linjc16/ctgov huggingface dataset:
Comparing The Cyberlink Control System to the Manual Letter Board for Communication Purposes in the ALS Patient Population

Study Overview
=================
Brief Summary
-----------------
New technologies are giving people with motor disabilities alternative communication and control channels. The investigators are interested in using the Cyberlink Control System as a hands free means to access a computer for people with Amyotrophic Lateral Sclerosis (ALS). The goal of this project is to determine whether this device is a practical and realistic means for ALS patients to communicate with only the use of facial muscle, brainwave, and eye movements. The benefit of this study may be of substantial value to many people with severe motor impairment. Additionally, it is hoped that some of the study subjects may benefit by incorporating hands-free computer use into their daily lives. This study is intended to evaluate the effectiveness of the cyberlink as a tool for daily communication compared to the standard manual letter board.

Official Title
-----------------
Comparing The Cyberlink Control System to the Manual Letter Board for Communication Purposes in the ALS Patient Population

Conditions
-----------------
Amyotrophic Lateral Sclerosis, Neurodegenerative Disease, Motor Neuron Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of definite or possible ALS by the El Escorial Criteria Between ages of 18 to 89 years. Scored two or less in the ALS FRS category 1 (Speech) Scored two or less in the ALS FRS category 4 (Handwriting) Cognitively intact with no other neurological diseases No unstable medical problems Exclusion Criteria: Any subject not meeting the inclusion criteria Patients unable to give informed consent either themselves or via a legally authorized personnel. Patients diagnosed with neurological problems other than ALS (upon examination by the principal investigator)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 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 |
| --- | --- |
| ALS<br>Subjects having either definite or probable ALS by El Escorial Criteria. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time Taken to Complete a Sentence |  | 1 session | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Amyotrophic Lateral Sclerosis, Cerebrospinal Fluid, Neurodegenerative Disease, Motor Neuron Disease, Autonomic Nervous System, Neurodegenerative Diseases, Movement Disorders
Clinical Outcome of Arthroscopic Lateral Release for Lateral Patellar Compression Syndrome

Study Overview
=================
Brief Summary
-----------------
We performed a prospective case series study of 48 patients who suffered Lateral patellar compression syndrome who were diagnosed by clinical examination and confirmed by M.R.I. and failed conservative management and underwent isolated arthroscopic lateral patellar retinaculum release in Erbil Teaching Hospital, PAR Private Hospital and Hawler Private Hospital between December 2016 and August 2019.

Official Title
-----------------
Clinical Outcome of Arthroscopic Lateral Release for Lateral Patellar Compression Syndrome

Conditions
-----------------
Knee Pain Chronic

Intervention / Treatment
-----------------
* Procedure: Lateral patellar release


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Lateral patellar compression syndrome proved by clinical,MRI and Arthroscopic examination Exclusion Criteria: Dislocated or history of dislocation. Patellar instability. Bony abnormality (trochlear groove hypoplasia or flat). Osteoarthritis of the knee 3rd and 4th grades. Infected knee. Varus and valgus knee. Rotational deformity of the lower extremity. Miserable malalignment triad. Anterior cruciate ligament, posterior cruciate ligament and medial collateral ligament rupture. History of fracture around knee. Focal Osteoarthritis of the lateral facet joint. Chondral lesion (Outerbridge 3 and 4).

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 45 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 |
| --- | --- |
| Other: Lateral patellar release<br>Arthroscopic lateral patellar retinacular release | Procedure: Lateral patellar release<br>* Arthroscopic lateral patellar reticular release<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lysholm Knee Score | Eight sections are assessed to produce an overall score on a scale of 0 to 100. Then an assignment is given as excellent for 95 to 100 points; good for 85 to 94 points, fair for 65 to 84 points, or poor for less than 65 points | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lateral patellar compression syndrome, Arthroscopic lateral release, Lysholm score
Parental Real-life Experience During the Neonatal Transfer

Study Overview
=================
Brief Summary
-----------------
The transfer of newborn child from Intensive Care Unit to maternity is very stressfull for parents.This anxiety could have repercussion on parents adaptation on their new environment, on parent's role and also on their relaional interaction with the baby. As StJoseph hospital receives an important number of premature babies, the neonatology service aim to evaluate the real life experience of mothers during the transfer to set up improvement axes with hospital departments upstream.

