linjc16/ctgov huggingface dataset:
Symphony IL-6 Cutoff Validation Study for Patients at Risk of Severe Sepsis

Study Overview
=================
Brief Summary
-----------------
Symphony IL-6 is a device that quantitates human IL-6 by fluorescence enzyme immunoassay (FEIA) from whole-blood specimens. Use of Symphony IL- 6 removes the need for plasma separation before testing. Symphony IL-6 comprises two components, the Symphony Fluorescence Immunoanalyzer and the Symphony IL-6 Cartridge. Whole blood is added to the cartridge and then up to six cartridges can be inserted into the immunoanalyzer. After 20 minutes a readout and printout are given with a quantitative IL-6 concentration. The used cartridges are fully enclosed and can be easily disposed of in general hospital bio-waste. Given the nature of this device and its portability, there is potential for future deployment as a point-of-care (POC) device. This study is to validate an interleukin-6 (IL-6) cutoff value using the Symphony IL-6 test for patients at high risk of severe sepsis caused by a COVID-19 infection

Official Title
-----------------
Symphony IL-6 Cutoff Validation Study for Patients at Risk of Severe Sepsis

Conditions
-----------------
Severe Sepsis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Whole blood specimen collected in EDTA anticoagulant tubes Subject is considered to have severe or critical illness per below: Severe Illness SpO2 < 94% on room air at sea level; Ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) < 300 mmHg; Respiratory frequency > 30 breaths/min; Or lung infiltrates >50% Critical Illness a) Respiratory failure; b) Septic shock; c) And/or multiple organ dysfunction d) At least one criteria of severe illness Subject confirmed to be COVID-19 positive by an EUA RT-PCR test Subject is 18+ years of age Minimum volume of 100µL for Symphony IL-6 testing Specimen is available for testing within 12 hours from collection Exclusion Criteria: Subject is receiving an anti-IL-6 treatment Subject is receiving corticosteroids Hemolyzed specimens

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of IL-6 Cutoff for Patients at High Risk of Severe Sepsis | Validation of the established interleukin-6 concentration in whole blood samples from patients with confirmed COVID-19 infection and are at high risk of severe sepsis | Specimen is tested within 12 hours from collection |
Psychological Impact of the Hospitalization of a Family Member in Intensive Care for Covid-19 Infection

Study Overview
=================
Brief Summary
-----------------
The hospitalization of a patient in intensive care is a traumatic experience for his family members. With the current COVID-19 epidemic, in view of the high risk of contamination, drastic measures to limit the transmission are necessary, with the creation of spaces dedicated to the care of Covid+ patients, and family are not allowed to visit. At the Strasbourg University Hospital, visits were prohibited from the start of the epidemic. Information concerning the patient's state of health is therefore delivered to families by telephone, on call by the healthcare team only, every day before 6 p.m. or in the event of a serious event at any time. The primary purpose of this project is to assess the psychological impact of the hospitalization of a loved one in intensive care for Covid-19 infection at 3 months post-hospitalization, in a context of pandemic with ban on visits.

Official Title
-----------------
Psychological Impact of the Hospitalization of a Family Member in Intensive Care for Covid-19 Infection

Conditions
-----------------
Depression, Covid-19, Stress Disorders, Post-Traumatic, Anxiety

Intervention / Treatment
-----------------
* Other: Questionnary


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Family member of a Covid-19 positive patient hospitalized in Intensive Care Unit who gave his oral agreement following the communication of the notice of non-opposition. A patient is considered to be Covid + if the RT-PCR is positive OR if characteristic images are taken with a chest scanner. The family member included in the study is preferably the patient's support person. In the absence of an expression of the patient's will, he is the close referent designated by the family as an interlocutor. Exclusion Criteria: Difficulties in understanding French

