linjc16/ctgov huggingface dataset:
Evaluation of a New Blood Pressure Measuring Device.

Study Overview
=================
Brief Summary
-----------------
A disposable blood pressure measuring device will be tested and compared to a standard mercury sphygmomanometer. Up to 100 subjects with various levels of blood pressure values will be tested.

Detailed Description
-----------------
The study will comprise 85 to 100 subjects with blood pressure values ranging between 90 and 170mmHg -systolic and 65-95 -diastolic. Three sets of measurements will be performed on each subject. The measurement with the tested device placed between twh determinations with a mercury sphygmomanometer. Each measurement will be performed simultaneously by two examiners specially trained. Informed consent will be obtained from all participants. The results will be evaluated by a standard statistical plan ANSI/AAMI SP-10 2002.

Official Title
-----------------
A Study to Evaluate the Safety and Effectiveness (Overall Performance) of the Press-O-Sense Non-Invasive Blood Pressure Measuring Device.

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

Intervention / Treatment
-----------------
* Device: Blood pressure measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, age 18 years or above Signed written informed consent Exclusion Criteria: A history of cardiac arrythmia Wrist circumference smaller than 13cm or larger than 19.5cm Documented peripheral vascular disease Damage or injury to the left wrist Participation in any other clinical study Any acute coronary of cardiovascular illness

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: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Blood pressure measurement|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference between the paired measurements with the tested device and the reference measurements (with a mercury sphygmomanometer) will differ by no more than +-5mmHg. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, Hypotension
Point-of-Care Testing of Coagulation in Patients Treated With Direct Oral Anticoagulants 1

Study Overview
=================
Brief Summary
-----------------
The investigators study aims to test the correlation between the CoaguChek point-of-care testing (POCT) device (Roche, Switzerland) and low plasma levels of all three currently approved direct oral anticoagulants (DOAC; rivaroxaban, apixaban and dabigatran) and to determine the diagnostic accuracy of POCT to rule out or detect relevant levels of DOAC in real-life stroke patients.

Official Title
-----------------
Point-of-Care Testing of Coagulation in Patients Treated With Direct Oral Anticoagulants 1

Conditions
-----------------
Anticoagulation With Direct Oral Anticoagulants

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stroke patients, who were newly started on oral anticoagulation with rivaroxaban, apixaban or dabigatran for secondary prevention of thromboembolic events Age ≥ 18 years Exclusion Criteria: Vitamin K antagonists or direct oral anticoagulants ≤ 14 days prior to study participation Low-molecular weight heparin ≤ 24 hours Unfractionated heparin ≤ 12 hours Abnormal coagulation values at baseline (Quick < 70% or activated thromboplastin time (aPTT) > 40sec.) History of coagulopathy

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 |
| --- | --- |
| Rivaroxaban<br>N=20 | |
| Apixaban<br>N=20 | |
| Dabigatran<br>N=20 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect/Correlation of direct oral anticoagulants (DOAC) on CoaguChek point-of-care testing (POCT) result | DOAC concentrations determined by ultra-performance liquid chromatography-tandem mass spectrometry | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of the CoaguChek POCT to rule out or detect relevant DOAC levels |  | 24h | 
| Effect/Correlation of DOAC on prothrombin time (PT), activated thromboplastin time (aPTT), anti-Xa activity and Hemoclot assay |  | 24h |
Pulmonary Vein (PV) Isolation Versus Box Isolation for the Treatment of Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
Curative catheter ablation has been established as an effective therapeutic option for atrial fibrillation (AF) that is resistant to pharmacologic rhythm or rate control. However, standard ablative approaches targeting the pulmonary veins (PVs) are associated with a success rate as low as 40%. In a recent study, Kumagai et al. described a new approach of catheter ablation of AF isolating the posterior left atrium including all PVs (called Box Isolation). In Kumagai's study, 46 patients with symptomatic AF underwent box isolation. At 6 months follow up, 43 of 46 patients (93%) were arrhythmia free without antiarrhythmic drugs, with a single procedure success rate of 87% (40/46). This study provided new evidence supporting the hypothesis that the posterior wall is of high importance for the maintenance of AF. The aim of the investigators study is to determine the efficacy of two different approaches of catheter ablation (Standard PV Isolation vs. Box isolation) for the treatment of chronic AF.

