linjc16/ctgov huggingface dataset:
Adjuvant Whole Breast Irradiation in Five Fractions Versus Fifteen Fractions in Early Breast Cancer

Study Overview
=================
Brief Summary
-----------------
the study aiming for compairing results of hypofractionaton radiotherapy treatment in patient with early breast cancer between two arms the first arm recieving five fractions and the other arm recieving fifteen fraction

Official Title
-----------------
Adjuvant Whole Breast Irradiation in Five Fractions Versus Fifteen Fractions in Early Breast Cancer

Conditions
-----------------
Study on Breast Cancer Patients

Intervention / Treatment
-----------------
* Radiation: radiation therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age group ( 18-80) years breast conservation surgery Stages (pT1-3, pN0-1, M0) breast cancer. Any histological type of invasive breast cancer. All grades of breast cancer (I,II,III) Exclusion Criteria: Stage (III or IV) breast cancer. Metastatic breast cancer (MBC) Recurrent breast cancer. Patients' co-morbidities that contraindicate radiotherapy

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| group 1 standared hypofractonation<br> | Radiation: radiation therapy<br>* the patient first is simulated then delineation is done<br>|
| group 2 fast forward group<br> | Radiation: radiation therapy<br>* the patient first is simulated then delineation is done<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1-disease free survival | the time free from disease | 2 years | 
| 2- overall survival | the period time from treatment till death | 2 years | 
| 3- toxicity from treatment | side effects from treatment | 2 years |
Sinus Floor Elevation Using Separately Two Different Xenografts - A Prospective Randomized Clinical Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the regenerative results of using separately two different xenografts after two-step sinus floor elevation.

Conditions
-----------------
Posterior Maxilla Edentulous Patients With Insufficient Alveolar Bone Height

Intervention / Treatment
-----------------
* Device: Alpha-Bio's GRAFT Natural Bovine Bone
* Device: Bio-Oss xenograft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who will present with a moderately or severely atrophic posterior maxilla with 1-6 mm residual alveolar bone . Men and women over the age of 18 years. Patient has signed the Informed Consent. Exclusion Criteria: Chronic steroid therapy. Uncontrolled diabetes. Cardiovascular disease. Past irradiation of head and neck. Maxillary sinus cysts. Active chronic sinusitis. Smoking more than ten cigarettes per day during the 3 months preceding this study . Malignant disease in the 5 years preceding this study. Uncontrolled bleeding disorders such as: hemophilia, thrombocytopenia, granulocytopenia Disease that compromise the immune system Psychiatric disorder Hypersensitivity to titanium, collagen or bovine bone. Women who are pregnant or nursing. Patients with non-treated periodontal disease. Medical and/or general contraindications for intraoral surgical procedures.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Alpha-Bio's GRAFT Natural Bovine Bone<br>two different bone substitutes commonly used in dental procedures. | Device: Alpha-Bio's GRAFT Natural Bovine Bone<br> <br> |
| Active Comparator: Bio-Oss xenograft<br>two different bone substitutes commonly used in dental procedures. | Device: Bio-Oss xenograft<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uneventful healing and histological bone formation |  | 6 months following sinus floor augmentation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| X-ray demonstration of volume - stable results |  | 6 months following augmentation procedures. | 
| Equally high implant survival rates and crestal bone loss |  | After 1,2 years |
The EVLW for Set the Positive End Expiratory Pressure (PEEP) in the Acute Respiratory Distress Syndrome (ARDS)

Study Overview
=================
Brief Summary
-----------------
ARDS is a severe pathology with high mortality and morbidity.Actual ventilatory management is clear for the set of the tidal volume and for the survey of the plateau pressure for the patients who require mechanical ventilation. The set of the PEEP (low or high levels) remains unclear : it seems that some patients need low levels of PEEP whereas anther need high levels; but there is no validated data that can discriminate them. We hypothesized that patients with low levels of EVLW ( measured with the Picco® system ) need low level of PEEP to ameliorate their oxygenation ( measured with the PaO2/FiO2 ratio ) whereas patients with high levels of EVLW) need high levels of PEEP.

Official Title
-----------------
Predictive Value of the Extra-Vascular Lung Water (EVLW) for the Alveolar Recruitment in the Acute Respiratory Distress Syndrome ( ARDS ).

