linjc16/ctgov huggingface dataset:
Role of Routine Nasogastric Decompression After Subtotal Gastrectomy

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate whether subtotal gastrectomy without post-operative nasogastric decompression is better in terms of early post-operative bowel function and chest complication.

Detailed Description
-----------------
Nasogastric decompression is an intra-operative routine in most of the time to facilitate exposure of operative field during elective subtotal gastrectomy, but whether it should be retained post-operatively is controversial. Nasogastric decompression helps to drain the gastric remnant in case there is edema around the gastrojejunostomy, ileus and delayed gastric emptying, which can theoretically relieve nausea and abdominal distension. Besides, it may help decrease diaphragmatic splintage and hence decrease chance of chest infection if ileus occurs. However, nasogastric intubation could cause patient discomfort; also it has been shown that it would cause gastroesophageal reflux which may be associated with chest complication. There have been studies showing that routine post-operative nasogastric decompression is not necessary for gastrectomy in general, but the role in subtotal gastrectomy for stomach cancer is not well defined.

Official Title
-----------------
Role of Routine Nasogastric Decompression After Subtotal Gastrectomy

Conditions
-----------------
Cancer of Stomach

Intervention / Treatment
-----------------
* Device: nasogastric tube


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:All patients suffering from carcinoma of stomach, decided for operation subtotal, D1/D2 dissection palliative resection Exclusion Criteria: actively bleeding tumor perforation of tumor patient present with gastric outlet obstruction combine organ excision known diabetes with nephropathy

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

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 |
| --- |
|Device: nasogastric tube|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bowel function and related symptoms early post-op |  |  |
Muscle Atrophy in Sepsis

Study Overview
=================
Brief Summary
-----------------
Severe sepsis will provoke signals leading to muscle atrophy and weakness. Electrical stimulation will reduce the impact of sepsis.

Detailed Description
-----------------
Hypothesis 1: Severe sepsis will be associated with downregulation of anabolic signaling molecules and genes, upregulation of catabolic signaling molecules and genes, and the development of histologic and electrophysiologic abnormalities within skeletal muscle. Hypothesis 2: Electrical stimulation will improve muscle strength in patients with sepsis. Hypothesis 3: Electrical stimulation will be associated with upregulation of anabolic signaling molecules and genes, downregulation of catabolic signaling molecules and genes, and improvement of histologic and electrophysiologic parameters within skeletal muscle of patients with sepsis. Hypothesis 4: The ratio of catabolic:anabolic gene expression on Day 3 will be positively correlated with the severity of clinical weakness on Day 7

Official Title
-----------------
Biochemical Pathways to Skeletal Muscle Atrophy in Human Sepsis

Conditions
-----------------
Atrophy, Sepsis, Weakness

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Severe sepsis for < 72hr

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electrical stimulation will be associated with upregulation of anabolic signaling molecules and genes, downregulation of catabolic signaling molecules and genes within skeletal muscle of patients with sepsis |  | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electrical stimulation will be associated with improvement of histologic and electrophysiologic and strength parameters within skeletal muscle of patients with sepsis |  | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sepsis, atrophy, muscle, weakness
Implantable Cardioverter Defibrillators And Magnetic Resonance Imaging of the Heart at 1.5 Tesla

Study Overview
=================
Brief Summary
-----------------
To evaluate short-term and long-term effects by MR imaging on the technical and functional status of implantable cardioverter defibrillators.

Detailed Description
-----------------
The presence of an implantable cardioverter defibrillators (ICD) is currently considered an absolute contraindication to MR imaging, and most patients with PM are excluded from having MRI. As a result from studies such as MADIT I, MADIT II, SCDHeft etc. the number of patients with ICDs has been continuously growing over the past years, ans this development will continue. The aim of this study is to develop a strategy for safe performance of MR imaging at 1.5T, which included restriction of specific absorption rate (SAR) values to minimize the risk of lead heating, and ICD reprogramming to avoid interference from time varying gradient fields. The safety of this approach is then evaluated in a large group of ICD patients including assessment of potential myocardial thermal injury by measuring serum troponin I and pacing capture thresholds, and performing a follow-up 6 weeks after MR imaging to evaluate long-term effects.

Official Title
-----------------
Evaluation of Safety and Feasibility Magnetic Resonance Imaging of the Heart at 1.5 Tesla In Patients With Implantable Cardioverter Defibrillators

Conditions
-----------------
Defibrillators, Implantable, Heart Failure, Congestive

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Implantable Cardioverter Defibrillator congestive heart failure informed consent Exclusion Criteria: Non-MRI-compatible implants
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Defibrillators, Implantable, Heart Failure, Congestive, Magnetic Resonance Imaging
Postoperative Changes in Optic Nerve Sheath Diameter in Patients Undergoing Spinal Anesthesia for Cesarean Delivery

Study Overview
=================
Brief Summary
-----------------
This is observational study. The investigator will measure optic nerve sheath diameter by ultrasound on the eye after cesarean section under spinal anesthesia.

