linjc16/ctgov huggingface dataset:
Hypoallergenicity To Substitutive Formulas In Children With Cow's Milk Allergy

Study Overview
=================
Brief Summary
-----------------
The management of children with confirmed cow's milk allergy is based on complete avoidance of cow's milk proteins and leaves the physician with several dietary options, none of which, given the prevalence, spectrum and potential seriousness of the condition, can be recommended to all patients. In the absence of an alternative to cow's milk, the management of cow's milk allergy is based on the use of safe, affordable and nutritionally adequate formulas. Extensively hydrolyzed cow's milk protein formulas, which are considered as safe for most children with cow's milk allergy, are still liable to contain residual peptides, and hypersensitivity reactions may occur in infants allergic to cow's milk protein. Thus, specific product allergenicity must be addressed on an individual basis before recommending a formula as a substitute for cow's milk. Soy-based formula can also concomitant sensitize cow's milk allergy children to soy. Amino acid-based formulas have been studied from safety and nutritional efficacy perspectives. These formulas have been proposed for subjects highly sensitive to cow's milk protein and that cannot be managed using extensively hydolyzed formula and for children with multiple food allergies. In these conditions aminoacid based formulas are able to effectively cure allergic symptoms and to improve body growth.

Official Title
-----------------
DETERMINATION OF HYPOALLERGENICITY TO SUBSTITUTIVE FORMULAS IN CHILDREN WITH COW'S MILK ALLERGY

Conditions
-----------------
Cow's Milk Allergy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subjects with a cow's milk allergy age between 0 to 36 months Exclusion Criteria: age more than 36 months eosinophilic disorders of the gastrointestinal tract, food protein induced enterocolitic syndrome, concomitant chronic systemic diseases, congenital cardiac defects, active tuberculosis, autoimmune diseases, immunodeficiency, chronic inflammatory bowel diseases, celiac disease, cystic fibrosis, metabolic diseases, lactose intolerance, malignancy, chronic pulmonary diseases, malformations of the gastrointestinal tract.

Ages Eligible for Study
-----------------
Maximum Age: 36 Months

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cow's milk allergy<br>Subjcets with a sure diagnosis of cow'a milk allergy on exclusion diet | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with cow's milk allergy tolerant substitutive formulas | Safety and tolerability of substitutive formulas | At diagnosis and for at least 1 months after the diagnosis |
Study Investigating Administration of Prevenar for Post-Marketing Surveillance

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify the following problems and questions with respect to the safety of Pneumococcal 7-Valent Conjugate Vaccine (Diphtheria CRM 197 Protein), Prevenar, during the post-marketing period in Korea, as required by Korea Food and Drug Administration (KFDA) regulations. Adverse reactions (especially serious adverse reactions) Incidences of adverse reactions under routine vaccine use Factors that may affect the safety of the vaccine

Official Title
-----------------
Investigation of Prevenar (Pneumococcal 7-Valent Conjugate Vaccine) Administration for Post-Marketing Surveillance

Conditions
-----------------
Pneumococcal Infections

Intervention / Treatment
-----------------
* Biological: Prevenar


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants and children aged 6 weeks to 9 years, provided the conditions pertaining to contraindications, warnings, precautions, and interactions stated in the package insert do not apply. Exclusion Criteria: Hypersensitivity to latex or to any component of the vaccine, including diphtheria toxoid Suffering from a current or recent febrile illness.

Ages Eligible for Study
-----------------
Minimum Age: 6 Weeks
Maximum Age: 9 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: Prevenar|Prevenar 0.5ml/ Vial and PFS|

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
-----------------
Vaccine, heptavalent pneumococcal conjugate vaccine
Aluminum and Auditory Function in ESRD

Study Overview
=================
Brief Summary
-----------------
Hearing impairment either clinical or subclinical is a characteristic of some renal disease patients. The hearing impairment could be result from specific etiologies or chronic renal failure itself. The causes of hearing impairment in renal disease patients ranged from drugs intoxication in both auditory and renal function, like gentamycin or isoniazid, congenital disease like Alport syndrome or other collagen-defective renal disease, or just aging related. End-stage renal disease (ESRD) patients are special in many parts to general population who have hearing impairment. First, inflammation in ESRD patients is well-documented, second, they suffered from various underlying diseases which auditory function was potentially impaired, third, they need to undergo renal replacement therapy either hemodialysis (HD) or peritoneal dialysis (PD) to maintain their life. Dialysis itself was found to be a cause of hearing impairment, too. The biochemical change and constitutive inflammation status are thought to be implicated in the pathogenesis of hearing impairment in ESRD patients. Aluminum (Al) is a well-documented heavy metal, which predisposes to Alzheimer's disease, dementia or some neurologic diseases. Al intoxication is very rare in general health population but elevated serum Al level is easily found in ESRD patients since they can not excrete Al by damaged kidneys and dialyzers. Inner ear per se is a neurologic tissue, so if serum Al level in ESRD patients has any association in their haring function needs to be studied.

