linjc16/ctgov huggingface dataset:
Single Balloon Catheter Compared With Double Balloon Catheter for Ripening of the Unfavorable Cervix

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare between single balloon catheter and double balloon catheter for ripening the cervix among pregnant with unfavorable cervix.

Official Title
-----------------
Single Balloon Catheter Compared With Double Balloon Catheter for Ripening of the Unfavorable Cervix

Conditions
-----------------
Induction of Labor

Intervention / Treatment
-----------------
* Device: Foley catheter
* Device: Atad catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Induction of labor is indicated Gestational age between 24 - 42 weeks Singleton pregnancy Bishop score less than 7 Exclusion Criteria: Any contraindication for vaginal delivery Previous cesarean delivery Low lying placenta Rupture of membranes Fetal malformations incompatible with life intrauterine fetal death Amnionitis Genital viral infection (HIV, hepatitis C virus , hepatitis B virus) Allergy to latex

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 48 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Ripening of the unfavorable cervix is done with Single balloon catheter (Foley catheter) | Device: Foley catheter<br>* Single balloon catheter<br>|
| Active Comparator: 2<br>Ripening of the unfavorable cervix is done with double balloon catheter (Atad catheter) | Device: Atad catheter<br>* Double balloon catheter<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Time in Hours From Insertion of the Catheter Until Delivery |  | At the end of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Compare Mode of Delivery, Catheter's Side Effects and Woman's Satisfaction Between the Groups |  | At the end of the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Induction of labor, Ripening, Single balloon catheter, Double balloon catheter
Functional and Morphological Characteristics of Neck Muscles in Acrobatic Skydivers

Study Overview
=================
Brief Summary
-----------------
An observational cohort study, following the Strengthening the Reporting of Observational Studies in Epidemiology(STROBE) guidelines. Two groups will be examined, a group composed by spanish acrobatic skydivers and a control group composed by general physically active population(GPAP).

Detailed Description
-----------------
Two groups will be examined for veryfing the morfology and the function of neck muscles. The profesional group composed by spanish acrobatic skydivers and a general group composed by general physically active population(GPAP). Both groups are matched at known confounder outcomes such as: physical activity level, age, sex, body weight and history of neck pain. Frequency matching will be carried out, subjects will be matched on known confounders.

Official Title
-----------------
Functional and Morphological Characteristics of Neck Muscles in Acrobatic Skydivers: an Observational Prospective Cohort Study

Conditions
-----------------
Neck Muscle Issue, Sternocleidomastoid; Contracture, Deltoid Muscle Strain

Intervention / Treatment
-----------------
* Behavioral: Observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pain-free in the neck area in the last three months didn't actually take any drugs that can interfere with muscle strength Exclusion Criteria: participants that not mached with the skydivers caracteristics

Ages Eligible for Study
-----------------
Maximum Age: 60 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 |
| --- | --- |
| Profesional acrobatics<br>Profesional Acrobatic Skyedivers as the cort group | Behavioral: Observation<br>* Verification of morfology and functionality of neck muscles<br>|
| General active participations<br>Adults with meched caracteristics with the profesional acrobatics | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anticipatory postural adjustment | Electromyographic test in ms.The myoelectric signal will be recorded by using mDurance R system (mDurance Solutions SL, Granada). The electrodes used will be pre-gelled Ag/AgCl with a diameter of 10mm and an interelectrode distance of 20mm. | 10 minutes | 
| Isometric cervical strength | Measured in newton with heandheld Dynamometer (model 001165, Lafayette Instrument Company) | 10 minutes | 
| Neck flexor and extensor endurance | Measures in seconds with a stopwatch | 10 minutes |
Identification of Genes and Pathogenesis Involved in Familial Thoracic Aortic Aneurysm

Study Overview
=================
Brief Summary
-----------------
The primary objectives of the study are to assess the contribution of alteration of each known gene on non-syndromic TAA. to map and identify unknown gene involved in the non-syndromic TAA.

Detailed Description
-----------------
The secondary objectives of the study are to study the correlation of phenotype-genotype, in particular, to compare the aortic phenotype of non-syndromic TAA patients and TAA syndromic patients. to develop national standardized strategies of genetic diagnosis and of clinical management using genetic data.

Official Title
-----------------
Identification of Genes and Pathogenesis Involved in Familial Thoracic Aortic Aneurysm (TAA)

Conditions
-----------------
Thoracic Aortic Aneurysm

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For all: Aged > 18 years. Written informed consent obtained. People with health insurance. For individual: people ≥ 45 years, thoracic aortic aneurysm without syndrome, or people > 45 years with familial TAA. For family: At least 2 members of family in 2 generations have TAA without syndrome and at least 2 patients of TAA will undergo blood collection. All people in family will undergo blood collection, each member should declare at first his (her) status (with or without TAA, unknown), the relationship (direct relative family or family in-law), no limit of age. For the children, only those with TAA will perform blood collection for the study. Exclusion Criteria: Thoracic aortic aneurysm with different syndromes (Marfan syndrome, Ehlers-Danlos syndrome, Loeys-Dietz syndrome, Turner syndrome, Noonan syndrome). Arterial hypertension.

