linjc16/ctgov huggingface dataset:
Study Evaluating the Safety and Tolerability of a New Intravenous Formulation of MOA-728 in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The primary objective is to determine the safety and tolerability of the new IV formulation versus the current formulation of MOA-728 focusing on the theoretical potential for infusion-related and formulation-related complications.

Official Title
-----------------
A Double-Blind, Placebo-Controlled, Multiple-Dose, 2-Period Crossover Study to Evaluate the Safety and Tolerability of a New Intravenous Formulation of MOA-728 in Comparison With the Current Formulation in Healthy Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: MOA-728


Participation Criteria
=================
Eligibility Criteria
-----------------
A signed and dated informed consent form. Men or nonlactating and nonpregnant women, aged 18 to 80 years, inclusive. Women of nonchildbearing potential (WONCBP) must be surgically sterile (hysterectomy, oophorectomy, and/or tubal ligation) or postmenopausal for ³1 year. Women of childbearing potential (WOCBP) must be using an acceptable nonhormonal method of contraception (intrauterine device [IUD], diaphragm, or condom with spermicidal jelly or foam, abstinence) for a period of at least 1 month before and after dose administration. All women must have a negative pregnancy test result within 48 hours before the start of the first test article administration. Body mass index in the range of 18 to 32 kg/m² and body weight ≥50 kg. Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG). Subjects aged 65 to 80 years should be healthy, but may be enrolled with a chronic illness, if such illness is well controlled and does not interfere with the primary objective of the study. Certain concomitant medications will be allowed for the treatment of these conditions and are listed in the Concomitant Treatment section. Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking from 48 hours before and throughout the inpatient stay. Have a high probability for compliance with and completion the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MOA-728|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IV site tolerability and urinary zinc excretion |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
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healthy, safety
Probiotics Pilot Project

Study Overview
=================
Brief Summary
-----------------
This pilot study is designed to determine if ingestion of Bacillus probiotics can cause alteration in levels of S. aureus colonization in the nose and intestine in preoperative orthopedic patients undergoing elective primary TJA.

Official Title
-----------------
Probiotic Bacillus for Decolonization of Methicillin-resistant Staphylococcus Aureus (MRSA) in Patients Undergoing Total Joint Arthroplasty: A Randomized, Prospective, Placebo-Controlled Pilot Study

Conditions
-----------------
Staphylococcus Aureus

Intervention / Treatment
-----------------
* Dietary Supplement: Bacillus subtilis probiotic
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults (age >18 years) Undergoing elective primary knee or hip arthroplasty Confirmed colonization of nares and/or rectum with S. aureus or MRSA on routine standard-of-care preadmission testing Written informed consent Exclusion Criteria: Regular use of a probiotic or prebiotic supplement within 3 months prior to enrollment Antibiotic use within 3 months prior to enrollment Active clinical infection Participation in other clinical trials Presence of pregnancy or lactation

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: Probiotic<br> | Dietary Supplement: Bacillus subtilis probiotic<br>* Bacillus probiotic which contains one confidential ingredient of Bacillus subtilis spores (2 x 1010 CFU/g). Over 5 days of interventional period, the patient receives one tablet (250 mg; 5 x 109 CFU) of probiotic per day.<br>|
| Placebo Comparator: No intervention<br> | Other: Placebo<br>* Over 5 days of interventional period, the patient receives 1 placebo tablet per day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Persistent Staphylococcus aureus colonization |  | post-intervention: following 5 days of dietary supplementation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in microbiome composition | as determine through next generation sequencing of samples collect from the patient | post-intervention: following 5 days of dietary supplementation |
A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin Sustained Release Versus 3-Day Azithromycin for the Treatment of Strep Throat in Adolescents and Adults

Study Overview
=================
Brief Summary
-----------------
To determine if a single 2.0-g dose of azithromycin SR is at least as effective as a 3-day course of azithromycin (500 mg once daily for 3 days) when used to treat adolescents and adults with strep throat, and to assess efficacy and safety for both treatment regimens.

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin SR Versus Three-Day Azithromycin for the Treatment of Group A β-Hemolytic Streptococcal Pharyngitis/Tonsillitis in Adolescents and Adults

Conditions
-----------------
Pharyngitis, Tonsillitis

Intervention / Treatment
-----------------
* Drug: azithromycin (Zithromax)
* Drug: placebo
* Drug: azithromycin SR
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with evidence of acute group A beta-hemolytic streptococcus (GABHS) pharyngitis/tonsillitis and a positive rapid antigen detection test or positive culture of the pharynx or tonsils for GABHS Exclusion Criteria: Patients were excluded if they had treatment with any systemic antibiotic within the previous 7 days, a history of rheumatic fever, a peritonsillar abcess, or were known carriers of GABHS.

