linjc16/ctgov huggingface dataset:
Comparison of Bizact With Electroscissor for Tonsillectomy

Study Overview
=================
Brief Summary
-----------------
In a randomized, partly double-blind prospective setup we want to compare traditional adult electro-scissor tonsillectomy With ultrasound Technology, Bizact.

Official Title
-----------------
Bizact Versus Electroscissor for Adult Tonsillectomy

Conditions
-----------------
Tonsillar Hypertrophy, Tonsillitis

Intervention / Treatment
-----------------
* Device: tonsillar dissection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: planned elective tonsillectomy informed consent Exclusion Criteria: regular use of analgesics pre-operatively known tendency of bleeding not able to communicate in Norwegian

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 40 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bizact<br>Tonsillectomy will be done With the Bizact device | Device: tonsillar dissection<br>* The tonsils will be removed by bizact device<br>|
| Active Comparator: Electro-scissor<br>Tonsillectomy will be done With electro-scissors | Device: tonsillar dissection<br>* The tonsils will be removed by bizact device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain: Number of days With need of analgesics | Number of days With need of analgesics | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain: Dose need of pain killers during first 24 hr postoperatively | Dose need of pain killers during first 24 hr postoperatively | 24 hrs | 
| Postoperative bleeding | Incidence of bleeding after discharge | 2 weeks | 
| Per-operative bleeding | Amount of bleeding during surgery | per-operative | 
| Duration of surgery | time from start of surgery to end | 0 - 1 hr |
Evaluation of Mesh Integration and Mesh Contraction After Open Preperitoneal Inguinal Hernia Repair Using a Memory Ring Containing Device

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate whether preperitoneal mesh placement using a nitinol containing large pore polypropylene mesh (REBOUND HRD™) offers a satisfying patient recovery, quick reconvalescence and adequate tissue integration with acceptable mesh contraction in a multicenter (Belgian) prospective trial. Patients treated by open preperitoneal mesh repair for an unilateral inguinal hernia according the current surgical practice in the participating centers will be observed during one year post-surgery, after which they will have a CT scan of the surgical area in the groin to evaluate the mesh changes regarding shrinkage and migration.

Official Title
-----------------
Evaluation of Mesh Integration and Mesh Contraction After Open Preperitoneal Inguinal Hernia Repair Using a Memory Ring Containing Device.

Conditions
-----------------
Unilateral Inguinal Hernia

Intervention / Treatment
-----------------
* Device: Rebound HRD Mesh


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elective repair for a primary unilateral inguinal hernia OR elective repair for a recurrent unilateral inguinal hernia after non-mesh repair 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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Unilateral inguinal hernia<br>A Nitinol containing large pore polypropylene mesh will be placed in patients with unilateral inguinal hernia. | Device: Rebound HRD Mesh<br>* Patients with unilateral inguinal hernia receive a nitinol containing large pore polypropylene mesh.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calculation and measurement of shrinkage (%) of mesh surface after surgical mesh implantation. | A CT scan is performed. | 12 months post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain assessment. |  | after 1 year | 
| Discomfort assessment. |  | after 1 year | 
| Use of oral analgetics. |  | after 1 year | 
| Wound morbidity. |  | after 4 weeks | 
| Recurrence of hernia. |  | after 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
inguinal hernia
Efficacy and Safety of Kochujang Pills on Blood Lipids Profiles in Hyperlipidemia Subjects

Study Overview
=================
Brief Summary
-----------------
The investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Kochujang pills on improvement of blood lipids. The investigators measured improvement of blood lipids parameters , including Total Cholesterol, LDL-C, Triglyceride and HDL-C, and monitored their blood pressure.

Conditions
-----------------
Hyperlipidemia

Intervention / Treatment
-----------------
* Dietary Supplement: Kochujang Pills
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females 19-55 years old Total Cholesterol 200 260 mg/dl or LDL-C 110 190 mg/dl Able to give informed consent Exclusion Criteria: Allergic or hypersensitive to any of the ingredients in the test products History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery History of alcohol or substance abuse Participation in any other clinical trials within past 2 months Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study Pregnant or lactating women etc.

