linjc16/ctgov huggingface dataset:
Gastrografin in Postoperative Ileus

Study Overview
=================
Brief Summary
-----------------
After abdominal surgery there is a period of unavoidable dysfunction of the gut. During this time patients are often unable to eat and drink, and do not pass any flatus or stool. Though this resolves within a few days for most, there are a significant number (around 30%) who go on to have a prolonged period of this dysfunction known clinically as postoperative ileus. It has been clearly shown that this group of patients have worse health outcomes and spend a longer time in hospital. The aim of this study is to trial a drug - gastrografin - in the management of prolonged postoperative ileus. Gastrografin is safe, economical, readily available, and has been used with great success in the similar condition of bowel obstruction. It is predicted that gastrografin will shorten the duration of a prolonged postoperative ileus, thus affording affected patients a better outcome from surgery.

Official Title
-----------------
Randomised Double-blind Placebo-controlled Trial of Gastrografin in the Therapeutic Management of Prolonged Postoperative Ileus Following Elective Surgery.

Conditions
-----------------
Prolonged Postoperative Ileus

Intervention / Treatment
-----------------
* Drug: Gastrografin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years. Current inpatient following elective laparoscopic or open surgery. Classified as having prolonged postoperative ileus. Able to understand risks/benefits of the study. Able to give informed consent. Exclusion Criteria: Pregnancy. ASA of 4 or greater. Previous allergic reaction to gastrografin or iodinated contrast agents. Manifest hyperthyroidism.

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 |
| --- | --- |
| Experimental: Gastrografin<br> | Drug: Gastrografin<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from diagnosis (and administration of study drug) to resolution of prolonged postoperative ileus. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay (days) |  | Days |
Phase 2 Study of EPI-743 in Children With Pearson Syndrome

Study Overview
=================
Brief Summary
-----------------
Treatment of Pediatric Subjects with Pearson syndrome

Detailed Description
-----------------
If effective, treatment with EPI-743 should result in a significant reduction in occurrence of sepsis, metabolic crisis, hepatic failure and transfusion dependence.

Official Title
-----------------
An Open-Label Phase 2 Safety and Efficacy Study of EPI-743 (VincerinoneTM) in Children With Pearson Syndrome

Conditions
-----------------
Pearson Syndrome

Intervention / Treatment
-----------------
* Drug: EPI-743


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Genetically confirmed diagnosis of Pearson syndrome Age less than 18 Availability of medical history for 12 months prior to enrollment Abstention from use of CoQ10, vitamin E, lipoic acid and Idebenone 14 days prior to treatment with EPI-743 Exclusion Criteria: Allergy to EPI-743, sesame oil or vitamin E Clinical history of bleeding/ abnormal PT/PTT Concurrent inborn errors of metabolism Use of anticoagulant medications Participation in any interventional study within 30 days of treatment Use of erythropoietin 30 days prior to trial enrollment

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EPI-743<br>15 mg/kg EPI-743 to be administered three times per day for 1 year | Drug: EPI-743<br>* EPI-743 is the quinone oxidation product of alpha-tocotrienol<br>* Other names: Vincerinone (TM);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurence of episodes of sepsis, metabolic crisis or hepatic faillure |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transfusion avoidance |  | 1 year | 
| Hematologic function |  | 1 year | 
| Neuromuscular function | Neuromuscular function as assessed by Gross Motor Function Measure | 1 year | 
| Disease severity | Disease severity as assessed by Newcastle Pediatric Mitochondrial Disease Scale | 1 year | 
| Renal function |  | 1 year | 
| Hepatic function |  | 1 year | 
| Weight gain |  | 1 year | 
| Hospitalizations |  | 1 year | 
| Pancreatic function | Pancreatic function as assessed by insulin requirement and hemoglobin A1c | 1 year | 
| Mortality |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pearson, EPI743, EPI-743, Vincerinone, Mitochondrial disorder, Mitochondrial disease
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), Food Effect of AMG 357 in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
Study to evaluate the safety, tolerability, PK, PD, and food effect of AMG 357 in healthy subjects

Conditions
-----------------
Inflammatory Disease

Intervention / Treatment
-----------------
* Drug: AMG 357
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Adult subjects between 25 and 55 years old Body mass index (BMI) between 18 and 32 kg/m2 Normal or clinically acceptable physical examination, clinical laboratory values, and ECG Additional inclusion criteria apply Exclusion Criteria: Any history or evidence of a clinically significant disorder, condition or disease that would pose a risk to subject safety. Additional exclusion criteria apply

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 55 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: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AMG 357<br>AMG 357 is a small molecule for treatment of inflammatory disease | Drug: AMG 357<br>* Oral administration available in varying dose strength.<br>|
| Placebo Comparator: Placebo<br>Matching placebo to AMG 357 containing no active drug | Drug: Placebo<br>* Matching placebo to AMG 357 containing no active drug<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability | Examine the number of adverse events per subject, and subject incidence of clinically significant changes in physical examinations, vital signs, laboratory safety tests and electrocardiograms, after single and multiple dose administration of AMG 357 in healthy subjects. | up to 35 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacodynamics | Measure the area under the plasma concentration curve versus time of AMG 357 after single and multiple dose administration in healthy subjects | up to 35 days | 
| Effect of Food on AMG 357 | To assess the effect of food on the PK parameters of AMG 357 | up to 11 days |
Dynamic Mediterranean Prospective Cohort: the SUN Project

Study Overview
=================
Brief Summary
-----------------
Dynamic prospective cohort of Spanish university graduates. The main objective is to evaluate the associations between nutrition and lifestyle and chronic diseases.

