linjc16/ctgov huggingface dataset:
High Intensity Focused Ultrasound in Uterine Myoma

Study Overview
=================
Brief Summary
-----------------
Aim to evaluate the efficacy of safety of newly developed, high intensity focused ultrasound device in women with symptomatic uterine leiomyoma

Official Title
-----------------
Prospective, Muti-institute, Single Arm, Confirmative Trial Evaluating Efficacy and Safety of High Intensity Focused Ultrasound Device (RODIN) in Women With Symptomatic Uterine Leiomyoma

Conditions
-----------------
Uterine Leiomyoma

Intervention / Treatment
-----------------
* Device: HIFU


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Premenopausal (FSH < 40 IU/L) Symptomatic uterine fibroids Willing to contracept during study period Exclusion Criteria: Pregnant or willing to be pregnant in future Cancer in female reproductive organ is suspected or diagnosed Inflammation in female reproductive organ Poorly controlled systemic disease Hematocrit < 25% Glomerular filtration rate(GFR) <= 30ml/min Cannot tolerate contrast-enhanced MR or Contrast-enhanced ultrasound(CEUS) Cannot lie down Previous treatment for leiomyoma, any of ① myolysis, ② myomectomy within 1 year, ③ hormonal therapy longer than 7 days within 4 weeks Cannot count the number or measure volume of leiomyoma using MRI Leiomyomas are inadequate (location, volume, number) for intervention Diameter of leiomyoma is over 5 cm Leiomyoma is not enhanced Lactating women Cannot communicate properly Participating or have participated in other trials within 30 days

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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: Treatment<br> | Device: HIFU<br>* Transvaginal high intensity focused ultrasound to ablate uterine myoma<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non perfused volume | Non perfused volume in myoma immediately after ablation | treatment day |
Hypoxia at Multiple Wavelengths of Light

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to assess the effect of progressive, incremental hypoxia at multiple wavelengths of light.

Detailed Description
-----------------
No additional information is required.

Official Title
-----------------
Effect of Induced Hypoxia at Multiple Wavelengths

Conditions
-----------------
Hypoxia in Healthy Individuals

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Is between 18 and 35 years of age Is American Society Anesthesiologist status 1 Has a BMI between 18 and 30 Exclusion Criteria: Currently taking any medications other than birth control pills Has participate in an investigational drug study within one month prior to the start of the study Fails the Allen's Test to confirm patency of the colateral artery Subject is female with a positive pregnancy test, or is female and is unwilling to use effective birth control between the time of screening and study termination Has a positive urine continine or drug test Has an reported allergy to Lidocaine Has anemia or other hemoglobinopathy Has a room air saturation less than 95% by pulse oximetry Has an abnormal EKG Has an abnormal pulmonary function test via spirometry Is intolerant to a breathing mask apparatus Has a COHb greater than 3%, or MetHb greater than 2% Has another condition, which in the opinion of the principle investigator would not be suitable for participation in the study Is unwilling or unable to provide informed consent or comply with the study procedures

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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 |
| --- | --- | --- |
| Assess the effect of progressive, incremental hypoxia at multiple wavelengths of light |  | Up to 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypoxia, Multiple wavelengths
A Study to Test the Effects of Riociguat in Patients With Pulmonary Hypertension Associated With Left Ventricular Diastolic Dysfunction

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to assess whether single oral doses of Riociguat safely improve the cardiovascular function in patients with pulmonary hypertension associated with left ventricular diastolic dysfunction

Official Title
-----------------
Acute Hemodynamic Effects of Riociguat (BAY63-2521) in Patients With Pulmonary Hypertension Associated With Diastolic Heart Failure: A Randomized, Double-blind, Placebo-controlled, Single-dose Study in Three Ascending Dose Cohorts

Conditions
-----------------
Hypertension, Pulmonary, Ventricular Dysfunction, Left