Official Title
-----------------
Parental Real-life Experience During the Neonatal Transfer From Intensive Care Unit to Maternity Service of St Joseph Hospital

Conditions
-----------------
Neonatology

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: new born child transfered to St Joseph neonatology service Having stayed at least five days Intensive Care Unit Regardless of the term have to stay at least five days in neonatology Exclusion Criteria: Non francophones parents Duration of predictable hospitalization of less than 5 days
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 |
| --- | --- | --- |
| mother's real life experience assessment during the transfer of new born child from intensive care unit to neonatology |  | day 3 to 5 |
Development and Application of Rapid Nucleic Acid Diagnostic Kits for Clinical Specimens

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to study the Development and Application of Rapid Nucleic Acid Diagnostic Kits for Clinical Specimens. Subjects are divided into two groups which are health group and Tuberculosis or lung cancer group in order to compare with the difference.

Official Title
-----------------
Development and Application of Rapid Nucleic Acid Diagnostic Kits for Clinical Specimens

Conditions
-----------------
Tuberculosis, Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Health group: between 17 to 90 years old Tuberculosis group: people who are tuberculosis or lung cancer patients and between 17 to 90 years old Exclusion Criteria: Women subjects are before or after the period within two days

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Health Group<br> | |
| Tuberculosis Group<br>Tuberculosis or lung cancer group | |

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
-----------------
Tuberculosis, Lung cancer
Prospective Population Study on Candidemia in Spain

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to describe the epidemiology of fungal blood infections in Spain (with emphasis on the incidence, fungal species distribution and antifungal susceptibility). The study is to be performed in five big cities which represent different geographic areas: Barcelona, Bilbao, Madrid, Sevilla and Valencia.

Official Title
-----------------
Prospective Population Study on Candidemia in Spain (Estudio Poblacional Prospectivo Sobre Candidemia en España)

Conditions
-----------------
Fungemia

Intervention / Treatment
-----------------
* Other: Non intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fungal isolate obtained from blood sample Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fungemia<br>Patients with a fungal isolate from a blood culture | Other: Non intervention<br>* Non interventional study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Describe fungemia epidemiology in Spain | Recollection of demographic variables (age, gender and ethnic origin); clinical variables (background diseases, other coinfections, treatment received, etc) and microbiological information of the isolate. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Describe differences among cities and institutions | Analyze results in function of the city and hospital where the isolate was obtained (5 cities in Spain and 29 participating hospitals) | 1 year | 
| Definition of risk factors | Determine risk factors for: bad clinical evolution infection by a specific Candida species fluconazole resistant isolate fungemia persistency | 1 year | 
| Determination of the fungal isolates susceptibility to fluconazole, voriconazole, caspofungine, anidulafungine, micafungine and anfotericine B | Analysis of resistant strains percentage according to the threshold established by CLSI to each specific antifungal | 1 year | 
| Correlation between fungemia with a diminished susceptibility fungal strain and clinical evolution | Chi-square and Kaplan-Meier survival curves | 1 year | 
| Correlation between reference and commercial microbiological methods | Comparison of results when a reference or a commercial fungal identification and antifungal susceptibility method is used. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fungemia, fungal infection, susceptibility, antifungal
THIRD NATIONAL REGISTRY OF ACUTE CORONARY SYNDROMES

Study Overview
=================
Brief Summary
-----------------
The Registry pretends to identify stratification, diagnosis and treatment approaches in patients with Acute Coronary Syndrome (ACS) in community hospitals with tertiary hospitals to optimize resources and identify strategies to improve health care quality through the creation of clinical guidelines that serve for unify management and treatment methods with adherence to international guidelines which include suggestions for treatment and medication.

