linjc16/ctgov huggingface dataset:
Assessing Clinical Trial Experiences of Patients With Osteosarcoma

Study Overview
=================
Brief Summary
-----------------
Clinical study participation has historically been heavily biased toward specific demographics. Several people will be invited to enroll in this study so that it may collect a variety of data about osteosarcoma clinical trial experiences and identify barriers to participation as well as the causes of participants' failure or withdrawal. People with osteosarcoma who are invited to take part in medical research will benefit from the analysis of the data.

Official Title
-----------------
An Observational Study Investigating The Experiences of Patients In Osteosarcoma Clinical Trials

Conditions
-----------------
Osteosarcoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has been diagnosed with osteosarcoma Patient has self-identified as planning to enroll in an interventional clinical trial Patient is a minimum of 18 years or older Exclusion Criteria: ECOG score of 4 Patient is pregnant Inability to perform regular electronic reporting Patient does not understand, sign, and return consent form

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 who decide to enroll in an osteosarcoma clinical trial |  | 3 months | 
| Rate of patients who remain in osteosarcoma clinical trial to trial completion |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
osteosarcoma
A Prospective Pharmacodynamic Study of Dabigatran

Study Overview
=================
Brief Summary
-----------------
The ability to explain bleeding or clotting complications in patients treated with dabigatran remains challenging. In addition, there is limited data on how coagulation tests perform in patients treated with therapeutic doses of dabigatran. Predicted responses of coagulation tests to therapeutic doses of dabigatran may be helpful in better understanding abnormal responses to dabigatran. The purpose of the study is to define a therapeutic reference range for peak and trough coagulation tests in patients taking FDA approved doses of dabigatran and to determine which tests may be most clinically useful for monitoring dabigatran.

Official Title
-----------------
A Prospective Pharmacodynamic Study of Dabigatran Using Peak and Trough Coagulation Test Results in Patients on Therapeutic Doses of Dabigatran

Conditions
-----------------
Blood Coagulation Tests

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Medication therapy with dabigatran 75 mg twice daily or 150 mg twice daily for a minimum of 3 days Exclusion Criteria: CrCl < 15 ml/min Non-FDA approved dose based on calculated CrCl with most recent SCr Age < 18 years Inability to communicate in the English language Decisionally-impaired individuals Incarcerated Pregnant/Lactating (Pregnancy category: C, unevaluated effects in lactation)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 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 |
| --- | --- |
| Experimental<br>Patient taking FDA approved dose of dabigatran | |
| Control group<br>Person not taking any form of anticoagulation. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
The Effects of Group Cycling (Spinning®) With Knee Osteoarthritis: A Randomized Control Trial

Study Overview
=================
Brief Summary
-----------------
Hypothesis: Group cycling classes (Spinning®) will improve pain and functional outcomes in patients with knee osteoarthritis Methods: Patients with symptomatic knee OA will be randomized to active Spinning® classes 2-3 per week or control group for 3 months. Outcomes including gait speed, WOMAC, KOOS, KOS, and VAS pain at rest and after 6 min walk will be performed at baseline and at 12 weeks.

Official Title
-----------------
The Effects of Group Cycling (Spinning®) On Gait and Pain-Related Disability in Persons With Knee Osteoarthritis: A Randomized Control Trial

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Other: Exercise
* Other: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: symptomatic and radiographic knee OA Exclusion Criteria: severe patella femoral knee pain that would make cycling difficult medical condition which would prohibit an exercise program

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Exercise intervention<br>Patients began the exercise intervention after randomization for 12 weeks | Other: Exercise<br>* Patients randomized to treatment arm attended 2-3 Spinning classes per week for 12 weeks.<br>|
| Placebo Comparator: Control<br>Patients were asked not to change their baseline exercise program | Other: Control<br>* Patients randomized to the control arm were instructed not to change their baseline exercise programs<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preferred gait speed |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC |  | 12 weeks | 
| KOS |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
osteoarthritis, knee, exercise, cycling
The Effects of Dexmedetomidine and Tracheal Intubation on Heart Rate Variability and QTc Interval

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate effect of dexmedetomidine and tracheal intubation on heart rate variability and QTc interval.

Conditions
-----------------
Anesthesia, General

Intervention / Treatment
-----------------
* Drug: 0.5 mcg/kg IV infusion for 10 min, 1.0 mcg/kg IV infusion for 10 min


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient who are regarded as ASA class I age 20 to 60 patient scheduled for Intubation for surgery Exclusion Criteria: QTc interval > 440 ms arrythmia Patient who is taking a medicine which effects QTc interval HTN DM renal disease hepatic disease pregnant illiterate

