linjc16/ctgov huggingface dataset:
Schizophrenia Trial of Aripiprazole

Study Overview
=================
Brief Summary
-----------------
Aripiprazole will show improved effectiveness over the standard of care treatment with one of three atypical antipsychotics (olanzapine, quetiapine and risperidone).

Official Title
-----------------
A Multicenter, Randomized, Naturalistic, Open-Label Study Between Aripiprazole and Standard of Care in the Management of Community-Treated Schizophrenic Patients (Schizophrenia Trial of Aripiprazole - STAR)

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: Aripiprazole
* Drug: Olanzapine or Quetiapine or Risperidone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of schizophrenia Schizophrenia symptoms not optimally controlled or antipsychotic medication not well tolerated Exclusion Criteria: Diagnosis of schizoaffective disorder Patients treatment-resistant to antipsychotics

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A1<br> | Drug: Aripiprazole<br>* Tablets, Oral, 10 - 30 mg, Once daily, 26 weeks.<br>* Other names: Abilify;|
| Active Comparator: B1<br> | Drug: Olanzapine or Quetiapine or Risperidone<br>* Olanzapine: Tablets, Oral, 5-20 mg, Once daily, 26 weeks. OR Quetiapine: Tablets, Oral, 100-800 mg, Once daily, 26 weeks. OR Risperidone: Tablets, Oral, 2-8 mg, Once daily, 26 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score on the Investigator Assessment Questionnaire at week 26 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression scale and patient preference of medication at endpoint |  |  |
Nasal Intubation Using King Vision Video Laryngoscopy

Study Overview
=================
Brief Summary
-----------------
This study was designed to determine the comparison between the King Vision video laryngoscope 、 McGrath MAC video laryngoscope and Macintosh laryngoscope for nasotracheal intubation.Patients were divided into 3 groups of 30 patients each.Patients of King Vision group [n=30]、 McGrath MAC group [n=30] and Macintosh group[n=30]were intubated using respective devices.This study is the first to search the use of King Vision video laryngoscope for nasotracheal intubation.

Official Title
-----------------
Comparison King Vision Video Laryngoscopy 、McGrath MAC Video Laryngoscopy With Macintosh Laryngoscopy for Nasal Intubation

Conditions
-----------------
Nasal Intubation

Intervention / Treatment
-----------------
* Device: King Vision video laryngoscope
* Device: McGrath MAC video laryngoscope
* Device: Macintosh laryngoscope


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA physical status 1-2 general anesthesia with nasotracheal intubation anticipated difficult airway Exclusion Criteria: contraindications to nasal intubation Patients with a history of anti-hypertensive drugs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: King Vision video laryngoscope<br> | Device: King Vision video laryngoscope<br>* nasal intubation using King Vision video laryngoscope Device after general anesthesia induction<br>|
| Experimental: McGrath MAC video laryngoscope<br> | Device: McGrath MAC video laryngoscope<br>* nasal intubation using McGrath MAC video laryngoscope Device after general anesthesia induction<br>|
| Active Comparator: Macintosh<br> | Device: Macintosh laryngoscope<br>* nasal intubation using Macintosh laryngoscope Device after general anesthesia induction<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Intubation | the interval between opening the mouth and the time when three consecutive end-tidal CO2 waves were appeared on the monitor | 0 min after nasal intubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Laryngoscopy Time | time to expose the glottis | after expose the glottis | 
| Number of Participants With Complications | sore throat, hoarseness, etc | 24h after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
King Vision
Self-reported Outcomes of Patients in ERAS Nursing

Study Overview
=================
Brief Summary
-----------------
We aimed to evaluate the effect of ERAS nursing program on self-reported outcomes of patients undergoing minimally invasive lung cancer surgery, and compared the differences in length of hospital stay, complications, and readmission rate between ERAS and non-ERAS nursing programs

Official Title
-----------------
Effect of ERAS Nursing on Self-reported Outcomes of Patients Undergoing Minimally Invasive Lung Cancer Surgery

Conditions
-----------------
Enhanced Recovery After Surgery

Intervention / Treatment
-----------------
* Procedure: ERAS nursing
* Procedure: non eras nursing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥18years,Minimally invasive elective surgery,cooperate Exclusion Criteria: Pneumonectomy was performed and converted to open surgery Surgery intensive care, unable to cooperate (language Speech disorders, psychopathology)

