linjc16/ctgov huggingface dataset:
Positive End-expiratory Pressure and Esophageal Catheter Optimal Calibration Volume in ARDS Patients

Study Overview
=================
Brief Summary
-----------------
The use of esophageal balloon catheter to estimate pleural pressure has gained renewed popularity in recent years. Indeed, measurement of transpulmonary pressure may allow a more pathophysiological-based approach to ventilator strategy in acute respiratory distress syndrome (ARDS) patients. Nevertheless, it is well known that esophageal balloon catheter derived parameters can be influenced by several patient-related or technical-related factors. During a PEEP trial, the investigators will observe in-vivo the esophageal pressure and derived measurements obtained using different esophageal balloon calibration volumes.

Official Title
-----------------
Positive End-expiratory Pressure and Esophageal Catheter Optimal Calibration Volume in ARDS Patients

Conditions
-----------------
ARDS

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of ARDS with a PEEP of at least 8 cmH2O Fraction of inspired oxygen not higher than 80% Intubated and ventilated in Volume Control Ventilation mode set by the attending physician according to clinical criteria Need of continuous sedation through intravenous anesthetics and full neuromuscular blockade Exclusion Criteria: Been pregnant or breastfeeding Hemodynamic instability Presence of tracheobronchial fistula Known pneumothorax Leak in airway circuitry Presence of any kind of inhalator therapy (e.g. Heliox, nitric oxide, anesthetic conserving device) Recent history of nasal trauma or lesion of nasal cavity Recent history of esophageal, gastrointestinal, ENT, thoracic or cardiac surgery (less than 2 months) Known or suspected esophageal varices Congenital, acquired or drug-induced hemostatic disorder Thrombocytopenia (less than 50000/mm3) Recent history of Traumatic Brain Injury or thoraco-abdominal trauma (less than 1 months) Rib or sternal fractures

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 |
| --- | --- | --- |
| transpulmonary pressure measured estimating pleural pressure through the esophageal balloon |  | within 10 minutes after esophageal balloon volume changing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| End-expiratory lung volume |  | within 60 minutes after PEEP changing |
An Interventional Study of Avastin (Bevacizumab) in Patients With Advanced/Metastatic Epithelial Ovarian Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer

Study Overview
=================
Brief Summary
-----------------
This multicenter prospective study will evaluate the safety and efficacy of Avastin (bevacizumab) in routine clinical practice in patients with advanced/metastatic epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer. Data will be collected from eligible patients until death, withdrawal of consent, loss to follow-up, or study closure.

Official Title
-----------------
An Indian Multicentric, Open Label, Prospective Phase 4 Study of Bevacizumab in the Front Line Management of Advanced/Metastatic Epithelial Ovarian Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer in Real-life Clinical Practice

Conditions
-----------------
Ovarian Neoplasms, Peritoneal Neoplasms, Fallopian Tube Neoplasms

Intervention / Treatment
-----------------
* Drug: Bevacizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Prescribed to receive bevacizumab or already ongoing on treatment with bevacizumab for advanced/metastatic ovarian cancer, fallopian tube cancer or primary peritoneal cancer (FIGO Stage IIIb, IIIc and IV) according to routine clinical practice Exclusion Criteria: Not eligible for treatment with bevacizumab according to the local prescribing information

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: Cohort<br> | Drug: Bevacizumab<br>* Participants will receive five cycles of bevacizumab 15 mg/kg concurrently with six cycles of the standard chemotherapy every three weeks (q3w), followed by extended cycles of bevacizumab 15 mg/kg q3w as a single agent for additional 16 cycles. A total of 21 cycles of bevacizumab will be administered in this study.<br>* Other names: Avastin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Incidence of adverse events |  | up to approximately 1.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | up to approximately 1.5 years | 
| Overall survival |  | up to approximately 1.5 years | 
| Overall response rate (complete response + partial response) |  | up to approximately 1.5 years | 
| Clinical benefit rate (complete response + partial response + stable disease) |  | up to approximately 1.5 years |
Role of the Catechol-O-methyltransferase (COMT) in the Physiological Regulation of Vigilance

Study Overview
=================
Brief Summary
-----------------
In this study, pharmacologic effects of COMT inhibition during sleep deprivation in healthy subjects in dependence of their Val158Met genotype of COMT are studied. Potential effects are identified by measurement of vigilance and cognitive performance as well as EEG measurements during wake and sleep. Trial with medicinal product

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled Examination of the Effects of Tolcapone (TASMAR) on Vigilance in Healthy Volunteers After Sleep Deprivation

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Tolcapone
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Healthy male subjects Age: 20-30 years written informed consent right handed non smoker Exclusion criteria: sleep disturbances irregular sleep-wake rhythm travelling with time-shift liver diseases (ALT: > 82 U/l; AST: > 76 U/l) diseases of the nervous system acute internal medicine diseases medication or drug abuse intake of more than 3 caffeine-containing drinks intake of more than 5 alcoholic drinks per week heart pacemaker or implanted medical devices Body-Mass-Index (BMI): 20< BMI >26

