linjc16/ctgov huggingface dataset:
Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy

Study Overview
=================
Brief Summary
-----------------
In the present study, midazolam and palonosetron in combination were more effective than palonosetron alone in lowering the incidence and severity of postoperative nausea and vomiting in the initial 2 h after laparoscopic cholecystectomy. Postoperative clinical complications were not different in both groups.

Official Title
-----------------
Comparison of Palonosetron With Combined Palonosetron and Midazolam for Preventing Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy

Conditions
-----------------
Postoperative Nausea, Postoperative Vomiting

Intervention / Treatment
-----------------
* Drug: midazolam and palonosetron group
* Drug: palonosetron group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients (aged 20 to 65 years) scheduled for laparoscopic cholecystectomy with American Society of Anesthesiologists (ASA) physical status classification of 1 or 2 Exclusion Criteria: The patients with a history of allergy to any other drugs used in this study, gastrointestinal disorder, previous PONV, pregnant woman, breastfeeding woman, use of antiemetics within 24 hours or body mass index > 30 kg/m2

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: midazolam and palonosetron<br>0.05 mg/kg of midazolam i.v. with 0.075 mg of palonosetron i.v. was administered after anesthetic induction | Drug: midazolam and palonosetron group<br>* intravenous midazolam and palonosetron administraion as prevention of postoperative nausea and vomiting<br>|
| Active Comparator: palonosetron<br>the same volume (0.05 mg/kg) of normal saline i.v. with 0.075 mg of palonosetron i.v. was administered after anesthetic induction | Drug: palonosetron group<br>* intravenous palonosetron administraion as prevention of postoperative nausea and vomiting<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of postoperative nausea and vomiting | 0=none; 1=occur | 24 hours after surgery | 
| severity of postoperative nausea and vomiting | 0 = absent; 1 = mild; 2 = moderate; 3 = severe | 24 hours after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
postoperative nausea and vomiting, midazolam, palonosetron
Ultrasound-guided Subclavian Venous Catheterization in Children

Study Overview
=================
Brief Summary
-----------------
The subclavian vein (SCV) is often the preferred site for central venous access. Ultrasound-guided SCV catheterizations with supraclavicular (SC) or infraclavicular (IC) approach have been proved to be useful in children. The investigators compared the success rate, number of attempts, time tocatheterization, and complication.

Official Title
-----------------
Comparision of Ultrasound-guided Supraclavicular and Infraclavicular Approach for Central Venous Catheterization in Children

Conditions
-----------------
Subclavian Venous Catheterization in Children

Intervention / Treatment
-----------------
* Other: Approach for ultrasound-guided subclavian venous catheterization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: central venous lines required patients children < 10 yr of age Exclusion Criteria: inadequate ultrasound visualization of the subclavian vein

Ages Eligible for Study
-----------------
Maximum Age: 10 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: supraclavicular<br>supraclavicular: supraclavicular approach for subclavian venous catheterization | Other: Approach for ultrasound-guided subclavian venous catheterization<br>* Each SCV catheterization was performed under ultrasound-guidance with supraclvicular or infraclavicular approach.<br>|
| Placebo Comparator: infraclavicular<br>infraclavicular: infraclavicular approach for subclavian venous catheterization | Other: Approach for ultrasound-guided subclavian venous catheterization<br>* Each SCV catheterization was performed under ultrasound-guidance with supraclvicular or infraclavicular approach.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The duration for susscessful placement of needle into subclavian vein | The time needed to place needle into the vein (from needle entry into the skin to aspiration of blood with syringe) was measured. When the duration was recorded as greater than 20 min, the procedure was defined unsuccessful and excluded from the analysis. | within 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of attempt for susscessful placement of needle into subclavian vein. | An 'attempt' was defined as each needle advancement to place needl into the vein. When the duration for susscessful placement of needle into subclavian vein was recorded as greater than 20 min, the procedure was defined unsuccessful and excluded from the analysis. | within 20 minutes |
Nexium Dyspepsia/AST

Study Overview
=================
Brief Summary
-----------------
The aim is to evaluate if the resolution of upper abdominal symptoms (pain or burning) during an acid suppressive test trial of esomprazole given daily for 7 days predicts symptoms resolution at the end of a subsequent treatment period of 7 weeks.

Official Title
-----------------
Supportive Test for Acid-Related Symptoms (STARS I) With Esomeprazole and a Following 7-week, Double-blind, Randomized, Placebo Controlled Treatment Period in Subjects With Upper Gastrointestinal Symptoms and With Normal Findings at Esophagogastroduodenoscopy.