Official Title
-----------------
PV Isolation Versus Box Isolation for the Treatment of Atrial Fibrillation

Conditions
-----------------
Atrial Fibrillation, Radiofrequency Ablation

Intervention / Treatment
-----------------
* Procedure: usual PV ablation
* Procedure: Box isolation of pulmonary veins


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing clinically indicated pulmonary vein ablation for atrial fibrillation. Exclusion Criteria: Unable to understand consent form. Not scheduled for clinically indicated pulmonary vein ablation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: usual ablation<br>Wide-area circumferential ablation of the pulmonary veins | Procedure: usual PV ablation<br>* usual PV ablation, per above<br>|
| Experimental: Box isolation of the pulmonary veins<br>Single Box lesion set encompassing all four pulmonary veins and the posterior wall of the left atrium. | Procedure: Box isolation of pulmonary veins<br>* as above<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| freedom from atrial fibrillation |  | 3 months following ablation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety of Box isolation |  | 3 months following procedure |
Vaccination Priming and Vaccine Boosting Trial of Allogeneic Human GM-CSF Gene Transduced Irradiated Prostate Cancer Cell Vaccines (GVAX® Vaccine for Prostate Cancer)

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the safety and efficacy of priming vaccinations, and subsequent boosting vaccinations with GVAX® Vaccine for Prostate Cancer. Clinical observations and laboratory measurements will be monitored to evaluate safety and toxicity. Additionally, the antitumor effects of GVAX® Vaccine for Prostate Cancer on serum PSA levels, will be evaluated and antitumor responses will be quantitated.

Official Title
-----------------
Phase I/II Study of Vaccination Priming and Vaccine Boosting With Allogeneic Human GM-CSF Gene Transduced Irradiated Prostate Cancer Cell Vaccines in Patients With Prostate Cancer

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

Intervention / Treatment
-----------------
* Biological: Immunotherapy allogeneic GM-CSF secreting cellular vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of adenocarcinoma prostate cancer that has recurred after surgery by PSA No evidence of measurable metastatic disease An ECOG performance status of 0 or 1 Exclusion Criteria: Transitional cell, small cell or squamous cell prostate carcinomas Any previous radiation therapy, prior anti-androgens or prior investigational therapy Previous hormonal therapy of any type for prostate cancer Previous biological therapy for cancer

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Immunotherapy allogeneic GM-CSF secreting cellular vaccine|nan|

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
-----------------
Vaccine, Cancer, Prostate, GVAX, Allogeneic cells
Health, Fitness, and Quality of Life in Adolescent Girls With Turner Syndrome

Study Overview
=================
Brief Summary
-----------------
This study plans to learn more about how the energy system works in girls with Turner syndrome. This is important to know so that the investigators understand how Turner syndrome relates to diseases such as diabetes, extra weight gain, heart disease and liver disease, and how this impacts day to day life.

Official Title
-----------------
Pilot Study of Health, Fitness, and Quality of Life in Adolescent Girls With Turner Syndrome

Conditions
-----------------
Turner Syndrome, Turner Syndrome Mosaicism, 45, X/46, XX or XY, Turner Syndrome Mosaicism 46,X,I(X)(Q10)/45,X, Turner Syndrome Karyotype 46,X With Abnormal Sex Chromosome , Except I(Xq)

