linjc16/ctgov huggingface dataset:
Erectile Dysfunction and Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
This study consists of filling out a questionnaire on possible erectile dysfunction.

Detailed Description
-----------------
Male diabetic patients who attend a diabetic routine year program visit will be asked to give their voluntary permission to fill out a questionnaire on possible erectile dysfunction. The questionnaire consists of two parts: Part 1 is the IIEF (International Index of Erectile Function) questionnaire and Part 2 is an additional questionnaire. The included patients have to fill out these questionnaires two times; once at the beginning at a diabetic year program visit and a second time one year later at the next diabetic year program consultation. The patients will also be asked to give their permission for using their results of the routine diabetic year program for scientific research.

Official Title
-----------------
Erectile Dysfunction and Diabetes Mellitus

Conditions
-----------------
Diabetes Mellitus, Erectile Dysfunction

Intervention / Treatment
-----------------
* Procedure: Filling out a questionnaire on the possible occurrence of erectile dysfunction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male diabetic patients Age older than 18 years Exclusion Criteria:

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Filling out a questionnaire on the possible occurrence of erectile dysfunction|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Documentation of the prevalence of erectile dysfunction in the diabetic convention |  |  | 
| Increase the awareness of diabetologist for erectile dysfunction |  |  | 
| Relation of erectile dysfunction with metabolic parameters |  |  | 
| Relation of erectile dysfunction with sex steroids |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adjustment of the systematic follow-up of diabetic complications. |  |  | 
| Optimalisation of the healthcare for diabetic patients, so that the quality of life for male diabetic patients can be improved |  |  |
Ketogenic Diet Survey in Patients With McArdle Disease (GSDV)

Study Overview
=================
Brief Summary
-----------------
The purpose of this survey is to report experiences with variants of a ketogenic diet in a group of individuals diagnosed with McArdle disease (glycogen storage disease type V). Further more the survey will report on physical activity, fatigue, sleep and quality of life in this cohort.

Detailed Description
-----------------
Currently, there is no satisfactory treatment for McArdle disease. The limitation in people with McArdle disease is due to a limited availability of energy in the muscle due to affected carbohydrate metabolism. A key element in improving muscle function is therefore to introduce alternative energy sources. Ketone bodies are a well-known source of energy for both brain and muscle. Ketone bodies are produced during fasting or when following a ketogenic diet. A ketogenic diet is a diet high in fat and low in carbohydrates. The classic ketogenic diet contains up to 90% fat, but there are several alternative diets with less fat, including a modified ketogenic diet, Atkins diet, LCHF (low carb high fat), OMAD (one meal a day) and more. This survey will collect information on all variations. The rationale for a ketogenic diet for persons with McArdle disease makes good sense in theory, as the diet would contribute with a new source of energy (ketone bodies) independent of the affected carbohydrate breakdown. However, evidence is sparse on whether the diet actually works. The primary purpose of this survey is to report experiences with variants of the ketogenic diet in a group of individuals diagnosed with McArdle disease. Secondarily this survey will collect information on physical activity, fatigue, sleep and quality of life in this cohort

Official Title
-----------------
Ketogenic Diet Survey in GSDV

Conditions
-----------------
McArdle Disease

Intervention / Treatment
-----------------
* Other: There is no intervention, as this is a survey study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Verified GSDV diagnosis Exclusion Criteria: Age under 18 years

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: There is no intervention, as this is a survey study|Survey|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questions on experiences with a ketogenic diet | Survey | Baseline | 
| IPAQ (INTERNATIONAL PHYSICAL ACTIVITY QUESTIONNAIRE) short form | Survey | Baseline | 
| MFI-20 (MULTIDIMENSIONAL FATIGUE INVENTORY) | Survey | Baseline | 
| ISI (insomnia severity index) | Survey | Baseline | 
| MGQOL 15 score (Myasthenia Gravis Quality Of Life) | Survey | Baseline |
Effect of Patient Cost Sharing on Treatment Discontinuation Among Rheumatoid Arthritis Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the impact of patient cost sharing on treatment discontinuation of biologic agents in patients with Rheumatoid Arthritis (RA)

Official Title
-----------------
Effect of Patient Cost Sharing on Treatment Discontinuation Among Rheumatoid Arthritis Patients Treated With Biologic Disease Modifying Antirheumatic Drug (DMARD) Therapies

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Patients diagnosed with Rheumatoid Arthritis (RA) who newly initiated a biologic DMARD (bDMARD) during a study timeframe of 1/01/06 to 3/31/09. Inclusion Criteria: 18 to 64 years of age at index date Diagnosis of RA during the study period (ICD-9CM 714.xx) Evidence of at least one biologic DMARD of interest during the study timeframe Continuous enrollment during the study timeframe Both medical and pharmacy benefits No evidence of a claim for a bDMARD in the 6-month pre-period Exclusion Criteria: Patients are excluded if they have a diagnosis of psoriasis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, or ulcerative colitis at any time during the study timeframe; have a claim for Rituxan, IV etanercept, or IV adalimumab; or have Medicare or Medicaid during the study timeframe

