linjc16/ctgov huggingface dataset:
Bacterial Assessment of Middle Ear Fluid in Children Undergoing Ventilation Tube Placement Surgery

Study Overview
=================
Brief Summary
-----------------
Children with chronic otitis media have more resistant bacteria that require surgical intervention to eradicate the infections. The study will evaluate the dominant bacteria and their sensitivities to antibiotics. The information will assist in better treatment plans for children with chronic infections. The data will also assess the changing patterns in the bacteria colonizing middle ear fluid.

Detailed Description
-----------------
ibid.

Official Title
-----------------
An Epidemiological and Bacteriological Assessment of Middle Ear Fluid in Children Undergoing Ventilation Tube Placement Surgery

Conditions
-----------------
Chronic Otitis Media, Age Determined Bacteria

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All children with chronic ear infections scheduled for surgical interventions Exclusion Criteria: Children who have undergone prior mastoid surgery, or children with oncologic treatments.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 15 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
-----------------
Ear infection, Chronic
Hepatitis C Among Opioid Addicts in Opioid Maintenance Treatment in Zurich, Switzerland

Study Overview
=================
Brief Summary
-----------------
Hepatitis C viral infection is common among opioid addicts in Zurich, Switzerland. The majority undergoes a maintenance treatment with methadone, heroin or buprenorphine. While stabilized by an opioid maintenance treatment (OMT)chronic hepatitis C can be treated with pegylated interferon plus ribavirin. As not sufficiently known, the results are comparable to the results of the treatment of nonaddicts. Our crossectional study investigates how many patients undergoing OMT are adequately investigated concerning hepatitis C. If not, why are they not adequately investigated and treated? Representative data are collected in the local clinics and medical practices involved in OMT in the Kanton of Zurich. The patients files are revised and the involved doctors are asked through a structured interview.

Detailed Description
-----------------
www.seidenberg.ch/hepcop.pdf

Official Title
-----------------
Hepatitis C Bei Opioidabhängigen in Der Praxis, Eine Querschnittsuntersuchung

Conditions
-----------------
Hepatitis C, Chronic, Substance Abuse Treatment Centers, Opioid-Related Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Medical practices and clinics involved in opioid maintenance treatment in the Kanton of Zurich, Switzerland
Sexes Eligible for Study
-----------------
All

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
-----------------
Hepatitis C, Opioid Maintenance Treatment, Methadone, Buprenorphine, Heroin, Interferon, pegylated
Effectiveness of Atypical Antipsychotics on Anhedonic Features in Patients With Schizophrenia

Study Overview
=================
Brief Summary
-----------------
This prospective, multi-center, 12 weeks naturalistic NIS trial will be conducted in 25 hospitals in naturalistic treatment setting. There will be no experimental component associated with this study and all observational activities have to be part of routine care visit: baseline (week 0), week 4 and week 12.

Official Title
-----------------
Effectiveness of Atypical Antipsychotics on Anhedonic Features in Patients With Schizophrenia

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented clinical diagnosis of schizophrenia meeting the Diagnostic and Statistical Manual of Mental Disorders,(DSM-IV-TR) criteria Patients who already take one atypical at inclusion it is started at least 1 week and up to 4 weeks before the inclusion Exclusion Criteria: Meeting the criteria for any other (than schizophrenia) DSM-IV Axis I Patients with antipsychotic combinations (more than two agents) Patients who are already on any mood stabilizers and antidepressant Known lack of response to clozapine or treatment with clozapine within 4 weeks prior to enrollment Patients who have been treated with antipsychotics in depot formulations for the last two months Previous enrollment or randomisation of treatment in the present NIS Patients who had participated in other clinical trials within 4 weeks prior to enrollment period Pregnant women or women who are breast-feeding

