linjc16/ctgov huggingface dataset:
How is Physical Activity Level and Educational Expectations of Patient With Knee Osteoarthritis : Epidemiological Study in Spa Therapy

Study Overview
=================
Brief Summary
-----------------
The primary purpose is to evaluate the level of physical activity in patients with knee osteoarthritis in a spa treatment and doing epidemiological study about this patient.

Detailed Description
-----------------
Explain the physical activity level of knee osteoarthritis by socio-demographic, clinical variables, barriers and facilitators of regular physical activity practice, fears and beliefs about their condition, functional limitations and physical inactivity.

Official Title
-----------------
How is Physical Activity Level and Educational Expectations of Patient With Knee Osteoarthritis : Epidemiological Study in Spa Therapy

Conditions
-----------------
Knee Osteoarthritis, Physical Activity

Intervention / Treatment
-----------------
* Other: Epidemiological study Survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients, male or female, aged 50 to 75 years. Patients with knee pain reported to osteoarthritis Patient affiliated to a social security scheme (beneficiary entitled) Patient registered spa Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 75 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 knee pain<br> | Other: Epidemiological study Survey<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of physical activity with IPAQ short form |  | During the spa treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Socio-demographic variables as assessed by : age, sex, family situation, level of study |  | During the spa treatment | 
| Fears and beliefs as assessed by KOFBeQ |  | During the spa treatment | 
| Pain as assessed by EVA |  | During the spa treatment | 
| Functional status as assessed by WOMAC |  | During the spa treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Physical activity level, Knee osteoarthritis, Non pharmacological treatment, Survey, Socio-demographic, clinical variables, Barriers, facilitators Fears and beliefs, Function
Comparison of SensaScope Intuboscope and McGrath Series 5 for Endotracheal Intubation

Study Overview
=================
Brief Summary
-----------------
A randomized controlled prospective study of laryngoscopy and intubation time comparing SensaScope and the McGrath® Series 5 video laryngoscope.

Detailed Description
-----------------
The use of videolaryngoscopy is increasing as a technique for rescue intubation as well as for elective intubation. Current airway management guidelines recommend video-assisted laryngoscopy as a choice for basic airway management. This is a proposed comparison study of a video laryngoscope, use in the daily anesthesia practice, and its likely increased success compared to semi-rigid stylet. An national, mono center, prospective randomized comparative trial (RCT) is proposed testing the superiority of oral tracheal intubation with the McGrath® Series 5 versus SensaScope in adult patients under general anaesthesia.

Official Title
-----------------
Comparative Study Between SensaScope Intuboscope and McGrath Series 5 Videolaryngoscope to Tracheal Intubation: a Prospective Randomised Study

Conditions
-----------------
Airway Morbidity

Intervention / Treatment
-----------------
* Device: Time for tracheal intubation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 Years No concurrent participation in another study capacity to consent Present written informed consent of the research participant Elective surgery under general anesthesia Exclusion Criteria: Age <18 years Existing pregnancy Lack of consent inability to consent emergency patients Emergency situations in the context of a Difficult Airway Management ASA classification> 3 situations where the possibility of accumulated gastric contents Participation in another study

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SensaScope<br>Time for tracheal intubation with the SensaScope | Device: Time for tracheal intubation<br>* In a randomised trial we measure the time for ventilation by means of endtidale CO2 Curve<br>|
| Experimental: McGrath Series 5<br>Time for tracheal intubation with the McGrath Series 5 | Device: Time for tracheal intubation<br>* In a randomised trial we measure the time for ventilation by means of endtidale CO2 Curve<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparison of different time for tracheal intubation | times for tracheal intubation, View of the glottic, experience in anesthesia | <2min | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
airway, videolaryngoscope
The Effect of Lifestyle Intervention Versus Gastric Bypass on Various Comorbidities in Morbidly Obese Subjects

Study Overview
=================
Brief Summary
-----------------
This follow up study (>1 year) aims to compare the effects of lifestyle intervention and gastric by pass surgery on various comorbidities associated with morbid obesity.

