linjc16/ctgov huggingface dataset:
Comparison of Insulin Glargine Against Insulin Aspart Infused Under the Skin in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The objective of the study is to investigate the effect and safety of continously basal delivered insulin aspart given by a pump versus once daily injection of insulin glargine.

Official Title
-----------------
An Open-label, Randomised, In-patient, Cross Over PK/PD Trial Investigating the Pharmackinectic and Pharmacodynamic Profiles Following Continuous Subcutaneous Infusion of Insulin Aspart or Injection of Insulin Glargine in Subjects With Type 2 Diabetes Mellitus

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2, Delivery Systems

Intervention / Treatment
-----------------
* Device: pump
* Drug: insulin glargine
* Drug: insulin aspart


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with type 2 diabetes for more than 2 years Subjects currently treated with unchanged insulin glargine dose (10 -100 units) for 2 weeks Subjects currently treated with unchanged dose(s) for at least 1 month on one or two Oral Anti-diabetic drugs BMI 25 - 40 kg/m2 HbA1c < 9.5 % Exclusion Criteria: Known or suspected allergy to trial product(s) or related products Previous randomisation in this trial Pregnancy, breast-feeding, intention of becoming pregnant or pre-menopausal women judged not to be using adequate contraceptive measures (Only sterilisation, intra uterine devices and contraceptive pills are considered adequate contraceptive methods) Mental incapacity, unwillingness or language barriers precluding adequate understanding and co-operation. Any other significant illness such as endocrine, cardiac, neurological, malignant or other pancreatic illness judged by Investigator Participation in other studies within the last three months

Ages Eligible for Study
-----------------
Minimum Age: 30 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: pump|nan|
|Drug: insulin glargine|nan|
|Drug: insulin aspart|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation in morning FPG |  | Collected in hospital on the last 5 days of 7 days hospitalization, and on the morning of discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation of plasma endogenous insulin and insulin aspart/glargine collected in hospital on the last 5 days and the morning on discharged |  |  | 
| Variation of pre-dinner plasma glucose collected in hospital on the last 3 days |  |  |
Collection of Anonymised Blood Pressure Data During High Risk Surgery

Study Overview
=================
Brief Summary
-----------------
This is a single centre, prospective, non-randomised clinical investigation to be undertaken at the Queen Elizabeth Hospital, Edgbaston, Birmingham. The clinical investigation will collect fully anonymised perioperative blood pressure data from patients undergoing elective high risk surgery. The Sponsor of this clinical investigation, Directed Systems Limited, is developing a new medical device, BP Assist, which provides guidance to anaesthetists in relation to the real-time management of patient cardiovascular physiology.

Detailed Description
-----------------
This clinical investigation is designed to collect fully anonymised perioperative blood pressure data from patients undergoing high risk surgical procedures. It is increasingly being recognised that in high risk surgery, the perioperative incidence and duration of hypotensive episodes (MAP <60mmHg) can adversely impact postoperative outcome. Collecting continuous perioperative blood pressure data will enable hypotensive episodes to be recorded. Such data will be used to aid the development and testing of algorithms involved in generating the guidance provided by BP Assist.

Official Title
-----------------
Collection of Fully Anonymised Blood Pressure Data From Patients Undergoing Elective High Risk Surgery

Conditions
-----------------
Perioperative Hypertension

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, 18 years of age or older; undergoiing elective high risk surgery Exclusion Criteria: <18 years of age

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No intervention|No intervention is involved int his study. Fully anonymised blood pressure data will be collected from the vital signs monitors in the operating room.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative blood pressure | The primary objective of this clinical investigation is to collect fully anonymised, continuous, perioperative blood pressure data from ten patients undergoing elective high-risk surgery. Systolic and mean arterial pressures will be recorded. | Duration of each patient's surgery, up to 6 hours. |
Effect of an Allergen Vaccine in Patients With Allergic Rhino-Conjunctivitis and Asthma Due to House Dust Mite Allergy

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to test the safety, tolerability, immunogenicity and clinical efficacy of the combination treatment AllQbG10 in patients with rhino-conjunctivitis and asthma due to house dust mite allergy in a single-center, open-label setting.

Official Title
-----------------
Safety, Immunogenicity and Clinical Efficacy of an Allergen Vaccine (AllQbG10) in Subjects With Allergic Rhino-Conjunctivitis and Asthma Due to House Dust Mite Allergy

Conditions
-----------------
Perennial Allergic Rhinoconjunctivitis, Allergic Asthma

Intervention / Treatment
-----------------
* Biological: CYT005-AllQbG10


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mild to moderate perennial allergic rhinoconjunctivitis due to sensitization against house dust mites Mild asthma Females only if non-reproductive or agree to practice an effective and accepted method of contraception Exclusion Criteria: Relevant cardiovascular, renal, pulmonary or endocrine disease History of autoimmune disease Severe allergies History of active infectious disease Current diagnosis or history of malignancy Relevant neurological or psychiatric disorder Pregnancy or lactation History of alcohol abuse or other recreational drugs Use of an investigational drug within three month before enrolment Blood donation within 30 days before enrolment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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> | Biological: CYT005-AllQbG10<br>* Immunomodulator CYT003-QbG10 in combination with commercial house dust mite extract as used for routine SIT<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Monitoring Stomach Function With an Intragastric Balloon - a Pilot

Study Overview
=================
Brief Summary
-----------------
In this pilot study the investigators test the hypothesis that gastric motility can be measured with an intragastric balloon.