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 30 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tolcapone<br>Tasmar | Drug: Tolcapone<br>* 2 x 100mg Tolcapone compared to placebo (randomized, double-blind, cross-over)<br>* Other names: Tasmar;Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of vigilance during prolonged wakefulness after intake of tolcapone when compared to placebo | Vigilance is measured subjectively (questionnaires and visual analogue scales) and objectively (e.g., psychomotor vigilance task: reaction times and number of lapses; waking EEG: spectral power) at 3-hour intervals during 40 hours prolonged wakefulness in 30 healthy male adults. | Participants will be studied during two weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sleep-wake, regulation, volunteers
Retrospective Evaluation of Clinical Performance of the Astra Tech Implant System EV When Used in Everyday Practice

Study Overview
=================
Brief Summary
-----------------
This study is designed as a retrospective, multi-center study. The study population consist of subjects who received one or more OsseoSpeed EV implants during the period January 1st 2015 to December 31st 2016. Two hundred subjects will be enrolled, approximately 25-30 subjects per site. The study includes retrospective data collection from subjects' medical records and data collection from one prospective study visit with a clinical examination.

Official Title
-----------------
Retrospective Evaluation of Clinical Performance of the Astra Tech Implant System EV When Used in Everyday Practice

Conditions
-----------------
Dental Implants

Intervention / Treatment
-----------------
* Device: OsseoSpeed EV implant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject ≥ 18 years at time of implant installation. Subject signed and dated the informed consent form. Having installed one or more OsseoSpeed EV implants between January 1st 2015 and December 31st 2016. Exclusion Criteria: Unlikely to be able to comply with study procedures, according to Investigator's judgement. Subject is not willing to participate in the study or not able to understand the content of the study. Involvement in the planning or conduct of the study. Simultaneous participation in another clinical study that may interfere with the present study. Severe non-compliance to CIP as judged by the Investigator and/or Dentsply Sirona Implants.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: OsseoSpeed EV implant|The investigational product (OsseoSpeed EV implant) is already included in a restoration in the subject at enrollment, thus this study does not involve the installation of any investigational products.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of survived implants at time of the follow-up visit | Survival defined as implant in situ at time of the follow-up visit. Primary analysis will be performed on implant level. | Minimum of 2 years of use up to a maximum of around 4½ years of use | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
EV, OsseoSpeed
Physical Activity for a Long and Healthy Life

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to 1) delineate the molecular mechanisms behind the large variation in insulin sensitivity among apparently healthy subjects and to 2) establish the dose-response relationship between physical training and a) metabolic health, b) appetite and c) cultural health.

Official Title
-----------------
Physical Activity for a Long and Healthy Life - Project FINE

Conditions
-----------------
Overweight, Insulin Resistance, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Behavioral: Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy according to interview Caucasian Sedentary, Vo2max < 45 ml/kg/min BMI 25-30 kg/m2 Fat percentage 25% < Weight stable (+/- 2 kg within past 6 months) Exclusion Criteria: First degree relatives with type 2 diabetes Hemoglobin concentration < 8 mmol/l Fasting plasma glucose 6.1 mmol/l < Blood pressure 140/90 mmHg < Regular intake of medicine

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 600 kcal/day<br>Exercise combusting 600 kcal/day, 7 days/week for 12 weeks. | Behavioral: Exercise<br>* Daily exercise for 12 weeks.<br>|
| Experimental: 300 kcal/day<br>Exercise combusting 300 kcal/day, 7 days/week for 12 weeks. | Behavioral: Exercise<br>* Daily exercise for 12 weeks.<br>|
| No Intervention: Sedentary<br>Continued sedentary living. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in insulin sensitivity at 12 weeks | As measured by a hyperinsulinemic, isoglycemic clamp combined with skeletal muscle and adipose tissue biopsies as well as low-dose PET/CT. | At baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in body composition af 2, 6 and 12 weeks | As measured by DEXA- and MRI-scanning. | At baseline, 2, 6 and 12 weeks | 
| Change from baseline in appetite at 12 weeks | As measured by food records, controlled diets, meal tests and appetite hormones | At baseline and 12 weeks | 
| Motivational factors for exercise | Ethnographic field work | During and for up to 1½ year after the intervention | 
| Diameter of t-tubuli in skeletal muscle | As measured in skeletal muscle biopsies by electron and confocal microscopy | At baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Exercise
Feasibility of Real-time Ultrasound-guided Spinal Anesthesia Using Dynamic Needle Tip Positioning

Study Overview
=================
Brief Summary
-----------------
Confirming the L4-L5 or L3-L4 vertebrae level with ultrasound in real time for adults who scheduled elective surgery under spinal anesthesia, and introduce the spinal needle into the subarachnoid space. The ultrasound probe continues to track needle tips in real time by sliding/tilting with short axis view. Check that the spinal needle reaches subarachnoid space, and that CSF is released through the needle hub, and administer the drug. In this process, it is recorded by observing the success of the procedure, the time taken for each step, the number of needle position changes, NRS pain score of the subject, satisfaction with anesthesia, and its side effects.