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>fentanyl 1 mcg/kg before induction | Drug: 0.5 mcg/kg IV infusion for 10 min, 1.0 mcg/kg IV infusion for 10 min<br>* ECG monitoring for evaluation of QTc interval<br>|
| Experimental: D 0.5 group<br>Dexmedetomidine 0.5 ug/kg + Propofol + Sevoflurane+ Vecuronium | Drug: 0.5 mcg/kg IV infusion for 10 min, 1.0 mcg/kg IV infusion for 10 min<br>* ECG monitoring for evaluation of QTc interval<br>|
| Experimental: D 1.0 group<br>Dexmedetomidine 1.0 ug/kg + Propofol + Sevoflurane+ Vecuronium | Drug: 0.5 mcg/kg IV infusion for 10 min, 1.0 mcg/kg IV infusion for 10 min<br>* ECG monitoring for evaluation of QTc interval<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of QTc interval | T1- baseline, T2- to evaluate the effect of dexmedetomidine on QTc interval, T3- to evaluate QTc interval just before intubation, T4,5,6 - to evaluate QTc interval after intubation | T1 (at rest), T2 (5 min after dexmedetomidine infusion), T3 (just before intubation), T4(1 min after intubation), T5(2 min after intubation), T6(3min after intubation) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dexmedetomidine, heart rate variability, QTc interval
The Brugada Syndrome: a Follow-up Study

Study Overview
=================
Brief Summary
-----------------
Although for many years the Brugada syndrome has been labelled as a purely electrical disease in the structurally normal heart, the evolution of imaging techniques has enabled the discovery of subtle morphofunctional alterations in some of the Brugada syndrome patients. We will use new echocardiographic techniques to assess cardiac function in these patients and new parameters will be evaluated for their prognostic value as risk stratificators.

Official Title
-----------------
Imaging and Risk Stratification in the Brugada Syndrome: a Follow-up Study

Conditions
-----------------
Brugada Syndrome

Intervention / Treatment
-----------------
* Diagnostic Test: Transthoracic echocardiography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older Diagnosis of Brugada syndrome Exclusion Criteria: history of pericarditis, ischemic heart disease, cardiomyopathy of any origin, structural heart disease, or any other channelopathy

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Transthoracic echocardiography|Transthoracic echocardiography Blood sample with assessment of biomarkers|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composed outcome of sudden cardiac death, appropriate ICD shock and witnessed ventricular fibrillation | Sudden cardiac death is death occuring within 24 hours after being seen in a healthy status or within 1 hour after initiation of symptoms. | 6 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Syncope | Loss of consciousness | 6 years |
A Study of Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to evaluate the safety, efficacy and pharmacokinetics of three doses of adalimumab in adult Japanese subjects with RA

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Biological: adalimumab
* Biological: adalimumab
* Biological: adalimumab
* Biological: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meet ACR criteria for diagnosis of active RA and have at both screening and baseline visits >10 swollen joints, >12 tender joints. Subjects must have failed prior treatment with one or more DMARDs. A negative (serum) pregnancy test for all female subjects of child-bearing potential at screening and a negative (urine) pregnancy test prior to study drug administration. Body weight less than or equal to 100 kg Exclusion Criteria: A history of, or current, acute inflammatory joint disease of different origin from RA. Prior treatment with any TNF antagonist, including adalimumab. Any ongoing chronic or active infection or any major episode of infection requiring hospitalization or treatment with IV antibiotics. Unstable ischemic heart disease, active inflammatory bowel disease, active peptic ulcer disease, recent stroke or any poorly controlled medical condition.

Ages Eligible for Study
-----------------
Minimum Age: 20 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: 20 mg<br>20 mg adalimumab eow | Biological: adalimumab<br>* 20 mg sc eow<br>* Other names: Humira;|
| Experimental: 40 mg<br>40 mg adalimumab eow | Biological: adalimumab<br>* 40 mg sc eow<br>* Other names: Humira;|
| Experimental: 80 mg<br>80 mg adalimumab eow | Biological: adalimumab<br>* 80 mg sc eow<br>* Other names: Humira;|
| Placebo Comparator: Placebo<br>Placebo eow | Biological: placebo<br>* placebo sc eow<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ACR20 |  | Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ACR20 |  | Week12 | 
| ACR50 |  | Weeks 12 and 24 | 
| ACR70 |  | Weeks 12 and 24 |
Taste Changes in Acute Otitis Media

Study Overview
=================
Brief Summary
-----------------
Detection of taste changes in Acute Otitis Media (AOM) patients.

Detailed Description
-----------------
Methods: Taste assessment will be done using Electrogustometer (EGM). Tongue stimulation will be performed using low currents of up to 100uA. Using the protocol as specified in the EGM user manual. Population: 40 Unilateral AOM patients, aged 8-40. Without chronic otitis media, pregnancy or impaired judgement.

Official Title
-----------------
Taste Changes in Acute Otitis Media

Conditions
-----------------
Acute Otitis Media

Intervention / Treatment
-----------------
* Diagnostic Test: Electrogustometery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Unilateral AOM Exclusion Criteria: Chronic Otitis Media Pregnancy Patients with lack of judgment

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 40 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>patients with AOM | Diagnostic Test: Electrogustometery<br>* Taste assessment using EGM<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Taste change in AOM | change in taste threshold in AOM patients | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Taste threshold, Acute otitis media, AOM, Electrogustometer, EGM
Effect of Sitagliptin on Postprandial Lipoprotein Metabolism

Study Overview
=================
Brief Summary
-----------------
The goal of the study is to evaluate whether sitagliptin can affect postprandial lipoprotein metabolism in type 2 diabetic patients.

