group | immediately after reperfusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
postreperfusion syndrome, phenylephrine, epinephrine, liver transplantation
Effect of Valsartan vs Perindopril on HOMA-IR Index in Patients With Chronic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the effect of valsartan and perindopril on HOMA-IR Index in patients with chronic kidney disease.

Detailed Description
-----------------
eligiable volunteers are administrated single-dose over the period I and II (crossover) of Valsartan (80mg) as of Perindopril (4mg). Every time before and after each medication, HOMA-IR index and other parameters and safety of Valsartan (80mg) and Perindopril (4mg) is performed using a blood sample and conducting some tests (vital signs, physical exam, ECG, laboratory test, etc.) respectively.

Official Title
-----------------
Effect of Valsartan vs Perindopril on HOMA-IR Index in Patients With Chronic Kidney Disease

Conditions
-----------------
Chronic Kidney Disease

Intervention / Treatment
-----------------
* Drug: Valsartan
* Drug: Perindopril


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of chronic kidney disease Serum creatinine:1 3mg/dl Exclusion Criteria: Diabetes Patients treated with corticosteroids or immunosuppressants BMI>30kg/m2 SP>180mmHg, DP>110mmHg Patients with serious medical problems requiring specific medical treatment
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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Valsartan<br>Valsartan 80mg/tablet, 1 tablet once daily (crossover) | Drug: Valsartan<br>* Valsartan 80mg/tablet, 1 tablet once daily (crossover)<br>* Other names: NOVARTIS;|
| Active Comparator: Perindopril<br>Perindopril 4mg/tablet, 1 tablet once daily (crossover) | Drug: Perindopril<br>* Perindopril 4mg/tablet, 1 tablet once daily (crossover)<br>* Other names: ACERTIL;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Homeostasis model of assessment for insulin resistence index (HOMA-IR index) | HOMA-IR=FINS*FGLU/22.5 | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glomerular filtration rate(eGFR) and Creatinine clearance rate(CCR) | eGFR and CCR are calculated with MDRD formula | 4 weeks | 
| Body mass index(BMI) | BMI=weight/(height)^2 | 4 weeks | 
| 24-h urine protein, urinary albumin-creatinin ration, retinol binding protein |  | 4 weeks | 
| Cholesterol, triglycerides, high density lipoprotein, low density lipoprotein |  | 4 weeks | 
| Glycosylated hemoglobin |  | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic kidney disease, Anti-hypertensive drugs
Bupropion Alone or Combined With Nicotine Gum

Study Overview
=================
Brief Summary
-----------------
Focus of this study was to determine if bupropion was more effective for smoking cessation when used alone or combined with nicotine gum.

Official Title
-----------------
Efficacy of Bupropion Alone and in Combination With Nicotine Gum

Conditions
-----------------
Tobacco Dependence

Intervention / Treatment
-----------------
* Drug: bupropion + nicotine gum
* Drug: Active bupropion-Placebo gum
* Drug: Placebo bupropion-Placebo gum


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Smoke 10 or more cigarettes per day Motivated to quit No physical or mental health issues that would prevent participation Not pregnant or willing to prevent pregnancy during treatment Exclusion Criteria: Carbon monoxide (CO) breath test score below 10 parts per million (ppm) Center for Epidemiologic Studies Depression Scale (CES-D) score greater than 16 Heavy alcohol use History of eating disorder Suicidality

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active bupropion-Active gum<br>150 mg bupropion twice daily + 4 mg nicotine gum as needed (up to 12 pcs/day) | Drug: bupropion + nicotine gum<br>* 150 mg bupropion twice daily plus 4 mg nicotine gum as needed (up to 12 pcs/day)<br>|
| Active Comparator: Active bupropion-Placebo gum<br>150mg bupropion twice daily + placebo gum as needed (up to 12 pcs/day) | Drug: Active bupropion-Placebo gum<br>* 150mg bupropion twice daily plus placebo nicotine gum as needed (up to 12 pcs/day)<br>|
| Active Comparator: Placebo medication-Placebo gum<br>Placebo bupropion, twice daily, plus placebo gum as needed (up to 12 pcs/day) | Drug: Placebo bupropion-Placebo gum<br>* Placebo bupropion twice daily + placebo nicotine gum as needed (up to 12 pcs/day)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7-day point prevalence abstinence measured at 6 months | No smoking, not evan a puff, during the 7 days prior to the 6 month follow-up | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
smoking cessation, tobacco dependence
Drug Use Investigation for AMERGE (Naratriptan Hydrochloride) Tablet

Study Overview
=================
Brief Summary
-----------------
The study is designed to investigate the information on safety and efficacy of naratriptan tablets on Japanese subjects with migraine headache during Japanese post-marketing surveillance period.

Official Title
-----------------
Drug Use Investigation for AMERGE (Naratriptan Hydrochloride) Tablet

Conditions
-----------------
Migraine Disorders

Intervention / Treatment
-----------------
* Drug: Naratriptan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with migraine headache Must use naratriptan tablets for the first time Exclusion Criteria: Subjects with hypersensitivity to naratriptan Subjects with history, symptoms, or signs of myocardial infarction, ischemic cardiac disease, or variant angina Subjects with history of peripheral vascular disorder Subjects with history of cerebrovascular disorder or transient ischemic attacks Subjects with uncontrolled high-blood pressure Subjects with severe hepatic function disorder or renal function disorder Subjects taking ergotamine, ergotamine derivative containing product, or 5-HT1B/1D agonist
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects prescribed naratriptan tablets<br>Subjects with migraine headache prescribed naratriptan tablets during study period | Drug: Naratriptan<br>* Collection of safety data<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of incidence of adverse events in subjects with migraine headache |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of cardiovascular-related adverse events | Occurrence of cardiovascular-related adverse events is investigated throughout study period | 2 months | 
| Occurrence of cerebrovascular disorder | Occurrence of cerebrovascular disorder is investigated throughout study period | 2 months | 
| Occurrence of serotonin syndrome | Occurrence of serotonin syndrome is investigated throughout study period | 2 months |