linjc16/ctgov huggingface dataset:
Types of Upper Limb and Hand in Patients With Cerebral Palsy

Study Overview
=================
Brief Summary
-----------------
Cerebral palsy (CP) has been defined as a group of permanent disorders of the development of movement and posture causing activity limitation(s) that are attributed to non-progressive disturbances that occurred in the developing fetal or infant brain. Investigators previously developed two classification systems, one for the upper limb and one for the hand, based on 100 films of patients with cerebral palsy. Separate classifications were developed following an initial study in which investigators found no correlations between upper limb and hand patterns, meaning that specific upper limb patterns are not always associated with specific hand patterns. Thumb patterns were not included in these classifications since robust classifications already exist, moreover thumb patterns are independent from hand patterns. The aim is to evaluate the inter- and intra-rater reliability of two previously developed classifications of upper limb and hand patterns.

Official Title
-----------------
Validation of a Classification of Types of Upper Limb and Hand in Patients With Cerebral Palsy

Conditions
-----------------
Cerebral Palsy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cerebral palsy Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 2 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 |
| --- | --- | --- |
| Change in upper limb pattern classification of each examiner between day 1 and month 2 | Intra-rater reliability of a classification of upper limb pattern in patients with cerebral palsy. | examiner classification at day 1 and at month 2. | 
| Change in hand pattern classification of each examiner between day 1 and month 2 | Intra-rater reliability of a classification of hand pattern in patients with cerebral palsy. | examiner classification at day 1 and at month 2. | 
| Change between examiner classification and the expert examiner classification | Level of agreement will be determined with Fleiss's kappa (k) and its 95% confidence interval Inter-rater reliability of a classification of upper limb pattern in patients with cerebral palsy. | Expert examiner classification (day 1) and examiner classification (week 4) | 
| Change between examiner classification and the expert examiner classification | Level of agreement will be determined with Fleiss's kappa (k) and its 95% confidence interval. Inter-rater reliability of a classification of hand pattern in patients with cerebral palsy. | Expert examiner classification (day 1) and examiner classification (week 4) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
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Cerebral palsy, reliability, upper limb and hand patterns, classification
Presence of IBD Specific Antibodies (ASCA, ALCA, ACCA, AMCA) in the Sera of Patients With Spondyloarthropathy

Study Overview
=================
Brief Summary
-----------------
A relationship between IBD and spondyloarthropathy is well recognized. ASCA ( anti saccharomyces cerevisiae antibodies)are considered to be a serological marker for Crohn's disease and have been studied in patients with spondyloarthropathy with conflicting results. More recently, new serological markers for IBD have been described. These markers are antibodies to certain defined glycans , and their use may permit an improved diagnosis of IBD. The aim of our study is to investigate wether these new serological markers are present in the sera of patients with spondyloarthropathy.

Conditions
-----------------
Psoriatic Arthritis, Ankylosing Spondylitis, Undifferentiated Spondyloarthropathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of psoriatic arthritis, ankylosing spondylitis, or undifferentiated spondyloarthropathy Exclusion Criteria: diagnosed inflammatory bowel disease

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
spondyloarthropathy, inflammatory bowel disease, antibodies
Breast Cancer in Pregnancy Register Study

Study Overview
=================
Brief Summary
-----------------
Women who were diagnosed with breast cancer during their pregnancy may be registered in this trial. Data is collected on the foetal outcome 4 weeks after delivery, maternal outcome of pregnancy as well as the breast cancer therapy applied (treatment, response to chemotherapy, type of surgery), diagnostic procedures applied (palpation, US, mammogram) and the outcome of mother and child after 5 years of therapy.

