linjc16/ctgov huggingface dataset:
Effect of Functional Endoscopic Sinus Surgery On Eustachian Tube Function in Patients With Nasal Polypi

Study Overview
=================
Brief Summary
-----------------
This study is conducted to : Correlate the incidence of ETD with nasal polypi. To evaluate the effects of functional endoscopic sinus surgery on eustachian tube function in patients with nasal polypi

Detailed Description
-----------------
Eustachian tube dysfunction (ETD) is a frequently applied diagnosis, used when abnormal ET function is believed to underlie any of a wide range of symptoms or middle ear (ME) abnormalities. Two distinct forms of the disorder are recognised, representing different ends of the spectrum of ET function: 1)obstructive ETD (OETD), in which tubal opening or patency is reduced, and 2) patulous ETD (PETD), in which the ET is too open. It has been suggested that some patients with OETD have either predominantly active dysfunction (failure of muscle-controlled opening), or passive dysfunction (failure of pressure-related opening). There are several explanations to account for the ET dysfunction associated with nasal diseases: Mechanical obstruction of ET orifice may occur due to nasal mass. Increased secretions from seromucous glands in the pharyngeal portion of ET may accumulate and block the tube. Lymphatic stasis due to edema of the submucosa of the tube resulting in compromise of the lumen may produce ET dysfunction. Further increase in hydrostatic pressure result in the accumulation of ME fluid by transudative process. Tubal dysfunction may be related to deficiency of surfactant that is thought to facilitate tubal opening. It has been postulated that this material is inactivated by inflammation. ETD symptoms will decrease post-endoscopic sinus surgery to a level comparable with a non-CRS population The use of the ETDQ-7 has the potential to enhance clinical care by highlighting the impact of ETD as well as guiding and evaluating appropriate management. Further prospective testing of

Official Title
-----------------
Effect of Functional Endoscopic Sinus Surgery On Eustachian Tube Function in Patients With Nasal Polypi

Conditions
-----------------
Functional Endoscopic Sinus Surgery

Intervention / Treatment
-----------------
* Device: Endoscope


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient Who have been diagnosed to have nasal polypi Both unilateral and bilateral before doing FESS Exclusion Criteria: children Patient. Patients with craniofacial abnormalities or active infection Patients with suspected nasal and nasopharyngeal tumour Patients with nasal and ear surgery
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Endoscope|effect of FESS on eustachian tube function|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of Eustachian tube dysfunction with nasal polyp |  | 2years |
Fixed Versus Flexible Gonadotropin-releasing Hormone (GnRH) Antagonist Initiation

Study Overview
=================
Brief Summary
-----------------
This is a comparison of pregnancy achievement between two GnRH antagonist protocols which differ in the timing of GnRH antagonist initiation.

Official Title
-----------------
Fixed Versus Flexible GnRH Antagonist Initiation

Conditions
-----------------
Subfertility

Intervention / Treatment
-----------------
* Drug: Cetrorelix (Cetrotide)
* Drug: Cetrorelix (Cetrotide)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: < 39 years of age BMI 18.5-29.9 <= 3 previous IVF cycles Exclusion Criteria: PCOS Endometriosis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 39 Years

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

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: fixed<br> | Drug: Cetrorelix (Cetrotide)<br>* fixed antagonist administration on day 6 of ovarian stimulation<br>* Other names: Cetrorelix, Cetrotide, Serono;|
| Experimental: flexible<br> | Drug: Cetrorelix (Cetrotide)<br>* flexible antagonist administration according to specified criteria<br>* Other names: Cetrorelix, Cetrotide, Serono;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Luteinizing hormone rise |  | 3-14 days (duration of ovarian stimulation) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GnRH antagonists
An Observational Study on Patients With Rheumatoid Arthritis Treated With MabThera (Rituximab)

Study Overview
=================
Brief Summary
-----------------
This observational study will assess the execution, efficacy and safety of treatment with MabThera in patients with rheumatoid arthritis. Data from patients receiving MabThera according to local treatment guidelines will be collected for 29 months. Target sample size is 100-200 patients.

Official Title
-----------------
Naturalistic Prospective Non-interventional Study on Rheumatoid Arthritis (RA) Patients Treated With Rituximab According to Local Treatment Guidelines

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: rituximab [Mabthera/Rituxan]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients, >/= 18 years of age rheumatoid arthritis treatment with rituximab Exclusion Criteria: unable/unwilling to give informed consent to data collection

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 |
| --- | --- |
| Cohort<br> | Drug: rituximab [Mabthera/Rituxan]<br>* As prescribed by physician<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: DAS28 |  | 29 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: TJC, SJC, ESR, HAQ, CRP, patient's assessment (VAS) |  | 29 months | 
| Safety: serious and non-serious adverse events |  | 29 months |
Post-Marketing Surveillance Of Olmesartan Medoxomil In Combination With Hydrochlorothiazide

Study Overview
=================
Brief Summary
-----------------
This is a Post-Marketing Surveillance study evaluating the Efficacy, Tolerability and Safety of Olmesartan medoxomil 20 mg in combination with 12.5 MG of hydrochlorothiazide in subjects with mild to moderate essential hypertension

