linjc16/ctgov huggingface dataset:
Near Infrared Spectroscopy and Transcutaneous Oxygen Pressure in Critical Limb Ischemia Before and After Treatment

Study Overview
=================
Brief Summary
-----------------
Comparison of two non-invasive methods for measuring tissue oxygenation. One is Transcutaneous Oxygen Pressure (TCPO2) and the other is the new method of Near Infrared Spectroscopy (NIRS) - near infrared spectroscopy in patients with critical limb ischemia (CLI) undergoing invasive treatment (surgical or endovascular).

Detailed Description
-----------------
Comparison of two non-invasive methods for measuring tissue oxygenation. One is TCPO2 and the other is the new method of NIRS - near infrared spectroscopy in patients with critical limb ischemia (CLI) undergoing invasive treatment (surgical or endovascular). The NIRS probe has been used to measure tissue oxygenation in the cerebral circulation up to now. While TCPO2 is the established method for measuring tissue oxygenation in patients with CLI to evaluate the potential for wound healing.

Official Title
-----------------
Comparison of Near Infrared Spectroscopy (NIRS) and Transcutaneous Oxygen Pressure (TCPO2) Measurements in Critical Limb Ischemia (CLI) Patients After Invasive Treatment (Endovascular or Surgery)

Conditions
-----------------
Peripheral Vascular Disease, Critical Limb Ischemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 10 patients admitted to the vascular surgical department and undergoing invasive treatment (surgical or endovascular) Exclusion Criteria: pregnancy allergy to iod advanced renal failure CCT<50 active peptic ulcer recent bleeding

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tissue oxygenation |  | the outcome will be assessed during the hospital stay up to a week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CLI Critical limb ischemia, PVD peripheral vascular disease, NIRS near infrared spectroscopy, TCPO2 - transcutaneous oxygen pressure
Non-invasive Assessment of Immediate Postoperative Analgesia Using Analgesia/Nociception Index (ANI)

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the clinical performance on Analgesia/Nociception Index (ANI) in the assessment of immediate postoperative analgesia in PACU in adult patients undergoing general anesthesia.

Detailed Description
-----------------
Evaluation of the relationship between ANI and numerical rating pain scale (NRS) by linear regression. Assessment of the performance of ANI to detect NRS>3 and NRS>=7 by building ROC curves.

Official Title
-----------------
Non-invasive Assessment of Immediate Postoperative Analgesia Using Analgesia/Nociception Index (ANI): A Prospective and Observational Study

Conditions
-----------------
Postoperative Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult surgical or endoscopic procedures performed on general anesthesia Exclusion Criteria: age <18 yrs or >75 yrs arrythmia administration of anticholinergic drugs or neuromuscular blockade reversal in the 20 previous minutes psychiatric diseases autonomic nervous system (ANS) disorders inability to understand the verbal rating pain scale.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- | --- |
| Analgesia/Nociception Index (ANI) | The ANI is a 0-100 index estimating the parasympathetic/sympathetic balance derived from heart rate variability, measured by the PhysioDoloris monitor (MetroDoloris, Loos, France). High ANI values indicate parasympathetic predominance (no pain) while during nociception (increase in sympathetic activity), ANI value decrease to 60 or less. | At arrival in post-operative care unit (PACU) or 10 min after extubation | 
| Pain Scores on a 0-10 Numeric Rating Scale (NRS) | Verbal pain scale, with 0 = no pain and 10 = worst pain imaginable. NRS<3 corresponds to no or mild pain NRS>=3 corresponds to moderate to severe pain NRS>=7 corresponds to severe pain | At arrival in PACU or 10 min after extubation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Analgesia/Nociception index
MitraClip® Registry

Study Overview
=================
Brief Summary
-----------------
Percutaneous mitral valve repair with the MitraClip® system has emerged as a therapeutic alternative to surgical valve repair (PMVR) in high risk patients. The aim of this registry is to collect prospectively and systematically clinical research data from patients undergoing PMVR with the MitraClip® system. This registry is an open-end observational study to assess the characteristics and outcomes patients with severe mitral regurgitation undergoing PMVR.

Official Title
-----------------
MitraClip® Registry - an Observational Study of Percutaneous Mitral Valve Repair Using the MitraClip® System

Conditions
-----------------
Mitral Regurgitation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: severe mitral regurgitation percutaneous mitral valve repair (PMVR) with the MitraClip® system Exclusion Criteria: < 18 years Patients considered by the heart team to be unlikely to receive meaningful or durable clinical benefit from the procedure

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 |
| --- | --- | --- |
| Major cardiac adverse events | increase in the 30-day risk of adverse events among patients receiving PMVR | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Proportion of patients who are alive at 1 year after receiving | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mitral regurgitation, MitraClip system, percutaneous mitral valve repair
Chronic Infections on Articular Prostheses With C. Acnes Diagnosed by Specific PCR

Study Overview
=================
Brief Summary
-----------------
Osteaoarticular infection due to C. acnes are known to be of late onset, causing chronic infection possibly pauci-symptomatic. Osteaoarticular infection due to C. acnes represents a diagnostic challenge, since C. acnes is slow and difficult to grow, and can also be considered a contaminant.A 16S universal PCR bacteriological diagnosis has been proposed but is lacking of sensitivity. A specific C. acnes PCR was developed in 2010, but is not used routinely.

