linjc16/ctgov huggingface dataset:
Tympanoplasty Using Conchal Cavum Approach and Conchal Pericondrium

Study Overview
=================
Brief Summary
-----------------
Tympanoplasty -- conchal cavum approach is a modification of Heermann endural approach to repair broken eardrums. The Heermann approach is a well recognized procedure, in common clinical practise for years. The new approach has been used in patients after informed consent was obtained from each patient.

Detailed Description
-----------------
From 2010 to 2013, a total of 96 patients had the procedure. The data are entered, and analyzed. All identifiable information would be hidden. This application is to obtain patients' consent for release and publication of the data. Patients would be assured their identities are protected.

Official Title
-----------------
Tympanoplasty -- Conchal Cavum Approach

Conditions
-----------------
Perforation of Eardrum.

Intervention / Treatment
-----------------
* Procedure: tympanoplasty -- conchal cavum approach


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with informed consent Exclusion Criteria: Patients without consent
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 |
| --- | --- |
| Other: perichondrium graft perforation<br>tympanoplasty -- conchal cavum approach is used. | Procedure: tympanoplasty -- conchal cavum approach<br>* Incision is made inside the ear canal. It is extended into the conchal cavum. The incision allows a direct approach to the eardrum, and also allow easy harvesting of the perichondrium to be used as graft material.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| success rate of repair of eardrum |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
perforation, tympanoplasty, conchal cavum approach, perichondrium/ cartilage, scar
Oxytocin and Emotion Recognition

Study Overview
=================
Brief Summary
-----------------
The present study was designed to investigate the effects of a single dose of synthetic oxytocin on facial emotion recognition in healthy adult man. Pictures of emotional faces are presented very briefly for a few milliseconds in a backward-masking paradigm in order to vary the level of awareness. In a randomized placebo-controlled between-subject design, recognition performance is compared between a drug (24 IU oxytocin) and a placebo condition. We hypothesize that oxytocin enhances emotion recognition even for facial stimuli processed with limited awareness.

Conditions
-----------------
Health

Intervention / Treatment
-----------------
* Drug: Syntocinon 24 IU
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males 18 to 40 years of age Exclusion Criteria: Any psychiatric diagnosis life-time Somatic disease IQ < 85 Smoker Psychoactive medication

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oxytocin<br> | Drug: Syntocinon 24 IU<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance on a facial emotion recognition task |  | 45 min. following drug administration |
Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Middle Ear Infections in Pediatric Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if a combination of an antibiotic plus a corticosteroid is safe and effective in treating middle ear infections in children with ear tubes.

Official Title
-----------------
A Multicenter, Randomized, Double-Blind Clinical Trial to Assess the Efficacy and Safety of DF289 Plus DF277 Otic Solution Compared to DF289 Otic Solution and to DF277 Otic Solution in the Treatment of Acute Otitis Media With Tympanostomy Tubes (AOMT) in Pediatric Patients

Conditions
-----------------
Acute Otitis Media

Intervention / Treatment
-----------------
* Drug: DF289
* Drug: DF277
* Drug: DF289 plus DF277


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 6 months to 12 years ear tube in the ear which will be treated otorrhea for 3 weeks or less moderate or severe otorrhea Exclusion Criteria: other ear diseases

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 12 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: DF289<br>Ear drops | Drug: DF289<br>* Ear drops<br>|
| Active Comparator: DF277<br>Ear drops | Drug: DF277<br>* Ear drops<br>|
| Experimental: DF289 plus DF277<br>Ear drops | Drug: DF289 plus DF277<br>* Ear drops<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Cessation of Otorrhea |  | From baseline until the end of the study (up to 22 days) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
with tubes
Post-Market Clinical Follow-Up to Access & Visualize the Anus, Rectum, & Distal Colon During Transanal Procedures

Study Overview
=================
Brief Summary
-----------------
To assess the safety and performance of the Medrobotics Flex Robotic System and Flex Rectoscope for accessing and visualizing the Anus, Rectum, and Distal Colon when used for Transanal procedures

Official Title
-----------------
A Multicenter Post-Market Clinical Follow-Up of the Medrobotics Flex Robotic System and Flex Rectoscope Used for Accessing and Visualizing the Anus, Rectum, and Distal Colon During Transanal Procedures

Conditions
-----------------
Disease or Lesions of the Anus, Rectum, or Distal Colon

Intervention / Treatment
-----------------
* Device: Transanal endoscopic surgical procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 22 years of age Candidate for transanal procedures in the areas of the anus, rectum, and distal colon. Exclusion Criteria: Candidates are excluded if they < 22 years of age and do not meet criteria for transanal surgery in the anus, rectum, and distal colon

