linjc16/ctgov huggingface dataset:
Quest Sound Recover (SR2) vs. Venture SR2

Study Overview
=================
Brief Summary
-----------------
Goal of this study is to determine the benefit of an improved feature on a new hearing aid platform. To investigate the improvements of this feature is compared on a new and older hearing aid platform. The obtained results will be used for future improvement for this feature. This feature should improve the speech understanding and speech recognition of the hearing aid user.

Conditions
-----------------
Hearing Loss

Intervention / Treatment
-----------------
* Device: hearing aid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed Consent as documented by signature (Appendix Informed Consent Form) Ability to fill in a question conscientious Healthy outer ear (w/o previous surgical procedures) Sensorineural symmetric hearing loss (HL) N4 to N7 (degree of HL) Exclusion Criteria: Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product, Limited mobility and not in the position to attend weekly appointments Limited ability to describe listening impressions/experiences and the use of the hearing aid Inability to produce a reliable hearing test result when pure tone audiometry is attempted by the audiologist Massively limited dexterity Known Psychological problems Central hearing problems

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Hearing aid | Device: hearing aid<br> <br> |
| Experimental: Test group<br>Hearing aid | Device: hearing aid<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional gain | Functional gain is to measure the aided threshold (in dB hearing level [HL]) in free field via loudspeaker. | after 2 weeks | 
| Phoneme Perception Test | Change of Detection thresholds after 4 weeks hearing instrument wearing time | after 2 | 
| Functional gain | Functional gain is to measure the aided threshold (in dB hearing level [HL]) in free field via loudspeaker. | after 8 weeks | 
| Phoneme Perception Test | Change of detection thresholds after 4 weeks hearing instrument wearing time | after 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sound quality ratings |  | after 6 and 12 weeks | 
| questionnaires |  | after 2, 6, 8 and 12 weeks |
Outcome of Babies With Asymetry of Lateral Brain Ventricles

Study Overview
=================
Brief Summary
-----------------
The investigators will follow up on babies that had prenatal diagnosis at 2nd or 3rd trimester of normal width and asymetry of lateral brain ventricles

Detailed Description
-----------------
Women who will attend 2nd or 3rd ultrasound prenatal scans will be included. Women where the fetus would be diagnosed with lateral ventricles that are normal width (<10 mm) but discrepacy of >3 mm will be followed up after delivery by head ultrasound and neurologic exam

Official Title
-----------------
Outcome of Babies With Asymetry of Lateral Brain Ventricles

Conditions
-----------------
Lateral Ventricles of Fetuses at Mid Trimester

Intervention / Treatment
-----------------
* Other: No intervention, only follow up


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy pregnant women between 19-30 weeks gestational age and asymetry of lateral ventricles Exclusion Criteria: Lateral ventricles >10 mm

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| pregnant women between 19-30 weeks gestational age<br>No intervention, only follow up | Other: No intervention, only follow up<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lateral ventricles width after delivery | The investigators will follow up on brain ultrasound of babies with normal width discrepant lateral brain ventricles | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurologic examination of babies with discrepant but normal lateral ventricles | After delivery, a neurologic examination will be carried out on all babies with discrepant but normal lateral ventricles | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asymetry, lateral ventricles
Treovance Stent-Graft With Navitel Delivery System for Patients With Infrarenal Abdominal Aortic Aneurysms

Study Overview
=================
Brief Summary
-----------------
The primary goal of the study is to assess the safety and performance of the Treovance device in subjects with infrarenal aortic aneurysms, specifically to evaluate if the diseased pathology can be treated with an acceptable adverse event rate and that the device performs as expected. The results of this study will permit the establishment of endpoints and clinical design for a subsequent U.S. trial.

Official Title
-----------------
A Phase I Clinical Study of the Safety and Performance of the Treovance Stent-Graft With Navitel Delivery System for Patients With Infrarenal Abdominal Aortic Aneurysms

Conditions
-----------------
Abdominal Aortic Aneurysms

Intervention / Treatment
-----------------
* Device: Treovance Abdominal Aortic Stent-Graft with Navitel Delivery System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with diagnosed with an infrarenal abdominal aortic aneurysm (AAA), with or without iliac artery involvement Subjects with an infrarenal AAA that is >/= 4.5 cm in diameter for males, or >/= 4.0 cm in diameter for females, or has increased in diameter by 0.5 cm in the last 6 months Subjects who consent to participate Subjects who agree to comply with the follow-up schedule Exclusion Criteria: Subjects with dissections, ruptured aneurysms, or symptomatic aneurysms Subjects with prior AAA repair Subjects with medical conditions that would complicate the endovascular procedure or confound results (e.g., Marfan's syndrome, morbid obesity, severe coronary artery disease) Subjects who are pregnant or lactating Subjects participating in other investigational studies Subjects with less than 2 years life expectancy