Detailed Description
-----------------
Not addressed

Official Title
-----------------
The Effect of Lifestyle Intervention vs Gastric Bypass on Various Comorbidities

Conditions
-----------------
Obstructive Sleep Apnea, Diabetes Mellitus, Hypertension

Intervention / Treatment
-----------------
* Procedure: Bariatric surgery
* Behavioral: Intensive lifestyle intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Morbidly obese patients Exclusion Criteria: -

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bariatric surgery<br>Bariatric surgery (gastric bypass) offered to patients after informed consent and shared decision. The surgical procedure was performed at Vestfold Hospital Trust by experienced bariatric surgeons. | Procedure: Bariatric surgery<br>* Bariatric surgery as a part of public health service offered treatment seeking morbidly obese patients.<br>|
| Active Comparator: Intensive lifestyle intervention<br>Intensive lifestyle intervention (1-year endurance) at a rehabilitation centre. The intervention consisted of motivation for behaviour change including calorie restriction and increased physical activity. | Behavioral: Intensive lifestyle intervention<br>* Intensive lifestyle intervention as a part of public health service offered treatment seeking morbidly obese patients.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of co-morbidities | 1-year comparative nonrandomized controlled trial | 1-year after treatment start | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety issues | Surgical complications and serious adverse events in both groups as published | 1-year |
Cryotherapy to Improve Outcomes in Lower Third Molar Surgery

Study Overview
=================
Brief Summary
-----------------
This study is looking to see whether cooling the face using a special cooling device (Hilotherm®) before and during the removal of wisdom teeth will reduce the pain and discomfort patients feel after the procedure. The surgical removal of lower third molars (wisdom teeth) is arguably the most commonly performed surgical procedure worldwide. If this study shows that application of cold before and throughout the procedure is a simple way to reduce post-operative symptoms, it could benefit thousands of patients every year.

Official Title
-----------------
Cryotherapy to Improve Outcomes in Lower Third Molar Surgery

Conditions
-----------------
Oral Surgery

Intervention / Treatment
-----------------
* Device: Hilotherm® cooling device and face mask


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 18+ years requiring surgical removal of a single (unilateral) mandibular wisdom tooth Tooth requiring full mucoperiosteal flap and bone removal for removal of tooth Written informed consent Exclusion Criteria: Patients refusing to give written informed consent Clinically significant or unstable physical or mental disability rendering the participants incapable of complying with the study protocol as judged by the investigator Pregnant women Patients taking long-term anti-microbial or anti-inflammatory drugs Patients requiring pre-operative antibiotics for surgery Patients requiring concomitant extractions or contralateral lower 3rd molar removal

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hilotherm® Device<br>Patients undergo removal of lower third molar with Hilotherm® cooling device applied. | Device: Hilotherm® cooling device and face mask<br>* Hilotherm® is an external cooling device and facial mask through which water circulates at a controlled temperature This allows continuous cooling of the face, and is thought to reduce post-operative swelling and pain.<br>|
| No Intervention: Control<br>Patients undergo removal of lower third molar without the Hilotherm® cooling device applied. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative pain | Post operative pain 7 days after operation as measured in mm from VAS scale | 7 days |
A Comparative Study of Azithromycin and S-P as Prophylaxis in Pregnant HIV+ Patients

Study Overview
=================
Brief Summary
-----------------
Randomized controlled single blind prospective comparative study

Detailed Description
-----------------
This study is intended to be a randomized controlled single blind prospective comparative study conducted to compare the efficacy of three monthly doses of sulphadoxine-pyrimethamine as intermittent preventive therapy for malaria with azithromycin in HIV positive pregnant women

Official Title
-----------------
A Comparative Study of Azithromycin and Sulphadoxine-pyrimethamine as Prophylaxis Against Malaria in Pregnant HIV Positive Patients