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ERAS group<br>the patients accepting eras nursing protocol ; | Procedure: ERAS nursing<br>* Patients were given education before surgery, fluid and anesthetic drug management during surgery, early ambulation, fluid management and early feeding after surgery, etc<br>|
| Active Comparator: non-eras group<br>the patients not accepting eras nursing protocol ; | Procedure: non eras nursing<br>* Patients were under the routine management without eras protocol<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported Outcomes of Patients(PRO) | Use MD Anderson Symptom Checklist - Lung Cancer Symptom to measure severity and functional status | at baseline, daily after surgery, and weekly up to 4 after discharge weekly. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of stay (LOS), postoperative cardiopulmonary complications (CPC) and readmission rate (READM) | length of stay (LOS), postoperative cardiopulmonary complications (CPC) and readmission rate (READM) | From admission to one month after the patient's discharge |
This Study is Being Performed to Evaluate the Effect of Genasense on the Efficacy and the Safety of Rituximab/Fludarabine Combination Treatment in Previously Untreated Subjects With Chronic Lymphocyctic Leukemia(CLL)

Study Overview
=================
Brief Summary
-----------------
To compare the efficacy and safety of combination treatment with Genasense, fludarabine, and rituximab versus combination treatment with fludarabine and rituximab in previously untreated subjects with CLL.

Official Title
-----------------
A Randomized Phase 3 Study of Fludarabine and Rituximab With or Without Genasense® (Oblimersen Sodium) in Previously Untreated Subjects With Chronic Lymphocytic Leukemia

Conditions
-----------------
Lymphocytic Leukemia

Intervention / Treatment
-----------------
* Drug: Genasense® (, oblimersen sodium G3139)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previously untreated subjects with intermediate-or high-risk CLL(modified Rai Stages I-IV) Measurable disease as primarily established by the National Cancer Institute-sponsored Working Group(NCI-WG) Guidelines for the diagnosis of CLL Requiring therapy for active disease, as primarily defined by the NCI-WG Guidelines Eastern Cooperative Oncology Group Performance Status < 2 Adequate organ function determined , 14 days prior to the first dose of study medication Exclusion Criteria: Absolute Lymphocyte count > 100,000/uL Prior chemotherapy or other therapy for CLL, including allogeneic transplant Less than 3 weeks from any prior major surgery at the time of informed consent Failure to recover from any serious adverse effect of surgery History of autoimmune hemolytic anemia or autoimmune thrombocytopenia Active serious infection requiring systemic anti-infective therapy

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?
-----------------

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Genasense® (, oblimersen sodium G3139)|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
-----------------
Evaluate the Effect of Genasense on the Efficacy/Safety of Rituximab/Fludarabine Treatment in Untreated Subjects With Chronic Lymphocyctic Leukemia
The Occurrence of MACE in Patients With AMI Receiving Pitavastatin/Valsartan Treatment

Study Overview
=================
Brief Summary
-----------------
Prospective Observation study to identify the rate of MACE in AMI with Livalo V(Pitavastatin/Valsartan) for 12 month in Korea

Detailed Description
-----------------
Following subjects with AMI event within 1 month will be assessed MACE event for 1year Essential hypertension or heart failure Idiopathic hypercholesterolemia (heterogeneous familial and non-familial hypercholesterolemia, Fredrickson classification type IIa) Mixed-type hypercholesterolemia (Fredrickson classification type IIb) with acute myocardial infarction (STEMI, NSTEMI),

Official Title
-----------------
A 12-month Open-label, Multicenter Observation Study on the Occurrence of Major Adverse Cardiac Events (MACE) in Patients With Acute Myocardial Infarction (AMI) Receiving Pitavastatin/Valsartan Treatment

Conditions
-----------------
Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: Pitavastatin 4mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: idiopathic hypercholesterolemia (heterogeneous familial and non-familial, Fredrickson type IIa) or mixed-type (Fredrickson type IIb) with AMI (STEMI, NSTEMI), including essential hypertension or heart failure diagnosed AMI (STEMI, NSTEMI) 1 months ago more than 19 years old and more than 2 years of life expectancy at screening informed consent Exclusion Criteria: cardiogenic shock or corresponding clinical events contraindicated to the IP unsuitable to this study judged by investigators

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Pitavastatin 4mg|combination therapy with pitavastatin/valsartan (LivaloV)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all-cause mortality, non-fatal MI, repeat re-vascularization | MACE | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of mortality | MACE | 6 and 12 months | 
| The rate of cardiac death | MACE | 6 and 12 months | 
| The rate of nonfatal MI | MACE | 6 and 12 months | 
| The rate of hospitalization due to heart failure | MACE | 6 and 12 months | 
| The rate of Coronary artery bypass graft(CABG) | MACE | 6 and 12 months | 
| The rate of target lesion re-vascularization | MACE | 6 and 12 months | 
| The rate of target vessel re-vascularization | MACE | 6 and 12 months | 
| The rate of cerebrovascular disease | MACE | 6 and 12 months | 
| The change of SBP, DBP | Hypertensive parameters | 6 and 12 months | 
| The change of TC, TG, HDL-C, LDL-C, hsCRP | Lipid parameters | 6 and 12 months | 
| The change of HbA1c, FBS | No Onset of Diabetes | 6 and 12 months |
Magnesium Supplementation in Stress Conditions

Study Overview
=================
Brief Summary
-----------------
This study aims to determine how a 6-week magnesium supplementation with 400 mg magnesium from magnesium citrate/magnesium oxide affects stress parameters in students in exam preparation.

