linjc16/ctgov huggingface dataset:
IS There a Correlation Between Sypmtoms of Gastroparesis and the Duration of Video Caspule Retention in the Stomach

Study Overview
=================
Brief Summary
-----------------
Gastroparesis is a syndrome characterized by delayed gastric emptying in absence of mechanical obstruction of the stomach. The cardinal symptoms include postprandial fullness (early satiety), nausea, vomiting, and bloating.Capsule endoscopy (CE) has evolved to become a first-line, noninvasive diagnostic technique for the small bowel. CE is now being utilized to assess patients for obscure gastrointestinal bleeding, possible Crohn's disease, celiac disease and small bowel tumors. Capsule endoscopy is preformed in a fasting state, and usually past the pylorus of the stomach into the duodenum after up to 30-40 minutes. The aim of the study is to determine the correlation between gasytoparesis symptoms to duration of capsule retention in the stomach

Official Title
-----------------
Open Prospective Single Center Study for the Determination of Correlation Between Video Capsule Period of Retention in the Stomach and Symptoms of Gastroparesis

Conditions
-----------------
Gastroparesis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years Undergoing video capsule endoscopy for any indication Exclusion Criteria: -Endoscopic intraduodenal insertion of the capsule -

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 |
| --- | --- |
| Video capsule examinee<br>Every subject having capsule endoscopy for any indication | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of capsule retention in the stomach |  | End of capsule examination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastroparesis, Small bowel video capsule, gastric retention
Patient Buddy App for the Prevention of Avoidable Readmission in Cirrhosis

Study Overview
=================
Brief Summary
-----------------
To use the PatientBuddy App to reduce 30-day avoidable readmissions in cirrhotic patients using a patient and caregiver perspective.

Detailed Description
-----------------
Specific aim 1: To perform a pilot and feasibility study of disseminating current knowledge of readmission prevention in cirrhosis by using the Patient Buddy App with patient and caregiver interfaces. Eighty subjects (40 cirrhotic inpatients and 40 caregivers) will be enrolled and trained on the Patient Buddy at discharge. The App focuses on daily communication between patient/caregivers and the study team based on previously identified risk factors associated with readmission. The study team will initiate measures to prevent readmission using these communications. A detailed analysis of 30-day readmissions and input of the patients,caregivers and nurse manager will be performed to improve the App. Avoidable readmissions will be defined by a committee of hepatologists who is not part of the study at VCU. Specific aim 2: To incorporate the opinion of key stakeholders (patients, caregivers and case managers) towards improving the Patient Buddy App in the prevention of avoidable readmission in cirrhosis. The input of the key stakeholders and the analysis of readmissions prevented during the pilot study will be used to update the App for preventing avoidable readmissions in future studies

Official Title
-----------------
Patient Buddy App for the Prevention of Avoidable Readmission in Cirrhosis

Conditions
-----------------
Cirrhosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cirrhosis patients ≥21 years of age hospitalized for non-elective reasons Adult caregiver and the patient living in the same house Both (caregiver and patient) should be able to complete the Patient Buddy training and evaluation Discharged home from the hospital Patients who have VCU as a primary hospital base Exclusion Criteria: Elective hospitalization Lack of an adult caregiver Active alcohol/substance abuse within 1 month of the hospitalization Unable to perform training or give consent Patients discharged to hospice, nursing home or extended care facilities Patients on Hemodialysis

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- |
| Patient Buddy<br>Subjects and caregivers will be given iphones loaded with the App that will be used to enter medications, issues and orientation questions. They will be seen at day 15 and day 30 and will receive a phone call day 7 and day 21 inquiring about issues that would need medical attention | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Readmission | Readmissions within 30 days | 30 days |
EXCEL Clinical Trial (Universal Registry)

Study Overview
=================
Brief Summary
-----------------
The purpose of the Universal Registry is to assess the proportion and reasons for which subjects with angiographically significant ULMCA disease requiring revascularization during the time course of this study are not randomized; to compare the baseline characteristics of subjects; and to assess the variability in randomization eligibility and treatment patterns.

Detailed Description
-----------------
Approximately 100 consecutive subjects who otherwise meet all enrollment criteria, will be analyzed separately as intermediate lesion subjects, and will be followed through the time of initial treatment per standard of care with intended PCI, CABG or medical treatment.

Conditions
-----------------
Chronic Coronary Occlusion, Left Main Coronary Artery Disease, Stent Thrombosis, Vascular Disease, Myocardial Ischemia, Coronary Artery Stenosis, Coronary Disease, Coronary Artery Disease, Coronary Restenosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who are either not eligible for randomization or for other reasons are not randomized will be consented for the Universal Registry

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 |
| --- | --- |
| Universal Registry<br>Subjects who are either not eligible for randomization or for other reasons are not randomized will be consented for the Universal Registry | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| This study has no Primary outcome measure, it is an observational study to collect information on subjects not randomized to the RCT portion of the study. | The purpose of the Universal Registry is to assess the proportion and reasons for which subjects with angiographically significant ULMCA disease requiring revascularization during the time course of this study are not randomized; to compare the baseline characteristics of subjects; and to assess the variability in randomization eligibility and treatment patterns. There are no follow-up time points for this study. | At the time of enrollment into the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Drug eluting stents, Stents, Angioplasty, Left Main Coronary Artery Disease
Monster Screw System Post-Market Clinical Follow-Up Study

Study Overview
=================
Brief Summary
-----------------
Post-market clinical follow-up study on the Monster Screw System

Detailed Description
-----------------
Ambispective, multi-surgeon, single site, consecutive case series to determine the safety, performance, and benefits of the Monster Screw System.

