linjc16/ctgov huggingface dataset:
Spot-Check Noninvasive Pulse CO-Oximeter Validation

Study Overview
=================
Brief Summary
-----------------
In this study, the accuracy of a noninvasive hemoglobin sensor(s) will be assessed by comparison to hemoglobin measurements from a laboratory analyzer.

Official Title
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Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation

Conditions
-----------------
Anemia

Intervention / Treatment
-----------------
* Device: Masimo Rad-67 Pulse Oximeter


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Male or female Age: Greater than one month Weight: Greater than or equal to 3kg Any racial or ethnic group The subject or the subject's legally authorized representative has given written informed consent/assent to participate in the study If an ICU patient, total hemoglobin of < 9 g/dL at time of screening. Exclusion Criteria: Subjects with skin abnormalities at the planned application sites that may interfere with sensor application, per directions-for-use (DFU) or trans-illumination of the site, such as burns, scar tissue, nail polish, acrylic nails, infections, abnormalities, etc. Subjects deemed not suitable for the study at the discretion of the investigator Subjects unlikely to be able to refrain from excessive motion during data collection. Excessive motion includes postural changes, making hand gestures, involuntary muscular movements, etc.

Ages Eligible for Study
-----------------
Minimum Age: 1 Month

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

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

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

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test group<br>All subjects are enrolled into the test group and receive Masimo Rad-67 Pulse Oximeter for measurement of hemoglobin. | Device: Masimo Rad-67 Pulse Oximeter<br>* Noninvasive pulse oximeter<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of sensor | Accuracy willl be determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value. | Up to 1 hr per subject | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
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Noninvasive, Pulse, CO-Oximeter, Validation
Serial Usage of Combitube in Anesthesiology

Study Overview
=================
Brief Summary
-----------------
Retrospective evaluation of a database of ETC routine uses during general anaesthesia.

Detailed Description
-----------------
Background: The oesophageal-tracheal Combitube (ETC) was designed for the use in the pre-hospital setting and has proven its value both there and in difficult airway management. The ETC is a double-lumen tube and as such it enables ventilation independent of its position in either the trachea or the oesophagus. Since laryngoscopy is not necessary for positioning the ETC, it is especially favoured in pre-hospital setting, but is also used in clinical setting. Objectives: Retrospective evaluation of a database of ETC routine uses during general anaesthesia.

Official Title
-----------------
Evaluation of Serial Usage of Combitube in Anesthesiology

Conditions
-----------------
Surgery

Intervention / Treatment
-----------------
* Device: Combitube


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients ASA class I and II Exclusion Criteria: patients not able to sign informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| Patients intubated with Combitube<br>Patients with Combitube intubation undergoing general anesthesia with ASA class I and II | Device: Combitube<br>* Intubation with Combitube<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate | Measurement time in seconds using a stopwatch between grasping the tube and successful intubation | 3 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI | Measurement of Body mass index by calculating height and weight of each patient | 1hour | 
| method of insertion and size of the tube, | insertion with different intubation devices and diameters of tubes | 1hour | 
| Intubator's qualification and experience in the use of the ETC; | years of training and experience in intubators as well as use of ETC for at least 10 times | 1 hour |
Duragen® Secure Post Marketing Clinical Follow-up (PMCF)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to gather information about post-market performance of DuraGen Secure.The aim of this post market clinical follow-up (PMCF) is to obtain post market clinical data to evaluate the presence of unintended residual risks associated with the use of DuraGen Secure that were not anticipated or identified in the animal studies, bench studies or clinical evaluation report.

Official Title
-----------------
Duragen® Secure Post Marketing Clinical Follow-up (PMCF)

Conditions
-----------------
Dura Mater Nick Cut or Tear, Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient who have undergone a neurosurgical procedure where DuraGen® Secure has been implanted Exclusion Criteria: Patient who does not agree to allow collection of his/her medical data
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Duragen Secure<br>Have undergone a neurosurgical procedure where DuraGen® Secure has been implanted | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's Outcome | Patient outcome from the procedure (recovered without sequelae, ongoing with medical intervention, ongoing with surgical intervention, deceased, other) | Day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurence of Adverse Event | Adverse event that occured 72 hours post-operatively | first 72 hours post-op | 
| Occurence of Adverse Event | Adverse event that occured between days 4-14 post-operatively | between days 4-14 | 
| Occurence of Adverse Event | Adverse event that occured between days 15-30 post-operatively | Between days 15-30 |
Heme Oxygenase (HO) Activity and Adenosine Induced Vasodilation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether heme oxygenase 1 induction by heme arginate treatment is of influence on adenosine induced vasodilation in healthy individuals.

