linjc16/ctgov huggingface dataset:
Testing for Bacterial Contamination During Gastric Surgeries

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate whether creating a gastrotomy (hole in the stomach) during gastric surgery increases a patient's risk of intra-abdominal infection. We hypothesize that a gastrotomy does not contaminate the abdomen with clinically significant bacterial pathogens.

Detailed Description
-----------------
We propose to investigate the bacterial load and contamination patients experience during laparoscopic roux-en-y gastric bypass while having their gastrotomy for gastrojejunostomy. In all patients who undergo laparoscopic roux-en-y gastric bypass, the stomach must be opened to the peritoneal cavity while placing an anvil for gastrojejunostomy. Samples of gastric fluid will be collected and sent for analysis in all patients. Samples of peritoneal fluid will be collected prior to and after the creation of the gastrotomy, using intraperitoneal irrigation with approximately 500 cc of normal saline. Bacterial counts and identification will be recorded for each sample.

Official Title
-----------------
Transgastric Bacterial Contamination of the Abdomen

Conditions
-----------------
Gastric Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: any patient undergoing roux-en-y gastric bypass Exclusion Criteria: lack of consent

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative and qualitative measure of the bacterial load and bacterial contamination of the abdomen during laparoscopic roux-en-y gastric bypass surgery while the gastrotomy is open to the abdominal cavity. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bacterial, contamination, gastrotomy, Complications
Efficacy and Safety of Inhaled Zanamivir in Treatment of Influenza A and B Virus Infections in China

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the clinical efficacy and safety of inhaled zanamivir in treatment of influenza A and B virus infections in China.

Official Title
-----------------
Randomised, Double-blind, Placebo-controlled Trial of Inhaled Zanamivir in Treatment of Influenza A and B Virus Infections in China

Conditions
-----------------
Influenza A Virus Infection, Influenza B Virus Infection

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Who had fever (>38.0ºC) At least two of the following symptoms: chills, headache, myalgia, fatigue, nasal symptoms, sore throat, cough Started therapy within 48 hours of onset of influenza-like illness Written informed consent Exclusion Criteria: Respiratory diseases, such as asthma or COPD Woman with a positive urine pregnancy test Woman without contraception during the study Allergic to zanamivir, Paracetamol or lactose WBC ≥ 10.5×109/L; neutrophil percentage ≥ 80% Hepatic function impairment: AST ≥ 2×ULN, ALT ≥ 2×ULN Renal function impairment: Cr > 221μmol/L Influenza vaccination in the 12 months prior the beginning of the study History of tumor, psychiatric disorders, epilepsy or drug abuse Patients receiving corticosteroids, immunosuppressants HIV positive

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zanamivir<br> | Drug: Zanamivir<br>* 10 mg inhaled by mouth, twice daily, for 5 days<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* inhaled by mouth, twice daily, for 5 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to alleviation of clinically important symptoms |  | up to 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom score AUC |  | 6 days | 
| Mean symptom scores |  | 6 days | 
| The use of relief medication |  | 6 days |
Midazolam Sedation for Neonatal Lumbar Puncture

Study Overview
=================
Brief Summary
-----------------
Lumbar puncture is one of the most common painful procedures performed on neonates in the Emergency Department (ED). The investigators will study in a randomized controlled trial, the efficacy of intravenous administration of a single dose of Midazolam in reducing pain and anxiety in neonates undergoing lumbar puncture in the ED, as well as the rate of adverse sedation reactions. The investigators hypothesize that compared with placebo, single dose Midazolam would significantly decrease pain and anxiety and will have low rate of adverse reactions.

Official Title
-----------------
Midazolam Sedation for Neonatal Lumbar Puncture in the Emergency Department: A Randomized Controlled Trial

Conditions
-----------------
Pain, Anxiety

Intervention / Treatment
-----------------
* Drug: Midazolam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologists (ASA) score I, II Post natal age ≤ 30 days Fasting of at least 2 hours before the procedure Exclusion Criteria: American Society of Anesthesiologists (ASA) score III or greater Gestational age of 37 weeks or younger Congenital disease or defect Any medication provided by the caregiver prior ED admission Fasting of less than 2 hours

Ages Eligible for Study
-----------------
Minimum Age: 3 Days
Maximum Age: 30 Days

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Midazolam<br>Administration of Midazolam prior Lumbar Puncture | Drug: Midazolam<br>* Intravenous infusion of 0.05 mg/kg of Midalolam<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Simplified Neonatal Facial Coding System will be used for assessment of pain. Scoring will be composed from four specific facial actions (brow bulge, nasolabial furrow, eye squeeze, and open mouth) and the presence or absence of crying |  | 20 seconds prior lumbar puncture, during needle insertion, and 20 seconds post insertion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician's level of satisfaction from the procedural conditions |  | Five minutes post successful LP | 
| LP Success rate |  | Five minutes post successful LP | 
| Adverse sedation reactions |  | During procedure and during recovery phase | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neonates
Enterobius Vermicularis Infestation of the Appendix

Study Overview
=================
Brief Summary
-----------------
This study identifies the incidence of appendiceal Enterobius vermicularis (E.v) infestation in all the patients undergoing appendectomy and evaluates the relationship between E.v infestation of the appendix and the acute appendicitis.

