linjc16/ctgov huggingface dataset:
Study of the Impact of Administering t the Scale of Brazelton on the Mother's Confidence in Her Newborn Born Premature at the Approach of Returning Home

Study Overview
=================
Brief Summary
-----------------
In France, the last national perinatal survey show that 6.6% of live births are premature. For these infants, transfer in Neonatology sector may result in mother-child separation can last several weeks or months. This hospital can complicate the implementation of the attachment process that allows parents to recognize their children as their own, to gain confidence in their abilities to deal with them and establish a relationship with him. A study of mothers of premature shows the interest of the Brazelton scale to help them identify the skills their child and adjust their own behavior.

Official Title
-----------------
Study of the Impact of Administering t the Scale of Brazelton on the Mother's Confidence in Her Newborn Born Premature at the Approach of Returning Home

Conditions
-----------------
Infant, Premature

Intervention / Treatment
-----------------
* Other: Brazelton scale


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mother: over the age of 18, affiliated to a health social security. Newborn: born to a term of less than 36 S.A., hospitalized in neonatology, said leaving in three days. Exclusion Criteria: Mother : Legally protected Inability to understanding and monitoring of the protocol's terms (not master the French language, intellectual impairment, psychotic disorder ...) Who have had a premature child born. New born : Opposition of one of the holders of parental authority to the award of the Brazelton Scale Having withdrawal syndromes or malformation syndromes requiring oxygen therapy, gastrostomy or nasogastric tube Twins and more.

Ages Eligible for Study
-----------------
Minimum Age: 0 Weeks
Maximum Age: 36 Weeks

Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Brazelton scale<br>Procurement across Brazelton scale | Other: Brazelton scale<br> <br> |
| No test<br>usual care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score GC (Global Confidence) of the MAPS scale (Mother Assessment Baby Scale) |  | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scale EVA Anxiety |  | 1 hour |
Treatment of Hypercholesterolaemia in South Asian Subjects (IRIS)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the effect of 6 weeks of treatment with Rosuvastatin with 6 weeks of treatment with Atorvastatin in South Asian subjects with hypercholesterolemia.

Official Title
-----------------
A 6-Week, Randomized,Open-Label, Comparative Study to Evaluate the Efficacy and Safety of Rosuvastatin and Atorvastatin in the Treatment of Hypercholesterolaemia in South Asian Subjects.

Conditions
-----------------
Hypercholesterolemia, Dyslipidaemia

Intervention / Treatment
-----------------
* Drug: Rosuvastatin
* Drug: Atorvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fasting low density lipoprotein & triglyceride levels as defined by the protocol. Self described South Asian race Subjects with coronary heart disease or at high risk of coronary heart disease. Exclusion Criteria: The use of lipid lowering drugs or dietary supplements after Visit 1. Active arterial disease eg Unstable angina, or recent arterial surgery Blood lipid levels above the limits defined in the protocol. Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Rosuvastatin | Drug: Rosuvastatin<br> <br> * Other names: Crestor;|
| Active Comparator: 2<br>Atorvastatin | Drug: Atorvastatin<br> <br> * Other names: Lipitor;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low density lipoproteins cholesterol levels |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: adverse events & abnormal laboratory markers |  | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cholesterol, low density lipoproteins, dyslipidaemia, Rosuvastatin, Crestor, Atorvastatin, Lipitor, South Asian
A Pilot Study Investigating the Effect of Omalizumab (Xolair) in Work-Related Animal Induced Asthma

Study Overview
=================
Brief Summary
-----------------
Management of animal induced occupational asthma is mainly avoidance, but this is not feasible for many occupations. Treatment with avoidance and conventional treatment is also not always successful. Omalizumab is FDA approved for the treatment of allergic asthma and may be effective at reducing symptoms and disease progression in the animal handlers population.

Official Title
-----------------
A Pilot Study Investigating the Effect of Omalizumab (Xolair) in Work-Related Animal Induced Asthma

Conditions
-----------------
Allergy Induced Asthma

Intervention / Treatment
-----------------
* Drug: omalizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ages 18-65 occupation that involves close contact with animals stable dose of ICS for 30 days Skin test positive to one or more animals evidence of asthma on spirometry demonstrate PEFR variability- Exclusion Criteria: on allergen immunotherapy on prohibited medications unstable asthma recent URI known hypersensitivity to omalizumab-

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: omalizumab<br>open-label | Drug: omalizumab<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Intubation Conditions With Atracurium After Three Minutes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate intubation conditions with the use of atracurium after a fixed three-minute delay

Detailed Description
-----------------
The recommended dose of a non-depolarizing curare to facilitate tracheal intubation is twice the active dose 95 (the dose that reduces muscle force by 95%). At this dosage, curarization of the laryngeal adductors allowing relaxation and abduction (opening) of the vocal cords is considered certain. With atracurium, the dose for intubation is 0.5 mg.kg-1 and the time to full effect is approximately 3 minutes. With the use of newer hypnotics, there are no data evaluating the conditions for intubation after a fixed time of 3 minutes as with current anesthetic practices.

