linjc16/ctgov huggingface dataset:
A Comparative Clinical Study to Assess the Accuracy of TensorTip MTX, a Non Invasive Device

Study Overview
=================
Brief Summary
-----------------
Aim- This study is aimed to access the accuracy of TensorTip MTX device measuring Hemoglobin A1C, Oxygen Concentration and Saturation ,Carbon Dioxide, Blood pH, Hemoglobin, Hematocrit, Red Cells Count, platelets, Blood Urea Nitrogen, Sodium, Potassium, Chloride, total bilirubin, cholesterol (HDL, LDL), Serum Creatinine, Peripheral Pulse Rate, Blood Pressure, Mean Arterial Pressure, cardiac output, cardiac index, stoke volume and blood gases compared with the simultaneous results from hospital references device (when available) Hypothesis- Human physiological biomarkers may be measured from the color distribution of the internal or external (skin) tissue. The technology of the TensorTip device is based on the color distribution of the peripheral blood tissue, which enables the measurement of certain biomarkers and vital signs under consideration

Detailed Description
-----------------
This is a comparative clinical trial in which the measurements obtained by the TensorTip device will be compared with those obtained by the reference devices used by the hospital on daily or periodic monitoring (the devices will be identified by name and version at the final report). Eligible real time color signal obtained by the TensorTip during the measurement shall be recorded simultaneously with the measurements obtained by the reference devices (as described in the above point).

Official Title
-----------------
A Comparative Clinical Study to Assess the Accuracy of TensorTip MTX, a Non Invasive Device for the Measurement of Physiological and Hematological Parameters

Conditions
-----------------
Blood Pressure

Intervention / Treatment
-----------------
* Device: TensorTip


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, age > 18 Agree to sign voluntary inform consent. Exclusion Criteria: Refusal to sign an informed consent and to participate in the study. Below the age of 18. Finger size not suitable for the measurement chamber. Injured skin in the measurement site. Long fingernails

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group A TensorTip<br>Male or female, age > 18 | Device: TensorTip<br>* Non Invasive screening of various physiological and hematological parameters.<br>* Other names: SoftTouc;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood pressure measurement of the TensorTip against hospital readings |  | 3 months |
Study to Observe Safety of Xarelto in VTE Prophlylaxis After Elective TKR (Total Knee Replacement) or THR (Total Hip Replacement)

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to evaluate the safety of Xarelto in the prophylaxis of VTE in Indian patients undergoing elective TKR/THR

Official Title
-----------------
Xarelto in the Prophylaxis of Post Surgical Venous Thromboembolism After Elective Major Orthopedic Surgery or Hip or Knee in Indian Patients

Conditions
-----------------
Prophylaxis, Thromboembolism, Venous, Total Knee Replacement, Total Hip Replacement

Intervention / Treatment
-----------------
* Drug: Rivaroxaban (Xarelto, BAY59-7939)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients of either sex, undergoing elective THR/TKR, in whom, Rivaroxaban is given for thromboprophylaxis Patients willing to give a written informed consent Exclusion Criteria: Exclusion criteria must be read in conjunction with the local product information Patients on UFH / LMWH therapy, fondaparinux and vitamin K antagonists are not eligible. Patients with history of hypersensitivity to active ingredients or excipient :cellulose microcrystalline, croscarmellose sodium, lactose monohydrate, magnesium stearate, sodium lauryl sulfate

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 |
| --- | --- |
| Group 1<br> | Drug: Rivaroxaban (Xarelto, BAY59-7939)<br>* The treatment with Xarelto 10mg tablets should comply with the recommendations. Rivaroxaban 10mg OD, 6-10 hours post-op, provided hemostasis has been achieved, for a period of 2 weeks (TKR) & 5 weeks (THR)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety related variables are bleeding events reported as major or non-major adverse events |  | 3 months after the day of surgery | 
| Symptomatic thromboembolic events (Deep vein thrombosis, Pulmonary embolism) reported as adverse events |  | 3 months after the day of surgery | 
| All cause mortality |  | 3 months after the day of surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Xarelto, Thromboembolism, Venous, Orthopedic surgery, Factor Xa inhibitor, Observational study
Sensory Processing in Subjects With Painful Bladder Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if clinically relevant subsets exist in patients meeting the diagnosis of Painful Bladder Syndrome (PBS). Subsets suggest differential responses to treatments and if verified, this will be important for the stratification of patients in clinical studies related to PBS.

