linjc16/ctgov huggingface dataset:
Mortality in Pediatric Intensive Care Unit

Study Overview
=================
Brief Summary
-----------------
With the development of national economy and medical technology, patients can extend life rely on high-end medical facilities. At the same time, the continued treatment cannot bring benefits to children, even resulting in poor quality of life of children and bringing high medical costs. This makes the limited medical resources are unreasonable distributed. Research showed that PICU mortality rate halved over ten years ago, but the data did not include death cases who left hospital before death. However, the death number of out-hospital were more than death in-hospital. Therefore, the data cannot actually reflect China's mortality rate of PICU. The reason analysis was limited to the cause of the disease, and does not take the social, economic factors into account. This study include eight PICUs of children's Hospital PICU. Critically ill patients are prospectively studied from death risk factors, admission status, disease diagnosis, severity of illness, analyzing of the risk factors of death from disease diagnosis and death risk factors. In addition, we will illuminate the relationship of death and economic factor, especially for who died out-hospital after withdraw or stop treatment.

Official Title
-----------------
Epidemiology of Death in the PICU of Southeast China

Conditions
-----------------
Intensive Care Units, Pediatric

Intervention / Treatment
-----------------
* Other: death


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ALL patients admitted to the PICU of eight study centers Exclusion Criteria: Postoperative monitoring of patients with stable hemodynamics PCIS score >90 and not up to the United States PICU admission standards

Ages Eligible for Study
-----------------
Minimum Age: 29 Days
Maximum Age: 18 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: death|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pediatric Critical Illness Score（PCIS） |  | first 24 hours after admission | 
| Pediatric Risk of Mortality score (PRISM III) |  | 24 hours | 
| Pediatric logistic organ dysfunction (PELOD) score |  | 24hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause mortality |  | one year |
Spanish Validation of Tool Questionnaire to Assess Patients´Perception About Antipsychotic Treatment

Study Overview
=================
Brief Summary
-----------------
Non-interventional, prospective study to validate Spanish version of TOOL questionnaire in patients with schizophrenia and bipolar disorder under antipsychotic treatment

Official Title
-----------------
Spanish Validation of Tool Questionnaire to Assess Patients´Perception About Antipsychotic Treatment

Conditions
-----------------
Schizophrenia, Bipolar Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Schizophrenia and bipolar disorder (DSM-IV criteria) Stabilized out-patients Treated with the same oral antipsychotic at least in the last month Exclusion Criteria: Participation in another clinical trial within 6 months prior to enrolment into this study Administration of a depot antipsychotic medication

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 |
| --- | --- | --- |
| TOOL questionnaire |  | 15 days | 
| PANSS & Young Mania Scale |  | 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montgomery Asberg Depression Scale |  | 15 days | 
| Euroqol 5D & SF-36D |  | performed only at baseline visit | 
| UKU modified scale |  | performed only at baseline visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
schizophrenia, bipolar disorder, antipsychotic treatment, patients´preferences
A Study of Pemetrexed in Small Cell Lung Cancer, Which Has Returned

Study Overview
=================
Brief Summary
-----------------
The purposes of this study are to determine 1) the safety of pemetrexed and any side effects that might be associated with it 2) whether pemetrexed can help patients with small cell lung cancer live longer 3) whether pemetrexed can make tumors smaller or disappear and for how long and 4) to see if patients feel better while taking pemetrexed

Official Title
-----------------
Phase II Trial of ALIMTA in Relapsed Small Cell Lung Cancer

Conditions
-----------------
Carcinoma, Small Cell

Intervention / Treatment
-----------------
* Drug: Pemetrexed


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of small cell lung cancer One prior treatment with chemotherapy or immunotherapy with greater than 3 weeks since the prior treatment At least 18 years of age Estimated life expectancy of at least 12 weeks Ambulatory and capable of self-care(eg, up and about greater than 50% of waking hours) Exclusion Criteria: Have received treatment within the last 30 days with a drug that has not received FDA approval for any indication Less than 2 weeks from radiation therapy Other serious illness that would compromise the safety of the patient Most second primary malignancies treated less than 5 years previously

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the antitumor activity for patients with both sensitive and refractory small cell lung cancer patients as measured by tumor response rate. To characterize the toxicities of pemetrexed in this patient population |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To better understand any side effects of pemetrexed |  |  |
Study Evaluating Sirolimus (Rapamune™) in Solid Organ Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety of long-term administration of sirolimus oral solution for up to 5 additional years, or until the tablet formulation is commercially available (whichever occurs first) in solid organ transplant recipients who are currently receiving sirolimus and who have completed clinical trials with sirolimus (with or without cyclosporine (CsA). To evaluate the pharmacokinetics and safety of long-term administration of sirolimus tablets administered for up to 5 years, or until the tablet formulation is commercially available in solid organ transplant recipients who are currently receiving sirolimus and who have completed clinical trials with sirolimus (with or without CsA) or who are currently enrolled in protocol 0468E1-306-US.