Conditions
-----------------
Gastrointestinal Disease, Signs and Symptoms, Digestive, Dyspepsia

Intervention / Treatment
-----------------
* Drug: Esomeprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 3 months of symptoms of pain or burning centered in the upper abdomen prior to enrollment. Both Helicobacter pylori positive and negative patients eligible (Helicobacter pylori is a bacterial infection of the stomach) Exclusion Criteria: Presence of clinical significant abnormal findings at the endoscopy (examination of esophagus and stomach) prior to enrollment. Patients with symptoms of other gastrointestinal diseases, such as Gastroesophageal Reflux Disease (GERD), Irritable Bowel Syndrome (IBS) or Inflammatory Bowel Disease (IBD). Helicobacter pylori eradication treatment during the last 12 months prior to enrollment.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome is whether the patient is a responder or not after 8 weeks treatment. |  |  | 
| The primary efficacy outcome is based on symptom score recorded daily during the study in a patient diary. |  |  | 
| The patient will judge their symptoms of pain or burning centered in the upper abdomen on a four-graded scale (none, mild, moderate or severe). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary efficacy outcomes are whether the patient is a responder or not after 4 weeks, |  |  | 
| The average symptom score and the percentage of symptom-free days during the 7-week treatment period, |  |  | 
| Presence/absence of specific GI symptoms after 4 and 8 weeks of therapy |  |  |
A Multi-center Study to Assess the Efficacy and Safety of LX211 in Active Non-infectious Anterior Uveitis

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the safety and efficacy of LX211 as therapy in subjects with active non-infectious anterior uveitis

Official Title
-----------------
A Double-Masked, Placebo-Controlled, Parallel-Group, Multi-Center, Dose-Ranging Study With an Optional Extension to Assess the Efficacy and Safety of LX211 as Therapy in Subjects With Active Sight Threatening, Non-infectious Anterior Uveitis

Conditions
-----------------
Uveitis, Anterior, Panuveitis

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: LX211
* Drug: LX211
* Drug: LX211


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented history of non-infectious anterior, anterior and intermediate- or panuveitis Currently uncontrolled uveitis for a minimum of 2 weeks despite use of oral and/or topical corticosteroid,or subjects who are intolerant of local corticosteroid therapy due to the development of an ocular hypertensive response or subjects for whom oral corticosteroid is contraindicated. Grade of 2+ or higher for anterior chamber cells at time of enrollment Considered by the investigator to require corticosteroid-sparing therapy. Subjects not planning to undergo elective ocular surgery during the study Exclusion Criteria: Uveitis of infectious etiology Presence of an ocular toxoplasmosis scar An immune suppression regimen that includes an alkylating agent within the previous 90 days

Ages Eligible for Study
-----------------
Minimum Age: 13 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* PO BID<br>|
| Active Comparator: LX211, 0.2 mg/kg<br> | Drug: LX211<br>* 0.2 mg/kg, twice a day (BID)<br>|
| Active Comparator: LX211, 0.4 mg/kg<br> | Drug: LX211<br>* 0.4 mg/kg, twice a day (BID)<br>|
| Active Comparator: LX211, 0.6 mg/kg<br> | Drug: LX211<br>* 0.6 mg/kg, twice a day (BID)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anterior chamber cells |  | 16 and 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BCVA |  | 24 weeks | 
| macular thickness |  | 16 and 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
uveitis, calcineurin, inflammation
Creation of the BioBank, Early Detection and Discovery Biomarkers

Study Overview
=================
Brief Summary
-----------------
To establish a multidisciplinary research structure for tissue repository that facilitates projects that bridge specialties that normally may or may not interact.

Detailed Description
-----------------
To establish a multidisciplinary research structure that facilitates projects that bridge specialties that normally may or may not interact. The tissue bank will build the platform for a novel application of translational research that links cutting edge molecular laboratory techniques to clinical outcome studies in a fast and direct manner. Tissue banks can be used for numerous discovery applications such as the identification and structural characterization of human genes, expression analysis, or discovery proteomics. Biological specimens, when coupled with standardized treatment and outcome data, will be essential resources for the identification, characterization, and validation of biomarkers that are predictive of disease and treatment.

Official Title
-----------------
Creation of the BioBank,To Establish a Multidisciplinary Research Structure That Facilitates Projects That Bridge Specialties That Normally May or May Not Interact.

Conditions
-----------------
Pancreatic Cancer, Head and Neck Cancer, Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female volunteers Exclusion Criteria: N/A volunteers
Sexes Eligible for Study
-----------------
All

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

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tissue Bank
A Prospective Cohort Study Of Myasthenia Gravis

Study Overview
=================
Brief Summary
-----------------
The average annual incidence of Myasthenia gravis is up to (8.0-20.0) / 100,000 people. Myasthenia gravis is an acquired autoimmune disease. All skeletal muscles of patients may be involved. When ocular muscles are involved, ptosis, diplopia and other symptoms may occur. When the laryngopharyngeal muscles are involved, the patient may develop dysarthria, dysphagia and other symptoms. However, when the respiratory muscles are involved, patients will have difficulty in breathing, and some patients may develope myasthenia crisis, and artificial assisted respiratory therapy is often needed. This study is a prospective observational study, in which patients are continuously enrolled, basic information of patients is collected, and biological samples are collected. The purpose of this study is to improve the diagnosis and prognosis of myasthenia gravis patients.