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- | --- |
| The change of total score of SHAPS |  | At baseline | 
| The change of total score of SHAPS |  | At 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of Clinical Global Impression (CGI)-Severity score |  | At baseline | 
| Changes of Clinical Global Impression (CGI)-Severity score |  | At 12 weeks | 
| Proportion of patients having a score of 1 or 2 in CGI-I score |  | At 12 weeks | 
| Proportion of significantly improved patients in SHAPS total score (more than 30%) |  | At baseline | 
| The mean change MADRS total score |  | At baseline | 
| The mean change MADRS total score |  | At 12 weeks | 
| Proportion of significantly improved patients in SHAPS total score (more than 30%) |  | At 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anhedonic features in patients with schizophrenia
Prognostic Value of RXR-α in Cutaneous Squamous and Basal Cell Carcinoma

Study Overview
=================
Brief Summary
-----------------
Vitamin D has a crucial role in cancer control and prevention.vitamin D receptor (VDR) and its heterodimer Retinoid X receptor (RXR) are equally important in the cell. This ligand (vitamin D) and receptors (VDR-RXR) complex together triggers downstream DNA damage response in the cell. Retinoid receptors are a superfamily of nuclear receptors. The preferred receptor that attaches to VDR is RXR, with its subunits α, β and γ. RXR α is more frequent in the skin than other tissues, while β occurs in internal organs and γ is frequently related to neural disorders. the investigator hopes to assess prognosis of SCC & BCC by using RXR-α biomarker & attempts to use it in the treatment.

Official Title
-----------------
Prognostic Value of RXR-α in Cutaneous Squamous and Basal Cell Carcinoma: An Immunohistochemical Study.

Conditions
-----------------
Non-melanoma Skin Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Squamous cell carcinoma and basal cell carcinoma. Incisional & excisional biopsies. All the studied cases include sufficient materials for the immunohistochemical study 4. Complete clinical data Exclusion Criteria: Patients with a history of preoperative chemotherapy and/or radiotherapy. Insufficient or tiny tissue biopsies.
Sexes Eligible for Study
-----------------
All

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prognostic Value of RXR-α in Cutaneous Squamous and Basal Cell Carcinoma | immuohistochemical expression of RXR-α in Squamous and Basal Cell Carcinoma | One or two days after staining sections with the marker. |
Survey on Return to Work After Stroke

Study Overview
=================
Brief Summary
-----------------
Survey of survivor perspective on critical elements that either facilitate or inhibit return to work after a stroke. Critical elements are queried in areas of finances, stroke impairments, interpersonal support, therapeutic support, organization influences, work or job specific issues and psychological issues.

Detailed Description
-----------------
The objective of this project is to more accurately describe the stroke survivor's perspective on return to work. The survey development included qualitative analysis of a set of interviews with stroke survivors to arrive at the critical elements described above, followed by item development with an expert panel and preliminary testing of the wording and format for legibility. The survey is being administered both on-line and by paper through the mail to a wide range of survivors with the objective of obtaining a large, diverse sample. The ultimate goal of the project is to arrive at a refined set of recommendations to inform stroke survivors, health care professionals and employers to increase their sensitivity to the needs and desires of individual attempting to return to work after stroke.

Official Title
-----------------
Survivor Perspective on Critical Factors to Return to Work After Stroke

Conditions
-----------------
Stroke

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: have returned to work, have thought about returning to work, or have tried to return to work Exclusion Criteria: non-stroke disability retired or no plan to return to work

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 |
| --- | --- |
| stroke survivors<br>stroke survivors who have either returned to work, have thought about returning to work, or have tried to return to work | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| critical factors that facilitate or inhibit return to work after stroke | 38 multiple choice items that assess psychological factors important to return to work, financial incentives and disincentives, the role of stroke impairments, interpersonal supports that facilitate and inhibit return, the role of therapeutic support especially vocational rehabilitation, organizational influences, and work specific issues that impact on return. Demographic information is also queried including work type and current work status. Data will be analyzed descriptively by these critical factors and also by other demographic factors such as age, work status, and race. | after collection of data on all surveys | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vocational rehabilitation, stroke, work
Effective High Aerobic Intensity Endurance Training Regimes in Chronic Obstructive Pulmonary Disease (COPD) Patients

Study Overview
=================
Brief Summary
-----------------
4 times 4 minutes interval training with and without hyperoxia is more effective than low intensity endurance training.