Official Title
-----------------
Postoperative Changes in Optic Nerve Sheath Diameter in Patients Undergoing Spinal Anesthesia for Cesarean Delivery

Conditions
-----------------
Intracranial Hypotension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing cesarean section under spinal anesthesia Exclusion Criteria: Patients who did not agree to participate in the study Patients has ophthalmic diseases Patients has previous history of ophthalmic surgery. Patients has neurological disorders. Patients has history of head surgery.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Spinal anesthesia<br>Patients undergoing cesarean section under spinal anesthesia | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change optic nerve sheath diameter | Change in Optic nerve sheathe diameter from baseline, 1,,6,24 and 48 hours after completion of surgery | 0,1,6,24 and 48 hours |
SB-742457 And Donepezil In Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find out if SB-742457 is a safe treatment and what effects it has on the symptoms of mild to moderate Alzheimer's Disease. SB-742457 is a new treatment which is thought to increase the levels of certain chemicals in the brain that are often decreased in patients with Alzheimer's Disease.

Official Title
-----------------
A Double-Blind, Randomised, Placebo-Controlled, Parallel Group Study to Investigate the Effects of SB-742457, Donepezil and Placebo on Cognition in Subjects With Mild to Moderate Alzheimer's Disease

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Drug: SB-742457
* Drug: donepezil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Clinical diagnosis of probable mild-to-moderate Alzheimer's Disease as determined by the NINCDS-ADRDA and DSM-IV criteria with an MMSE score of 12-24. Subjects and their caregivers must provide informed consent prior to study entry. Adequate blood pressure and laboratory values. Exclusion criteria: Females of child-bearing potential. Have other causes of dementia such as vascular damage, depression, bipolar affective disorder, schizophrenia, syphilis, vitamin B12 deficiency or thyroid deficiency. Subjects taking medication for Alzheimers disease or centrally acting agents which might impact study outcomes. Subjects taking agents for which there is a theoretical risk of interaction with SB-742457 or donepezil. Subjects with conditions which might be exacerbated by exposure to donepezil. Subjects with known hypersensitivity to sunlight or seizures.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 85 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: SB-742457|nan|
|Drug: donepezil|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cognition and function after 24 weeks. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in behavioral symptoms, activities of daily living and caregiver burden after 24 weeks Changes in all symptoms at 8 and 12 weeks Safety and tolerability PK (pharmacokinetic) profiling. Efficacy related to ApoE and HTR6 status |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cognition global functioning, Alzheimer's Disease, symptomatic, SB-742457
Pathogen Identification of Bacterial Pneumonia Via DNA Detection

Study Overview
=================
Brief Summary
-----------------
Pneumonia is a common cause of morbidity and mortality. The diagnosis of pneumonia from the microbiology perspective has been challenging. Recent reports suggest the utility of nuclear acid detection for rapid and accurate diagnoses of these pathogens and their antibiotic-resistant spectrum. Extracted bacterial nucleic acid in sputum specimen will be identified by Nuclear acid detection assay kit with Microfluidic Pumping Chip and LAMP methods

Detailed Description
-----------------
Sputum specimens normally collected from the patients with pneumonia for routine microbiologic testing and extra specimens will be evaluated via nuclear acid assay developed in our laboratory. The assay will be directed at variety of both pathogens, including Streptococcus pneumoniae, Hemophilus influenzae, Klebsiella pneumoniae, Staphylococcus aureus, Pseudomonas aeruginosa, Acinetobacter, Mycoplasma pneumonia, Chlamydia pneumoniae and Legionella pneumophila, and common antibiotic-resistant genes, such as ESBLs genes, MecA, OprD. The ultimate goal is to have an available panel of highly accurate and rapid (same day) assay, which will be carried out in several hours for identification. The extracted pathogen nucleic acid in sputum specimen will be identified by Nuclear acid detection assay with Microfluidic Pumping Chip and LAMP methods. The species of bacteria and their antibiotic-resistant gene to be detected are as listed above. As nucleic acid extracts will be archived, other pathogens can be investigated in the future if the correlated assay is developed. All results obtained by nuclear acid detection will be compared to results for conventional testing as listed above. Sensitivity, specificity and predictive values will be calculated. In cases where discordant results occur, additional testing and or medical history review will be properly conducted.

Official Title
-----------------
Identification of Bacterial Species and Their Antibiotic-Resistant Spectrum in Sputum Specimen From the Patients With Pneumonia Via Nuclear Acid Detection Assay

Conditions
-----------------
Pneumonia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Greater than 18 years of age. Cough present greater than one day History of fever X-ray evidence of pneumonia. Exclusion Criteria: Pneumonia caused by TB, fungi and virus

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pneumonia
The CZT Dynamic Myocardial Perfusion Imaging

Study Overview
=================
Brief Summary
-----------------
To develop and validate the noninvasive measurement of MBF and MFR by using dynamic imaging with a CZT camera, and evaluate the diagnostic and prognostic implications in various heart disease.