Detailed Description
-----------------
Non Probability Sampling

Official Title
-----------------
A Post Marketing Surveillance, Multicenter, Open-Label, Dose-Titrating, 4-Week Study Evaluating The Efficacy, Tolerability And Safety Of Olmesartan Medoxomil 20mg In Combination With 12.5mg Hydrochlorothiazide In Subjects With Stage 1 To Stage 2 Hypertension

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Olmesartan medoxomil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and Female patients 18 to 65 y/old Patient previously taking low-dose medoxomil or any other ARB alone with uncontrolled BP Patient with uncontrolled mild to moderate hypertension (SBP>= 140 and <=179 mmHg OR DBP of >=90 and <=109 mmHg) Exclusion Criteria: Pregnant of Lactating women History of secondary hypertension

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Olmesartan medoxomil + HCTZ<br> | Drug: Olmesartan medoxomil<br>* olmesartan medoxomil 20 mg and HCTZ 12.5 mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (Adverse Events) |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure |  | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Efficacy; Tolerability; Safety; Essential Hypertension
The Effect of PinnoThin on Satiety and Food Intake

Study Overview
=================
Brief Summary
-----------------
Based upon an increased secretion of gastrointestinal satiety hormones (CCK, GLP-1), PinnoThin is hypothesized to be more satiating, and to limit energy intake in humans. Therefore, the objective of this study is to investigate whether PinnoThin leads to an increase in satiety as determined by VAS ratings? Additionally, does PinnoThin consumed during breakfast, in comparison to placebo, in overweight women, lead to a decrease in energy intake during an ad libitum lunch?

Official Title
-----------------
The Effect of PinnoThin on Satiety and Food Intake

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Dietary Supplement: PinnoThin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age over 18 and under 45 women BMI over 23 and under 30 breakfast eaters Exclusion Criteria: men age under 18 and over 45 BMI under 23 and over 30 use of medication pregnant and breastfeeding

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

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: inulin<br>oligofructose | Dietary Supplement: PinnoThin<br>* 6.0 gram of the oil extract from the korean pine nut (PinnoThin) as a single dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| appetite profile ratings |  | 10 timepoints | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| energy intake |  | 3.5 hours after PinnoThin |
An Exploratory Pharmacogenomic Study of Monotherapy Erbitux in Subjects With Metastatic Non Small Cell Lung Carcinoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to predict responses to Erbitux as a single agent in patients with Non Small Cell Lung Cancer

Official Title
-----------------
An Exploratory Pharmacogenomic Study of Monotherapy Erbitux in Subjects With Metastatic Non Small Cell Lung Carcinoma

Conditions
-----------------
Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis

Intervention / Treatment
-----------------
* Drug: Cetuximab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Measurable disease tumor available for biopsies Life expectancy of at least 3 months Exclusion Criteria: Known or documented brain metastases prior to Cetuximab therapy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: Cetuximab<br>* IV solution, IV, 400 mg/m2 initial dose followed by weekly doses of 250 mg/m2, Weekly, until disease progression.<br>* Other names: Erbitux;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prediction of response to Erbitux with non small cell lung cancer |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic Response |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metastatic Non Small Cell Lung Cancer
The MIRROR Registry: Minimally Invasive IntRaceRebral HemORrhage Evacuation

Study Overview
=================
Brief Summary
-----------------
This registry will study the use of the Aurora® Surgiscope to provide surgical access and visualization in minimally invasive removal of hematoma in the brain. Many methods of hematoma removal are available and will be based on surgeon preference. The impact of patient selection and time to surgery from last known well time will be explored.

Official Title
-----------------
The MIRROR Registry: Minimally Invasive IntRaceRebral HemORrhage Evacuation

Conditions
-----------------
Supratentorial Hemorrhage

Intervention / Treatment
-----------------
* Device: Aurora Surgiscope System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject Age is > 18 Subject with a Head CT that demonstrates an acute, spontaneous, primary, supratentorial ICH of volume > 20 mL, assessed via standard of care techniques Subject Surgery can be initiated within 24 hours of the last known well time or, in patients with wake-up onset, within 24 hours of the time the patient awoke with symptoms. Subject has a NIHSS score > 5 Subject has a baseline Modified Rankin Scale (mRS) Score ≤ 2 Subject with a CT Angiography demonstrating no vascular malformation Exclusion Criteria: Subject has an underlying vascular lesion defined as causative source of ICH Subject has a profound neurological deficit defined as fixed/dilated pupils or bilateral extensor motor posturing Subject has an Infratentorial or brainstem ICH Subject has a known life expectancy < 6 months Subject has an uncorrectable coagulopathy Subject has a mechanical heart valve Subject is pregnant Subject participates in another concurrent interventional clinical trial Subject who is unable to meet study follow-up requirements

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 |
| --- | --- |
| AURORA<br>Aurora® Surgiscope used for MIS evacuation of supratentorial hematoma | Device: Aurora Surgiscope System<br>* MIS evacuation of hematoma using the Aurora Surgiscope System<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Surgical Success | Rate of surgical success defined as reduction to < 15 cc total volume of the supratentorial intracerebral hemorrhage on immediate Post-op CT Scan | During surgical procedure to evacuate supratentorial intracerebral hemorrhage |
Fetoscopic Tracheal Balloon Occlusion in Unborns With Severe Congenital Diaphragmatic Hernia - EUROTRIAL I

