linjc16/ctgov huggingface dataset:
Study of Virus-specific Lymphocytic Cell Populations in Non-invasive Nasal Mucosa Samples of MIS-C Patients

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to make an accurate assessment of immune cells obtained from nasal mucosa and peripherial blood of MIS-C patients during the disease and the period of health.

Detailed Description
-----------------
The study will consist of two parts. Initially, it will be of a cross-cutting comparative nature, when a group of healthy patients (control group) and a group of patients diagnosed with MIS-C/PIMS syndrome are compared with each other, based on nasal curettage swabs and peripheral blood, before the inclusion of systemic anti-inflammatory treatment (study group). In addition, an observation of the research group will be carried out, during which swabs and peripheral blood will be taken at two more control points.

Official Title
-----------------
Study of Virus-specific Lymphocytic Cell Populations in Non-invasive Nasal Mucosa Samples of MIS-C Patients, and Intra-population Shifts in Inflammatory Tissues in the Acute Phase of MIS-C and in Health

Conditions
-----------------
MIS-C Associated With COVID-19, COVID-19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: MIS-C diagnosis based of WHO diagnostic criteria. Exclusion Criteria: immunosuppressive treatment received up to 3 months before intranasal drugs received up to 7 days before COVID-19 vaccination no consent

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- |
| Control group<br>Healthy patients under 18 years of age. | |
| MIS-C group<br>Patients with MIS-C diagnosed, based on WHO diagnostic criteria. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in leukocyte subpopulations in nasal mucosa and peripherial blood during MIS-C and convalescence. | The cellular subpopulations will be characterized and clustered using prepared immunomarker array. | Three clinical timepoints: (i) baseline (preferably before immunomodulatory treatment), (ii) convalescence, after major symptoms resolution (1 week +/-2 days after treatment introduction), (iii) outpatient control visit (6 weeks after hospital discharge) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
leukocytes, immunophenotype, nasal mucosa, curettage
Use of ROTEM for Multi-level Spine Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to obtain coagulation profiles of patients undergoing multi-level spine surgeries with ROTEM® and routine coagulation tests. The investigators will compare the data from ROTEM® and routine coagulation tests with each other and with blood loss and transfusion therapies used.

Official Title
-----------------
A Prospective Observational Study to Evaluate Perioperative Coagulation Profiles Using Rotational Thromboelastometry (ROTEM®) in Patients Undergoing Multi-level Spine Surgery

Conditions
-----------------
Coagulation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing elective open spine (cervical, thoracic, and/or lumbar) surgery with anticipated blood loss of > 1 L Males and females Age 18 to 100 years of age ASA physical status 1 to 3 Arterial line indicated for the intraoperative management of the patient and in place prior to incision Informed consent obtained Exclusion Criteria: Known pre-existing hemostatic abnormality Known clopidogrel use within 10 days prior to surgery Known warfarin use within 5 days prior to surgery Known pregnancy Has physical, mental, or medical conditions which, in the opinion of the Investigator, could compromise the subject's welfare, ability to communicate with the study staff, complete study activities, or would otherwise contraindicate study participation. Inclusion in another clinical research study An investigator of this study Subject's refusal or inability to agree to and sign the Informed Consent form in English

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients undergoing multi-level spine surgery<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coagulation profiles. |  | One measurement before surgery, one after surgery is completed, and one measurement at each i-stat or 10% total blood volume loss. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
To determine the efficacy of ROTEM on assessing coagulation profiles.
The Efficacy & Safety of the UAS Immunotherapy Protocol

Study Overview
=================
Brief Summary
-----------------
Hypothesis: The UAS Immunotherapy protocol is efficacious and at least as efficacious as protocols described in the Allergy literature.

Detailed Description
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Patients will be assessed for efficacy of the immunotherapy protocol by completing Consented-IRB approved clinical, medication, quality of life survey questions comparing current status while on therapy in contrast to 12 months before the inception of therapy.

Official Title
-----------------
The Efficacy and Safety of the United Allergy Service (UAS) Immunotherapy Protocol

Conditions
-----------------
Perennial Allergic Rhinitis With Seasonal Variation

Intervention / Treatment
-----------------
* Other: allergen immunotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Allergic rhinitis between 18 and 65 years old who have chosen to undergo immunotherapy. Exclusion Criteria: No beta blocker use, no pregnancy, no systemic steroids, no severe asthma/copd, no severe collagen vascular disorders, no neoplastic or uncontrolled seizure activity, no previous anaphylaxis, no significant cardiovsacular disease.

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: allergen immunotherapy|allergy shots|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in symptom scores from 12 months before therapy initiation in contrast to determination during 1 to 2 years of therapy (retrospective). | Enrolled patients completed surveys pertinent to symptom scores, contrasting current status on immunotherapy compared (by recall) to a 12 month time point prior to initiation of therapy. | Assessment contrasts current status (at 1 to 2 years of therapy) to a point 12 months prior to the onset of therapy. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in medication plus symptom aggregate score. | Aggregate Medication and Symptom surveys were compared to determine changes from a 12 month time point prior to inception of therapy to current time point of 1 to 2 years of therapy. | Assessment contrasts current status (at 1 to 2 years of therapy) to a point 12 months prior to the onset of therapy. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Allergic Rhinitis, Allergen Immunotherapy
A Study to Investigate the Food Effect on the Pharmacokinetics of YM178 in Healthy, Non-elderly Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the effect of food intake on the pharmacokinetics of YM178 in healthy, non-elderly adult subjects.

