linjc16/ctgov huggingface dataset:
Prevention Trial of Nosocomial Infections in Neutropenic Prematures With G-CSF

Study Overview
=================
Brief Summary
-----------------
Prevention trial of nosocomial infections in neutropenic prematures with G-CSF

Official Title
-----------------
Prevention Trial of Nosocomial Infections in Neutropenic Prematures With G-CSF

Conditions
-----------------
Neutropenia in Prematures

Intervention / Treatment
-----------------
* Drug: filgrastim
* Drug: dextrose 5%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: < 33 weeks GA neutropenic during at least 24 hours in the first 3 weeks of life and not infected at time of inclusion < 35 if birth weight < 1500 g

Ages Eligible for Study
-----------------
Minimum Age: 2 Days
Maximum Age: 35 Weeks

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: groupe filigrastin<br> | Drug: filgrastim<br>* The G-CSF (filigrastin) will be administered by intravenous way with the amount of 10 µg/kg/day during 3 days . The infusion will last from 20 to 40 minutes according to weight of the child and the product will be diluted in dextrose 5%.<br>|
| Placebo Comparator: groupe placebo<br> | Drug: dextrose 5%<br>* The placebo (dextrose 5% ) will be injected by intravenous way with the amount of 0.66 ml/kg during 3 days consecutive. The infusion will last from 20 to 40 minutes.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival without infection at 4 weeks after treatment |  | one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival free of infection at 2 weeks after treatment,mortality, increase of neutrophile, number of septic event, incidence of chronic lung disease, necrotizing enterocolitis, cerebral us abnormalities, retinopathy , duration of hospitalisation stay |  | one month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neutropenia, prematurity, nosocomial infection, G-CSF
A Study of the Expression of Nogo and Reticulon Genes in Skeletal Muscle of Patients With Amyotrophic Lateral Sclerosis

Study Overview
=================
Brief Summary
-----------------
This is a study of the expression of nogo and reticulon genes in the skeletal muscle of patients with amyotrophic lateral sclerosis (ALS).

Official Title
-----------------
A Study of the Expression of Nogo and Reticulon Genes in Skeletal Muscle of Patients With Amyotrophic Lateral Sclerosis

Conditions
-----------------
Amyotrophic Lateral Sclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with definite ALS Males or females Age > 18 Exclusion Criteria: Patients with other neuromuscular affections

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Amyotrophic lateral sclerosis, Nogo gene, reticulon genes
Frequency of Hypodontia After Chemotherapy in Childhood Cancer Survivors Study

Study Overview
=================
Brief Summary
-----------------
This study aims to provide information on the frequency of hypodontia in children cancer survivors receiving chemotherapy before 4 years of age.Patients who met the eligibility criteria will be given a structured questionnaire to fill followed by a radiographic examination (dental panorama) for confirmation and standardization of the results.

Official Title
-----------------
Frequency of Hypodontia After Chemotherapy in Childhood Cancer Survivors: A Cross Sectional Study

Conditions
-----------------
Hypodontia

Intervention / Treatment
-----------------
* Diagnostic Test: dental panorama


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 4 years or less when they first started their antineoplastic chemotherapy Both genders Able to cooperate Exclusion Criteria: Children with known family history of hypodontia Children with any associated developmental anomalies (eg, ectodermal dysplasia, cleft lip or palate and Down syndrome) Children who received radiotherapy Children with previous loss of teeth due to trauma, caries, periodontal disease or extraction 5- Children who received bone marrow transplantation 6-Parents/patients unwilling to give informed consent

Ages Eligible for Study
-----------------
Minimum Age: 6 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: dental panorama|radiographic examination|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypodontia | missing not formed teeth | 1 year |
Whole-Body MRI in Suspected Victims of Abusive Head Trauma

Study Overview
=================
Brief Summary
-----------------
The purpose: to pilot whole-body MRI scanning in infants who are already getting brain MRI for suspected child abuse Research design: prospective, blinded reading of Whole-Body MRI (WB-MRI) images during the routine care of the hospitalized infant with comparison to routine radiographic skeletal survey images Procedures to be used: whole-body MRI images Risks and potential benefits: no additional risk (the infant will be receiving and MRI of their brain as part of routine care, the additional images will be obtained at the same time without additional sedation); benefits to the infant include the identification of injuries which would have otherwise been missed by routine care importance of knowledge that may reasonably be expected to result: results from this study will potentially influence the use of radiographic skeletal survey and decrease the radiation exposure to infants being evaluated for suspected child abuse.

