linjc16/ctgov huggingface dataset:
Comparison of Two Biphasic Insulin Aspart Treatments in Subjects With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this trial is to compare two different active treatment regimens of biphasic insulin aspart in subjects with type 2 diabetes.

Official Title
-----------------
A Randomised, Double-blind, 4-week, Crossover Trial on Two Treatment Regimens With Biphasic Insulin Aspart 70 and 50 in Patients With Type 2 Diabetes

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

Intervention / Treatment
-----------------
* Drug: biphasic insulin aspart 70
* Drug: biphasic insulin aspart 70
* Drug: biphasic insulin aspart 50


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes Duration of diabetes for longer than 12 months Body mass index (BMI) below 35.0 kg/m^2 HbA1c below 11.0 % Treatment with BHI (biphasic human insulin) 20 or 30 twice daily for at least three months and in the last month as sole anti-diabetic treatment (i.e., no additional oral hypoglycaemic medication or daily use of short-acting insulin supplement) Exclusion Criteria: Current treatment with agents affecting glucose metabolism History of drug or alcohol dependence Impaired hepatic function Impaired renal function Cardiac disease Proliferative retinopathy Recurrent severe hypoglycaemia or advanced neuropathy

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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BIAsp 70<br> | Drug: biphasic insulin aspart 70<br>* Administered subcutaneously (s.c., under the skin) at breakfast, lunch and dinner<br>|
| Experimental: BIAsp 70 + BIAsp 50<br> | Drug: biphasic insulin aspart 70<br>* Administered subcutaneously (s.c., under the skin) at breakfast and lunch<br>Drug: biphasic insulin aspart 50<br>* Administered subcutaneously (s.c., under the skin) at dinner<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting serum glucose |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24-hour serum glucose profiles |  |  | 
| 24-hour insulin profiles |  |  | 
| Incidence of hypoglycaemic episodes |  |  | 
| Incidence of adverse events |  |  |
Ketoprofen Gel vs Placebo in Low Back Pain

Study Overview
=================
Brief Summary
-----------------
This study aimed to analyse the analgesic effect of ketoprofen gel in patients presented with mechanical low-back pain to the emergency department.

Detailed Description
-----------------
Mechanical low-back pain which warrants immediate pain relief is not an infrequent symptom for emergency department physicians to deal with. Parenteral analgesic is the most common drugs for the these patients in emergency department. However, pain killers in gel forms have not been studied sufficiently for ceasing the pain of these patients. This study aimed to analyse the analgesic effect of ketoprofen gel in patients presented with mechanical low-back pain to the emergency department.

Official Title
-----------------
Ketoprofen Gel vs Placebo in Patients Presented With Low-back Pain to Emergency Department: A Ranodmized Controlled Trial

Conditions
-----------------
Mechanical Low Back Pain

Intervention / Treatment
-----------------
* Drug: Ketoprofen
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over 18 and lower 65 years old Patients presented with mechanical low-back pain Exclusion Criteria: Pain more than 24 hours Pain lower than with a pain score of 40 mm Allergy to ketoprofen Drug or alcohol addiction pregnancy and breast feeding

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketoprofen<br>Ketoprofen gel | Drug: Ketoprofen<br>* 2.5% Ketoprofen gel with a 2 g local use<br>* Other names: Fastjel;|
| Placebo Comparator: Placebo<br>Placebo form of ketoprofen gel | Other: Placebo<br>* Placebo gel with a 2 g local use<br>* Other names: normal saline;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale | Pain reduce will be measured by visual analogue scale score at 30 minutes | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse outcome |  | 30 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gel, mechanical low back pain, emergency department, ketoprofen
An Observational Study of Herceptin (Trastuzumab) in Patients With HER2-positive Advanced Gastric Cancer

Study Overview
=================
Brief Summary
-----------------
This observational, multicenter study will assess the efficacy and safety of Herceptin (trastuzumab) in routine clinical practice in patients with HER2-positive advanced adenocarcinoma of the stomach or gastro-esophageal junction. Data from patients will be collected for approximately 12 months.

Official Title
-----------------
Clinical Practice Surveillance of the Use of Herceptin in Patients With HER2-positive Advanced Adenocarcinoma of the Stomach or Gastro-esophageal Junction (GEJ) (HERMES)

Conditions
-----------------
Gastric Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, >/=18 years of age Histologically confirmed advanced adenocarcinoma of the stomach or gastro-esophageal junction (GEJ) with locally advanced and/or metastatic disease HER2-positive tumor Patients who are eligible for treatment with Herceptin according to the judgment of the physician Exclusion Criteria: Unwilling or unable to sign informed consent form Any contraindications, interactions and incompatibilities to Herceptin

