linjc16/ctgov huggingface dataset:
Health-related Quality of Life in Patients Undergoing Surgery for Pectus Carinatum

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to assess changes in health-related quality of life in patients undergoing surgical correction of pectus carinatum. In addition, the study assessed long-term effects of surgical intervention in relation to the development of persistent postoperative pain and / or sensory disturbances in the surgical field.

Official Title
-----------------
Short and Long-term Effects of Surgical Repair of Pectus Carinatum - A Questionnaire Study of Health-related Quality of Life, Persisten Post-surgical Pain and Sensory Disturbances.

Conditions
-----------------
Pectus Carinatum, Quality of Life, Pain, Postoperative, Somatosensory Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients undergoing surgery for pectus carinatum Exclusion Criteria: patients without pectus carinatum

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 55 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 |
| --- | --- |
| Pectus carinatum<br>Patients who have undergone surgical repair of pectus carinatum. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in health-related quality of life at 6 months | Health-related Quality of Life (HRQoL) will be assessed by means of a validated Danish version of the Short-Form 36 Health Survey (SF-36) | From baseline (the day before surgery) to six month follow-up (six months after surgery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Persistent post-surgical pain | In this study persistent post-surgical pain is defined as pain developing after pectus surgery and lasting for at least 4 months. Other causes of pain (e.g. infection) and pain continuing from a pre-existing pain problem will be excluded. | Six month following surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pectus carinatum, Quality of life, Pain, postoperative, Somatosensory disorders
Head Positions to Open the Airway IV

Study Overview
=================
Brief Summary
-----------------
After routine induction of general anaesthesia peak airway pressure (= P max) and other respiratory parameters(i.e. expiratory tidal volume, expiratory CO2) are measured with and without head support in three different head positions: neutral position, reclination of the head, a position deemed ideal by the anaesthesist; primary study goal is pmax depending on different head positions;

Official Title
-----------------
Head Positions to Open the Upper Airway IV

Conditions
-----------------
Cardiac or Respiratory Arrest, Anaesthesia

Intervention / Treatment
-----------------
* Procedure: head extension
* Procedure: neutral position
* Procedure: anaesthesiologist´s position


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male and female patients ≥ 18 years elective operations in general anaesthesia patient´s written informed consent American Society of Anesthesiology scale I-III Exclusion Criteria: non fasting patient body mass index > 35 kg/m2 anamnestic cervical spine pathologies or other peripheral neurological deficiences due to pathologies of the cervical spine malformations of the head or upper airway history of perforation of stomach or esophagus anamnestic hiatus hernia or reflux acute respiratory infection or obstructive airway disease

Ages Eligible for Study
-----------------
Minimum Age: 18 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: with head support<br>patients are ventilated with their heads positioned on a support | Procedure: head extension<br>* the lungs are ventilated with the patient´s head extended<br>Procedure: neutral position<br>* the lungs are ventilated with the patient´s head in neutral position<br>Procedure: anaesthesiologist´s position<br>* the lungs are ventilated with the patient´s head positioned deemed ideal by the anaesthesiologist<br>|
| Sham Comparator: without head support<br>patients are ventilated without head support | Procedure: head extension<br>* the lungs are ventilated with the patient´s head extended<br>Procedure: neutral position<br>* the lungs are ventilated with the patient´s head in neutral position<br>Procedure: anaesthesiologist´s position<br>* the lungs are ventilated with the patient´s head positioned deemed ideal by the anaesthesiologist<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak airway pressure |  | peak airway pressure is measured over one minute | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anesthesia, cardiac arrest, resuscitation, ventilation
Semi-blunt Needles: is Outcome Better?

Study Overview
=================
Brief Summary
-----------------
The aim of this observational study in patients chronically hemodialyzed by a native arterio-venous fistula is to determine the impact of the use of semi-blunt needles on the quality of the punction. The investigators have observed that cannulation with blunt needles (button-hole method) is sometimes difficult and the use of a sharp needle may be necessary, with consequently more hematomes and infections. Our hypothesis is that canulation with semi-blunt needles would be easier than with classical blunt needles, and consequently the use of sharp needles would become less frequent. Inclusion criteria and study design are detailed below.