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 |
| --- |
|Other: Questionnary|Family member's will answer the questionnaires by phone|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Existence of a post-intensive care syndrome-family ((combined score of the HAD ( Hospital Anxiety and Dépression scale) and IES-R ( Impact of Event Scale-Revised) questionnaires)) | An overall score of 19 or more indicates a major depressive episode (HAD) and a total score of 22 as in favor of significant symptoms of acute stress (IES-R) | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Psychological impact, COVID-19, Family members
Pregnancy Rate After Unilateral Tubal Disconnection

Study Overview
=================
Brief Summary
-----------------
Unilateral disconnection of one tube that had hydrosalpinx

Detailed Description
-----------------
In cases suffering from infertility and all other factors were normal except hysterosalpingogram that showed hydrosalpinx. We either did intracytoplasmic sperm injection (ICSI) in one group and spontaneous follow up for 2 years after laparoscopy Pregnancy rate in both groups was assessed

Official Title
-----------------
Pregnancy Rate After Laparoscopic Unilateral Tubal Disconnection

Conditions
-----------------
Pregnancy Rate

Intervention / Treatment
-----------------
* Procedure: Unilateral tubal disconnection + Spontaneous follow up for pregnancy
* Procedure: Unilateral tubal disconnection + ICSI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: infertile women either primary or secondary Hydrosalpinx Exclusion Criteria: other factors of infertility

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

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Unilateral tubal disconnection and spontaneous pregnancy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>Unilateral tubal disconnection and waiting for pregnancy for 2 years after laparoscopy | Procedure: Unilateral tubal disconnection + Spontaneous follow up for pregnancy<br>* Unilateral tubal disconnection + Spontaneous follow up for pregnancy<br>|
| Experimental: Control group<br>Unilateral tubal disconnection and ICSI | Procedure: Unilateral tubal disconnection + ICSI<br>* Unilateral tubal disconnection + ICSI<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy rate | Number of pregnant women after procedure | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pregnancy rate, Lasparosocpy, Unilateral tubal disconnection, Intracytoplasmic sperm injection
Pharmacoepidemiological Evaluation of Autophagy Inhibition in Treatment of HCV Patients Resistant to Standard Therapy. Pilot Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the efficacy of Chloroquine comparing with placebo for treatment of non- response HCV patients.. In this triple blind pilot study, 20 patients with confirmed chronic hepatitis C will be randomize into treatment group (Chloroquine 150 mg daily, for 8 weeks) or control group (placebo once daily, for 8 weeks). Patients who have receiving anti neoplastic, anti viral or Immunomedullator drugs during 6 months prior to study, have co-infection Hepatitis A,C,D or HIV, severe liver or renal dysfunction, are pregnant or breast fed, or refuse to sign informed consent will be excluded.. At the end of therapy (12 weeks) and at baseline, first, second and third month after receiving drug and placebo HCV Virus load, CBC LFT and biochemical parameters will be evaluated and compared between groups.

Conditions
-----------------
Hepatitis C Virus

Intervention / Treatment
-----------------
* Drug: 150 mg/daily chloroquine compare to placebo for 12 week
* Drug: Chloroquine
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who failed to achieve a decline of 2 log HCV RNA IU/ml after 12 weeks of treatment who never achieved undetectable HCV RNA during treatment of a minimum duration of 24 weeks Exclusion Criteria: Receiving anti neoplasm, anti viral or immunomedulator drugs during 6 months prior to study coinfection with Hepatitis A,C,D viruses or HIV Severe dysfunction of liver and kidney pregnancy breast feeding refusing to give informed consent active Alcohol user presence of decompensate cirrhosis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: chloroquine<br>150 mg chloroquine and lacebo , one tablet daily for 2 month | Drug: 150 mg/daily chloroquine compare to placebo for 12 week<br> <br> Drug: Chloroquine<br> <br> |
| Experimental: placebo<br>150 mg chloroquine and lacebo , one tablet daily for 2 month | Drug: 150 mg/daily chloroquine compare to placebo for 12 week<br> <br> Drug: placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Loss of HCV RNA at end of treatment which is 8 weeks |  | march 2014 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Two log decrease in HCV RNA at the end of treatment |  | july 2014 |
Evaluation of the Preparation of Runners and the Impact of an Ultra-trail Event in a Hot and Humid Environment

