linjc16/ctgov huggingface dataset:
The Diagnosis of Beta-lactam Hypersensitivity in Thailand

Study Overview
=================
Brief Summary
-----------------
The true prevalence of drug allergy in patients with a history of beta-lactam hypersensitivity will be determined by using commercially available standard skin test reagents and the diagnostic agents available in Thailand. We hypothesize that only minority of patients with such a history are truly allergic.

Detailed Description
-----------------
Patients with a history of beta-lactam hypersensitivity will be evaluated by the standard skin test reagents (major and minor determinants of penicillin, amoxicillin, and clavulanic if applicable), and intravenous forms of beta-lactam antibiotics . Diagnostic values of the measurement of specific Immunoglobulin E to penicillin/aminopenicillin and skin test reagents currently available in Thailand will be comparatively analyzed with the standard skin test reagents. The measurement of drug-induced interferon-gamma releasing cells will be measured in patients with a history of non-immediate reaction.

Official Title
-----------------
The Optimized Diagnostic Methods for the Confirmation of Beta-lactam Hypersensitivity in Thailand

Conditions
-----------------
Penicillin Allergy, Aminopenicillin Allergy, Beta Lactam Adverse Reaction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a history of beta-lactam hypersensitivity Exclusion Criteria: Being pregnant Having serious medical illnesses

Ages Eligible for Study
-----------------
Minimum Age: 7 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 |
| --- | --- |
| Patients with suspected drug allergy<br>Patients with a history of hypersensitivity reaction to beta-lactam antibiotics | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The true prevalence of drug allergy in patients with a history of beta-lactam hypersensitivity | The skin test positive rate in patients with a history of beta-lactam hypersensitivity | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical values of various diagnostic modalities in patients with a history of beta-lactam hypersensitivity | The diagnostic values of skin testing, drug-specific Immunoglobulin E measurement, and interferon-gamma ELISpot assay for the diagnosis of beta-lactam hypersensitivity | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
drug allergy, drug hypersensitivity, beta-lactam allergy, penicillin allergy, adverse drug reaction
Presbyopia-Correcting Intraocular Lenses (IOLs)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to prospectively evaluate postoperative visual and refractive parameters in a series of subjects bilaterally implanted with Presbyopia-Correcting Intraocular Lenses (IOLs).

Official Title
-----------------
A Randomized, Subject-masked Comparison of Visual Function After Bilateral Implantation of Presbyopia-correcting IOLs

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Device: ReSTOR +3
* Device: Crystalens HD
* Device: Crystalens AO


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed with bilateral cataracts candidate for presbyopic lens Exclusion Criteria: > 1 Diopter preoperative astigmatism by Keratometry readings pre-existing conditions that could skew the results

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ReSTOR +3<br>Bilateral implantation of ReSTOR +3 Intraocular Lens (IOL) | Device: ReSTOR +3<br>* Bilateral implantation of the AcrySof ReSTOR Aspheric +3 Model SN6AD1 Intraocular lens (IOL) for the treatment of cataract.<br>|
| Active Comparator: Crystalens HD<br>Bilateral implantation of Crystalens HD Intraocular Lens (IOL) | Device: Crystalens HD<br>* Bilateral implantation of the Crystalens HD intraocular lens (IOL) for the treatment of cataract.<br>|
| Active Comparator: Crystalens AO<br>Bilateral implantation of Crystalens AO Intraocular Lens (IOL) | Device: Crystalens AO<br>* Bilateral implantation of the Crystalens AO intraocular lens (IOL) for the treatment of cataract.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best Corrected Visual Acuity | Best corrected vision was tested at 4 meters (m), 60 centimeters (cm), 40cm and at preferred distance (distance chosen by each subject) with a standard ETDRS chart for distance and a hand held chart for near. Scores were calculated using logMAR values. LogMAR is the logarithm of the minimum angle of resolution. A lower logMAR value indicates better visual acuity. Preferred distance for each study group was as follows: ReSTOR +3 = 38.7 +/- 6.8 cm, Crystalens HD = 49.9 +/- 9.8 cm, Crystalens AO = 53.1 +/- 9.8 cm. | 6 Months after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ReSTOR +3
A Repeated Dose Study of KHK6640 in Japanese Patients With Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of KHK6640, given as a repeated dose in Japanese patients with Mild to Moderate Alzheimer's Disease.