Detailed Description
-----------------
Breast cancer is the most common cancer malignancy in women of childbearing age after the age of 25 years. Since the incidence of breast cancer under the age of 40 is increasing, and women tend to delay pregnancy into later reproductive years, the coincidence of pregnancy and breast cancer is increasing. About 1 in 1,000 pregnancies is complicated by breast cancer. Nevertheless, little is known about the right therapy for the mother and the unborn child. We are therefore carrying out a trial, collecting prospective and retrospective data about pregnant women, with histological confirmed breast cancer. Data on the biology of the tumour and placenta tissues is also collected. The anonymous data is collected in a database.

Official Title
-----------------
Prospective and Retrospective Register Study of the German Breast Group (GBG) for Diagnosis and Treatment of Breast Cancer in Pregnancy

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with histologically confirmed breast cancer during pregnancy. Informed consent for data and specimen collection. Exclusion Criteria: Diagnosis of breast cancer outside the period of pregnancy.
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast Cancer in Pregnancy, Prospective and Retrospective Register, Study
Ketotifen Ophthalmic Solution With Emedastine in Patients With Seasonal Allergic Conjunctivitis

Study Overview
=================
Brief Summary
-----------------
Medications available for the treatment of seasonal allergic conjunctivitis include antihistamines. These medicines block the release of histamine, a substance in the body that is released when an allergic reaction occurs. Novartis (NVS) has developed an eye drop formulation of a well tried antihistamine called ketotifen. This study will compare the efficacy and the tolerability of ketotifen eye drops with emedastine, which is a popular treatment for seasonal allergic conjunctivitis in China.

Official Title
-----------------
Safety and Efficacy Comparison Ketotifen Ophthalmic Solution in Patients With Seasonal Allergic Conjunctivitis

Conditions
-----------------
Seasonal Allergic Conjunctivitis

Intervention / Treatment
-----------------
* Drug: Ketotifen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 3 years or older. History of seasonal allergic conjunctivitis Presence of bilateral ocular itching/conjunctival hyperaemia (redness) at baseline: at least intensity degree 2 for itching, and at least intensity degree 4 for composite score of itching and conjunctival hyperaemia Exclusion Criteria: Other systemic/ophthalmic conditions Presence of any form of allergic conjunctivitis other than seasonal allergic conjunctivitis (e.g. perennial allergic conjunctivitis, vernal keratoconjunctivitis, atopic keratoconjunctivitis, giant papillary conjunctivitis). Active bacterial or viral conjunctivitis or history of ocular herpes. Presence or history of severe dry eye. Previous treatments Any systemic or ocular corticosteroids within two (2) weeks prior to randomization. Any systemic or ocular mast cell stabilizers within two (2) weeks prior to randomization. Any other ophthalmic medication within three (3) days prior to randomization. Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 3 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

| Intervention/Treatment |
| --- |
|Drug: Ketotifen|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Allergic, Conjunctivitis, Ketotifen, Histamine
Deep Brain Stimulation (DBS) for Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
Background: Alzheimer disease (AD) is a debilitating brain disorder that affects over 4.75 million people in the US and Canada. People with AD have difficulty remembering general facts and previously experienced autobiographical events. Animal and human research demonstrates that this type of memory depends on neural function within specific brain areas, and that it may be possible to enhance memory with electrical stimulation of these brain areas. We have recently shown that deep brain stimulation (DBS) of a brain area called the fornix enhances memory in a human. Hypotheses: We hypothesize that fornix DBS will safely enhance memory in early AD patients by activating memory circuits in the brain. Methods: Six early AD patients will take part in a phase I clinical study over a 1-year period. The study involves bilateral fornix DBS implantation, detailed neuropsychological and neurological testing, and brain imaging to detect alterations in brain activity induced by stimulation. These assessments will occur one month before surgery, then again at one month, 6 months, and 12 months after surgery.