Official Title
-----------------
An Open-label Extension Study of the Safety of Long-term Administration of Sirolimus (Rapamune™) in Solid Organ Transplant Recipients

Conditions
-----------------
Graft vs Host Disease, Kidney Transplantation

Intervention / Treatment
-----------------
* Drug: Sirolimus (RAPAMUNE)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Completion of sirolimus/blinded therapy in solid organ clinical trials (with or without CsA) with satisfactory compliance and an adequate safety profile. Women of childbearing potential who have a negative pregnancy test before enrollment into this study and who agree to practice either a hormonal or barrier method of birth control throughout the treatment period and for 3 months following discontinuation of sirolimus may be enrolled into the study. Signed and dated informed consent Exclusion Criteria: Unstable disease states, which in the opinion of the investigator would present a risk to the patient. Known hypersensitivity to macrolide antibiotics

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 |
| --- |
|Drug: Sirolimus (RAPAMUNE)|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
-----------------
Transplant, Kidney
Effectiveness of Cortiment® in Patients With Ulcerative Colitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate Cortiment® with regard to its use by clinicians in routine clinical practice and its effectiveness and tolerability in a real-life setting.

Official Title
-----------------
A Prospective Multi-centre Observational Cohort Study Assessing the Effectiveness of Cortiment® for the Treatment of Mild-to-moderate Active Ulcerative Colitis in Routine Clinical Practice

Conditions
-----------------
Ulcerative Colitis

Intervention / Treatment
-----------------
* Drug: budesonide MMX®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women aged ≥ 18 years Outpatients Patients who have been prescribed Cortiment® for the treatment of mild to moderate active ulcerative colitis within a 5 days' time window prior to being included in the study Patients who have received adequate information regarding this non-interventional study and are able to understand and voluntarily sign the Informed Consent Exclusion Criteria: Patients with severe active / fulminant ulcerative colitis Patients treated with antibiotics or corticosteroids for the current flare. Use of Antibiotics for other conditions non-related to the gastrointestinal tract, either before enrolment or during the observational period is permitted. History of total / sub-total colectomy Hypersensitivity to the active substance, lecithin (derived soya oil, peanut oil) or to any of the excipients Patients enrolled and involved in an interventional study Patients whom investigators consider inappropriate to participate in the study

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 |
| --- | --- |
| Cortiment®<br>Treatment according to routine clinical practice. | Drug: budesonide MMX®<br> <br> * Other names: Cortiment®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical benefit in routine practice, defined as % of patients with clinical improvement ≥ 3-point in Ulcerative Colitis Disease Activity Index (UCDAI) clinical sub-score |  | From Day 1 to end of induction treatment (recommended duration up to 8 weeks) |
Study of Hemospray for Lower Gastrointestinal Hemorrhage

Study Overview
=================
Brief Summary
-----------------
This study is to evaluate the performance of Hemospray for the teatment of nonvariceal lower gastrointestinal bleeding.

Official Title
-----------------
A Prospective Observational Cohort Study of Hemospray for Lower Gastrointestinal Hemorrhage (APPROACH LGI)

Conditions
-----------------
Colonic Diverticula, Angiodysplasia, Colonic Polyp

Intervention / Treatment
-----------------
* Device: Hemospray


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient in which Hemospray is used to treat an endoscopically confirmed nonvariceal lower GI bleed requiring hemostasis Exclusion Criteria: Less than 19 years old Unwilling or unable to sign and date the informed consent Pregnant, lactating or planning to become pregnant within 30 days of the procedure Contraindicated to undergo colonoscopy Medical/Endoscopic Exclusion Criteria Actual or suspected lower GI perforation or fistula Bleeding originating from inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis) Actual or suspected ischemic colitis or infectious colitis Unable to visualize site of active bleeding (such as suspected diverticular bleed where source is unable to be identified) Unable to treat active site of bleeding (e.g., bleeding site cannot be reached by the colonoscope)

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| Hemospray to treat lower GI bleeds<br> | Device: Hemospray<br>* The Hemospray™ device comes in a 7F kit and a 10F kit. Each kit includes two 220 cm Teflon application catheters, a handle with CO2 cartridge and a syringe containing approximately 20 g of the Hemospray™ material. Hemospray™ is a proprietary inorganic mineral powder that acts as a mechanical barrier when sprayed over a bleeding lesion and the surrounding mucosa.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of device related adverse events |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of recurrent bleeding that occurs outside the blood vessel |  | 30 days | 
| Percentage of hemostasis of lower GI bleeds originating from multiple sources |  | 30 days | 
| All cause mortality | Mortality within 30 days of index procedure | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Digestive, Hemostasis, Gastriointestinal, Lower gastriointestinal, Recurrent bleeding, Hemospray
Anti Free Radical & Anti Inflammatory Effect & Safety of Rebamipide in Chronic Gastritis

Study Overview
=================
Brief Summary
-----------------
To study the anti free radical & inflammatory effect and safety of Rebamipide in patients suffering of dyspepsia due to chronic gastritis.