Conditions
-----------------
Acute Respiratory Distress Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age>18; ARDS criteria. Exclusion Criteria: severe pulmonary hypertension; chronic right ventricular failure; pulmonary embolism; tricuspidian valvulopathy; history of spontaneous pneumothorax; severe emphysema; bronchomalacia; recent pulmonary surgery; BMI>40; Interstitial pulmonary fibrosis; End of life; Chronic neuromyopathie; Recent neurosurgery or intracranian hypertension; Pregnancy.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1: High level PEEP<br> | |
| 2: Low level PEEP<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimate the Lung Water Extra-Vascular as predictive marker of the answer (Variation of needs in oxygen) to the ventilatory strategy: the low level, and high level of pressure positive expiratory, in the SDRA |  | During all the period of stay of the patient Intensive care unit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ARDS, Mechanical ventilation, PEEP with low level, PEEP with high level, EVLW, Picco® system, PaO2/FiO2 ratio
Evaluation of Clinical and Genetic Modifiers of Long-term Survival in Heart Failure

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the beta-adrenergic receptor gene polymorphisms in the long-term effects of beta-blockade in patients with chronic heart failure.

Official Title
-----------------
Evaluation of Beta-adrenergic Receptor Gene Polymorphisms in the Long-term Effects of Beta-blockade in Patients With Chronic Heart Failure

Conditions
-----------------
Heart Failure

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older; Patients are required to have chronic heart failure (NYHA II-IV) with a left ventricular ejection fraction lower than 40%; Patients are voluntary and signed informed consent. Exclusion Criteria: Pregnant women or plan to; Participate in any drug clinical trials within 3 months; Serious neurological disease (Alzheimer's disease, Parkinson syndrome, progressive lower limbs or deaf patients); Previous history of cancer or tumor, or pathological examination confirmed precancerous lesions; Patients refused to comply with the requirements of this study to complete the research work; According to the researchers, patients can not complete the study or not to comply with the requirements of this study (because of the reasons for the management or other reasons).

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 |
| --- | --- |
| patients with heart failure<br> | Other: No intervention<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular death |  | up to 24 months | 
| Heart transplantation |  | up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause death |  | up to 24 months | 
| Heart failure recuring |  | up to 24 months | 
| Readmission because of cardiovascular diseases |  | up to 24 months |
Assessment of Prokinetic Effects of Erythromycin in Emergency Patients With a Full Stomach

Study Overview
=================
Brief Summary
-----------------
The aims of the study is to assess whether the intravenous infusion of 3 mg/kg erythromycin has a significant gastrokinetic effect leading to empty the stomach in less than 90 minutes in non-fasting patients undergoing emergency trauma surgery.

Conditions
-----------------
Emergency Surgery, Full Stomach

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Emergency surgery for trauma ASA 1 and 2 patients Full stomach (antral area > 550 mm²) Adult patients Exclusion Criteria: No contraindication to erythromycin Extreme emergency surgery (time frame < 90 min between arrival in the service and the start of the surgery) gastroparesis or pathology associated with gastroparesis

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 |
| --- | --- | --- |
| ultrasonographic measurement of antral area |  | 30 minutes and immediately before erythromycin infusion, and 30, 60 and 90 min after the start of erythromycin infusion |
Pilot Study of Internet-based Cognitive Behavior Therapy for Fibromyalgia

Study Overview
=================
Brief Summary
-----------------
This pilot trial will include 30-40 participants with a diagnosis of fibromyalgia. The purpose of the study is to evaluate an internet-based treatment protocol based on cognitive behavioral therapeutic principles. Participants are required to have a previous diagnosis of fibromyalgia before entering into the trial. The treatment will be 10 weeks long and all included participants will be given treatment, i.e. there is no randomization to a comparison group.

Official Title
-----------------
Pilot Study of Internet-based Cognitive Behavior Therapy for Fibromyalgia

Conditions
-----------------
Fibromyalgia

Intervention / Treatment
-----------------
* Behavioral: Internet-based CBT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Current diagnosis of fibromyalgia Exclusion Criteria: Current diagnosis of severe psychiatric disorder

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet-based CBT<br> | Behavioral: Internet-based CBT<br>* 10 weeks of internet-based CBT with online therapist contact<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Fibromyalgia Impact Questionnaire |  | Once, 1 week before start of treatment | 
| The Fibromyalgia Impact Questionnaire |  | Once, immediately after treatment | 
| The Fibromyalgia Impact Questionnaire |  | Once, 6 months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short form 12-item Questionnaire |  | Once, 1 week before start of treatment | 
| Short form 12-item Questionnaire |  | Once, immediately after treatment | 
| Short form 12-item Questionnaire |  | Once, 6 months after treatment | 
| Hospital Anxiety and Depression Scale |  | Once, 1 week before start of treatment | 
| Hospital Anxiety and Depression Scale |  | Once, immediately after treatment | 
| Hospital Anxiety and Depression Scale |  | Once, 6 months after treatment |
Is Non-cycloplegic Photorefraction Applicable for Screening Refractive Risk Factors of Amblyopia?