Intervention / Treatment
-----------------
* Drug: Riociguat (BAY63-2521)
* Drug: Riociguat (BAY63-2521)
* Drug: Riociguat (BAY63-2521)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients with symptomatic pulmonary hypertension due to left ventricular diastolic dysfunction Exclusion Criteria: Types of pulmonary hypertension other than group 2.2 of Dana Point Classification

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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: Arm 1<br> | Drug: Riociguat (BAY63-2521)<br>* 0.5 mg single oral dose<br>|
| Experimental: Arm 2<br> | Drug: Riociguat (BAY63-2521)<br>* 1 mg single oral dose<br>|
| Experimental: Arm 3<br> | Drug: Riociguat (BAY63-2521)<br>* 2 mg single oral dose<br>|
| Placebo Comparator: Arm 4<br> | Drug: Placebo<br>* single oral dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary artery mean pressure at rest |  | Peak change from baseline within 6 hours after a single dose of study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event collection |  | until 30 days after study drug treatment | 
| Plasma concentrations to obtain pharmacokinetic profile of Riociguat |  | Within 24 hours after study drug treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulmonary Hypertension, Left ventricular dysfunction
TRAIL: Treatment of Intracranial Aneurysms With LVIS® System

Study Overview
=================
Brief Summary
-----------------
A prospective, multicenter, observational assessment of the safety and effectiveness of the LVIS® device in the treatment of wide necked intracranial aneurysms.

Official Title
-----------------
TRAIL: Treatment of Intracranial Aneurysms With LVIS® System

Conditions
-----------------
Intracranial Aneurysms

Intervention / Treatment
-----------------
* Device: LVIS®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient or patient's legally authorized representative has been informed about the confidentiality of the study and has agreed to the collection of his/her personal data Patient has a ruptured or unruptured intracranial aneurysm for which: The parent artery has a diameter ≥ 2.0mm and ≤ 4.5 mm; The aneurysm neck size is ≥ 4mm or its dome-to-neck ratio is < 2 (wide neck) Endovascular treatment with coils and one or more LVIS® devices has been determined necessary for the patient by the multidisciplinary team Patient is aged ≥ 18 years Patient presents with a WFNS score between 0 and 3 Patient has agreed to attend follow-up appointments Exclusion Criteria: The use of an endovascular stent other than LVIS® has been determined necessary Patient presents with medical or surgical co-morbidities limiting his/her life expectancy to less than one year Patient has a contraindication to platelet inhibition treatment Patient requires retreatment of an aneurysm previously treated with a stent Patient is pregnant Patient has multiple aneurysms to be treated in one procedure

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 |
| --- | --- |
| LVIS®<br> | Device: LVIS®<br>* Low-profile Visualized Intraluminal Support device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anatomical stability of aneurysm treatment compared to the initial occlusion rate of the aneurysm |  | 6 months | 
| Anatomical stability of aneurysm treatment compared to the initial occlusion rate of the aneurysm |  | 18 months | 
| Retreatment rate |  | 6 months | 
| Retreatment rate |  | 18 months | 
| Morbidity rate |  | 6 months | 
| Morbidity rate |  | 18 months | 
| Mortality rate |  | 6 months | 
| Mortality rate |  | 18 months |
Hypertension in Management of Military Medicine

Study Overview
=================
Brief Summary
-----------------
This study is a retrospective database review of primary care appointments of patients' charts with new diagnoses of hypertension.

Detailed Description
-----------------
Compare the degree of blood pressure control of patients with stage 1 (BP < 130/80 mmHg) and stage 2 hypertension (BP > 20/10 mm Hg above goal BP) before and after the release of the Seventh report of Joint Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure (JNC 7) recommendations.

Official Title
-----------------
Hypertension in Management of Military Medicine

Conditions
-----------------
Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed hypertension

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypertension
a Randomized Clinical Trial Evaluating Plaque Removal Around Dental Implants

Study Overview
=================
Brief Summary
-----------------
This aim of this study is to compare different oral hygiene aids for the ability to remove plaque in patients who went through dental implant treatment and are currently on a maintenance program at the Graduate Periodontal Clinic, at the University of Manitoba, Faculty of Dentistry.