Detailed Description
-----------------
All the patients undergoing appendectomy surgical procedure for clinical picture of acute appendicitis in 3-years period at our referral hospital were evaluated to pick up the Enterobius vermicularis infestation of the appendix. These cases were evaluated for clinico-laboratory characterization to define the incidence in our country and the relationship between the E.v and initiation of the the inflammatory process to study the possibility of limitation of surgical intervention in acute abdomen conditions.

Official Title
-----------------
Enterobius Vermicularis in Appendectomy Specimens; Clinicopathological Assessment

Conditions
-----------------
Parasitic Disease

Intervention / Treatment
-----------------
* Diagnostic Test: Pathology examination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All routine examined appendectomy specimens Exclusion Criteria: Cases with clinical suspicion of tumor Cases attached to the colectomy specimens

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 90 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non-parasitic<br> | Diagnostic Test: Pathology examination<br>* Gross and microscopic evaluation<br>|
| Parasitic<br> | Diagnostic Test: Pathology examination<br>* Gross and microscopic evaluation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between acute inflammation and Enterobius vermicularis infestation | All the studied Enterobius vermicularis cases will be evaluated microscopically to record the count of acute inflammatory cells per millimeter (mm) and per High Power Field (HPF) using the microscope scale measurement. This count will be compared with the inflamed appendectomy specimens without Enterobius infestation to assess the hypothesis of the association between the Enterobius infestation and the acute appendicitis. Also special stain (congo red) will be implicated in some indicated cases to detect eosinophils, eosinophils will be positively staines (orange color stain means positive) if the stain is faint that means negative and the cell is not eosinophil | 3 years | 
| Incidence of Appendiceal Enterobius vermicularis | An incidence of Enterobius infestation will be assessed by studying all the received specimens during a 3 years-period using formatting a master sheet and processing in Excel program | 3 years |
Bioequivalency Study of 300 mg Lithium Carbonate Under Fed Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was the bioequivalence of a Roxane lithium carbonate 300 mg extended release tablet formulation compared to Solvay's Lithobid 300 mg extended release tablet under fed conditions using a single-dose, randomized, 2 treatment, 2-period, 2-sequence crossover design.

Official Title
-----------------
A Single Dose, Two-Period, Two-Treatment Crossover Bioequivalency Study of 300 mg Lithium Carbonate Extended Release Tablets Under Fed Conditions

Conditions
-----------------
Bipolar Disorder

Intervention / Treatment
-----------------
* Drug: Lithium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. Exclusion Criteria: Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to lithium, or any comparable or similar product.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 38 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence |  | Baseline, Two period, Fourteen day washout |
The Analysis of Ocular Deviations Between Dominant and Non-dominant Eye Using Video-oculography (VOG) in Intermittent Exotropia

Study Overview
=================
Brief Summary
-----------------
Fifteen subjects with intermittent exotropia were included. The subjects were asked to fixate on a black-on-white optotype at 1 m, which subtended a visual angle of 50 min of arc, equating to a Snellen optotype of 20/200. The video files and data about ocular deviations were obtained using VOG with alternate cover test. Investigators analyzed angles of ocular deviations in dominant and non-dominant eyes, compared with values of VOG and deviation angles of the alternative prism cover test.

Official Title
-----------------
The Analysis of Ocular Deviations Between Dominant and Non-dominant Eye Using Video-oculography (VOG) in Intermittent Exotropia

Conditions
-----------------
Strabismus, Intermittent Exotropia

Intervention / Treatment
-----------------
* Diagnostic Test: Video-oculography
* Diagnostic Test: Alternative prism cover test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Visual acuity >= 1.0/1.0 Intermittent exotropia Cooperative Exclusion Criteria: Other eye disease Have hyperopia, myopia > 2 diopter Have horizontal strabismus > 50 prism diopter Not cooperative, no agree