Detailed Description
-----------------
The examinations are carried out in 70 students in exam preparation (6 weeks before exam). The target parameters are determined in blood and 24h-urine. Blood sampling takes place at confinement, after 3 weeks and at the end of the study (week 6). In addition, heart rate variability is determined.

Official Title
-----------------
Randomized, Double-blind, Placebo-controlled Intervention Study About the Effects of Magnesium Supplementation Using Nutritional Supplements on the Stress Parameters of Students Preparing for Examination

Conditions
-----------------
Stress Physiology

Intervention / Treatment
-----------------
* Dietary Supplement: Magnesium
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy students in exam preparation Exclusion Criteria: pregnancy any chronic diseases

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>identically tasting and looking Placebo | Dietary Supplement: Placebo<br> <br> |
| Active Comparator: Magnesium<br>Supplementation with 400 mg Magnesium from Magnesium Citrate / Magnesium Oxide once daily | Dietary Supplement: Magnesium<br>* Magnesium citrate / Magnesium oxide<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood sampling | measurement of stress metabolites | 6 weeks | 
| 24h-urine | measurement of stress metabolites | 6 weeks | 
| heart rate variability | measurement of heart rate variability | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
magnesium, stress, metabolomics, heart rate variability
Follow-up of Person-centered Care of Young Adults With Rheumatic Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to study how a person-centered structured team caretaking of young adults (16-23 years) with newly diagnosed rheumatoid arthritis (RA), spondartrit (SpA) and psoriasartrit (PsA) in routine clinical care affect and predict the patient's health and ability to manage their everyday lives. Also included in the project is a long-term follow-up (up to 50 years) where the investigators want to investigate factors predicting good general health, low disease activity, good physical function, and comorbidity.

Official Title
-----------------
Follow-up of Person-centered Care of Young Adults With Rheumatic Disease Uppföljning av Personcentrerat omhändertagande av Unga Vuxna Med Reumatisk Sjukdom (Unga-vuxna Studien) (Swedish)

Conditions
-----------------
Arthritis, Rheumatoid, Spondylarthritis, Arthritis, Psoriatic

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 16-23 years newly diagnosed RA according to the ACR / EULAR 2010 criteria, SpA according to CASPAR criteria, or AS according to the ASAS criteria. Ability to understand the Swedish language in speech and writing. Exclusion Criteria: Existing rheumatic disease Other healthcare demanding serious illness

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 23 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: no intervention|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General health as measured by VAS |  | This study consists of a 1-year primary study and a long term follow-up (up to 50 years) |
Patient-Ventilator Dyssynchrony: How is the Effect of Management?

Study Overview
=================
Brief Summary
-----------------
Although patient-ventilator asynchrony is a frequent phenomenon, its course following management is unknown. As the aid of a data recording system, we try to observe the consequence of patient-ventilator asynchrony following management. Our target is aimed at the patients with high asynchronization index ( > 10%) as this group of patients have been shown to have prolonged course in intensive care unit and are also prone to be tracheostomized

Official Title
-----------------
Patient-Ventilator Dyssynchrony: How is the Effect of Management?

Conditions
-----------------
Respiratory Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients admitted to respiratory intensive care unit with acute respiratory failure and presence of patient-ventilator asynchrony(AI of more than 10%) patient can trigger the ventilator Exclusion Criteria: High oxygen fraction: > 60%. High PEEP need: > 12cmH2O. Hemodynamic unstable: shock Central nervous system problem. Hyperacitve delirium Without informed consent

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 |
| --- | --- |
| 1<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asynchrony index (AI). (Number of asynchrony events/total respiratory rate) |  | 20 minutes after alternation of ventilator settings or any therapeutic means | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ventilator, patient-ventilator asynchrony
Registry Study for Radiation Therapy Outcomes

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to collect and analyze information from patients being treated with various forms of radiation therapy.

Official Title
-----------------
Evaluation Tracking Project: A Prospective Chart Review of Patients Treated With Radiation Therapy

Conditions
-----------------
Solid Tumors

Intervention / Treatment
-----------------
* Radiation: Proton Therapy, Photon Therapy, SRS, Brachytherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Planned treatment with radiation therapy Ability to understand and sign IRB approved consent
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treatment with Radiation Therapy<br>Includes 16 different arms to capture patient data by disease site | Radiation: Proton Therapy, Photon Therapy, SRS, Brachytherapy<br>* Outcomes Tracking<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Define outcomes for patients treated at participating institutions |  | PRN | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine strategies necessary to improve patients outcome and decrease toxicities related to treatments and procedures |  | Annually PRN | 
| Improve patient care by an adequate understanding of the results and patient population at participating institutions |  | Reviewed Annually PRN | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cancer, proton, radiation