Official Title
-----------------
A Pharmacokinetic Study in Healthy Non-elderly Male and Female Volunteers to Investigate the Effect of Food on the Pharmacokinetics of YM178

Conditions
-----------------
Healthy Volunteer, Pharmacokinetics of YM178

Intervention / Treatment
-----------------
* Drug: YM178


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy as judged by the investigator/subinvestigator based on the results of physical examinations and all lab tests Body weight (at screening); female ≥40.0 kg, <70.0 kg, male ≥50.0 kg, <80.0 kg BMI (at screening): ≥17.6, <26.4 Written informed consent has been obtained Exclusion Criteria: Received any investigational drugs within 120 days before the screening test Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or blood components within 14 days before the screening test Received medication within 7 days before hospital admission or is scheduled to receive medication Females who are lactating, pregnant, potentially child-bearing, or willing to get pregnant during the study period History of drug allergies Upper gastrointestinal disease (e.g. nausea, vomiting, stomachache) within 7 days before hospital admission

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 54 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low dose group<br>3 way cross-over. Fasting, normal diet and high-fat diet | Drug: YM178<br>* oral<br>* Other names: mirabegron;|
| Experimental: High dose group<br>3 way cross-over. Fasting, normal diet and high-fat diet | Drug: YM178<br>* oral<br>* Other names: mirabegron;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentration of unchanged YM178 |  | Up to 96 hours post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary concentration of unchanged YM178 |  | Up to 96 hours post dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Overactive Bladder, Urinary incontinence, YM178, mirabegron
Sugammadex Versus Neostigmine Use in Patients Undergoing Septoplasty Operations

Study Overview
=================
Brief Summary
-----------------
The purpose of this study to determine the effectiveness of sugammadex in septoplasty patients whose mask ventilation would be difficult after extubation.

Detailed Description
-----------------
Patients undergoing septoplasty operation will be included to this study. After coming to operation room all the patients will have standard monitorisation and induction. After intubation they will have inhalational anesthesia as maintenance. According to the TOF (train of four) measurement all patient will have neuromuscular relaxant if needed. After the operation they will be extubated according to TOF or clinical parameters. And time for extubation, mask assistance need, any complication, mask difficulty, and time spent in postoperative care unit will be recorded. Then the results will be compared, whether sugammadex or neostigmine is better for these patients in means of extubation and postoperative status.

Official Title
-----------------
Phase IV Study of the Use of Sugammadex Versus Neostigmine in Septoplasty Operations

Conditions
-----------------
Nasal Septum Deviation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA (American Society of Anesthesiologist) I-II patients undergoing septoplasty operation Exclusion Criteria: patient refusal any allergy to any medication used

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- | --- |
| easy mask ventilation for septoplasty patients |  | time between end of surgery and extubation of the patient, approximately 5 to 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quick and safe transfer from postoperative care unit |  | time spent in postanesthesia care unit approximately 10 to 60 minutes |
Outpatient Office Based Endovascular Procedures

Study Overview
=================
Brief Summary
-----------------
The results of this study will serve as a starting point for future trials concentrating on the effectiveness and clinical outcomes of the procedures performed in an office based angiosuite. Additionally, other studies could compare clinical outcomes between procedures performed in an office based angiosuite and other settings.

Detailed Description
-----------------
Endovascular surgery combined with the demands of patients and physicians for less invasive procedures, have make this type of surgery one of the most innovative fields in medicine. However the endovascular experience in an office-based angiosuite is different from that in a hospital suite, and has been viewed in the past by some physicians as unsafe because it lacks the safety net of immediate hospital resources. In 2005, medicine allowed endovascular procedures to be performed in the office setting. The results of this study will serve as a starting point for future trials concentrating on the effectiveness and clinical outcomes of the procedures performed in an office based angiosuite.

Official Title
-----------------
Outpatient Office Based Endovascular Procedures

Conditions
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Chronic Venous Insufficiency, Peripheral Arterial Disease, Dialysis Access Malfunction, Arterio-venous Fistula, Thoracic Outlet Syndrome, Vertebral Artery Insufficiency, Varicose Veins

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years. Diagnosis of peripheral arterial disease (PAD), chronic venous insufficiency, dialysis access and malfunctioning arteriovenous fistulas, varicose veins, vertebrobasilar insufficiency, and thoracic outlet syndrome. Procedures performed as an outpatient in an office based angiosuite. Exclusion Criteria: Age ≤ 18 years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discharge location | classified as home, hospital floor, ICU and emergency room. | April 2006 to December 2018 | 
| postoperative complications | events that disrupted the normal recovery process of the patient within the 24 hours following the procedure | April 2006 to December 2018 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
office based angiosuite
Pterygium Treatment Using Single Beta-therapy as Adjuvant Treatment Compared to Conjunctival Autograft

