linjc16/ctgov huggingface dataset:
Osteoarthritis in Older Adults: Recovery of Mobility and Pain With a Topical Analgesic

Study Overview
=================
Brief Summary
-----------------
Biofreeze® is a topical ointment that has menthol and alcamphor. Its analgesic effect lies in the stimulation of A and C fibers by cold and nociceptive stimulation, respectively, which is produced by menthol, apparently through the newly discovered receptor TRPM8 (Transient Receptor Potential melastatin-8) The aim of this study is to investigate if BIOFREEZE ® treatment (Performance Health Inc., Export, PA) improves symptoms associated with moderate knee osteoarthritis, which would decrease the immobility and isolation in older adults.

Official Title
-----------------
Osteoarthritis in Older Adults: Recovery of Mobility and Pain With a Topical Analgesic

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Drug: Biofreeze
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Moderate osteoarthritis of the knee Age 60 to 80 years Ambulatory Exclusion Criteria: Other conditions that affect mobility Severe chronic diseases such as cardiac or renal failure Cancer Presence of gout Cognitive impairment

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 80 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Biofreeze<br> | Drug: Biofreeze<br>* Use of Biofreeze ointment<br>|
| Placebo Comparator: Placebo<br>Use of placebo ointment | Other: Placebo<br>* Use of placebo ointment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC score | WOMAC score corresponds to Western Ontario and McMaster Universities Index of Osteoarthritis | 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life measured using SF 36 | SF 36 correponds to a health related quality of life score | 60 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoarthritis, Pain, Quality of life
Evaluation of Lipid Emulsion on GCX in Critically Ill Patients

Study Overview
=================
Brief Summary
-----------------
Characterisation of the lipidome and parenteral nutrition modulate the endothelial glycocalyx. The aim of the study A is to detect any influence of the lipid emulsion on the endothelial glycocalyx in patients in critical care. The targeted cohort is patients on ICU with an indication for parenteral nutrition including lipid emulsion. 15 patients are planned to be enrolled. Monitored variables: demographic data, type of the population, type of the lipid emulsion, selected variables of the lipid metabolism, sublingual microcirculation (SDF imaging),

Official Title
-----------------
Alterations of Glycocalyx in Critical Illness and During Major Surgery and Approaches for Glycocalyx Protection. Effect of Parenteral Nutrition and Plasma Lipidome on GCX

Conditions
-----------------
Endothelial Dysfunction

Intervention / Treatment
-----------------
* Device: Sublingual microcirculation assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients in ICU indication for lipid administration as a part of TPN Exclusion Criteria: shock or clinical/laboratory signs of tissue hypoperfusion previous lipid infusions (within 3 months before entering study) hyperlipidaemia hyperglycaemia (over 10 mmol/l) current or previous (within 72 hours before entering the study) use of propofol pancreatitis severe liver failure current use of statins

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 |
| --- | --- |
| Patients in ICU requiring parenteral nutrition<br> | Device: Sublingual microcirculation assessment<br>* Non-invasive investigation of the endothelial glycocalyx in the sublingual microcirculation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial Glycocalyx Thickness | Endothelial glycocalyx thickness was measured indirectly by PBR, which is a lateral movement of the red blood cells from the median column in the microcirculation in micrometers. The higher the PBR is the more damaged the endothelial glycocalyx is. | One week within the ICU care |
The Role of Central Neck Dissection in Stage N0 Papillary Thyroid Carcinoma

Study Overview
=================
Brief Summary
-----------------
The benefits of prophylactic central neck dissection (pCND) remain controversial in clinically node-negative (cN0) papillary thyroid carcinoma (PTC). This study main goal is to investigate benefits of prophylactic central neck dissection in clinically node-negative papillary thyroid carcinoma.

Detailed Description
-----------------
Papillary thyroid carcinoma (PTC) is the most common type of differentiated thyroid carcinoma. Recurrence rate is still high. The standard management is total thyroidectomy. regional lymph node metastasis is noted in recurrent cases. Some studies stated benefits of central neck dissection in orevention of recurrence and others said there is no benefits. so prophylactic central neck dissection (pCND) remain controversial in clinically node-negative (cN0) papillary thyroid carcinoma (PTC).

Official Title
-----------------
The Role of Central Neck Dissection in Stage N0 Papillary Thyroid Carcinoma

Conditions
-----------------
Papillary Thyroid Cancer

Intervention / Treatment
-----------------
* Procedure: central neck dissection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with papillary thyroid cancer with clinically node negative. Exclusion Criteria: patients with clinical evidence of nodal metastases. patients with a previous history of thyroidectomy. patients with mixed-type papillary thyroid cancer.

