linjc16/ctgov huggingface dataset:
Predictive Clinical and Biological Parameters in Gynecological Cancer

Study Overview
=================
Brief Summary
-----------------
Research of predictive clinical and biological factors in breast cancer : genomic, proteomic, mutation

Official Title
-----------------
Predictive Clinical and Biological Parameters in Gynecological Cancer - GC-BIO-IPC 2013-010

Conditions
-----------------
Ovarian Cancer, Endometrium Cancer, Cervix Cancer

Intervention / Treatment
-----------------
* Other: gynecological cancer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: gynecological cancer suspicion age > 18 signed informed consent Exclusion Criteria: - emergency Exclusion criteria after histological exam Any diagnosis that is not a gynecological cancer (ovarian, cervix, endometrium).

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: gynecological cancer<br>blood and tumor samples | Other: gynecological cancer<br>* blood and tumor samples<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| molecular alteration in gynecological cancer | gene expression level | average of 4 weeks after diagnosis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| relation between molecular alteration and clinical and histological characteristics | hazard ratio between molecular alteration and clinico-histological characteristics | up to 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ovarian, endometrium, cervix cancer
Use of Diuretics in Maintenance Hemodialysis Patients Undergoing Bioimpedance-guided Fluid Management

Study Overview
=================
Brief Summary
-----------------
Background.The objective of the present study is to verify whether using diuretics will improve either blood pressure or fluid overload in maintenance hemodialysis patients with residual diuresis kidney function.

Detailed Description
-----------------
Methods.46 maintenance hemodialysis patients will be given three stages of diuretic intervention: 100mg furosemide every day for 1 month, 200mg furosemide every day for 1 month, and 100mg furosemide combined with 25mg hydrochlorothiazide every day for 1 month. The 24-hour urine volume, 24-hour urine sodium, 24-hour urine potassium, blood pressure, OH(overhydration) and dry weight will be collected. OH will be measured by bioelectrical impedance.

Official Title
-----------------
Use of Diuretics in Maintenance Hemodialysis Patients With Residual Renal Function Undergoing Bioimpedance-guided Fluid Management

Conditions
-----------------
Diuretic Abuse

Intervention / Treatment
-----------------
* Drug: Furosemid hydrochlorothiazide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: maintenance hemodialysis patient unrine volume more than 100ml. Exclusion Criteria: myocardial infarction; unrine volume less than 100ml.
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: diuretics<br> | Drug: Furosemid hydrochlorothiazide<br>* furosemide 100mg for one month;furosemide 200mg for one month;furosemide 100mg and hydrochlorothiazide 25mg for one month;<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| urine volume increasing after diuretic use in maintenance hemodialysis patients with residual renal function |  | up to 16 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
furosemide, hydrochlorothiazide, residual renal function
The Effect of Lidocaine Patch for Postoperative Pain

Study Overview
=================
Brief Summary
-----------------
The lidocaine patch is currently only permitted for post herpetic neuralgia but the investigators want to study its effectiveness in post operative pain after inguinal herniorrhaphy

Detailed Description
-----------------
After open unilateral inguinal herniorrhaphy, patients are randomly divided into group L and group P groups. Group L attaches two lidocaine patches for 12 hours, above and below the incision site. Group P attaches two placebo patches for 12 hours, above and below the incision site. Pain scores are recorded for 30 minutes, 2 hours, 24 hours, and 1 week after surgery.

Official Title
-----------------
The Efficacy and Safety of 5% Lidocaine Patch for Postoperative Pain in Unilateral Inguinal Herniorrhaphy

Conditions
-----------------
Acute Pain

Intervention / Treatment
-----------------
* Drug: Group L


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologists physical status I - II Scheduled open unilateral herniorrhaphy Exclusion Criteria: body mass index (BMI) < 18.5 or ≥ 35 kg/m2 severe renal or hepatic dysfunction allergy to amide-based local anesthetic agents taking class 1 antiarrhythmic drugs (tocainide and mexiletine, etc.)

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Group P(placebo)<br>Attach two placebo patches for 12 hours, above and below the incision site. | |
| Experimental: Group L(lidocaine patch)<br>Attach two lidocaine patches for 12 hours, above and below the incision site. | Drug: Group L<br>* Attach two lidocaine patches for 12 hours, one above and below the incision site.<br>* Other names: lidotopcaplasma;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The pain score | VAS(visual analog scale) measurement for 24 hours after surgery(0-10) 0: no pain 10: severe pain | 24 hours after the anesthesia finished. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The pain score | VAS(visual analog scale) measurement for 24 hours after surgery(0-10) 0: no pain 10: severe pain | 30 min after the anesthesia finished. | 
| The pain score | VAS(visual analog scale) measurement for 24 hours after surgery(0-10) 0: no pain 10: severe pain | 2 hours after the anesthesia finished. | 
| Total amount of cumulative analgesics | total amount of analgesics are measured for 24 hours after surgery. | 24 hours after the anesthesia finished. |
Does Lead Burden Alter Neuropsychological Development?