Conditions
-----------------
End-Stage Renal Disease (ESRD)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ESRD patients and healthy volunteers, without history of occupational noise exposure, ear infection, ear surgery, active systemic infection, previous ototoxic drugs exposure or congenital hearing defect Exclusion Criteria: Unsuitable to undergo hearing test, with history of occupational noise exposure, ear infection, ear surgery, active systemic infection, previous ototoxic drugs exposure or congenital hearing defect

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 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 |
| --- | --- | --- |
Naturally Banded Sleeve Gastrectomy

Study Overview
=================
Brief Summary
-----------------
the idea is to use an omental flap or round ligament as a natural band in stead of synesthetic band in bariatric procedures, mainly gastric sleeve

Detailed Description
-----------------
the idea is to use an omental flap or round ligament as a natural band in stead of synesthetic band in bariatric procedures, mainly gastric sleeve

Official Title
-----------------
Naturally Banded Sleeve Gastrectomy

Conditions
-----------------
Obesity, Morbid

Intervention / Treatment
-----------------
* Procedure: LSG with omental band
* Procedure: LSG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: obese patients with BMI more than 40 with or without co-morbidity or more than 35 with co-morbidity patients fit for laparoscopic surgery give approval to share in the study previous restrictive bariatric procedure Exclusion Criteria: patients unfit for surgery patients aged less than 18 and older than 60 patient with previous upper abdominal surgery either for obesity or other diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LSG<br>just laparoscopic sleeve gastrectomy without banding | Procedure: LSG<br>* just to do sleeve gastrectomy<br>|
| Experimental: LSG with omental band<br>laparoscopic sleeve gastrectomy with omental banding | Procedure: LSG with omental band<br>* LSG with omental band<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the effect on weight loss | the effect on weight loss determined by percentage of excess weight loss, percentage of total weight loss and change of BMI | 12 months | 
| the size of gastric pouch at one year | the size of gastric pouch after sleeve gastrectomy in cc at one year using gastric volumetric study | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the effect on comorbidities | change in comorbidities including diabetes by change in hemoglobin C level, hypertension by measuring arterial blood pressure using sphygmomanometer | 12 monthts | 
| operative time | operative time in minutes from skin incision to skin closure | 6 hours | 
| the incidences of complications | the incidences of complications including early complication like leak and bleeding and late complications like stricture diagnosed by vomiting's and imaging and GERD dignosed by symptoms and endoscopy | 12 monthss |
Long-term Follow-up of Subjects Exposed to Lentiviral-based CART-EGFRvIII Gene-modified Cellular Therapy Products in Cancer Studies

Study Overview
=================
Brief Summary
-----------------
This is a non-therapeutic, long-term follow-up (LTFU) study of subjects who have received retroviral-based gene therapy products in cancer studies. All subjects in this LTFU protocol have received lentiviral modified T cells engineered to express an anti-EGFRvIII scFv Chimeric Antigen Receptor (CAR).

Detailed Description
-----------------
The primary objective of this study is to monitor adult subjects, who as participants of a clinical trial, received T cells modified by a lentiviral vector encoding a chimeric antigen receptor specific for EGFRvIII, for adverse events that may be associated with lentiviral vector gene transfer such as insertional oncogenesis.

Official Title
-----------------
Long-term Follow-up of Subjects Exposed to Lentiviral-based CART-EGFRvIII Gene-modified Cellular Therapy Products in Cancer Studies

Conditions
-----------------
Subjects Entering Into This Protocol Will be Followed for up to 15 Years After Initial CART-EGFRvIII Infusion

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects will be enrolled into this destination protocol because they have received CART-EGFRvIII cells that were genetically modified with a lentiviral vector. All subjects who have participated in a lentiviral vector study under IND 15968 and have received CART-EGFRvIII cells will be asked to participate in this protocol. Subjects 18 years of age and older Subjects who have provided informed consent prior to their study participation. Exclusion Criteria: none

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 |
| --- | --- | --- |
| Number of adverse events |  | 15 years |
Autoantibodies and Clinical Symptoms in Infective Endocarditis Patients

Study Overview
=================
Brief Summary
-----------------
The purpose is to evaluate autoantibodies in infective endocarditis patients before, at the beginning of treatment, and after the end of the treatment, and to correlate the autoantibodies in the presence of clinical symptoms.

Official Title
-----------------
Study of Autoantibodies in Infective Endocarditis

Conditions
-----------------
Infective Endocarditis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infective endocarditis patients by DUKES criteria Exclusion Criteria: HIV positive Patients suffering from other infective diseases other than endocarditis. Patient suffering from collagen diseases for example: systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), mixed connective tissue disease, and scleroderma.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>infective endocarditis patients before treatment | |
| 2<br>infective endocarditis treatment after treatment | |
| 3<br>control | |

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
-----------------
profile autoantibodies, clinical symptoms
Ultrasound Guided Peripheral Intravenous Catheter Insertion in the Hospitalized Patient: Long vs. Short Axis Placement

Study Overview
=================
Brief Summary
-----------------
Comparison of peripheral IV catheters inserted by ultrasound using the long axis vs. the short axis technique. Our hypothesis is that long axis ultrasound placement will increase the longevity of the IV catheter.