Official Title
-----------------
Whole-Body MRI in Suspected Victims of Abusive Head Trauma

Conditions
-----------------
Shaken Baby Syndrome

Intervention / Treatment
-----------------
* Other: Whol-Body MRI scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: younger than 12 months admitted to the hospital getting an MRI for suspected abusive head trauma Exclusion Criteria: -

Ages Eligible for Study
-----------------
Maximum Age: 12 Months

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Whol-Body MRI scan|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI findings of skeletal injuries, soft tissue injuries or visceral injuries | Whole Body MRI images will be read by a masked pediatric radiologist and compared with findings obtained by routine imaging and clinical evaluation | During hospitalization; MRI will typically be obtained on hospitalization day #2 |
18841- Sun Protection Factor Assay

Study Overview
=================
Brief Summary
-----------------
To evaluate the Sun Protection Factor efficacy on human skin.

Official Title
-----------------
Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay on Minimal Persistent Pigment- Darkening Dose.

Conditions
-----------------
Sunscreening Agent

Intervention / Treatment
-----------------
* Drug: Coppertone (BAY 987517)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing. Male and female Aged between 18-70 years old. Good health as determined from the HRL SHF Signed and dated Informed Consent Form Signed and dated HIPAA Form An unambiguous MED or MPPD (Minimal Persistent Pigment Darkening Dose) Exclusion Criteria: Subjects on test at any other research laboratory or clinic. Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light. Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study. Pre-existing other medical conditions (e.g. adult asthma. diabetes). Treatment with antihistamines or corticosteroids within one week prior to initiation of the test. Treatment with antibiotics within two weeks prior to initiation of the test. Chronic medication which could affect the results of the study. Known pregnant or nursing women.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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: BAY 987517<br>Each test site area is divided into test subsite areas that are approximately at least 0.5 cm*2. The application of test material is 2 mg/cm*2. Thus, each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. | Drug: Coppertone (BAY 987517)<br>* Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.(Formulation- SR16-07)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimal Erythema Dose (MED) |  | Up to 15 minutes | 
| Minimal Persistent Pigment DArkening Dose (MPPD) |  | Up to 15 minutes |
Rosiglitazone and Exercise in Patients With Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
The aim of the present study is to investigate the influence of systemic exercise, rosiglitazone administration and combined pharmaceutical and lifestyle intervention on cardiovascular risk factors

Official Title
-----------------
Rosiglitazone and Exercise in Patients With Type 2 Diabetes Mellitus

Conditions
-----------------
Type II Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: Rosiglitazone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type II diabetes mellitus Poor glycemic control Exclusion Criteria: Heart failure Renal disease Liver disease Cardiovascular event

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?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular risk factors alterations |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rosiglitazone,exercise,cardiovascular risk factors
Evaluation of Post-ERCP Pain as a Predictor for Post-ERCP Pancreatitis

Study Overview
=================
Brief Summary
-----------------
Pancreatitis is the most common complication after ERCP, although its frequency varies significantly depending on the study from < 2% up to 40%. Based upon data from studies that have included unselected patients, post-ercp pancreatitis (PEP) is mild, moderate, and severe in 45%, 44%, and 11% of cases, respectively. Dysfunction of the sphincter Oddi, female gender, younger age, previous history of pancreatitis, prolonged procedure time and pancreatic guidewire passages are well-known independent risk factors for PEP. This study will assess whether the development of PEP can be predicted by Visual analogue scale (VAS) level 1 hour after ERCP.

Official Title
-----------------
Evaluation of Post-Post-Endoscopic Retrograde Cholangiopancreaticography Pain (ERCP) as a Predictor for Post-ERCP Pancreatitis

Conditions
-----------------
Post-ERCP Acute Pancreatitis

Intervention / Treatment
-----------------
* Other: Visual analogue scale


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 years Scheduled for ERCP for any reason Exclusion Criteria: Absence of consent Language barrier No endoscopic advance to the papilla vateri Active pancreatitis at the time of the procedure Mental disability

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

| Intervention/Treatment |
| --- |
|Other: Visual analogue scale|Post procedural pain assessment using the visual analogue scale (VAS) will be performed in patients undergoing ERCP|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between Pain 1 hour after ERCP |  | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictive value of VAS for PEP Predictive value of VAS for PEP |  | 1 hour | 
| Association between VAS level and severity of PEP |  | 1 hour |
Spinal Aesthesia in Women With Placenta Previa Percreta

Study Overview
=================
Brief Summary
-----------------
Placenta previa percreta is a dangerous complication during surgery. Due to the high risk of hemorrhage, most parturients with placenta previa have to accept cesarean section. In this study investigators compare the effect of different anesthetic techniques on these patients.