Official Title
-----------------
Monster Screw System Post-Market Clinical Follow-Up Study

Conditions
-----------------
Ankle Injuries, Foot Injury

Intervention / Treatment
-----------------
* Device: Monster Screw System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject has undergone a foot and/or ankle procedure using the Monster Screw System and completed by one of the investigators. The subject has adequate radiographic and medical records For the Prospective Data Collection: - The subject is willing to provide written informed consent Exclusion Criteria: -None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Monster Screw System<br> | Device: Monster Screw System<br>* Subjects who have undergone a foot and/or ankle procedure involving the index device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of secondary procedures | Safety will be assessed by recording the incidence of secondary procedures related to the index procedure | Up to 9 months | 
| Incidence of adverse events | Safety will be assessed by recording the incidence of adverse events | Up to 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Nonunion | Safety as related to the rate of nonunion of the area treated with the index device | Up to 9 months | 
| Rate of Maintenance of Correction | Safety as related to the rate of the maintenance of correction | Up to 9 months | 
| Rate of Index Device Failure | Safety as related to the rate of the failure of the index device | Up to 9 months | 
| Foot and Ankle Mobility Measure | Device performance and benefits as related to Foot and Ankle Mobility Measure Activities of Daily Living (0-84) subscale and current level of daily activity rating (0-100). The higher the score, the higher the level of function, with 100% representing no dysfunction. | Up to 54 months | 
| Visual Analog Scale | Device performance and benefits as related to pain levels based on the Visual Analog Scale (range: 0 to 100; 0 = no pain; 100 = worst pain imaginable) | Up to 54 months | 
| Patient satisfaction | Device performance and benefits as related to patient satisfaction (very satisfied, good, fair, not satisfied) | Up to 54 months |
Blood Glucose Monitoring System Clinical Study

Study Overview
=================
Brief Summary
-----------------
Verify the following with blood glucose monitoring system: precision and accuracy versus YSI reference user evaluation labeling comprehension

Official Title
-----------------
Blood Glucose Monitoring System Clinical Study

Conditions
-----------------
Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be diagnosed with Diabetes Be between 12 and 70 years of age Be able to read, write, and understand English Be able and willing to give Informed Consent Have used an SMBG meter system for at least one year Be currently testing blood glucose levels at least once per day Exclusion Criteria: Inability to provide Informed Consent Subject does not meet Inclusion Criteria Subject does not agree to test for infectious diseases per clinical protocol Subject has minimally one positive test for any infectious disease listed under Exclusion Criteria per protocol Subject with any condition (in addition to those which are listed in the pre-screen Exclusion Criteria tests) which in the opinion of the Investigator may place the subject or site personnel at excessive risk Subject's physical condition/limitation prevents the person from using a BGMS on their own

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 70 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 with diabetes<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Neurofibromatosis Type 1 Brain Tumor Genetic Risk

Study Overview
=================
Brief Summary
-----------------
This study will analyze DNA samples to determine associations between maternal and offspring genetic factors and pediatric brain tumor development in children with Neurofibromatosis Type 1. Participating families (mother, father, child) will be asked to complete a short questionnaire and provide DNA samples (either saliva or blood). The information gained from your participation may one day help doctors develop strategies to reduce brain tumor risk in individuals with NF1. Please note: there is no therapy associated with this study.

Detailed Description
-----------------
The prenatal period is a developmentally vulnerable time point during which environmental conditions, including nutrition, can have life-long impacts on health.1,2 This is particularly relevant to many childhood cancers that are thought to initiate during pregnancy.3 As a consequence, there has been intense interest in whether prenatal exposures can modulate childhood cancer risk.4-6 It is important to recognize that both maternal and offspring genetic factors including those in nutritional pathways may play an important role in pediatric cancer risk through their effect on the child's exposure to nutrients important in development during the prenatal period. The purpose of this research study is to evaluate whether there are any maternal or offspring genetic factors in the folate pathway that may contribute to the development of brain tumors in children with Neurofibromatosis Type 1 through analysis of DNA samples collected from families.