Detailed Description
-----------------
The SUN Project (University of Navarra Follow-Up Study) began in 1999, and currently more than 20,500 people participate. The Project is permanently open to new volunteers, and around 2,000 new participants are invited each year. A new questionnaire is sent to participants every two years. The questionnaires are named with the letter Q, followed by the number of years that have passed since the participant first volunteered. The first questionnaire is titled Q0 and is followed by Q2,Q4, etc. The cohort is dynamic thanks to the fact that it is permanently open to new volunteers. Although the Project was created by the Department of Preventive Medicine and Public Health of the University of Navarra, it now counts on the invaluable collaboration of other Spanish university centers. Thanks to the invaluable collaboration of our participants, the investigators are able to research cardiovascular diseases, depression, fertility, arterial hypertension, and car accident injuries, among other areas.

Official Title
-----------------
Dynamic Mediterranean Prospective Cohort: the SUN Project

Conditions
-----------------
Lifestyle, Chronic Disease, Dietary Habits

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Spanish university graduates Exclusion Criteria: not Spanish university graduates
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 |
| --- | --- |
| No intervention<br>No Intervention | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | 50 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular disease | cardiovascular death, acute coronary syndromes (myocardial infarction with or without ST elevation), revascularization procedures or fatal or non-fatal stroke. | 50 years | 
| Obesity | BMI>30 kg/m2 | 50 years | 
| Depression | Diagnosed depression through the Structured Clinical Interview (SCID-I) for the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) | 50 years | 
| Cognitive function | Telephone Interview of Cognitive Status-modified (TICS-m) | 50 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nutritional epidemiology, Prospective
Monitoring Community Trends in Heart Failure

Study Overview
=================
Brief Summary
-----------------
To examine temporal trends from 1995 and 2000 in the incidence rates of heart failure, its therapeutic management, and changes over time in the hospital and long-term survival of patients with heart failure.

Detailed Description
-----------------
BACKGROUND: Heart failure is estimated to contribute to nearly 1 million hospitalizations and approximately 250,000 deaths annually in the U.S. The number of new cases of heart failure in the U.S. is estimated to exceed 400,000 annually. Though reliable estimates of the magnitude, incidence, and mortality of heart failure remain sorely lacking, heart failure is associated with a grim prognosis. However, little recent data exist, particularly from a community-wide perspective, to determine whether the incidence or survival associated with heart failure, and the management of this clinical syndrome, has changed over time. DESIGN NARRATIVE: The study uses residents of the Worcester (MA) metropolitan area (1990 census 437,000) and examines changes over time in these and additional outcomes for patients with validated heart failure during 1995 and 2000. Complimenting the hospital surveillance of heart failure, newly diagnosed cases of heart failure occurring in members of the largest HMO in Central Massachusetts during 1995 and 2000 will be identified and monitored over time. To accomplish the study objectives, the medical records of residents of the Worcester metropolitan area hospitalized with a discharge diagnosis of heart failure and related diagnostic rubrics will be individually reviewed and validated according to pre-established diagnostic criteria. The use of traditional criteria for heart failure as well as development of new criteria for the epidemiological study of heart failure will be an important focus of this observational study. Records for additional hospitalizations and death certificates will be reviewed to examine trends in long-term survival of discharged hospital patients through the year 2005.

Conditions
-----------------
Cardiovascular Diseases, Heart Failure, Congestive, Heart Diseases

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

Ages Eligible for Study
-----------------
Maximum Age: 100 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 |
| --- | --- | --- |
Serum and Urine Ghrelin in Adult Epileptic Patients

Study Overview
=================
Brief Summary
-----------------
Several neuropeptides have concerned with epilepsy pathogenesis, ghrelin showed an anticonvulsant effect. There is a potential relation between its level and antiepileptic drugs (AED) response.

Detailed Description
-----------------
Several neuropeptides have concerned with epilepsy pathogenesis, ghrelin showed an anticonvulsant effect. There is a potential relation between its level and antiepileptic drugs (AED) response. Objective: to evaluate ghrelin effect in adult epileptic patients and in response to AED. Methods: This case control study included 40 adult epileptic patients and 40 healthy controls. Participants were subjected to history taking of seizure semiology, full general and neurological examination, electroencephalography and cranial CT or MRI. Fasting serum acylated ghrelin (AG) and unacylated ghrelin (UAG) and urine AG levels were estimated to all participants by enzyme - linked immunosorbent assay (ELIZA).