Official Title
-----------------
Influence of Spinal Anaesthesia on Hemodynamic Stability in Women With Placenta Previa Percreta Undergoing Caesarean Section

Conditions
-----------------
Complications; Cesarean Section

Intervention / Treatment
-----------------
* Procedure: spinal anesthesia
* Procedure: general anesthesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women with placenta previa and increta-percreta (diagnosed by ultrasound and/or magnetic resonance imaging and confirmed during cesarean section) women accepted cesarean section Exclusion Criteria: women with baseline systemic blood pressure higher than 180 mmHg women with coagulation disorder

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| spinal anesthesia<br>patients receive spinal anesthesia before general anesthesia | Procedure: spinal anesthesia<br>* bupivacaine injected by spinal puncture<br>|
| general anesthesia<br>patients receive general anesthesia | Procedure: general anesthesia<br>* general anesthesia with intubation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of hypotension |  | from beginning of the surgery to the end of the surgery,approximately 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| usage of norepinephrine |  | from beginning of the surgery to the end of the surgery,approximately 1 hour | 
| dose of norepinephrine |  | from beginning of the surgery to the end of the surgery,approximately 1 hour | 
| lowest systemic blood pressure |  | from beginning of the surgery to the end of the surgery,approximately 1 hour | 
| maximal decrease of systemic blood pressure |  | from beginning of the surgery to the end of the surgery,approximately 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cesarean section, spinal anesthesia, general anesthesia
A Study to Evaluate the Effects of Tyramine in Patients Who Completed the PRESTO Study.

Study Overview
=================
Brief Summary
-----------------
This study is to determine if Tyramine has any side effects on patients receiving 0.5mg, 1mg of Rasagiline or Placebo

Official Title
-----------------
Sub-study to Evaluate the Effect of An Oral Dose of Tyramine in Subjects Completing 26 Weeks of Participation in PRESTO (TVP-1012/133)

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Drug: rasagiline mesylate
* Other: tyramine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women with idiopathic Parkinson's disease (PD) who have met inclusion criteria for PRESTO, and have completed the 26-week PRESTO study. The subject should be available to participate in the sub-study immediately following the last PRESTO visit (same day). Subjects must continue PRESTO study drug until the morning of the Tyramine Sub-Study. Subjects must provide separate informed consent to participate in the Tyramine Sub-Study. Exclusion Criteria: Subjects must not have a history of intracranial aneurysm or stroke. Subjects should not have uncontrolled hypertension, defined as systolic pressure > 160 mmHg, or diastolic pressure > 90 mmHg.
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: rasagiline mesylate|0.5 or 1 mg oral, once-daily|
|Other: tyramine|50 mg once daily|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| An increase in systolic blood pressure of > 30mmHg from the mean baseline value (documented by at least 3 consecutive measurements). Or Bradycardia with a heart rate below 40 beats per minute |  | 26 weeks |
Rollover Protocol Continued Access to Emtricitabine/Tenofovir Disoproxil Fumarate for Adults in United States

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to provide open label emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) for an additional 5 years (240 weeks) to adults completing study GS-US-203-0107.

Official Title
-----------------
A Rollover Protocol to Provide Open-Label Emtricitabine/Tenofovir Disoproxil Fumarate Combination Product to Subjects Completing the GS-US-203-0107 Study

Conditions
-----------------
Chronic Hepatitis B

Intervention / Treatment
-----------------
* Drug: FTC/TDF


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Complete all end of study visit procedures and pharmacokinetic (PK) substudy (if applicable) for the GS US 203 0107 study. A negative pregnancy test is required for female individuals at the end of study visit for GS US 203 0107 (unless surgically sterile or greater than two years post-menopausal). All sexually active female individuals who are not post menopausal, or surgically sterile and are of childbearing potential must agree to use a highly effective method of contraception during heterosexual intercourse throughout the study. Male individuals who are sexually active are required to use barrier contraception (condom with spermicide) during heterosexual intercourse through to study completion. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: FTC/TDF<br> | Drug: FTC/TDF<br>* 200/300 mg tablet administered orally once daily<br>* Other names: Truvada®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Had Access to, and Received the Intervention | This endpoint has been included to satisfy the requirements of ClinicalTrials.gov. However, there were no prespecified endpoints in this study. | Up to 240 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prevention of chronic hepatitis B recurrence, post orthotopic liver transplant, prevention of chronic hepatitis B recurrence in patients who have undergone orthotopic liver transplant