linjc16/ctgov huggingface dataset:
CH-EUS in Diagnosis of Inoperable Bile Duct Tumors

Study Overview
=================
Brief Summary
-----------------
VALIDATION OF THE SUPERIORITY OF CONTRAST ENHANCED ENDOSCOPY TO STANDARD ENDOSCOPY IN THE DIAGNOSIS OF BILE DUCT TUMORS

Official Title
-----------------
Contrast-enhanced Endoscopic Ultrasound in Diagnosis of Inoperable Bile Duct Tumors

Conditions
-----------------
Inoperable Disease, Bile Duct Cancer

Intervention / Treatment
-----------------
* Procedure: Endoscopic ultrasound with fine needle biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Bile duct tumor diagnosed at endoscopic US, CT scan or MRI INR<1.5; platelets > 50.000 written consent form Exclusion Criteria: INR>1.5; platelets < 50.000 duodenal invasion or stenosis patients denial previous treatment for hepato-biliary tumors

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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EUS-FNA<br> | Procedure: Endoscopic ultrasound with fine needle biopsy<br>* Patients with unresectable bile duct tumors will be investigated by either CH-EUS with FNA or conventional EUS with FNA<br>|
| Experimental: CH-EUS-FNA<br> | Procedure: Endoscopic ultrasound with fine needle biopsy<br>* Patients with unresectable bile duct tumors will be investigated by either CH-EUS with FNA or conventional EUS with FNA<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CH-EUS FNA has higher diagnostic accuracy for bile tuct tumors | To asses if CH-EUS FNB is superior to CH-EUS FNA when assessing bile duct tumors. To determine the diagnostic accuracy, sensitivity and sensibility. | one week |
Tumor Immune Microenvironment Involvement in Colorectal Cancer Chemoresistance Mechanisms

Study Overview
=================
Brief Summary
-----------------
Colorectal cancer is the third most common cancer worldwide and its progression-free survival is still low, around 10 months. Thirthy to 50% of patients do not respond to chemotherapy upon initiation of treatment, suggesting that early development of chemoresistance mechanisms remains a major challenge. In order to better characterize these mechanisms, we aim to develop a model of tumoroids derived from patients with a colorectal tumors prior to any systemic anti cancer treatment. This project will both allow us to study the role of the immunological microenvironment in chemoresistance and identify new predictive markers of tumor response. It will then serve to develop innovative personalized medicine strategies by targeting the newly identified mechanisms. This study should in fine help to improve the cancer patient's care.

Official Title
-----------------
Tumor Immune Microenvironment Involvement in Colorectal Cancer Chemoresistance Mechanisms: a Patient-derived Tumoroids Prospective Collection From Systemic Treatment Naive Tumors

Conditions
-----------------
Development of an Organoid Collection From Fresh Human Primary Colonic Tumor Tissue

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female over 18 years old. Managed at the CHUGA for a colorectal adenocarcinoma With an indication for immediate surgical resection as part of the care. Patient naive from neo-adjuvant chemotherapy Patient did not object to the CRC-ORGA-2 study Exclusion Criteria: Patients protected by law (pregnant or breastfeeding women, minors, patients under guardianship or trusteeship, persons deprived of their liberty or hospitalized under duress). Patients with positive HIV, HBV, HCV serology.

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 |
| --- | --- | --- |
| Percentage of viable organoids for 60 days of culture maintenance. |  | 60 days of culture maintenance. |
Study With Improved Solubility Pazopanib

Study Overview
=================
Brief Summary
-----------------
The pharmacokinetics of a new formulation with Pazopanib will be studied. This will be done in a patient cohort of n = 12.

Official Title
-----------------
Proof of Principle and Pharmacological Phase 0 Study With Improved Solubility Pazopanib

Conditions
-----------------
Pharmacokinetics of Pazopanib

Intervention / Treatment
-----------------
* Drug: New Pazopanib formulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Locally advanced or metastatic cancer; Able and willing to give written consent; WHO performance status of 0, 1 or 2; Able and willing to undergo blood sampling for PK analysis; Minimal acceptable safety laboratory values; Negative pregnancy test for female patients with childbearing potential; Able and willing to swallow oral medication. Exclusion Criteria: Any treatment with investigational drugs within 30 days prior to receiving the investigational treatment; Any treatment with CYP3A4, BCRP or PGP interfering drugs; Patients who received treatment with Votrient(R) kess than 1 week ago; Woman who are pregnant or breast feeding; Patients suffering from any known condition that may influence the dissolution or absorption of Pazopanib.

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: Treated patients<br> | Drug: New Pazopanib formulation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentration | Concentration of pazopanib in plasma | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 1 week | 
| Area under the plasma concentration versus time curve (AUC) | Area under the plasma concentration versus time curve (AUC) | 24 hours |
Desarda Repair for Inguinal Hernia

Study Overview
=================
Brief Summary
-----------------
Unlike Lichtenstein tension free repair for inguinal hernia, Desarda's repair was introduced as a pure tissue repair with no need for mesh. In other words; the complications which may arise from the use of a foreign body (mesh) will be avoided. The idea was to evaluate the efficacy of this new repair and compare it to the standard Lichtenstein repair.

