linjc16/ctgov huggingface dataset:
Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine.

Study Overview
=================
Brief Summary
-----------------
Three dose primary vaccination study of reactogenicity and immunogenicity in healthy infants between 6-12 weeks of age at the time of the first vaccination against Streptococcus pneumoniae.

Detailed Description
-----------------
Test groups: 2 (120 subjects/group). 1 group receiving GSK Biologicals' 10-valent pneumococcal conjugate vaccine + DTPa combined vaccine; Control group receiving GSK Biologicals' Havrix + DTPa combined vaccine

Official Title
-----------------
To Assess Reactogenicity and Immunogenicity of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine, When Co-administered With GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine (Infanrix™ Hexa) at 2, 4 and 6 Months of Age.

Conditions
-----------------
Hepatitis A

Intervention / Treatment
-----------------
* Biological: Pneumococcal (vaccine)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, free of obvious health problems and with written informed consent obtained from the parent/guardian of the subject. Exclusion Criteria: Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from one month before the first dose of vaccine(s) and during the entire study period.

Ages Eligible for Study
-----------------
Minimum Age: 6 Weeks
Maximum Age: 12 Weeks

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

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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Pneumococcal (vaccine)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| After each dose: Grade 3 AEs |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| After each dose: solicited/unsolicited AEs (4/31 days),SAEs (whole study); 1 month post 3: antibody concns to vaccine antigens |  |  |
Early Detection of Postoperative Anastomotic Leak by CT

Study Overview
=================
Brief Summary
-----------------
Postoperative anastomotic leak is rare but life threatening complication after gastric cancer surgery. Early diagnosis is key to minimize other hazards which are caused by anastomotic leak. Investigators introduced a novel method to detect early diagnosis of anastomotic leak after gastric cancer surgery.

Detailed Description
-----------------
Postoperative anastomotic leak is rare but life threatening complication after gastric cancer surgery. Early diagnosis is key to minimize other hazards which are caused by anastomotic leak. Investigators introduced a novel method to detect early diagnosis of anastomotic leak after gastric cancer surgery. Oral contrast agent is used for CT. Investigators carefully collected all the data prospectively and standard definition of anastomotic leak was applied.

Official Title
-----------------
Early Detection of Postoperative Anastomotic Leak by CT

Conditions
-----------------
Anastomotic Leak

Intervention / Treatment
-----------------
* Diagnostic Test: computed tomography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with gastric cancer surgery Exclusion Criteria: Patients with non gastric cancer surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: computed tomography|computed tomography|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis of anastomotic leak | CT was routinely used to detect early anastomotic leak after gastric cancer surgery | 5-10 days after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gastric cancer, postoperative complication, anastomotic leak, oral contrast agent, computed tomography
Timing for the Medical Treatment of Patent Ductus Arteriosus in Preterm Infants

Study Overview
=================
Brief Summary
-----------------
This is a retrospective chart review to look at the timing of using indomethacin and ibuprofen for PDA closure for infants admitted into the NICU of the University of Utah Hospital from 1/2007-8/2008. The purpose is to compare the outcomes of medical intervention in preterm infants if intervention occurs day of life 4 or less, or day of life 5 or greater, with the birthdate being counted as day of life 1.

Detailed Description
-----------------
This is a retrospective chart review to look at the timing of using indomethacin and ibuprofen for PDA closure for infants admitted into the NICU of the University of Utah Hospital from 1/2007-8/2008. The purpose is to compare the outcomes of medical intervention in preterm infants if intervention occurs day of life 4 or less, or day of life 5 or greater, with the birthdate being counted as day of life 1. All infants born less than 1200 gms will be evaluated for whether or not an echocardiogram was done. If an echocardiogram was done that showed a PDA, data will be collected as to what medical interventions were done, at what age, and what were the results of the medical intervention. Infants will be stratified into birthweights <800 gm and 800-1200 gm.

Official Title
-----------------
Timing for the Medical Treatment of Patent Ductus Arteriosus in Preterm Infants

Conditions
-----------------
Patent Ductus Arteriosus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: birth weight less than 1200 gm Exclusion Criteria: none

Ages Eligible for Study
-----------------
Maximum Age: 3 Months

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 |
| --- | --- | --- |
| Early versus Late Medical Treatment of PDA | The primary objective is to compare early (day of life 4 or less) versus late (day of life 5) medical treatment of PDA. Data will be collected via a retrospective chart review. Information will be collected on both the use of indomethacin and ibuprofen. Both medications are used as standard of care in the NICU for closure of PDAs. | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Efficacy of early vs late use of ibuprofen for PDA closure
Myo-inositol in Obese Pregnant Women

Study Overview
=================
Brief Summary
-----------------
Myo-Inositol is classified as a member of the vitamin B complex. It is a constituent of living cells and is widespread in many food. It is involved in a number of biological processes, including insulin signal transduction, resulting in modulating insulin sensitivity. This is a prospective, randomized, double center, placebo-controlled study. Two hundred and twenty obese pregnant women will be included in the trial and, after an informed consent, will assume randomly 2 g of myo-inositol twice a day or placebo from 12-13th weeks gestation until delivery. Then,they will perform an Oral Glucose Tolerance Test (OGTT) at 24-28th weeks gestation. Records about delivery (gestational age, neonatal weight...) will be registered.