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kochujang Pills<br> | Dietary Supplement: Kochujang Pills<br>* Kochujang Pills (34.5g/day)<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* Placebo (34.5g/day)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Total Cholesterol | Total cholesterol was measured in study visit 1(0 week) and visit 3(12 week). | 12 weeks | 
| Changes in LDL-C (LDL Low Density Lipoprotein-cholesterol) | LDL-C (LDL Low Density Lipoprotein-cholesterol) was measured in study visit 1(0 week) and visit 3(12 week). | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Triglyceride | Triglyceride was measured in study visit 1(0 week) and visit 3(12 week). | 12 weeks | 
| Changes in HDL-C(High Density Lipoprotein-cholesterol) | HDL-C(High Density Lipoprotein-cholesterol) was measured in study visit 1(0 week) and visit 3(12 week). | 12 weeks |
Developing and Validating a Patient-reported Outcome Instrument to Monitor Symptom Management in Pulmonary Exacerbation in CF

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to develop a reliable and valid instrument to measure symptom management (experience and / or management strategies) during exacerbation episodes in CF patients. For the development a sequential exploratory two phase mixed-method study will be applied. In a first step, up to 25 CF patients will be interviewed: approximately 15 CF patients who experienced at least one episode of exacerbation in the past year and approximately CF 10 patients who are currently experiencing an exacerbation. The latter group will be interviewed up to 3 times during and after the antibiotic treatment. The instruments initial item list will be developed on basis of the interviews. Up to five health professionals will rate the items' relevance. In a further step, items' clarity and relevance will be assessed by cognitive debriefing interviews with no more than 10 patients. In the last step (part III), the instrument's preliminary construct and concurrent validity and reliability will be tested in a larger sample up to 150 patients experiencing exacerbation. Patients will be asked to complete the newly developed questionnaires and a set of other questionnaires at one time point. For part III, ethic approval will be asked at a later date (2015).

Official Title
-----------------
Developing and Validating a Patient-reported Outcome Instrument to Monitor Symptom Management in Pulmonary Exacerbation of Patients Living With Cystic Fibrosis - Item Development

Conditions
-----------------
Cystic Fibrosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Part I A & II: Patients with a confirmed diagnosis of cystic fibrosis Age ≥ 18 Experience of at least one exacerbation during the last year requiring antibiotic treatment (oral or intravenous) Part I B: Patients with a confirmed diagnosis of cystic fibrosis Age ≥ 18 Experience of an acute exacerbation requiring antibiotic treatment (oral or intravenous) Exclusion Criteria: Part I & II Do not speak or understand German Inability to verbally communicate Cognitive 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in patient experience of symptom management |  | Patients will be followed up for 4 weeks after start of antibiotic treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
patient reported outcome instrument
Alicaforsen (ISIS 2302) in Patients With Active Crohn's Disease

Study Overview
=================
Brief Summary
-----------------
ISIS 2302 is an antisense oligonucleotide drug that reduces the production of a specific protein called intercellular adhesion molecule (ICAM-1), a substance that plays a significant role in the increase of inflammation. People with Crohn's disease have been shown to over-produce ICAM-1 in their gut tissues. Alicaforsen works by blocking ICAM-1 messenger RNA, the instruction molecule that is required for the production of ICAM-1 protein. This trial will examine effects of alicaforsen delivered by 2-hour intravenous infusion over a four-week period, compared to a placebo. Patients may remain on stable background 5-ASA, antibiotic, or immunosuppressive drugs, and prednisone (or equivalent) at </= 30 mg per day.

Official Title
-----------------
ISIS 2302-CS20, Phase 3 Double-Masked, Placebo-Controlled Study of Alicaforsen (ISIS 2302), an Antisense Inhibitor of ICAM-1, for the Treatment of Patients With Active Crohn's Disease

Conditions
-----------------
Crohn's Disease

Intervention / Treatment
-----------------
* Drug: Alicaforsen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Age >/= 12 years Weight >/= 36 kg CDAI score of 220 - 400 Documentation of Crohn's disease activity by endoscopy, biopsy or imaging in the last 2 years No TNF-α inhibitor treatment for three months prior to first study drug infusion Exclusion Criteria Known severe, fixed, symptomatic stenosis of the small or large intestine with significant dilation Extensive external fistulization (> 3 external fistulae which are expressible with gentle compression); colostomy or ileostomy Active infection, including infectious colitis, or infection with HIV, Hepatitis B or Hepatitis C Malignancy within 3 years or poorly controlled medical illness Requires intravenous heparin therapy or with a history of a bleeding problem

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: Double


Arms and Interventions

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

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
-----------------
Crohn's
Androcur Non-interventional Study Among Patients With Carcinoma of the Prostate

Study Overview
=================
Brief Summary
-----------------
Cyproterone acetate (CPA) is a steroidal antiandrogen which has affinity with progesterone and with glucocorticoid receptors. Cyproterone acetate is long-term proven effective treatment of inoperable carcinoma of the prostate. Sexual functions remain very important in men with prostate cancer. However sexual functions are deteriorating fast with course of the disease. The influence of CPA on sexual functions remains controversial. IIEF-5 erectile dysfunction questionnaire is currently widely used validated simple scoring system for diagnosing of erectile dysfunction and belongs to most used systems in Czech Republic. At present there are no data on CPA influence on IIEF-5 scored erectile dysfunction within the use of its indication in prostate cancer.

