linjc16/ctgov huggingface dataset:
Prognostic PET/CT Model in Non Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
Prospective validation of a prognostic model based on advanced PET/CT image analysis in non small cell lung cancer

Detailed Description
-----------------
Validation on a prospective cohort of patient of a predictive model for survival based on image derived parameters

Official Title
-----------------
Prognostic Positron Emission Tomography/Computed Tomogrpahy Model in Non Small Cell Lung Cancer

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: non small cell lung cancer initial fluorodeoxygluoces (FDG) PET/CT before treatment exclusion criteria: none

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 |
| --- | --- | --- |
| validation of a multiparametric PET/CT prognostic model | overall survival rate | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PET/CT, image processing, outcome
Study of 400mcg Sublingual Versus 400mcg Buccal Misoprostol Following 200mg Mifepristone for Medical Abortion up to 63 Days Last Menstrual Period (LMP)

Study Overview
=================
Brief Summary
-----------------
This open-label, randomized study is being conducted to determine whether a dose of 400 mcg of buccal misoprostol (i.e., in the cheek) taken 24 hours following administration of mifepristone 200 mg is as effective and acceptable at inducing an abortion compared with misoprostol taken sublingually (under the tongue). Women presenting for voluntary termination of intrauterine pregnancy with gestational ages of <63 days will be offered the option of participating in the study.

Official Title
-----------------
A Randomized Study of Sublingual and Buccal Misoprostol Administration Following Mifepristone 200 mg for Abortion up to 63 Days Gestation

Conditions
-----------------
Abortion, Induced

Intervention / Treatment
-----------------
* Drug: Misoprostol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gestational age less than or equal to 63 days General good health including absence of conditions which contraindicate the use of mifepristone and misoprostol for pregnancy termination; and Willing to provide an address and/or telephone number for purposes of follow-up. Exclusion Criteria: Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass IUD in place Chronic renal failure Concurrent long-term corticosteroid therapy History of allergy to mifepristone, misoprostol or other prostaglandin Hemorrhagic disorders or concurrent anticoagulant

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

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>400mcg sublingual misoprostol | Drug: Misoprostol<br>* 400mcg misoprostol taken sublingually or buccally<br>|
| Active Comparator: 2<br>400mcg buccal misoprostol | Drug: Misoprostol<br>* 400mcg misoprostol taken sublingually or buccally<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of safety and efficacy of 2 different routes of misoprostol after mifepristone administration |  | July 2007-March 2009 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects experienced |  | July 2007- March 2009 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Medical Abortion, Mifepristone, Misoprostol, Sublingual administration, Buccal administration
Neramexane for Tinnitus

Study Overview
=================
Brief Summary
-----------------
Tinnitus is commonly referred to as ringing of the ears - the perception of sounds in the absence of an external source of acoustic signals. Tinnitus may represent a severe disease and symptoms include depression, sleeping difficulties, decreased sound tolerance and hearing loss. One hypothesis is that tinnitus is caused by an increased activity of NMDA glutamate and dysfunctional alpha9/alpha10 acetylcholine receptors in the inner ear and central nervous system. Neramexane may alleviate tinnitus symptoms due to its NMDA and alpha9/alpha10 nACh receptor blocking activity. The purpose of this study is to assess the safety and efficacy of Neramexane compared with placebo in patients with subjective tinnitus.

Official Title
-----------------
A Randomised, Double-Blind, Placebo-Controlled, Clinical Dose-Ranging Trial to Evaluate Efficacy and Safety of a NMDA Antagonist for Oral Administration in Patients With Subjective Tinnitus

Conditions
-----------------
Tinnitus

Intervention / Treatment
-----------------
* Drug: Neramexane
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: main inclusion criterion: persistent, subjective, uni- or bilateral tinnitus Exclusion Criteria: main exclusion criterion: intermittent or pulsatile tinnitus

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neramexane 25mg/d<br> | Drug: Neramexane<br>* Oral tablets, duration: 16 weeks<br>|
| Experimental: Neramexane 50mg/d<br> | Drug: Neramexane<br>* Oral tablets, duration: 16 weeks<br>|
| Experimental: Neramexane 75mg/d<br> | Drug: Neramexane<br>* Oral tablets, duration: 16 weeks<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Oral tablets, duration: 16 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in tinnitus severity at the endpoint visit |  | Week 16 | 
| Comparison of adverse events (type, severity, seriousness, frequency, relatedness) between treatment arms |  | From baseline until week 20 |
Systemic Organ Communication in STEMI

Study Overview
=================
Brief Summary
-----------------
Despite progress in pre-hospital care, ambulance logistics, pharmacotherapy and PPCI techniques, ST-segment elevation myocardial infarction (STEMI) continues to confer a substantial burden of morbidity and mortality. Within the STEMI population, there is a spectrum of higher and lower risk patients. The aim of this cohort study is to collect prospectively and systematically clinical research data from STEMI patients. This cohort study is an open-end observational study to identify master switches in myocardial ischemia.

