linjc16/ctgov huggingface dataset:
Pre-operative Chemotherapy in Operable Breast Cancer, Phase III Study Comparing a Short Intensive Pre-operative Chemotherapy With the Same Therapy Initiated Shortly After Surgery(Peri-operatively)(POCOB)EORTC 10902)

Study Overview
=================
Brief Summary
-----------------
Pre-operative chemotherapy in operable breast cancer, phase III study comparing a short intensive pre-operative chemotherapy with the same therapy initiated shortly after surgery (peri-operatively) (POCOB) (EORTC 10902)

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

Intervention / Treatment
-----------------
* Drug: Fluorouracil/Epirubicin/Cyclophosphamide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Disease Characteristics: Palpable, operable breast cancer that has been diagnosed by core needle biopsy (mandatory for T1c tumors) or fine needle aspiration within 21 days prior to entry Stage T1c-4b, N0-1, M0 Hormone receptor status: Not specified No bilateral breast cancer Prior/Concurrent Therapy: No previous treatment for breast cancer Biologic therapy: Not specified Chemotherapy: No previous chemotherapy Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Core needle biopsy or fine needle aspiration within 21 days prior to entry Repeated core needle biopsy permitted Patient Characteristics: Age: 16 to 70 Sex: Women only Menopausal status: Not specified Performance status: WHO 0-2 Hematopoietic: WBC at least 4,000 Platelets at least 100,000 Hepatic: Bilirubin no greater than 2.8 mg/dL (50 micromoles/L) Renal: Creatinine no greater than 1.3 mg/dL (120 micromoles/L) Cardiovascular: No congestive heart failure No significant arrhythmia No bilateral bundle branch block No recent myocardial infarction No uncontrolled hypertension (diastolic pressure greater than 110 mm Hg) Other: No male breast cancer No pregnant or nursing women No second malignancy except adequately treated: Nonmelanomatous skin cancer Cervical cancer

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

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

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

| Intervention/Treatment |
| --- |
|Drug: Fluorouracil/Epirubicin/Cyclophosphamide|Phase III Comparison of Preoperative vs Postoperative FEC (Fluorouracil/Epirubicin/Cyclophosphamide) in Women with Operable Breast Cancer|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy |  | overall |
Investigation of Analgesic and Anti-hyperalgesic Effect of Opioids in Experimental Pain

Study Overview
=================
Brief Summary
-----------------
To compare the analgesic and anti-hyperalgesic effect of Buprenorphine and Fentanyl against experimental pain in skin, muscle and bone. The study will be performed with healthy volunteers.

Official Title
-----------------
Investigation of Analgesic and Anti-hyperalgesic Effect of Opioids in Experimental Pain

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Buprenorphine
* Drug: Fentanyl
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: written informed consent men > 18 years Exclusion Criteria: women known allergy against the investigated drugs ongoing participation in other experiments or participation in other experiments 14 days before screening previously pain or psychiatric conditions simultaneously use of pain killers alcohol previously drug-addict or member of family with drug-addicts chronic constipation ileus inflammatory bowel syndrome abdominal surgery within the last three months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Buprenorphine<br> | Drug: Buprenorphine<br>* Buprenorphine: 20microg/h<br>* Other names: Norspan;|
| Active Comparator: Fentanyl<br> | Drug: Fentanyl<br>* Fentanyl: 25microg/h<br>* Other names: Durogesic;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo: '5microg/h' (not active drug, it is just called '5microg/h')<br>* Other names: Norspan;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Data will be electronically recorded or written directly in case report form. Outcome measure will be a subjective rating of the pain with a visual analogue scale. |  | Continuously | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Buprenorphine, Fentanyl, Analgesic effect, Anti-hyperalgesic effect, Experimental pain
Ability to Cope With Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to learn about the relationship that exists between coping skills and blood glucose control. In addition to this, we will study the effect of Type 1 diabetes on coping skills in different age groups, genders, ethnicities, socioeconomic groups, and the duration of diabetes.

Detailed Description
-----------------
Coping with type 1 diabetes can be very difficult. Type 1 diabetes is a very unique chronic disease because it requires constant attention to several responsibilities such as daily glucose monitoring, multiple daily insulin doses, and strict diet and exercise. Several studies have shown that increased rates of poorer glucose control are a result of struggling to cope with type 1 diabetes. This may be due to the fact that many type 1 diabetics experience a feeling of exhaustion, or burnout, after a certain period of time due to an overwhelming amount of responsibility. In our study we would like to determine how children's ability to cope with diabetes affects glucose control. By completing several questionnaires, we can analyze different kinds of coping skills through a complex scoring system. These scores will then be analyzed in comparison to your glucose control using HbA1c.

Official Title
-----------------
Evaluation of Coping Skills in Type 1 Diabetes

Conditions
-----------------
Depression

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must be type 1 diabetic English/Spanish speaking The legal guardian must be present Exclusion Criteria: Non-cognitive or mentally ill Under the age of 8.0 years

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 21 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
-----------------
Depression, Socioeconomic status, Type 1 diabetes mellitus, Children, Adolescents
Does End-fire Technique Increase Detection Rate of Prostate Cancer at First Re-biopsy Compared to Side-fire Technique?

