linjc16/ctgov huggingface dataset:
Topical Anesthesia Versus Placebo to Decrease Pain in Rubber Band Ligation for Treatment of Internal Hemorrhoids

Study Overview
=================
Brief Summary
-----------------
Rubber band ligation is a simple and effective procedure for the management of hemorrhoidal disease. However, 90% of patients have some degree of discomfort associated with the procedure and up to 40% develop clinically significant pain. Some studies have used local anesthesia to reduce pain with promising results, but the use of topical anesthesia has not been reported before. The investigators hypothesize that the use of topical anesthesia before rubber band ligation significantly reduces post procedure pain.

Official Title
-----------------
Topical Anesthesia Versus Placebo to Decrease Post Procedure Pain in Rubber Band Ligation for the Treatment of Grade I - III Symptomatic Internal Hemorrhoids. A Single Institution, Double Blinded, Placebo Controlled Trial.

Conditions
-----------------
Hemorrhoids, Pain

Intervention / Treatment
-----------------
* Drug: Topical 2,5% lidocaine + 2,5% prilocaine gel
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptomatic grade I - III hemorrhoidal disease Exclusion Criteria: Chronic liver disease Use of class 3 antiarrythmics Coagulopathy Grade IV hemorrhoidal disease Inflammatory bowel disease Pregnancy

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: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Topical anesthesia<br>Application of topical 2,5% lidocaine + 2,5% prilocaine gel to the anal canal before the procedure | Drug: Topical 2,5% lidocaine + 2,5% prilocaine gel<br>* The topical gel is administered in the anal canal at the moment of the anoscopy<br>|
| Placebo Comparator: Placebo<br>Application of placebo gel into the anal canal before the procedure | Drug: Placebo<br>* Placebo gel to mimic topical anesthesia administered in the anal canal at the moment of the anoscopy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain measured in analog visual scale |  | up to 72 hours post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure morbidity |  | up to 30 days post procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hemorrhoids, Rubber band ligation, pain
Early Propranolol After Traumatic Brain Injury: Phase II

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to determine in patients with traumatic brain injury (TBI) the safe dosing of propranolol. Safety will be measured by episodes of bradycardia (heart rate < 60 beats per minute), hypotension (defined as systolic blood pressure < 90) or decreased cerebral perfusion pressure (defined as CPP less than 60mmHg) that are refractive to Brain Trauma Foundation guidelines for treatment. A no-treatment arm will establish the number of episodes of bradycardia, hypotension and reduced cerebral pressure refractory to treatment that occur without propranolol.

Official Title
-----------------
A Phase II, Dose Escalation, Single Center Study on the Effects of Early Propranolol on Heart Rate, Blood Pressure, and Cerebral Perfusion Pressure in Subjects Who Present With Moderate to Severe Traumatic Brain Injury.

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

Intervention / Treatment
-----------------
* Drug: Propranolol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who present within 6 hours of traumatic brain injury who have 1) a Glasgow Coma Scale (GCS) score of ≤8 or a GCS of 9-12 with computerized tomography brain scans demonstrating brain injury. Exclusion Criteria: pregnancy, patients already treated with beta-blockers, patients treated for antiarrhythmic, immunosuppressive or antiinfective treatment, myocardial infarction during the last 3 months, unstable or severe heart disease, severe chronic obstructive pulmonary disease, serious liver disease, cardiac ischemia that prevents the initiation of vasopressors, signs of cardiac arrhythmia or heart block on EKG, ischemic limb disease that prevents the initiation of vasopressors, vasopressors at maximum dose defined as norepinephrine at 40µg/min or neosynephrine at 300µg/min.

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?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Propranolol<br>Propranolol 1mg iv | Drug: Propranolol<br> <br> |
| No Intervention: Control<br>Routine care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine in Patients With Traumatic Brain Injury (TBI) the Safe Dosing of Early Propranolol. | The primary outcome is to determine the safety of early propranolol treatment after TBI by recording the number of episodes of bradycardia (heart rate < 60 beats per minute), hypotension (defined as systolic blood pressure < 90) or decreased cerebral perfusion pressure (defined as CPP less than 60mmHg) refractive to treatment. | 24 months |
Effect Of Case Management Following Discharge From Methadone Treatment

Study Overview
=================
Brief Summary
-----------------
The purpose of this project is to assess whether enhanced outreach counseling (EOC) is an effective outreach strategy for discharged methadone maintenance patients compared to a standard referral procedure. EOC is a brief (30 minute) face-to-face intervention, followed by six weeks of ongoing telephone counseling/case management designed to help eligible out-of-treatment methadone patients re-enter treatment. Several studies have shown those patients who voluntarily re-enter treatment improve significantly following re-enrollment.

Official Title
-----------------
Enhanced Outreach Counseling Following Methadone Treatment Discharge

Conditions
-----------------
Opioid-Related Disorders

Intervention / Treatment
-----------------
* Behavioral: Case Management


Participation Criteria
=================
Eligibility Criteria
-----------------
Patients who have been discharged from methadone maintenance treatment at the PVAMC who consented (as active patients) to be contacted for follow-up upon discharge.