Conditions
-----------------
Malaria, Pregnant, HIV

Intervention / Treatment
-----------------
* Drug: Sulphadoxine-pyrimethamine
* Drug: Azithromycin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant HIV positive patients, Gestational age 16 weeks and above, No history of azithromycin or sulphadoxine-pyrimethamine use four weeks prior to recruitment Exclusion Criteria: Anaemia packed cell volume less than 30%, pre-existing medical conditions- diabetes mellitus, hypertension, allergy to sulphadoxine-pyrimethamine or azithromycin

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Azithromycin<br>Tabs Azithromycin 500mg daily for 3 days | Drug: Sulphadoxine-pyrimethamine<br>* Sulphadoxine-Pyrimethamine 500mg of Sulphadoxine and 25mg of Pyrimethamine 3tablets monthly for 3 doses<br>* Other names: Vitadar;Drug: Azithromycin<br>* Tabs Azithromycin 500mg daily for 3 days<br>* Other names: Zithromax;|
| Active Comparator: Sulphadoxine-pyrimethamine<br>500mg of sulphadoxine and 25mg of pyrimethamine 3 tablets every 4 weeks for 3 doses | Drug: Sulphadoxine-pyrimethamine<br>* Sulphadoxine-Pyrimethamine 500mg of Sulphadoxine and 25mg of Pyrimethamine 3tablets monthly for 3 doses<br>* Other names: Vitadar;Drug: Azithromycin<br>* Tabs Azithromycin 500mg daily for 3 days<br>* Other names: Zithromax;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of malaria parasitemia at delivery in HIV positive women following administration of Azithromycin or Sulphadoxine- pyrimethamine as intermittent preventive therapy for malaria in pregnancy |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IPT, malaria, pregnant, HIV positive
Bone Mineral Markers in Hypogonadism

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate the markers of bone mineral metabolism in an unconfounded group of patients with hypogonadism and to search for a relationship between endothelial dysfunction and insulin resistance.

Detailed Description
-----------------
Cardiometabolic disorders are prevalent in patients with hypogonadism. Endothelial dysfunction and insulin resistance are used in determining cardiovascular risk. The role of markers of bone mineral metabolism in hypogonadism is not clearly presented. 49 male patients with hypogonadotropic hypogonadism (HH) and 43 BMI and age matched healthy male subjects were enrolled. Osteoprotegerin (OPG), fibroblast growth factor-23 (FGF-23), vitamin D and asymmetric dimethylarginine (ADMA) levels were measured. The insulin sensitivity was estimated by homeostatic model assessment-insulin resistance (HOMA-IR) formula.

Official Title
-----------------
Osteoprotegerin, Fibroblast Growth Factor 23 and Vitamin D3 Levels in Male Patients With Hypogonadism

Conditions
-----------------
Hypogonadotropic Hypogonadism, Endothelial Dysfunction, Insulin Resistance

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male patients with hypogonadotropic hypogonadism being under the age of 45 and over the age of 18 not previously given testosterone or human chorionic gonadotropin therapy not have any chronic metabolic disorders or organ dysfunction Exclusion Criteria: female patients Other reasons hipogondism receive any treatment of hypogonadism presence of comorbid diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| control patients<br>BMI and age matched healthy male subjects | |
| hypogonadism patients<br>unconfounded group of patients with hypogonadism | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Osteoprotegerin, Fibroblast Growth Factor 23 and Vitamin D3 levels | investigate the markers of bone mineral metabolism in patients with hypogonadism | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| relationship between bone mineral metabolism and endothelial dysfunction, insulin resistance |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypogonadism, Asymmetric Dimethyl Arginine, Osteoprotegerin, Fibroblast Growth Factor, Vitamin D
Chronic Subdural Hematoma - Reduction of Recurrence by Treatment With Angiotensin Converting Enzyme Inhibitors

Study Overview
=================
Brief Summary
-----------------
The project aims at investigating if treatment with the Angiotensin Converting Enzyme inhibitor Coversyl (perindopril) for 3 months after surgery for chronic subdural hematoma will decrease the risc of recurrence.

