linjc16/ctgov huggingface dataset:
Dermacyd PH_DETINLYN Sweet Flower (Lactic Acid) - Safety

Study Overview
=================
Brief Summary
-----------------
To prove the safety of the gynaecological formulation in normal conditions of use.

Official Title
-----------------
Safety Dermatological Evaluation: Genital Mucous Irritation - Product Tested: Dermacyd PH_DETINLYN Sweet Flower (Lactic Acid).

Conditions
-----------------
Hygiene

Intervention / Treatment
-----------------
* Drug: Dermacyd PH_DETINLYN Sweet Flower (Lactic Acid)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Integral skin test in the region, Use of cosmetic product of the same category Exclusion Criteria: Lactation or gestational risk or gestation Use of Anti-inflammatory, immunosuppression or anti-histaminic drugs Atopic antecedent or allergic to cosmetic product Active cutaneous disease in the evaluation area Diseases which cause immunology decrease, such as diabetes and HIV Endocrinal pathologies Intense solar exposure 15 days before the evaluation Treatment until four months before the selection The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 20 Years

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Dermacyd PH_DETINLYN Sweet Flower (Lactic Acid) | Drug: Dermacyd PH_DETINLYN Sweet Flower (Lactic Acid)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The absence of irritation and the good acceptability will be evaluated using one specific scale which describes the intensity of the reaction. |  | From treatment start to the end of study |
Saliva Testosterone Increases in Irritable Bowel Syndrome (IBS) Patients Beginning Choir Singing

Study Overview
=================
Brief Summary
-----------------
The hypothesis was that a one-year experience of choir singing once a week is more beneficial than group discussions to saliva concentration of testosterone.

Detailed Description
-----------------
The project aimed to study the health effects of regular choir singing for persons who are in a psychosomatic condition (Irritable Bowel syndrome - IBS). A group of IBS patients were randomized to choir singing or an information group were followed during one year with biological and psychosocial assessments. The choir group participated in various relaxation, breathing and vocal exercises with the choir leader, and received the material To live with IBS for home studies. At the same time a comparison group with IBS patients meet in groups, studying and discussing on the same materials under the direction of a group leader. Both groups meet once per week.

Official Title
-----------------
Saliva Testosterone Increases in Choir Singer Beginners: a Randomised Controlled Trial to Test the Efficacy of Choir Singing in Irritable Bowel Syndrome (IBS) Patients

Conditions
-----------------
Irritable Bowel Syndrome

Intervention / Treatment
-----------------
* Behavioral: Choir singing
* Behavioral: Information Group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: IBS according to physician certificates. Wish to start choir singing but no such experience during past ten years. Acceptance of randomisation condition. Exclusion Criteria: No serious somatic diseases. No abuse of alcohol or drugs. No ongoing acute psychiatric condition.
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 |
| --- |
|Behavioral: Choir singing|Choir group participated in various relaxation, breathing and vocal exercises with the choir leader, and received the material To Live with IBS for home studies, weekly for 1 year. Saliva testosterone assessed 6 times per occasion; baseline, after 6, 9 and 12 months.|
|Behavioral: Information Group|Meet in groups, studying and discussing on the same materials under the direction of a group leader, weekly, for 1 year. Saliva testosterone assessed 6 times per occasion; baseline, after 6, 9 and 12 months.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| More reduction in bowel pain according to standardised international IBS questionnaire in choir group than in study group after one year. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Significant increase in saliva testosterone concentration during study period in choir group. |  | 1 year |
Evaluation of Diabetes Care at Austrian GPs

Study Overview
=================
Brief Summary
-----------------
This registery should show the medical care of patient with Type 2 Diabetes (T2D) at GP-offices. Furthermore data of co morbidities and risk factors should be evaluated. Objectives of this NIS (cross-sectional study) are: To evaluate which characteristics or co-morbidities are being existent for patient with T2D at GP level, To evaluate representative profile of patient with T2D in Austria, To evaluate which medical therapies are used.

Official Title
-----------------
Diabetes Care Austria 2009

Conditions
-----------------
Type 2 Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetes mellitus type II Exclusion Criteria: Diabetes mellitus type I Gestation diabetes Induced diabetes
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 type 2 diabetes<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate characteristics or co morbidities being existent for patient with T2D at GP |  | Once per patient | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes Care at GPs in Austria, Characteristic of diabetes patients at GPs in Austria
Study of Endothelial Cells in Patients With Hereditary Haemorrhagic Telangiectasia

Study Overview
=================
Brief Summary
-----------------
Hereditary Haemorrhagic Telangiectasia (HHT, also known as Osler-Weber-Rendu Syndrome) is an disease that leads to the development of dilated and fragile blood vessels. We propose to culture endothelial cells from patients with HHT, to culture cells that express the proteins mutated in HHT, namely endoglin and ALK-1. We will study the properties of these cells which will involve their growth in different conditions and anticipate that DNA, mRNA and proteins will be extracted from these cells for study of cell responses and association with expression levels of endoglin and ALK-1. We hypothesize that these cells which express half-normal endoglin or ALK-1 will show altered protein synthetic differences when compared to normal white blood cells. We anticipate that that these findings may help to explain aspects of the HHT disease phenotype.