Ages Eligible for Study
-----------------
Minimum Age: 5 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VOG group<br>Measurement: Video-oculography(VOG) measure and analyze angles of ocular deviations between dominant and non-dominant eye using VOG with alternate cover. | Diagnostic Test: Video-oculography<br>* measure and analyze angles of ocular deviations between dominant and non-dominant eye using VOG with alternate cover.<br>|
| Active Comparator: APCT group<br>Measurement: Alternative prism cover test(APCT) measure and analyze angles of ocular deviations between dominant and non-dominant eye using APCT | Diagnostic Test: Alternative prism cover test<br>* measure and analyze angles of ocular deviations between dominant and non-dominant eye using APCT<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The angles of ocular deviations between dominant and non-dominant eye using VOG with alternate cover | The angles of ocular deviations between dominant and non-dominant eye using VOG with alternate cover | 2 weeks after approval | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Video-oculography, Intermittent exotropia, ocular deviation
The Effects of Isoflavone and Estrogen in Sex Response in Climacteric Women

Study Overview
=================
Brief Summary
-----------------
Climacterium is marked by hypoestrogenism and it is associated to drastic vasomotors symptoms, genital atrophy and humor alteration. Additionally, these symptoms impair sexual life and life quality. These effects can be counteracted by administration of estrogen therapy. However, estrogen therapy has side effects and isoflavone has been proposed as an estrogen substitute in reposition therapy. The aim of the randomized controlled trial is to evaluate the effects of isoflavone in the sex life assessed by a modified McCoy's sexual questionnaire.

Official Title
-----------------
Effects of Isoflavone and Estrogen in Sex Response in Climacteric Women

Conditions
-----------------
Postmenopausal Symptoms

Intervention / Treatment
-----------------
* Drug: estradiol
* Drug: isoflavone
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women aged 45-65 years old presenting climacteric symptoms sexual complaints Exclusion Criteria: hormonal therapy counter indication to hormonal therapy uncontrolled comorbidities

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 65 Years

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

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Estrogen<br>Women randomized to this group will receive daily pills containing 1 mg of estradiol | Drug: estradiol<br>* 1 mg daily for 6 months<br>|
| Experimental: Isoflavone<br>Women randomized to this group will receive daily pills of 150 mg isoflavone | Drug: isoflavone<br>* 150 mg isoflavone daily for 6 months<br>|
| Placebo Comparator: Placebo<br>Women randomized to this group will be administered daily placebo pills | Drug: Placebo<br>* sugar pill daily for six months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| McCoy's sexual questionnaire |  | at recruitment and six months later | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kupperman's index |  | at recruitment and six months later | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
climacterium, sexual life, isoflavone, estrogen, McCoy's sexual questionnaire, Kupperman index
Tumor Associated Macrophage in Advanced Non-small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the effects of tumor associated macrophage (TAM) in advanced non-small cell lung cancer (NSCLC) patients on the treatment response and outcome of these subjects. Pathologic specimens from tissue bank will be stained by immunostaining methods with CD68 antibody. The clinical treatment response and outcomes will be analyzed between high or low TAM.

Official Title
-----------------
Tumor-Associated Macrophages Correlate With Response and Outcomes in Advanced Non-Small Cell Lung Cancer After First Line Treatment.

Conditions
-----------------
Advanced Nonsmall Cell Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: advanced NSCLC, more than 20 years old, measurable tumor, response and outcome recorded after the first line treatment. Exclusion Criteria: Early stage NSCLC, less than 20 years, pregnancy, unmeasurable NSCLC.

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Advanced NSCLC with high TAM<br>All patients with advanced non-small cell lung cancer who had been treated at the Linkou Branch of Chang Gung Memorial Hospital were included. Tumor specimens with high TAM were included as one cohort group. | |
| Advanced NSCLC with low TAM<br>All patients with advanced non-small cell lung cancer who had been treated at the Linkou Branch of Chang Gung Memorial Hospital were included. Tumor specimens with low TAM were included as one cohort group. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to treatment of advanced NSCLC with high or low TAM. | All patients with advanced non-small cell lung cancer (NSCLC) who had been treated were included. The decision of advanced NSCLC treatment was a consensus by the patient and clinician, and approved by team conference (including the oncologists, pulmonologists, pathologists, radiologists, surgeons, radiation oncologists, and nuclear medicine specialists). The tumor response was evaluated using computerized tomography according to the Response Evaluation Criteria in Solid Tumors (RECIST). The treatment response of advanced between high and low TAM patients were compared. | 2-3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcomes of advanced NSCLC with high and low TAM. | The outcomes of advanced NSCLC with high and low TAM will be compared. The outcomes include overall survival (OS) and progression-free survival (PFS). Survival curves were estimated by the Kaplan-Meier method while the log-rank test was used to compare the patient survival times per groups. | 12-24 months |