Official Title
-----------------
A Pilot Study to Investigate Whether Intragastric Pressure During Food Intake Can be Measured Using an Intragastric Bag in Healthy Volunteers

Conditions
-----------------
Functional Disorders of Stomach

Intervention / Treatment
-----------------
* Device: intragastric bag


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: They are between 18-60 years old. Male and female. Patients must provide witnessed written informed consent prior to any study procedures being performed. Exclusion Criteria: They are older than 60 years old. Have severely decreased kidney function. Have severely decreased liver function. Have severe heart disease, for example a history of irregular heartbeats, angina or heart attack. Have severe lung disease. Have severe psychiatric illness or neurological illness. Have any gastrointestinal disease. Have any dyspeptic symptoms. Women that are pregnant or breastfeeding.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1. Bag inflated so that intrabagpressure increases with 2 mmHg<br> | Device: intragastric bag<br> <br> |
| Other: 2. Bag inflated to ¾ volume of 1<br> | Device: intragastric bag<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intragastric pressure during food intake | The intragastric pressure determined with the manometer and the intragastric bag will be compare before, during and after nutrient drink infusion. | max 3 hours |
Effect of F2695 on Functional Recovery After Ischemic Stroke

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to assess the efficacy of a new serotonin-norepinephrine reuptake inhibitor (SNRI) nin functional recovery after ischemic stroke.

Official Title
-----------------
Effect of 3-month Treatment With F2695 (75mg OD) on Improving Functional Recovery of Patients With Ischemic Stroke. A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-Controlled Study

Conditions
-----------------
Ischemic Stroke

Intervention / Treatment
-----------------
* Drug: F2695
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patient, 18 to 80 years of age Confirmed acute ischemic stroke within the past 2 - 10 days Unilateral motor deficit, National Institutes of Health stroke scale (NIHSS) motor score >= 5 Modified Rankin Scale (mRS) of 4 or 5 Able and willing to comply with the site rehabilitation program requirements Exclusion Criteria: Aphasia Severe post-stroke condition Active depressive episode Intra-cerebral hemorrhage Use of anti-depressant drugs Cardiac rhythm disorder Uncontrolled arterial hypertension Other severe acute or chronic medical or psychiatric condition.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: F2695<br> | Drug: F2695<br>* 75 mg OD in 2 capsules<br>|
| Placebo Comparator: placebo<br> | Drug: placebo<br>* 2 capsules<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with a Modified Rankin Scale (mRS) less than or equal to 1 at Week 12 |  | week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with NIHSS score less than or equal to 5 at Week 12 |  | week 12 | 
| Percentage of patients with at least one moderate to severe depressive |  | Baseline to week 12 | 
| Change from baseline to Week 12 of the mean NIHSS total and motor scores |  | baseline to week 12 | 
| Safety and tolerability assessed by the investigator including SAEs, AEs, vital signs, ECG,physical examination and laboratory tests |  | baseline to week 12 | 
| Percentage of patients with a mRS score less than or equal to 2 at Week 12 |  | baseline to week 12 |
A Study in Patients With Diabetes Mellitus Type II of the Effect on Albuminuria of 24 Week Treatment With Valsartan, Benazepril, and Valsartan+Benazepril

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of valsartan, benazepril or the combination of both in reduction of microalbuminuria in Type 2 diabetic patients.

Official Title
-----------------
A 24-Week Study to Assess Blood Pressure Independent Effects of Valsartan Treatment, Benazepril Treatment and Combination of Both Valsartan and Benazepril Treatment on Urinary Albumin Excretion Rate With Type II Diabetes Mellitus and Microalbuminuria

Conditions
-----------------
Hypertension, Diabetic Nephropathy

Intervention / Treatment
-----------------
* Drug: valsartan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male or female patients aged 35-75 years with type 2 diabetes mellitus and recent evidence of persistent microalbuminuria patients with a median (of 3 samples) timed overnight UAER in the microalbuminuric range of 20-200 g/min in the formal screening period prior to entry patients who give written, signed, informed consent. patients with/without mild /moderate hypertension. patients who are not on hypertensive treatment, or if they are already on treatment, those who accept to enter a 3 weeks no-treatment wash-out period before switching their treatment. patients without any accompanying systemic disease Exclusion Criteria: pregnant or nursing women, or women of childbearing potential not using an acceptable method of contraception patients with type I diabetes mellitus defined by onset below the age of 35 years and requiring insulin within the first year after diagnosis Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 75 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: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in urine albumin excretion rate after 24 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in urine albumin excretion rate after 24 weeks in those patients with blood pressure greater than 140/90, or who had previously taken blood pressure medicine, at study entry |  |  | 
| Percent of patients returning to normal urine albumin excretion rate after 24 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HYPERTENSION, DIABETES MELLITUS TYPE II, VALSARTAN, BENAZAPRIL
Influence of Mild Therapeutic Hypothermia on Leukocyte Count

Study Overview
=================
Brief Summary
-----------------
Mild therapeutic hypothermia is indicated in patients surviving out-of-hospital cardiac arrest due to ventricular fibrillation. Potential immunologic responses are unknown.