Detailed Description
-----------------
Home care and Oral hygiene regimes are as well an important aspect of short and long term dental implant survival and success. The investigators profession demands us to educate the patients about the risk of peri implantitis and peri mucositis in plaque infected dentitions. In periodontal patients the areas of most ineffective plaque removal are typically the palatal/lingual and interdental areas. there is therefore a need to developing scientific evidence to form a framework for professionals to follow when educating patients about their home care.

Official Title
-----------------
Evaluation of Plaque Removal Using Different Plaque Control Therapies Around Single Crown Dental Implants and Splinted Implant Crowns in Patients Under 3 Months Maintenance;a Randomized Clinical Trial

Conditions
-----------------
Peri Implantitis

Intervention / Treatment
-----------------
* Other: dental interproximal brush
* Other: dental floss


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non smokers, with clinical probing depth around implants is less than or equal to 6mm and are currently maintained every 3 months at the graduate periodontal program Exclusion Criteria: Smokers Probing Depth 6 or > 6mm Non compliant patients and patients with severe systemic conditions

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group : implants and oral hygiene<br>dental floss | Other: dental floss<br>* use of this to maintain oral hygiene<br>|
| Experimental: implants and oral hygiene<br>dental interproximal brush | Other: dental interproximal brush<br>* use of this to maintain oral hygiene<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plaque index | plaque removal | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
plaque removal around dental implants
Non-interventional Study to Evaluate the Ease of Reaching Individual Goals in Serum Phosphorus (Steering)

Study Overview
=================
Brief Summary
-----------------
The objective of this non-interventional study is to confirm that with standard OsvaRen® treatment it is possible to achieve in at least 60% of the patients the levels of phosphorus, total calcium, and iPTH seen in the CALMAG study also in the normal clinical practice.

Detailed Description
-----------------
Only a small fraction of haemodialysis patients meet the published NKF-KDOQI standards for calcium, phosphorus, calcium x phosphorus product and intact parathyroid hormone. One of the reasons is the still difficult and insufficient therapy with phosphate binders. Even though calcium containing phosphate binders have been proven to be effective, they are reported to lead in certain patients to hypercalcaemia. This observational study therefore not only evaluates the efficacy of the phosphate binder OsvaRen® (containing calcium acetate and magnesium carbonate) but also the frequency of untoward events in daily practice as well as to the state of hyper-/ hypoparathyroidism as represented by serum iPTH values and the practice patterns used to adjust to and to fully exploit the qualities of the different available phosphate binders. In addition, the compensatory actions of the physicians, such as adaptation of the dialysate calcium or the combination with non-calcium containing phosphate binders, are going to be monitored. In order to receive additional safety data in the context of daily practice, the frequency of untoward events related to the treatment will be documented and analysed.

Official Title
-----------------
Non-interventional Study to Evaluate the Ease of Reaching Individual Goals in Serum Phosphorus (Steering)

Conditions
-----------------
Hyperphosphataemia, ESRD

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Signed Informed Consent Patient on maintenance haemodialysis, online haemodiafiltration, or peritoneal dialysis at the time of OsvaRen® prescription Patients being treated with OsvaRen® for up to 6 months at the day of inclusion Exclusion Criteria: Prior participation in this observational study Use of OsvaRen® for purposes other than those indicated in the Summary of Product Characteristics (SmPC) / package leaflet

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 |
| --- | --- |
| OsvaRen treatment<br>Dialysis patients on OsvaRen treatment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum phosphorus |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse drug reactions |  | 12 months |
Tiotropium + Procaterol vs Tiotropium + Placebo in COPD Patients

Study Overview
=================
Brief Summary
-----------------
Study compares the efficacy and safety of tiotropium + a beta agonist (procaterol) vs. tiotropium alone among patients with moderate chronic obstructive pulmonary disease

