linjc16/ctgov huggingface dataset:
Hypofractionated Radiation Therapy for Glioblastoma

Study Overview
=================
Brief Summary
-----------------
Notwithstanding major improvements in treatment modalities, the prognosis of patients with glioblastoma is poor. Hypofractionated radiation therapy as an alternative of the standard 6-week regimen could be an attractive approach as an effort to prevent tumor cell repopulation and reduction the total treatment period promoting patient comfort and convenience.

Official Title
-----------------
Hypofractionated Radiation Therapy Plus Concomitant and Adjuvant Temozolomide for Glioblastoma

Conditions
-----------------
Glioblastoma Multiforme

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 18 to 70 years of age with newly diagnosed and histologically confirmed glioblastoma. WHO performance status of 2 or less and adequate hematologic, renal, and hepatic function. Exclusion Criteria: Prior diagnosis of cancer, unless disease free for > 3 years Previous history of radiotherapy in the head and neck region (except initial larynx tumor - T1, T2 / N0M0). Specific severe, active co-morbidities Tumor located in the brainstem Presence of leptomeningeal carcinomatosis Multicentric tumor

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypofractionated radiation therapy<br>Hypofractionated radiation therapy Total dose: 60 Gy (20 fractions / 3 Gy per fraction) with concurrent temozolomide 75 mg/m2 given 7 days/week. After a 30-days break, adjuvant temozolomide days 1-5 every 28 days for 6 cycles. | Radiation: Hypofractionated radiation therapy<br>* Hypofractionated radiation therapy Total dose: 60 Gy (20 fractions / 3 Gy per fraction)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | From date of the start of treatment to date of death due to any cause. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | The time between the start of treatment and tumor progression or death due to any cause. | 24 months |
The Effect of Coenzyme Q10 on Hearing and Tinnitus Characteristics of Chronic Tinnitus Patients

Study Overview
=================
Brief Summary
-----------------
The study is a randomised double-blinded trial. A group of 40 tinnitus patients with a naturally low Q10 level will be selected out of a preselected group of 160 screened out of a pre-existed database or patients which visited the ENT-consultation. The 40 patients with the lowest level will be asked to take 2 months Q10 (n=20) or the placebo (n=20). To evaluate the effect on hearing and tinnitus characteristic; audiometric test, tinnitus analysis and auditory evoked responses will be used as outcome measurements.

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

Intervention / Treatment
-----------------
* Dietary Supplement: Q10
* Dietary Supplement: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic non-pulsatile tinnitus > 3 months tinnitus has a clear otological cause age > 18 years Exclusion Criteria: pulsatile tinnitus persons who take already Q10 pregnancy cervical tinnitus holocranial tinnitus depression mental of neurological disorders history of chemotherapy middle ear diseases

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
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: Q10|nan|
|Dietary Supplement: placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tinnitus Functional Index |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Audiometric tresholds test |  | 2 months | 
| Tinnitus Analysis _ loudness matches |  | 2 months | 
| Tinnitus Analysis_Minimal masking level |  | 2 months | 
| Visual Analogue Scale of loudness |  | 2 months | 
| Hospital Anxiety and Depression Scale |  | 2 months | 
| Hyperacusis Questionnaire |  | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Q10, ubiquinol
Assessment of Early Treatment Response by Diffusion and Perfusion MRI in Patients With Brain Metastasis

Study Overview
=================
Brief Summary
-----------------
Magnetic resonance imaging (MRI) is a diagnostic study that makes pictures of organs of the body using magnetic field and radio frequency pulses that can not be felt. The purpose of this study is to determine if new imaging methods can help tumor evaluation in the brain. The extra images will be obtained using diffusion and perfusion MRI techniques to assess early treatment response in patients with brain metastasis, and will be compared to methods currently being used.

Official Title
-----------------
Assessment of Early Treatment Response by Diffusion and Perfusion MRI in Patients With Brain Metastasis

Conditions
-----------------
Brain Cancer

Intervention / Treatment
-----------------
* Procedure: MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults aged 18 and over. Patients/Subjects able to give informed consent Patients/Subjects whose weight does not exceed 275 lbs. Patient with metastatic brain tumors greater than or equal to 1.0 cm that will be treated with stereotactic radiosurgery and scheduled for an MRI scan as part of their routine care Exclusion Criteria: Patients who are unwilling or unable to undergo MRI including patients with contra-indications to MRI such as the presence of cardiac pacemakers or non-compatible intracranial vascular clips.