Ages Eligible for Study
-----------------
Minimum Age: 13 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: 1<br> | Drug: azithromycin (Zithromax)<br>* azithromycin 500 mg tablet by mouth once daily for 3 days<br>Drug: placebo<br>* placebo<br>|
| Experimental: 2<br> | Drug: azithromycin SR<br>* azithromycin SR 2.0 g by mouth as an oral slurry for 1 dose<br>Drug: placebo<br>* placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bacteriologic response in the Bacteriologic per Protocol population |  | Test of Cure (TOC) visit (Days 24-28) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sponsor assessment of clinical response in the Bacteriologic per Protocol population |  | TOC visit | 
| bacteriologic response for the remaining study populations |  | TOC visit | 
| sponsor assessment of clinical response for the Bacteriologic per Protocol population |  | Long-Term Follow-Up (LTFU) visit (Days 38-45) | 
| bacteriologic response for the Bacteriologic per Protocol population |  | TOC visit | 
| summary of baseline susceptibilities |  | Study endpoint | 
| adverse events |  | Continuous |
PCR Technique to Identify Methicillin-sensitive and Methicillin-resistant Staphylococcus Aureus in Nasal and Respiratory Tract Samples

Study Overview
=================
Brief Summary
-----------------
In patients on mechanical ventilation, it is not known whether the identification of S. aureus in LRT samples improves the performance of its nasal detection. To assess the MSSA or MRSA carrier status of patients requiring mechanical ventilation for more than 48 hours after major heart surgery: comparing the performance of the diagnostic technique Xpert® SA Nasal Complete assay in nasal swab and LRT samples.

Detailed Description
-----------------
Patients undergoing heart surgery require ventilation for more than 48 hours. These patients, placed on mechanical ventilation for a median of 7 days, will be followed weekly until their discharge from hospital. We estimate we will need 500 determinations. Samples will be obtained according to usual clinical practice. Thus, rather than discarding a sample, it will be subjected to the two laboratory diagnostic techniques (conventional culture and the Xpert® assay). No patient will be subjected to any procedure outside that of routine clinical practice. Patient with a tracheal tube in whom nasal and LRT secretions can be simultaneously obtained. Patients may also be included if LRT samples can be obtained via a different approach (tracheostomy, fibrobroncoscopy etc.).

Official Title
-----------------
Impact of the Introduction in a Heart Surgery ICU of a PCR Technique (Cepheid Xpert® SA Nasal Complete Assay) to Identify Methicillin-sensitive and Methicillin-resistant Staphylococcus Aureus in Nasal and Respiratory Tract Samples

Conditions
-----------------
Thoracic Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults (≥ 18 years) Signed Informed consent Patient admitted to the HS-ICU before or after undergoing heart surgery Patient on mechanical ventilation for >2 calendar days on the date of event (suspicion of LRT infection) ), taking the day of ventilator placement as day 1 Patient with a tracheal tube in whom nasal and LRT secretions can be simultaneously obtained. Patients may also be included if LRT samples can be obtained via a different approach (tracheostomy, fibrobroncoscopy etc.).

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Staphylococcus aureus presence in nasal and respiratory tract samples | diagnostic technique Xpert® SA Nasal Complete assay in nasal swab and LRT samples. | every 7 days from date of randomization, an average of two weeks |
Outcome of Capsular After Pediatric Cataract Surgery With Primary Intraocular Lens Implantation

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the outcome of capsular in children with cataract, and to explore potential preoperative structural clues for postoperative glaucoma. The investigators included children with cataract planning to have cataract surgery in our institute. Exclusion criteria were: a history of ocular trauma, a history of intraocular surgery, preoperative glaucoma, steroid use before surgery, a history of maternal rubella syndrome, chronic anterior uveitis, persistent fetal vasculature, ocular anomalies associated with an increased risk of glaucoma, unable to complete examinations. The investigators recorded age at surgery, gender and relevant ocular and systemic histories. All patients underwent slit lamp biomicroscopy, slit lamp adapted anterior segment photography.All patients were examined at 1 week, 1 month, 3 months, 6 months, 1 year, 18 months, and two years after surgery. Patients were followed for two years or until the development of severe VAO requiring Nd: YAG laser capsulotomy, whichever came first. The examinations consisted of visual acuity, IOP measurement by a Tonopen tonometer (Reichert, Inc., Seefeld, Germany), fundoscopy, an assessment by high-resolution digital retroillumination imaging (detailed protocol presented below).The primary outcomes were the areas of the posterior capsular opening at different postoperative follow-up visits and during operation.A paired T test was used to compare the areas of the PCO between the postoperative visits and baseline.

Official Title
-----------------
Outcome of Capsular After Pediatric Cataract Surgery With Primary Intraocular Lens Implantation

Conditions
-----------------
Pediatric Cataract

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants included eyes of children with unilateral or bilateral cataract. Exclusion Criteria: Patients with glaucoma, ocular trauma, corneal disorders, persistent hyperplastic primary vitreous, rubella, Lowe syndrome, capsular fibrosis, or surgical complications, as well as those whose pupils could not dilate normally postoperation or who could not complete the follow-up, were excluded.

Ages Eligible for Study
-----------------
Maximum Age: 10 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 |
| --- | --- | --- |
| area of PCO | area of posterior capsular opening | 2015.5.1- 2020.8-1 |
Subtle Myocardial Deformation Abnormalities in Asymptomatic Nf-1 Patients

Study Overview
=================
Brief Summary
-----------------
Subtle myocardial deformation abnormalities in asymptomatic nf-1 patients: is cardiac screening needed?