Detailed Description
-----------------
Previous studies have indicated that treatment with ACE inhibitors can reduce the risk of recurrence of CSDH after surgical evacuation. This randomized clinical trial was designed to investigate this

Official Title
-----------------
Chronic Subdural Hematoma - Reduction of Recurrence by Treatment With Angiotensin Converting Enzyme Inhibitors

Conditions
-----------------
Hematoma, Subdural, Chronic

Intervention / Treatment
-----------------
* Drug: Perindopril
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with chronic subdural hematoma that needs surgical evacuation Age > 18 year Exclusion Criteria: Lack of compliance Kidney artery stenosis Stenosis of the aorta Severely decreased kidney function Allergy or intolerance/contraindications toward ACE inhibitors Already in ACE inhibitor treatment Coagulopathies Malignant disorders Fertile women Other neurological disorders Treatment with pharmaceuticals contraindicating treatment with ACE inhibitors

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ACE inhibitor<br>patients randomized to this arm will be treated with ACE inhibitors after surgery | Drug: Perindopril<br>* 2,5 mg daily for 3 months<br>* Other names: coversyl;|
| Placebo Comparator: Placebo<br>patients randomized to this arm will be treated with placebo after surgery | Drug: Placebo<br>* Placebo dayli for 3 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Size of Chronic Subdural Hematoma (CSDH) | Volume of CSDH remnant three months after evacuation measure using xyz/2 on CT scans | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composition of Chronic Subdural Hematoma Fluid | Post-Hoc Outcome Measure | years |
A Phase 1b Study of SGN-75 in Combination With Everolimus in Patients With Renal Cell Carcinoma

Study Overview
=================
Brief Summary
-----------------
This is a phase 1, open-label, dose-escalation clinical trial to evaluate the safety of SGN-75 in combination with everolimus in patients with CD70-positive metastatic renal cell carcinoma.

Official Title
-----------------
A Phase 1b, Open-label, Dose-escalation Study to Evaluate the Safety and Tolerability of SGN-75 in Combination With Everolimus in Patients With CD70-positive Metastatic Renal Cell Carcinoma

Conditions
-----------------
Renal Cell Carcinoma

Intervention / Treatment
-----------------
* Drug: SGN-75
* Drug: everolimus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of metastatic renal cell carcinoma with confirmed CD70 expression Previously treated with at least 1 tyrosine kinase inhibitor (TKI) Measurable disease Eastern Cooperative Oncology Group performance status 0 or 1 Adequate lung and renal function Exclusion Criteria: Prior treatment with anti-CD70-directed therapy Received more than one prior treatment with an mTOR inhibitor

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>SGN-75, everolimus | Drug: SGN-75<br>* 1-2 mg/kg IV every 21 days<br>Drug: everolimus<br>* 10 mg PO daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events and laboratory abnormalities |  | Through 1 month post last dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best clinical response according to RECIST Version 1.1 |  | Through 1 month post last dose | 
| Progression-free survival |  | Until disease progression or start of new anticancer treatment, an expected average of 6 months | 
| Overall survival |  | Until death or study closure, an expected average of 1 year | 
| Blood concentrations of SGN-75 and metabolites |  | Cycle 1: pre-dose, 30 minutes, and 2, 4, 8, 24, 168, and 336 hours post dose start; pre-dose in subsequent cycles, and 1 month post last dose | 
| Incidence of antitherapeutic antibodies |  | Pre-dose in most cycles and 1 month post last dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Carcinoma, Renal Cell, Antibody-Drug Conjugate, monomethylauristatin F, Antigens, CD70, Drug Therapy