Ages Eligible for Study
-----------------
Minimum Age: 22 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 |
| --- | --- |
| Male and/or females ≥ 22 yrs old<br>≥ 22 years of age requiring transanal procedures in the areas of the anus, rectum, and distal colon Transanal endoscopic surgical procedure | Device: Transanal endoscopic surgical procedure<br>* Resection of tumors or lesions<br>* Other names: Laparoscopy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Access and Visualization | Ability to access/touch with compatible flexible instruments and visualize/see with the scope/camera each of the four anatomical locations in the anus, rectum, and distal colon. The 4 areas to be accessed/touched and visualized/seen from the most proximal to the most distal are; Lower Rectum, Mid Rectum, Upper Rectum, Rectosigmoid Junction | 0-24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance of transanal surgical procedure | Ability to complete the planned transanal surgical procedure using the Flex Robotic System, Flex Rectoscope and Flex compatible flexible instruments | 0-24 hours |
Patellofemoral Pain After Unicondylar Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
Unicondylar knee arthroplasty (UKA) is a proven procedure in patients suffering from unicompartmental knee osteoarthritis. Two different types of UKA design are available - both with different pros and cons. The so-called 'mobile-bearing UKA' requires the removal of an additional amount of cartilage and bone close to the implantat. It is unclear whether this is of clinical relevance. We speculate that the amount of cartilage/bone removal is related to the clinical outcome of the UKA-surgery. In patients receiving a mobile-bearing UKA that amount of cartilage/bone removal is measured during the surgery. The clinical success of the procedure will be determined with certain knee questionnaires (Kujala & KOOS)preoperatively, 3 months postoperatively, 6 months postoperatively and 1 year postoperatively. Additionally, the so-called bone-remodelling around that area of resected cartilage and bone will be measured (SPECT-CT) postoperatively. The three variables (removed amount of cartilage/bone; clinical success with regard to the questionnaires; bone remodelling) are then analyzed with statistical methods to find out potential assoziations among them.

Conditions
-----------------
Mobile-bearing Unicondylar Knee Arthroplasty

Intervention / Treatment
-----------------
* Procedure: mobile-bearing unicondylar knee arthroplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - osteoarthritis or osteonecrosis in the medial or lateral tibiofemoral compartment Exclusion Criteria: failed upper tibial osteotomy insufficiency of the collateral or anterior cruciate ligaments a fixed varus or valgus deformity (not passively correctable) above 15° a flexion deformity greater than 15° rheumatoid arthritis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| mb-UKA<br>Patients with unicondylar osteoarthritis of the knee | Procedure: mobile-bearing unicondylar knee arthroplasty<br>* mobile-bearing unicondylar knee arthroplasty<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Size of anterior femoral notch | Required cartilage / bone removal adjacent to the femoral implant | day 0 | 
| Kujala Score changes |  | -1 days, 3 months, 6 months, 1 year | 
| KOOS questionnaire changes |  | -1 days, 3 months, 6 months, 1 year | 
| Radionuclide tracer uptake at the surgically created notch |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
unicondylar knee arthroplasty, mobile-bearing, patellofemoral pain
IgA Nephropathy, Lymphocyte Homing and IgA Class Switch

Study Overview
=================
Brief Summary
-----------------
IgA nephropathy (IgAN) is the most common primary glomerulonephritis in the world and it represents an important cause of end-stage kidney failure. This disease was described as a distinct entity in 1968 by J Berger and N Hinglais. The aetiology and the pathogenesis remain still obscure. Clinical observations and immunisation studies indicate that IgAN represents a dysregulation of the immune system, rather than an intrinsic renal abnormality. Twenty years ago, some authors proposed the mucosa-bone marrow axis to explain the pathogenesis of the disease. Mucosal IgA plasmocytes are displaced and take up residence in systemic sites. The unusual characteristics featured by the IgA produced by these cells (charge, size, glycosylation) drive their accumulation, deposition and mesangial activation characteristic of IgAN. Evidence is emerging that altered lymphocyte homing may ultimately explain this aberrant localization.

Official Title
-----------------
IgA Nephropathy, Lymphocyte Homing and IgA Class Switch

Conditions
-----------------
IgA Nephropathy

Intervention / Treatment
-----------------
* Other: blood test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 and < 70 years IgA nephropathy documented by the kidney biopsy in the six months preceding the inclusion Glomerular filtration rate (MDRD formula as simplified) < 90 ml/mn and > 30 ml/mn/1,73 m2 Consent form signed Exclusion Criteria: Patients with cirrhosis or chronic liver disease Patients with a history of Crohn's disease or celiac disease Patients who received treatment with corticosteroids or affiliates for six months Patients who received a live attenuated vaccine during the past 4 weeks Patients with a known infection such as HIV, hepatitis B or C Patients who presented with a serious infection during the last month Breastfeeding women Patients not affiliated with a social security scheme Under guardianship patient

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: blood test<br> | Other: blood test<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Primary Outcome Measure of this study is the level of expression of the molecules of intestinal localization. |  | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary outcome measure is the level of expression of the homing molecules in lymphocytes B IgA memory |  | 30 minutes |
Safety and Efficacy of SA09012 in Asthma

Study Overview
=================
Brief Summary
-----------------
Clinical Study to Evaluate the Efficacy, Dose-response and Safety of SA09012 in Bronchial Asthma Patients

Official Title
-----------------
Double Blinded, Randomized, Placebo Controlled, Multi-center, Phase II Exploratory Clinical Study to Evaluate the Efficacy, Dose-response and Safety of SA09012 in Bronchial Asthma Patients