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- |
| patients with node negative papillary thyroid carcinoma<br> | Procedure: central neck dissection<br>* dissection of central cervical lymph node grope in low grade papillary thyroid cancer<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence metastatic lymph node in patients with clinically node-negative thyroid carcinoma who underwent total thyroidectomy with central neck dissection | numbers of positive histopathological lymph node biopsies postoperative | 12 months |
Sedation of Morbidly Obese for Balloon Insertion

Study Overview
=================
Brief Summary
-----------------
This prospective study will assess the value of different supplements to orpofol bases anesthesia in morbidly obes e patients scheduled for balloon insertion. Two common drugs will be added to propofol bases anesthesia;Ketamine or fentanyl. Effect on prpofol consumption, post-procedure recovery profile, and patient satisfaction will be the study objectives.

Official Title
-----------------
Fentanyl Versus Ketamine Supplementation for Prpofol Anesthesia During Balloon Insertion in Morbidly Obese Patients

Conditions
-----------------
Morbid Obesity

Intervention / Treatment
-----------------
* Drug: Fentanyl
* Drug: Ketamine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: morbid obese indicated for gastric balloon insertion Exclusion Criteria: - Refusal Hypersensitivity to any of the study drugs

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 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: Fentanyl group<br> | Drug: Fentanyl<br>* 0.5 mic/kg fentanyl will be given immediately before the procedure<br>|
| Experimental: Ketamine group<br> | Drug: Ketamine<br>* 0.25 mg ketamine will be administered immediately before the procedure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Propofol consumption (milligrams) | Dose of prpofol (mg/kg) required for sedation during gastric balloon insertion | 24 hours after the endoscopy |
Pain Associated With Neonatal Frenotomy

Study Overview
=================
Brief Summary
-----------------
The present study sought to examine the efficacy of two oral anesthetic drugs in reducing the pain associated with neonatal frenotomy.

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Analgesic effect of topical tetracaine 2 %


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: infants diagnosed with ankyloglossia at the nursery of the RHCC, who will be referred by a qualified neonatologist to the OCAD for a routine tongue-tie frenotomy procedure because of breast feeding difficulties. Ankyloglossia type 1 or 2 Exclusion criteria Abnormal oral or nasopharyngeal anatomy Any known congenital malformations Ankyloglossia type 3 or 4 Exclusion Criteria: -

Ages Eligible for Study
-----------------
Maximum Age: 8 Weeks

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2<br>Topical Anesthetic, 2% Tetracaine oral gel - Group A Topical Anesthetic, 20% Benzocaine oral gel - Group B | Drug: Analgesic effect of topical tetracaine 2 %<br>* The patient will be held by the parents and comforted after local anesthesia is applied by a research investigator. Then, he will be placed on procedure's board repositioned for clipping, restrained by the parent/nurse (holding both head and arms, keeping with conventional practice). Exactly 5 minutes after the topical anesthetic was applied, the pediatric dentist will press down the chin gently straddling the frenulum while and holding it in place with visualization of tongue base. Then the frenulum will be snipped along the underside of the tongue to its base. The area will be checked to ensure complete release. Bleeding will be controlled by pressuring with a 2x2 gauze pad under the tongue. A study investigator will film the procedure using GO PRO Video Camera mounted on the forehead of the pediatric dentist<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal Facial Coding System (NFCS) |  | During procesure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cry Duration |  | Post procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Frenotomy, Pain
A Study to Compare to the Pharmacokinetic Profile of Two Paracetamol Formulations

Study Overview
=================
Brief Summary
-----------------
A repeat dose pharmacokinetic study investigating two paracetamol formulations

Official Title
-----------------
A Repeat Dose PK Study Investigating the Extent of Paracetamol Absorption From Two Sustained Release Paracetamol Formulations

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Drug: Experimental paracetamol formulation
* Drug: Marketed paracetamol
* Drug: Higher dose marketed paracetamol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination. Exclusion Criteria: Subject does not agree to refrain from alcohol consumption for the 10-day period prior to visit 2 and throughout the study. Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit. Current (within 14 days of screening) or regular use of any prescription, over-the-counter drugs including paracetamol/acetaminophen, herbal medicine or drug known to induce or inhibit hepatic drug metabolism in the 30 days prior to dosing (e.g. barbiturates, theophylline, cimetidine, or erythromycin), excluding prescription birth control, if applicable.

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental paracetamol formulation<br>test formulation | Drug: Experimental paracetamol formulation<br>* experimental<br>|
| Active Comparator: Marketed paracetamol<br>Marketed paracetamol | Drug: Marketed paracetamol<br>* Marketed paracetamol<br>|
| Active Comparator: Higher dose marketed paracetamol<br>higher dose marketed paracetamol | Drug: Higher dose marketed paracetamol<br>* Higher dose marketed paracetamol<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence as measured by Area Under the Curve (AUC) |  | last 24 hours of dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time duration at or above minimal therapeutic plasma paracetamol concentration |  | last 24 hours of dosing | 
| To assess pharmacokinetic parameters (Cmax, AUC, Tmax and Kel) |  | last 24 hours of dosing | 
| Adverse events |  | Baseline to 72 hours post dosing | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pharmacokinetic, paracetamol, Healthy volunteer, steady state
Trial of Unicompartmental Versus Total Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
This study is a prospective, randomized trial to compare patient outcomes of unicompartmental knee arthroplasty (UKA) and total knee arthroplasty (TKA) for the treatment of medial compartment osteoarthritis.

