linjc16/ctgov huggingface dataset:
Osteoradionecrosis and PENTOCLO Protocol: Retrospective Study

Study Overview
=================
Brief Summary
-----------------
osteoradionecrosis (ORN) affects up to 30% of irradiated patients and can occur up to several decades after stopping treatment. Differents therapeutics exist but there is no consensus concerning the management of the maxillary ORN. The understanding of new pathological mechanisms opens the way to new therapeutic perspectives.

Official Title
-----------------
Osteoradionecrosis and PENTOCLO Protocol: Retrospective Study.

Conditions
-----------------
Osteoradionecrosis of Jaw

Intervention / Treatment
-----------------
* Drug: Pentoxifylline-Tocopherol-Clodronate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient over 18 being or having been treated by pentoclo combination for an osteoradionecrosis of the jaw Exclusion Criteria: Tumoral recidivism Precocious stop of pentoclo

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

| Intervention/Treatment |
| --- |
|Drug: Pentoxifylline-Tocopherol-Clodronate|the aim of this retrospective study is to analyze from patient records the impact of the PENTOCLO protocol on maxillofacial osteoradionecrosis at Brest Hospital University, France.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical evolution of the osteoradionecrosis lesion after introducing PENTOCLO protocol | Retrospective study based on recovering patient data from medical records | 2 years |
Evaluation of Protein in the Urine in Patients Receiving Bevacizumab

Study Overview
=================
Brief Summary
-----------------
This is a clinical research study to look at the incidence of proteinuria (a condition in which urine contains an abnormal amount of protein) caused by shortened infusions (given into the vein over 10 or 15 minutes) of bevacizumab (a medication prescribed for colon, lung, or breast cancer). There are currently no published studies or clinical data looking at how safe shortened infusions of bevacizumab are in relationship to the side effect of proteinuria. We hypothesis that shortened infusions of bevacizumab will result in an increased risk for proteinuria compared to the standard infusions of this agent.

Official Title
-----------------
An Evaluation of Proteinuria in Patients Receiving Shortened Infusions of Bevacizumab

Conditions
-----------------
Colon Cancer, Rectal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must be 18 years older Patients must be receiving his/her first dose of bevacizumab Patients must sign an informed consent Exclusion Criteria: Patients receiving > 10 mg/kg doses of bevacizumab

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>Shortened infusions of bevacizumab | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effect of shortened infusions (0.5 mg/kg/min) of bevacizumab on the incidence of proteinuria. |  | 3-6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the time (number of days) to the incidence of proteinuria with shortened infusions of bevacizumab AND to evaluate the effect of controlled versus uncontrolled hypertension and the incidence of proteinuria. |  | 3-6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bevacizumab, proteinuria
Effect of Coaching on Surgeon Well-Being, Job Satisfaction, & Fulfillment

Study Overview
=================
Brief Summary
-----------------
Researchers are trying to determine if individualized professional coaching improves physicians' sense of well-being and job satisfaction.

Official Title
-----------------
Effect of Coaching on Surgeon Well-Being, Job Satisfaction, & Fulfillment

Conditions
-----------------
Professional Burnout, Professional Stress, Job Stress

Intervention / Treatment
-----------------
* Behavioral: Professional Coaching


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Surgeons at Mayo Clinic Exclusion Criteria: Retired surgeons at Mayo Clinic; physicians in other disciplines or organizations
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate Coaching Intervention<br>Subjects will receive 6 professional coaching sessions | Behavioral: Professional Coaching<br>* 6 individualized professional coaching sessions via phone<br>|
| Experimental: Delayed Coaching Intervention<br>Subjects will receive no coaching for the first six months of the study, at which point they cross over and receive 6 professional coaching sessions | Behavioral: Professional Coaching<br>* 6 individualized professional coaching sessions via phone<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Burnout | Change in self-reported Maslach Burnout Inventory (MBI) Score using a scale of never, a few times a year or less, once a month or less, a few times a month, once a week, a few times a week, every day | Baseline, 6 months | 
| Job Satisfaction | Change in self-reported Physician Job Satisfaction Scale score using a scale of 1=very strongly disagree to 5= very strongly agree | Baseline, 6 months | 
| Professional Fulfillment | Change in the self-reported Empowerment at Work Scale score using a scale of 1=very strongly disagree to 7=very strongly agree | Baseline, 6 months |
Effectiveness of On-demand Meteospasmyl® Use in Irritable Bowel Syndrome (IBS)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the effectiveness of 2 IBS treatment strategies: Strategy A = MeteoSpasmyl®, on-demand therapy Strategy B = standard of care chosen by the physician

Official Title
-----------------
Assessment of On-demand MeteoSpasmyl® Use Effectiveness in Irritable Bowel Syndrome

Conditions
-----------------
Irritable Bowel Syndrome

Intervention / Treatment
-----------------
* Drug: anti spasmodic agents
* Drug: alverine citrate, simeticone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male or female ambulatory patients, aged >= 18 years with IBS as defined by Rome III criteria for more than 1 year and less than 10 years with a IBS-SSS between 175 and 400 Exclusion Criteria: Acute diarrhea, bowel disorders due to an underlying cause Patient treated with MeteoSpasmyl® within the past 6 months Recent history of gastro intestinal surgery