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| New to bDMARD<br>New to bDMARD RA patients with high and low cost share who continue or discontinue treatment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of patient cost share on discontinuation |  | Assessed from first prescription date and followed for 1-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RA-related healthcare utilization and costs |  | Pre-index: 6-month period prior to the index drug date | 
| All-cause healthcare utilization and costs |  | Pre-index: 6-month period prior to the index drug date | 
| RA-related healthcare utilization and costs |  | Post-period: Index date+365 days | 
| All-cause healthcare utilization and costs |  | Post-period: Index date+365 days |
Prognostic Factors in NOP-LBBB After TAVI

Study Overview
=================
Brief Summary
-----------------
The goal of this observational study is to find prognostic factors in patients with a new-onset persistent left bundle branch block (NOP-LBBB) after transcatheter aortic valve implantation (TAVI). The main question it aims to answer is: Are there any factors influencing heart failure or death risk during the year following TAVI in patients with NOP-LBBB ? Participants will have data collection about TAVI procedure and clinical evolution during a one-year follow-up.

Official Title
-----------------
Prognostic Factors in New-Onset Persistent Left Bundle Branch Block After Transcathether Aortic Valve Implantation

Conditions
-----------------
Transcatheter Aortic Valve Replacement

Intervention / Treatment
-----------------
* Device: Transcatheter aortic valve implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: New-onset persistent left bundle branch block after transcatheter aortic valve implantation Exclusion Criteria: Pre-existing left bundle branch block Pre-existing right bundle branch block Pre-existing permanent pacemaker Immediate procedural mortality (death ≤72 h post-procedure)
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NOP-LBBB<br>Patients with new-onset persistent left bundle branch block after transcatheter aortic valve implantation | Device: Transcatheter aortic valve implantation<br>* Transcatheter aortic valve implantation in cases of severe aortic stenosis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalisation for heart failure or all-cause mortality | Hospitalisation for heart failure or all-cause mortality | At one-year after transcatheter aortic valve implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalisation for heart failure | Hospitalisation for heart failure | At one-year after transcatheter aortic valve implantation | 
| All-cause mortality | All-cause mortality | At one-year after transcatheter aortic valve implantation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
transcatheter aortic valve implantation, aortic stenosis, permanent pacemaker, left bundle branch block, heart failure, cardiac dyssynchrony
The Use of Guide Wire in Biliary Cannulation: Angled or Straight Tipped Guide Wire?

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to prospectively evaluate the deep biliary cannulation in ERCP with the angled tipped guide wire or the straight tipped guide wire.

Detailed Description
-----------------
Patients coming to ERCP examination are being divided randomly to two different groups. The deep biliary cannulation is started with predetermined guide wire. If the cannulation does not succeed in two minutes, the procedure is continued as normal.

Official Title
-----------------
The Use of Guide Wire in Biliary Cannulation: Angled or Straight Tipped Guide Wire?

Conditions
-----------------
Deep Biliary Cannulation

Intervention / Treatment
-----------------
* Procedure: angled and straight tipped guide wire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: the need for ERCP assessed by a specialist in gastrointestinal surgery Exclusion Criteria: prior sphincterotomy age under 18 age over 90 contrast media allergy inability to give informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: angled tipped guide wire<br>angled tipped guide wire used to deep biliary cannulation | Procedure: angled and straight tipped guide wire<br>* Angled or straight tipped guide wire is used in the beginning of deep biliary cannulation in ERCP . If there is no success, other normal procedures (e.g. double wire cannulation and precut) are performed.<br>|
| Active Comparator: straight tipped guidewire<br>straight guide wire used to deep biliary cannulation | Procedure: angled and straight tipped guide wire<br>* Angled or straight tipped guide wire is used in the beginning of deep biliary cannulation in ERCP . If there is no success, other normal procedures (e.g. double wire cannulation and precut) are performed.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The success rate of deep biliary cannulation |  | October 2010 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of post-ERCP pancreatitis |  | October 2010 | 
| time spent to deep biliary cannulation |  | October 2010 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ERCP, deep biliary cannulation, guide wire cannulation, post-ERCP pancreatitis, Success of deep biliary cannulation, Rate of post-ERCP pancreatitis, Time used to deep biliary cannulation
Growth Factors and Hepatic Progenitor Cells in Acute Liver Failure

Study Overview
=================
Brief Summary
-----------------
To study the correlation of serological growth factors and the hepatic progenitor cells involved in liver regeneration of liver failure.

