linjc16/ctgov huggingface dataset:
Cytological Screening for Early Diagnosis of Precancerous or Cancerous Lesions of Oral Cavity

Study Overview
=================
Brief Summary
-----------------
Prospective study of diagnosis validation of a cytological technique. 200 patients with oral cavity cancerous and precancerous lesions will be enrolled. A cytological sample of the lesion will be performed by transepithelial brushing ( Orcellex® Rovers brush) in cytology liquid-based technology (methode ThinPrep 2000 (Hologic®)). A microscopic double blind reading will be performed. A biopsy sampling will be carried out in accordance with current strategy of screening. The brushing diagnosis quality will be compared to the biopsy which is the gold standard.

Official Title
-----------------
Interest of Cytological Screening for Early Diagnosis of Precancerous or Cancerous Lesions of Oral Cavity by Transepithelial Brushing in Liquid-based

Conditions
-----------------
Mouth Neoplasms

Intervention / Treatment
-----------------
* Device: Orcellex® Rovers brush


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: one or several cancerous or pre-cancerous lesions of oral cavity newly diagnosed or detected during a follow-up visit Exclusion Criteria: pregnant or lactating women patients under juridical protection

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: transepithelial brushing<br>transepithelial brushing in liquid-based technology + biopsy | Device: Orcellex® Rovers brush<br>* transepithelial brushing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic validity of lesion (Bethesda system, 2001) | Diagnostic validity (specificity and sensibility, the classification of lesions is performed according Bethesda system, 2001 and the reference is the histology of biopsy of lesion | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic validity - predictive value (positive and negative) | Calculation of predictive value (positive and negative) of cytology / the reference is histology of biopsy | baseline | 
| Feasibility of cytology | sample rate not satisfactory= hemorrhage hiding the cells of interest | Baseline | 
| Feasibility of cytology | sample rate not satisfactory : low cellularity of the material | Baseline | 
| Reproducibility intra and inter observers (coefficient of kappa de cohen) | reproducibility intra and inter observers of cytology interpretation (kappa de cohen) | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oral cavity, cancerous and precancerous lesions
Long Term Safety Trial to Compare Insulin Treatment With Preprandial Inhaled Human Insulin to s.c. Insulin Aspart Both Combined With NPH in Subjects With Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Oceania. The aim of this trial is to compare the safety of using pulmonary inhaled human insulin to s.c. insulin aspart both combined with NPH insulin in subjects with type 1 diabetes.

Official Title
-----------------
A 24-month Multicentre, Open-label, Randomised, Parallel Group, Long Term Safety Trial Comparing Intensive Treatment of Pulmonary Inhaled Human Insulin With Insulin Aspart Administered s.c., Both in Combination With NPH, in Subjects With Type 1 Diabetes

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Drug: inhaled human insulin
* Drug: insulin aspart
* Drug: insulin NPH


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 diabetes Current treatment with any insulin in any regimen Body mass index (BMI) below 38.0 kg/m2 HbA1c below or equal to 13.0% Exclusion Criteria: Total daily insulin dosage more than 100 IU/day Current acute or chronic pulmonary disease (excluding asthma) Recurrent major hypoglycaemia Proliferative retinopathy or maculopathy requiring acute treatment Smoker Chest X-ray with clinically significant abnormalities

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

| Intervention/Treatment |
| --- |
|Drug: inhaled human insulin|nan|
|Drug: insulin aspart|nan|
|Drug: insulin NPH|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long term pulmonary safety profiles |  | during treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycaemic control as measured by HbA1c |  |  | 
| Incidence of hypoglycaemic episodes |  |  | 
| Long-term safety profiles (laboratory, ECG, insulin antibodies) |  |  | 
| Physical examination and body weight and vital signs |  |  | 
| Adverse events |  |  | 
| Treatment satisfaction |  |  |
Notify 2: An Evaluation of the Impact of Notification of Incidental Coronary Artery Calcium on Statin Rates

Study Overview
=================
Brief Summary
-----------------
The primary objective is to estimate the impact of notification of primary care provider and patient of at least moderate incidental coronary artery calcification (CAC) on a prior non-gated chest CT on statin prescription rates at 4 months among patients without a clinical history of atherosclerotic cardiovascular disease not actively on statin therapy. This study will determine if notifying patients and their primary care clinician about an existing finding will influence shared decision-making around statins between patients and their primary care clinician.