Detailed Description
-----------------
This study aims to determine the efficacy and safety of tiotropium plus procaterol in comparison to tiotropium plus placebo in Filipino patients seen in Manila, with moderate COPD. After a 1-week wash-out period, 6-minute walk test, and St. George's Respiratory Questionnaire (SGRQ) will then be administered prior to a run-in period of 1 week wherein all patients will be started on tiotropium alone. The patients will then be randomly allocated to either of the two arms for a two-week treatment, followed by one week washout, and crossed-over to the other treatment for another two weeks. The procaterol or placebo dose is given 2 hrs after the tiotropium dose.

Official Title
-----------------
A Randomized Crossover Trial Comparing the Efficacy and Safety of Tiotropium + Procaterol vs. Tiotropium + Placebo in Moderate COPD Patients

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
-----------------
* Drug: Procaterol
* Drug: Tiotropium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: GOLD criteria for moderate COPD (post-bronchodilator) FEV1/FVC < 70% 50% ≤ FEV1 < 80% predicted With or without symptoms Willing to undergo the treatment protocol with signed informed consent Exclusion Criteria: Exacerbation within 1 month prior to run-in period Significant hypoxemia and/or desaturation at rest and during exercise. Significant cardiac, renal, or other systemic disease History of adverse reaction to any of the two test drugs (tiotropium and procaterol)

Ages Eligible for Study
-----------------
Minimum Age: 40 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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Procaterol|nan|
|Drug: Tiotropium|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| [Efficacy] Improvement spirometry (FEV1, FVC, FEV1/FVC, 6 MWD, TDI) and SGRQ at 2 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| [Safety] HR (Heart Rate) and BP (Blood Pressure) |  |  | 
| Incidence of adverse reactions and changes |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Procaterol, Chronic Obstructive Pulmonary Disease, Tiotropium
Cross Correlation of Pain Hypersensitivity and Clinical Features and Electromyography in Low Back Pain Patients

Study Overview
=================
Brief Summary
-----------------
Diagnostic and prognostic value of pain hypersensitivity in low back pain (LBP) is not fully understood.Increased pain sensitivity in the primary area of pain (local pain) is considered a sign of predominantly peripheral pain sensitization,value of pain hypersensitivity in low back pain (LBP)is not fully understood whereas pain sensitivity in distal and remote areas is considered to present a more central phenomenon. It is suggested that pat ents with enhanced pain sensitivity report high level of disability. Despite fact that pain and disability are associated in chronic LBP the exact mechanisms of sensitivity contribution in LBP disability is unknown. It has also been suggested that muscle function changes may be driven by pain. The possible role and contribution of trunk muscles function to pain and disability phenomena remain unknown. This study was aimed to estimate prevalence and possible correlation among pain hypersensitivity and functional and electromyography parameters of trunk muscles in patients reporting early phase of chronic LBP.

Official Title
-----------------
Cross Correlation of Pain Hypersensitivity and Clinical and EMG Parameters

Conditions
-----------------
Low Back Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Low back pain for at least 12 weeks Magnetic resonance imaging (MRI) confirmation of prolapsed intervertebral disc (PID) No meeting excluding criteria. Exclusion Criteria: No response to initial contact Red flag symptoms Diabetes mellitus, Neurological problems and Cancer Pregnant patients Patients treated chirurgically for the same problem or treated with oral corticosteroids and steroid injections for any reason in the previous month.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| patients with LBP<br> | |
| healthy individulas<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain hypersensitivity parameters: pain threshold and pressure pain tolerance threshold will be measured by pressure algometer pressure was applied using a probe with an area of 1 cm2 and intensity to a maximum of 1,000 kPa at a rate of 30 kPa/s. | pain detection threshold and pressure pain tolerance threshold (PPTT) )will be measured at the site of maximal pain and of more distant nonpainful point at the back, and the ipsilateral great toe 3 times and average value will be taken for statistics analyses | up to 3 months |