Study Overview
=================
Brief Summary
-----------------
Inner city children are at an increased risk for lead overburden. This in turn affects cognitive functioning. However, the underlying neuropsychological effects of lead overburden and its age-specific effects have not been well delineated. This study is part of a larger study on the effects of lead overburden on the development of attention and memory. The larger study is using a multi-model approach to study the effects of lead overburden on these effects including the event-related potential (ERP), electrophysiologic measures of attention and memory are studied. Every eight months, for a total of three sessions the subjects will complete ERP measures of attention and memory which require them to watch various computer images while wearing scalp electrodes recording from 11 sites. It is this test that we are going to be doing on CRC. There will be 30 lead overburdened children recruited from the larger study for participation in the ERP studies on CRC. These 30 children will be matched with 30 children without lead overburden. This portion of the study is important in providing an index of physiological functioning to be used along with behaviorally based measures of attention and memory, and for providing information about the different measures.

Conditions
-----------------
Lead Poisoning

Intervention / Treatment
-----------------
* Procedure: ERP measures of attention and memory


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant mothers of the Phillips neighborhood in Minneapolis, Minnesota. Subject recruitment will take place in local clinics which serve pregnant women and offspring

Ages Eligible for Study
-----------------
Minimum Age: 0 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: ERP measures of attention and memory|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
-----------------
lead overburden
Effect of Resistant Wheat Starch on Subjective Appetite and Food Intake in Healthy Adults

Study Overview
=================
Brief Summary
-----------------
A randomized, single-blind, cross-over study was conducted to determine the effect of replacing standard wheat flour (SWF) with resistant wheat starch (RWS) on markers of appetite and food intake in healthy adults.

Official Title
-----------------
Effect of Resistant Wheat Starch on Subjective Appetite and Food Intake in Healthy Adults

Conditions
-----------------
Feeding Behavior

Intervention / Treatment
-----------------
* Dietary Supplement: Resistant Starch Type 4


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI 18.5-29.9 kg/m2 Regular breakfast consumers (>5 days/week) Exclusion Criteria: not weight stable (?3 kg weight change in previous 3 months) use/used tobacco products presence of acute or chronic illness restrained eater (>13 on the restraint section of the three-factor eating questionnaire)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control (SWF)<br>Standard Wheat Flour (SWF) Muffins | |
| Experimental: Resistant Starch Type 4<br>Resistant Wheat Starch Muffins | Dietary Supplement: Resistant Starch Type 4<br>* single dose 26g fiber given at the breakfast meal<br>* Other names: Fibersym;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caloric intake | calories consumed at post-treatment lunch meal and total calories consumed on the treatment day | Single Day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue scale measures of subjective appetite | 0-100mm scale to assess hunger, fullness, thirst, desire to eat and prospective consumption | Single Day | 
| Serum concentrations of biomarkers of appetite | CCK, ghrelin, PYY3-36 and GLP-1 | 150 minutes | 
| Plasma concentrations of biomarkers of glycemic response | Glucose, Insulin, GLP-1 | 150 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Appetite, Food Intake, Satiety Hormones
Flexible, Intensive Insulin Therapy in Patients With Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
To prospectively evaluate the long term metabolic and psychological effects of flexible intensive insulin therapy (FIT) courses in an unselected population of type 1 diabetic patients at the University of Basel Hospital. We hypothesize that both metabolic control and psychological parameters will improve.

Official Title
-----------------
Flexible, Intensive Insulin Management in Patients With Type 1 Diabetes and Changes in Metabolic Control, Quality of Life, Locus of Control and Diabetes Knowledge

Conditions
-----------------
Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Behavioral: Flexible insulin therapy (FIT)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients participating in 5 consecutive FIT courses that began between April 2002 to April 2004 Exclusion Criteria: None

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 |
| --- | --- |
| Type 1 diabetes<br> | Behavioral: Flexible insulin therapy (FIT)<br>* Flexible insulin therapy (FIT) courses consisting in 7 weekly ambulatory sessions lasting 90 minutes each<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic control (HbA1c, severe hypoglycemic events), psychological effects, diabetes knowledge |  | Over 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in insulin doses, changes in weight |  | Over 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
flexible insulin therapy, diabetes education, diabetes, insulin, Weekly ambulatory sessions
VentrAssistTM LVAD as a Bridge to Cardiac Transplantation - Feasibility Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to determine the safety and feasibility of the VentrAssist LVAD in providing circulatory support for patients who require an LVAD as a bridge to cardiac transplantation.