Official Title
-----------------
Evaluation of Intubation Conditions With the Use of Atracurium After a Fixed Three-minute Delay

Conditions
-----------------
Obesity Female Patients Require General Anaesthesia With Intubation and Atracurium Curarization

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult female Patient to undergo general anesthesia with intubation for scheduled gynecological surgery Patient informed about the study and not opposed to it Exclusion Criteria: Patients with severe and morbid obesity (BMI>35kg/m2) Pregnancy Patients with difficult intubation Allergy to atracurium and to any other drug used. Patient under tutorship / curatorship Not affiliated with social insurance Patient with AME

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

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

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 |
| --- | --- | --- |
| Intubation condition | The intubating conditions were evaluated on the basis of the consensus conference on Good Clinical Research Practice in Pharmacodynamic Studies of Neuromuscular Blocking Agents. The score used include the following variables: (1) ease of laryngoscopy, (2) vocal cord position, and (3) reaction to the insertion of the endotracheal tube and the cuff inflation (eg, diaphragmatic movement due to patient cough). Each of these variables was rated as (1) excellent, (2) good, or (3) poor. Intubating conditions were scored as excellent if all variables were excellent; the score was good if at least 1 variable was good and the rest were excellent; the conditions were considered poor if any of the variables was rated poor. Evaluation of intubation conditions with the use of atracurium after a fixed three-minute delay | 3 minutes after atracurium injection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tracheal intubation, Atracurium
A Comparison of the Safety and Comfort of AC-170

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and comfort of AC-170 compared to a placebo.

Conditions
-----------------
Normal Ocular Health

Intervention / Treatment
-----------------
* Drug: AC-170 0.17%
* Drug: AC-170 0.24% (Formulation 1)
* Drug: AC-170 0.24% (Formulation 2)
* Drug: Olopatadine hydrochloride 0.2%/Tears Naturale II


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able and willing to avoid the use of ocular medications or topical ocular preparations within protocol specific time period. Exclusion Criteria: Known contraindications or sensitivities to the study medication or its components. Any ocular condition that, in the opinion of the investigator, could affect the subjects safety or trial parameters. Use of disallowed medications during the period indicated prior to the study enrollment or during the study.

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AC-170 0.17%<br> | Drug: AC-170 0.17%<br>* 1 drop in one eye at one timepoint<br>|
| Experimental: AC-170 0.24% (Formulation 1)<br> | Drug: AC-170 0.24% (Formulation 1)<br>* 1 drop in one eye at one timepoint<br>|
| Experimental: AC-170 0.24% (Formulation 2)<br> | Drug: AC-170 0.24% (Formulation 2)<br>* 1 drop in one eye at one timepoint<br>|
| Placebo Comparator: Olopatadine hydrochloride 0.2%/Tears Naturale II<br> | Drug: Olopatadine hydrochloride 0.2%/Tears Naturale II<br>* 1 drop in one eye at one timepoint<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drop Comfort Score | drop comfort on 0-10 scale | during 3 minute period |
Safety, Tolerability and Efficacy of Micardis® in Patients With Essential Hypertension

Study Overview
=================
Brief Summary
-----------------
This post-marketing surveillance study was designed to supplement under conditions of normal clinical practice the data on the safety, tolerability and efficacy of Micardis® collected during the clinical studies.

Official Title
-----------------
Safety, Tolerability and Efficacy of Micardis® (Telmisartan) in Patients With Essential Hypertension

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Micardis®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of both sexes with essential hypertension and a minimum age of 18 years Exclusion Criteria: (Not applicable)

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Micardis®<br> | Drug: Micardis®<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Indicence of ulcera |  | Up to 6 months after start of study | 
| Incidence of gastrointestinal (GI) bleedings |  | Up to 6 months after start of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events (GI-complaints inclusive) |  | Up to 6 months after start of study | 
| Change from baseline in office blood pressure |  | Up to 6 months after start of study | 
| Response rate | full response: reduction of diastolic blood pressure (DBP) by >= 10 mmHg or final DBP <= 90 mmHg overall response: reduction of DBP by >= 7mmHg or final DBP <= 90 mmHg | Up to 6 months after start of study |
Validity of the Kinematic Classification of Gait in Diplegic Children With Cerebral Palsy (CP)

Study Overview
=================
Brief Summary
-----------------
In recent years Ferrari et al. proposed a new classification of gait in diplegic children with spastic diplegia that describes four different patterns of gait by analyzing the strategies that each children adopts to need his/her needs to walk. The investigators believe that this classification provides the clinician with clinically meaningful information in terms of coping strategies adopted to maximize the ability to walk. The aim of this study is to determine the criterion validity of the new classification of the pattern of gait in children with spastic diplegia by correlating pattern of diplegic gait with the score of the Functional performance measure.