Detailed Description
-----------------
Absolute myocardial blood flow (MBF) and myocardial flow reserve (MFR) provide incremental diagnostic and prognostic information over relative perfusion alone. Recent development of dedicated cardiac SPECT cameras with better sensitivity and temporal resolution make dynamic SPECT imaging more practical. The potential roles of myocardial perfusion in subjects with cardiovascular risks and heart failure warrant further investigations. The present project aims to develop and validate the noninvasive measurement of MBF and MFR by using dynamic imaging with a CZT camera, and evaluate the diagnostic and prognostic implications.

Official Title
-----------------
The Quantification, Clinical Application of Dynamic Imaging Using Cadmium-zinc-telluride (CZT) Cameras to Assess Myocardial Perfusion

Conditions
-----------------
Cardiac Disease

Intervention / Treatment
-----------------
* Radiation: thallium-201


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Coronary heart disease Clinical diagnosis of heart failure Clinical diagnosis of metabolic diseases (such as metabolic syndrome, obesity, diabetes, hyperlipidemia, micro vascular diseases, etc.), heart failure or coronary heart disease in high-risk groups persons. Exclusion Criteria: Significant systemic disease (except heart disease) such as cirrhosis, end-stage renal disease or active malignancy, estimated life expectancy of less than three months, persons; pregnant or lactating women have the possibility of pregnancy.

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: thallium-201|Thallium (Tl-201) myocardial single photon emission tomography, dynamic imaging|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coronary artery disease (CAD) diagnosis | CAD defined as more than 50% stenosis in any vessel by coronary angiography or computed tomography. | 12 months after the index MPI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE (major adverse cardiac events) | revascularization, acute myocardial infarction, hospitalization for heart failure, cardiac death, non-cardiac death | 5 years after the index MPI | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cadmium-zinc-telluride，CZT cameras, myocardial blood flow，MBF, myocardial flow reserve，MFR
Social Participation After Childhood Craniopharyngioma

Study Overview
=================
Brief Summary
-----------------
Craniopharyngioma is a rare, benign central nervous system tumor, which may be a source of multiple complications, from endocrinology to vision, neurology and neurocognitive functions. This morbidity can lead to reduced participation in life activities, as described in the International Classification of Functioning, Disability, and Health (ICF). The primary objective of this study is to measure participation in life activities in a population of children affected by childhood craniopharyngioma, using the assessement of life habits questionnaire (LIFE-H questionnaire), validated as a social participation measurement tool in various pediatric disabilities.

Official Title
-----------------
Social Participation After Childhood Craniopharyngioma

Conditions
-----------------
Children With a Craniopharyngioma

Intervention / Treatment
-----------------
* Other: observational study so no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children with a craniopharyngioma Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
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: observational study so no intervention|observational study, so no intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LIFE-H questionnaire (Assessment of Life Habits) | The LIFE-H questionnaire is sent by mail to parents' patient. For parents who do not return the questionnaire completed, a telephone call is made and the LIFE-H questionnaire is completed by phone. | At maximum 6 months after inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Children, Social participation, Life-H questionnaire, Craniopharyngioma
Sleep Satisfaction and Psychomotor Performance of Adults

Study Overview
=================
Brief Summary
-----------------
Primary Objective: To assess sleep satisfaction before and after Zolpidem CR (Ambien CR) administration Secondary Objective: To assess Psychomotor Performance before and after Zolpidem CR (Ambien CR) administration

Official Title
-----------------
National, Multicenter, Open Label, Phase IV, Before-after Design Study, in Adult Patients With Primary Insomnia to Evaluate Sleep Satisfaction and Psychomotor Performance After 1 Month of Treatment With Zolpidem CR (Ambien®CR) in 6 Sites in Argentina

Conditions
-----------------
Sleep Disorders

Intervention / Treatment
-----------------
* Drug: ZOLPIDEM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients consulting Psychiatrists (private or hospital) -whatever the reason for consulting- who present with chronic primary insomnia from the DSM IV (Diagnostic and Statistical Manual - Revision 4). Accepting to participate in the study and signing informed consent Exclusion criteria: Pregnancy or breastfeeding. Current severe neuropsychiatric disorder (i.e. psychosis, obsessive compulsive disorder, major depression, dementia of Alzheimer or vascular type) according to DSM IV criteria. History of substance abuse or dependence (including alcohol) within the past year. Hypersensitivity to zolpidem or its excipients. Severe hepatic insufficiency Severe and/or acute respiratory insufficiency Myasthenia gravis. OTC (Over The Counter) sleep remedies or prescription sleep medications within 2 weeks or 5 half-life before screening. Severe medical illness. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 21 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: AMBIEN CR<br>AMBIEN CR 12.5 mg once daily immediately before bedtime or in elderly/hepatically impaired patients: 6.25 mg once daily immediately before bedtime | Drug: ZOLPIDEM<br>* Pharmaceutical form: tablet Route of administration: oral Dose regimen: once daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep satisfaction score (LSEQ = Leeds sleep evaluation questionnaire) |  | at Baseline, at V2 (26 +/- 2 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychomotor Performance (DSST / Digit Symbol Substitution Test and ESS / Epworth Sleepiness Scale) |  | at Baseline, at V2 (26 +/- 2 days) |