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 |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) |  | 12 months | 
| Progression-free survival according to Response Evaluation Criteria in Solid Tumors (RECIST) |  | 12 months | 
| Overall survival according to Response Evaluation Criteria in Solid Tumors (RECIST) |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Documentation of the testing process for HER2-positive tumors |  | 12 months | 
| Assessment of implementation of guidelines and recommendations of Herceptin administration in routine clinical practice |  | 12 months | 
| Documentation of backbone chemotherapy treatment and concomitant medication |  | 12 months | 
| Quality of Life questionnaire |  | 12 months | 
| Surveillance of pain intensity and analgesic consumption |  | 12 months | 
| Surveillance of weight change |  | 12 months | 
| Safety (incidence of adverse events) |  | 12 months |
Clinical Study Of Migraine Evolution

Study Overview
=================
Brief Summary
-----------------
Understanding the speed at which migraine headaches develop is of importance to patients. Determining the proportions in which different headache pain build-up occurs, may provide health care practitioners with valuable information with which to prescribe the most appropriate treatment. Patients who experience a slow pain build-up may gain more benefit from medications which have a slow onset of effect, high tolerability and long action. Conversely, medications with a rapid onset of effect may be of greater benefit to patients who experience rapid onset of migraine pain.

Official Title
-----------------
A Multicenter Study to Determine the Clinical Characteristics of the Temporal Aspects of Migraine in a Canadian Population: Clinical Study Of Migraine Evolution (C-SOME)

Conditions
-----------------
Migraine Headache

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is outpatient. Subject has a diagnosis of migraine with/without aura according to IHS criteria, of at least 1 years duration. Subject is able to comprehend the study procedures and to comply with study requirements. Exclusion Criteria: Subject has other chronic pain condition(s) not associated with migraine Subject is unable to understand the schedule/questionnaire.

Ages Eligible for Study
-----------------
Minimum 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
-----------------
Migraine, headache, observational
Quinolone Resistance in Bloodstream Isolates of Escherichia Coli

Study Overview
=================
Brief Summary
-----------------
This proposed study aims to document the risk factors for quinolone resistance in bloodstream isolates of E. coli. Additionally, the adequacy of empiric antibiotic therapy for E. coli bloodstream infections will be assessed. Finally, outcome will be recorded - this is all-cause mortality at 28 days from the time of the first positive blood culture. Hypothesis: Ciprofloxacin resistant strains are associated with admission from nursing home and with prior quinolone use.

Detailed Description
-----------------
The following information will be collected: age, sex, occupation, hospital location at the time of positive culture (ER, medical ward, ICU etc), date of positive culture, prior hospitalization, receipt of outpatient dialysis, home care or other regular medical care (eg, outpatient chemotherapy), presence of invasive devices, receipt of antibiotics, including their type and whether they were adequate for the resistance profile of the organism, prior positive microbiologic cultures, time and location of positive cultures, underlying diseases and severity of illness, presence of urinary or intravascular devices, recent immunomodulative therapies or radiation therapy, physical exam findings, laboratory and radiographical data, antimicrobial usage within 30 days of onset of the infection, microbiological data and resistance patterns, choice of antibiotics once organism identified, bacteriological outcomes, laboratory results, demographic information, medications, clinical outcome,gender, height, weight, ethnicity, and past medical history. We will collect information retrospectively.

Official Title
-----------------
Quinolone Resistance in Bloodstream Isolates of Escherichia Coli

Conditions
-----------------
Bacterial Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical information is collected by chart review of case and control patients. A case A patient is defined as follows: One or more blood cultures are positive for E. coli. The organism is ciprofloxacin resistant. A case B patient is defined as follows: One or more blood cultures are positive for E. coli. The organism is ciprofloxacin susceptible. Additionally, 4 controls who are in hospital at the same time as cases will be selected for each case. Exclusion Criteria: If they do not meet inclusion criteria

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- | --- |
| dead or alive | health status | end of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
positive isolates, ecoli, blood cultures, positive cultures for ecoli, blood stream infections
Safety and Pharmacokinetics Study of DWC20155 and DWC20156 in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study to Compare the safety and pharmacokinetics between co-administration and fixed dose combination of DWC20155 and DWC20156 in healthy subjects

Official Title
-----------------
A Randomized, Open-label, Oral Dose, Crossover Study to Compare the Safety and Pharmacokinetics Between Co-administration and Fixed Dose Combination of DWC20155 and DWC20156 in Healthy Subjects

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

Intervention / Treatment
-----------------
* Drug: Co-administration of DWC20155 and DWC20156
* Drug: DWJ1366 Tab.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI ≥ 18.5 and ≤ 27.0 kg/m2. No clinically significant findings Age 19-55 years at screening Exclusion Criteria: Who has allergy to investigational product