Official Title
-----------------
A Phase 1 Randomized, Double-blind, Placebo-controlled, Repeated Dose Study of KHK6640 in Japanese Patients With Alzheimer's Disease

Conditions
-----------------
Alzheimer Disease

Intervention / Treatment
-----------------
* Drug: KHK6640
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with mild to moderate Alzheimer's Disease Body weight ≥ 40 kg and < 100 kg Clinical Dementia Rating (CDR) score of 1 or 2 Mini Mental State Examination (MMSE) score of ≥ 17 amd ≤ 26 Exclusion Criteria: Previous active treatment with an Alzheimer's Disease immunotherapy in an investigational study Use of another investigational drug within 16 weeks prior to the enrollment Subjects who meet National Institute of Neurological Disorders and Stroke/Association Internationale pour la Recherche et l'Enseignement en Neurosciences (NINDS/AIREN) criteria for vascular dementia Subjects with a history of presence of clinically significant seizures, brain trauma, transient ischemic attack, and/or cerebrovascular disease Subjects with a presence of a neurological condition that could be contributing to cognitive impairment above and beyond that caused by the subject's Alzheimer's Disease Subjects who have evidence of infection, tumor, or other clinically significant lesions that could indicate a dementia diagnosis other than Alzheimer's Disease

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 84 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: KHK6640<br>Intravenous administration | Drug: KHK6640<br>* Intravenous administration<br>|
| Placebo Comparator: Placebo<br>Intravenous administration | Drug: Placebo<br>* Intravenous administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events | Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Up to 197days after first dosing |
Night Driving Pilot

Study Overview
=================
Brief Summary
-----------------
Pilot study to evaluate usability of Mesotest II for assessment of night driving capacity of pseudo-phakic patients implanted with aspheric monofocal posterior chamber IOL *AT.Smart 46LC. Target Criterion: Measurement of contrast sensitivity and sensitivity to light under mesopic conditions (Mesotest II, Oculus).

Official Title
-----------------
Prospective Clinical Study to Evaluate Usability of Mesotest II for Assessment of Night Driving Capacity of Pseudophakic Patients Implanted With Monofocal IOL *AT.Smart 46LC

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Device: *AT.Smart 46LC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy eyes with cataract Patient age 50-75 years Written Patient Informed Consent Assured follow-up examination Exclusion Criteria: Any kind of macula degeneration and impairment of retina (clinical diagnosis) Amblyopia Intraoperative complications; damaged posterior bag; intraocular haemorrhage Astigmatism > 1.5 D (objective, preoperative) Pregnancy or lactation period for female patients

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: *AT.Smart 46LC<br>The *AT.Smart 46LC is indicated for primary implantation for the visual correction of aphakia in persons in whom the cataractous lens has been removed by phacoemulsification extracapsular cataract extraction. The IOL is intended to be placed only in an intact capsular bag. When implanted, the *AT.Smart 46LC replaces the natural lens of the eye and functions as a refracting medium in the correction of aphakia. | Device: *AT.Smart 46LC<br>* Primary implantation of *AT.Smart 46 LC into the eye's capsular bag for the visual correction of aphakia in persons in whom the cataractous lens has been removed by phacoemulsification extracapsular cataract extraction. The IOL is intended to be placed only in an intact capsular bag. When implanted, the *AT.Smart 46LC replaces the natural lens of the eye and functions as a refracting medium in the correction of aphakia.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of contrast sensitivity and sensitivity to light under mesopic conditions (Mesotest II, Oculus). |  | 8 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cataract, Intraocular Lens (IOL), Mesotest II, Evaluation of usability of Mesotest II for assessment of night driving capacity of pseudo-phakic patients
Effectiveness of a French Automated Web-based Smoking Cessation Program

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the effectiveness of a French fully automated web-based smoking cessation program known as the coaching, by comparing it to an online self-help guide.