Official Title
-----------------
Effective High Aerobic Intensity Interval Training to Improve Maximal Oxygen Uptake in COPD Patients

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive, Hyperoxia

Intervention / Treatment
-----------------
* Behavioral: 4 times 4 minutes high aerobic intensity one leg cycling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COPD Exclusion Criteria: Heart disease Walking or cycling inabilities Other diseases

Ages Eligible for Study
-----------------
Minimum Age: 20 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>High aerobic intensity treadmill walking. 4 by 4 minutes interval training on a 5% graded treadmill at a heart rate corresponding to 85-95% of maximal heart rate. 3 times per week for 10 weeks. | Behavioral: 4 times 4 minutes high aerobic intensity one leg cycling<br>* 3 times per week for 10 weeks<br>|
| Active Comparator: 2<br>4 times 4 minutes interval training in hyperoxia - 100% oxygen | Behavioral: 4 times 4 minutes high aerobic intensity one leg cycling<br>* 3 times per week for 10 weeks<br>|
| Active Comparator: 3<br>One leg at a time training 4 times 4 minutes interval training using cycling ergometer | Behavioral: 4 times 4 minutes high aerobic intensity one leg cycling<br>* 3 times per week for 10 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VO2peak |  | 10 weeks | 
| Ventilation |  | 10 weeks | 
| FEV1 |  | 10 weeks | 
| Walking performance |  | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  | 3 months | 
| SPSS |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, training, VO2peak, performance, ventilation, high aerobic intensity treadmill walking, one leg training by cycling
Rational Fluid Therapy in Germany

Study Overview
=================
Brief Summary
-----------------
The purpose of this observational study is the prospective documentation and evaluation of the status quo of volume therapy in German intensive care units.

Detailed Description
-----------------
The purpose of RaFTinG is the prospective documentation and evaluation of the demographic, diagnostic and therapeutic characteristics of unselected patients and their treatment in intensive care units (ICU) in Germany. Documentation will not only include their stay in the ICU but a follow up query 90 days after discharge from the ICU.

Official Title
-----------------
Klinisches Register RaFTinG - Rational Fluid Therapy in Germany

Conditions
-----------------
Patients in ICU

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ICU patients with an indication for fluid/volume therapy Exclusion Criteria: Patients hospitalized by order of a court of law or a government agency

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
-----------------
Volume therapy, Fluid therapy, Patients in ICU
Prevalence Rate, and Clinical Characteristics of Obesity Hypoventilation Syndrome Via Screening Patients Admitted to Medical Intensive Care Units

Study Overview
=================
Brief Summary
-----------------
A prospective observation study to screen adult obese (BMI ≥30 kg/m2) patients who were newly admitted to the medical intensive care units and turned out to be diagnosed as Obesity hypoventilation syndrome(OHS). The investigators purpose is to look into the prevalence, predictive factors, and outcomes of OHS in these critically ill patients.

Official Title
-----------------
Prevalence Rate, and Clinical Characteristics of Obesity Hypoventilation Syndrome Via Screening Patients Admitted to Medical Intensive Care Units

Conditions
-----------------
Obesity Hypoventilation Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI ≥ 30 kg/m2 Suspected chronic hypercapnia as following Paco2 ≥ 45 mmHg, HCO3- ≥ 27mEq/L or base excess, BE ≥ 2 mEq/L Exclusion Criteria: Malignancy with lung involvement Autoimmune disease with lung involvement Moderate to severe obstructive respiratory pattern via spirometry Uncontrolled endocrine disease Pregnancy Pneumonia confirmed by image Out-of-hospital cardiac arrest Lung edema Foreigner of Taiwan