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
Intervention Model: Single Group Assignment
Interventional Model Description: AAA device
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treovance<br> | Device: Treovance Abdominal Aortic Stent-Graft with Navitel Delivery System<br>* Stent-graft implant<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| major morbidity and mortality |  | 1, 6, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device performance | Rateof delivery/deployment success will be recorded. Rates of endoleak, patency, migration will be documented a 1, 6, 12 months | implant, 1, 6, and 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Treovance, aneurysm, AAA
The Relationship Between Hypoalbuminemia and Development of Acute Kidney Failure (AKI) According to KDIGO Criteria

Study Overview
=================
Brief Summary
-----------------
This study was designed to determine the association between preoperative and postoperative hypoalbuminemia and AKI in older age hip fracture surgeons, to determine which period of hypoalbuminemia contributes more to AKI development, the incidence of AKI according to anesthesia type, the presence of other factors affecting AKI development, the duration of hospitalization and cost- to be investigated.

Official Title
-----------------
The Relationship Between Preoperative and Postoperative Hypoalbuminemia and Development of Acute Kidney Failure (AKI) According to KDIGO Criteria in Advanced Age Hip Kidney Surgery

Conditions
-----------------
Hypoalbuminemia, Acute Kidney Failure

Intervention / Treatment
-----------------
* Other: hypoalbuminemia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with femur fracture surgery 65 years and over Patients with ASA I - IV physical condition patients with spinal anesthesia or peripheral nerve block Exclusion Criteria: Patients undergoing emergency surgery patients with preoperative serum creatinine (sCr) level> 1.5 mg / dl patients with low serum albumin levels in both preoperative and postoperative periods patients receiving preoperative ventilator care patients with spinal anesthesia or peripheral nerve block contraindications (coagulopathies, local infection at the puncture site, spot infection) or nonsteroidal antiinflammatory drug (NSAID)

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- |
| preoperative albumin levels <3.8<br> | Other: hypoalbuminemia<br>* hypoalbuminemia and acute kidney injury<br>|
| preoperative albumin level >3.8<br> | Other: hypoalbuminemia<br>* hypoalbuminemia and acute kidney injury<br>|
| postoperative Day 2 albumin level <2.9<br> | Other: hypoalbuminemia<br>* hypoalbuminemia and acute kidney injury<br>|
| postoperative Day 2 albumin level >2.9<br> | Other: hypoalbuminemia<br>* hypoalbuminemia and acute kidney injury<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hypoalbuminemia and AKI - incidence of AKI | hypoalbuminemia and incidence of AKI according to KDIGO criterias | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anesthesia type - incidence of AKI | incidence of AKI according to anesthesia type | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypoalbuminemia, Acute Kidney Failure, older age, hip fracture
Observational Study Describing the Usual Clinical Practice Use of NovoSeven® in the Home Treatment of Joint Bleeds in Patients With Haemophilia A or B and Inhibitors

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Africa and Asia. The aim of this study is to evaluate the efficacy of home treatment of joint bleeds (haemarthrosis) with NovoSeven® (activated recombinant human factor VII) in patients with haemophilia A and B patients with inhibitors.

Official Title
-----------------
A Prospective Observational Study on the Home Treatment of Haemarthrosis With rFVIIa (Activated Recombinant Factor VII) in Haemophilia A and B Patients With Inhibitors

Conditions
-----------------
Congenital Bleeding Disorder, Haemophilia A, Haemophilia B

Intervention / Treatment
-----------------
* Drug: activated recombinant human factor VII


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with congenital haemophilia and inhibitors to factor VIII or IX Indication of activated recombinant human factor VII for the treatment of joint bleeding located in elbow, shoulder, wrist, hip, knee, ankle Exclusion Criteria: Known or suspected allergy to study product(s) or related products Clinically relevant coagulation disorders other than congenital haemophilia A or B

Ages Eligible for Study
-----------------
Minimum Age: 2 Years

Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br> | Drug: activated recombinant human factor VII<br>* Prescription is done at the discretion of the prescribing physician as part of normal clinical routine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of bleeds managed at home |  | Month 8 | 
| Number of treatments resulting in the control of bleeding episode |  | within 9 hours after the first injection of study product | 
| Number of treatments resulting in effective pain relief |  | within 9 hours after the first injection of study product | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patient/caregivers with no need of any intervention from the physician to treat the bleeding episode at home |  | Month 8 | 
| Proportion of patients who used their entire treatment at home |  | Month 8 |
CathOlic Medical Center percutAneous Coronary inTervention Registry (COACT)

Study Overview
=================
Brief Summary
-----------------
COACT registry is a multicenter registry of consecutive patients undergoing coronary stent implantation at 8 centers in the Catholic University of Korea to evaluate the real world management of patients with coronary artery disease and to assess their in-hospital, medium and long-term outcomes.