Official Title
-----------------
Validity of the Kinematic Classification of Gait in Diplegic Children With Cerebral Palsy

Conditions
-----------------
Cerebral Palsy, Diplegia, Spastic

Intervention / Treatment
-----------------
* Other: classification of gait in diplegic children with CP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diplegia and CP; Exclusion Criteria: severe mental retardation attested by the Diagnostic and Statistical Manual of mental disorders IV pharmaco-resistant epilepsy behavioural disorders

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 17 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 |
| --- | --- |
| spastic diplegia due to Cerebral Palsy<br> | Other: classification of gait in diplegic children with CP<br>* To determine the criterion validity of the classification of the pattern of diplegic gait proposed by Ferrari et al. we correlated gait patterns with the score of the FMS.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Mobility Scale (FMS) | correlation between the new classification of diplegic gait and the FMS which classifies the functional mobility in children | at the age of 12 to 17 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cerebral palsy, diplegia, gait, classification
Effects of Arzoxifene on Bone Mass and the Uterus

Study Overview
=================
Brief Summary
-----------------
The purposes of this study are to determine: The effects of arzoxifene on bone mineral density (bone mass) at the spine and hip in postmenopausal women. The effects of arzoxifene on the uterus (womb) in postmenopausal women. The effects of arzoxifene on blood tests that measure changes in bone rebuilding in postmenopausal women with low bone density. The effects of arzoxifene on blood lipids (fats) and other blood markers of heart disease risk. The safety of arzoxifene and any side effects that might be associated with its use.

Official Title
-----------------
Effects of Arzoxifene on Bone Mineral Density and Endometrial Histology in Postmenopausal Women.

Conditions
-----------------
Postmenopausal Bone Loss

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female 45 to 60 years of age, inclusive At least 2 years since last menstrual cycle Intact uterus (womb). Exclusion Criteria: Existing fracture of the spine. Bone disorders, other than low bone mass History of cancer in the last 5 years. Also, any history, at any time, of breast cancer or cancer of the lining of the uterus. Abnormal or unexplained vaginal bleeding.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 60 Years

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

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

| Intervention/Treatment |
| --- |
|Drug: Arzoxifene|nan|
|Drug: Placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effects of arzoxifene on bone mineral density (bone mass) at the spine and hip in postmenopausal women |  |  | 
| The effects of arzoxifene on the uterus (womb) in post menopausal women |  |  | 
| The safety of arzoxifene and any side effects that might be associated with its use |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effects of arzoxifene on blood tests that measure changes in bone rebuilding in postmenopausal women with low bone density |  |  | 
| The effects of arzoxifene on blood lipids (fats) and other blood markers of heart disease |  |  | 
| The effects of arzoxifene on breast density |  |  |
Effect of Herbal Extracts on Gingival Inflammation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the minimal number of patches needed to get an effective response. Patients enrolled in the study will be given 1, 2, 3 or 4 patches in a cycle by the order they enter the study. After the first 20 patients [5 cycles], the effect of the number of patches will be tested. If there is no distinct reduction of beta glucuronidase in the GCF or of gingival index at the tested sites, more patients will be enrolled. Patients will be added one cycle at a time with results being tested and analyzed. The enrollemnts of patients will stop when a dose response will be noticed or 15 cycles have been reached.

Official Title
-----------------
The Effect of Herbal Extracts on Inflammatory Enzymes in the Gingiva: a Dose Finding Study.

Conditions
-----------------
Gingivitis

Intervention / Treatment
-----------------
* Drug: periopatch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 -75. Severe localized gingival inflammation [GI index 2 or greater Exclusion Criteria: Pregnancy or a wish to become pregnant during the study. History of periodontal treatment within the last month. Antibiotic treatment within the last month Use of any antimicrobial mouthrinse within the last month. Participation in another trial one month prior to the study. Inability to behave compliant to the trial protocol by not placing all the patches given, or attending scheduled appointments. Systemic Disease. Patients using salicylate

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: periopatch|Patients enrolled in the study will be given 1, 2, 3 or 4 patches in a cycle by the order they enter the study.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the correct dosing of the herbal Patch [THPP] |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstarte the safety of THPP on the gingival tissue and in the oral cavity |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gingivitis, localized treatment