Official Title
-----------------
THIRD NATIONAL REGISTRY OF ACUTE CORONARY SYNDROMES

Conditions
-----------------
Acute Coronary Syndromes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients with suspected ACS and will analyze risk factors, chest pain and electrocardiographic characteristics. Exclusion Criteria: Patients with secondary ischemia (anaemia, pulmonary thromboembolism, myocarditis) and type II infarction.

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 |
| --- | --- | --- |
| Number of patients with complications after presenting ACS | The main objective will be to know the evolution of ACS in third and second level hospitals with a monitoring at a minimum of one year for each patient. | up to one year |
Local Measures to Prevent Diabetes in the Værnes Region.

Study Overview
=================
Brief Summary
-----------------
This is a development project involving four different municipalities in Central Norway. The aim is to identify adults with overweight and with an increased risk of developing diabetes mellitus type 2, then to prevent the disease to develop by the means of a behaviour change programme. The programme is group based.

Official Title
-----------------
The VEND RISK-study. Preventing Diabetes Type 2 in Overweight Persons in the Værnes Region, Central-Norway.

Conditions
-----------------
Diabetes Mellitus Type 2, Obesity

Intervention / Treatment
-----------------
* Behavioral: Behavioural change programme


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Living in Central Norway Find Risc score > 15 Written, informed consent Exclusion Criteria: Severe mental disorder Not being able to function in the group programme

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: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group programme<br>Group based behaviour change programme | Behavioral: Behavioural change programme<br>* The programme consists of a introductory course, organised physical activity 2-3 times a week, meetings every 3rd month with lectures and theme nights, and organising self-help groups.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetes mellitus type 2 |  | Visit 1 (baseline) till Visit 9 (5 years) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prevention, public health, community health services, Norway
The Effects of Aerobic Exercise in Microvascular Endothelium Function in Patients With Cardiovascular Diseases

Study Overview
=================
Brief Summary
-----------------
This study evaluates the effects of different volumes of aerobic exercise training in cardiovascular parameters of patients with cardiovascular diseases enrolled in a cardiac rehabilitation program.

Detailed Description
-----------------
Aerobic exercise training is well known to improve endothelium dependent vasodilatation in the microcirculation. However, the impact of exercise frequency on this response in patients with coronary artery disease remains unclear.

Official Title
-----------------
The Effects of Aerobic Exercise Training in Patients With Cardiovascular Diseases Related to Microvascular Endothelium Function, Angiogenesis, Oxidative Stress and Aerobic Capacity

Conditions
-----------------
Cardiovascular Diseases

Intervention / Treatment
-----------------
* Behavioral: Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: sedentarism for at least 6 months; clinical diagnosis for coronary artery disease (occurrence of any acute coronary syndrome, including ST elevation or non-ST elevation myocardial infarction or unstable angina or by the diagnosis of obstructive coronary artery disease on coronary angiography in patients with stable angina). Exclusion Criteria: nephropathies; decompensated cardiovascular diseases; liver diseases.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 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 |
| --- | --- |
| 2x/wk<br>This group will be consisted of patients that will perform exercise two times a week. | Behavioral: Exercise<br>* Patients included in the study will be enrolled in a cardiac rehabilitation program, in an independent manner of the study protocols.<br>|
| 3x/wk<br>This group will be consisted of patients that will perform exercise three times a week. | Behavioral: Exercise<br>* Patients included in the study will be enrolled in a cardiac rehabilitation program, in an independent manner of the study protocols.<br>|
| Control<br>This group will not perform exercise. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Skin microvascular blood flow | Measured through a Laser Speckle Contrast Imaging equipment | Change from baseline in skin microvascular blood flow at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in peak oxygen consumption | Measured at a maximal graded exercise test | Change from baseline in peak oxygen consumption at 6 months | 
| Change in weight | Measured with a calibrated digital scale | Change from baseline in weight at 6 months |
An Observational Study on Patients With Non-Squamous NSCLC Who Reached A Long PFS After Avastin (Bevacizumab)-Based First-Line Therapy