Official Title
-----------------
Desarda Versus Lichtenstein's Repair for Inguinal Hernia: a Comparative Study

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

Intervention / Treatment
-----------------
* Procedure: Lichtenstein tension free reair
* Procedure: Desarda's repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: inguinal hernia Exclusion Criteria: recurrent inguinal hernia giant inguinal hernia mental disorder refusal to participate

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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lichtenstein tension free reair<br>mesh repair of inguinal hernia | Procedure: Lichtenstein tension free reair<br>* a mesh is apllied on the posterior wall of the inguinal canal and sutured to the inguinal ligament below, to the internal oblique muscle above , and to rectus sheath medially.<br>* Other names: pure synthetic repair;|
| Active Comparator: Desarda's repair<br>non-mesh repair of inguinal hernia | Procedure: Desarda's repair<br>* the repair is done using a flap of the external oblique aponeurosis sutured to the inguinal ligament below and to the aponeurotic part of the internal oblique muscle above.<br>* Other names: pure tissue reapir;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients with recurrence of inguinal hernia |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS score for pain |  | one year | 
| number of patients develped postoperative complications |  | 2 years |
Multi-center, Prospective, Cohort Study to Evaluate the Relationship of Stroke Recurrence and Anti-platelet Resistance in Ischemic Stroke Patients

Study Overview
=================
Brief Summary
-----------------
This cohort study will evaluate the relatiobship of stroke recurrence and anti-platelet resistance in ischemic stroke patients

Official Title
-----------------
Multi-center, Prospective, Cohort Study to Evaluate the Relationship of Stroke Recurrence and Anti-platelet Resistance in Ischemic Stroke Patients

Conditions
-----------------
Ischemic Stroke

Intervention / Treatment
-----------------
* Drug: Aspirin, Clopidogrel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women over 60 years old at the time of written consent Those admitted to the hospital within 72 hours after acute cerebral infarction and treated with Aspirin 100 mg and Clopidogrel 75 mg Written informed consent voluntarily signed Exclusion Criteria: Those with evidence other brain lesions such as brain tumors Those who need oral anticoagulants other than vitamin K antagonists or anticoagulant therapy of warfarin Contraindicate to Aspirin or Clopidogrel or allergic to the drug Subjects who are at risk of active pathological bleeding such as digestive ulcer and intracranial hemorrhage Cancer disease that can shorten life expectancy Patient's condition that may interfere with participation in study such as mental illness, mental retardation, dementia, drug abuse, and alcoholism Subjects other than the above unsuitable for this clinical study identified by Investigator

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Aspirin, Clopidogrel|to evaluate the relationship of stroke recurrence and anti-platelet resistance in ischemic stroke patients receiving aspirin and clopidogrel|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluate the relationship of stroke recurrence and anti-platelet resitance | To evaluate the relationship of stroke recurrence and anti-platelet resitance in ischemic stroke patients receiving aspirin 10mmg and clopidogrel 75mg for 12weeks | 12weeks |
ONO-7436 Phase II Study in Japan

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the efficacy and safety of ONO-7436 for the prevention of cancer chemotherapy-induced nausea and vomiting in patients with malignant tumor

Official Title
-----------------
ONO-7436 Phase II Study - A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Examine the Efficacy and Safety of ONO-7436 for the Prevention of Cancer Chemotherapy-Induced Nausea and Vomiting in Japan

Conditions
-----------------
Malignant Tumor

Intervention / Treatment
-----------------
* Drug: ONO-7436


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients age 20 years or older Patients with malignant tumor who are to be intravenously administered cisplatin as a single dose of 70 mg/m2 or more in under 3 hours Patients whose performance status is 0 to 2 Other inclusion criteria as specified in the study protocol Exclusion Criteria: In case of patients who are previously treated with cisplatin, those having no past history of vomiting as of administration of cisplatin Patients who had vomiting or dry vomiting within 24 hours before the initial administration of the moderate or severe emetic chemotherapy (including cisplatin) on Day 1 of the study Pregnant women, nursing women, women of child-bearing potential, women who wish to become pregnant or women using oral contraception Other exclusion criteria as specified in the study protocol

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ONO-7436|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient proportion of complete response (no vomiting and no rescue treatment). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with no vomiting, no rescue treatment, and no nausea (in each category or combination), frequency of vomiting, and time to first vomiting, and first rescue treatment. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ONO-7436, Aprepitant, Vomiting, Nausea
Light to Maximize Vision, Minimize Insomnia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether specific wavelengths of light at night can be used to improve mobile balance while simultaneously not increasing alertness.