Conditions
-----------------
Chronic Hemodialysis Patients, Vascular Abord: Native Arterio-venous Fistula, Buttonhole Cannulation

Intervention / Treatment
-----------------
* Procedure: Buttonhole cannulation with semi-blunt needles


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic hemodialysis patients Aged 18 years or more Dialyzed by a native arterio-venous fistula Cannuled by buttonhole method with blunt needles Exclusion Criteria: Acute hemodialysis Puncture with 14G needles Puncture with a sole needle Arterio-venous grafts Patients transferred from another centre

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<br>Chronic hemodialysis patients, native arterio-venous fistula | Procedure: Buttonhole cannulation with semi-blunt needles<br>* Use of semi-blunt needles, compared to blunt needles, at every dialysis session<br>|
| 2<br>Chronic hemodialysis patients, native arterio-venous fistula | Procedure: Buttonhole cannulation with semi-blunt needles<br>* Use of semi-blunt needles, compared to blunt needles, at every dialysis session<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of AVF hematomes |  | Two months | 
| Incidence of use of sharp needles |  | Two months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of trampoline-effect |  | Two months | 
| Incidence of AVF infections |  | Two months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Blunt needles, Semi-blunt needles, Buttonhole cannulation method
Zenith® p-Branch™: Single-Center Study

Study Overview
=================
Brief Summary
-----------------
The Zenith® p-Branch™: Single-Center Study is a clinical trial approved by Swedish Regulatory Authority to study the safety and effectiveness of the Zenith® p-Branch™ in the treatment of abdominal aortic aneurysms.

Official Title
-----------------
Zenith® p-Branch™: Single-Center Study

Conditions
-----------------
Aortic Aneurysm, Abdominal Aortic Aneurysm

Intervention / Treatment
-----------------
* Device: Endovascular treatment (Zenith® p-Branch™ endovascular graft)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pararenal or juxtarenal AAA >5.0 cm in diameter Pararenal or juxtarenal AAA with history of growth >0.5 cm/year Exclusion Criteria: Age < 18 years Life expectancy < 2 years Pregnant or breast feeding Inability or refusal to give informed consent by the patient or a legally authorized representative Unwilling or unable to comply with the follow-up schedule Additional medical restrictions as specified in the Clinical Investigation Plan Additional anatomical restrictions as specified in the Clinical Investigation Plan

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: Endovascular<br>Endovascular treatment | Device: Endovascular treatment (Zenith® p-Branch™ endovascular graft)<br>* Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical Success | Technical success is described as: 1) successful access of the aneurysm site, 2) successful deployment of the Zenith® p-Branch™ endovascular graft in the intended location, 3) Zenith® p-Branch-™ endovascular graft is patent at deployment completion as evidenced by intraoperative angiography, and 4) all vessels targeted with a fenestration are patent at deployment completion as evidenced by intraoperative angiography. | Up to 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Abdominal aortic aneurysm, Endovascular, Fenestration, Juxtarenal, Off-the-shelf, Pararenal
Evaluation of the Reproducibility Inter-observer of the Ultrasound Anomalies of the Salivary Glands in Sjogren's Disease

Study Overview
=================
Brief Summary
-----------------
This aim of this study is to compare the reproducibility of reading of five international experts concerning the anomalies of the salivary glands. The reproducibility is measure on patients and not on recorded data.

Official Title
-----------------
Evaluation of the Reproducibility Inter-observer of the Ultrasound Anomalies of the Salivary Glands in Sjogren's Disease : Etude ETREINTE.

Conditions
-----------------
Sjogren's Disease

Intervention / Treatment
-----------------
* Procedure: Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women from 18 to 80 years old Patients recruited during the multidisciplinary consultation of Sjogren's Disease, filling the criteria of Sjogren's Disease or patients having a salivary recidivate pathology and selected players on the basis of their voluntary service to benefit from an ultrasound of the main salivary glands The patients will have to be capable of adhering to the protocol of study and of having understood it. The patients will have to be capable of giving a signed informed consent, the latter being obtained before the inclusion Exclusion Criteria: Not cooperative patient and having refused to sign the informed consent. Patient incapable to understand the protocol, under guardianship or under guardianship. Unaffiliated patients to the Social Security.

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

Design Details

Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Procedure<br>5 ultrasounds were done on 20 patients by 5 different sonographers | Procedure: Ultrasound<br>* Ultrasound examinations are done 5 times<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reproducibility between experts | The outcome measure will be assessed bythe answer of a questionnaire which will be complete by the 5 international experts. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reproducibility by the sonographer | The sonographer's reproductibility will be assesses by the answer of a questionnaire which will be complete by the 5 international experts. | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
reproductibility
Medical Care at a Mass-gathering Music Festival

Study Overview
=================
Brief Summary
-----------------
Key Objective is to describe Patient Presentation Rate and Transport to Hospital rate at an Austrian Music Festival. If significant changes in specific incidence rates are found, a causal explanation will be looked for.