Official Title
-----------------
In Vitro Studies pf Endothelial Cells Derived From HHT Patients

Conditions
-----------------
Telangiectasia, Hereditary Hemorrhagic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with hereditary haemorrhagic telangiectasia and family members Exclusion Criteria: Unable to provide informed consent
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 |
| --- | --- | --- |
Iatrogenic Drug Risk in People Over 75, With or Without Cognitive Disorders, From an Inventory of Their Family Pharmacy

Study Overview
=================
Brief Summary
-----------------
Many hospitalizations or emergency room visits are due to problems of iatrogenic medication, especially in elderly patients who are very often polymedicated. Moreover, they are more at risk because of fragility. This has an important socio-economic impact. It therefore seems important to act upstream of these adverse events and a review of the drugs available in the homes of elderly patients seems a good starting point.

Official Title
-----------------
Iatrogenic Drug Risk in People Over 75, With or Without Cognitive Disorders, From an Inventory of Their Family Pharmacy

Conditions
-----------------
Elderly, Iatrogenic Drug Risk

Intervention / Treatment
-----------------
* Other: Family pharmacy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient over 75 years with or without cognitive disorders Exclusion Criteria: Refusal to participate

Ages Eligible for Study
-----------------
Minimum Age: 75 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 |
| --- | --- |
| Elderly<br>Patient over 75 years seen with the mobile extra hospital geriatric team | Other: Family pharmacy<br>* Observation of the family pharmacy in elderly group<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Iatrogenic drug risk in patients' homes | Description of potential drug contraindications and potential unadvisable drug interactions highlighted from the analysis of the family pharmacy by Theriaque databased | At the inclusion (baseline) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Elderly, Iatrogenic drug risk, Family pharmacy
Characterization of Enterococcus Faecalis Endocarditis and Impact of Amoxicillin MIC Elevation on Patient Outcome

Study Overview
=================
Brief Summary
-----------------
Infective endocarditis is a complex infection that can be life-threatening. These infections also cause anatomical lesions that can be severe. Their management is complex and involves several disciplines: cardiology, bacteriologists, infectious diseases specialists, radiologists, nuclear medicine specialists, cardiac surgeons, neurologists, pharmacologists, etc. The incidence of Enterococcus faecalis endocarditis is increasing due to the aging of the population and the disappearance of rheumatic fever. The adequate management of these infections is complex and relies on the prolonged administration of high-dose antibiotics, classically the combination of amoxicillin and ceftriaxone. In the context of Streptococcal endocarditis, the impact of increasing the Minimum Inhibitory Concentration (MIC) of amoxicillin on patient mortality has been demonstrated but no study has yet examined the impact of increasing the MIC of amoxicillin on the outcome of patients treated for Enterococcus faecalis infective endocarditis.

Official Title
-----------------
Characterization of Enterococcus Faecalis Endocarditis and Impact of Amoxicillin MIC Elevation on Patient Outcome

Conditions
-----------------
Infectious Endocarditis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient over 18 years of age with a diagnosis of Enterococcus faecalis infective endocarditis based on Duke criteria Patient hospitalized in one of the participating centers French-speaking patient Exclusion Criteria: Patient with suspected infective endocarditis who does not meet Duke criteria Patient under guardianship or curatorship Patient deprived of liberty Patient under court protection Patient objecting to the use of their data for this research

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 |
| --- | --- | --- |
| Describe the epidemiology and clinical presentations of patients with Enterococcus faecalis endocarditis | This outcome corresponds to the evaluation of factors associated with mortality in patients with Enterococcus faecalis endocarditis. | Month 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of increasing the minimum inhibitory concentrations of amoxicillin on the outcome of Enterococcus faecalis infective endocarditis | This outcome corresponds to the description of the epidemiology of Enterococcus faecalis endocarditis in France. | Month 1 |
Markers in Follicular Fluid and in Embryo Culture Medium as a Marker of Oocyte and Embryo Quality

Study Overview
=================
Brief Summary
-----------------
Assessment of the quality of follicular fluid and early embryo via chemical markers.