Conditions
-----------------
Mild to Moderate Bronchial Asthma

Intervention / Treatment
-----------------
* Drug: SA09012 Low dose
* Drug: SA09012 High dose
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis or presence of asthma within 3 months of the prestudy visit Increase in PEF ≥ 20% or ≥ 60L/min from baseline value after taking Bronchodilator at screening or within the 3 months of the prestudy visit Increase in FEV1 ≥ 12% and ≥ 200mL from baseline value after taking Bronchodilator at screening or within the 3 months of the prestudy visit FEV1 or PEF between 60% and 85% of the predicted value at screening or within the 3 months of the prestudy visit Having signed an informed consent Exclusion Criteria: Patient who has severe asthma Patient who has any significant medical condition that might compromise patient safety, interfere with evaluation or preclude completion of the study other protocol-defined inclusion/exclusion criteria may apply Patient with an AST or ALT > 2x ULN (upper limit of normal) in the screening visit Patient with more than 10 pack year of cigarettes history

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 79 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 |
| --- | --- |
| Experimental: SA09012 Low dose<br> | Drug: SA09012 Low dose<br>* Tablet, b.i.d<br>|
| Experimental: SA09012 High dose<br> | Drug: SA09012 High dose<br>* Tablet, b.i.d<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Tablet, b.i.d<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline of PEF(Peak Expiratory Flow)at week 6 |  | 6 week treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline in FEV1 at week 6 |  | 6 week treatment period | 
| Mean change from baseline in ACT(Asthma Control Test) at week 6 |  | 6 week treatment period | 
| Safety assessment(Comparison of the adverse event profiles throughout the course of the study) |  | 6 week treatment period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma
Cardiovascular Disease Mortality in The NAS-NRC Twin Registry

Study Overview
=================
Brief Summary
-----------------
To analyze cardiovascular disease mortality and total mortality in the NAS-NRC Twin Registry using a new methodology that allowed for censored observations of outcomes, environmental covariates, and unmeasured genotype-environment interactions.

Detailed Description
-----------------
BACKGROUND: Methodologically, statistical methods in genetics and epidemiology have developed largely independently; and as a result, there seemed to be little communication between the two fields. Some of the most important hypotheses regarding familial aggregation of chronic diseases related to gene-environment interactions which drew on both fields. The method of analysis used in this study dealt simultaneously with survival time nature of the outcome variable, multiple and continuous environmental risk factors, and correlation in outcomes between related individuals. The study was supported by the Small Grants Program established by the National Heart, Lung, and Blood Institute in January 1990 to extend analyses of research data generated by clinical trials, population research, and demonstration and education studies. DESIGN NARRATIVE: Data available from two epidemiologic questionnaires administered ten years apart were used to determine the extent to which an increased familial risk in cardiovascular disease mortality among twins was mediated by similarities in behavioral risk factors such as smoking, diet, weight changes, physical activity, and socioeconomic variables. The contributions of genetic and environmental factors to twin similarities in health behavior were also examined. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Hypertension, Diabetes Mellitus, Obesity, Coronary Disease, Myocardial Ischemia

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |
Donepezil Therapy and Changes of Symptoms and Glucose Metabolism in Patients With Dementia With Lewy Bodies (DLB)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate change of cerebral glucose metabolism by donepezil therapy and to associate change of glucose metabolism and symptoms.

Official Title
-----------------
Donepezil Therapy and Changes of Symptoms and Glucose Metabolism in Patients With Dementia With Lewy Bodies (DLB)

Conditions
-----------------
Dementia With Lewy Bodies (DLB)

Intervention / Treatment
-----------------
* Drug: Donepezil
* Drug: Donepezil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: DLB patients: who fulfill the diagnostic criteria of DLB 60 to 85 years old right-handed Clinical Dementia Rating (CDR) ≧ 0.5 Mini Mental State Examination (MMSE) score from 10 to 26 Normal Controls: who are independent who have no subjective or objective cognitive impairment 60 to 85 years old right-handed MMSE score over 24 Exclusion Criteria: DLB patients: who have diabetes mellitus who have pathological change on MRI other than brain atrophy who have complication or history of dementia other than DLB, psychiatric disease, and physical disorder that affect brain function who have severe complication of cardiovascular, hepatic, renal, or other diseases unable to secure the safety who have severe digestive ulcus who have severe bronchitic asthma or obstructive lung disease who have no caregiver who knows patient's condition well Normal Controls: who have diabetes mellitus who have taken donepezil before who have abnormal findings on MRI who have complication or history of brain injury, psychiatric disease, and physical disorder that affect brain function

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 85 Years

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 |
| --- | --- |
| Experimental: donepezil<br> | Drug: Donepezil<br>* Dosage: 3mg PO/day for the first 2 weeks and 5mg PO/day for the next 14 weeks Duration: 16 weeks<br>Drug: Donepezil<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FDG-PET |  | 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive function, psychiatric symptoms, global clinical function, and burden of caregiver |  | 14 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dementia with Lewy bodies (DLB), FDG-PET