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 |
| --- | --- |
| Experimental: meteospasmyl<br> | Drug: alverine citrate, simeticone<br>* on-demand therapy<br>|
| Active Comparator: standard of care<br> | Drug: anti spasmodic agents<br>* best standard of care prescriptions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Irritable Bowel Syndrome Quality Of Life Overall Score | Irritable Bowel Syndrome Quality of Life total score (IBSQoL) is a health-related Quality of Life (QoL) disease-specific scale adapted for French patients. Total score ranges from minimum=0 to maximum = 100 representing the best outcome. | Baseline and 6 months | 
| Percentage of Improvement of the Total IBSQoL Scores | Improvement of the total IBSQoL scores from baseline to month 6 calculated in percentage | Baseline and 6 Months |
The Relationships Between the Noradrenergic, Opioid and Pain System

Study Overview
=================
Brief Summary
-----------------
The role of alpha2 receptor agonist on pain perception and modulation will be examined. In addition whether this is mediated through the opioid system will be examined. Pain perception and modulation will be examined before and after administration of Clonidine or placebo together with Naloxone or saline.

Conditions
-----------------
Experimental Pain Perception

Intervention / Treatment
-----------------
* Drug: Clonidine
* Drug: Naloxone
* Drug: placebo
* Other: saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers Age 18-40 No chronic disease Exclusion Criteria: Subjects who suffer from chronic pain / pain syndrome use of anti-depressant or anti-psychotic drugs suffering from cardiovascular disease breast feeding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Clonidine+ Saline<br>Clonidine 0.15 mg and saline 0.15 mg/kg | Drug: Clonidine<br>* Clonidine 0.15 mg<br>Other: saline<br> <br> |
| Active Comparator: Clonidine + Naloxone<br>Clonidine 0.15 mg and Naloxone 0.15 mg/kg | Drug: Clonidine<br>* Clonidine 0.15 mg<br>Drug: Naloxone<br>* naloxone 0.15 mg/kg<br>|
| Active Comparator: Placebo +Naloxone<br>Placebo 0.15 mg+ naloxone 0.15 mg/kg | Drug: Naloxone<br>* naloxone 0.15 mg/kg<br>Drug: placebo<br> <br> |
| Placebo Comparator: Placebo +saline<br>Placebo 0.15 mg+ saline 0.15 mg/kg | Drug: placebo<br> <br> Other: saline<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The changes in pain responses after administration of alpha 2 agonist and mu receptor antagonist | The change in pain perception (pain thresholds and pain ratings of suprathresholds stimuli) and in the excitatory and inhibitory pain modulation responses (assessed by the temporal summation and conditioned pain modulation paradigms) will be examined before and after administration of alpha 2 agonist with and without mu receptor antagonist | 2 years |
Survey of Regional Anesthesia Practice in Poland

Study Overview
=================
Brief Summary
-----------------
The study is being conducted to gain insight into regional anesthesia practice in polish hospitals specifically asking for methods used, accessibility to equipment and preference for regional blockade and perioperative analgesia.

Detailed Description
-----------------
In recent years, regional anesthesia has become one of the most dynamic parts of anesthesiology. This is in part due to less invasive surgical procedures, surgical enhanced recovery protocols as well as the incorporation of ultrasonography into the daily practice of regional anesthesia. The aim of this retrospective survey is to track and analyse the changes in everyday practice of regional anesthesia in Poland that have occurred in the year 2018. An invitation to the survey will be sent to all heads of anesthesiology departments in Poland. The answers to the survey will be collected using an internet based website created by the authors of the study.

Official Title
-----------------
Survey of Regional Anesthesia Practice in Poland - National Survey 2018

Conditions
-----------------
Anesthesia, Regional

Intervention / Treatment
-----------------
* Other: Invitation to regional anesthesia survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All Polish hospitals practising anesthesiology and intensive care in the national register of medical practices (www.rpwdl.csioz.gov.pl) Exclusion Criteria: Hospitals and medical practices not practising anesthesiology or intensive care
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Polish Hospitals<br>Hospitals with anesthesia or intensive care practices | Other: Invitation to regional anesthesia survey<br>* An invitation letter sent to Head of Anesthesiology and Intensive Care Department of Polish Hospital<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Regional anesthesia practice | Answers of head of anesthesiology and intensive care departments regarding regional anesthesia practice in their respective department by completing the Regional Anesthesia Survey 2018: multiple and single choice answers | Up to 12 months practice in the year 2018 | 
| Regional anesthesia practitioners | Answers of head of anesthesiology and intensive care departments regarding number of anesthesiologists practicing regional anesthesia | Up to 12 months in the year 2018 |
Descriptive Epidemiology Study for Patients With Paraphilia Sex Offenders and Receiving Androgen Antagonists

