linjc16/ctgov huggingface dataset:
Imatinib Mesylate Treatment of Patients With Malignant Peripheral Nerve Sheath Tumors

Study Overview
=================
Brief Summary
-----------------
This study assesses the safety and efficacy of imatinib mesylate treatment of patients with malignant peripheral nerve sheath tumors

Official Title
-----------------
An Open-label Multicenter Phase II Study of Imatinib Mesylate Treatment of Patients With Malignant Peripheral Nerve Sheath Tumors

Conditions
-----------------
Malignant Peripheral Nerve Sheath Tumors

Intervention / Treatment
-----------------
* Drug: imatinib mesylate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients ≥18 years of age Histologically documented diagnosis of malignant MPNST Unresectable local MPNST or metastatic MPNST and therefore incurable with any conventional multimodality approach Life expectancy of at least 6 months. Exclusion criteria: Patient has received any other investigational agents within 28 days of first day of study drug dosing. Chemotherapy and or radiotherapy in between the last 6 weeks before study entry, surgery in between the last 14 days before study entry. Female patients who are pregnant or breast feeding or women of child bearing potential who are not using a highly effective method of birth control. Known CNS metastases Other protocol-defined inclusion/exclusion criteria may apply.

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: STI571<br> | Drug: imatinib mesylate<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate assessed by a Tumor MRI scan every 6 weeks or if clinically indicated. |  | Every 36 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression assessed by an MRI scan. |  | Every 36 weeks | 
| Overall survival |  | Every 36 weeks | 
| Safety and tolerability assessed by abnormal lab values (hematology, biochemistry, urinalysis), by physical examination and vital signs |  | Every 36 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Malignant,, peripheral,, nerve sheath tumors,, MPNST,, neurofibromatosis,, NF1,, Imatinib mesylate
Role of Choline PET/CT in Predicting Survival in Patients With Hepatocellular Carcinoma

Study Overview
=================
Brief Summary
-----------------
¹¹C-choline positron emission tomography/computed tomography (PET/CT) has been used in patients with some types of solid cancers, but few data are available in patients undergoing hepatectomy for hepatocellular carcinoma (HCC). The aim of this study was to analyze the prognostic value of metabolic imaging data by using ¹¹C-choline PET/CT in patients with HCC before hepatectomy.

Detailed Description
-----------------
Our prospectively maintained liver unit database was queried for patients with HCC preoperatively staged with ¹¹C-choline PET/CT. This metabolic imaging modality was performed in addition to standard abdominal CT or magnetic resonance imaging. Several PET/CT parameters were recorded and analyzed. Univariate and multivariate analyses were performed to identify whether those PET/CT parameters could be predictors of overall survival (OS) and disease-free survival (DFS) of HCC patients.

Official Title
-----------------
What is the Prognostic Value of ¹¹C-choline PET/CT in Patients Undergoing Hepatectomy for Hepatocellular Carcinoma?

Conditions
-----------------
Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Procedure: Hepatectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient with HCC candidate to surgical resection preoperatively staged with ¹¹C-choline PET/CT Exclusion Criteria: R2 resection; Intraoperative use of RFA/MWI Postoperative death (90-days)

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 |
| --- |
|Procedure: Hepatectomy|Surgery of the liver: removal of a given part of the liver affected by hepatocellular carcinoma|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of PET/CT parameters that can be predictors of survival | Identification of specific PET/CT parameters that can be used as independent predictors of overall and/or disease-free survival | From date of surgery until the date of first documented progression or date of death from any cause, whichever came first assessed up to 72 months |
Bilateral Sacrospinous Colposuspension (BSC) in the Female Genital Prolapse With Urinary Urge Symptomatology

Study Overview
=================
Brief Summary
-----------------
Prospective non-randomised trial investigating the effect of vaginal vault Suspension on urge symptomatology in female patients with pelvic organ prolapse

Detailed Description
-----------------
A multicenter multinational Trial is performed in 250 female patients with pelvic organ prolapse (POP) and symptoms of urinary urge incontinence. Dependent on the presence or abscence of the uterus patients are treated with bilateral sacrospinous uterine or vaginal vault suspension (BSC) by means of a tape specifically designed for this purpose.