Study Overview
=================
Brief Summary
-----------------
Purpose: : This study was performed to compare the accuracy of non-cycloplegic photorefraction with cycloplegic refraction in detection of refractive amblyopia risk factors and determine some corresponding beneficial cut points. Method: In this diagnostic accuracy study, right eyes of 185 children (1 to 14 years) underwent first non-cycloplegic photorefraction (with PlusOptix SO4 photoscreener) and then cycloplegic refraction from October 2009 to August 2010. Based on the cycloplegic refraction results, hyperopia (≥+3.5D), myopia (≥-3D), astigmatism (≥1.5D), and anisometropia (≥1.5D) were set as criteria based on AAPOS guidelines. The difference in detection of refractive amblyopia risk factors between the two methods was the main outcome measure.

Official Title
-----------------
Is Non-cycloplegic Photorefraction Applicable for Screening Refractive Risk Factors of Amblyopia?

Conditions
-----------------
Amblyopia

Intervention / Treatment
-----------------
* Device: photorefraction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 1 year old /with consent Exclusion Criteria: mental retardation impaired fixation strabismus ptosis and any other organic ophthalmic disorder interfering with refraction

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 14 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: one arm<br> | Device: photorefraction<br>* photorefraction is a name of device.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| refraction | cycloplegic auto refraction & Non-cycloplegic photorefraction | 10 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hyperopia (≥+3.5D), myopia (≥-3D), astigmatism (≥1.5D), and anisometropia (≥1.5D) were set as criteria based on AAPOS guidelines. | cycloplegic auto refraction & Non-cycloplegic photorefraction | 10 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non-cycloplegic photorefraction, cycloplegic refraction,, Amblyopia
Post-operative Results of the Trapezometacarpal (TMC) Prosthesis for Advanced Pre-operative Deformities

Study Overview
=================
Brief Summary
-----------------
Trapezometacarpal protheses are implanted for patients with trapezometacarpal arthritis. Having a pre-operative thumb adduction angle of less than 25 degrees with hyperextension, meaning a  Z-deformity  are somehow a reason to go for another surgical treatment: trapezectomy with ligament reconstruction. This study will aim at analyzing the results of another surgical treatment which is the trapezometacarpal arthroplasty in this type of deformities.

Official Title
-----------------
Comparative Study of the Results of Trapeziometacarpal Prostheses According to the Preoperative Deformation

Conditions
-----------------
Rhizarthrosis, Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patient with TMC joint arthritis Patient with adduction <25 degrees Patients with Z deformity Patient operated for TMC joint arthroplasty Exclusion criteria: - TMC arthroplasty implanted for fractures
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 Participants with Mobility of the trapezometacarpal joint | Mobility of the trapezometacarpal joint | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Grasping force measured | Grasping force measured | 1 day | 
| Number of Participants with Pinching force | Pinching force | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Trapezometacarpal joint arthritis, Adduction angle <25 degrees, Decrease of the grasping and pinching forces, Z deformity of the thumb
Minimal Invasive Surgery for Gastric Subepithelial Tumor

Study Overview
=================
Brief Summary
-----------------
The investigators conducted a retrospective study of those patients with gastric SETs receiving ER or LR at the operative theater in the single institution from January 2013 to December 2021. Medical records were retrospectively reviewed to define patient/tumor characteristics and operative outcomes.

Official Title
-----------------
Different Approach of Minimal Invasive Surgery for Gastric Subepithelial Tumor From A Single-Center Experience

Conditions
-----------------
Gastric Subepithelial Tumor

Intervention / Treatment
-----------------
* Procedure: Endoscopic resection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with gastric subepithelial tumors patients received minimal invasive surgery (endoscopy or laparoscopy) for tumor resection Exclusion Criteria: patients had gastric anatomic changes due to previous surgery patients converted open surgery

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| endoscopic resection (ER)<br>ER with backup surgery was indicated for patients with endoscopic intent, and a small tumor size tolerated endoscopic retrieval. | Procedure: Endoscopic resection<br>* Complete resection of gastric SETs was recommended if the tumor size was >2 cm, presence of malignant features, or if the patient was symptomatic, declined periodical surveillance, and preferred to undergo diagnostic and therapeutic resection.<br>* Other names: Laparoscopic resection;|
| laparoscopic resection (LR)<br>LR was indicated for patients with surgical intent, and those with the following conditions, which were not suitable for ER: (1) large tumor size with difficult endoscopic retrieval ; (2) symptoms of gastrointestinal tract bleeding with difficulty in endoscopic visualization; (3) suspicion of tumor rupture that required intra-abdominal exploration; and (4) histologic diagnosis of GIST with initial treatment of target therapy. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure duration | minutes of procedure time | during the procedure/surgery | 
| Length of hospital stay | days of hospitalization | upto one month after surgery | 
| Rate of postoperative major complications | complications required further intervention, clavien dindo classification upto Grade III | upto one month after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gastric subepithelial tumors, endoscopic resection, laparoscopic resection