linjc16/ctgov huggingface dataset:
The Effects of Azithromycin Ophthalmic Solution, 1% Versus Placebo in Subjects With Blepharitis During a Two-Week Treatment Period

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to compare the safety and efficacy of azithromycin ophthalmic solution, 1% versus placebo over a two-week treatment period.

Conditions
-----------------
Blepharitis

Intervention / Treatment
-----------------
* Drug: Azithromycin ophthalmic solution, 1%
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have best corrected visual acuity in both eyes of at least +0.7 or better If female, are non-pregnant or non-lactating Have a current diagnosis of blepharitis in one or both eyes Exclusion Criteria: Have lid structural abnormalities Have suspected ocular fungal or viral infection Have practiced warm compress therapy within 14 days prior to Visit 2 Unable to withhold the use of contact lenses during the treatment or follow-up periods Unable to withhold the use of ocular cosmetic products within 24 hours prior to study visits Have had penetrating intraocular surgery within 90 days prior to Visit 2 Have had ocular surface surgery within the past year prior to Visit 2 Have a serious medical condition which could confound study assessments

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Azithromycin ophthalmic solution, 1%<br>* One drop in each eye twice a day for the first two days; then one drop in each eye once a day for 12 days<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* One drop in each eye twice a day for the first two days; then one drop in each eye once a day for 12 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eyelid margin erythema |  | Two weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Signs and symptoms of Blepharitis |  | One week, two weeks, three weeks, four weeks |
Use of 50% Nitrous Oxide / 50% Oxygen Premix in Primary Care Dental Centers

Study Overview
=================
Brief Summary
-----------------
A 50% nitrous oxide / 50% oxygen premix is administrated to the patient during the realization of dental cares. This openly clinical trial is done in 36 French primary care dental centers, especially on anxious and phobic patients but also on infants or mental deficient adults. At least 480 patients will be included in this clinical protocol.

Official Title
-----------------
Sedation Faisability by Inhalation of Kalinox 170 Bar During Therapeutic Cares in Primary Care Dental Centers

Conditions
-----------------
Dental Cares

Intervention / Treatment
-----------------
* Drug: Kalinox 170 bar


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: anxious and/or phobic patients having a vomiting reflex very young children requiring selective dental cares mental deficient patient patient having specific phobia linked to the dental care to be done patient from 1 year old ASA 1 or ASA 2 patient existing of efficient contraception Exclusion Criteria: ASA 3 or ASA 4 patient patient already treated without using Kalinox's sedation patient already included in this protocol in a delay lower than 7 days contraindication linked to the experimental product Kalinox's inhalation duration higher than 1 hour pregnant or breast-feeding women

Ages Eligible for Study
-----------------
Minimum Age: 1 Year

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Misture of 50% nitrous oxide and 50% oxygen | Drug: Kalinox 170 bar<br>* Flow of gas administrated to the patient between 4 and 15 litre/min and less than 1 hour<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain measurement by using Visual Analog Scale (VAS) and Face Pain Scale (FPS) |  | At the end of the dental care | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's acceptance and doctor's satisfaction |  | At the end of dental care |
Effect of Adjunctive Treatment With Arestin on the Subgingival Microflora in Patients With Moderate to Advanced Periodontitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to measure the antimicrobial effects of Arestin in subjects with moderate to advanced periodontal disease

Conditions
-----------------
Periodontitis

Intervention / Treatment
-----------------
* Drug: Minocycline HCL Microspheres


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Generalized moderate to advanced chronic periodontitis, five sites with probing depths of >5 mm in 5 non-adjacent interproximal spaces, excluding the distal of terminal teeth, at least 16 teeth excluding 3rd molars and implants Exclusion Criteria: Allergy to tetracycline Subjects with aggressive periodontitis Acute necrotizing ulcerative gingivitis, or gross decay Systemic conditions which could influence the course of periodontal disease (i.e, diabetes, autoimmune disease, etc) Individuals requiring prophylactic antibiotics Any periodontal therapy within the previous 3 months (excluding maintenance therapy) Systemic or local antibiotic therapy within three months

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 65 Years

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Minocycline HCL Microspheres|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in the mean sum of primary pathogens (P. gingivalis, To forsythensis, and T. denticola) from baseline to 30 days. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the numbers of each of the primary pathogens, changes in pocket depth, attachment level, and proportion of sites bleeding on probing |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic periodontitis, mouth, Moderate to advanced chronic periodontitis
Gastric Volume in the Fasted Pediatric Cerebral Palsy Patients

Study Overview
=================
Brief Summary
-----------------
In children with cerebral palsy, the gastric volume is measured through ultrasound after fasting before surgery to evaluate whether the risk of aspiration is higher than that of the general population.