Official Title
-----------------
Multicenter Prospective Non-randomised Trial of Bilateral Sacrospinous Colposuspension (BSC) in the Treatment of Female Genital Prolapse Accompanied by Urinary Urge Symptomatology

Conditions
-----------------
Urinary Urge Incontinence

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: urge urinary incontinence or symptoms thereof 18 years old or older Compliance regarding data collection, therapy and follow-up written informed consent simultaneous performance of surgical colporrhaphy permitted Exclusion Criteria: pelvic organ prolapse without symptoms of urinary urge age less than 18 years no informed consent lack of compliance adverse reaction to polypropylene life expectancy less than anticipated duration of protocol ASA 4

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

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

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 |
| --- | --- | --- |
| Influence of BSC placement on symptoms of urinary urge expressed by change in clinical examination | The change in symptoms after the surgical intervention is evaluated by clinical examination . The clinical examination is descriptive, not quantitative and no units are applicable or reportable. | Checked after 6 weeks, six months and twelve months | 
| Change in score of standardized ICIQ documentation | The International Consultation on Incontinence Questionnaire is used to evaluate Change in Quality of life and urge symptomatology | Checked after 6 weeks, six months and twelve months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anatomical correction of female pelvic organ prolapse | Clinical examination of pelvic floor anatomy | Checked after 6 weeks, six months and twelve months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mesh, urge, pelvic organ prolapse, incontinence, minimally invasive, vaginal surgery, macroporous, lightweight, polypropylene, POP
Pain Management After Elective Shoulder Surgery

Study Overview
=================
Brief Summary
-----------------
Postoperative pain management plays an important role in elective shoulder surgery. The aim of this randomized quantitative study is to compare two frequently used postoperative pain regimes (hydromorphone versus piritramide) regarding onset and duration after the effectiveness of the single-shot interscalene block has diminished.

Official Title
-----------------
Pain Management After Elective Shoulder Surgery: A Randomized Quantitative Study Comparing Hydromorphone With Piritramide

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Drug: Hydromorphone Hcl 4Mg Tab
* Drug: Piritramide 15mg s.c.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients undergoing elective shoulder surgery with a single-shot interscalene plexus brachialis block in addition to general anesthesia patients aged 18-99 years patients being capable of giving an informed consent to participation in this study Exclusion Criteria: patients aged below 18 years patients with decompensated liver, heart or renal insufficiency patients with any kind of lung disease patients with a chronic pain syndrome patients with a previous pain medication with more than 3 drugs over more than 3 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| Active Comparator: Hydromorphone<br>Hydromorphone Hcl 4 milligram (mg) Tab 2 times after surgery as basic medication. Hydromorphone Hcl 2.6mg maximum 2 per 24h when numeric rating scale (NRS) > 5. | Drug: Hydromorphone Hcl 4Mg Tab<br>* Hydal retard 4Mg Tab 2 times after surgery as basic medication. Hydal retard 2.6Mg maximum 2 per 24h when NRS > 5.<br>* Other names: Hydal retard 4Mg;|
| Active Comparator: Piritramide<br>Piritramide 15mg s.c. 2 times after surgery as basic medication. Piritramide 7.5mg s.c. maximum 2 per 24h when numeric rating scale (NRS) > 5. | Drug: Piritramide 15mg s.c.<br>* Dipidolor 15mg s.c. 2 times after surgery as basic medication. Dipidolor 7.5mg s.c. maximum 2 per 24h when NRS > 5.<br>* Other names: Dipidolor 15mg s.c.;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain management after elective shoulder surgery | Comparison of hydromorphone versus piritramide using the numeric rating scale (NRS; range 0 - 10 points; level 0 representing no pain; level 10 representing the highest pain level) | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Elective shoulder surgery, hydromorphone, piritramide
Nutrition Support for Hirschsprung Disease

Study Overview
=================
Brief Summary
-----------------
A multi-center, prospective,randomized, non-blind, controlled study was conducted to investigate the effects of different pre-operative nutritional support modes on perioperative nutritional status, surgical treatment success rate, and rehabilitation process in children with Hirschsprung disease.

Official Title
-----------------
A Multicentric Study on Pre-operative Nutritional Support for Hirschsprung's Disease

Conditions
-----------------
Nutrition Supporting, Hirschsprung Disease, Infants, Prospective Study

Intervention / Treatment
-----------------
* Dietary Supplement: supplement nutritional supporting


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children aged 0-5 years. Clinical diagnosis with Hirschsprung's disease who requires surgery; Exclusion Criteria: Complicated with severe complications such as enterocolitis associated with Hirschsprung disease; History of diseases associated with various organ systems that may be life-threatening; Other severe digestive tract malformations or other diseases that may interfere with the treatment or compliance of the child; Patients who have participated in other clinical trials within the last 1 month; Any other conditions in which the investigator considers it inappropriate to participate in the trial.