Official Title
-----------------
Myo-inositol May Prevent Gestational Diabetes in Obese Women

Conditions
-----------------
Gestational Diabetes

Intervention / Treatment
-----------------
* Dietary Supplement: myo-inositol
* Other: folic acid 400 mcg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Obese pregnant women: BMI > 30 Kg/cm2 first trimester fast glycaemia < 126 mg/dl single pregnancy Exclusion Criteria: Pregnant women with BMI < 30 Kg/cm2 first trimester fast glycaemia > 126 mg/dl previous gestational diabetes twin pregnancy pregestational diabetes associated therapies with corticosteroids

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: myo-inositol<br> | Dietary Supplement: myo-inositol<br>* myo-inositol 2 grams plus folic acid 400 mcg twice a day<br>|
| Placebo Comparator: placebo<br>acid folic 400 mcg twice per day | Other: folic acid 400 mcg<br>* 2 pills a day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of gestational diabetes cases diagnosed with OGTT |  | 24-28th weeks gestation | 
| difference in HOMA values |  | from first trimester to OGTT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of pregnancy complications: hypertension, preterm delivery. macrosomia, shoulder dystocia, etc. |  | at delivery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gestational diabetes, macrosomia, hypertension in pregnancy, HOMA-IR, obesity
Study to Evaluate the Efficacy of Rituximab in Combination With Low-dose Radiotherapy in Patients With Relapsed Non-Hodgkin's Lymphoma

Study Overview
=================
Brief Summary
-----------------
This study aims to assess the short term efficacy of a combination of rituximab and low-dose radiotherapy in patients with non-Hodgkin's lymphoma.

Detailed Description
-----------------
Rituximab and low-dose total-nodal irradiation both have shown promising activity in patients with NHL. Moreover, the radiolabelled antibody Zevalin has been approved for the treatment of relapsed NHL. The patients in this study have a poor prognosis. The treatment strategy aims to control the disease and to ameliorate disease related symptoms with minimal toxicity. Both, rituximab and low-dose radiotherapy are associated with minor toxicity if applied alone. The primary objective of the study is therefore to assess the short term efficacy of a combination of rituximab and low-dose radiotherapy in patients with non-Hodgkin's lymphoma.

Official Title
-----------------
A Phase II Study of Rituximab Plus Low-Dose Radiotherapy in Patients With Relapsed Non-Hodgkin's Lymphoma

Conditions
-----------------
Non-Hodgkin's Lymphoma

Intervention / Treatment
-----------------
* Drug: Rituximab
* Procedure: Total nodal irradiation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: B-cell non-Hodgkin's lymphoma At least one prior antitumor therapy ECOG performance status 0-2 No major organ dysfunction Written informed consent Exclusion Criteria: The following histologies are excluded: Burkitt's lymphoma, mantle-cell lymphoma, primary CNS-lymphoma, HIV-associated lymphoma

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Rituximab|nan|
|Procedure: Total nodal irradiation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate (complete and partial response rate) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity |  |  | 
| Time to progression |  |  | 
| Response duration |  |  | 
| Quality-of-Life |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NHL, Lymphoma, Radiotherapy, Rituximab, Palliative treatment
Ultrasound-guided Rectus Sheath Block In Children

Study Overview
=================
Brief Summary
-----------------
Inguinal hernia repair is one of the common day-case surgery in children. The aim of this study is to compare the effects of ultrasound guided rectus sheath block and intravenous tramadol on peroperative anesthetic requirement and postoperative analgesia.

Detailed Description
-----------------
After approval the faculty ethical committee and informed consent from the parents (legal guardian) forty children aged 2-7 years scheduled for inguinal hernia repair were included in this prospective, randomized study. The patients were divided into two groups. After induction of general anesthesia, ultrasound guided rectus sheath block was applied to Group R with 0.2 mL/kg levobupivacain 0.25%. Tramadol 1 mg/kg intravenously was given to Group T before closure of the fascia. Intraoperative and postoperative hemodynamic parametres, postoperative pain by means of the FLACC were evaluated. Primary end point was pain score using FLACC scale.