Official Title
-----------------
Ultrasound Assessment of Gastric Volume and Aspiration Risk Evaluation in the Fasted Pediatric Cerebral Palsy Patients

Conditions
-----------------
Aspiration, Respiratory, Cerebral Palsy

Intervention / Treatment
-----------------
* Device: Assessment of gastric volume


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with cerebral palsy under the age of 18 undergoing surgery under general anesthesia Exclusion Criteria: Levin tube or gastrostomy tube in situ Decline to participate

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Assessment of gastric volume|Measuring the cross-sectional area of stomach in supine and right lateral decubitus|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gastric volume | Volume = -7.8 + (3.5 x RLD CSA) + 0.127 X age (months) | preoperative 1 days to postoperative 1 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grade of gastric fullness | Grade 0: Neither in supine, right lateral decubitus / Grade 1: stomach content only in lateral decubitus , Grade 2: Both in supine, lateral decubitus | preoperative 1 days to postoperative 1 days |
Clinical Study of Solo Tympanostomy Tube Device (TTD)

Study Overview
=================
Brief Summary
-----------------
This is a multi-centre, single arm study to evaluate the placement of tympanostomy tubes with the AventaMed Solo Tympanostomy Tube Device (TTD)

Official Title
-----------------
Post-Market Approval Study of the Solo Tympanostomy Tube Device

Conditions
-----------------
Otitis Media, Middle Ear Effusion

Intervention / Treatment
-----------------
* Device: Solo TTD


Participation Criteria
=================
Eligibility Criteria
-----------------
Basic Inclusion Criteria: Listed for bilateral tympanostomy tube insertion only Basic Exclusion Criteria: Anatomy that precludes sufficient visualisation of both the left and right eardrum with the Solo TTD in place. Anatomy that precludes safe access to both the left and right eardrum with the Solo TTD Patients in whom a reliable audiogram is not possible

Ages Eligible for Study
-----------------
Maximum Age: 18 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Solo TTD<br>Placement of tympanostomy tube with Solo TTD | Device: Solo TTD<br>* Placement of tympanostomy tube with Solo TTD<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative Device Success | Number of ears in which tube placement is achieved with the Solo TTD | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conversion from moderate sedation | Number of patients requiring conversion from moderate sedation to general anaesthesia | Intraoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tympanostomy Tube, Ventilation Tube, Grommet, Otitis Media, Middle Ear Effusion
Lymphatic Osteopathic Manipulative Medicine to Enhance Coronavirus (COVID-19) Vaccination Efficacy

Study Overview
=================
Brief Summary
-----------------
The purpose of this project is to study the impact of Osteopathic Manipulative Medicine (OMM) treatments, such as lymphatic myofascial release and thoracic pump techniques severe acute respiratory syndrome-associated coronavirus 2 (SARS-Cov-2) antibody levels in patients who receive the mRNA-1273 (Moderna) COVID-19 vaccine and to consider if these OMM strategies allow a stronger more robust immune response.

Official Title
-----------------
Lymphatic Osteopathic Manipulative Medicine to Enhance COVID-19 Vaccination Efficacy

Conditions
-----------------
COVID-19

Intervention / Treatment
-----------------
* Other: Lymphatic OMM
* Other: Light Touch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inclusion criteria will include age greater than 18 years old and having safely received the COVID-19 vaccine. Exclusion Criteria: Exclusion criteria will include age under 18 years old, malignancy/cancer, ongoing infection, coagulopathy history, use of anticoagulant medications, and fracture or acute injury of the torso neck or upper extremities. Lymphatic OMM is safe during pregnancy and this does not need to be an exclusion criteria.

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lymphatic OMM plus Moderna COVID-19 Vaccine regimen<br>Patients receive OMM treatments that will include thoracic inlet and outlet myofascial release, pectoral traction myofascial release, and Miller Thoracic Lymphatic Pump technique plus the Moderna COVID-19 Vaccine regimen. | Other: Lymphatic OMM<br>* Patients receive lymphatic myofascial release and thoracic pump techniques.<br>|
| Sham Comparator: Light Touch plus Moderna COVID-19 Vaccine regimen<br>Patients receive a series of light touch techniques plus the Moderna COVID-19 Vaccine regimen. | Other: Light Touch<br>* Patients receive a series of light touch techniques.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| severe acute respiratory syndrome-associated coronavirus 2 (SARS-Cov-2) antibody levels | Antibody levels collected via blood draw | The day of first vaccine dose (baseline), the day of second vaccine dose (at about 4-weeks post first vaccine dose), and 2-weeks post second vaccine dose (at about 6-weeks post first vaccine dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, Osteopathic Manipulative Medicine, Antibody
Screening of TMA Patients für ADAMTS13 Activity (Adamscreen)