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Case Management|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Observational Study to Evaluate the Safety of DILATREND SR Cap. in Korean Patients With Essential Hypertension, Chronic Stable Angina and Congestive Heart Failure

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to Evaluate the Safety of DILATREND SR Cap. in Korean Patients with Essential hypertension, Chronic stable angina and Congestive heart failure for 52 weeks.

Official Title
-----------------
Prospective, Multi-center, Observational Study to Evaluate the Safety of DILATREND SR Cap. in Korean Patients With Essential Hypertension, Chronic Stable Angina and Congestive Heart Failure

Conditions
-----------------
Essential Hypertension, Chronic Stable Angina, Congestive Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 19 years or older Patients with Essential hypertension, Chronic stable angina and Congestive heart failure Possible to take Dilatrend SR on the label not taking Caverdilol for 6 month from Agreement date Agreement with written informed consent Exclusion Criteria: Pregnancy or lactation Known hypersensitivity to Carvedilol Cardiogenic shock Abnormality of the conduction system as Severe bradycardia(In particular, pulse <50beats / min), 2nd degree AV block, Complete AV block, Sinus Block, Sick Sinus Syndrome Cor pulmonale IDDM with ketoacidosis, metabolic acidosis has severe heart disease(Heart failure NYHA functional class 4) Respiratory diseases as Asthma, Chronic Obstructive Pulmonary Disease Secondary hypertension Prinzmetal's angina Acute pulmonary embolism Pheochromocytoma Take MAO lnhibitor(except for MAO-B) Hypotension ( SBP 90mmHg or less) Severe hepatic dysfunction Peripheral circulatory disturbance( ex. Raynaud syndrome, intermittent claudication) Has edema glottitis Has heart attack with complication Fluid retention or overload to required intravenous inotropes Allergic rhinitis

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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 |
| --- | --- |
| patients who check the safety data after taking Dilatrend SR<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence and severity of adverse events and adverse drug reactions at 24 weeks |  | for 24 weeks | 
| The incidence and severity of unexpected adverse events and adverse drug reactions at 24 weeks |  | for 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Carvedilol SR Cap, Essential hypertension, Chronic stable angina, Congestive heart failure
Microbiota Community of Irritable Bowel Syndrome in Episodes and Remission Phase

Study Overview
=================
Brief Summary
-----------------
Analyze microbiota community of irritable bowel syndrome in episodes phase and remission phase.

Detailed Description
-----------------
The pathophysiology of IBS is incompletely understood, it may involve an altered intestinal microbiota. Since the microflora composition of IBS is various in different studies, The investigators plan to compare the intestinal microbiota of IBS patients in episodes phase and remission phase with healthy controls,trying to find the difference.

Official Title
-----------------
Microbiota Community of Irritable Bowel Syndrome in Episodes and Remission Phase

Conditions
-----------------
Irritable Bowel Syndrome

Intervention / Treatment
-----------------
* Other: collect faeces from participants


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: the presence of Rome III criteria for IBS ; Patients scheduled for colonoscopy examination or having negative screening examinations Aged between 18 and 65 years old Exclusion Criteria: Antibiotic, probiotic or laxative usage within 4 weeks. organic gastrointestinal diseases Severe systematic disease: diabetes mellitus, hepatic, renal or cardiac dysfunction, thyroid disease or tumor etc. pregnancy or lactation. previous major or complicated abdominal surgery. severe endometriosis and dementia

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IBS patients in episodes phase<br>collect faeces from IBS patients in episodes remission phase | Other: collect faeces from participants<br>* analyze the fecal microbiota community using 16S rDNA detection technique<br>|
| IBS patients in remission phase<br>collect faeces from IBS patients in remission phase | Other: collect faeces from participants<br>* analyze the fecal microbiota community using 16S rDNA detection technique<br>|
| healthy controls<br>collect faeces from healthy controls | Other: collect faeces from participants<br>* analyze the fecal microbiota community using 16S rDNA detection technique<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| microbiota community among IBS patients in episodes phase,remission phase and healthy controls |  | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life in IBS patients |  | 5 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IBS, microbiota community
Prandial Orientated Biphasic Insulin Aspart 30 Therapy - the Physiological Premix Insulin Therapy for Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Europe. The aim of this observational study is to document the glycaemic parameters, adverse events, including drug reactions, as well as hypoglycaemic episodes, in patients that switched from insulin glargine combined with oral antidiabetic drugs (OADs) to biphasic insulin aspart 30 (NovoMix® 30) combined with OADs, when applicable.