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Procedure: rectus sheath block
* Drug: Tramadol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The children aged 2-7 years scheduled for inguinal hernia repair Exclusion Criteria: American Society of Anesthesiologists (ASA) classification III or greater, history of long term analgesic use, use of any analgesic within 24 hours before surgery, bleeding disorder, infection of application area, ultrasound imaging was inadequate and inability of the FLACC pain scoring system, substance sensitivity to local anesthetics.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 7 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rectus sheath block<br>rectus sheath block | Procedure: rectus sheath block<br>* ultrasound-guided rectus sheath block with 0.25% 0.2 ml/kg levobupivacaine<br>|
| Active Comparator: tramadol<br>tramadol control group | Drug: Tramadol<br>* tramadol 1 mg/kg iv<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Scores |  | postoperative 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ultrasound, rectus sheath block, children, inguinal hernia
Increasing Patient Experience Survey Responses

Study Overview
=================
Brief Summary
-----------------
This project aims to evaluate the effect of thank you cards on patient experience survey response rate.

Official Title
-----------------
Increasing Patient Experience Survey Responses

Conditions
-----------------
Patient Satisfaction

Intervention / Treatment
-----------------
* Other: Thank you card


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who have been discharged from the designated hospital units during the study period Exclusion Criteria: N/A
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intervention Group<br>The cohort receiving Thank you cards during their stay. | Other: Thank you card<br>* A card thanking the patient for choosing NYU and entrusting us with their care. The card notifies the patient that they may receive a patient satisfaction survey after discharge.<br>|
| Control Group<br>The cohort not receiving thank you cards during their stay. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survey response rate | The rate at which patients complete and submit the patient satisfaction survey | 1 year |
Hemodynamic Measurements During Liver Transplantation

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine if the less invasive monitors are as reliable for measuring heart function in patients undergoing liver transplantation as the more invasive pulmonary artery.

Detailed Description
-----------------
Pulmonary artery catheter (PAC)is considered the gold standard in monitoring of heart function during orthotopic liver transplantation (OLT). Placement of PAC is very invasive (it passes thorough the heart chambers and into the pulmonary artery) and its benefits on the outcomes have not been proven. This study compares two newer FDA approved much less invasive devices to the PAC. The two new devices assess the heart function based either on the peripheral arterial waveform alone (Vigileo, Edwards Lifesciences)or the combination of peripheral arterial waveform and chemical indicator dilution (LiDCO, Cambridge, UK).

Official Title
-----------------
Comparing Different Methods For Measurement of Cardiac Output During Orthotopic Liver Transplantation

Conditions
-----------------
Liver Transplantation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over 18 years of age Scheduled for liver transplantation Patient undergoing vascular surgery where invasive arterial pressure is indicated (control subjects) Exclusion Criteria: We will exclude patients taking lithium based medication Patients who weigh less than 40 kg; AND Patients who are pregnant

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 |
| --- | --- | --- |
| Agreement between cardiac output measurements obtained with PAC, Vigileo and LiDCO |  | Specific phases of liver transplantation surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
End-stage liver disease, Hemodynamic measurements, Hyperdynamic circulation, Pulmonary artery catheter, Cardiac output
Enhancing Referrals to Child and Adolescent Mental Health Services: EnCAMHS

Study Overview
=================
Brief Summary
-----------------
Our aim is to find low-cost and widely reusable mechanisms to reduce inappropriate referrals. Our key objectives are: Engage with key stakeholders to identify problems with making appropriate referrals Analyse CAMHS referral data to understand and identify problems (quantitatively) Identify requirements for sustainable solutions Explore with key stakeholders how we can improve the referral process Identify how the best proposed solutions could be embedded within routine CAMHS referral pathways

Detailed Description
-----------------
The Investigators shall conduct a series of focus groups with key stakeholders involved in the referral to CAMHS process; children and young people (CYP), parents/carers, key referrers, CAMHS professionals in order to better understand the challenges that exist with the current referral process. Following this, the Investigators will conduct further focus groups with the key stakeholders above, in which they will suggest sustainable solutions to the problems that have been identified. The Investigators shall then identify how the propose solutions can be embedded into routine CAMHS referral pathways.

Official Title
-----------------
Enhancing CAMHS Referrals: EnCAMHS

Conditions
-----------------
Mental Health Issue

Intervention / Treatment
-----------------
* Other: Focus Groups


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 16 years and above have experience of CAMHS referral pathway Exclusion Criteria: younger than 16 years

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- |
| Children and young people (CYP)<br>Children and young people who have been referred to CAMHS | Other: Focus Groups<br>* Focus Groups<br>|
| Parents/carers<br>Parents/carers of CYP who have been referred to CAMHS | Other: Focus Groups<br>* Focus Groups<br>|
| Key referrers<br>Key referrers (e.g. Teachers, GPs, SENCOs, Social Workers) who have referred CYP to CAMHS | Other: Focus Groups<br>* Focus Groups<br>|
| CAMHS Professionals<br>CAMHS Professionals who have received referrals to CAMHS | Other: Focus Groups<br>* Focus Groups<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Solutions to enhance the referral process for CAMHS | Solutions to help improve the referrals into CAMHS, using data collected during focus groups | By end of study - within 1 year |