Study Overview
=================
Brief Summary
-----------------
Prostate cancer is the most common cancer among men in Sweden. During investigation of suspected cancer transrectal ultrasound with needle biopsies from prostate leeds to diagnosis. The most common technique today is side-fire where the needle enter the prostate in angle from the probe. In end-fire technique the needle enters the prostate at tip of probe without angle. The difference in techniques side-fire vs. end-fire affects the possibility to reach the ventral and apical aspects of prostate. Today´s standard is at least five cores from each side of the prostate at first biopsy. If first sample is negative there will usually be another urological exam and a first re-biopsy. The study aim to compare these two methods in cancer detection. The investigators' hypothesis is that when using end-fire technique at first re-biopsy, investigators find more cancers compared to side-fire. Patients are prospectively randomized into two groups, both assessing 12 core biopsies according to study protocol. Primary endpoint is cancer detection. Data will be collected about patient age, PSA-level, prostate size, digital rectal exam, hypoechogenic zones and length of cancers.

Official Title
-----------------
Does End-fire Technique Increase Detection Rate of Prostate Cancer at First Re-biopsy Compared to Side-fire Technique, in Investigating a Raised Prostatic Specific Antigen (PSA)?

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: first re-biopsy PSA over 3ng/ml T1c to T2a palpatory finding Exclusion Criteria: prostate cancer T2b or more advanced cancer more than one previous biopsy done
Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Side-fire<br>Using side-fire technique during transrectal ultrasound. | |
| End-fire<br>Using end-fire technique during transrectal ultrasound. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cancer detection | After finished study inclusion, data will be analyzed and presented within 12-18 months. | Study inclusion continues until 400 patients is included. Estimated time frame from study start 5 years. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Biopsy technique, Transrectal ultrasonography probe, Side-fire, Prostate cancer, End-fire
Four Week Safety and Efficacy Study With a Topical Gel to Treat Common Warts in Pediatric Subjects

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to evaluate the effectiveness in pediatric subjects of three different strengths of resiquimod gel applied to common wart(s) three times a week for four weeks. A second purpose is to evaluate the safety of the drug.

Official Title
-----------------
A Single-Blind, Dose-Escalating Study to Assess Efficacy and Safety of Resiquimod Gel Applied 3 Times Per Week for 4 Weeks for the Treatment of Common Warts in Pediatric Subjects

Conditions
-----------------
Warts

Intervention / Treatment
-----------------
* Drug: Resiquimod


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of common warts Ages between 3 to 11 Exclusion Criteria: Other types of wart(s), ie. plantar Currently participating in another clinical study Chronic viral hepatitis B or C

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 11 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: Single


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clearance of treated wart(s) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Partial clearance of treated wart(s) |  |  | 
| Wart recurrence |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Wart(s), Common Wart(s), Pediatric, Children, 3M Pharmaceuticals, Resiquimod
Efficacy and Safety of TORS for SCCA

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to learn more about the outcomes of treatment of throat and voice box cancers using transoral robotic surgery (TORS). TORS is a relatively new option involving the use of the da Vinci surgical robot to remove these cancers through the mouth.

Official Title
-----------------
A Single Arm Study of Efficacy and Functional Quality of Life in Patients Treated With Transoral Robotic Surgery for Oropharyngeal and Supraglottic Squamous Cell Carcinoma

Conditions
-----------------
Oropharyngeal Squamous Cell Carcinoma, Supraglottic Squamous Cell Carcinoma

Intervention / Treatment
-----------------
* Procedure: Transoral robotic surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult male or female Diagnosis of either oropharyngeal or supraglottic squamous cell carcinoma Exclusion Criteria: Metastatic disease

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transoral robotic surgery<br>Transoral robotic surgery | Procedure: Transoral robotic surgery<br>* Transoral robotic surgery using the daVinci robot to remove primary tumor<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | Duration of time from date of surgery to date of recurrence or death | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease specific survival | Duration of time from the date of surgery until death with disease present | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Surgery, Robotic, Carcinoma, squamous cell of head and neck
Blood Glucose Control in Intensive Care Patients Using the Space GlucoseControl System

Study Overview
=================
Brief Summary
-----------------
Glucose metabolism is impaired in many critically ill patients and is often aggravated by parenteral feeding, infections and/or pre-existent diabetes.Therefore insulin infusion protocols, which are based on frequent bedside glucose monitoring, have been implemented on most critical care units. Despite extensive efforts of the intensive care unit staff difficulties were experienced in achieving efficient and safe glucose control. Several barriers to the implementation of glycemic control have been identified. Most importantly, there is concern about increased frequency of severe hypoglycemic episodes. To overcome these problems Space GlucoseControl was developed as a decision support system which helps to achieve safe and reliable blood glucose control in the desired ranges (4.4 - 6.1 mmol/l or 4.4 - 8.3 mmol/l). The objective of this non-interventional study is to gain additional information on the performance of the Space GlucoseControl system for glycaemic control in ICU patients when used in routine clinical practice.