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 |
| --- | --- | --- |
| Impact of known mutations and research of new genes involved in non syndromic TAA | Research for mutations in known genes such as FBN1, TGFBR1, TGFBR2, ACTA2, or MYH11. Research for new genes in families and in individuals TAA patients without known mutation. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thoracic Aortic Aneurysm (TAA), gene, familial TAA, blood collection
Effectiveness and Possible Complications of Core Needle Biopsy of Orbital Tumors

Study Overview
=================
Brief Summary
-----------------
Core needle biopsy of orbital mass lesions with a semiautomated needles is a safe procedure that provides a sufficient amount of tissue material for standard histological and immunohistochemical analysis and can be an alternative or supplement to fine needle aspiration biopsy

Conditions
-----------------
Orbial Mass Lesion

Intervention / Treatment
-----------------
* Device: semi automated core needle biopsy of orbital tumors


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: unresectable mass lesions with diffuse involvement of the orbit or the tumors with infiltrative growth and indistinct borders which needed to have morphologic verification Exclusion Criteria: An anti-coagulant therapy at the time of biopsy, bleeding diathesis, suspected hypervascular lesions, orbital roof destruction with a tumor, apical location of the tumor
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: tissue core<br>semi automated core needle biopsy of the orbital tumors | Device: semi automated core needle biopsy of orbital tumors<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| true identification of an orbital tumor with a core needle biopsy |  | five years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
orbit; tumor; core biopsy
Prospective Study on Asthma Control

Study Overview
=================
Brief Summary
-----------------
Accordingly, the new update of the Global Initiative for Asthma (GINA) guidelines 2006 is based on the control of the disease and attempts to quantify and graduate the level of control by using a classification of asthmatic subjects into controlled,partly controlled and uncontrolled groups. Achieving and maintaining optimal asthma control is a major goal of asthma management. Although the results of clinical trials advocate that asthma control can be reached in most patients, there is evidence that many subjects with asthma have poorly controlled disease and that there is a significant gap between the treatment goals and the current level of asthma control achieved in the general population. The aim of this study is to assess the prevalence of uncontrolled and partly controlled asthma in Italy using a patient-based tool such as Asthma Control Test.

Official Title
-----------------
Cross-sectional and Prospective Observational Study Aimed to Assess the Prevalence of Uncontrolled and Partially Controlled Asthmatics in Italy and the Prevalence of Uncontrolled/Partially Controlled Patients Achieved Asthma Control After 12 Months

Conditions
-----------------
Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent obtained Male or female patients with asthma diagnosis (at least 6 months) ability to understand and fill in questionaires Exclusion Criteria: Patients included in a clinical trial within the last 12 weeks Patients with serious illnesses Pregnant women

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 |
| --- | --- | --- |
| Asthma control test score |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EuroQoL test score |  | 3 months |
Epidemiology of Septic Shock in Medical or Polyvalent ICU in the North-East Region of France

Study Overview
=================
Brief Summary
-----------------
The epidemiology of this study aims and outcome of patients with septic shock in the intensive care unit (or versatile) of the North-East region in france as well as the modalities of care.

Conditions
-----------------
Severe Sepsis, Persistent Hypotension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients in septic shock defined by hypotension that is not reversed by volume resuscitation and requires the use of vasopressors. Exclusion Criteria: None
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 in septic shock<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sequential Organ Failure Assessment |  | baseline |
Feeding Study in Premature Infants

Study Overview
=================
Brief Summary
-----------------
To evaluate weight gain of preterm infants fed fortified human milk.

Official Title
-----------------
Feeding Study in Premature Infants

Conditions
-----------------
Premature Infants

Intervention / Treatment
-----------------
* Other: Liquid human milk fortifier
* Other: Powder human milk fortifier


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: premature infant birth weight less than/equal to 1250 g exclusively breast fed Exclusion Criteria: metabolic or chronic disease major surgery ventilator dependent

Ages Eligible for Study
-----------------
Maximum Age: 40 Days

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Liquid human milk fortifier | Other: Liquid human milk fortifier<br>* Liquid human milk fortifier added to human milk<br>* Other names: No other names -- experimental product;|
| Active Comparator: 2<br>Powder human milk fortifier | Other: Powder human milk fortifier<br>* Powder human milk fortifier added to human milk<br>* Other names: Enfamil Human Milk Fortifier;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight gain |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feeding tolerance |  | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
premature, infants
Study To Assess The Efficacy Of A Cholesterol Lowering Drug On Top Of Statins In Patients After Myocardial Infarction (MI)(0653A-150)

Study Overview
=================
Brief Summary
-----------------
Collecting local data, safety and experience trial.