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 5 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention group<br>Intravenous nutrition or oral high-calorie diet 7-10 days before surgery | Dietary Supplement: supplement nutritional supporting<br>* Special medical formula for the purpose of formula food<br>|
| No Intervention: control group<br>normal diet before surgery | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of postoperative HAEC | Incidence of postoperative HAEC | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Z score | weight/age | 3 months | 
| LOS | length of postoperative stay | 1 months | 
| reoperation | rate of reoperation | 3 months | 
| readmission | rate of readmission | 3 months |
Endocan Level in Patients With Erectile Dysfunction and Relationship With Tadalafil Treatment

Study Overview
=================
Brief Summary
-----------------
The investigators analyze the patients' endocan levels, IIEF scores, and hormon levels both before and after tadalafil (5 or 20mg) treatment. The investigators want to see erectile dysfunction severity and tadalafil treatment relations with endocen level.

Detailed Description
-----------------
The investigators will include at least 90 patients in study. Blood tests will taken before and after tadalafil treatment and will store at -80 celcius degree.

Official Title
-----------------
Endocan Level in Patients With Erectile Dysfunction and Relationship With Tadalafil Treatment

Conditions
-----------------
Erectile Dysfunction

Intervention / Treatment
-----------------
* Diagnostic Test: Endocan
* Drug: tadalafil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Patients with erectile dysfuction Exclusion Criteria: Psychogenic erectile dysfunction Erectile dysfunction associated with hormonal disorders Drug related erectile dysfunction

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 5mg tadalafil<br>5mg tadalafil | Diagnostic Test: Endocan<br>* Endocan will measured before and after treatment<br>Drug: tadalafil<br>* tadalafil<br>|
| Other: 20mg tadalafil<br>20 mg tadalafil | Diagnostic Test: Endocan<br>* Endocan will measured before and after treatment<br>Drug: tadalafil<br>* tadalafil<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of IIEF Score | Levels of Endocan relationship with IIEF | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of Endocan | Levels of Endocan with tadalafil treatment | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endocan, Erectile dysfunction, Tadalafil
Pilot Evaluation of Two Multipurpose Solutions in Regards to Corneal Staining

Study Overview
=================
Brief Summary
-----------------
To evaluate corneal staining after contact lens instillation with two different multi purpose solutions.

Conditions
-----------------
Corneal Staining

Intervention / Treatment
-----------------
* Drug: sodium citrate, sodium chloride, sodium borate, propylene glycol. citrate, tetronic 1304, AMP 95


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 18 yrs or older Males or females Any race or ethnic background CL patients using (multipurpose solutions) MPS Patients using Acuvue 2 lenses Exclusion Criteria: Corneal refractive surgery within 6 months of this study. Contact lens use on day of examination. Corneal ectasia. Current use of Restasis

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: sodium citrate, sodium chloride, sodium borate, propylene glycol. citrate, tetronic 1304, AMP 95|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Ultrasound Assessment of Gastric Contents in Fasted Elderly Patients With Hip Fracture

Study Overview
=================
Brief Summary
-----------------
Evaluation of gastric contents in fasted elderly patients with hip fracture. The gastric contents will be examined by using ultrasonography in fasted elderly patients scheduled for hip fracture surgery. The primary outcome is the number of patients with stomach contents, and the secondary outcome is the component of residual gastric contents.

Detailed Description
-----------------
In the patients who has femur fracture, they are immobilized because of the pain. This condition makes the gastric movement slow, and the pain also contributes to delayed digestion. In the present study, the gastric content is assessed by using ultrasonography in fasted elderly patients for hip fracture surgery. Ultrasound assessment is performed in the supine position. All patients scheduled elective surgery for hip fracture over 65 years old are objects. The primary outcome is the number of patients with not empty stomach and full stomach, and the secondary outcome is the component of residual gastric contents.

Official Title
-----------------
Ultrasound Assessment of Gastric Contents in Fasted Elderly Patients With Hip

Conditions
-----------------
Hip Fractures

Intervention / Treatment
-----------------
* Other: Ultrasound assessment of gastric contents


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Who has hip fracture and agrees with the purpose of the study Exclusion Criteria: gastrointestinal pathology history of any type of gastrectomy gastrointestinal anomaly

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- |
| Hip fracture patients<br>Fasted elderly patients scheduled for hip fracture surgery except exclusion criteria are enrolled. | Other: Ultrasound assessment of gastric contents<br>* Ultrasound assessment of gastric contents is performed in fasted elderly patients for hip fracture surgery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ultrasound assessment of the presence of gastric contents. | The presence of of gastric contents is assessed by using ultrasonography; yes/no | Before the induction of anesthesia (Baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ultrasound assessment of the component of residual gastric contents | The component of residual gastric contents is assessed by using ultrasonography; empty, clear fluid, solid content | Before the induction of anesthesia (Baseline) | 

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