Official Title
-----------------
Prandial Oriented NovoMix 30® - the Physiological Insulin Therapy of Diabetes Type 2

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: biphasic insulin aspart 30


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with diabetes mellitus type 2
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BIAsp 30 users<br> | Drug: biphasic insulin aspart 30<br>* Prescription at the discretion of the treating physician<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c (glycosylated haemoglobin) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight |  |  | 
| Preprandial and postprandial blood glucose values (self measured) |  |  | 
| Insulin dosage |  |  | 
| Incidence of (serious) adverse drug reactions |  |  | 
| Incidence of hypoglycaemic episodes |  |  |
Staging System in Amyotrophic Lateral Sclerosis

Study Overview
=================
Brief Summary
-----------------
Recently two staging systems have been proposed for amyotrophic lateral sclerosis (ALS), based on clinical milestones The King's college clinical staging system (1) and ALS Milano-Torino Staging (ALS-MITOS) (2). Further research to validate and develop an accurate staging system in different populations will improve our understanding of its pathogenesis, disease activity and progression. General objective : To validate the two previously proposed staging system and to test the interest of considering Neurofilament biomarkers in these systems. Specific objectives: 1) To validate the two classification systems in an independent cohort of patients with ALS followed-up in the ALS expert center of Limoges (France) 2) To assess the interest of Nf biomarkers to predict neurological decline

Detailed Description
-----------------
Amyotrophic lateral sclerosis (ALS) is a rare, fatal neurodegenerative disease of the human motor system. Recently two new staging systems have been proposed for ALS, based on clinical milestones related also to the spreading pattern of the disease (1,2). Furthermore, biomarker development is still an essential component of future therapeutic development in ALS. Thus, it is also important to acknowledge the value of biomarker research in supporting or revealing fundamental pathophysiological mechanisms in ALS. The proposed staging systems: have been recently tested in two independent cohorts (3,4) with results that were not fully consistent (ii) did not considered the potential value of biomarkers.

Official Title
-----------------
Staging System in Amyotrophic Lateral Sclerosis

Conditions
-----------------
Amyotrophic Lateral Sclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ALS cases recruited for retrospectively (between) 2007 to 2016 for the retrospective cohort ALS cases recruited for prospectively by the ALS expert center of Limoges for one year. Exclusion Criteria: Previous neurosurgical operations A recent history of neurotrauma Peripheral neuropathies ALS/frontotemporal dementia (ALS/FTD)
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 |
| --- | --- | --- |
| To validate the two previously proposed staging system and to develop an accurate staging system in ALS considering Neurofilament (Nf) biomarkers. | To validate the two previously proposed staging system and to develop an accurate staging system in ALS considering Neurofilament (Nf) biomarkers | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Amyotrophic Lateral Sclerosis, ALS, Staging, Biomarker
Micardis®. Observational Study in Patients With Essential Hypertension

Study Overview
=================
Brief Summary
-----------------
This study is designed to supplement, under conditions of usual clinical practice, the data on the efficacy and safety of Micardis® collected during the clinical studies.

Official Title
-----------------
Micardis®. Observational Study

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Low dose of Telmisartan, once daily
* Drug: High dose of Telmisartan, once daily


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of either sex over the age of 18 years suffering from essential hypertension requiring treatment according to the physician Exclusion Criteria: Hypersensitivity to the active component or to any of the excipients Pregnancy and lactation Biliary obstructive disorders Severe hepatic impairment Severe renal impairment

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 |
| --- | --- |
| Outpatients with essential hypertension<br> | Drug: Low dose of Telmisartan, once daily<br> <br> * Other names: Micardis®;Drug: High dose of Telmisartan, once daily<br> <br> * Other names: Micardis®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in systolic and diastolic blood pressure |  | Baseline, 4 weeks and 3 months after start of treatment | 
| Percentage of patients with dose titration to 80 mg |  | 4 weeks and 3 months after start of treatment | 
| Number of patients with adverse events |  | Up to 3 months after start of treatment | 
| Global evaluation of treatment compliance by investigator, a 6-point rating scale |  | 4 weeks and 3 months after start of treatment |
To Evaluate the Effect of Food on the Pharmacokinetics (PK) of AZD0328

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the effect of food on the pharmacokinetics of AZD0328 in healthy male volunteers. AZD0328 will be administered as a single oral dose (capsule) during two treatment periods, after food intake or during fasting condition.

Official Title
-----------------
A Phase I, Open, Randomized, Single-Dose, Two-Treatment (Fed Versus Fasting), Two-Period Cross-Over Single-Centre Study to Evaluate the Effect of Food on the Pharmacokinetics of AZD0328 Following Oral Administration (Capsule) in Healthy Male Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: AZD0328


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male Caucasian subjects. Clinically normal physical findings, laboratory values, vital signs and resting ECG as judged by the investigator. Signed informed consent form Exclusion Criteria: History of clinically significant cardio or cerebrovascular, pulmonary, renal, hepatic, neurological, mental or gastrointestinal disorder (including dyspepsia or GERD) or any other major disorder that may interfere with the study. Intake of another investigational drug or participation in another study which may interfere with the objectives of the study, within 12 weeks before the administration of the investigational product.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>AZD0328 administration during fasting condition | Drug: AZD0328<br>* Oral capsule, single dose<br>|
| Experimental: 2<br>AZD0328 administration after food intake | Drug: AZD0328<br>* Oral capsule, single dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK variables |  | Several PK samples during the study days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety variables (adverse events, blood pressure, laboratory measurements and paper ECGs) |  | During the whole treatment period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AZD0328, Food Effect