Official Title
-----------------
Genetic Variation and Risk of Pediatric Brain Cancers

Conditions
-----------------
Neurofibromatosis Type 1, Pediatric Brain Tumor

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric participant (born during 1994-2012) with NF1 and diagnosed with a brain tumor Biological mother or father (or full sibling if mother or father is unable to participate) able to participate All family members (pediatric participant, biological mother, and biological father or full sibling) must be willing to contribute a blood or saliva sample ability to understand consent forms Exclusion Criteria: -those who do not meet inclusion criteria

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- |
| Family<br>Families with a child with Neurofibromatosis Type 1 who has been diagnosed with a brain tumor. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain Tumor |  | September 1, 2012-February 1, 2014 |
Preoperative Oral Nutritional Supplement (preOP Booster) in Visceral Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this pilot study is to investigate the effect of an oral nutritional supplement (preOP booster) versus placebo regarding metabolic criteria in patients undergoing elective pancreaticoduodenectomy.

Official Title
-----------------
Efficacy and Tolerability of a Preoperative Oral Nutritional Supplement (preOP Booster) Versus Placebo in Visceral Surgery

Conditions
-----------------
Enteral Nutrition (Food for Special Medical Purposes)

Intervention / Treatment
-----------------
* Dietary Supplement: preOP booster (oral nutritional supplement, food for special medical purposes)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective pancreaticoduodenectomy Exclusion Criteria: Concomitant chemotherapy Severe malnutrition (SGA score C) Conditions affecting gastric emptying

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

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: preOP booster<br> | Dietary Supplement: preOP booster (oral nutritional supplement, food for special medical purposes)<br>* 3x1 dosage pre-operatively<br>|
| Placebo Comparator: preOP booster placebo<br> | Dietary Supplement: preOP booster (oral nutritional supplement, food for special medical purposes)<br>* 3x1 dosage pre-operatively<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| laboratory measurements: total endogenous antioxidant capacity, free radicals, CRP; |  | up to 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative complications, pre- and postoperative discomfort (well-being), muscle strength at 7 days post-op, length of stay (hospital / ICU), ambulation time, gastro intestinal tolerance |  | up to 30 days after surgery |
Rasburicase for Treatment of Hyperuricemia in Children and Adolescence Patients With Tumor Lysis Syndrome

Study Overview
=================
Brief Summary
-----------------
To provide treatment opportunity to children and adolescent patients with hematologic malignancies by supplying the delayed marketed product and also to observe the efficacy and safety of rasburicase used in the treatment of hyperuricemia

Official Title
-----------------
Phase IV, Compassionate Use Program of Rasburicase for Treatment of Hyperuricemia in Children and Adolescence Patients With Tumor Lysis Syndrome

Conditions
-----------------
Hyperuricemia

Intervention / Treatment
-----------------
* Drug: Rasburicase


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute hyperuricemia patients before / during chemotherapy for hematologic malignancies ( uric acid greater than 7.5 mg/dL ) With a minimum life expectancy of 3 months Having previously signed a written informed consent. Exclusion Criteria: Hypersensitivity to uricase or any of the excipients. Known history of G6PD deficiency. Previous treatment with Rasburicase or Uricozyme. Treatment with any investigational drug within 30 days before planned first Rasburicase administration. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
-----------------
Maximum 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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response will be defined as achievement of normal uric acid levels (less than or = to 7.0mg/dL) |  |  |
EPIC US Pivotal Study

Study Overview
=================
Brief Summary
-----------------
Multicenter, prospective, pivotal study designed to demonstrate the safety and efficacy of the Lumen Biomedical, Inc. FiberNet® Embolic Protection System as an adjunctive device during carotid artery percutaneous intervention in high surgical risk patients.

Official Title
-----------------
Evaluating the Use of the FiberNet Embolic Protection System in Carotid Artery Stenting: The EPIC US Pivotal Study.

Conditions
-----------------
Percutaneous Intervention of the Carotid Arteries.

Intervention / Treatment
-----------------
* Device: Percutaneous intervention of the carotid artery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: One or more of the high surgical risk criteria. Symptomatic with atherosclerotic stenosis ≥ 50% or asymptomatic with atherosclerotic stenosis ≥ 70% of the carotid artery by NASCET Criteria. Exclusion Criteria: Prior stenting of ipsilateral carotid. Planned treatment of contralateral carotid within 30 days. Experienced a myocardial infarction within the last 14 days. Undergone an angioplasty or PTCA/PTA procedure within the past 48 hours. Undergone cardiac surgery within the past 60 days. Suffered a stroke within the past 14 days. Suffered a transient ischemic neurological attack (TIA) or amaurosis fugax within the past 48 hours. Abnormal baseline blood counts; platelets <50,000 or >700,000/mm3 or WBC count < 3 x103/uL. Intracranial stenosis that exceeded the severity of an extracranial stenosis. Total occlusion of the target vessel. Lesion within 2cm of the ostium of the common carotid artery. A stenosis that is known to be unsuitable for stenting Serial lesions that requires more than one stent to cover entire lesion.

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 |
| --- |
|Device: Percutaneous intervention of the carotid artery|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of all death, all stroke and myocardial infarction within 30 days of the procedure. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Endpoints are: all death and all stroke rates, non-stroke neurological event rates, technical success rates, procedural success rates, and access site complication rates. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
carotid artery, distal protection device, carotid stenting