Official Title
-----------------
Chronic Infections on Articular Prostheses With C. Acnes Diagnosed by Specific PCR : Descriptive Study of 6 Patients

Conditions
-----------------
Bone and Joint Infection

Intervention / Treatment
-----------------
* Other: Prosthetic joint infection with Cutibacterium acnes


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients having had infection prothesis vith C. acnes identified by PCR Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prosthetic joint infection with Cutibacterium acnes<br>Chronic infections on articular prostheses with Cutibacterium acnes diagnosed by specific PCR | Other: Prosthetic joint infection with Cutibacterium acnes<br>* patients having a prosthesis infection with C.acnes identified by specific PCR<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of diagnostic delay | time between surgery and detection of C. acnes by PCR | Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of radiologic signs | prosthesis loosening or not | Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption | 
| rate of duration of antibiotherapy | measures of duration of the antibiotherapy | Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption | 
| rate of use of this diagnostic | descriptions of patients managed with this diagnostic | Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bone and joint infection, Propionibacterium acnes, Cutibacterium acnes
Comparison of Positive End Expiratory Pressure Titration Methods in ARDS Patients

Study Overview
=================
Brief Summary
-----------------
This study aims at assessing the short-term physiological effects of 2 positive end expiratory pressure titration strategies in patients with ARDS.

Official Title
-----------------
Comparison of Positive End Expiratory Pressure Titration Methods in Patients With Acute Respiratory Distress Syndrome: a Physiological Study

Conditions
-----------------
Acute Respiratory Distress Syndrome

Intervention / Treatment
-----------------
* Other: Strategy 1
* Other: Strategy 2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age> 18 years Moderate or severe ARDS Consent to participation obtained from a relative Exclusion Criteria: Protect adult Pregnant or breastfeeding woman No-affiliation to the social security scheme Contra-indication to the placement of an esophageal pressure measuring catheter Pneumothorax Hemodynamic and / or respiratory instability Extra-corporeal membrane oxygenation

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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arms A<br>Strategy 1 - Washout period - Strategy 2 | Other: Strategy 1<br>* PEEP titration according to transpulmonary-end-expiratory pressure<br>Other: Strategy 2<br>* PEEP titration according to chest wall elastance measurement<br>|
| Experimental: Arms B<br>Strategy 2 - Washout period - Strategy 1 | Other: Strategy 1<br>* PEEP titration according to transpulmonary-end-expiratory pressure<br>Other: Strategy 2<br>* PEEP titration according to chest wall elastance measurement<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short-term effects of 2 PEEP titration strategies on gas exchange |  | 2 hours 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short-term effects of 2 PEEP titration strategies on respiratory mechanics |  | 2 hours 15 min | 
| Short-term effects of 2 PEEP titration strategies on hemodynamics |  | 2 hours 15 min | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ARDS, Esophageal pressure, Mechanical ventilation
Impact of Quinoa Milk Fermented With Lactic Acid Bacteria From Foods on Human Oral and Intestinal Flora

Study Overview
=================
Brief Summary
-----------------
The demand for alternatives to dairy products has increased in recent years and a lot of proposals for vegetable milk and yogurt products have taken place in the market. Quinoa is a plant from South America that has growth in popularity in recent years as many sought out nutritious and healthier eating, the herb is known for its high nutritional value. It is complete protein source containing all the essential amino acids. If this herb were fermented with probiotic bacteria, there is a potential for a product that is lactose free, gluten free and cholesterol free. The probiotic potential of quinoa milk, fermented with food associated lactic acid bacteria will be investigated. This includes a study that examines how daily consumption of this vegetable drink changes the composition of the oral and intestinal flora. Therefore, healthy people are now seeking to participate in the study, which will be for just over 2 weeks.

Official Title
-----------------
Impact of Quinoa Milk Fermented With Lactic Acid Bacteria From Foods on Human Oral and Intestinal Flora

Conditions
-----------------
Microbial Colonization

Intervention / Treatment
-----------------
* Dietary Supplement: fermented quinoa


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Above 18 years and healthy volunteers Exclusion Criteria: Participants that have any kind of diseases, such as colon inflammation

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fermented drink<br> | Dietary Supplement: fermented quinoa<br>* Quinoa drink fermented with lactic acid bacteria isolated from food<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survivability of the lactic acid bacteria | If the bacteria can be isolated in a adequate amount by cultivation on MRS broth and rogosa agar | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the human microbiota | Changes in the saliva and stool samples by analyzes with Terminal Restriction Fragment Length polymorphism | 2 weeks | 
| Changes in the human microbiota | Changes in the saliva and stool samples by quantitative polymorphic chain reaction | 2 weeks |
Partial Replicated Crossover Clinical Study to Compare Pharmacokinectic Characteristics of Eperisone Hydrochloride and Aceclofenac With HCP1104 Treatment to Those of Co-administration of Eperisone Hydrochloride 50mg Tablet and Aceclofenac 100mg Tablet in Healthy Adult Male Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate pharmacokinetics and safety after oral administration of HCP1104 and Eperisone Hydrochloride plus Aceclofenac.