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female Age 12-21 years 45,XO karyotype in >50% of cells tested with a diagnosis of Turner syndrome (TS) Tanner stage 2-5 for breast development Exclusion Criteria: Growth hormone treatment within the past 3 months Diagnosis of type 1 or type 2 diabetes Untreated hypertension with blood pressure > 99%ile for sex, age and height or >140/90 Weight > 300 lbs Height < 54 Aortic sinus of Valsalva or ascending aorta z-score > 2 Other cognitive, psychiatric, or physical impairment resulting in inability to tolerate the study procedures, including vigorous exercise Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 21 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adolescents<br>Adolescents and young adults with Turner syndrome will undergo studies of cardiometabolism, fitness, quality of life questionnaires, and a brief interview. | Other: No intervention<br>* No intervention<br>|
| Parents<br>One parent of a participant will complete parent-report quality of life questionnaires and a brief interview. | Other: No intervention<br>* No intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak oxygen consumption | Peak oxygen consumption (VO2 peak) with a standard graded exercise (bicycle) test | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life Survey | Self and parent reported quality of life | Baseline | 
| Percent body fat | Body composition by dual-energy x-ray absorptiometry | Baseline | 
| Insulin resistance (IR) | Fasting insulin and glucose used to calculate homeostatic model assessment (HOMA) | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Turner syndrome, 45,XO, body composition, cardiometabolism, quality of life, fitness
Impact of Implant Insertion Torque on Peri-implant Bone Level.

Study Overview
=================
Brief Summary
-----------------
Observational study with one single arm. The purpose of this study was to evaluate the impact of the insertion torque and of the implant stability on the marginal bone level changes for dental implants placed into healed ridges.

Detailed Description
-----------------
The primary outcome would be to evaluate the peri-implant bone level changes (marginal bone level) around the implant platform. The secondary outcomes would be: To evaluate the Implant Stability Quotient (ISQ) changes according to the measurements performed with the instrument Penguin RFA To evaluate the implant and prosthetic failure rate as well as the implant and prosthetic complication rates The patient satisfaction related to the implant treatment

Official Title
-----------------
Impact of Implant Insertion Torque on Peri-implant Bone Level.

Conditions
-----------------
Implant Complication

Intervention / Treatment
-----------------
* Device: Penguin RFA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All partially edentulous patients requiring simple Implant placement, being at least 18-year-old and able to sign an informed consent, The patients that will be enrolled must have a bone quantity that allows the placement of regular implants according to the radiographic evaluations (pre-operative radiographic examination). Exclusion Criteria: Heavy smokers (more than 10 cigarettes/day). Immunosuppressed or immunocompromised patients Uncontrolled diabetes Active periodontal disease Patients with a full mouth marginal bleeding score higher than 20% Addiction to alcohol or drugs Psychiatric problems Severe caries, periapical lesions, acute infection (abscess) Immediate post-extractive implants (at least 2 months after extraction have to elapse) Patients unable to commit to 3-year follow-up. Patients treated or under treatment with intravenous amino- bisphosphonates. Patients participating to other studies, if the present protocol could not be fully adhered to.

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 |
| --- |
|Device: Penguin RFA|to evaluate the peri-implant bone level changes (marginal bone level) around the implant platform.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| radiographic marginal bone level changes around the implant platform | the changes (in mm) of the marginal bone level around the implant platform | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant Stability Quotient (ISQ) changes | the measurements will be performed with the instrument Penguin RFA | 3 years |
Feasibility Study of HIPEC for Patients With Stage III or Only Pleural Stage IV Ovarian Carcinoma in First Line Therapy

Study Overview
=================
Brief Summary
-----------------
First line treatment for advanced ovarian carcinoma hyperthermic intraperitoneal chemotherapy (HIPEC) after optimal debulking.

Detailed Description
-----------------
Addition of HIPEC to the standard first line treatment of ovarian carcinoma.

