linjc16/ctgov huggingface dataset:
Outpatient Management of Tonsillectomy in Adults

Study Overview
=================
Brief Summary
-----------------
Tonsillectomy is a frequent surgical procedure in the ENT specialty but it can be a source of postoperative pain that can be important. These pains complicate the intake of food and in particular the intake of analgesic drugs per os and require the prolongation of the hospitalization in order to continue an intravenous analgesia. The aim is to set up a protocol for ambulatory care of adult tonsillectomies. Then, it would allow an improvement of the postoperative quality of life for the patient, who prefers a quicker return home.The study aims to allow patients to come back home early after tonsillectomies with intravenous analgesia. Pain, feeding and quality of life will be evaluated regularly through an application called MAELA during a few days after surgery. They will also be evaluated by nurses coming via providers.

Official Title
-----------------
Outpatient Management of Tonsillectomy in Adults

Conditions
-----------------
Tonsillectomy, Pain, Ambulatory

Intervention / Treatment
-----------------
* Procedure: Tonsillectomy
* Other: daily follow-up


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Indication for a tonsillectomy defined in the French recommendations Age between 18 and 60 yo Providing free and informed consent to participate Having a smartphone able to process MAELA application Affiliation to french social security

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tonsillectomy<br> | Procedure: Tonsillectomy<br>* Tonsillectomy<br>Other: daily follow-up<br>* daily follow-up of clinical parameters (pain, feeding) and analgesia adapted to the pain<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients EVA score less or equal at 3 | EVA score is a pain scale from 0 to 10. 10 is the highest pain level. | day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tonsillectomy, Pain, ambulatory
Comparison of Three Different Surgical Approaches on the Functional Outcome After Total Hip Arthroplasty

Study Overview
=================
Brief Summary
-----------------
This study aimed to determine differences in functional recovery after total hip arthroplasty between a group of patients operated on using a direct lateral approach, an anterolateral minimally invasive approach, and a posterior approach to the hip joint. Arthroplasty is the most commonly performed surgical procedure in orthopedics and is also considered the gold standard for treating the final stage of osteoarthritis. There are several different approaches, but there are still conflicting studies that talk about the benefits of a particular approach. There is an insufficient number of scientific, prospective studies that monitor the basic functional and rehabilitation parameters, which are also indicators of the success of the performed procedure.

Official Title
-----------------
Comparison of Three Different Surgical Approaches on the Functional Outcome After Total Hip Arthroplasty

Conditions
-----------------
Total Hip Arthroplasty, Functional Recovery

Intervention / Treatment
-----------------
* Other: Functional recovery analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hip osteoarthritis Exclusion Criteria: N/A
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Functional Recovery<br> | Other: Functional recovery analysis<br>* Functional recovery analysis with force evaluator & tester<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional recovery after total hip arthroplasty / Range of motion | Investigators analyze active and passive range of motion (ROM) measured in degrees. | 2 years | 
| Functional recovery after total hip arthroplasty / Walking speed | Investigators analyze walking speed in seconds for the 50 meters long walk. | 2 years | 
| Functional recovery after total hip arthroplasty / Harris Hip Score | Investigators take a questionnaire (Harris Hip Score, HHS), the maximum point is 100. | 2 years | 
| Functional recovery after total hip arthroplasty / Hip abductors strength | Investigators analyze hip abductors strength measured with a dynamometer in kilograms (kg). | 2 years |
Correlation of Ultrasonography Indices of Venous Congestion With Intra-abdominal Pressure in ICU Patients.

Study Overview
=================
Brief Summary
-----------------
The goal of this prospective observational study is to examine the potential association between intra-abdominal pressure and venous congestion as assessed by abdominal ultrasound, in critically ill patients in the Intensive Care Unit (ICU). The main question it aims to answer is whether there is association between intra-abdominal pressure and Venous Excess Ultrasound (VExUS) score. Participants will be sonographically assessed and their intra-abdominal pressure measured once within the first 3 days of ICU admission.

Official Title
-----------------
Correlation of Ultrasonography Indices of Venous Congestion With Intra-abdominal Pressure in ICU Patients.

Conditions
-----------------
Intra-Abdominal Hypertension, Venous Congestion

Intervention / Treatment
-----------------
* Diagnostic Test: Abdominal ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Intubated ICU patients on controlled mechanical ventilation, receiving sedation. Patients must have urethral catheter in place. Exclusion Criteria: age < 18 year old pregnancy / lactation primary liver disease (hepatic cirrhosis, hepatic space-occupying lesions, Budd-Chiari syndrome, portal vein thrombosis) or hepatic surgery end stage renal failure or on chronic dialysis non-intubated patients or intubated patients on non-controlled mechanical ventilation mode absence of urethral catheter, presence of suprapubic catheter, continuous bladder irrigation poor abdominal echogenicity