Official Title
-----------------
Evaluation of the VentrAssistTM Left Ventricular Assist Device as a Bridge to Cardiac Transplantation - Feasibility Trial

Conditions
-----------------
End-Stage Heart Failure, Cardiomyopathies

Intervention / Treatment
-----------------
* Device: VentrAssist Left Ventricular Assist Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria (The following are general criteria; more specific criteria are included in the study protocol): Approved and listed for cardiac transplantation. Patient for whom LVAD implantation is planned as a clinically indicated bridge to cardiac transplantation. Exclusion Criteria(The following are general criteria; more specific criteria are included in the study protocol): Presence of heart conditions that would contraindicate LVAD implantation by adversely affecting patient survival or LVAD function. Primary coagulopathy or platelet disorder; contraindication to anticoagulant or anti-platelet agents. Presence of any mechanical circulatory support other than intra-aortic balloon pump. Therapy with an investigational intervention at the time of screening.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: VentrAssist Left Ventricular Assist Device|nan|

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

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  |  | 
| Functional status |  |  | 
| Neurocognitive function |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
VentrAssistTM, LVAD, End-stage heart failure, Cardiomyopathy
Seifem Surveillance of Antifungal Combination Therapy In Hematologic Italian Centers

Study Overview
=================
Brief Summary
-----------------
This trial is an observational study about combination antifungal therapy in hematologic patients with proven and probable invasive fungal infections (IFI).

Official Title
-----------------
Seifem Observational Study of Antifungal Combination Therapy In Hematologic Italian Centers

Conditions
-----------------
Fungal Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Haematologic patients with proven or probable IFI Therapy with a combination of antifungal drugs Exclusion Criteria: Haematologic patients with possible IFI
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Outcome of combination antifungal therapy<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety, efficacy and duration of therapy |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
antifungal therapies
Comparison of Tamsulosin and Solifenacin in Treatment of Ureteral Stent Symptoms

Study Overview
=================
Brief Summary
-----------------
This study will be conducted to compare the effectiveness of alpha blocker (Tamsulosin) and Anticholinergic (Solifenacin) in relieving lower urinary tract symptoms caused DJ ureteral stents.

Detailed Description
-----------------
Eligible patients who signed the informed consent will randomly assigned to one of 3 groups; group 1 (control), group 2 (tamsulosin) and group 3 (Solifenacin). Ureteral stent symptom questionnaire (USSQ) will be used to compare health related quality of life scores.

Official Title
-----------------
A Randomized Clinical Trial Comparing Alpha Blacker (Tamsulosin) and Anticholinergic (Solifenacin) in Treatment of Ureteral Stent Related Symptoms

Conditions
-----------------
Relieve of Ureteral Stent Symptoms

Intervention / Treatment
-----------------
* Drug: Tamsulosin
* Drug: Solifenacin
* Drug: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient who will undergo unilateral ureteral stent fixation: To relieve upper urinary tract obstruction caused by ureteric calculi After ureteroscopic lithotripsy for ureteral calculi. Exclusion Criteria: Patients who had LUTS before stent fixation. Ureteral stent fixation after open or laparoscopic surgery. Bilateral ureteral stents. Patients who developed complications related to the primary endoscopic procedure Patients who developed stent related complications such as hematuria, acute pyelonephritis or stent displacement

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 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 |
| --- | --- |
| Placebo Comparator: Group A<br>Patients in this group will receive placebo | Drug: Control<br>* Patients in this are will receive placebo<br>|
| Active Comparator: Group B<br>Patients in this group will receive Tamsulosin | Drug: Tamsulosin<br>* Patients in this arm will receive Tamsulosin 0.4 mg daily<br>* Other names: Tamsulin;|
| Active Comparator: Group C<br>Patients in this group will receive Solifenacin | Drug: Solifenacin<br>* Patients in the arm will receive Solifenacin<br>* Other names: Sofinacin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Efficacy of tamsulosin and solifenacin in relieving ureteral stent symptoms will be evaluated by comparing the scores of ureteral stent symptoms questionnaire in the studied groups |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Double J, Ureteral stents, Symptoms, Alpha blockers, Anticholinergic
Effects of Statins on Pro- and Antioxidant Status : Link With Statin-Associated Myopathy.

Study Overview
=================
Brief Summary
-----------------
To evaluate the effects of a 8-week treatment with 80 mg/day simvastatin on prooxidant and antioxidant status at rest and after exercise, on mitochondrial respiration and calcium release in skeletal muscle, and on aérobic aptitude in 24 healthy male subjects.

Detailed Description
-----------------
Day 1 : baseline oxidative status, lipid profile, exercice test, start of randomized treatment Day 53 : muscular biopsy Day 57 : follow-up oxidative status, lipid profile, exercice test, end of treatment

Official Title
-----------------
Effects of Statins on Pro- and Antioxidant Status : Link With Statin-Associated Myopathy. A Randomized, Placebo-Controlled, Double-Blind Study.

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

Intervention / Treatment
-----------------
* Drug: Simvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI between 18.0 and 25.00 Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood antioxidant status before treatment and after treatment. |  |  | 
| Lipid and protein peroxidation indexes before treatment and after treatment. |  |  | 
| In vitro mitochondrial respiration, enzymatic activities and calcium release parameters before treatment and after treatment. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood lipids before treatment and after treatment |  |  | 
| LDL composition before and after treatment |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
persons