Official Title
-----------------
Effectiveness of a French Automated Web-based Smoking Cessation Program : a Randomized Controlled Trial

Conditions
-----------------
Tobacco Consumption

Intervention / Treatment
-----------------
* Behavioral: Web-based automated coaching by e-mails
* Behavioral: Self-help guide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18 and older Smoker Willing to quit smoking in the next two weeks Having a regular access to Internet Having a personal e-mail address Not having benefited from the coaching the investigators want to assess yet Exclusion Criteria: No personal e-mail address Not able to give the informed consent

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Web-based coaching<br>Those in the coaching arm will benefit from e-mails with advice, information, support for smoking cessation. These mails will be adapted to their personal profile. | Behavioral: Web-based automated coaching by e-mails<br> <br> |
| Active Comparator: Self-help guide<br>Those in the active comparator arm will be allowed to download a self-help guide with step-by-step advice for smoking cessation. | Behavioral: Self-help guide<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the percentage of abstinent people between the two arms of the trial, 6 months after inclusion | The investigators will compare the percentage of smokers who successfully quit, 6 months after their inclusion in the study. Point prevalence abstinence will be measured (not smoking, event a puff, in the week preceding the questioning). | 6 months after inclusion |
Pediatric Cardiac Surgery Comparing Short 24-hour Antibiotic Prophylaxis to Extended Antibiotic Prophylaxis

Study Overview
=================
Brief Summary
-----------------
The objective of antibiotic prophylaxis is to prevent bacterial proliferation in order to reduce the risk of postoperative infection. Numerous recent recommendations show a benefit of a reduced duration of antibiotic prophylaxis in surgery, particularly in pediatrics. The study focuses on the incidence of postoperative infection by comparing antibiotic prophylaxis with 2nd generation cephalosporin (G2G) for 48 hours to a short antibiotic prophylaxis protocol limited to 24 hours. The bacterial infections considered were those said to be care-related, according to the criteria of the French Society of Anesthesia and Intensive Care if they occurred within the 3 months postoperative interval and were not present before the surgery: sepsis superficial or deep surgical site infection (mediastinitis, sternitis, scar infection) catheterization infection, urinary tract infection or respiratory infection such as pneumopathy acquired under mechanical ventilation The hypothesis is that reducing the duration of antibiotic prophylaxis does not expose patients to an increased risk of infection and limits exposure to antibiotics

Official Title
-----------------
Non-inferiority Study in Pediatric Cardiac Surgery Comparing Short 24-hour Antibiotic Prophylaxis to Extended Antibiotic Prophylaxis

Conditions
-----------------
Antibiotic Prophylaxis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Child less than 18 years of age, Operated for cardiac surgery at the University Hospital of Strasbourg between January 2015 and June 2019, by sternal approach (sternotomy), Child and holders of parental authority who have not expressed, after information, their objections to the reuse of his for the purpose of this research. Exclusion criteria: Child who has undergone thoracic heart surgery (thoracotomy), Child with an infection at the time of heart surgery, Child and parental authority holders who have expressed their objections to participating in this research

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 17 Years

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

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 |
| --- | --- | --- |
| Number of postoperative care-related infections in cardiac surgery |  | 24 hours after antibiotic prophylaxis | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antibiotic Prophylaxis, Bacterial proliferation, Bacterial infections, Postoperative infection, Pediatric cardiac surgery
Effectiveness of Rubber Dam Isolation Versus Cotton Roll Isolation on Bonded Fissure Sealant Retention

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate and compare the clinical retention of bonded fissure sealants placed under rubber dam isolation and cotton roll isolation.