Study Overview
=================
Brief Summary
-----------------
PURPOSE: To affirm the effectiveness and complication rate of postoperative single-dose beta-irradiation (RT) with (90) Sr in the case of primary pterygium in a clinical trial. METHODS AND MATERIALS: This trial was designed as a prospective, randomized, single center study. Surgery was performed in all cases according to the conjunctival autograft technique. One thousand and four patients with 108 pterygia were postoperatively randomized to either beta-RT or observation. In the case of beta-RT, a (90) Sr eye applicator was used to deliver 1000 cGy to the sclera surface at a dose rate of between 200 and 250 cGy/min. After treatment, both an ophthalmologist and a radiation oncologist performed the follow-up examinations. The accumulated data were analyzed using a group sequential test. RESULTS: Between February 2007 and September 2008, 104 eyes with primary pterygium were operated on according to the trial protocol. Additional treatment was performed within 24 hours postoperatively. Four patients were lost to follow-up, resulting in 104 patients who could be analyzed. In the 54 eyes randomized to receive beta-RT, 5 relapses occurred compared with 8 recurrences in the 50 eyes that no received RT, for a crude control rate of 90.7 % vs. 84 %, respectively. At a mean follow-up of 9 months (range 4- 18), major treatment complications had not been observed . CONCLUSION: Single-dose beta-RT of 1000cGy after conjunctival autograft surgery is a simple, effective, and safe treatment that reduces the risk of primary pterygium recurrence.

Conditions
-----------------
Pterygium

Intervention / Treatment
-----------------
* Radiation: beta-irradiation
* Procedure: conjunctival autograft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fresh pterygium without previous treatment. Adult patients with age higher than 18 years. Exclusion Criteria: Diagnosis of glaucoma. Previous treatment of pterygium. Patients with age less than 18 years old.

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: conjunctival autograft plus beta-irradiation<br> | Radiation: beta-irradiation<br> <br> |
| Active Comparator: conjunctival autograft<br> | Procedure: conjunctival autograft<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
beta-irradiation;conjunctival autograft;pterygium;recurrence; clinical trial
Musculoskeletal Ultrasound for Diagnosis of Shoulder Dislocation Reduction

Study Overview
=================
Brief Summary
-----------------
This study will compare the current standard of care post reduction plain film x ray for confirmation of shoulder reduction to point of care ultrasound. Patients will receive both the current standard of care post reduction x ray and point of care ultrasound to act as their own comparators

Official Title
-----------------
Musculoskeletal Ultrasonography to Diagnose Successful Reduction of Shoulder Dislocation

Conditions
-----------------
Ultrasound, Shoulder Dislocation, Musculoskeletal Injury

Intervention / Treatment
-----------------
* Diagnostic Test: Point of care ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults greater than or equal to 18 years Acute shoulder dislocation Exclusion Criteria: Associated fracture Associated neurovascular injury

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Self Controlled<br>Patients will active as their own comparator | Diagnostic Test: Point of care ultrasound<br>* Patients will receive a point of care ultrasound at the bedside in the Emergency Department and compare the impression to the x ray result<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of X ray to Ultrasound for Shoulder Reduction | Compare the impression of the x ray to the ultrasound for successful shoulder reduction | through study completion up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of X ray to Ultrasound in the diagnosis of post shoulder reduction complications | Compare the impression of the x ray to the ultrasound for shoulder dislocation complications | through study completion up to 1 year |
This Clinical Study Evaluates the Performance and Safety of Biorithm Research Kit Versus CTG in Prenatal Monitoring of Pregnant Participants.

Study Overview
=================
Brief Summary
-----------------
This clinical study will evaluate the safety and comparative performance of Biorithm Research Kit vs CTG (gold standard) in prenatal monitoring of pregnant participants.

Detailed Description
-----------------
The Biorithm Research Kit system used in this study consists of femom fetal monitor (known as fetal monitor), a digital gateway and a cloud storage. It's intended for monitoring of maternal and fetal physiological parameters. It includes non-invasive fetal monitor or device, that monitors fetal heart rate (FHR), maternal heart rate (MHR), and uterine activity (UA) in the antepartum period.

Official Title
-----------------
AMBulatory Fetal ECG Monitoring in High Risk Pregnancies

Conditions
-----------------
Pregnancy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have a singleton pregnancy Should be at and above 28 weeks of pregnancy Should have a valid indication for antenatal FHR monitoring as part of their pregnancy management, as per local hospital policy Able to speak English or have access to an interpreter and provide Informed Consent Exclusion Criteria: Participants with an intellectual or mental impairment Participants with a known allergy or hypersensitivity to ECG gel electrodes Participants in pain, with contractions or in labour Known fetal cardiac or genetic abnormality Participant with a pacemaker

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fetal Heart Rate (FHR) | FHR agreement between Biorithm Research Kit and standard of care (CTG) | 60 minutes | 
| Maternal Heart Rate (MHR) | MHR agreement between Biorithm Research Kit and standard of care (CTG) | 60 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
antepartum monitoring