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 |
| --- | --- |
| Pts having an MRI<br>Patients will undergo a 20 minute pretreatment MRI scan and a 30 minute post treatment MRI scan with contrast agent administration. Ten patients with brain metastasis will be recruited in the study. All the patients will be undergoing SRS (Stereotactic Radiosurgery). Patients will have 1 pretreatment evaluation and 2 post treatment evaluations [1-72 hours post treatment and 8 weeks (+/- 2 weeks) post treatment] for early response. Patients are to be administered contrast prior to obtaining MRI scans. These research scans are estimated to take 20 minutes of scan time (+/- 10 minutes), which includes patient set up and conducting the research sequences.. | Procedure: MRI<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| feasibility of diffusion and perfusion magnetic resonance imaging (MRI) | This is a technology assessment protocol for response to treatment. The study is designed to assess the utility of the technology using a limited number of participants. We will assess whether the MR parameters are predictive markers of early response. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MRI, Brain metastases, 13-094
Effects of Physical Training on Heart Rate Variability and Exercise Capacity in Diabetes With Autonomic Neuropathy

Study Overview
=================
Brief Summary
-----------------
This study aimed to investigate effects of physical training on exercise capacity and changes of heart rate variability (HRV) at rest, during exercise, and post-exercise in the patient with diabetes with autonomic neuropathy (DAN).

Official Title
-----------------
Effects of Physical Training on Heart Rate Variability and Exercise Capacity in Diabetes With Autonomic Neuropathy

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Other: exercise training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged under 65 years old receiving regular treatment HbA1c < 8.0 decreased HR response in deep breathing maneuver Exclusion Criteria: heart disease neuro-musculo-skeletal diseases taking any medication that may affect HRV (such as α or β-blockers)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

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

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

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

Design Details

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: exercise<br>arm: intervention | Other: exercise training<br>* The exercise group took supervised aerobic training twice per week at hospital and thrice per week at home for eight weeks at the intensity of 60-70% VO2peak<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| heart rate variability |  | 8 weeks | 
| exercise capacity |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetes mellitus, autonomic neuropathy, exercise training, exercise capacity, heart rate variability
Itopride in Functional Dyspepsia:a Dose Finding Study

Study Overview
=================
Brief Summary
-----------------
This study aims to determine the efficacy and optimal dose of the prokinetic itopride for the treatment of patients with functional dyspepsia. The study will test in patients with functional dyspepsia the hypothesis that itopride is superior to placebo with regard to the improvement of symptoms.

Detailed Description
-----------------
Treatment of patients with functional dyspepsia remains unsatisfactory. We will assess the efficacy of Itopride, a D2 antagonist with acetylcholinesterase effects in patients with functional dyspepsia. Patients with functional dyspepsia will be randomized to Itopride (50, 100 or 200 mg tid) or placebo. After 8 weeks of treatment, three primary efficacy endpoints will be analyzed: a) change of the severity of functional dyspepsia symptoms (assessed by the Leeds Dyspepsia Questionnaire), b) patient's global assessment of efficacy (proportion of patients symptom-free or markedly improved)and c) improvement of pain and/or fullness by at least one grade on a 5-grade scale.

Official Title
-----------------
A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled Dose Finding Study in 4 Parallel Groups to Establish the Efficacy and Safety of an Eight Week Treatment With Itopride Three Times Daily Compared to Placebo in Patients Suffering From Functional Dyspepsia

Conditions
-----------------
Functional Dyspepsia

Intervention / Treatment
-----------------
* Drug: Itopride (drug)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of functional dyspepsia (Rome criteria) - Exclusion Criteria: structural or biochemical abnormalities explaining the symptoms, concomitant symptoms of gastroesophageal reflux disease or irritable bowel syndrome dominating the clinical picture -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 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

| Intervention/Treatment |
| --- |
|Drug: Itopride (drug)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| After 8 weeks of treatment: |  |  | 
| Change of the severity of functional dyspepsia symptoms assessed by the Leeds Dyspepsia Questionnaire) |  |  | 
| Patient's global assessment of efficacy (proportion of patients symptom-free or markedly improved) |  |  | 
| Improvement of pain and/or fullness by at least one grade on a 5-grade scale. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety parameters |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
functional dyspepsia, non ulcer dyspepsia, drug treatment
Effectiveness of Nasal-alar Elevator Combined With Taping Vs. Taping Alone on Improving the Nose Esthetics and Maxillary Arch Dimensions in Infants With Unilateral Complete Cleft Lip and Palate

Study Overview
=================
Brief Summary
-----------------
This randomized trial is designed to assess the effectiveness of nasal elevator as a presurgical infant orthopedics on improvement of nose esthetics vs taping alone.

