linjc16/ctgov huggingface dataset:
Video Consent Form Versus Written Consent Form for ERCP

Study Overview
=================
Brief Summary
-----------------
To prove that video about endoscopic retrograde cholangiopancreatography (ERCP) combined with written informed consent provides participants more information about the procedure, which can make participants understand the procedure well. Investigators advocate the development of institutional and national guidelines to ensure optimal practices of acquiring informed consent.

Official Title
-----------------
Combination of Video and Written Information Provides the Patient With a More Comprehensive Level of Knowledge About Endoscopic Retrograde Cholangiopancreatography: Study Protocol for Randomized Controlled Trial

Conditions
-----------------
Consent Forms of ERCP

Intervention / Treatment
-----------------
* Procedure: written informed consent
* Procedure: video+written informed consent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All inpatients who will receive ERCP Exclusion Criteria: under 18 years or more than 70 years pregnancy or breast-feeding women circulatory and respiratory disorders mental illness

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: written informed consent<br>participants read the written informed consent documents befor ERCP | Procedure: written informed consent<br> <br> |
| Experimental: video+written informed consent<br>participants watch a video about the ERCP and read the written informed consent documents before ERCP | Procedure: video+written informed consent<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time for informed consent practices before ERCP |  | 2 days | 
| time for extra explanation about ERCP |  | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| satisfaction degree about the informed consent practices |  | 2 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
informed consent, ERCP, video
Visual Acuity and Optical Coherence Tomography One Year After ILM-flap Transposition

Study Overview
=================
Brief Summary
-----------------
ILM-flap (internal limiting Membrane-flap) transposition is a new surgical option in repair of macular holes, therefore one year outcomes are needed to better evaluate that method.

Detailed Description
-----------------
Patients that have been scheduled for vitrectomy with ILM-flap transposition, a new surgical option in repair of macular holes, are invited to a follow-up one year after surgery, including optical coherence tomography and visual acuity testing.

Official Title
-----------------
Visual Acuity and Optical Coherence Tomography One Year After ILM-flap Transposition for Surgical Repair of Macular Holes

Conditions
-----------------
Macular Hole

Intervention / Treatment
-----------------
* Device: optical coherence tomography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: history of ILM-flap transposition Exclusion Criteria: none

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 |
| --- | --- |
| ILM-flap<br>Patients after surgical repair of macular holes with ILM-flap transposition are invitied to a follow-up for optical coherence tomography and visual acuity testing one year after surgery | Device: optical coherence tomography<br>* optical coherence tomography enables diagosis of macular structures and therefore provides information on macular hole closure.<br>* Other names: visual acuity test;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OCT | macular hole closure is assessed with optical coherence tomography | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual acuity | visual acuity describes functional outcomes of the eye | 5 minutes |
TLR-9 Antagonism in Steroid Resistant Optic Neuritis

Study Overview
=================
Brief Summary
-----------------
Although idiopathic steroid resistant optic neuritis is very uncommon, there is no established treatment protocol for such patients. Toll like receptors (TLRs) especially TLR-9 has been shown to play a role in the pathogenesis of optic neuritis. This small case series aims to determine whether immunomodulators directed specifically at TLR-9(i.e. TLR-9 antagonism)play any role in improving the visual function in such patients.

Official Title
-----------------
Outcomes of TLR-9 Antagonism in Steroid Resistant Optic Neuritis; A Pilot Study

Conditions
-----------------
Optic Neuritis

Intervention / Treatment
-----------------
* Drug: Mycobacterium w.(Mw)-freeze dried extract 0.5ml


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Unilateral Steroid Resistant Optic Neuritis Exclusion Criteria: bilateral optic neuritis Associated Systemic disease Prior treatment received
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: Mw.<br>Administration of immunomodulator Mw. | Drug: Mycobacterium w.(Mw)-freeze dried extract 0.5ml<br>* 0.5 ml of Mw in 500ml 0.9% normal saline administered over two hours as an infusion. 2ml(4mg/ml) of dexamethasone administered two hours prior to Mw administration<br>* Other names: IMMUVAC;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in all aspects of visual function |  | upto 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Best corrected Visual Acuity, Pupillary Reaction, Colour vision, Disc edema
Predictors of Cardiovascular Disease in the Elderly

Study Overview
=================
Brief Summary
-----------------
To evaluate factors associated with cardiovascular morbidity and mortality in a cohort of 795 men and women aged 75 years or older at the time of a comprehensive examination conducted between 1984 and 1987.