Detailed Description
-----------------
The selectin of an embryo for transfer is currently based on detailed morphological assessment and scoring system. morhpokinetics introduced recently to IVF laboratories can define annotations and provide an algorithm for optimal cleavage rates and embryonic development. however more data and validations are requested when it comes to choosing the best single embryo from a cohort of available similarly graded embryos. Consequently, non-invasive quantitative methods for embryo selection prior to transfer have been sought. In the current study metabolic profile of follicular fluid and the embryos produced in IVF procedure will be assessed

Official Title
-----------------
Markers in Follicular Fluid and in Embryo Culture Medium as a Marker of Oocyte and Embryo Quality

Conditions
-----------------
Infertility/Sterility

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing IVF procedures at Carmel Medical Center and are able to sign an informed consent form. Female patients age 18-45 Exclusion Criteria: Women with any malignancy Patient's request to be withdrawn from the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| High and low grade embryos<br>The distribution for the high and low grade embryos is based on common morphological grading criteria. | |
| High and low quality follicles<br>The distribution for the high and low grade oocytes is based on common morphological grading criteria and on different features of the participants such as age. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Different markers discriminating the studied groups. | High correlation between the studied markers and the currently used morphological assessment of the quality of embryos and oocytes will define the potential of the studied markers as a mean for embryo and quality assessment. The current study is pioneer in the field of assessment of embryos and follicles and this group of markers have not been studied previously, therefore we prefer not to clarify more details | two years |
Clinical Trial of Lamotrigine to Reverse Cognitive Impairment in Chronic Corticosteroid-Treated Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if lamotrigine therapy is associated with improvement in mood, memory and hippocampal size and function in patients receiving chronic corticosteroid therapy. Standard care for mood changes associated with corticosteroid therapy, if severe, includes antidepressants or other medications which can influence mood. No therapies, other than dose reduction or discontinuation, are currently available for memory loss associated with corticosteroid treatment. However, very little information is available on the treatment of either mood or memory changes associated with corticosteroid treatment, thus the proposed project may improve standard care.

Conditions
-----------------
Memory Impairment Due to Corticosteroid Use, Hypomania Due to Corticosteroid Use, Hippocampal Atrophy Due to Corticosteroid

Intervention / Treatment
-----------------
* Drug: Lamotrigine (Drug)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Current Corticosteroid Use of 7 mg or more for 6+ months 18-65 years of age Exclusion Criteria: Primarily non-English speaking Pregnant/nursing woman Currently taking Depakote Currently taking Rifampin Has diagnosis of major depressive disorder, schizophrenia, PTSD, bipolar I or bipolar II (not related to corticosteroid use) Diseases with CNS involvement Is to start a brief steroid taper History of Alcohol/drug abuse/dependence

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lamotrigine (Drug)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rey Auditory Verbal Learning Test (RAVLT) | Rey Auditory Verbal Learning Test (RAVLT) is a test of verbal learning and declarative memory. During the test, 15 nouns that are read aloud for 5 consecutive trials. Each trial is followed by a free recall test (participant is asked to recall the words that were just read to them). The sum of correctly recalled words across 5 trials is called the total raw score. On completion of Trial 5, an interference list of 15 words (List B) is presented, followed by a free recall test of that list. After a 20-min delay, the examinee is again required to recall the words from list A - this is called the delay raw score. The raw scores on both the total recall and the delay trials (number of words correct across trials 1-5) are converted to standardized T-scores (Mean=50; SD=10; range 20-100) based on participant age and gender. The scores below are presented as T-scores, with higher scores indicative of better performance. | 24 weeks |
Manual Ventilation Versus Pressure Controlled Mechanical Ventilation in Children

Study Overview
=================
Brief Summary
-----------------
The investigator will compare the feasibility of manual ventilation and pressure-controlled mechanical ventilation during facemask ventilation in children. The hypothesis is that the incidence of gastric insufflation would be lower during pressure-controlled mechanical ventilation when compared to manual ventilation.

Official Title
-----------------
Comparison Between Pressure Controlled Mechanical Ventilation and Manual Ventilation During Mask Ventilation for Induction of Anesthesia in Children

Conditions
-----------------
Ventilation

Intervention / Treatment
-----------------
* Other: manual ventilation
* Other: Pressure controlled mechanical ventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children with American Society of Anesthesiologist (ASA) physical status 1, 2 Children with normal body mass index Exclusion Criteria: Difficult airway management pulmonary disease upper respiratory infection risk of pulmonary aspiration intestinal obstruction or abdominal distension stroke history or moyamoya disease

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 5 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Manual ventilation<br>During anesthetic induction, facemask ventilation is performed by manual bagging, after setting adjustable pressure limiting (APL) valve at 13 cmH2O. During mask ventilation, gastric ultrasonography is continuously performed to detect gastric insufflation. | Other: manual ventilation<br>* Facemask ventilation is performed by manual bagging with reservoir bag.<br>|
| Active Comparator: Pressure controlled mechanical ventilation<br>During anesthetic induction, facemask ventilation is performed with mechanical ventilator by pressure controlled mode, with inspiratory pressure of 13 cmH2O. During mask ventilation, gastric ultrasonography is continuously performed to detect gastric insufflation. | Other: Pressure controlled mechanical ventilation<br>* Facemask ventilation is performed with mechanical ventilator by pressure controlled mode.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of gastric insufflation |  | During facemask ventilation (90 seconds) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of patients with adequate tidal volume | Tidal volume of 6 - 10 ml/kg | During facemask ventilation (90 seconds) |