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of obesity hypoventilation syndrome in Asian critically ill patients | Detecting obesity hypoventilation syndrome via screening obesity(BMI>=30kg/m^2) in critical care units in Asian. | 2-year |
Study of the Fixation of Various Vectors in PET/CT in Patients With a With Lung Cancer Before and During of CRT or RT

Study Overview
=================
Brief Summary
-----------------
Study of the modification of the fixation(binding) of Fluoro-2-deoxy-D-glucose (FDG), fluoro-misonidazole (FMISO) and 3'deoxy-3-fluoro-thymidine deoxy-3-fluoro-thymidine (FLT) measured in tomography by broadcast(emission,issue) of positrons (PET) at patients before and in the course of exclusive radiotherapy or concomitant radiochemotherapy for primitive bronchial cancer. This protocle allows to study the simultaneous variations of the metabolism, the hypoxie and the cellular proliferation by PET SCAN at 5 patients reached(affected) by a primitive bronchial cancer in the course of exclusive radiotherapy for primitive bronchial cancer not small cell lung. The investigators are also going to study several scenarii of optimization of the radiotherapy according to the variations of the tumoral metabolism, the hypoxie and the cellular proliferation measured in the course of radiotherapy (theoretical study on console using the scanner and the various examinations).

Official Title
-----------------
Study of the Modification of the Fixation of FDG, F-Miso and FLT Measured in PET/CT at Patients Before and in the Course of Exclusive Radiotherapy or Concomitant Radiochemotherapy for Primitive Bronchial Cancer

Conditions
-----------------
Bronchial Neoplasms, Carcinoma, Non-Small-Cell Lung

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with non-small-cell lung carcinoma hitologicaly proved Candidate patients in a treatment with aim guardian by exclusive thoracic radiotherapy or of concomitant radiochemotherapy (tumoral dose superior to 60 Gy) ( n=5 ). Measurable tumor according to the criteria of evaluation RECIST Exclusion Criteria: Histology other one than primitive bronchial cancer not in small cells lung The patients for whom no tumoral target is assessable (forgiveness completes after first chemotherapy, operated patients). Patients for whom a radiotherapy with curative aim is not indicated (tumoral extension, metastases, general state, co-morbidity). Patient having benefited from an examination PET in the FDG with in more than 4 weeks and for which a new PET in the FDG is not necessary with in the framework of its disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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
-----------------
Positron-Emission Tomography, PET Scan, FDG, FLT, FMISO, Non-Small-Cell Lung Carcinoma, chemo-Radiation Oncology, SUV
Urinary Leukotriene E4 Levels in Children With Obstructive Sleep Apnea

Study Overview
=================
Brief Summary
-----------------
Investigate urinary leukotriene E4 levels and determine if there is a correlation with severity of obstructive sleep apnea. The investigators then would like to determine a threshold level which could then be used for confirmation of diagnosis of obstructive sleep apnea (OSA).

Official Title
-----------------
Urinary Leukotriene E4 Levels in Children With Obstructive Sleep Apnea

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children 2-16 years of age scheduled for polysomnogram Exclusion Criteria: cardiovascular, neuromuscular, immunologic or craniofacial disorders pharmacologic treatment including corticosteroids and leukotriene receptor antagonists in the last month subjects who have already received treatment for OSA with an oral appliance, continuous positive airway pressure (CPAP) device previously undergone tonsillectomy and/or adenoidectomy

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 16 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 |
| --- | --- |
| no treatment<br>no treatment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| urine leukotriene level | assess urinary leukotriene E4 levels in children with obstructive sleep apnea (OSA | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation between Urine LTE4 and the apnea hypopnea index (AHI) | determine if there is a correlation between urine LTE4 levels and the severity score as determined by the AHI | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obstructive sleep apnea