Official Title
-----------------
Anti Free Radical & Anti Inflammatory Effect & Safety of Rebamipide in Chronic Gastritis

Conditions
-----------------
Dyspepsia, Chronic Gastritis

Intervention / Treatment
-----------------
* Drug: Rebamipide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are 18 - 80 years old have symptoms of dyspepsia that need endoscopic examination are suffering from chronic moderate to severe gastritis which is confirmed endoscopically are able to give informed concern Exclusion Criteria: Patients who are treated with drugs that induce gastritis/ulcer, such as: NSAID are chronic alcoholism, are drug abuser are contraindicated for endoscopy examination has erosive or ulcerative esophagitis has peptic ulcer that has been confirmed by endoscopy has pyloric stenosis has active gastrointestinal bleeding has major absorption disorder has history of gastric surgery with renal disorder (creatinine > 2 mg/dL) with liver disease ( SGOT, SGPT, bilirubin) have hematologic disorder ( confirmed with hemoglobin, erythrocytes, leucocytes,differential blood count) are suffering from congestive gastropathy due cirrhosis are suffering from congestive heart disease are pregnant or giving breast feeding are hypersensitive to Rebamipide are treated with gastroprotective drugs such as : teprenone, sucralfate. are treated with acid suppressing medicine (H2A, PPI) are treated with antibiotics, mesalazine (Salofalk)

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rebamipide<br>Rebamipide 100 mg tid for 28 days | Drug: Rebamipide<br>* Rebamipide 100 mg tid for 28 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the efficacy of Rebamipide 100 mg t.i.d. in reducing gastric mucosal damage due to free radical and inflammation |  | 2 times (at day-0 and day-28) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To confirm the improvement of dyspepsia syndrome |  | 3 times (at day-0, day-7 and day-28) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patients suffering of dyspepsia due to chronic gastritis
New Pharmacological Treatment for Obstructive Sleep Apnea

Study Overview
=================
Brief Summary
-----------------
This study will determine if mirtazapine, a unique antidepressant that does not disturb sleep, will improve obstructive sleep apnea (OSA). The design is randomized, crossover, double blind, and placebo controlled. On two consecutive nights of one week, the patients receive either 30 mg mirtazapine or placebo at bedtime. The following week, the alternative medication is administered. The patients have known mild to moderate sleep apnea. The endpoints of the study are the apnea + hypopnea index (AHI), sleep quality, and the degree of arterial oxygen desaturation.

Official Title
-----------------
New Pharmacological Treatment for Obstructive Sleep Apnea

Conditions
-----------------
Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Drug: mirtazapine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Known OSA mild to moderate Exclusion Criteria: On antidepressant or antipsychotic medications

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Crossover Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The apnea + hypopnea index (AHI) |  |  | 
| Sleep quality |  |  | 
| The degree of arterial oxygen desaturation |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sleep apnea, mirtazapine, sleep
Dose-response Study of Exendin-9,39 on Glucose Metabolism

Study Overview
=================
Brief Summary
-----------------
Multiple studies have examined the effect of endogenous GLP-1 secretions by using a competitive antagonist of GLP-1 - Exendin-9,39 - infused at rates of 300pmol/kg/min. However, the presence of an effect does not necessarily imply that this effect is due to the blockade of the endogenous GLP-1 actions at the receptor. It is possible that the supraphysiologic concentrations of Exendin may have effects of its own. To examine the effect of Exendin on glucose metabolism the investigators propose a dose-response study to determine whether the compound has effects in a dose-dependent fashion.

Official Title
-----------------
A Dose-response Study of the Effects of Exendin-9,39 on Glucose Metabolism, Glucagon and Insulin Secretion and on Insulin Action.

Conditions
-----------------
Pancreatic Effects of 9,39-Exendin and 9,36-GLP-1

Intervention / Treatment
-----------------
* Drug: saline infusion
* Drug: GLP-1-9,36 infusion
* Drug: Exendin-9,39 at low dose
* Drug: Exendin-9,39 at high dose


Participation Criteria
=================
Eligibility Criteria
-----------------
Healthy Not on any medication other than thyroid hormone replacement or OCP No history of diabetes No prior upper GI surgery

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 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 |
| --- | --- |
| Placebo Comparator: Saline<br> | Drug: saline infusion<br>* saline infused at 30ml/hour<br>|
| Active Comparator: GLP-1-(9,36)-amide<br> | Drug: GLP-1-9,36 infusion<br>* infused @ 1.2pmol/kg/min<br>|
| Active Comparator: Exendin-9,39 @30pmol/kg/min<br> | Drug: Exendin-9,39 at low dose<br>* infused at 30pmol/kg/min<br>|
| Active Comparator: Exendin-9,39 @300pmol/kg/min<br> | Drug: Exendin-9,39 at high dose<br>* infused @ 300pmol/kg/min<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin Secretion |  | over 360 minutes of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glucagon secretion |  | over 360 minutes of study |