Official Title
-----------------
Feasibility Study of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Patients With Stage III or Only Pleural Stage IV Ovarian Carcinoma in First Line Therapy

Conditions
-----------------
Ovarian Carcinoma, Fallopian Tube Carcinoma, Primary Peritoneal Carcinoma

Intervention / Treatment
-----------------
* Procedure: HIPEC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: stage III or only pleural stage IV ovarian carcinoma first line treatment Exclusion Criteria: incomplete surgery poor performance status bad general condition

Ages Eligible for Study
-----------------
Minimum Age: 18 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: HIPEC surgery with chemotherapy<br>3 courses of pre-operative chemotherapy: carboplatin AUC = 5 IV + paclitaxel 175 mg/m2 IV every 3 weeks Debulking surgery HIPEC with cisplatin 50 mg/m2 intraperitoneally at the end of surgery 3 courses of post-operative chemotherapy: carboplatin AUC = 5 IV + paclitaxel 175 mg/m2 IV every 3 weeks | Procedure: HIPEC<br>* HIPEC with cisplatin 50 mg/m2 intraperitoneally at the end of surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality rate | We will record the mortality rate of our interventions: 3 cycles of pre-operative chemotherapy, surgery and HIPEC, 3 cycles of post-operative chemotherapy. | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival |  | 3 years | 
| Overall survival |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIPEC, ovarian carcinoma, Bordet
Pain Types and Pain Severity in Chronic Neck Pain

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to characterize the distribution of pain phenotypes in people with chronic neck pain and to determine the effects of pain phenotypes on pain severity, functional status and quality of life. Participants will be examined to determine the type of pain and questions will be asked to assess pain severity and impact.

Official Title
-----------------
The Effects of Pain Types on Pain Severity and Quality of Life in Chronic Neck Pain

Conditions
-----------------
Chronic Neck Pain

Intervention / Treatment
-----------------
* Diagnostic Test: Visual Analogue Scale


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: having chronic neck pain be over 18 years old Exclusion Criteria: those under the age of 18 Those with major psychiatric illness, Those with communication problems

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Visual Analogue Scale|pain type severity determination and quality of life assessment|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| identification of pain types(determination of nociceptive, neuropathic, nociplastic pain rates) | Neuropathic pain with PainDETECT scale, Clinical criteria and rating system for nociplastic pain affecting the musculoskeletal system nosplastic pain will be evaluated | 01.06.2023 | 
| determination of pain intensity and effects(Pain severity,quality of life,disability,pain status) | Pain severity with Visual Analogue Scale, quality of life with SF-36, disability with Neck Disability İndex, pain status with Pain Catastrophizing Scale | 01.06.2023 |
Minimizing Ventricular Pacing

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the effect of minimizing right ventricular pacing in dual-chamber pacemaker patients with sinus node disease (SND) and first degree atrioventricular block (AVIB)on exercise capacity, quality of life and other heart failure measures.

Official Title
-----------------
Minimizing Right Ventricular Pacing in Dual-chamber Pacemaker Patients With Sinus Node Disease and First Degree Atrioventricular Block.

Conditions
-----------------
Sinus Node Disease., First Degree Atrioventricular Block.

Intervention / Treatment
-----------------
* Device: Prolonging atrioventricular (AV) delay.
* Device: Standard atrioventricular (AV) delay.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: prolonged PQ interval > 200 ms, percentage of right ventricular pacing with standard AV delay > 90. Exclusion Criteria: second or third degree atrioventricular block, permanent atrial fibrillation.

Ages Eligible for Study
-----------------
Minimum Age: 40 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Long AV delay.<br> | Device: Prolonging atrioventricular (AV) delay.<br>* Prolonging atrioventricular (AV) delay to maximum 350 ms.<br>|
| Active Comparator: Short AV delay.<br> | Device: Standard atrioventricular (AV) delay.<br>* Standard atrioventricular (AV) delay - approximately 180/140 ms depending on heart rate.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen uptake (cardiopulmonary exercise testing). |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular ejection fraction. | Assessed in echocardiography. | 3 months | 
| Quality of life | SF36 questionnaire. | 3 months | 
| Arrhythmia | 24 hours Holter monitoring, pacemaker storage data. | 3 months | 
| Ventilatory anaerobic threshold (cardiopulmonary exercise testing) |  | 3 months | 
| VE/VCO2 slope (cardiopulmonary exercise testing). |  | 3 months |