Official Title
-----------------
Serum and Urine Ghrelin in Adult Epileptic Patients

Conditions
-----------------
Epilepsy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All participants were included if their age more than or equal to 18 years. Body mass index < 30 kg/m2, total cholesterol < 200mg/dl, serum triglycerides < 200 mg/dl and random blood glucose level < 126 mg/dl. Exclusion Criteria: Participants had acute or chronic metabolic disorders (liver, kidney, thyroid, endocrine or gastrointestinal disorders). Females with irregular menstrual cycle or on estrogen therapy (7). Participants with organic cerebral lesion that was detected on cranial computed tomography (CT) or cranial magnetic resonance imaging (MRI).

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| group 1<br>Epileptic participants group consisted of 40 adults (15 females and 25 males) clinically and electrophysiological were diagnosed according to the international league against epilepsy classification 2010. | |
| group 2<br>Control group consisted of 40 adults (16 females and 24 males) non - epileptic healthy subjects. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum ghrelin in Adult Epileptic Patients | evaluation of the effect of Serum ghrelin in adult epileptic patients and in their response to anti- epileptic drugs | 6 months | 
| Urine ghrelin in Adult Epileptic Patients | evaluation of the effect of Urine ghrelin in adult epileptic patients and in their response to anti- epileptic drugs | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
epilepsy, serum ghrelin, urine ghrelin
Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Device to Reduce Mitral Regurgitation

Study Overview
=================
Brief Summary
-----------------
Improvement of heart failure with moderate to severe mitral regurgitation using a percutaneously delivered implanted device.

Official Title
-----------------
An Open-Label, Single-Arm Feasibility Study of the Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty (PTMA) Device Used to Reduce Mitral Regurgitation.

Conditions
-----------------
Heart Failure, Mitral Regurgitation

Intervention / Treatment
-----------------
* Device: PTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: symptomatic heart failure moderate to severe mitral regurgitation 20 - 50% LVEF Exclusion Criteria: mitral regurgitation of organic origins recent interventions severe comorbidities

Ages Eligible for Study
-----------------
Minimum Age: 50 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Patient is screened for study, and given baseline assessments. Patient receives a diagnostic PTMA assessment and if responsive, receives a PTMA implant. | Device: PTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant<br>* Percutaneous access from right or left subclavian vein with placement of assessment and placement of PTMA Implant into the coronary sinus, great cardiac vein. Device remains accessible from a subclavicular pocket.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percent of patients who remain free from device-related major adverse events (death, myocardial infarction, tamponade, emergent cardiac surgery) |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percent of implanted patients who maintain a sustained 1 grade reduction in mitral regurgitation and reduction of mitral annulus anterior posterior dimension |  | 30 days | 
| improvement of clinical symptoms of heart failure as defined by percent of patients who exhibit one of the following: decrease in NYHA class, improvement in Minnesota QOL survey, increase in exercise capacity: 6 minute walk or VO2max |  | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
heart failure, mitral regurgitation
Personalized Fingertip Glucose Measurement With a Touch Sensor

Study Overview
=================
Brief Summary
-----------------
Self-testing of glucose by patients living with diabetes mellitus (DM) involves needles, which causes discomfort or inconvenience eventually lead to decreased willingness to perform such needle-based check-ups that are vital to DM management. While technology has evolved, currently there is no glucose monitoring device that is needle-free. The investigators are studying a glucose sensor that detects glucose non-invasively, from sweat on an individual's fingertip. As it has not yet been tested in individuals with DM, the team will examine its accuracy and acceptability in these patients. Results from this clinical trial could serve as the basis for further development of a non-invasive glucose sensor.

Official Title
-----------------
Personalized Fingertip Glucose Measurement With a Touch Sensor

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Device: Testing sensor vs glucometer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: An existing diagnosis of diabetes mellitus, either T1DM or T2DM, or any other type or etiology of diabetes Having a hemoglobin A1c < 9.0%, and taking medication for diabetes. Individuals will bring their own lab report. Ability to provide informed consent for participation. Exclusion Criteria: Individuals without diabetes Uncontrolled medical conditions, including diabetes with a hemoglobin A1c > 9.0%, hypertension, heart, kidney, or liver failure. Those who cannot speak or read English. Participation will be limited to those who read and speak English, as this is a pilot study of a small number of participants, that will very unlikely offer the prospect of direct benefit from participating. Individuals who have frequent hypoglycemia, hypoglycemia unawareness, or who are at high risk for hypoglycemia.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sensor group<br> | Device: Testing sensor vs glucometer<br>* Will test accuracy of this sensor; there will be no intervention.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy: glucose readings in mg/dL | Correlation of touch sensor glucose readings compared with glucometer measurements | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability: questionnaire ratings on a scale of 1-5, with 5 being the highest | ease of use, and any other comments to optimize the design and function of this sensor, as reported by the participants | 1 day |