Study Overview
=================
Brief Summary
-----------------
The main objective of the study is to describe the french population of individuals with paraphilia who have committed a sexual offence in whom androgen antagonists was prescribed. The secondary objectives are the description of social demographic profiles, the personal and family histories,psychiatric co-morbidities, the side effects of androgen antagonists treatment. This study, the first of its kind in France, may allow to better understand the social demographic and clinical profile of sexual offenders with paraphilias treated with androgen antagonists. To be included, the subject must have committed a sexual offense and must present a diagnosis of paraphilia with an indication of treatment with androgen antagonists. Paraphilia is defined by the Diagnostic and Statistical Manual as a sexual behavior disorder characterized by sexually arousing fantasies, needs or recurrent and intense sexual behaviors generally involving (1) of non-human objects, (2) the suffering or humiliation of oneself or partner, (3) children or other persons without their consent, occurring during a period of at least six months (Criterion A). This disorder is responsible for sexual behavior which is clinically significant disturbances in social, occupational or other important areas of functioning (Criterion B). The inclusion of approximately 200 subjects is expected in this study. The inclusion period will last for 12 months. Data will be codified and only a few investigators will have access to these data. The statistical analyse will use the usual descriptive parameters: mean, standard deviation, median, interquartile range and range for quantitative variables, frequencies and cumulative frequencies (if applicable) for qualitative variables.

Official Title
-----------------
A Retrospective Non-interventional Descriptive Epidemiology Study for Patients With Paraphilia Sex Offenders Receiving Androgen Antagonists Treatment

Conditions
-----------------
Paraphilia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of paraphilia based on DSM-IV-TR antecedent of sexual offence Exclusion Criteria: no diagnostic of paraphilia
Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- | --- |
| current deviant sexual activity assessed with the frequency of deviant sexual activity per month | The primary outcome measure concerns the patient current deviant sexual activity. These data are reported routinely by the patient during his medical consultation and consigned in the medical record. | first visit (day 1) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
androgen antagonists
Open-label Study of the Efficacy and Safety of VESIcare® in Patients With Overactive Bladder Symptoms

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and efficacy of solifenacin succinate in subjects with overactive bladder symptoms (urgency, with or without urge incontinence, usually with frequency and nocturia).

Detailed Description
-----------------
Study included a 24 week extension that did not occur due to FDA approval of the product.

Official Title
-----------------
An Open-label Study of the Efficacy and Safety of 5 and 10mg VESIcare® (Solifenacin Succinate) in Patients With Overactive Bladder Symptoms VOLT: VESIcare® Open-Label Trial

Conditions
-----------------
Urinary Bladder, Overactive

Intervention / Treatment
-----------------
* Drug: solifenacin succinate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptoms of OAB (urgency, with or without urge incontinence, usually with frequency and nocturia) for ≥3 or more months. Patients may be included if they are on another OAB medication; however, patients must washout from other OAB medications for at least 7 days prior to receiving solifenacin succinate. Previous non-drug treatment of OAB is allowed if it has been established at least 4 weeks prior to study entry and is continued throughout the study. Exclusion Criteria: -Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor Evidence of urinary tract infection; chronic inflammation such as interstitial cystitis and bladder stones Clinically significant outflow obstruction (benign prostatic hyperplasia)

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: solifenacin succinate<br>* oral<br>* Other names: YM905;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy of 5 and 10mg solifenacin succinate in patients with OAB symptoms |  | Weeks 4, 8 and 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients satisfied with 5mg treatment |  | Week 12 | 
| Percentage of patients obtaining additional benefit with increase to 10mg dose |  | week 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Urgency, Urinary Bladder, Overactive, VESIcare®, Solifenacin succinate
Effect of Electronic Monitoring and Feedback on Adherence to Easyhaler Controller Medication in Patients With Asthma

Study Overview
=================
Brief Summary
-----------------
Effect of Electronic Monitoring and Feedback on Adherence to Easyhaler Controller Medication in Patients with Asthma

Official Title
-----------------
Effect of Electronic Monitoring and Feedback on Adherence to Easyhaler Controller Medication in Patients With Asthma

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Other: Reminders and feedback to improve adherence
* Other: No reminders and feedback to improve adherence


Participation Criteria
=================
Eligibility Criteria
-----------------
Main inclusion Criteria: written informed consent male and female subjects with documented diagnosis of asthma age 18 to 65 years ACT score 19 or less at screening treatment wih oral corticosteroids or hospital or emergency department admission due to asthma exacerbation within the past year subject's able to use Easyhaler inhalers and comply with study requirements Main exclusion Criteria: recent (within 1 month) asthma exacerbation concomitant major respiratory disease which may complicate the measurement of asthma control >20 pack-year history of smoking recent upper or lower respiratory tract infection pregnant or lactating female subjects

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Subjects will receive reminders and feedback to improve their adherence via a sensor attached to Easyhaler inhaler and mobile application | Other: Reminders and feedback to improve adherence<br>* Subjects will receive reminders and feedback to improve their adherence.<br>|
| Active Comparator: Usual care<br>Subjects do not receive reminders and feedback, but receive treatment as usual. | Other: No reminders and feedback to improve adherence<br>* Subjects will not receive reminders and feedback to improve their adherence.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean weekly adherence to controller medication | Adherence (percentage of doses taken of the doses prescribed) to controller medication during last six weeks of study | Weekly during each of the last 6 weeks of treatment |