Official Title
-----------------
Notify 2: An Evaluation of the Impact of Notification of Incidental Coronary Artery Calcium on Statin Rates

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Other: Notification


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater than or equal to 18 and less than 85 Non-gated chest CT from 1/1/2016-6/30/2020 with algorithm screening estimating CAC score of at least 100 Agatston Units with radiologist confirmation of moderate or severe CAC Encounter with Palo Alto VA affiliated primary care since 2020 Exclusion Criteria: Prior diagnosis of coronary artery disease, peripheral artery disease, or cerebrovascular disease Dementia Metastatic cancer or active cancer undergoing chemotherapy CT coronary angiogram since 2016 Invasive Coronary angiogram since 2016 CAC scan since 2016 Statin therapy within prior 6 months Prior ezetimibe or PCSK9 inhibitor therapy Prior rhabdomyolysis with statin therapy Schizophrenia Substance abuse disorder (alcohol, amphetamines, cocaine, opioids) Hospice Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Notification<br>Notification of the presence of at least moderate coronary artery calcium on a prior non-gated chest CT | Other: Notification<br>* Notification of patient and primary care clinician of presence of at least moderate coronary artery calcium on a prior non-gated chest CT<br>|
| No Intervention: Usual Care<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Statin prescription rate | Prescription of statin medication | 4 months |
Cleft Palate Technique and Maxillary Growth

Study Overview
=================
Brief Summary
-----------------
comparison of the maxillary growth between cleft palate patients that underwent to repair by 2 flap palatoplasty versus Furlow with buccinator technique

Official Title
-----------------
Effect of 2 Flap Palatoplasty Versus Furlow With Buccinators Flap During Palatal Cleft Repair on the Maxillary Development Patterns in Comparison to Non-cleft Children at 5-6years of Age

Conditions
-----------------
Cleft Palate, Growth

Intervention / Treatment
-----------------
* Procedure: 2 flap palatoplasty technique
* Other: normal group
* Procedure: Furlow with buccinator technique


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 5-6 years old childreen with previous treated complete cleft lip and palate, nonsyndromic. lip and palate repair performed by one craniofacial surgeon Exclusion Criteria: Patients with syndromic cleft lip. Redu cases Bilateral cleft lip Patient older 6years or younger 5 years. Associated Cardiac anomalies. Any systemic condition

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 6 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| normal group<br> | Other: normal group<br>* control normal group<br>|
| 2flap palatoplasty group<br> | Procedure: 2 flap palatoplasty technique<br>* cleft palate repair by 2 flap palatoplasty technique<br>|
| Furlow with buccinator group<br> | Procedure: Furlow with buccinator technique<br>* cleft palate repair by Furlow with buccinator technique<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maxillar growth | evaluation of the maxillary growth through Inter-canine width (ICW) measurement by mm | through study completion, an average one week |
Benefit of the Oxygen Reserve Index for Control of Success of Preoxygenation in Adults

Study Overview
=================
Brief Summary
-----------------
Valuation of the probability for a correct detection of paO2 < 100 mmHg and paO2 > 200 mmHg using the Oxygen Reserve Index

Detailed Description
-----------------
As mentioned above

Official Title
-----------------
Benefit of the Oxygen Reserve Index for Control of Success of Preoxygenation in Adults

Conditions
-----------------
Preoxygenation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Indication of an elective surgery with invasive arterial blood pressure measurement in awake patients written informed consent Exclusion Criteria: Emergency surgery Patients with expected difficult airway and indication for an awake fiberoptic intubation and therefore no need of preoxygenation no written informed consent

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of the probability for a correct detection of paO2 < 100 mmHg and paO2 > 200 mmHg using the Oxygen Reserve Index | As mentioned above | preoxygenation of 3 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient characteristics | age, sex, weight, pre-existing conditions | 48 hours | 
| MAP | mean arterial pressure | preoxygenation of 3 minutes | 
| NIRS (Near-infrared spectroscopy) | cerebral O2 saturation in %, rSO2C | preoxygenation of 3 minutes | 
| PI | perfusion index | preoxygenation of 3 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anaesthesia, Preoxygenation, blood gas analysis, Oxygen Reserve Index, Decarboxylation
Evaluation of Ocular Comfort With ISTA Tears vs Systane

Study Overview
=================
Brief Summary
-----------------
To assess the comfort preference of ISTA Tears vs Systane in patients with dry eye disease (DED)

Official Title
-----------------
Evaluation of Ocular Comfort With ISTA Tears vs Systane

Conditions
-----------------
Dry Eye Disease

Intervention / Treatment
-----------------
* Drug: ISTA Tears
* Drug: Systane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: OSDI >12 Exclusion Criteria: Presence of any active ocular disease other than dry eye

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: ISTA Tears<br>Sterile ophthalmic solution | Drug: ISTA Tears<br>* sterile ophthalmic solution<br>|
| Active Comparator: Systane<br>Sterile ophthalmic solution | Drug: Systane<br>* Sterile ophthalmic solution<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Preference for One of the Treatments | There were 35 participants who applied ISTA Tears to the right eye and Systane to the left eye (70 eyes total). Participants were asked to indicate which treatment they preferred, or if they preferred neither. | 30 days |
Skin Testing and ELISPOT Assay in Patients With a History of Non-Immediate Reactions to Cephalosporins

Study Overview
=================
Brief Summary
-----------------
This study aims to compare the results of skin testing and ELISPOT assay in patients with a history of non-immediate reactions to cephalosporins

Detailed Description
-----------------
Patients with a history of non-immediate reactions to cephalosporins will be tested by patch test and/or intradermal test. Peripheral blood mononuclear cells will be collected to analyzed cytokine secretions by ELISPOT assay