Official Title
-----------------
A Multicenter, Open Study To Evaluate The Efficacy Of Ezetimibe 10 Mg Added On Statin Therapy, In Reducing LDL Cholesterol To Target Levels In Patients After Acute Coronary Syndrome

Conditions
-----------------
Cardiovascular Disorder

Intervention / Treatment
-----------------
* Drug: Ezetimibe
* Drug: simvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients; Post Acute Coronary Syndrome Exclusion Criteria: -

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>arm 1 - Ezetimibe 10 mg daily that was added on Statin Therapy (prescribed clinically suitable dose by the physician). | Drug: Ezetimibe<br>* Ezetimibe 10 mg daily for 42 days.<br>* Other names: MK0653;Drug: simvastatin<br>* simvastatin (prescribed clinically suitable dose by the physician), for mean follow up of 42 days.<br>* Other names: MK0733;|
| Active Comparator: 2<br>arm 2- simvastatin (prescribed clinically suitable dose by the physician), for mean follow up of 42 days. | Drug: simvastatin<br>* simvastatin (prescribed clinically suitable dose by the physician), for mean follow up of 42 days.<br>* Other names: MK0733;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL levels |  | 42 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety measures |  | 42 days | 
| Total cholesterol levels. |  | 42 Days |
Identification of Undiagnosed Gaucher Disease

Study Overview
=================
Brief Summary
-----------------
Partners HealthCare maintains a Patient Data Registry (PDR) with information from all patient encounters at Partners HealthCare facilities. We intend to utilize the PDR to identify groups of patient who are of high clinical suspicion for undiagnosed Gaucher disease. A group of potential participants will be identified through the PDR. Detailed records will be requested to further narrow to ideal participants based upon previously existing diagnoses and symptoms. Participants will be invited to partake in the study via a letter from their Partners care provider with supporting study details. Study participants will be evaluated in a one-time visit. A complete family and medical history will be collected. A physical exam will be performed, and up to 20cc of blood will be drawn. All participants will be notified of their disease status via letter and phone call from the study staff. If the study participant is diagnosed with GD through this evaluation, proper follow-up recommendations and referrals will be provided. Our intent is to determine if existing patient data can successfully be utilized to aid in the identification of patients with rare genetic disease.

Official Title
-----------------
Identification of Undiagnosed Gaucher Disease

Conditions
-----------------
Gaucher Disease

Intervention / Treatment
-----------------
* Other: Enzyme analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must have records available in the Partners HealthCare Patient Data Registry Exclusion Criteria: Must not have a diagnosis of Gaucher disease

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Enzyme analysis<br>Patients invited for evaluation will undergo glucocerebrosidase enzyme analysis | Other: Enzyme analysis<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients with previously undiagnosed GD identified |  | up to 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gaucher disease, lysosomal storage disorder, metabolic disease, medical records review
Early Pelvic Floor Muscle Training Improves Pelvic Floor Muscle Strength in Patient After Low Anterior Resection

Study Overview
=================
Brief Summary
-----------------
The aim of study is to investigate the difference in Maximum Squeeze Pressure in patients with and without pelvic floor muscle training in low anterior resection in peri-operative period

Detailed Description
-----------------
The functional outcome after low anterior resection varies greatly. Proportion of patient suffers from urgency and incontinence. Pelvic muscle disuse with atrophy and fibrosis may be a cause for the poor function. Peri-operative pelvic floor muscle training may preserve pelvic floor muscle bulk and function and thus improve functional outcome after surgery.

Official Title
-----------------
Early Pelvic Floor Muscle Training Improves Pelvic Floor Muscle Strength in Patient After Low Anterior Resection

Conditions
-----------------
Cancer of Rectum

Intervention / Treatment
-----------------
* Other: Pelvic floor exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who will undergo low anterior resection of rectum Patient consented for study Exclusion Criteria: Patient unable to understand pelvic floor exercise Patient who underwent alternative procedure Patient who suffers anastomotic complications after surgery Patient who ileostomy not closed

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: Pelvic floor exercise<br> | Other: Pelvic floor exercise<br>* Pelvic floor strengthening exercise<br>|
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Squeeze Pressure |  | 1 week before operation and 3 months after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Outcomes | Bowel frequency, Fecal incontinence score | 1 week before operation and 3 months post operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer of rectum, Physiotherapy