Official Title
-----------------
CathOlic Medical Center percutAneous Coronary inTervention Registry (COACT)

Conditions
-----------------
Drug Eluting Stent, Coronary Artery Disease, Polymorphism, Cholesterol, Biomarker

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all consecutive patients who underwent percutaneous coronary intervention written informed consent for the DNA and serum databank Exclusion Criteria: patients who did not agreed to participate

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 |
| --- | --- | --- |
| All causes mortality |  | 6month, each year | 
| Cardiac death |  | 6 month, each year | 
| Myocardial infarction |  | 6 month, each year | 
| target lesion revascularization |  | 6 month, each year | 
| target vessel revascularization |  | 6 month, each year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| non target vessel revascularization |  | 6 month, each year | 
| Stent thrombosis |  | 6 month, each year | 
| Serum databank for evaluation of biomarkers outcomes |  | 6 month, each year | 
| Pharmacogenetic and cardiovascular genetic studies associated to clinical outcomes |  | 6 month, each year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
drug eluting stent, coronary artery disease, Korean registry
5 Fractions of Pelvic SABR With Intra Prostatic SABR

Study Overview
=================
Brief Summary
-----------------
Stereotactic Ablative Radiation(SABR) 35 Gy in 5 fractions, once weekly to prostate with simultaneous intraprostatic boost to the MR detected nodule up to 50Gy + 25 Gy in 5 fractions, once weekly simultaneously to seminal vesicles (SV's) and pelvic lymph nodes + 6-18 months of ADT

Detailed Description
-----------------
SABR 25Gy / 5 fractions to pelvis; 35Gy / 5 fractions to prostate; up to 50Gy / 5 fractions to MR nodule

Official Title
-----------------
5 Fractions of Pelvic SABR With Intra Prostatic SABR

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Radiation: Pelvic SABR with intra-prostatic SABR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed prostate adenocarcinoma (centrally reviewed) High- tier intermediate risk defined as: PSA 10-20ng/ml AND (T2b-2c OR Gleason 7 ) • High-risk prostate cancer, defined as at least one of: T3, OR Gleason 8-10, OR PSA > 20 ng/mL Willing to give informed consent to participate in this clinical trial Able and willing to complete Expanded Prostate Index Composite (EPIC) questionnaire Exclusion Criteria: Prior pelvic radiotherapy Contra-indication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease Contraindication to prostate MRI Anticoagulation medication (if unsafe to discontinue for gold seed insertion) Diagnosis of bleeding diathesis Large prostate with significant arch interference on TRUS after 3 months of neoadjuvant ADT. Previous TURP Poor baseline urinary function defined as International Prostate Symptom Score (IPSS) >20 Significant medical co-morbidity rendering patient unsuitable for general anesthetic No evidence of castrate resistance (defined as PSA < 3 ng/ml while testosterone is < 0.7nmol/l. Patients could have been on combined androgen blockade but are excluded if this was started due to PSA progression. Definitive extrapelvic nodal or distant metastatic disease on staging investigations.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
Male

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: Arm 1<br>Pelvic SABR with intra-prostatic SABR | Radiation: Pelvic SABR with intra-prostatic SABR<br>* described elsewhere<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To document the number of patients with grade 3 or higher acute urinary and/or bowel toxicity using the Common Terminology Criteria for Adverse Events (CTCAE v4.0) criteria |  | 3 months after accrual target is reached |
Closing Uterine Incision During C-section Using Barbed Suture (Stratafix) or Vicryl Suture.

Study Overview
=================
Brief Summary
-----------------
A Randomized prospective single blinded trial. The investigator seek to evaluate the surgical outcome of Stratafix barbed suture compared to standart Vicryl sutures in reducing the suturing time during C-Section.

Detailed Description
-----------------
A Randomized prospective single blinded trial. The investigator seek to evaluate the surgical outcome of Stratafix barbed suture compared to standart Vicryl sutures in reducing the suturing time during C-Section. In addition, the need of additional sutures to control bleeding after the 2- layer closure will be estimated.These will be the primary outcome measures. The secondary outcome measures will be factors related to the blood loss at the time of the uterine closure, surgical complications, duration of hospital stay, postoperative infection (endometritis) and wound infection..

Official Title
-----------------
Closing Uterine Incision During C-section Using Barbed Suture (Stratafix) or Vicryl Suture: a Randomized Control Study

Conditions
-----------------
Cesarean Section

Intervention / Treatment
-----------------
* Device: Stratafix suture
* Device: Vicryl suture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Pregnant patients with an obstetrical indication for delivery by Cesarean section Exclusion Criteria: • Patients with blood clotting disorders.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 42 Years

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

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

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

Design Details

Primary Purpose: Device Feasibility
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stratafix suture<br> | Device: Stratafix suture<br>* Stratafix barbed sutures during C-Sections.<br>|
| Active Comparator: Vicryl suture<br> | Device: Vicryl suture<br>* Standart Vicryl suture during C- Sections.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time required for uterine closure. | Time measured in minutes and seconds | From the beginning of first uterine suture till the last suture ending uterine incision complete closure and any additional hemostatic sutures if applicable. The estimated period of time is 8 minutes (average). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood loss during uterine closure | Intraoperative during uterine closure and by blood work during post-operative hospital stay | Estimated period of time is 4 days. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Suture, Cesarean section, C- section