Official Title
-----------------
The Results of Skin Testing and The Detection of Cytokine Secretion From Drug Specific Peripheral Blood Mononuclear Cells Using ELISPOT Assay in the Diagnosis of Nonimmediate Reactions to Cephalosporins

Conditions
-----------------
Cephalosporin Allergy, Non-immediate Drug Reactions

Intervention / Treatment
-----------------
* Procedure: Skin tests and ELISPOT assay


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a history of non-immediate hypersensitivity reactions to cephalosporins At least 18 years of age Exclusion Criteria: Suffering from severe systemic disease/ in bad health Being pregnant Patients with a history of immediate reactions to cephalosporin

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Cephalosporins allergic patients<br> | Procedure: Skin tests and ELISPOT assay<br>* Patch test and/or intradermal test will be performed in patients as well as cytokine secretions from PBMCs will be analyzed by ELISPOT assay<br>* Other names: ELISPOT;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The skin testing results of Cephalosporin skin test compared to ELISPOT assay |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The result of cross reactivity between Cephalosporins and other Betalactams determined by skin testing and ELISPOT assay |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cephalosporins, Drug hypersensitivity
Total Knee Replacement With the ROCC Knee

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to assess the results of a Total Knee prosthesis specifically intended to enhance functional performance , especially in terms of physical and sports activity.

Detailed Description
-----------------
Clinical and radiographic results , complications, early post-operative and late functional outcome and survivorship were studied in a continuous prospective series of 500 patients ( 602 knees) managed using the ROCC knee ( BIOMET INC - Warsaw- IND, USA). A minimum follow-up of 5 years was required.

Official Title
-----------------
Prospective Study of Total Knee Replacement With the ROCC Knee

Conditions
-----------------
Osteoarthritis, Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Device: Total knee replacement with the ROCC® knee prosthesis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients receiving a total knee Exclusion Criteria: patients with severe psychiatric, neurologic, cardiologic or locomotor pathology occuring after the total knee replacement

Ages Eligible for Study
-----------------
Minimum Age: 42 Years
Maximum Age: 90 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

| Intervention/Treatment |
| --- |
|Device: Total knee replacement with the ROCC® knee prosthesis|replacement of an osteoarthritic knee with a total knee prosthesis operation may be for a single knee ( unilateral) or both knees of a patient ( bilateral)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| locomotor function with the Knee society score |  | at a minimum of 5 years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| physical and sports activities with the UCLA activity score |  | at last follow-up examination, with minimum of 5 years after surgery | 
| clinical status with the Oxford Knee Score |  | before surgery | 
| clinical status with the Oxford knee score |  | at last follow-up examination, with minimum of 5 years after surgery | 
| WOMAC ARTHRITIS INDEX |  | before surgery | 
| WOMAC ARTHRITIS INDEX |  | at last follow-up examination, with minimum of 5 years after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
knee prosthesis, total knee replacement, total knee arthroplasty, prospective study, Therapeutic level IV
SB-773812 Administered In Adults With Schizophrenia

Study Overview
=================
Brief Summary
-----------------
This is a two part study designed to evaluate the safety and efficacy of SB-773812 in the treatment of acute schizophrenia. Subjects with acute schizophrenia will be randomized in an adaptive design study to receive placebo, SB-773812 60mg or olanzapine 15mg for 12 weeks in Part A. An interim analysis will be conducted to assess the efficacy and safety of the SB-773812 60mg dose compared with placebo. Based on these data, up to two further doses of SB-773812 will be added to the randomization for Part B.

Official Title
-----------------
A Multi Centre, Double-Blind, Double-Dummy, Placebo-Controlled, Randomised, Adaptive, Dose-Range Study To Evaluate the Safety and Efficacy of SB-773812 Administered Once Daily for 12 Weeks in Adults With Schizophrenia

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: SB-773812
* Drug: Olanzapine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meets the diagnostic criteria for schizophrenia as defined in DSM-IV. PANSS total score of at least 70 at Screen and Baseline and a minimum score of 4 (moderate) on at least 2 of the following: conceptual disorganization (P2) hallucinatory behaviour (P3) suspiciousness (P6) or unusual thought content (G9) at the Screen and Baseline visits Exclusion Criteria: Subjects with a history of epilepsy or other seizure disorder, first episode of schizophrenia or other psychotic disorders (e.g. residual type schizophrenia, schizophreniform disorder, schizoaffective disorder, delusional disorder, etc.) Bipolar disorder, a history of substance dependence, or a medical or psychiatric disorder that would interfere with the accurate assessment of safety or efficacy are not eligible.

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SB-773812|nan|
|Drug: Olanzapine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total score for each SB-773812 dose versus placebo at Week 6. |  | 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate safety of SB-773812 versus placebo and compared to olanzapine using PANNS scores -Measure the preliminary pharmacokinetic/pharmacodynamic relationships for SB-773812 -Assessment of movement disorders and cognitive functioning |  | 12 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia, PANSS, Acute, Cognition