Conditions
-----------------
Diabetes Mellitus Type 2

Intervention / Treatment
-----------------
* Drug: sitagliptin
* Drug: glimepiride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: type 2 diabetes dietary therapy Exclusion Criteria: lipid-lowering therapy anti-hyperglycemic drug therapy

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 70 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: sitagliptin<br> | Drug: sitagliptin<br>* sitagliptin 100 mg/d for 10 weeks<br>|
| Active Comparator: glimepirid<br> | Drug: glimepiride<br>* glimepiride 1 mg/d for 10 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incremental area under the triglyceride curve (iAUC-TG) | incremental area under the plasma triglyceride concentration curve following a standardized oral fat challenge | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL-cholesterol | fasting LDL-cholesterol | 10 weeks | 
| HDL-cholesterol | fasting HDL-cholesterol | 10 weeks | 
| VLDL-cholesterol | fasting VLDL-cholesterol | 10 weeks | 
| triglycerides | fasting triglycerides | 10 weeks | 
| area under the triglyceride curve (AUC-TG) | area under the plasma triglyceride concentration curve following a standardized oral fat challenge | 10 weeks | 
| area under the VLDL-triglyceride curve (AUC-VLDL-TG) | area under the plasma VLDL-triglyceride concentration curve following a standardized oral fat challenge | 10 weeks | 
| incremental area under the VLDL-triglyceride curve (iAUC-VLDL-TG) | incremental area under the plasma VLDL-triglyceride concentration curve following a standardized oral fat challenge | 10 weeks | 
| glucose | fasting glucose concentration | 10 weeks | 
| insulin | fasting insulin concentration | 10 weeks | 
| HOMA |  | 10 weeks | 
| HbA1c |  | 10 weeks | 
| interleukin-6 |  | 10 weeks | 
| hs-CRP |  | 10 weeks |
Repetitive Transcranial Magnetic Stimulation for Freezing of Gait

Study Overview
=================
Brief Summary
-----------------
Freezing of gait (FOG) means that patients cannot walk without any known causes, other than parkinsonism, which is very disabling symptom. Patients descirbe their feeling of the feet suddenly being glued to the floor. Transcranial magnetic stiumation is a noninvasive procedure using electromagnetic induction to stimulate brain. Transcranial magnetic stiumation (rTMS) can selectively change brain activity to enhance desired effects. The aim of this study is to the therapeutic effect of rTMS for the FOG.

Official Title
-----------------
Repetitive Transcranial Magnetic Stimulation for Freezing of Gait

Conditions
-----------------
Parkinsonian Disorders

Intervention / Treatment
-----------------
* Device: rTMS Motor cortex
* Device: rTMS Supplementary motor area


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parkinson's disease or Primary progressive freezing of gait age 18 and older Freezing of gait Exclusion Criteria: pregnant or any, other medical, surgical, neurological or psychiatric conditions other restrictions which prevent you from undergoing TMS recording, such as; surgically or traumatically implanted foreign bodies such as a pacemaker, an implanted medication pump, a metal plate in the skull, or metal inside the skull or eyes (other than dental appliances or fillings), and/ or heart/cardiac lines any past or current history of seizure disorder or epilepsy unable to give informed consent

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rTMS Motor cortex<br>rTMS will be applied over the motor cortex | Device: rTMS Motor cortex<br> <br> |
| Active Comparator: rTMS Supplementary motor area<br>rTMS will be applied over the supplementary motor area | Device: rTMS Supplementary motor area<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of steps | The number of steps during the stand-walk-sit (SWS) test | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The completion time during the SWS test |  | 2 days | 
| Freezing episodes of gait trajectory |  | 2 days | 
| Patient and Clinical Global Impression Scale |  | 2 days |
OSA and Sudden Sensorineural Hearing Loss

Study Overview
=================
Brief Summary
-----------------
This study studies the prevalence between obstructive sleep apnea syndrome and sensorineural hearing loss. We recruit patients who have been treated for sudden sensorineural hearing loss in Poitiers' University Hospital between 2010 et 2017, and we detect if they have OSA with a ventilatory polygraphy.

Official Title
-----------------
Prevalence of Obstructive Sleep Apnea Syndrome in Patients With a History of Sudden Sensorineural Hearing Loss

Conditions
-----------------
Obstructive Sleep Apnea, Sudden Hearing Loss

Intervention / Treatment
-----------------
* Diagnostic Test: ventilatory polygraphy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: past medical history of sudden hearing loss between 2010 and 2017 no contraindication to a non supervised sleeping monitoring Exclusion Criteria: past medical history of fluctuant hearing loss or pre-existant significative hearing loss

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: past medical history of sudden hearing loss<br>sleep examination and ventilatory polygraphy device for 1 night | Diagnostic Test: ventilatory polygraphy<br>* we put a ventilatory polygraphy device on the patient in the evening, they come back home to sleep while the device is recording ventilatory parameters and they come back the morrow to give the device back<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study of the prevalence of OSA on patient with a history of sudden hearing loss |  | 1 night |