Official Title
-----------------
Systemic Organ Communication in STEMI

Conditions
-----------------
ST-segment Elevation Myocardial Infarction (STEMI)

Intervention / Treatment
-----------------
* Other: collection of clinical data


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients suffering from STEMI Exclusion Criteria: < 18 years

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 |
| --- |
|Other: collection of clinical data|prospectively and systematically collection of clinical research data from STEMI patients|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACCE (cardiovascular death, non-fatal stroke or myocardial infarction) | MACCE (cardiovascular death, non-fatal stroke or myocardial infarction) | 12 months | 
| Rehospitalization due to heart failure | Rehospitalization due to heart failure | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patency rate |  | 6 months | 
| left ventricular enddiastolic volume index (LVEDVi) | left ventricular enddiastolic volume as indexed on body surface area by either cardiovascular magnet resonance or echocardiography | 6 months | 
| Ejection fraction (%) | Ejection fraction (%) indexed on body surface area measured by either cardiovascular magnet resonance or echocardiography | 6 months | 
| stroke volume | stroke volume indexed on body surface area measured by either cardiovascular magnet resonance or echocardiography | 6 months | 
| Restenosis rate | Percent of patients with restenosis | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
STEMI, infarction, coronary artery disease, comorbidities, diabetes, anemia
Post Approval Commitment Study

Study Overview
=================
Brief Summary
-----------------
An agreement has been made to conduct a post-approval commitment study that provides supplementary information relating to the use of Xiapex® as well as other non-pharmacological treatments for Dupuytren's contracture by health care professionals in a real world clinical setting.

Detailed Description
-----------------
phase 4, open label, multi-center, prospective non-interventional descriptive

Official Title
-----------------
A Non-Interventional Post Approval Commitment Study To Evaluate The Outcomes Of The Various Treatment Options For Dupuytren's Contracture

Conditions
-----------------
Dupuytren's Contracture

Intervention / Treatment
-----------------
* Drug: Xiapex
* Procedure: surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults with a palpable cord eligible for the treatment of Dupuytren's contracture Exclusion Criteria: none

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 |
| --- | --- |
| xiapex<br>Subject treated with Xiapex | Drug: Xiapex<br>* Xiapex administration will follow SMPC<br>|
| Surgery<br>Fasciotomy or fasciectomy | Procedure: surgery<br>* Non-pharmacological treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical treatment success as assessed by goniometry |  | an expected average of 5 weeks | 
| treatment satisfaction using the Patient or Physician Global Assessment and Satisfaction questionnaires |  | an expected average of 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment option as determined by treating physician in consultation with patient |  | at day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
'Dupuytren's contracture', 'xiapex', 'surgery'
Proton Magnetic Resonance Spectroscopy of Normal Breast Tissues in Women Volunteers

Study Overview
=================
Brief Summary
-----------------
Magnetic resonance spectroscopy (MRS) is a diagnostic technique in MRI that distinguishes various metabolites on the basis of their slightly different chemical shifts or resonance frequencies. The Proton is the most abundant nucleus in the body. We will try to establish the typical proton MRS pattern of normal women breasts to be a guideline for future further investigations.

Detailed Description
-----------------
There are few reports regarding proton MRS in normal female breasts. The fibroglandular tissues and fat are the two major gross components in the breast. The water content in the fibroglandular tissues is much higher than that in the fat. There is still no documented report discussing proton MRS in normal female breasts of premenopausal and postmenopausal women. Our study is to evaluate the proton MRS findings among normal premenopausal and postmenopausal women breasts, to find out if there are statistical differences on the main proton MRS patterns, water and lipid peak intensities and ratios between the two groups.

Conditions
-----------------
Breast Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women age ranged 30 years of age or older, with normal mammograms or ultrasound in recent 3 months Exclusion Criteria: any women not fulfilling the inclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 30 Years

Sexes Eligible for Study
-----------------
Female

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

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
-----------------
Magnetic resonance imaging,, breast disease
Benefits of an Oocyte Pickup Simulation Training Program

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study was to evaluate oocyte pick up simulation training program for teaching residents. The secondary objectives were to evaluate resident satisfaction and the overall current state of oocyte pick up training in France.