Official Title
-----------------
Effectiveness of Nasal-alar Elevator (NE) Combined With Taping Vs. Taping Alone on Improving the Nose Esthetics and Maxillary Arch Dimensions in Infants With Unilateral Complete Cleft Lip and Palate: A Randomized Clinical Trial

Conditions
-----------------
Cleft Lip and Palate

Intervention / Treatment
-----------------
* Device: Nasal Elevator
* Device: Taping Alone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants with age range from 1-30 days. Unilateral complete cleft lip and alveolus. Medically free subjects. Both males and females. Cleft gap more than 10 mm. Exclusion Criteria: Patients older than 30 days. Syndromic patients with other defects in addition to cleft lip and palate. Patients with bilateral cleft lip and palate. Incomplete Cleft lip. Patient with previous surgical lip repair or adhesion. Patients with previous presurgical infant orthopedic treatment. Medically compromised patients. Cleft gap distance less than 10mm

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 30 Days

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 |
| --- | --- |
| Experimental: Nasal Elevator<br> | Device: Nasal Elevator<br>* A device aiming to elevate the clefted nostril extraorally and fixed on the forehead.<br>|
| Active Comparator: Taping Alone<br> | Device: Taping Alone<br>* Horizontal tape alone.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nasal Esthetics | Nasal esthetics will be following Dr Farkas' measurements and it will be carried out as linear and angular measurements on standardized photographs. it will be measured using photoshop software. | 3 months | 
| Maxillary arch changes | Different maxillary arch dimensions (e.g. cleft and arch widths and symmetry) will be measured virtually on digital models in mm using 3shape software. | 3 months |
Spectral-domain Optical Coherence Tomography Findings in Retinal Vessel Occlusion

Study Overview
=================
Brief Summary
-----------------
Retinal vessel occlusions might lead to ischemia of the inner retina, more severe so in artery occlusions. Intracellular edema may develop and decrease transparency of those layers, showing retinal edema. In spectral domain optical coherence tomography (SD-OCT) retinal reflectivity changes as a result of retinal edema. The investigators examine the reflectivity changes of different retinal layers between healthy eyes and eyes with retinal artery occlusion and ischemic or non-ischemic vein occlusions. Aim of the study is to evaluate whether those changes can be used to measure the level of ischemia in the inner retina.

Detailed Description
-----------------
Several studies tried to classify retinal ischemia due to retinal artery or vein occlusion into different grades. In some cases prognosis is dependent on grade of severity, especially in cases of retinal vein occlusion. State of the art to Diagnose the severity of retinal ischemia is lfuorescein angiography. However, this technique is invasive and might cause Problems like anaphylactic shock. Optical coherence tomography is a non-invasive technique, but up to now there is no standardized method to quantify the grade of severity of retinal ischemia in such conditions like retinal vessel occlusion. The study hope to find criteria by which such a classification can be constructed.

Official Title
-----------------
Spectral-domain Optical Coherence Tomography Findings in Retinal Vessel Occlusion - A Pilot Study of Detecting Ischemia in OCT

Conditions
-----------------
Retinal Ischemia

Intervention / Treatment
-----------------
* Other: optical coherence tomography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute Retinal vessel occlusion on one eye healthy contralateral eye examined with spectral Domain optical coherence tomography Exclusion Criteria: retinal occlusion older than 1 week OCT Image not obtainable/missing

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: optical coherence tomography|measurement of reflectivity in different retinal layers based on optical coherence tomography findings|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reflectivity | optical density of different retinal layers | December 2017 |
The Effects of Tactile Speech Feedback on Stuttering Frequency

Study Overview
=================
Brief Summary
-----------------
The purpose of this research project is to test the effects of exposure of different forms of tactile speech feedback on overt stuttering frequency.

Detailed Description
-----------------
A new medical grade device (FDA - category exempt) has been newly designed and built at the University of Mississippi within the departments of Communication Sciences & Disorders, Exercise Science, and Computer and Electrical Engineering. The device records either sound waves (via a small standard microphone) or three dimensional accelerometer data from the throat of a stuttering subject. This data is digitally signal processed, and fed back to the user in the form of a small vibrating disk/film that can be held between the fingers or mounted on the skin. This feedback data does not require the subject to attend to the incoming signal.

Official Title
-----------------
The Effects of Tactile Speech Feedback on Stuttering Frequency

Conditions
-----------------
Stuttering

Intervention / Treatment
-----------------
* Device: Tactile Stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults diagnosed with persistent developmental stuttering Exclusion Criteria: Subjects below 18 years of age

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
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device: Tactile Stimulation<br>A new medical grade device (FDA - category exempt) has been newly designed and built at the University of Mississippi within the departments of Communication Sciences & Disorders, Exercise Science, and Computer and Electrical Engineering. The device records either sound waves (via a small standard microphone) or three dimensional accelerometer data from the throat of a stuttering subject. This data is digitally signal processed, and fed back to the user in the form of a small vibrating disk/film that can be held between the fingers or mounted on the skin. This feedback data does not require the subject to attend to the incoming signal. | Device: Tactile Stimulation<br>* See Arms<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speech Fluency | Speech fluency was defined by either reading or saying a set syllable sentence in a book which is normally 8th grade reading level or lower. Pauses or stutters are considered positive indicators of dis-fluent speech. | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stuttering, haptic, feedback, fluency