Official Title
-----------------
Prospective Observational Non-interventional Study of Correlation of Treatment With Androcur, Disease Stage, Testosterone Level, Age With Sexual Function and Erectile Dysfunction (Measured by IIEF-5 Validated Questionnaire)

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: Cyproterone Acetate (Androcur, BAY94-8367)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males > 18 years previously untreated with Androcur. No contraindication to Androcur. Exclusion Criteria: Liver diseases, malignant liver tumours and wasting diseases (except for carcinoma of the prostate). A history of or existing thrombosis or embolism. Severe chronic depression. Hypersensitivity to cyproterone. Cyproterone acetate in previous therapy.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br> | Drug: Cyproterone Acetate (Androcur, BAY94-8367)<br>* Patients in regular clinical practice receiving Androcur according to local drug information<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of treatment with Androcur (concomitant treatment), disease stage, testosterone level, age with erectile dysfunction (measured by IIEF-5 validated questionnaire) |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of PSA level and erectile dysfunction |  | 6 months | 
| Sexual activity of Czech patients with inoperable prostate cancer |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Inoperable Prostate Cancer, Erectile Dysfunction
The Impact of Tamoxifen and Aromatase Inhibitors on Platelet Proteins

Study Overview
=================
Brief Summary
-----------------
Single phlebotomy study involving women receiving tamoxifen or aromatase inhibitor therapy.

Official Title
-----------------
Platelet Modulation in the Control of Angiogenesis: The Impact of Tamoxifen and Aromatase Inhibitors on Platelet Activation and Angiogenic Proteins

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women routinely taking tamoxifen or aromatase inhibitor therapy as prescribed by their oncologist Exclusion Criteria: Use of heparin, warfarin

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

Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| tamoxifen or aromatase inhibitors<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Angiogenic Protein levels |  | following 6 months of therapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tamoxifen, aromatase inhibitors, breast cancer, platelets
Clinical Evaluation of the Aptima® Combo 2® Assay Using the Panther® System in Female Urine Samples

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the performance characteristics of the AC2 assay on the Panther system using female urine specimens.

Official Title
-----------------
Clinical Evaluation of the Aptima® Combo 2® Assay Using the Panther® System in Female Urine Samples

Conditions
-----------------
Chlamydia Trachomatis, Gonorrhea

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject is ≥14 years of age at the time of enrollment and is currently sexually active (eg, has had penile/vaginal intercourse within the past 6 months). For subjects under 18 years old, assent of the subject and/or parental/legal guardian permission has been obtained if required by the institutional review board (IRB). The subject and/or legally authorized representative is willing and able to undergo the informed consent process prior to study participation, and: reports symptoms consistent with a suspected STI (eg, abnormal discharge, genital itching, pain/discomfort during sexual intercourse or urination, and/or lower abdominal discomfort); or is asymptomatic and known to be partners with, or a contact of, a person with a confirmed or suspected STI; or is asymptomatic and undergoing screening evaluation for possible STIs; or is asymptomatic and undergoing a routine pelvic examination. Exclusion Criteria: The subject took antibiotic medications within the last 21 days prior to collection. The subject already participated in the study. The subject has a history of illness that the PI or designee considers could interfere with or affect the conduct, results, and/or completion of the study.

Ages Eligible for Study
-----------------
Minimum Age: 14 Years

Sexes Eligible for Study
-----------------
Female

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity |  | Enrollment ongoing until estimated March 2017 |
Expanded Access Program Using Uromune for Patients With Recurrent Urinary Tract Infections (rUTI)

Study Overview
=================
Brief Summary
-----------------
An Expanded Access Program for UROMUNE® for patients suffering from recurrent/chronic urinary tract infections of diverse etiology. This is for individuals for whom antibiotic therapy has failed, but of consideration in all cases, taking into account antibiotic-induced adverse reactions and increasing antibiotic resistance.

Detailed Description
-----------------
UROMUNE® is a mucosal immunotherapy indicated for the prevention of urinary tract infections caused by different pathogens. It works by stimulating the immune system, thus increasing the resistance against recurrent infections. The active substances are 4 inactivated and selected bacterial strains: Klebsiella pneumoniae 25% Escherichia coli 25% Enterococcus faecalis 25% Proteus vulgaris 25%

Official Title
-----------------
Expanded Access Program Using Uromune for Patients With Recurrent Urinary Tract Infections (rUTI)

Conditions
-----------------
Urinary Tract Infections, Chronic Urinary Tract Infection, Recurrent Urinary Tract Infection, Urinary Tract Infection Bacterial, Bladder Infection

Intervention / Treatment
-----------------
* Biological: Uromune


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients suffering recurrent urinary tract infections of diverse etiology. Exclusion Criteria: Individuals being allergic to any of the ingredients of UROMUNE®. Pregnancy and breast feeding. There are neither specific studies nor a formal contraindication, the physician should value benefits/risk.
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Uromune|2 sprays of solution once daily for a total of 3 months.|

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

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