Official Title
-----------------
Modulation of Cognitive Function Using Electrical Brain Stimulation in Patients With Early Alzheimer Disease

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

Intervention / Treatment
-----------------
* Procedure: Bilateral fornix DBS implantation,


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women aged 40 to 80 years old, who Satisfy the diagnostic criteria for probable AD, Have received the diagnosis of AD within the past 2 years, Have a CDR of 0.5 or 1.0, and Score between 20 and 28 on the Mini Mental State Examination Exclusion Criteria: Pre-existing structural brain abnormalities, Other neurologic or psychiatric diagnoses, or Medical comorbidities that would preclude them from undergoing surgery

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 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: Experimental<br> | Procedure: Bilateral fornix DBS implantation,<br>* Fornix DBS for Alzheimer Disease<br>* Other names: DBS;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| memory performance on neuropsychological tests |  | one year |
Severe Hypoglycemia in Pregnant Women With Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
Background: The risk of stillbirth and preterm delivery is three times increased among pregnant women with type 1 diabetes compared with healthy pregnant women. Normal blood glucose levels are mandatory in order to prevent these complications. Severe hypoglycemia (requiring assistance from another person) is the decisive limiting factor for obtaining near-normal blood glucose regulation in pregnant women with type 1 diabetes. Severe hypoglycemia occurs in about one third of pregnancies complicated with type 1 diabetes and can result in unconsciousness, traffic accidents and deaths. Aim: To test the following hypotheses: Severe hypoglycemia is frequent in pregnancy complicated by type 1 diabetes with the highest incidence in gestational weeks 8-16 and the lowest incidence in gestational weeks 28-34 Predictors for severe hypoglycemia during pregnancy complicated with type 1 diabetes can be identified at the first pregnancy visit Possible pathophysiological mechanisms include changes in the growth hormone system and in the renin-angiotensin-system during pregnancy Methodology: One hundred and eight pregnant women with type 1 diabetes are consecutively and prospectively included. In connection with the clinical control at the first pregnancy visit at week 9 and in gestational weeks 14, 22, 28, 34 and one day postpartum the following tests are carried out: The patients are asked to answer a validated questionnaire about mild and severe hypoglycemia and hypoglycemia-associated factors such as blood glucose level during hypoglycemia, the degree of awareness, pregnancy-associated nausea and vomiting, insulin type and dose etc. Other medication, exercise habits, coffee- and alcohol intake, smoking and social status will be recorded. In case of severe hypoglycemia a structured interview concerning the episode will be performed within 24 hours. Blood glucose, HbA1c, the degree of insulin resistance and the levels of IGF1, placenta growth hormone and of the renin-angiotensin-system will be monitored.

Official Title
-----------------
Severe Hypoglycemia in Pregnant Women With Type 1 Diabetes. Incidence, Risk Markers and Possibilities for Prevention

Conditions
-----------------
Pregnancy, Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 diabetes Pregnancy before gestational week 14 Exclusion Criteria: Other diseases that might influence the risk of severe hypoglycemia
Sexes Eligible for Study
-----------------
Female

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Bronchoprotection of Salbutamol in Asthma and Chronic Obstructive Pulmonary Disease

Study Overview
=================
Brief Summary
-----------------
This study will investigate potential differences in how two puffs of salbutamol protects airway smooth muscle from contracting in people with asthma and chronic obstructive pulmonary disease (COPD).

Detailed Description
-----------------
In asthma, the administration (inhalation) of a selective β2 receptor agonist (e.g. salbutamol), prior to methacholine challenge has been shown to shift the dose response curve to the right and bronchoprotect the airway against airway smooth muscle contraction. The extent of β2 receptor agonist bronchoprotection in COPD is unknown. Airway hyperresponsiveness (AHR) to direct acting agents such as histamine and methacholine is a feature of both asthma and COPD. In asthma, the abnormality leading to AHR is believed to be due to changes in airway smooth muscle (e.g. hypertrophy, hyperplasia, contractile apparatus) whereas in COPD the AHR is likely due to structural or geometric changes. The investigators hypothesize that the bronchoprotection afforded by salbutamol against methacholine challenge will be greater in asthma than in COPD due to differences in underlying airway abnormalities.