Official Title
-----------------
Medical Care at a Mass-gathering Music Festival: A Retrospective Study Over Seven Years (2011 - 2017) of the Frequency Festival

Conditions
-----------------
All Health Problems Occurring During a Music Festival

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All persons seeking help from the local ambulance service at the music festival Exclusion Criteria: Incomplete Data
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: no intervention|no intervention will be done|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Presentation Rate | Patients per 1000 visitors | 2011-2017 | 
| Transfer to Hospital Rate | Hospitalisations per 1000 visitors | 2011-2017 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the Incidence of single Illnesses |  | 2011-2017 |
Use Sonography in Patients With Intrauterine Device Presenting With Bleeding

Study Overview
=================
Brief Summary
-----------------
Intrauterine contraceptive device is one of the most efficient and reversible methods of birth control with low cost and long duration of use However, in the first year after insertion, between 5 and 15% of women will have their Intrauterine contraceptive device removed because of irregular uterine bleeding which have been attributed to the effect of contact between the device and the endometrium and even the pressure on the uterine muscle . The disharmonious relationship between the Intrauterine contraceptive device and the uterus is the cause of most of the bleeding complaints, so bleeding is related to improper position rather than the contraceptive method itself which should be excluded before abandoning the Intrauterine contraceptive device for any other method of birth control

Official Title
-----------------
Intrauterine Contraceptive Device:Clinical and Sonographic Correlation in Patients Presenting With Bleeding

Conditions
-----------------
Contraception

Intervention / Treatment
-----------------
* Device: intrauterine device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients using intrauterine contraceptive device complaining of bleeding Exclusion Criteria: a-Associated uterine, cervical,or adenexal pathology b-Associated pelvic infection c-Generalized bleeding disorders d-Medications causing coagulation defects e-Medical disorders causing bleeding e.g hypertention f-Endocrine disorder as thyroid dysfunction g-Who refuse to share in the study
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: intrauterine device|a method of contraception inserted in the uterus|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The intrauterine device-Endometrial distance |  | 3 months |
Quality of Life After Radiofrequency Ablation of Pancreatic Cancer

Study Overview
=================
Brief Summary
-----------------
A prospective clinical study evaluating quality of life (QoL) in pancreatic cancer patients treated with intraoperative radiofrequency ablation (RFA).

Official Title
-----------------
Quality of Life After Intraoperative Radiofrequency Ablation of Pancreatic Cancer

Conditions
-----------------
Pancreatic Cancer

Intervention / Treatment
-----------------
* Procedure: Radiofrequency ablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically proved locally advanced or metastatic pancreatic cancer. Patients with histologically proved resectable pancreatic cancer with low Karnofsky index. informed consent Exclusion Criteria: cystic tumor age under 18

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: RFA group<br>Twenty-fourth consecutive patients with histologically proved pancreatic cancer [stage IIb (n=4), III (n=15), IV (n=5) ]underwent intraoperative RFA of primary tumor. | Procedure: Radiofrequency ablation<br>* After laparotomy, intraoperative IOUS quided RFA of primary tumor was performed.<br>* Other names: RFA;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life after RFA of pancreatic cancer | Quality of life will be evaluated using EORTC C 30 and pan 26 questionaire preoperatively and three months after RFA | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3- months perioperative morbidity and mortality | Three months morbidity and mortality will be evaluated using Dindo-Clavien classification | 3 years |
Tissue Study of Bv8/PK-2 Inhibition in Human Cancer

Study Overview
=================
Brief Summary
-----------------
Study hypothesis is that inhibition of Bv8 production in bone marrow cells of a mice wil reduce the rate of growth of a primary human tumor implanted in the mice. we will take mice and transform their bone marrow cells into non-Bv8 producing cells. than we will implant primary human tumor tissue (taken from surgical specimens after informed consent)in those mice and follow-up on the mice.

Detailed Description
-----------------
1-10 grams of human cancer tissue will be taken from surgical specimen without interference to the pathological data gathering process. those tissues will be implanted in nude mice that will either be treated with anti-Bv8 antibodies or will be transplanted with bone marrow in which Bv8 expression is silenced.

Official Title
-----------------
Study of Human Primary Cancer Tissue Implanted in Mice Lacking Bv8/PH-2 in Their Bone Marrow-derived Cells

Conditions
-----------------
Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ages 18-85 years Pathologically-confirmed diagnosis of pancreatic ductal adenocarcinoma undergoing surgical pancreaticoduodenectomy Exclusion Criteria: refuse to take part preoperative chemotherapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- | --- |
| Tumor growth in xenograft model |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bv8/PK-2, MDSC Myeloid Derived Suppressor Cells, BMDC Bone Marrow Derived Cells, Angiogenesis, Pancreatic Cancer