Study Overview
=================
Brief Summary
-----------------
Screening of TMA patients for ADAMTS13 activity and the description of systemic organ damage and/or organ failure in different entities of thrombotic microangiopathies (TMA)

Detailed Description
-----------------
This is a prospective diagnostic analysis enrolling 100 patients with clinically suspected thrombotic microangiopathy (TMA) on the basis of laboratory findings such as thrombocytopenia, Coombs negative haemolytic anemia with increased LDH and increased schistozytes. As a first step of differential diagnosis, patients are classified by determining ADAMTS13 activity and antigen concentration and also analyzing for Shigatoxin and Shigatoxin producing bacteria respectively. Primary objective is to determine the relative incidences of the three major entities i.e. aHUS, STEC-HUS and TTP considering distribution of age and gender as well. Mean value of ADAMTS13 activity and antigen measured at date of first diagnosis is considered to line out a threshold value for ADAMTS13 activity pronouncing clinical apparent TMA. Furthermore the present study intends to characterize clinical presentation, clinical course and outcome of different TMA forms particularly with regard to treatment procedures. Monitoring of how ADAMTS13 activity and antigen changes in the course of the disease and in response to treatment is of particular concern for this study. Family history and special clinical conditions should be noted identifying potential genetic predisposition and definite clinical triggers leading to disease manifestation.

Official Title
-----------------
Screening of TMA Patients for ADAMTS13 Activity and the Description of Systematic Organ Damage and/or Organ Failure in Different Entities of Thrombotic Microangiopathies (TMA)

Conditions
-----------------
Thrombotic Microangiopathies

Intervention / Treatment
-----------------
* Biological: Technozyme


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Patients with first history of TMA as patients with recurrent TMA or TMA in complete or partial remission are eligible for analysis Exclusion Criteria: -Patients who received plasma intervention more than 3 weeks prior to screening must be excluded from the observational study

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

| Intervention/Treatment |
| --- |
|Biological: Technozyme|determination of ADAMTS13 activity|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| relative incidences of different entities of TMA |  | at baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean value of ADAMTS13 activity and antigen measured at date of first diagnosis. |  | at baseline |
Efficacy and Safety of ONCOXIN in Patients With Breast Fibrocystic Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate whether Oncoxin, a nutritional supplement, improves the clinical and ultrasonographic results in comparison with placebo during 24 weeks of treatment.

Official Title
-----------------
Efficacy and Safety of Nutritional Supplement ONCOXIN in Patients With Breast Fibrocystic Disease

Conditions
-----------------
Breast Fibrocystic Disease

Intervention / Treatment
-----------------
* Dietary Supplement: Oncoxin
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with clinical and ultrasonographic confirmation of breast fibrocystic disease. Patients older than 20 years. Female patients. Informed consent. Exclusion Criteria: Presents of another disease not well controlled. Pregnant women or lactating. Patient which are receiving another products from other investigations trials.

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Oncoxin, a nutritional supplement | Dietary Supplement: Oncoxin<br>* (caplets 300 mg), three oral caplets per day for 24 weeks<br>|
| Placebo Comparator: B<br> | Dietary Supplement: Placebo<br>* (caplets 300 mg), three oral caplets per day for 24 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The ultrasonographic improvement at 24 weeks (end of the treatment) |  | 24 weeks | 
| Adverse effects at 24 weeks (end of the treatment) |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lesion size according clinical measurement at 24 weeks (end of the treatment) |  | 24 weeks | 
| Pain according patient examination at 24 weeks (end of the treatment) |  | 24 weeks |
Explorative Study on a New Device' Ability to Register Hydration Change in Elderly Subjects During Rehabilitation.

Study Overview
=================
Brief Summary
-----------------
Test the ability of continuous measurements from a new sensor patch to set the hydration state in subjects who are malnourished/dehydrated or overhydrated or otherwise not optimally hydrated. Specifically, clinical examination, blood pressure, blood tests, and weight change at the admission and at the discharge will be used to establish the true hydration status of the subjects.

Official Title
-----------------
CTR025 FAUN - Hydration Status

Conditions
-----------------
Dehydrated, Water-Electrolyte Imbalance, Malnutrition

Intervention / Treatment
-----------------
* Other: No intervention done


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elderly patients eligible for rehabilitation Exclusion Criteria: Subjects with end stage cancer

Ages Eligible for Study
-----------------
Minimum Age: 70 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 |
| --- | --- |
| Elderly<br>Elderly (> 70 yrs) eligible for a short term rehabilitation | Other: No intervention done<br>* No intervention was done. This was an observational study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hydration state | Set correct hydration state with a sensitivity of 0.90 and a specificity of 0.80 | During rehabilitation period (3 - 5 weeks) |