Detailed Description
-----------------
BACKGROUND: The study was needed because evidence in 1991 suggested that cardiovascular risk factors which had been identified by studies of middle-aged populations did not have the same predictive value in the elderly; especially the oldest old aged 75 and above. DESIGN NARRATIVE: The study analyzed data that had been collected over the years. At the time of the analysis, mortality follow-up was complete for over 99 percent of subjects, and incident morbidity information was available for myocardial infarction, coronary bypass surgery and stroke. The database included measurements which allowed: 1) prospective analyses of the effects of putative cardiovascular risk factors on disease incidence in the elderly, 2) prospective analyses of the impact of change in risk factors on events in the elderly, 3) exploration of risk factors not classically associated with cardiovascular events in younger populations but which may be important in the very old, and, 4) cross-sectional description of putative risk factors in an aged population. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Myocardial Infarction, Cerebrovascular Accident, Coronary Disease, Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- | --- |
Assessment of Post-operative Sore Throat After Scheduled General Anesthesia

Study Overview
=================
Brief Summary
-----------------
Precise description of the technique for intubation or laryngeal mask placement during general anesthesia Research on factors that can influence sore throat due to the placement of an endobuccal or endotracheal device during general anesthesia

Official Title
-----------------
Assessment of Post-operative Sore Throat After Scheduled General Anesthesia

Conditions
-----------------
Sore Throat, Intubation;Difficult

Intervention / Treatment
-----------------
* Device: Endotracheal sonde or laryngeal mask


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - General Anesthesia required Endotracheal or endobuccal device Exclusion Criteria: Tracheotomy per or post surgery Patient with pre-operative pharyngeal irritation. Patient with a prior respiratory tract infection. Surgery of the laryngeal or tracheal vein, old or new Surgery scheduled less than 24 hours ago.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Endotracheal sonde or laryngeal mask|Healthy subjects ; requiring general anesthesia with endotracheal or endobuccal device|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of sore throat |  | Within 24 hours of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of sore throat, |  | At exit of the post-interventional monitoring room, at 24 hours of surgery or exit of hospital | 
| type of sore throat risk factor | (technique of intubation, analgesic treatment for surgery…) | At exit of the post-interventional monitoring room, at 24 hours of surgery or exit of hospital |
Cannabinoid Augmentation of Fear Response in Humans

Study Overview
=================
Brief Summary
-----------------
The purpose of this double blind, randomized, controlled, proof-of-concept study is to test the effects of cannabinoid receptor augmentation on the facilitation of fear conditioning. On three days over not more than two weeks, subjects will be trained to associate cues with two different stimuli, then this association will be extinguished. Cannabinoid receptor stimulation will be accomplished indirectly by harnessing the brain's capacity to endocannabinoids through the administration of an enzyme (FAAH inhibitor) that prevents degradation of anandamide. Subjects will receive placebo or the FAAH-inhibitor PF-04457845. Some details of this study have not been disclosed to preserve the study design.

Official Title
-----------------
Cannabinoid Augmentation of Fear Response in Humans

Conditions
-----------------
Fear Conditioning

Intervention / Treatment
-----------------
* Drug: PF-04457845
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between the ages of 18 and 65 Male and female No major medical problems Exclusion Criteria: Hearing problems Psychiatric or mental problems

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PF-04457845<br>Acquisition of conditioning Administration of drug Extinction of conditioning | Drug: PF-04457845<br>* Acquisition of conditioning Administration of drug Extinction of conditioning<br>Drug: Placebo<br>* Acquisition of conditioning Administration of placebo Extinction of conditioning<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: PF-04457845<br>* Acquisition of conditioning Administration of drug Extinction of conditioning<br>Drug: Placebo<br>* Acquisition of conditioning Administration of placebo Extinction of conditioning<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Galvanic skin response | Measure of sympathetic autonomic activation | Test days #1, #2, and #3, on average a week | 
| Cortisol levels measured in blood | Salivary b-amylase and serum cortisol levels will be assessed as neurochemical measures of stress response. | Test days #1, #2, and #3, on average a week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fear Conditioning, Cannabinoids, Fear Response
A Study of Tocilizumab in Patients With Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
This is an open-label, uncontrolled, observational study in patients with rheumatoid arthritis (RA) who are receiving tocilizumab concomitantly with methotrexate as part of their standard of care.

Detailed Description
-----------------
This single arm, open label study evaluates the safety and pharmacodynamic profile of tocilizumab in RA patients. Participating patients are among those for whom tocilizumab is indicated and who are scheduled to receive tocilizumab as part of their normal care, in full compliance with the FDA-approved prescribing information. Study assessments consist of clinical evaluations and laboratory tests conducted in conjunction with the first three monthly intravenous infusions of tocilizumab. These assessments are designed to provide a better understanding of the pharmacodynamic effects and mechanistic actions of tocilizumab and help guide the clinical development of other therapeutic agents for RA. A total of 15 patients are expected to participate for approximately 10 weeks.