Official Title
-----------------
Evaluation of Blood Glucose Control in Intensive Care Patients Using the Space GlucoseControl System

Conditions
-----------------
Intensive Care Patients

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: Intensive care patients who require blood glucose control by intravenous application of insulin Exclusion: All contraindication of intravenous insulin therapy
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 |
| --- | --- | --- |
| Blood glucose values: Percentage of time within the chosen glucose target range of 4.4 - 6.1 mmol/l or 4.4 - 8.3 mmol/l |  | From start of treatment to the last glucose measurement under treatment, typically up to 14 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of hypoglycaemic episodes |  | From start of treatment to the last glucose measurement under treatment, typically up to 14 days. | 
| Adherence to the advice of the Space GlucoseControl system |  | From start of treatment to the last glucose measurement under treatment, typically up to 14 days. | 
| Blood glucose measurement interval |  | From start of treatment to the last glucose measurement under treatment, typically up to 14 days. |
The Use of Selenium to Treat Secondary Lymphedema - Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study to assess the effectiveness of selenium compared to placebo in reducing the lymphedema in-patients with breast cancer. Secondary objectives are to assess the impact of selenium on patient's quality of life and to assess the incidence of adverse effects of selenium therapy.

Official Title
-----------------
A Randomized Phase II Placebo-controlled Double Blind Study of Using Selenium in the Treatment of Secondary Lymphedema in Breast Cancer Patients

Conditions
-----------------
Breast Neoplasms, Lymphedema

Intervention / Treatment
-----------------
* Drug: sodium selenite


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with clinically documented lymphedema of upper limb secondary to breast cancer management (surgery - axillary nodal dissection, and radiotherapy) patients who have had other modalities of management can be included, e.g. physical therapy, pharmacological therapy ECOG performance 0-2 informed consent Exclusion Criteria: active cellulitis/skin infection of the limb venous thrombosis of the upper limbs active malignancy any other medical condition or congenital or traumatic injury involving either limb patients already on selenium medication patients participating in another clinical study related to lymphedema

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

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

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

| Intervention/Treatment |
| --- |
|Drug: sodium selenite|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the effectiveness of orally administered selenium compared to placebo in reducing arm lymphedema in patients treated with surgery (axiallary nodal dissection) and radiotherapy for breast cancer. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the toxicity of selenium. |  |  | 
| To assess the association of selenium, quality of life and limb function. |  |  |
Evaluation of the Effect of Minimally Invasive Procedures Used in Management of Salivary Ductal Pathologies on Patients' Symptomatology and Gland Function

Study Overview
=================
Brief Summary
-----------------
Aim of the current study was to evaluate the minimally invasive techniques in the management of salivary gland ductal pathologies

Official Title
-----------------
Evaluation of the Effect of Minimally Invasive Procedures Used in Management of Salivary Ductal Pathologies on Patients' Symptomatology and Gland Function - A Clinical Trial

Conditions
-----------------
Salivary Gland Stone, Salivary Gland Diseases

Intervention / Treatment
-----------------
* Procedure: Minimally invasive techniques


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients manifesting with either submandibular or parotid salivary gland ductal pathologies including: Sialolithiasis (salivary stones). Salivary ductal stenosis or stricture. Children with juvenile recurrent parotitis. Sjogren's syndrome. Radio-iodine induced sialadenitis. Exclusion Criteria: Patients who are unfit for surgery. Patients with previous submandibular or parotid surgical resection. Patients with salivary tumors either benign or malignant.

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: Minimally invasive techniques<br> | Procedure: Minimally invasive techniques<br>* All patient will be treated under general anaesthesia An appropriate gland-preserving minimally-invasive surgical procedure will be performed for all patients according to the nature and extent of the disease for either submandibular or parotid ducts. Minimally invasive techniques for ductal salivary gland pathologies include: Sialolithotomy through a simple cutdown Sialendoscopy Transoral microscopic-assisted sialolithotomy.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective salivary gland performance | This was done using a questionnaire to measure salivary score (this questionnaire is formulated by the multidisciplinary salivary gland society MSGS). The questionnaire consists of 20 questions divided in two groups: 13 regarding xerostomia and 7 regarding sialadenitis. Each question is scored from 0 to 10 and the total score could vary from 0 to 200 points. | up to 12 months | 
| Objective salivary gland performance (salivary flow measurement) | We have chosen 6 minutes as our standard time to collect saliva and we have chosen on purpose to collect saliva separately from the two parotids and jointly from the submandibular gland. A 5cmx5cm gaze is applied on the papilla of each Stenson duct and a third one is placed under the tongue. All these tampons are weighted separately after 6 minutes and the results collected. | up to 12 months |