Official Title
-----------------
Relationship of Serological Growth Factors and Hepatic Progenitor Cells in Acute Liver Failure

Conditions
-----------------
the Focus of the Study is to Correlate the Growth Factors in Serum With the Progenitor Cells in Liver

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute liver failure Received iver transplantation Exclusion Criteria: Pregnancy Sepsis Heart failure

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Real Time Vital Sign Assessment to Predict Neurological Decline After Traumatic Brain Injury

Study Overview
=================
Brief Summary
-----------------
This study will look to validate predictive algorithms developed in a previous study where we collected relevant data from trauma registry and after using advanced signal-processing and machine-learning, determined prediction scores regarding neuroworsening and other outcomes following traumatic brain injury.

Official Title
-----------------
Real Time Vital Sign Assessment to Predict Neurological Decline After Traumatic Brain Injury (RAPID-TBI)

Conditions
-----------------
Traumatic Brain Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Arrival to the hospital within 6 hours of injury Age >= 18 years old Patients with traumatic brain injury(TBI). TBI is defined as any alteration or loss of consciousness with or without positive head C.T findings. Exclusion Criteria: Deemed to have a non-survivable TBI Brain dead on arrival Active substance abuse for opiates and cocaine as noted by admission toxicology screen. Any thoracic or abdominal injury resulting in open surgical intervention Pregnancy Prisoners Active military Non - English speaking (due to necessity for consent in aims 2 and 3) Age > 89 years

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 79 Years

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurological Decline | Neurological decline is defined as a worsening in neurological status determined by a 2 point decline GCS, pupillary change, radiographic worsening defined by Rotterdam score, need for neurological or neurosurgical intervention (eg. treatment of seizure, raised ICP, hematoma evacuation) | First 48 hours of injury |
Tolerability, Safety and Efficacy of RKI983 Eye Drops in Subjects With Primary Open Angle Glaucoma and Ocular Hypertension

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the tolerability and safety of RKI983 ophthalmic solution and explore the effect of the compound on intraocular pressure in subjects with ocular hypertension.

Official Title
-----------------
A Multicenter, Randomized, Placebo-Controlled, Latanoprost-Controlled, Parallel Group Study to Assess the Tolerability, Safety and Efficacy of RKI983 Ophthalmic Solution Given Twice a Day Over One Week in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension

Conditions
-----------------
Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: RKI983


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females, ≥18 years of age, with primary open angle glaucoma and ocular hypertension Females must be post-menopausal or surgically sterile Exclusion Criteria: Other types of glaucoma Eye pressure lowering surgeries A history of or current eye conditions or medical problems that would prohibit the use of an investigational drug Other protocol-defined inclusion/exclusion criteria may apply.

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: RKI983|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of adverse events and serious adverse events, as well as changes in ophthalmic evaluations, laboratory values, ECGs and vital signs over period of 7 days treatment. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ocular hypertension from Baseline to Day 7. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glaucoma, Ocular Hypertension, RKI983, Primary Open Angle Glaucoma and Ocular Hypertension
Relationship Between Effect Duration of Rocuronium and Body Composition Analysis Data.

Study Overview
=================
Brief Summary
-----------------
The induction dose of rocuronium is typically decided based on the patient's body weight, but the effect duration of rocuronium is variable. Some studies suggest that body composition analysis data, such as skeletal muscle mass or total body water, may correlate better with the duration time of rocuronium. Therefore, we plan to analyse body composition in patients undergoing total intravenous general anesthesia, give the patients a fixed dose (50mg) of rocuronium, and check the correlation between duration time of rocuronium and body composition analysis data.

Official Title
-----------------
Relationship Between Effect Duration of Rocuronium and Body Composition Analysis Data.

Conditions
-----------------
Rocuronium, Body Composition

Intervention / Treatment
-----------------
* Device: body composition analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients with ASA class I-II undergoing total intravenous general anesthesia Exclusion Criteria: too overweight (over 111.11kg, which corresponds to less than 0.45mg/kg of induction dose of rocuronium) too underweight (under 41.67kg, which corresponds to more than 1.2mg/kg of induction dose of rocuronium) pregnancy prediagnosed muscle or nerve related disease unsuitable for body composition analysis using bioelectrical impedance method unsuitable for neuromuscular block monitoring

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| rocuronium<br>The patient will be given 50mg of rocuronium intravenously for induction. | Device: body composition analysis<br>* Patients will undergo body composition analysis using bioelectical impedance method before anesthesia.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to TOF1 | correlation between the time from induction to recovery of 1st TOF twitch and age, sex, ASA class, body weight, and body composition analysis data | up to 1 hour after rocuronium administration during induction of anesthesia | 
| time to TOF4 | correlation between the time from induction to recovery of 4th TOF twitch and age, sex, ASA class, body weight, and body composition analysis data | up to 1.5 hour after rocuronium administration during induction of anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to loss of TOF | correlation between the time from injection of rocuronium to complete loss of TOF twitch and age, sex, ASA class, body weight, and body composition analysis data | up to 5 minutes after rocuronium administration during induction of anesthesia |