Conditions
-----------------
Atherosclerotic Cardiovascular Disease

Intervention / Treatment
-----------------
* Drug: L-arginine + heme arginate
* Drug: Heme arginate + L-arginine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: at least 18 and no older than 65 on the day of first dosing healthy Quetelet Index (Body Mass Index) of 18 to 30 kg/m2 In general, results of haematology and chemistry should be within the laboratory's reference ranges. Determinants of renal and hepatic function should be within twice the upper limit of normal range. Exclusion Criteria: Documented history of sensitivity / idiosyncrasy to medicinal products or excipients history of smoking within the past year history of or current abuse of drugs, alcohol and/or solvents Current use of any (over the counter) medication potentially influencing heme oxygenase or the cardiovascular system Inability to understand the nature and extent of the trial and the procedures required Participation to a drug trial within 60 days prior to the first dose Febrile illness within 3 days before the first dose Heterozygosity (LS) or homozygosity (LL) with regard to the number of GT repeats in the HO-1 promoter region

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>L-arginine treatment first, heme arginate treatment second | Drug: L-arginine + heme arginate<br>* L-arginine first, heme arginate second three day treatment<br>|
| Experimental: 2<br>Heme arginate treatment first, L-arginine treatment second | Drug: Heme arginate + L-arginine<br>* Heme arginate first, L-arginine second three day treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenosine induced vasodilation |  | following a three day treatment with either heme arginate or L arginine | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| heme oxygenase expression and activity |  | assessed during and following a three day treatment with either heme arginate or L-arginine |
Safety and Efficacy Study of JTT-705 in Combination With Atorvastatin 20 mg in Patients With Low High-Density Lipoprotein (HDL) Levels

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate safety of JTT-705 and to demonstrate efficacy of JTT-705 compared with placebo when co-administered with atorvastatin 20 mg in patients with low HDL

Official Title
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A 4-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study Evaluating the Safety and Efficacy of JTT-705 600 mg Versus Placebo Administered Once Daily in Combination With Atorvastatin 20 mg in Patients With Low HDL Levels

Conditions
-----------------
Dyslipidemia

Intervention / Treatment
-----------------
* Drug: JTT-705 600 mg and atorvastatin 20 mg
* Drug: Placebo and atorvastatin 20 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients having lipid values as indicated below: HDL-C ≤ 1.0 mmol/L (40 mg/dL) TG ≤4.5 mmol/L (400 mg/dL) Patients with CHD or CHD risk equivalent Male and females between 18 and 70 years of age (female patients must be post-menopausal, surgically sterile or using an acceptable form of contraception) Exclusion Criteria: Body Mass Index of ≥ 35 kg/m2 Females that are pregnant or breast-feeding, and females of child bearing potential who are not using an effective method of contraception Concomitant use of medications identified in the protocol

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: 1<br>JTT-705 600 mg and atorvastatin 20 mg | Drug: JTT-705 600 mg and atorvastatin 20 mg<br>* JTT-705 300 mg tablets, 600 mg dose, oral, once daily, immediately following breakfast and/or assessment Atorvastatin 20 mg tablets, 20 mg dose, oral, once daily, immediately following breakfast and/or assessments<br>|
| Placebo Comparator: 2<br>Placebo and atorvastatin 20 mg | Drug: Placebo and atorvastatin 20 mg<br>* Placebo tablet, 2 tablets, oral, once daily, immediately following breakfast and/or assessments Atorvastatin 20 mg tablets, one tablet, oral, once daily, immediately following breakfast and/or assessments<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % change from baseline in HDL-C; inhibition of CETP activity |  | 4-weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % change from baseline in LDL-C and TC/HDL-C |  | 4-weeks | 
| Plasma concentration of JTT-705 |  | 4-weeks |
Developing Effectiveness Evaluation and Therapeutic Programs of Rehabilitation

Study Overview
=================
Brief Summary
-----------------
Using robotics, sensors, and sEMG to develop clinic-oriented quantitative effectiveness evaluation and individualized programs of rehabilitation

Detailed Description
-----------------
Using robotics, sensors, sEMG or other methods to develop clinic-oriented quantitative effectiveness evaluation and individualized programs of rehabilitation

Official Title
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Developing Clinic-oriented Quantitative Effectiveness Evaluation and Individualized Therapeutic Programs of Rehabilitation

Conditions
-----------------
Healthy Volunteers, Motor Deficits, Dysphagia

Intervention / Treatment
-----------------
* Diagnostic Test: Motor function assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria (for healthy people): no history of psychological/psychotic problems, no history of important diseases. Exclusion Criteria (for healthy people): history of psychological/psychotic problems Inclusion Criteria (for patients with motor deficits or dysphagia): patients with motor function impairment such as post stroke hemiplegia. Exclusion Criteria (for patients with motor deficits or dysphagia): cognitively or physically unable to cooperate with the examiner to finish the test