Official Title
-----------------
Bronchoprotection of Salbutamol in Asthma and COPD

Conditions
-----------------
Asthma, COPD

Intervention / Treatment
-----------------
* Drug: salbutamol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: asthma or COPD Exclusion Criteria: asthma and COPD

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: salbutamol<br>There are two groups, asthma and COPD, which are being compared with respect to bronchoprotection from an active treatment (salbutamol). | Drug: salbutamol<br>* 200 micrograms salbutamol from MDI<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| methacholine PC20 dose shift |  | one hour |
COPD MSA 3 Regions: Epidemiology and Risk Factors of COPD in Rural Environment (BM3R)

Study Overview
=================
Brief Summary
-----------------
The agricultural environment presents a unique profile in terms of epidemiology of pulmonary diseases. Certainly due to persistent exposure to organic particles, the prevalence of COPD is higher in farmers than in the general population, despite less smoking. It is likely that the risk of COPD depends on several factors, such as the type of farm, local conditions and the region where the farm is located. It is important to diagnose COPD at an early stage in order to initiate appropriate therapy, and implement secondary prevention with a view to limiting deterioration of respiratory function and reducing complications. In this context, the aims of BM3R project were: (1) to study the epidemiology of COPD in a large representative sample of French farmers, in order to identify the types of farming, working conditions and regions that are associated with the presence of COPD; and (2) to develop a score to identify patients at risk and optimise diagnosis of COPD in the context of a screening programme.

Official Title
-----------------
COPD MSA 3 Regions: Epidemiology and Risk Factors of COPD in Rural Environment (BPCO MSA 3Régions : épidémiologie et Facteurs de Risque de la BPCO en Milieu Rural)

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
-----------------
* Diagnostic Test: Spirometry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 40 years old and < 75 years old Affiliated to the MSA Exclusion Criteria: COPD known

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum 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 |
| --- | --- |
| COPD<br>Subject with FEV1/FVC post BD < 0.7 or LLN | Diagnostic Test: Spirometry<br> <br> |
| Non COPD<br>Subject with FEV1/FVC post BD >= 0.7 or LLN | Diagnostic Test: Spirometry<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV1/FVC |  | At the inclusion time |
Resin Infiltratration on the Sealing of Proximal Early Caries

Study Overview
=================
Brief Summary
-----------------
Material for caries prevention dont have better results compared with non-operatory interventions.

Detailed Description
-----------------
Two gruops will be compared. One using ICON and another gruop with non-operatory interventions consisted in hygiene instrutions and fluoride topical application. The caries progression will be evalueted with radiographic observation.

Official Title
-----------------
Resin Infiltration on Teh Sealing of Proximal Early Caries Lesins: a Randomized Trial

Conditions
-----------------
Tooth; Lesion, White Spot Lesions

Intervention / Treatment
-----------------
* Other: ICON
* Behavioral: instruction oral hygiene


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Two early caries lesion in the same patient, lesion with the same radiolucencies images Exclusion Criteria: Pregnancy, use of orthodontics appliences, use of drugs modified salivar flow, ausence of adjacent teeth

Ages Eligible for Study
-----------------
Minimum Age: 9 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ICON - low viscosity resin<br>APPLICATION OF A LOW VISCOSITY RESIN IN EARLY PROXIMAL CARIES LESIONS | Other: ICON<br>* LOW VISCOSITY RESIN WILL BE APPLIED IN EARLY PROXIMAL CARIES LESIONS<br>* Other names: ICON (DMG) Hamburg Germany;|
| Active Comparator: INSTRUCTIONS ORAL HYGIENE<br>INSTRUCTION ORAL HYGIENE AND DIET AND TOOPICAL FLUORIDE APPLICATIONS | Behavioral: instruction oral hygiene<br>* Instructions diet and hygiene oral and topical fluoride<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| caries progression in the proximal surfaces | progression in the proximal surfaces will be compared with two procedures. | One year after interventions | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CARIES INFILTRATION, CARIES LESION, INFILTRANT