Conditions
-----------------
Ventricular Fibrillation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Survivors of cardiac arrest due to VF Age 18-90 Exclusion Criteria: Suspected / proven pregnancy Immunodeficiency

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
post resuscitation, post ventricular fibrillation, patients receiving mild therapeutic hypothermia
Ammonia Metabolism Assessed by Ammonia Infusion

Study Overview
=================
Brief Summary
-----------------
The present study will develop a method to assess ammonia metabolism by ammonia infusion and investigate ammonia production and clearance in healthy individuals and in patients with liver cirrhosis.

Official Title
-----------------
Ammonia Metabolism Assessed by Ammonia Infusion

Conditions
-----------------
Ammonia; Metabolic Disorder, Liver Failure, Chronic

Intervention / Treatment
-----------------
* Other: Ammonia infusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria - Healthy controls: Alcohol < 40g/day BMI < 30 Diseased or medicated Inclusion Criteria - Patients with cirrhosis: Child-Pugh A or B cirrhosis BMI < 30 Exclusion Criteria: Child-Pugh score C Kidney failure (eGFR < 60 mL/min/1.73m2) Overt hepatic encephalopathy or more than one previous 1 episode of overt hepatic encephalopathy Acute bacterial infection Cancer Diabetes Ammonia-targeted treatment of hepatic encephalopathy other than lactulose (including Rifaximin and branched-chain amino acids)

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

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

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

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

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Healthy and Cirrhosis<br>Ammonia infusion with and without ammonia targeting | Other: Ammonia infusion<br>* Ammonia metabolism investigated in healthy individuals and patients with cirrhosis with and without ammonia lowering agent: glycerolphenylbutyrat (healthy) and Lactulose + Rifaximin (Cirrhosis)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of clearance (L/min) and production (micromol/min) of ammonia | A physiological parameter | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in clearance (L/min) and production (micromol/min) of ammonia when measured while on ammonia modulating agents | Proof of concept | 2 years |
The Impact of Pulmonary Rehabilitation in Interstitial Lung Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if pulmonary rehabilitation has any effect on breathlessness, quality of life, physical function and depression in persons with interstitial lung disease.

Official Title
-----------------
The Impact of Pulmonary Rehabilitation in Interstitial Lung Disease: A Prospective Cohort Study

Conditions
-----------------
Interstitial Lung Disease

Intervention / Treatment
-----------------
* Other: Pulmonary rehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults (> 18 years old) with a diagnosis of ILD who are referred to a participating PR program Exclusion Criteria: Inability to provide informed consent Inability to read and write English Any other medical condition that significantly limits the subject's ability to perform the functional measures Emphysema / Chronic bronchitis (FEV1 / FVC ratio < 60%) Previous pulmonary rehabilitation

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 |
| --- | --- |
| Pulmonary rehabilitation<br> | Other: Pulmonary rehabilitation<br>* Structured education and supervised exercise program, lasting between 6 and 9 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-minute walk distance |  | Immediately following completion of pulmonary rehabilitation and 6 months following the start of pulmonary rehabilitation | 
| Quality of life |  | Immediately following completion of pulmonary rehabilitation and 6 months following the start of pulmonary rehabilitation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dyspnea |  | Immediately following completion of pulmonary rehabilitation and 6 months following the start of pulmonary rehabilitation | 
| Depression |  | Immediately following completion of pulmonary rehabilitation and 6 months following the start of pulmonary rehabilitation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulmonary rehabilitation, Exercise therapy, Interstitial lung disease, Pulmonary fibrosis, Mobility limitation, Dyspnea, Mental health
Utility of Laboratory Testing for Children With Seizure in Emergency Department

Study Overview
=================
Brief Summary
-----------------
Objective: To evaluate the predisposing factors associated with abnormal laboratory findings in patients who came to the emergency room due to a first seizure. Methods: Patients were divided into separate groups based on normal and abnormal laboratory results for sodium, potassium, calcium, and glucose. The difference in age, gender, whether this was the first attack, whether there was fever, whether there were gastrointestinal symptoms, the duration and pattern of the seizure, and whether there was a seizure at the emergency department, were evaluated.

Conditions
-----------------
Seizure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: less than 18 years old The patient came to emergency department due to seizure The patient received blood sampling including serum sodium, potassium, calcium and glucose. Exclusion Criteria: The patient came to the outpatient department. The patient did not received blood sampling at emergency room. The seizure occurred after admission.

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Seizure, electrolyte, risk factor