Study Overview
=================
Brief Summary
-----------------
Human beings are characterized by their extraordinary ability to thermoregulate. During a physical exercise, only 25% of the energy provided by the substrates is converted into muscular mechanical work. The remaining 75% is released as heat. In fact, thermoregulation has always been an integral part of exercise's physiology. Due to current climate change, study and understand the mechanisms of thermoregulation and the practices of runners to cope with these constraints becomes increasingly necessary in order to optimize the sports performance and protect the health of athletes of all levels. Heat stroke is responsible for more deaths than any other environmental disaster and is the second leading cause of sport mortality after heart problems. The exercise-related hyperthermia and malignant hyperthermia, dehydration and hyponatremia problems have been relatively well studied in several sports. For ultra endurance disciplines, the data remains very fragmentary.

Official Title
-----------------
Evaluation of the Preparation of Runners and the Impact of an Ultra-trail Event in a Hot and Humid Environment (Ultra Trail Adaptation Environment)

Conditions
-----------------
Intensive Sport

Intervention / Treatment
-----------------
* Other: questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All major runners participating in one of the 3 individual races of the Grand Raid 2019 in Reunion Island Exclusion Criteria: Refusal to participate Runners who do not understand French

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| runner participating of the Grand Raid<br> | Other: questionnaire<br>* questionnaire before and after race<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Repercussion of the race on health evaluate by proportion of heat symptoms on our sample |  | during the 3 days of the race |
Efficacy Study of Lisdexamfetamine to Treat Binge Eating Disorder

Study Overview
=================
Brief Summary
-----------------
The specific aim of this study is to examine the efficacy and safety of lisdexamfetamine compared with placebo in outpatients with binge eating disorder

Official Title
-----------------
Lisdexamfetamine in Binge Eating Disorder of Moderate or Greater Severity

Conditions
-----------------
Binge Eating Disorder

Intervention / Treatment
-----------------
* Drug: lisdexamfetamine
* Drug: Placebo control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients will meet DSM-IV criteria for BED for at least the last 6 months Exclusion Criteria: Women who are pregnant or lactating and women of childbearing potential who are not taking adequate contraceptive measures. If there is a possibility a female subject might be pregnant, a pregnancy test will be performed. (All women of childbearing potential will have a negative pregnancy test before entering the study.) Subjects who are displaying clinically significant suicidality or homicidality. A current or recent (within 6 months of the start of study medication) DSM-IV diagnosis of substance abuse or dependence

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lisdexamfetamine<br>drug | Drug: lisdexamfetamine<br>* oral; 20-70mg/day<br>|
| Placebo Comparator: Placebo<br>Placebo comparator | Drug: Placebo control<br>* 20-70mg; oral<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frequency of binge eating episode | frequency of binge eating episode | 12 weeks |
Comparison of Routine Endotracheal Intubation With McGrath Videolaryngoscope and Pentax AirwayScope

Study Overview
=================
Brief Summary
-----------------
Recently many kinds of indirect videolaryngoscopes were developed. These videolaryngoscopes provide easier intubation, help intubation difficulty, are used good tool for education. McGrath Videolaryngoscope and Pentax AirwayScope are kinds of these videolaryngoscopes. The purpose of this study is to compare of routine endotracheal intubation with McGrath Videolaryngoscope and Pentax AirwayScope by means of providing better laryngeal view, easier and faster intubation.