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normal intra-abdominal pressure<br> | Diagnostic Test: Abdominal ultrasound<br>* Measurement of venous congestion in abdominal target-organs (liver, kidneys) by calculating VExUS score<br>* Other names: VExUS score calculation;|
| Elevated intra-abdominal pressure<br> | Diagnostic Test: Abdominal ultrasound<br>* Measurement of venous congestion in abdominal target-organs (liver, kidneys) by calculating VExUS score<br>* Other names: VExUS score calculation;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VExUS score difference between the 2 study groups (normal and elevated intra-abdominal pressure) |  | 01.12.2023 - 01.08.2024 |
The Surveillance Clinical Study of Rickettsiosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this surveillance (non-interventional) clinical study is to genotype the causative agents of rickettsiosis in biological samples of patients from the Altai Republic, Russian Federation. This is a solely observational study in the patients with diagnosed or suspected tick-borne rickettsioses, with no intervention to the routine treatment and diagnostic process. During the study the medical history, diseases progress and symptoms, as well as treatments are being registered in individual case report forms. The rests of the samples used for standard diagnostics (plasma, or serum, and/or swabs of the tick bite site) are being collected and afterwards will be analyzed for a new rickettsia type. These data will be compared to the medical history and symptoms of the patients in order to identify clinical pattern specific for the new rickettsia type. Informed consents from all patients or their legal representatives are being collecting. The study was approved by the local ethical committee.

Official Title
-----------------
The Surveillance (Non-interventional, Observational) Clinical Study of Rickettsiosis Caused by a New Genotype of Rickettsia in the Altai Republic, Russian Federation

Conditions
-----------------
Rickettsiosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written patient's informed concent for study participation; Male and female patients of any age with diagnosed or suspected tick-born rickettsioses. Exclusion Criteria: - Unwillingness to participate in the study by any reason.
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 |
| --- | --- | --- |
| Genotype the causative agents of rickettsiosis | Genotype the causative agents of rickettsiosis in biological samples (blood and swab) of patients from the Altai Republic, Russian Federation | up to 4 weeks |
Evaluate the Efficacy and Safety of SHR-1918 in Patients With Hyperlipidemic

Study Overview
=================
Brief Summary
-----------------
This is a Multicenter, Randomized, Double-Blind, Placebo-Parallel-Controlled, Phase II Clinical Stud to assess the reduction of low-density lipoprotein cholesterol (LDL-C) by SHR-1918 in patients with Hyperlipidemic.

Official Title
-----------------
An Efficacy, Safety Study to Evaluate Multiple Subcutaneous SHR-1918 in Combination With Lipid-Lowering Drugs for the Stable Treatment of Hyperlipidemic Patients With Poor Lipid Control-A Multicenter, Randomized, Double-Blind, Placebo-Parallel-Controlled, Phase II Clinical Study

Conditions
-----------------
Hyperlipidemic

Intervention / Treatment
-----------------
* Drug: SHR-1918
* Drug: SHR-1918 placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Regularly taking any moderate-intensity or higher dose* of statin stabilization therapy for ≥4 weeks at screening: ASCVD risk is ultra-high risk Fasting LDL-C ≥ 1.4 mmol/L; ASCVD risk very high risk Fasting LDL-C ≥1.8 mmol/L; ASCVD risk is intermediate or high risk Fasting LDL-C ≥ 2.6 mmol/L. Any other condition that is not met at screening Regularly taking any moderate intensity and higher dose* statin stabilization therapy for ≥4 weeks; a) Fasting LDL-C ≥ 2.6 mmol/L. Fasting triglycerides ≤ 5.6 mmol/L. Exclusion Criteria: Previously diagnosed type 1 diabetes or poorly controlled type 2 diabetes at screening (HbA1c > 8.5%). eGFR <30ml/min/1.73m2 at the screening visit. CK >5times ULN at the screening visit.

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase II Clinical Study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SHR-1918<br> | Drug: SHR-1918<br>* SHR-1918<br>|
| Placebo Comparator: SHR-1918 placebo<br> | Drug: SHR-1918 placebo<br>* SHR-1918 placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in calculated LDL-C from baseline to week 16 |  | from baseline to week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in calculated LDL-C from baseline to week 16 |  | from baseline to week 16 |
Pharmacogenomics Effects on High-Dose Methotrexate Clearance in Patients With Diffuse Large B-Cell Lymphoma

Study Overview
=================
Brief Summary
-----------------
This study evaluates pharmacogenomic effects on high-dose methotrexate clearance in patients with diffuse large B-cell lymphoma.

Detailed Description
-----------------
PRIMARY OBJECTIVES: I. To identify SNPs associated with delayed MTX clearance. II. To explore any association between SNPs and increased toxicity. OUTLINE: This is an observational study. Participants undergo blood sample collection and have their medical records reviewed on study.