Detailed Description
-----------------
Patients with the diagnosis of painful bladder syndrome (PBS) constitute two or more phenotypes that are distinguished by differential neurophysiological processing of sensory information. Further, these differing phenotypes can be predicted by the presence or absence of the co-morbidity fibromyalgia.

Official Title
-----------------
Sensory Processing in Subjects With Painful Bladder Syndrome

Conditions
-----------------
Painful Bladder Syndrome

Intervention / Treatment
-----------------
* Other: Physical examination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: NIDDK criteria for Painful Bladder Syndrome Age 19 years or older Must be able to read and speak English since testing materials are validated in English Exclusion Criteria: PBS subjects must be independent of co-existing pain disorders or use of medications Uncontrolled hypertension or significant cardiopulmonary disease No chronic daily pain Older than 75 years of age

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 75 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 |
| --- | --- |
| Healthy subjects<br> | Other: Physical examination<br>* Physical examination and multiple questionnaires will be administered<br>|
| PBS subjects<br> | Other: Physical examination<br>* Physical examination and multiple questionnaires will be administered<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| This study proposes to examine the sensations that are produced by warming the skin, poking the skin, pressure on muscles and by applying a blood pressure cuff. |  | One and half to two hours. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Painful Bladder Syndrome, Urinary Bladder
European Study of Dronedarone in Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the efficacy of dronedarone for the control of ventricular rate at rest and during exercise in patients with atrial fibrillation (AF) and to assess the tolerability of dronedarone in the target population.

Official Title
-----------------
Efficacy and Safety of Dronedarone for the Control of Ventricular Rate During Atrial Fibrillation (ERATO)

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Drug: Dronedarone (SR33589)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with symptomatic permanent AF (>6 months) for which cardioversion is not considered and resting ventricular rate > or equal 80 bpm at screening measured on a 6-seconds rhythm strip, Exclusion Criteria: Unstable angina pectoris, recent myocardial infarction or history of torsades de pointes Third degree atrioventricular block at the screening ECG or significant sinus node disease without a permanent pacemaker implanted Clinically overt congestive heart failure at randomization Patients treated with amiodarone, other antiarrhythmic drugs or previous participation in this trial or in other dronedarone trials or taking an investigational drug Clinically relevant haematologic, hepatic, gastro-intestinal, renal, pulmonary, endocrinologic or psychiatric disease Pregnant and/or breastfeeding women or women of child-bearing potential with no adequate birth control The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Dronedarone (SR33589)<br> <br> |
| Placebo Comparator: 2<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in mean ventricular rate at rest and during exercise |  | Day 14 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart disease
The Optimization of Medications in Chronic Heart Failure Using a Website

Study Overview
=================
Brief Summary
-----------------
Heart failure (HF) is the most common hospital discharge diagnosis among older adults in the United States. Strikingly, 2 in 5 patients are readmitted within 1-year following their first HF admission. This results in significant potentially avoidable costs to our already strained healthcare system since hospitalizations result in 70% of yearly HF management costs. One of the most common causes of readmission is lack of medication optimization. This study will determine the effectiveness of a medication optimization website.

Detailed Description
-----------------
In a prospective design, 100 patients will be randomized to the intervention or usual care in a 1:1 fashion. Patients randomized to the intervention will receive an evidence-based medication recommendation intervention. Outcome measures will be collected at baseline and at 2 weeks post-intervention.

Official Title
-----------------
The Optimization of Medications in Chronic Heart Failure Using a Website

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Other: Med Optimization Arm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: left ventricular ejection fraction (LVEF) </= 40% Exclusion Criteria: pregnancy active cancer with a life expectancy less than 12 months hospice chronic inotropic therapy

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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medication Optimization Group<br>Patients randomized to the medication optimization group will receive an evidence-based medication recommendation intervention. | Other: Med Optimization Arm<br>* An evidence-based medication recommendation website that is provided to the patients.<br>|
| No Intervention: Control Group<br>Patients in the control group will receive the same intervention, delayed 2 weeks after the intervention group. During those initial 2 weeks they will act as a control. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in medications will be measured by the Evidence Based Medicine Percent Score (EBMPS). | The Evidence Based Medicine Percent Score (EBMPS) is calculated by the medications and doses the patient is taking (in points) divided by the total eligible medications based on the evidence (in points). | Change over 2 weeks |
Active Monitoring And Determinants of Incidence Infection of COVDI-19

Study Overview
=================
Brief Summary
-----------------
7. Objectives To apply e-health methods to perform active monitoring and assess determinants of incident Infection of COVID-19 in a hospital population. 8. Study design Prospective, Single-centre, observational clinical study. 9. Disease or disorder under study Healthy people in risk of COVID-19 infection. 10. Main variable. Symptoms related to infection caused by SARS-Cov2. 11. Study population and total number of patients Men and women in general god health status aged between 18 and 80 years that currently are employees of Hospital de La Princesa . 12. Duration of treatment Each subject will be monitored, since its recruitment, for a period of 12 weeks. 13. Timetable and expected date of completion The overall duration of the study is estimated at about 6 months, from patient recruitment to the last data recorded by last subject. The aim is to carry out this study from March 2020 onwards.