Ages Eligible for Study
-----------------
Minimum Age: 19 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test / Reference Drug<br>DWJ1366 Tab. followed by co-administration of DWC20155 and DWC20156 Tab. | Drug: Co-administration of DWC20155 and DWC20156<br> <br> Drug: DWJ1366 Tab.<br> <br> |
| Experimental: Reference / Test Drug<br>Co-administration of DWC20155 and DWC20156 Tab. followed by DWJ1366 Tab. | Drug: Co-administration of DWC20155 and DWC20156<br> <br> Drug: DWJ1366 Tab.<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Plasma Concentration (Cmax) |  | 0-24 hours | 
| Area under the plasma concentration versus time curve (AUC) |  | 0-24 hours |
Evaluation of Surgical Techniques in Cirrhotic Patients With Ventral Hernias

Study Overview
=================
Brief Summary
-----------------
ventral hernias are defects of the anterior abdominal wall, which can be congenital or acquired including epigastric, umbilical and incisional hernia. Umbilical hernias represent a common surgical problem in cirrhotic patient with ascites with 20% incidence. This work was deigned to assess outcome of different techniques of closure of ventral hernias in cirrhotic patients.

Detailed Description
-----------------
Ventral hernias are defects of the anterior abdominal wall, which can be congenital or acquired including epigastric, umbilical and incisional hernia. Incisional ventral hernia is a frequent complication of laparotomy that occurs in up to 11 % of surgical abdominal wounds Umbilical hernia represent a common surgical problem in cirrhotic patient with ascites with 20% incidence.Factors that play role in occurance of umbilical hernia in cirrhotic patient with ascites patients is chronic increased intra-abdominal pressure, recanalization of the left umbilical vein, muscle wasting and fascial weakening from nutritional deficiencies (3,4). Most of interventions for umbilical herniorrhaphy in cirrhotic patients with ascites done in emergency setting due to the concept of high perioperative morbidity and mortality rates in those patients. However, this strategy leads to a high risk of life-threatening complications such as incarceration and skin rupture.

Official Title
-----------------
Ventral Hernias in Cirrhotic Patients

Conditions
-----------------
Ventral Hernias in Cirrhotic Patients

Intervention / Treatment
-----------------
* Procedure: hernia repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all cirrhotic patients with ventral hernia Exclusion Criteria: hepatic encephalopathy
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients<br>cirrhotic patients with ventral hernia | Procedure: hernia repair<br>* different methods for hernia repair<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ventral hernia repair | different technique for repair of ventral hernia | Baseline |
The Effect of Calorie Deprivation on Adipose Tissue Distribution

Study Overview
=================
Brief Summary
-----------------
In this study, we will be studying the effects of acute calorie deprivation (a 10-day fast) on bone marrow fat, other fat stores and bone parameters. We will be measuring changes in bone marrow fat using magnetic resonance spectroscopy and will use MRI to measure subcutaneous and visceral fat depots. Our hypothesis is that levels of bone marrow fat will increase after an acute fast.

Official Title
-----------------
The Effect of Calorie Deprivation on Adipose Tissue Distribution

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

Intervention / Treatment
-----------------
* Behavioral: Fasting


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women, ages 21-45 years 101-130% of ideal body weight as defined by the 1983 Metropolitan Life Insurance Height and Weight Tables Normal thyroid function Regular menses (women) Normal liver transaminases Exclusion Criteria: Any disease known to affect bone metabolism, including untreated thyroid dysfunction, Cushing's syndrome, or renal failure Any medication known to affect bone metabolism -- including systemic steroids or immunosuppressants -- within three months of the study, excluding estrogen and progestins. Patients receiving depot medroxyprogesterone (Depo-Provera) will be excluded from participating for six months after their last injections. Bisphosphonates must have been discontinued for at least one year before participation Serum potassium <3.0 meq/L Pregnant and/or breastfeeding (women) Diabetes mellitus Active substance abuse, including alcohol Contraindications to MRI: cardiac pacemaker, metal implants, claustrophobia

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 45 Years

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

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 |
| --- | --- |
| Experimental: Fasting<br>Ten day fast | Behavioral: Fasting<br>* Ten day fast<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Bone Marrow Adiposity over 10 day fasting period | Bone marrow adiposity will be measured before and after the 10 day fast using magnetic resonance spectroscopy. | Baseline, After 10 day fasting period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy subjects, Fasting, Weight loss
Expression of Inflammatory Proteins in Pancreatic Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to investigate the expression of different inflammatory proteins in cancer and normal pancreatic tissue.

Detailed Description
-----------------
Purpose: to investigate the expression of different inflammatory proteins in cancer and normal pancreatic tissue Trial with surgical intervention

Official Title
-----------------
Expression of Inflammatory Proteins in Pancreatic Cancer

Conditions
-----------------
Pancreatic Neoplasms

Intervention / Treatment
-----------------
* Behavioral: Expression type


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients with pancreatic cancer or chronic pancreatitis Exclusion criteria: Patients with alpha 1-antitrypsin deficiency

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

| Intervention/Treatment |
| --- |
|Behavioral: Expression type|to investigate the expression of different inflammatory proteins in cancer and normal pancreatic tissue|

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

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