Detailed Description
-----------------
simulation workshop using PickupSim simulator. inclusion: obstetrics and gynecology residents from France simulator: 7 scenarios available 1 simulation training/resident main outcome: successful completion of the scenario (oocyte retrieval rate >=70%) secondary outcome: time for completion, complications, satisfaction survey

Official Title
-----------------
Benefits of an Oocyte Pickup Simulation Training Program Using a High-fidelity Simulator for Obstetrics and Gynecology Residents

Conditions
-----------------
IVf, Simulation Training, Education

Intervention / Treatment
-----------------
* Other: oocyte pick up simulator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: obstetrics and gynecology residents french residents Exclusion Criteria: no
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 |
| --- | --- |
| residents<br>obstetrics and gynecology residents from France with or without previous experience in oocyte pick up | Other: oocyte pick up simulator<br>* oocyte pick up simulation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| successful scenario | oocyte retrieval rate >=70% | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| completion time | time to successfully complete the scenario | 1 day | 
| complications | complications that may occurs during the simulation training (lesions of vitals organs, forget to change collection tubes) | 1 day |
Prevention of Fetal Alcohol Spectrum Disorder (FASD) by the Use of Technology

Study Overview
=================
Brief Summary
-----------------
The Institute of Health Economics is conducting a study to determine how a breathalyzer linked to a cloud based alcohol monitoring system changes alcohol consumption during pregnancy in women with alcohol dependency issues. IHE posits that the ability to self-monitor blood alcohol concentration and the ability to share sobriety via email or text with loved ones and counselors may reduce alcohol consumption and thus reduce the possibility of delivering a child with FASD. The study will provide useful evidence for tailoring future optimal maternal and child healthcare for women, with the potential of decreasing healthcare utilization by prevention of FASD. Breathalyzer device usage plus secure document sobriety should improve patient monitoring convenience and demonstrate reductions in alcohol use outside of traditional office visits and patient self-reports.

Official Title
-----------------
Prevention of Fetal Alcohol Spectrum Disorder (FASD) by the Use of Technology

Conditions
-----------------
Alcoholism, Pregnancy

Intervention / Treatment
-----------------
* Device: specialized breathalyzer w face recognition technology


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant, Alcoholic, actively in treatment for alcoholism addiction Exclusion Criteria: Not pregnant, not in treatment/therapy for addiction

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

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Intervention is pregnant women enrolled and using specialized breathalyzer device w face recognition technology linked to a cellphone | Device: specialized breathalyzer w face recognition technology<br> <br> * Other names: Soberlink;|
| No Intervention: Control Group<br>No intervention. No breathalyzer given. Access granted by participant to IHE to collect data from Alberta Health Services (medical records) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in FASD Birthrate Levels | Binary- yes or no dx FASD within 3 years of birth | 3 years |
The Effects of Manual and Automatic Lancets on Pain and Stress in Newborn Capillary Heel Blood Collection

Study Overview
=================
Brief Summary
-----------------
Heel blood sampling is a routine but painful procedure for newborns. A limited number of international studies have shown that automatic lancets are more effective with less pain and tissue damage than manual lancets. In line with this information, this study was planned to investigate the effects of manual and automatic lancets on pain and stress in newborn capillary heel blood collection.

Official Title
-----------------
The Effects of Manual and Automatic Lancets on Pain and Stress in Newborn Capillary Heel Blood Collection

Conditions
-----------------
Newborn, Pain, Stress

Intervention / Treatment
-----------------
* Device: Automatic lancet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postnatal age zero day Term newborn No congenital anomalies No advanced medical intervention at birth Infants not receiving oxygen or respiratory support Exclusion Criteria: Legal guardian not giving consent to research

Ages Eligible for Study
-----------------
Minimum Age: 0 Days
Maximum Age: 1 Day

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Automatic Lancet<br>Manual lancet, needle tips and automatic lancets are used in the heel blood collection process. It has been reported that there may be complications arising from health professionals in the use of manual lancet or needle tip. In this study, an automatic lancet penetrating 2.4 mm-3 mm depth was used for safe puncture in term newborns. | Device: Automatic lancet<br>* An automatic lancet, which can reach a depth of 2.4 mm-3 mm, was used for safe piercing in babies.<br>|
| No Intervention: Control<br>No intervention, routine maintenance performed | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The neo pain assessment scale | The neo scale was developed (2014) to assess pain and stress in premature and mature neonates. The Neo is a five-item scale including facial expression, breathing pattern, tone of extremities, hand and foot activity, and level of activity. The lowest and the highest scores obtainable from the scale are 0 and 10, respectively. As the score increases, stress and pain increase. | 12 week | 
| Crying time in second |  | 12 week |