Official Title
-----------------
A Prospective Cohort Study Of Myasthenia Gravis

Conditions
-----------------
Myasthenia Gravis, Myasthenia Gravis Crisis

Intervention / Treatment
-----------------
* Device: biomarkers


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meeting the diagnosis of myasthenia gravis Exclusion Criteria: Malignant tumor or other serious chronic disease

Ages Eligible for Study
-----------------
Maximum Age: 80 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 |
| --- | --- |
| ocular myasthenia gravis<br> | Device: biomarkers<br>* biomarkers<br>|
| generalized myasthenia gravis<br> | Device: biomarkers<br>* biomarkers<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myasthenia gravis foundation of America post intervention status | Complete Stable Remission (CSR) Pharmacologic Remission (PR) Minimal Manifestations (MM) Change in Status: Improved (I) Unchanged (U) Worse (W) Exacerbation (E) Died of MG (D of MG) | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Myasthenia Gravis, Prognostic prediction
Effects Of GW679769 On Sleep Onset And Maintenance And Next Day Functioning In Subjects With Primary Insomnia

Study Overview
=================
Brief Summary
-----------------
This study is designed to find the optimal (best) doses of GW679769 that could be given daily to promote sleep onset and maintain sleep during the night without significant next-day thinking impairment and drowsiness in subjects with primary insomnia.

Official Title
-----------------
A 28 Day, Polysomnographic and Subjective Assessment of GW679769 for the Treatment of Primary Insomnia: A Randomized, Double-blind, Parallel-Group, Placebo-Controlled Trial.

Conditions
-----------------
Sleep Initiation and Maintenance Disorders, Insomnia

Intervention / Treatment
-----------------
* Drug: GW679769


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Difficulty going to sleep and/or staying asleep for at least the past 3 months. Insomnia must result in significant distress or impairment in functioning at home, socially or at work. Otherwise good health with no significant or unstable medical disorder including psychiatric, neurological, endocrine, heart, lung or gastrointestinal disorders, drug/alcohol abuse, cognitive impairment, cancer or chronic pain conditions such as arthritis. Exclusion Criteria: History of other sleep disorders such as sleep apnea or restless leg syndrome. Regular sleep habits, including bedtime between 9 PM and midnight. No nightshift/rotating shift work, frequent napping or planned travel across >2 time zones. Use of nicotine, caffeine and alcoholic products.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 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

| Intervention/Treatment |
| --- |
|Drug: GW679769|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of GW679769 and placebo on the time needed to fall asleep at bedtime on Nights 1/2, 13/14 and 27/28 of treatment, as assessed by electroencephalography and other physiological changes during sleep. |  | 28 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of GW679769 and placebo effects on sleep maintenance and duration on Nights 1/2, 13/14 and 27/28 of treatment, as assessed by electroencephalography and subject diaries, and on next-day memory, alertness and physical coordination. |  | 28 Days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cognition, Polysomnography, Primary Insomnia, Electroencephalography, Sleep
Identification of New Genetic Markers of Risk of Venous Thromboembolism Recurrence by Analyzing Whole Genome

Study Overview
=================
Brief Summary
-----------------
Venous thromboembolism (VTE) is a common and potentially fatal disease. It is considered a chronic disease with a recurrence rate of 30% at 10 years. Reduce the risk of recurrence is a serious public health issue. For this it is necessary to identify patients at high risk of recurrence. However, until now, only 50% of recurrences are in the presence of known risk factors, suggesting that there are still yet unidentified risk factors. The assumption behind this project is that there are specifically associated genetic polymorphisms to the risk of VTE recurrence. The aim of our project is to identify these polymorphisms from genome-wide data MARTHA cohort. This cohort is composed of 1542 subjects from the Marseille region with at least one episode of VTE documented. Patients in the cohort MARTHA have all been genotyped for approximately 500,000 polymorphisms. The investigators want to achieve a case-control study nested in the cohort MARTHA. Subjects with recurrent VTE (the case) will be compared to subjects with only one episode of VTE (the controls). The allelic frequencies of polymorphisms previously genotyped 500,000 will be compared between cases and controls. The identification of these new genetic variants associated with VTE recurrence should allow us to improve the pathophysiological knowledge of the disease, reduce the frequency of episodes and focus research on new therapeutic approaches.

Conditions
-----------------
Venous Thromboembolism

Intervention / Treatment
-----------------
* Biological: Extra Blood Draw


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Caucasian topic Personal history of VTE confirmed by the reference diagnostic tests Exclusion Criteria: Pregnant or breastfeeding women

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: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patients with recurrent VTE<br> | Biological: Extra Blood Draw<br> <br> |
| Active Comparator: patients with only one episode of VTE<br> | Biological: Extra Blood Draw<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| allelic frequency of 500,000 already genotyped polymorphisms |  | 36 months |