Official Title
-----------------
Prevalence of Subtle Myocardial Deformation Abnormalities in Asymptomatic Nf-1 Patients: is Cardiac Screening Needed?

Conditions
-----------------
Neurofibromatosis Type 1

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: asymptomatic NF1 patients aged 0-17y and 11 months Exclusion Criteria: clinical heart failure, history of cardiovascular disease chronic renal insufficiency

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 18 Years

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

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 |
| --- | --- | --- |
| myocardial deformation indices as measured in percentage (change of original length) |  | up to 2 years |
Pilot Text Message for Influenza Vaccination

Study Overview
=================
Brief Summary
-----------------
Influenza is an important and potentially preventable cause of morbidity and mortality, yet only 46% of U.S. adults were vaccinated by the end of the 2011-12 influenza season despite influenza vaccination being widely recommended, effective, and safe. Influenza vaccination rates are even lower in racial/ethnic minority groups. In order to address the problem of low influenza vaccination rates in minority adults, we plan to build on the well-accepted practice of immunization recall-reminders and the emerging practice of using text message to pilot the feasibility of using text messaging to improve influenza vaccination coverage rates in a low health literacy, largely minority, publicly insured adult population.

Official Title
-----------------
Pilot Study of Text Message Reminders for Flu Vaccine For Adults

Conditions
-----------------
Influenza

Intervention / Treatment
-----------------
* Behavioral: text message


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > or = 18 years of age, at least one visit to the AIM clinic during the previous year a cell phone number in the registration system fluent in English or Spanish. Exclusion criteria Exclusion Criteria: Receipt of influenza vaccination during the 2012-2013 influenza season prior to randomization.

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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: text message<br>receipt of text message | Behavioral: text message<br> <br> |
| No Intervention: usual care<br>usual care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Receipt of an influenza vaccine dose | Proportion of individuals in each group receiving an influenza dose by the end of the influenza season | March 31, 2013 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Influenza vaccination
Neurophysiological Study of tDCS Effects in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
Transcranial direct current stimulation is a tool to modulate cortical excitability.

Detailed Description
-----------------
Anodal transcranial direct currenti stimulation over visual cortex is able to decrease the thermo-nociceptive sensibility and thermonociceptive potentials, whilst cathodal transcranial direct current stimulation has the opposite effect, it decreases VEP amplitude and habituation. This neuromodulation technique is probably a tool in the prevention in episodic and chronic migraine. The aim of the study is to study short and long term effect of tDCS over pain treshold, contact heat evoked potentials, blink reflex and visual evoked potentials in healthy volunteers.

Official Title
-----------------
Neurophysiological Study of tDCS Effects in Healthy Volunteers

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Device: Cefaly tDCS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy volunteers Exclusion Criteria: age below 18 or above 65 years personal history of recurrent headache or other neurological diseases especially seizures, familial history of recurrent headache child migraine equivalents (motion sickness, cyclic vomiting or recurrent abdominal pain, somnambulism etc.. . .) chronic pain syndromes analgesics intake at the time of recording contra-indications to tDCS neurostimulation (metal prosthetics in the head or internal stimulation like a pacemaker).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cefaly tDCS<br>Cathodal Cefaly tDCS is delivered over the visual cortex at 2 mA of intensity, for 20 minutes, for 5 consecutive days in 9 HV. The anode is placed over the left DLPFC. 2 mA anodal tDCS is delivered over the visual cortex, for 20 minutes, for 5 consecutive days in 9 HV | Device: Cefaly tDCS<br>* Cefaly tDCS (transcranial direct current stimulation) is able to modify cortical excitability, in particular anodal tDCS increases it. The side effects of tDCS are minor, especially sensations of itching and scalp paresthesias.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurophysiological mesures changes | Modifications in neurophysiological test after direct current stimulation | up to 1 month |
Endoscopic Ultrasound-guided Needle-based Confocal Laser Endomicroscopy for Evaluation of Malignant Lymph Nodes - a Pilot Study

Study Overview
=================
Brief Summary
-----------------
Current modalities for lymph node staging in cancer can be limited. Needle-based confocal laser endomicroscopy (nCLE) is a novel endoscopic technique, which is compatible with the 19-gauge FNA needle. Under endoscopic ultrasonography (EUS) guidance, nCLE enables real-time in vivo imaging of lesion tissues at cellular and subcellular levels.This study aimed to evaluate the feasibility of needle-based confocal laser endomicroscopy (nCLE) at the time of endoscopic ultrasound (EUS) and to describe the nCLE features that distinguish between benign and malignant lymph nodes.

Conditions
-----------------
Malignancy or Benign of Enlarged Lymph Nodes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing EUS for staging of malignancy or assessment of enlarged lymph nodes Exclusion Criteria: Patients aged <18 years or >80 years Known allergy to fluorescein dye Previous EUS-FNA performed within the past 3 months, and usualcontraindications to EUS-FNA Pregnancy or breastfeeding Inability to provide informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| The nCLE interpretation criteria for the characterization of malignant lymph nodes |  | 20 months |