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 |
| --- | --- |
| Heahlthy people<br>perform motor function assessment by using scales, sEMG, and inertia sensors | Diagnostic Test: Motor function assessment<br>* perform motor function assessment by using scales, sEMG, and inertia sensors<br>|
| People with motor deficits<br>perform motor function assessment by using scales, sEMG, and inertia sensors | Diagnostic Test: Motor function assessment<br>* perform motor function assessment by using scales, sEMG, and inertia sensors<br>|
| Patients with dysphagia<br>perform motor function assessment by using scales, sEMG, and inertia sensors | Diagnostic Test: Motor function assessment<br>* perform motor function assessment by using scales, sEMG, and inertia sensors<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motor function assessment | Fugl-Meyer Assessment | Change from Baseline scores at 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| surface EMG | high-density surface EMG | Change from Baseline status at 1 month | 
| Kinematics test | Using inertia sensors to assess kinematics during movement | Change from Baseline status at 1 month |
Phase II Study of SPI-1620 in Combination With Docetaxel as a Second-Line to Treat Biliary Cancer

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to determine the effectiveness of SPI-1620 in combination with docetaxel in patients with advanced biliary cancer.

Official Title
-----------------
Phase II Study of SPI-1620 in Combination With Docetaxel as a Second-Line Treatment for Patients With Advanced Biliary Cancer

Conditions
-----------------
Biliary Cancer

Intervention / Treatment
-----------------
* Drug: SPI-1620
* Drug: Docetaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed biliary tract or gallbladder cancer that have relapsed or are refractory after one prior gemcitabine-based chemotherapy regimen for advanced biliary cancer Evaluable disease ECOG PS ≤ 2 Adequate bone marrow, liver and renal function Exclusion Criteria: Treatment with more than one prior chemotherapy regimen Known, uncontrolled CNS metastases Baseline peripheral neuropathy ≥ grade 2. Significant circulatory disorders in the past 6 months Concomitant use of phosphodiesterase inhibitors

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPI-1620 & Docetaxel<br>Patients will receive 11 μg/m2 of SPI-1620 intravenously over one minute. Ten minutes after (±2 min) SPI-1620 administration, patients will receive docetaxel 75 mg/m2 intravenous. This regimen will be repeated every 3-weeks cycles until progression or intolerable toxicity. | Drug: SPI-1620<br>* SPI-1620 11 μg/m2 will be given intravenously over 1 minute.<br>Drug: Docetaxel<br>* Docetaxel 75 mg/m2 infusion will be administered per standard of care 10 (±2) minutes after SPI-1620.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate |  | 18 months | 
| Overall survival |  | 18 months | 
| Duration of Response |  | 12 months | 
| Safety of SPI-1620 when administered in combination with docetaxel | Periodic physical examinations with vital sign monitoring, safety laboratories and monitoring of adverse events will be performed | 12 months |
Individualized Medical Training and Calcipotriol and Betamethasone Dipropionate Gel in Plaque Psoriasis

Study Overview
=================
Brief Summary
-----------------
The aim of the study will be to evaluate the impact of this individualized practical training on efficacy (evaluated by Psoriasis Area and Severity Index (PASI) and Body Surface Area (BSA) score performed by a physician blinded to the study groups) and adherence (calculated as days wherein gel was applied and as BSA/weight of gel applied rate) to a 4 week long treatment with dovobet gel. On the other hand, the investigators will evaluate in both groups as demographic (as sex, age, job,..) or disease (as severity, duration, impact of quality of life,..) characteristics influence the adherence to the treatment.

Official Title
-----------------
Role of an Individualized Medical Training in Improving Efficacy and Adherence to a 4-week Treatment With Calcipotriol and Betamethasone Dipropionate Gel for Mild-to-moderate Plaque Psoriasis

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Procedure: Individualized practical training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of psoriasis will be maid mainly on clinical findings. If doubts, a skin sample will be obtained and evaluated by histopathological examination. Exclusion Criteria: Patients with palmoplantar, scalp, inverse, erythrodermic, guttate, pustular psoriasis will be excluded.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Receiving training<br>Patients will be visited and receive information about the prescribed topical treatment according to the normal course and procedure of an outpatient visit at our institution. At the end of the visit, they will also receive practical instructions on dosages and application modalities of the topical therapy. | Procedure: Individualized practical training<br> <br> |
| No Intervention: No-receiving training<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy as measured by PASI improvement |  | 1 month | 
| Efficacy as measured by BSA improvement |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence as measured by days wherein gel was applied |  | 1 month | 
| Adherence as measured by BSA/weight of gel applied rate |  | 1 month |