Official Title
-----------------
Toileting at Night in Older Adults: Light to Maximize Vision, Minimize Insomnia

Conditions
-----------------
Postural Balance

Intervention / Treatment
-----------------
* Other: Light


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 55-85 At least 20/200 corrected visual acuity Greater than 20° visual field with no lower visual field loss Stable health Male or female Normal color vision Normal hearing Exclusion Criteria: Extreme chronotype Sleep disorders Dementia Smoker Depression Alcohol abuse Use of illegal drugs Use of sleep/wake altering drugs on an acute or as needed basis (including nutraceuticals, antihistamines) Use of light sensitizing drugs Self-reported history of nocturia (>3 times per night)

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 85 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dim light<br>15 minutes of very dim (<1 lux) light during the night | Other: Light<br> <br> |
| Active Comparator: Room light<br>15 minutes of normal room light ( 100 lux) during the night | Other: Light<br> <br> |
| Experimental: Colored light<br>15 minutes of colored light during the night | Other: Light<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mobile balance | Mobile balance as determined using a GaitRite walkway | 15 minutes | 
| Alertness | Alertness as determined by electroencephalographic power density | 15 minutes |
Serum Bupivacaine Concentration Levels After Injection of Liposomal Bupivacaine Into the Knee

Study Overview
=================
Brief Summary
-----------------
Serum levels of bupivacaine over time after peri-articular injection of a mixture of liposomal bupivacaine and plain bupivacaine during total knee arthroplasty.

Official Title
-----------------
Serum Bupivacaine Concentration Levels After Injection of the Knee Joint With a Mixture of Liposomal Bupivacaine and Free Bupivacaine During Total Knee Arthroplasty

Conditions
-----------------
Anesthesia, Local

Intervention / Treatment
-----------------
* Drug: liposomal bupivacaine/plain bupivacaine peri-articular injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults of at least 18 years of age having a primary, unilateral total knee arthroplasty with a surgical plan to have an intra-articular injection of a mixture of 266 mg of Exparel, 125 mg of bupivacaine, 1:300,000 epinephrine, and 0.9% saline to make a total volume of 100 ml. Exclusion Criteria: Known hepatic dysfunction or renal insufficiency (creatinine > 1.5 mg/dL); allergy to the study medications; pregnancy; incarceration; inability to communicate with the investigators; morbid obesity (body mass index > 40 kg/m2).

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: liposomal bupivacaine/plain bupivacaine peri-articular injection|Injection of a mixture of liposomal and plain bupivacaine around the knee during total knee arthroplasty.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Bupivacaine levels |  | 5 minutes to 24 hours after injection |
Therapeutic Use of Oral Sodium Phosphate (Z-521) in Primary Hypophosphatemic Rickets

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the efficacy and safety of oral phosphate (Z-521) in subjects with primary hypophosphatemic rickets.

Official Title
-----------------
Therapeutic Use of Oral Sodium Phosphate (Z-521) in Primary Hypophosphatemic Rickets

Conditions
-----------------
Primary Hypophosphatemic Rickets

Intervention / Treatment
-----------------
* Drug: Z-521


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed as primary hypophosphatemic rickets based on familial history, genetic test or laboratory test results. Exclusion Criteria: A hyperparathyroidism

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 14 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Z-521<br> | Drug: Z-521<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum ALP level |  | 6 month | 
| Serum phosphate level |  | 6 month |
Dysrhythmias During General Anesthesia in Children

Study Overview
=================
Brief Summary
-----------------
To describe the types and incidence of cardiac dysrhythmias that occur under anesthesia in the present anesthesia environment.

Detailed Description
-----------------
It is unclear what the current state of anesthesia associated dysrhythmias is in the pediatric population. This was last investigated retrospectively in 1992 when the predominant volatile agent used for inhalation induction was halothane. Sevoflurane was approved by the Food and Drug Administration in 1995. Since that time, Sevoflurane has displaced halothane as the agent of choice for inhalation induction and has relegated halothane to be used in a narrow niche which primarily involves patients with very specific congenital heart diseases. It has been described that halothane has a larger proarrhythmic effect than sevoflurane for ventricular dysrhythmias. With the transition from the halothane to the sevoflurane era, a reassessment of the incidence and types of dysrhythmias occurring in non-cardiac pediatric patients is important.

Official Title
-----------------
Dysrhythmias During General Anesthesia in Children

Conditions
-----------------
Arrhythmias, Cardiac

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children, while under anesthesia, having circumstances of tachycardia and bradycardia, administration of medications used in the treatment of dysrhythmias, the commentary which includes comment about the heart rhythm or therapy for dysrhythmia, in the quality assurance database for evidence of dysrhythmia Exclusion Criteria: Children with a known pre-operative: prior history of dysrhythmia and/or residual congenital heart disease anti/pro dysrhythmic medications
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1-Children receiving anesthesia<br>The sample of patients screened will be the entire electronic anesthesia record database from 1998 until 2004 looking for subjects that have dysrhythmias. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arrhythmias During General Anesthesia in Children |  | July 1998 through July 2004 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Children, Cardiac Arrhythmia, General Anesthesia