Official Title
-----------------
Active Monitoring And Determinants of Incidence Infection of COVDI-19 in a Hospital Population (AMADIICH) Study Protocol

Conditions
-----------------
Coronavirus Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subject age ≥ 18 years. The subject has no symptoms in last week of COVID-19 infection such as: Body temperature ≤ 37, 1 ºC. Normal lung and breath functions. The subject belongs to the Hospital de La Princesa workforce. Exclusion Criteria: 1. People with any symptom suspicious of COVID-19 infection.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Hospital de la Princesa employees<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COVID-19 App-based platform | The primary objective of this trial is to investigate whether the use of a cell phone App-based platform is a useful tool to monitor the symptoms of a population in risk of SARS-Cov2 infection. The final aim is to assess determinants of incidence of infection of COVID-19 in people working in Hospital during the pandemia of SARS-Cov-2. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COVID-19 infection | To monitor in real-time COVID-19 symptoms in the hospital workforce, which are a proxy of incident infection (Step 1) To identify in real-time clusters of COVID-19 symptoms and to facilitate control measures. To determine the incidence of new infection of COVID-19. To identify the determinants and risk/protective factors associated with this infection, in a workforce hospital population free of COVID-19 at the start of our study. | 6 months |
Mandibular Advancement Devices Tali® in Patients With Syndrome of Obstructive Sleep Apnea and Hypopneas

Study Overview
=================
Brief Summary
-----------------
The main objective is to evaluate middle term compliance (≥ 2 years) of the Mandibular Advancement Devices Tali® in patients with Syndrome of Obstructive Sleep Apnea and Hypopneas.

Conditions
-----------------
Syndrome of Obstructive Sleep Apnea and Hypopneas

Intervention / Treatment
-----------------
* Device: Mandibular Advancement Devices


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients > 18 years treated with Mandibular Advancement Device Tali® from at least 2 years and at the latest 5 years. Patients who agree to participate to the study.

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Mandibular Advancement Devices|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| compliance (no stop of the Mandibular Advancement Device) |  | 2 years or more after the beginning of device |
Clinical Evaluation of Two New Silicone Hydrogel Multifocal Products

Study Overview
=================
Brief Summary
-----------------
The objective of this trial is compare the visual performance, ratings, and preference of two multifocal, soft contact lenses.

Official Title
-----------------
Clinical Evaluation of Two New Silicone Hydrogel Multifocal Products

Conditions
-----------------
Presbyopia

Intervention / Treatment
-----------------
* Device: Lotrafilcon B
* Device: Senofilcon A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be at least 35 years of age Best-corrected distance visual acuity of at least 20/40 in each eye. Spectacle add between +0.75D and +1.50D (inclusive). Able to be fit in available study sphere powers (-1.00 to -5.00D) Currently wearing soft contact lenses at least 5 days a week. Other protocol inclusion/exclusion criteria may apply. Exclusion Criteria: Eye injury or surgery within twelve weeks immediately prior to enrollment. Currently enrolled in an ophthalmic clinical trial. Evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions. Any use of medications for which contact lens wear could be contraindicated as determined by the investigator. Astigmatism ≥ 1.00D. Currently wearing either of the study products. Other protocol inclusion/exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 35 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Lotrafilcon B / Senofilcon A<br>Lotrafilcon B, followed by Senofilcon A | Device: Lotrafilcon B<br>* Silicone hydrogel, soft, multifocal contact lens<br>Device: Senofilcon A<br>* Silicone hydrogel, soft, multifocal contact lens<br>|
| Other: Senofilcon A / Lotrafilcon B<br>Senofilcon A, followed by Lotrafilcon B | Device: Lotrafilcon B<br>* Silicone hydrogel, soft, multifocal contact lens<br>Device: Senofilcon A<br>* Silicone hydrogel, soft, multifocal contact lens<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity | Tested while reading charts distant to the subject with both eyes together in normal lighting. This outcome is measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 equates to 20/20 Snellen acuity and is considered normal. Positive logMAR values indicate poorer vision and negative values denote better visual acuity. | After 1 week of wear |