Official Title
-----------------
Pharmacogenomics Effects on High-Dose Methotrexate Clearance in Patients With Diffuse Large B-Cell Lymphoma

Conditions
-----------------
Central Nervous System Lymphoma, Diffuse Large B-Cell Lymphoma

Intervention / Treatment
-----------------
* Other: Non-Interventional Study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: * Adult (age ≥ 18 years at diagnosis) Diagnosis of DLBCL or PCNSL Planned to undergo treatment with HDMTX (≥ 3 g/m^2) at the James Cancer Hospital. Note: patients with CKD are eligible to participate regardless of eGFR provided the treating physician is planning a dose of HDMTX of at least 3 g/ m^2. Ability to provide informed consent. Exclusion Criteria: * Patients with a currently active second malignancy that, in the opinion of the principal investigator, will interfere with patient participation, or confound data interpretation Pregnancy (positive serum or urine pregnancy test), lactating or breast feeding Prisoners or incarcerated patients Total bilirubin > 5 mg/dL

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational<br>Participants undergo blood sample collection and have their medical records reviewed on study. | Other: Non-Interventional Study<br>* Non-interventional study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SNPs (single nucleotide polymorphisms) associated with delayed MTX clearance | Determine the SNPs associated with delayed methotrexate clearance | Up to 24 weeks |
Affera Global Registry

Study Overview
=================
Brief Summary
-----------------
The Affera Global Registry is a prospective, global, multi-center, observational post-market registry (PMR). The purpose of this study is to describe clinical performance and safety data in a broad patient population treated with the Affera Platform.

Official Title
-----------------
The Affera Global Registry is a Prospective, Global, Multi-center, Observational Post-market Registry (PMR)

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Device: Affera Platform


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is ≥ 18 years of age or minimum age as required by local regulations Planned procedure using the commercially available Affera Platform Willing and able to comply with study requirements and give IC (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this clinical study) or authorization per institution and geographical requirements Exclusion Criteria: Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the global study manager Subject with exclusion criteria required by local law

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treatment Arm<br>Patients enrolled and treated with the Affera Platform | Device: Affera Platform<br>* A cardiac ablation will be performed using the Affera Platform<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Objective #1 (Efficacy) | Estimate freedom from recurrence of the arrhythmia(s) treated at the study index ablation procedure using the Affera Platform. | 12 Month Post Proceedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Objective #2 (Safety) | Estimate serious device and serious procedure-related adverse events for the Affera Platform. | 90 Days Post Proceedure |
Evaluation of Different Psychiatric Symptoms in Patients With Thyroid Dysfunction

Study Overview
=================
Brief Summary
-----------------
Evaluate psychiatric symptoms in patients with thyroid dysfunction. Investigate effect of treatment on psychiatric symptoms after 2 months.

Detailed Description
-----------------
Thyroid dysfunction is associated with psychiatric symptoms in addition to endocrinal manifestations. The study aims to evaluate the prevalence of psychiatric symptoms in patients with thyroid dysfunction and investigate the response after thyroid treatment.

Official Title
-----------------
Assessment of Different Psychiatric Symptoms in Patients With Thyroid Dysfunction: Pre and Post Thyroid Treatment

Conditions
-----------------
Anxiety, Depression, Thyroid Dysfunction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients newly diagnosed as having thyroid dysfunction. Exclusion Criteria: Patients with other endocrinological disorders or significant medical or neurological diseases. Alcohol or substance abuse
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 |
| --- | --- | --- |
| The effect of thyroid treatment on psychiatric symptoms | Investigate the effect of thyroid treatment on psychiatric symptoms associated with thyroid dysfunction. | 2 months |
Effects of Subcutaneously Infiltrated Nicardipine on the Success Rate of Radial Artety Cannulation

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to compare the success rate of subcutaneously infiltrated nicardipine to normal saline in radial artery cannulation

Official Title
-----------------
Effects of Subcutaneously Infiltrated Nicardipine on the Success Rate of Radial Artety Cannulation

Conditions
-----------------
Radial Artery Cannulation

Intervention / Treatment
-----------------
* Drug: Nicardipine
* Other: Normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-75 years the patient who need to arterial line Exclusion Criteria: allergy to nicardipine history of peripheral artery disease BMI > 40 kg/m2 unwilling to participate or denial of informed consent

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nicardipine<br>Using nicardipine 0.5 mg(0.5ml) subcutaneously infiltrated by ultrasound before redial artery cannulation. | Drug: Nicardipine<br>* Subcutaneous infiltrate drug at puncture site by ultrasound-guided<br>|
| Placebo Comparator: Normal saline<br>Using normal saline 0.5ml subcutaneously infiltrated by ultrasound before redial artery cannulation | Other: Normal saline<br>* Subcutaneous infiltrate NSS at puncture site by ultrasound-guided<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate of radial artery cannulation since first skin puncture | Success rate of radial artery cannulation since first skin puncture | 10 minute from puncture at skin | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| radial artery diameter | Pre-induction radial artery diameter, post-induction radial artery diameter, radial artery diameter after subcutaneous infiltration at 0,1,2 and 3 minute | Pre-induction to 3 minute after subcutaneous infiltration | 
| Time from first skin puncture to success cannulation | Time from first skin puncture to present of arterial wave form, assessed less than 10 minutes | 10 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nicardipine, radial artery, artery cannulation, ultrasound