Official Title
-----------------
Comparison of Routine Endotracheal Intubation With McGrath Videolaryngoscope and Pentax AirwayScope

Conditions
-----------------
Intubation

Intervention / Treatment
-----------------
* Device: Pentax Airwayscope
* Device: McGrath Videolaryngoscope


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: an American Society of Anesthesiologists physical status (ASA) 1 or 2 Exclusion Criteria: a suspected difficult airway (Mallampati score Ⅳ) known cervical spine injury required rapid sequence induction emergency operation

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 65 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 |
| --- | --- |
| McGrath<br>McGrath Videolaryngoscope | Device: McGrath Videolaryngoscope<br>* intubation using McGrath Videolaryngoscope<br>|
| Pentax<br>Pentax Airwayscope | Device: Pentax Airwayscope<br>* intubation using Pentax Airwayscope<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to intubation | from entering of blade between incisors to appearance of first end tidal CO2 curve using capnograph | 10 minutes around intubation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
videolaryngoscope
Does Adding Magnesium Sulphate to Low Dose Rocuronium Affects Depth of Blockade

Study Overview
=================
Brief Summary
-----------------
This study aim is to compare the effect of magnesium sulphate combined with low dose rocuronium versus standard dose rocuronium

Detailed Description
-----------------
Comparing the effect of magnesium sulphate combined to low dose rocuronium versus standard dose rocuronium in cancer patients undergoing direct laryngoscopy for laryngeal tumors regarding intubating conditions, intraoperative relaxation, depth of anesthesia and recovery time.

Official Title
-----------------
Does Adding Magnesium Sulphate to Low Dose Rocuronium Affects the Depth of Blockade in Cancer Patients Undergoing Direct Laryngoscope Surgical Procedures

Conditions
-----------------
Anesthesia

Intervention / Treatment
-----------------
* Drug: standard rocuronium dose
* Drug: Magnesium sulfate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Laryngeal tumors ASA I-II Age 30-70 years Exclusion Criteria: Renal and or hepatic insufficiency Neuromuscular disease Large glottic and/or supra-glottic lesions with or without breathing difficulties Known allergy to any of the used drug

Ages Eligible for Study
-----------------
Minimum Age: 30 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard rocuronium<br>patients received rocuronium 0.6mg/kg | Drug: standard rocuronium dose<br>* 0.6 mg/kg rocuronium during induction of anesthesia<br>* Other names: standard dose rocuronium;|
| Experimental: Magnesium<br>patients received 100 ml saline with 50mg/kg magnesium sulphate infusion over 10 minutes | Drug: Magnesium sulfate<br>* 50 mg/kg magnesium sulphate added to 0.40 mg/kg rocuronium<br>* Other names: low dose rocuronium;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onset and duration of muscle relaxant | Onset time of muscle relaxant and duration | 90 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of muscle relaxation | depth of blockade | 90 minutes |
Use Of Esomeprazole In Postoperative Bariatric Surgery Patients Users And Non-Users Of Nonsteroidal Anti-Inflammatory Drugs (NSAIDS)

Study Overview
=================
Brief Summary
-----------------
Phase IV, open-label, multicenter, non-randomized, with 2 non-comparative investigational arms study, carried out in morbid obesity patients who had undergone gastric bypass surgery for body weight reduction

Official Title
-----------------
Use Of Esomeprazole In Postoperative Bariatric Surgery Patients Users And Non-Users Of Nonsteroidal Anti-Inflammatory Drugs (NSAIDS)

Conditions
-----------------
Postoperative Bariatric Surgery

Intervention / Treatment
-----------------
* Drug: Esomeprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent signed and dated BMI ≥40 kg/m2 or BMI between 35 and 40 kg/m2, but with a severe disease together with obesity Indication for gastric bypass surgery Upper digestive endoscopy prior to surgery not showing esophagitis, erosions, ulcers or neoplasia, examination performed up to 30 days before surgery being considered valid Helicobacter pylori non-infected patients, diagnosed by tests carried out up to 30 days before surgery Exclusion Criteria: Contraindication for gastric bypass surgery Contraindication to use Omeprazole and derivatives Patients carriers of gastrinoma or having hypergastrinemia Patients contraindicated to perform UDE Patients with previous esophagogastroduodenal surgery

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Esomeprazole|Esomeprazole 20mg oral tablet|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy of Esomeprazole in preventing anastomotic stomal ulcer after gastric bypass surgery for weight loss |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy of Esomeprazole in avoiding appearance of related peptic acid symptoms after gastric bypass surgery for weight loss. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bariatric surgery, ulcer prevention