Official Title
-----------------
Ultrasound Guided Peripheral Intravenous Catheter Insertion in the Hospitalized Patient: Long vs. Short Axis Placement

Conditions
-----------------
Need for IV Access

Intervention / Treatment
-----------------
* Device: Long axis IV placement with ultrasound
* Device: Short axis IV placement with ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A patient who needs PIV access for intravenous medications and resuscitation either on a medical-surgical floor or in the ICU After floor team (including RN and/or house staff) and IV Nurse have attempted and failed or is not available Exclusion Criteria: Need for vasopressors Need for TPN Need for hemodynamic monitoring Non English speaking patient Patients who are unable to consent

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: Long axis ultrasound placement of IV<br>Long axis ultrasound placement of IV catheter | Device: Long axis IV placement with ultrasound<br>* Peripheral IV placement with the ultrasound probe viewing the vessel in the long axis.<br>|
| Active Comparator: Short axis ultrasound placement of IV<br>Long axis ultrasound placement of IV catheter | Device: Short axis IV placement with ultrasound<br>* Peripheral IV placement with the ultrasound probe viewing the vessel in the short axis.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| catheter survival | How many catheters survived for 3 days or as long as they are needed. | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for central venous access |  | for 3 days | 
| success rate of peripheral IV using ultrasound assistance |  | 30 minutes | 
| Complication rate |  | 3 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intravenous placement, Ultrasound
A Study of RO5267683 in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
This investigator-blind, subject-blind, randomized, placebo-controlled study will evaluate the safety, pharmacokinetics and pharmacodynamics of multiple ascending doses of RO5267683 in healthy volunteers. Subjects will be randomized to receive either RO5267683 or placebo orally daily for 28 days. Follow-up will be 10 weeks after the last dose.

Official Title
-----------------
Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO5267683 in an Adaptive, Randomized, Investigator-blind and Subject-blind, Multiple-ascending Dose, Placebo-controlled, Study Following Oral Administrations in Healthy Subjects for 28 Days

Conditions
-----------------
Healthy Volunteer

Intervention / Treatment
-----------------
* Drug: RO5267683
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and female subjects, 18 to 45 years of age, Body mass index (BMI) 18 to 30 kg/m2 inclusive, and a minimum weight of 50 kg at screening Female subjects must be surgically sterile or post-menopausal Male subjects must use a barrier method of contraception for the duration of the study and for 90 days after the last dose Exclusion Criteria: History or evidence of any clinically significant disease or disorder Administration of an investigational drug or device within 3 months prior to dosing on Day 1 Positive for hepatitis B, hepatitis C or HIV at screening Subjects on hormone replacement therapy who have not been receiving a stable dose for at least 2 months prior to start of dosing

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

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br> | Drug: RO5267683<br>* Multiple ascending doses<br>|
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* Multiple ascending doses<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Incidence of adverse events |  | 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: Plasma concentrations |  | 14 weeks | 
| Pharmacokinetics: Urine concentrations |  | 4 weeks | 
| Lipid levels in the blood |  | 14 weeks |
SAS in Patients With Bronchial Carcinoma

Study Overview
=================
Brief Summary
-----------------
In this study it will be analyzed how often the sleep apnea syndrome can be observed in patients with newly diagnosed lung cancer with the help of ApneaLink device by ResMed.

Detailed Description
-----------------
Determination of the SAS- frequence in patients with bronchial carcinoma. The patients will be screened at home for 1 night with the ApneaLink device by ResMed. The apneaLink device is a standard screening tool for sleep apnea in clinical practice.

Official Title
-----------------
Incidence of Sleep Apnea Syndrome (SAS) in Patients With Bronchial Carcinoma

Conditions
-----------------
Sleep Apnea Syndrome, Bronchial Carcinoma

Intervention / Treatment
-----------------
* Device: sleep apnea screening with ApneaLinkTM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with reasonable suspicion of bronchial carcinoma or histologically proven bronchial carcinoma, which has not been medicated until the study entry and Patients with sleep apnea who had recently been diagnosed with bronchial carcinoma. Exclusion Criteria: Pregnancy other already known malignancies or tumors Patients with non-invasive artificial respiration due to a chronic respiratory insufficiencies

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: sleep apnea screening with ApneaLinkTM<br>This is the only group in the present study. Patients with bronchial carcinoma (or reasonable suspicion) perform sleep screening with ApneaLinkTM at home or during the hospitalization. | Device: sleep apnea screening with ApneaLinkTM<br>* ApneaLink is sleep-screening tool that objectively identifies patients with sleep apnea<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percent of sleep apnea in patients with bronchial carcinoma | The percent of sleep apnea in a cohort of patients with bronchial carcinoma will be evaluated. The duration of the study participation is two days. | two days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ApneaLink, bronchial carcinoma, sleep apnea screening