Official Title
-----------------
Clinical Retention of Bonded Resin Sealants Placed With Rubber Dam Versus Cotton Roll Isolation

Conditions
-----------------
Dental Caries in Children, Dental Caries on Pit and Fissure Surface, Dental Leakage

Intervention / Treatment
-----------------
* Device: Rubber Dam Set
* Device: Dental Cotton Roll


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Teeth having a clinical indication of sealing with bonded resin pit and fissure sealants Patients with four fully-erupted permanent molars, with unstained, caries-free and unsealed pit and fissures Exclusion Criteria: Patients having incipient carious lesions, fewer erupted molars or teeth without pits on buccal/palatal surfaces. Patients with systemic diseases.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 16 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rubber Dam<br>Isolation of single tooth using rubber dam | Device: Rubber Dam Set<br>* Rubber dam set is the generic name of an isolation device that consists of a rubber sheet that isolates the tooth from saliva, a clamp to hold the rubber sheet on the tooth to be isolated, and a metal frame to keep the rubber sheet in a stretched position during dental procedures.<br>|
| Active Comparator: Cotton Roll<br>Isolation of quadrant using cotton rolls | Device: Dental Cotton Roll<br>* Cotton roll is the generic name of a disposable isolation device made of cotton in a cylindrical form. Cotton rolls are used to isolate the teeth from saliva, by being placed in the cheek and tongue during placement of sealants or filings.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The US Public Health Service criteria for retention of sealants | Alpha: No Loss of sealant, Bravo: Partial Loss of Sealant, Charlie: Total loss of sealant | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The US Public Health Service criteria for secondary caries on sealants | Alpha: Charlie: There is no clinical diagnosis of caries. Charlie: There is clinical diagnosis of caries | 12 months |
Exemestane + Celecoxib vs Exemestane + Placebo in Metastatic Breast Cancer

Study Overview
=================
Brief Summary
-----------------
To discover if the adding of a coxib increases the efficacy of the Aromasine.

Official Title
-----------------
A Multicenter Randomized Phase III, Double-blind Study Comparing Efficacy of the Association of Exemestane and Celecoxib Versus Exemestane and Placebo in Menopausal Patients With Metastatic Breast Cancer.

Conditions
-----------------
Metastatic Breast Cancer

Intervention / Treatment
-----------------
* Drug: placebo
* Drug: Celecoxib
* Drug: Exemestane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Femal patient aged > 18 years Histologically proven breast cancer Menopausal patient according to the following definition: amenorrhoea > 1 year or menopause affirmed by a rate of oestradiol or hypophyseal gonadotrophin surgical ovariectomy treatment by LHRH analog ovarian suppression by radiotherapy amenorrhoea induced by chemotherapy > 1 year Oestradiol and/or progesterone positive receptors Presence of one or several metastatic lesion: mesurable lesion bone metastase were detected by bone scintigraphy Patient who can have received: Adjuvant chemotherapy and/or hormonotherapy (Tamoxifen) Metastatic Treatment by chemotherapy PS < 2 Adequate biological values Patient who has clearly given her consent by signing on informed consent form prior to participation Exclusion Criteria: Patient previously treated with hormonotherapy in metastatic phase Antecedent of treatment with aromatase inhibitors local relapse (with the exception of cutaneous thoracic nodes) Patient with only one metastatic lesion like: pleurisy , ascites, lung Lymphangitis carcinomatosa

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Aromasin + placebo in place of Celebrex | Drug: placebo<br>* 2 tablets twice a day per os<br>Drug: Exemestane<br>* Exemestane 25 mg per day per os<br>* Other names: Aromasin;|
| Experimental: Celebrex<br>Aromasin + Celebrex | Drug: Celecoxib<br>* 2*200 mg tablets twice a day per os<br>* Other names: Celebrex;Drug: Exemestane<br>* Exemestane 25 mg per day per os<br>* Other names: Aromasin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate |  | 6 months | 
| Quality Of Life + pain |  | 6 months | 
| Overall survival |  | 5 years | 
| Tolerance |  | 6 months |