Detailed Description
-----------------
The purpose of this study is to evaluate pharmacokinetics and safety after oral administration of HCP1104 and Eperisone Hydrochloride plus Aceclofenac.

Official Title
-----------------
A Randomized, Open-label, Single Dose, 3-sequence and 3-period Partial Replicated Crossover Clinical Study to Compare Pharmacokinectic Characteristics of Eperisone Hydrochloride and Aceclofenac With HCP1104 Treatment to Those of Co-administration of Eperisone Hydrochloride 50mg Tablet and Aceclofenac 100mg Tablet in Healthy Adult Male Volunteers

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

Intervention / Treatment
-----------------
* Drug: HCP1104 / Mulex Tab. and Airtal Tab.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male volunteers, age between 20 and 45 BMI of >20kg/m2 and <28kg/m2 subject Informed of the investigational nature of this study and voluntarily agree to participate in this study Exclusion Criteria: Use of any prescription medication within 14 days prior to Day 1 Use of any medication within 7 days prior to Day 1 Participation in another clinical study within 60 days prior to start of study drug administration

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

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: HCP1104<br>HCP1104 | Drug: HCP1104 / Mulex Tab. and Airtal Tab.<br>* HCP1104 / Eperisone plus Aceclofenac<br>|
| Active Comparator: Mulex Tab. and Airtal Tab.<br>Eperisone Hydrochloride and Aceclofenac | Drug: HCP1104 / Mulex Tab. and Airtal Tab.<br>* HCP1104 / Eperisone plus Aceclofenac<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under Curve(AUC) last |  | 0, 20, 40min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24h hours post-dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HCP1104, Eperisone Hydrochloride, Aceclofenac
Adriamycin, Vinblastine, DTIC and Revlimid in Elderly Hodgkin Lymphoma Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine within the scope of the trial what the maximum tolerated dose (MTD) of lenalidomide in combination with AVD should be.

Official Title
-----------------
Phase I Trial of AVD Plus Lenalidomide (Revlimid) in Elderly Intermediate or Advanced Stage Hodgkin Lymphoma Patients

Conditions
-----------------
Hodgkin Lymphoma

Intervention / Treatment
-----------------
* Drug: Doxorubicine
* Drug: DTIC
* Drug: Lenalidomide
* Drug: Vinblastine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hodgkin Lymphoma, intermediate or advanced stage Age >60 and <75 years ECOG 2 or better No major organ dysfunction Ability to take aspirin or LMW Heparin Exclusion Criteria: HL as composite lymphoma Prior use of lenalidomide Prior use of chemo- or radiotherapy

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 75 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: AVD-Rev<br>Patients with intermediate stage HL receive 4 cycles of AVD-Rev followed by 30 Gy IF-RT Patientes with advanced stage HL receive 6 to 8 cycles of AVD-Rev followed by 30 GY IF-RT depending on the FDG-PET results | Drug: Doxorubicine<br>* 50mg/m2 day 1 + 15<br>Drug: DTIC<br>* 375mg/m2 day 1 + 15<br>Drug: Lenalidomide<br>* day 1 - 21<br>Drug: Vinblastine<br>* 6mg/m2 day 1 + 15<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose limiting toxicities (DLT) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate (ORR) |  |  | 
| Progression free survival (PFS) |  | 2 years |
The Impact of Pediatric Skin Disorders: The Big Study

Study Overview
=================
Brief Summary
-----------------
This study leverages the availability of a validated series of instruments to measure the effect of highly visible, chronic skin disorders, including atopic dermatitis (AD), on patients 8 years of age and above in causing stigma and psychiatric issues, particularly anxiety and depression.

Detailed Description
-----------------
This is a multi center study with Northwestern University/Lurie Children's Hospital serving as the Data Coordinating Center. Site selection has been completed through members of PeDRA.

Official Title
-----------------
The Impact of Pediatric Skin Disorders: The Big Study

Conditions
-----------------
Chronic Pediatric Skin Conditions

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must be aged 8-17 years of age Subject must be diagnosed with a chronic skin disease deemed to be severe enough and/or in a visible location that could be stigmatizing as determined by the study doctor Subject and parent must both be English speaking with at least one parent/guardian who will complete the questionnaires Subject and Parent/Guardian must be able to complete the relevant questionnaires Exclusion Criteria: Children under 8 years of age Children with developmental delay and/or a behavioral disorder that would preclude participation in form completion Children with a non-cutaneous disorder that is considered by the Study doctor to be stigmatizing

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 17 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 |
| --- | --- | --- |
| Measure the stigma experienced by children as a function of the child's perceived skin lesion visibility using the altered Neuro-QoL stigma tool | Measure the stigma experienced by children as a function of the child's perceived skin lesion visibility using the altered Neuro-QoL stigma tool | Past 7 days |