Study Overview
=================
Brief Summary
-----------------
Diaphragmatic hernia detected in fetal life carries a high risk for postnatal demise due to lung underdevelopment. Clinical experience from prospective controlled non-randomized case series with fetoscopic tracheal balloon occlusion has seen improved survival rates in contrast to untreated controls. Therefore, the purpose of this randomized clinical trial is to provide further evidence about the efficacy and safety of the prenatal interventional approach. Primary outcome measure is postnatal survival to discharge from hospital treatment.

Official Title
-----------------
Randomized Clinical Trial for the Assessment of the Life-Saving Potential of Fetoscopic Tracheal Balloon Occlusion in Fetuses With Severe Congenital Diaphragmatic Hernia - EUROTRIAL I

Conditions
-----------------
Diaphragmatic Hernia

Intervention / Treatment
-----------------
* Procedure: Fetoscopic tracheal balloon occlusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women from European countries carrying fetuses with congenital right or left diaphragmatic hernias Normal karyotype, no further severe anomalies on prenatal ultrasound study Fetal liver herniation into the chest, Lung-to-head ratio of ≥0,40 ≤0,84 between 30+0 - 33+5 weeks+days of gestation Exclusion Criteria: Any maternal disease or condition that would result in an increased risk to her personal health from the experimental procedure Abnormal fetal karyotype Further severe fetal anomalies on prenatal ultrasound

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Fetoscopic tracheal balloon occlusion|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival to discharge from hospital |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal morbidity |  |  | 
| Fetal morbidity |  |  | 
| Premature preterm rupture of membranes |  |  | 
| Unintended preterm delivery |  |  | 
| Conventional ventilation strategies possible |  |  | 
| ECMO required |  |  | 
| Days in intensive care |  |  | 
| Days in hospital |  |  | 
| Oxygen dependency on discharge |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fetus, Congenital diaphragmatic hernia, tracheal occlusion, fetal surgery, fetoscopy
A Study of rhBMP-2/CPM in Closed Fractures of the Humerus

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to assess whether fracture union is accelerated in subjects with humeral fractures (proximal,diaphyseal) treated with conservative therapy (standard of care) and a single dose of rhBMP-2/CPM compared to subjects who receive standard of care alone.

Official Title
-----------------
A Phase 2, Multicenter, Double-Blind, Randomized, Stratified, Controlled, Efficacy, Safety and Feasibility Study of Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2)/Calcium Phosphate Matrix (CPM) as an Adjuvant Therapy in Closed Fractures of the Humerus

Conditions
-----------------
Fractures

Intervention / Treatment
-----------------
* Drug: rhBMP-2/CPM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Skeletally mature subjects age 18 years or older. Subjects with either a closed proximal humeral fracture or a diaphyseal humeral fracture. Treatment plan that includes only conservative (nonoperative) therapy within 48 hours following injury. Exclusion Criteria: Shoulder dislocation at the time of injury. Planned procedure(s) at that would stimulate fracture union at the time of application of the initial immobilization device. Fractures located in the distal third of humerus.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>1.0 mg/mL rhBMP-2/CPM + SOC | Drug: rhBMP-2/CPM<br> <br> |
| Experimental: B<br>2.0 mg/mL rhBMP-2/CPM + SOC | Drug: rhBMP-2/CPM<br> <br> |
| Active Comparator: C<br>Buffer/CPM + SOC | Drug: rhBMP-2/CPM<br> <br> |
| Other: D<br>Standard of Care Alone (SOC) | Drug: rhBMP-2/CPM<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary efficacy variable in this study is radiographic union. |  | Fracture union is assessed at 4, 6, 8, 10, 12, 16, 26 and 52 week visits. The goal of acceleration of fracture union will be met if median time to radiographic fracture union is decreased by 4 weeks in an active treatment arm compared to SOC alone. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fracture, Humerus
Glycemic Response to Road Cycling in Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the glycemic response to cycling road races (using continuous glucose monitoring ) in elite athletes with type 1 diabetes and non-diabetic controls. The investigators will also assess the relationship between power/work during cycling (using a power meter) and the subject's glucose profile.

Official Title
-----------------
A Pilot Study Assessing the Glycemic Response and Its Relationship to Performance During Road Cycling in Elite Athletes With Type 1 Diabetes and Non-Diabetic Controls

Conditions
-----------------
Type 1 Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥18 years of age A1C ≤8.0% if diagnosed with type 1 DM Exclusion Criteria: If diagnosed with type 1 diabetes, has had recurrent severe hypoglycemia (greater than 2 episodes in previous 6 months requiring assistance by a third party) Has any medical condition or medical history that may affect successful completion of the study and/or personal well-being (as assessed by the PI)

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

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

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

Study Plan
=================
How is the study designed?
-----------------
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
-----------------
Type 1 Diabetes, Exercise, Continuous glucose monitoring