Official Title
-----------------
Feasibility of Real-time Ultrasound-guided Spinal Anesthesia Using Dynamic Needle Tip Positioning

Conditions
-----------------
Regional Anesthesia Morbidity

Intervention / Treatment
-----------------
* Procedure: Real-time ultrasound guided spinal anesthesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who scheduled for elective surgery under spinal anesthesia Age >= 20 Exclusion Criteria: Patient refusal Coagulopathy (INR ≥1.2, anticoagulant therapy) Sepsis or local infection at the site of injection BMI > 35 Spine deformity

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Spinal anesthesia<br> | Procedure: Real-time ultrasound guided spinal anesthesia<br>* The neuraxial US scan will be performed with the patient in the lateral position with the hip and knees flexed using full aseptic technique. The spinal needle will be inserted in real-time under direct ultrasound guidance using dynamic needle tip positioning to administer the spinal anesthetic.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful perfomance of spinal anesthesia | Rate of successful performance of real-time ultrasound guided spinal needle insertion using dynamic needle tip positioning | Assessed at time of spinal anesthetic injection (baseline) |
Effects of Corneal Anatomical Match Between Donor and Recipient During DALK Surgery on Final Visual and Refractive Outcomes in Patients With KCN

Study Overview
=================
Brief Summary
-----------------
Patients with KCN who undergo cornea transplantation divided to 2 groups: Group1: After mechanical trephination, horizontal meridian of donor's cornea sutured to horizontal meridian of recipient cornea Group 2: After mechanical trephination, horizontal meridian of donor's cornea sutured to vertical meridian of recipient cornea After suture removal, best corrected visual acuity, refractive error, corneal keratometry, irregularity of corneal surface and high order aberration of two groups will compare

Official Title
-----------------
Effects of Corneal Anatomical Match Between Donor and Recipient During DALK Surgery on Final Visual and Refractive Outcomes in Patients With KCN: a Clinical Trial

Conditions
-----------------
Keratoconus

Intervention / Treatment
-----------------
* Procedure: After mechanical trephination, horizontal meridian of donor's cornea sutured to horizontal meridian of recipient cornea
* Procedure: : After mechanical trephination, horizontal meridian of donor's cornea sutured to vertical meridian of recipient cornea


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with KCN who undergo DALK surgery Exclusion Criteria: Penetrating Keratoplasty surgery Other corneal diseases dystrophies Corneal graft rejection

Ages Eligible for Study
-----------------
Minimum Age: 15 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: horizontal meridian of donor's cornea sutured to horizontal<br>horizontal meridian of donor's cornea sutured to horizontal meridian of recipient cornea | Procedure: After mechanical trephination, horizontal meridian of donor's cornea sutured to horizontal meridian of recipient cornea<br>* After mechanical trephination, horizontal meridian of donor's cornea sutured to horizontal meridian of recipient cornea<br>|
| Active Comparator: horizontal meridian of donor's cornea sutured to vertical<br>horizontal meridian of donor's cornea sutured to vertical meridian of recipient cornea | Procedure: : After mechanical trephination, horizontal meridian of donor's cornea sutured to vertical meridian of recipient cornea<br>* : After mechanical trephination, horizontal meridian of donor's cornea sutured to vertical meridian of recipient cornea<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best corrected visual acuity | Snellen chart | 14 months | 
| graft astigmatism | Topography | 14 months |
Clinical Responsiveness of Dermatomyositis Using Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI)

Study Overview
=================
Brief Summary
-----------------
The Evaluation of Clinical Responsiveness Using the Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI), established in 2008, is a one-site database study conducted at the University of Pennsylvania. The database has yielded valuable information and clinical insights into the pathophysiology, disease processes, including psychological responses, treatments and quality of life associated with dermatomyositis. The CDASI database incorporates the Cutaneous Dermatomyositis Disease Area and Severity Index), a validated outcome measure of disease responsiveness in patients, and other assessment tools, surveys and patient information to help validate the clinical course and quality of life of patients with dermatomyositis. The CDASI database has led to publication of comparison studies of CDASI and other clinical instruments and the effect of dermatomyositis on Quality of Life (QoL). The CDASI database is an ongoing resource that enables clinicians to evaluate the evolving clinical changes, treatment modalities and patient response to a challenging disease. Data will be analysed over a 5 years.

Official Title
-----------------
Evaluation of Clinical Responsiveness Using the Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI)

Conditions
-----------------
Dermatomyositis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gender/Age: Males or females above 18 years old Diagnosis: Cutaneous Dermatomyositis Subjects able to give informed consent Exclusion Criteria: Subjects without cutaneous DM Penn employees Penn students Cognitively impaired persons

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 |
| --- | --- | --- |
| Cutaneous Dermatomyositis Disease Area and Severity Index | Disease severity tool | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin quality of life tool | Quality of life tool | through study completion, an average of 1 year |