Official Title
-----------------
A Phase 4, Open-label, Repeat-Dose Study of the Safety and Pharmacodynamic Profile of Tocilizumab and Concomitant Methotrexate in Patients With Rheumatoid Arthritis

Conditions
-----------------
Rheumatoid Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 18 years of age Moderately to severely active rheumatoid arthritis Inadequate response to previous treatment with an anti-TNF agent Receiving methotrexate for at least 12 wks before study Exclusion Criteria: Previous treatment with tocilizumab Previous treatment with other IL-6 receptor inhibitors Treatment with corticosteroids (oral prednisone >10 mg/day or equivalent) within 4 wks Conditions noted in the tocilizumab prescribing information

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 |
| --- | --- | --- |
| Safety (clinical and laboratory parameters) | Proportion of patients with neutropenia, elevated transaminase, and/or decreased platelet count | Throughout the study until week 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment emergent adverse events | Post-baseline changes in vital signs, and hematological and biochemical parameters | Throughout the study until week 10 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rheumatoid arthritis, tocilizumab
Butterfly Sensor With Rev K Version

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to assess the accuracy of the newly released Masimo SpHb Butterfly Sensor with RevK version and compare the results to a blood hemoglobin level analyzed in the UCSF Clinical Laboratories. A secondary purpose is to assess the blood hemoglobin using the Masimo Pronto-7 hand-held device immediately prior to surgery.

Detailed Description
-----------------
Masimo SpHb™ continuous hemoglobin monitoring The Masimo SpHb™ monitor with the Butterfly Sensor with RevK version will be used to continuously monitor hemoglobin electronically. The Butterfly Sensor will be connected to the 3rd or 4th finger on either the right or left hand. Masimo Pronto-7™ intermittent hemoglobin monitoring The Masimo Pronto-7™ is a hand-held, noninvasive device used for intermittent measuring of blood hemoglobin. The device is connected to a re-usable sensor which is clipped onto a finger for quick spot-check readings. A reading from the Pronto-7 will be taken immediately before surgery. Blood sampling for hemoglobin determination For the study, about a ½ tsp of blood will be collected from the arterial line placed for the purpose of surgery approximately every hour during the surgery to obtain a hemoglobin measurement to be analyzed in the UCSF Clinical Lab.

Official Title
-----------------
Assessing the Accuracy of the Butterfly Sensor With RevK Version for Non-Invasive Hemoglobin Monitoring

Conditions
-----------------
Blood Loss

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male of non-pregnant female 18 y/o or older American Society of Anesthesiologists Classification 1,2 or 3 Scheduled to undergo spine or hip surgery Exclusion Criteria: Pregnant or nursing Patients who in the investigators clinical judgement would not be suitable for research

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 |
| --- | --- |
| Patients undergoing spine surgery<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary purpose of this study is to assess the accuracy of the newly released Masimo SpHb Butterfly Sensor with RevK version and compare the results to a blood hemoglobin level. |  | During surgery |
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Obesity

Study Overview
=================
Brief Summary
-----------------
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding obesity.

Detailed Description
-----------------
The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records, particularly regarding obesity.

Official Title
-----------------
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Obesity

Conditions
-----------------
Overweight and Obesity, Overweight or Obesity, Obesity, Obesity, Morbid, Obesity, Abdominal, Obesity; Familial, Obesity; Endocrine, Obesity, Visceral, Obesity Hypoventilation Syndrome

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent by patient Male or female patients age 18 and older. Diagnosis of obesity based on Body Mass Index (BMI) of 30 or greater. Exclusion Criteria: Refusal by patient to sign informed consent form Treatment with antibiotics within two weeks prior to screening Treatment with probiotics within six weeks prior to screening History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy Postoperative stoma, ostomy, or ileoanal pouch Participation in any experimental drug protocol within the past 12 weeks Treatment with total parenteral nutrition Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial Inability of patient to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study

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 |
| --- | --- |
| Obsese individuals<br>Patients with a BMI greater than or equal to 30 | Other: No intervention<br>* There is no intervention for this study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of Microbiome to Obesity via Relative Abundance Found in Microbiome Sequencing | Relative abundance of bacterial classes within taxonomic phyla and, more broadly, within their domain will be analyzed by sequencing the gut microbiome. These data will then be categorized among obesity types | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of Sequencing Methods | To validate the methods used to sequence samples | 1 year |