Official Title
-----------------
A Prospective Randomized Trial of Unicompartmental Versus Total Knee Arthroplasty for the Treatment of Medial Compartment Osteoarthritis

Conditions
-----------------
Osteo Arthritis Knee

Intervention / Treatment
-----------------
* Procedure: Unicompartmental knee arthroplasty
* Procedure: Total knee arthroplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: medial compartment osteoarthritis of the knee knee flexion greater than greater than 90 degrees flexion contracture of less than 10 degrees varus deformity < 20 degrees grade IV degeneration of the medial compartment Exclusion Criteria: lateral compartment degenerative changes previous lateral meniscectomy anterior cruciate ligament deficiency body mass index > 40 inflammatory arthritis history of septic arthritis hemoglobin A1c > 8.0 chronic liver disease stage 3A or greater chronic renal disease active IV drug abuse patients requiring thromboembolic prophylaxis

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: UKA<br>Medial unicompartmental knee arthroplasty | Procedure: Unicompartmental knee arthroplasty<br>* Implant to replace the medial compartment of a patient with knee osteoarthritis<br>|
| Active Comparator: TKA<br>Total knee arthroplasty | Procedure: Total knee arthroplasty<br>* Implant to replace the knee joint of a patient with knee osteoarthritis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Society Score | Functional outcome questionnaire ranging from 0-100, with 100 being best | 1 year | 
| Knee Society Score | Functional knee outcome questionnaire ranging from 0-100, with 100 being best | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Revision | complication requiring revision surgery | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
unicompartmental knee, total knee arthroplasty, osteoarthritis
INSPIRE Continuation Post-Approval Study

Study Overview
=================
Brief Summary
-----------------
To evaluate long-term BOS-free survival outcomes of the OCS™ Lung INSPIRE Trial patients.

Official Title
-----------------
OCS Lung INSPIRE Long-Term Continuation Post-Approval Study - INSPIRE Continuation PAS

Conditions
-----------------
Bronchiolitis Obliterans

Intervention / Treatment
-----------------
* Device: OCS Lung System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant in TransMedics OCS Lung System INSPIRE trial Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| OCS Lung INSPIRE Trial<br> | Device: OCS Lung System<br>* No active interventions are part of this study. This study will collect long-term survival and BOS data in subjects who were part of the INSPIRE trial.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brochiolitis Obliterans Syndrome (BOS) -free survival | BOS-free survival | 5 years post transplant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | Survival post transplant | 5 years | 
| Freedom from Bronchiolitis Obliterans Syndrome (BOS) as determined from pulmonary function tests (PFT's) | Freedom from BOS | 5 years |
Drug Interaction Study - Effect of AZD5672 on the Pharmacokinetics of Digoxin

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to examine the effect of AZD5672 (dosed to steady state) on the pharmacokinetics of digoxin (single dose administration).

Official Title
-----------------
An Open-label Study to Assess the Effect of AZD5672 at Steady State on the Pharmacokinetics of Digoxin Following Single Dose Administration in Healthy Volunteers

Conditions
-----------------
Healthy Volunteers, Pharmacokinetics

Intervention / Treatment
-----------------
* Drug: AZD5672
* Drug: Digoxin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of signed written informed consent. Females should not be of childbearing potential Clinically normal physical and laboratory findings as judged by the investigator, including negative drug test and negative tests of Hepatitis B surface antigen, antibodies to Hepatitis C virus and antibodies to HIV. Exclusion Criteria: Any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or may influence the results of the study, or the subject's ability to participate Known allergy to digoxin or previous complications to digoxin therapy. Participation in any clinical study involving an investigational product in the 3 months prior to enrolment.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>AZD5672 + Digoxin (single dose on day 12) | Drug: AZD5672<br>* 50 mg, for 13 days<br>Drug: Digoxin<br>* 0.5mg dose<br>* Other names: Lanoxin;|
| Experimental: 2<br>AZD5672 (increasing dose up to 150mg) + digoxin (single dose on day 12) | Drug: AZD5672<br>* 50 mg, for 13 days<br>Drug: Digoxin<br>* 0.5mg dose<br>* Other names: Lanoxin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK variables |  | Frequent sampling occasions during study periods | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety variables (adverse events, blood pressure, pulse, safety lab) |  | During the whole treatment periods | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AZD5672, digoxin