Study Overview
=================
Brief Summary
-----------------
This retrospective observational study will analyse demographic, clinical and treatment-related data of patients with non-squamous non-small cell lung cancer (NSCLC) who had reached >/= 9 months of progression-free survival after Avastin (bevacizumab)-based first-line therapy. Data will be collected for approximately 9 months.

Official Title
-----------------
Retrospective Study to Determinate the Clinical Phenotype of Patients With Non Squamous NSCLC Treated With First Line Bevacizumab-based Therapy That Reached a Long PFS

Conditions
-----------------
Non-Squamous Non-Small Cell Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, >/= 18 years of age Non-squamous non-small cell lung cancer (NSCLC) treated with first-line Avastin-based therapy Progression-free survival of >/= 9 months reached Exclusion Criteria: N/A

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 |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (>9 months) according to clinical phenotype |  | approximately 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | approximately 9 months | 
| Safety: Incidence of adverse events |  | approximately 9 months |
Cetuximab as Induction Treatment in Head and Neck Squamous Cell Carcinoma (HNSCC)

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to investigate the efficacy and safety of cetuximab, docetaxel, cisplatin combination as induction therapy in locally advanced head and neck squamous cell carcinoma.

Official Title
-----------------
A Randomized, Multicenter, Open Phase II Study of Cetuximab With Docetaxel, Cisplatin as Induction Chemotherapy in Unresectable, Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)

Conditions
-----------------
Head and Neck Neoplasm

Intervention / Treatment
-----------------
* Drug: Cetuximab
* Drug: Docetaxel
* Drug: Cisplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Unresectable, locally advanced (cT4b &/or cN2-3) HNSCC ECOG performance status 0-1 Age 18 or older than 18 years Measurable disease by RECIST criteria Having signed informed consent ALT and AST<2.5 times ULN Serum albumin level ≥3.0g/dL Serum AKP < 2.5 times ULN Bilirubin level < 1.5mg/dL Serum creatinine <1.5 times ULN WBC>3000/mm3, absolute neutrophil count ≥1500/mm3, platelet>75,000/mm3, Hb>9g/dl Exclusion Criteria: Previous cytotoxic chemotherapy for HNSCC Radiotherapy for targeted lesions within six months Previous EGFR pathway-targeting therapy Prior surgery for cancer (excluding diagnostic biopsy within 4 weeks prior to study entry) Distant metastatic disease Heart failure, coronary artery disease, myocardial infarction within the last 6 months Known allergy to any study treatment Pregnancy or lactation period Any investigational agent within the past 28 days Other previous malignancy within 5 year, except adequately treated in situ cervical cancer, or non-melanoma skin cancer Legal incapacity

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Docetaxel+CDDP | Drug: Docetaxel<br>* 75 mg/m2, day 1 of every 3 weeks for 9 weeks (3 cycles)<br>Drug: Cisplatin<br>* 75 mg/m2, day 1 of every 3 weeks for 9 weeks (3 cycles)<br>|
| Experimental: 2<br>Docetaxel+CDDP+Cetuximab | Drug: Cetuximab<br>* 400 mg/m2 first dose, then 250 mg/m2 weekly for 9 weeks<br>Drug: Docetaxel<br>* 75 mg/m2, day 1 of every 3 weeks for 9 weeks (3 cycles)<br>Drug: Cisplatin<br>* 75 mg/m2, day 1 of every 3 weeks for 9 weeks (3 cycles)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  | after induction treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
head and neck neoplasm, cetuximab, docetaxel, cisplatin, radiotherapy