linjc16/ctgov huggingface dataset:
Febrile Infants - Diagnostic Assessment and Outcome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess how clinicians apply guidance in the assessment of febrile infants presenting the the Emergency Department. The measurable outcomes are: Primary Objective Report the rates of serious and invasive bacterial infections in febrile infants Secondary Objectives Report on the predictive value of different clinical features for predicting bacterial infections. Report on the value of biomarkers for predicting serious and invasive bacterial infections. Assess the performance of clinical practice guidelines for the assessment of febrile infants.

Detailed Description
-----------------
The assessment of febrile infants is difficult. In the UK and Ireland current guidance advocates that most children under 3 months of age with a fever undergo a full septic screen including lumbar puncture and receive parenteral antibiotics. Approaches in the United States and Europe including the PECARN and StepByStep approach allow for the discharge home of some low risk young infants. We intend to assess the current approach to febrile infants and compare that to the available clinical practice guidelines. We also intend to determine which clinical and/or laboratory features are most predictive of serious bacterial infection.

Official Title
-----------------
Febrile Infants - Diagnostic Assessment and Outcome

Conditions
-----------------
Meningitis, Bacterial, Bacterial Infections, Urinary Tract Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any infant aged 0 to 90 days (inclusive) with a fever of 38 degrees centigrade or higher recorded in the Emergency Department.

Ages Eligible for Study
-----------------
Maximum Age: 90 Days

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>All infants aged 0-90 days (inclusive) undergoing routine assessments for fever without source. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Invasive bacterial infection | Invasive Bacterial Infection (non-contaminant) confirmed by culture or molecular diagnostic testing of a sterile site i.e. blood or cerebrospinal fluid (CSF). Staphylococcus epidermidis, Propionibacterium acnes, Streptococcus viridans, or Diphtheroides were considered contaminants. | seven days | 
| Serious bacterial infections | Urinary tract infections defined as growth of ≥100 000 cfu/mL | seven days |
Decompression and Drainage Seton for Treatment of High Horseshoe Anal Fistula

Study Overview
=================
Brief Summary
-----------------
Patients with high horseshoe anal fistula will be randomized to one of two equal group: treatment group will have decompression and drainage seton and control group will undergo cutting seton.

Official Title
-----------------
Clinical Study of Decompression and Drainage Seton for the Treatment of High Horseshoe Anal Fistula

Conditions
-----------------
Anal Fistula

Intervention / Treatment
-----------------
* Procedure: Decompression and drainage seton
* Procedure: Cutting seton


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients suffering from high horseshoe anal fistula Exclusion Criteria: Specific cause of fistula e.g. Crohn's disease. Previous anorectal surgery. Patients with malignant tumors or mental illness or other reasons unable to cooperate with the treatment. Patients with serious primary diseases such as tumor, malnutrition, endocrine and hematopoietic system.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Decompression and drainage seton<br>Decompress the pressure in intersphincteric space,and drainage seton will be put around the external anal sphincter. | Procedure: Decompression and drainage seton<br>* Incision the internal sphincter over the fistula tract in intersphinteric space to achieve decompression then drainage seton will be put around external sphincter.<br>Procedure: Cutting seton<br>* Cutting seton is introduced from outside openning to internal openning and encircling the internal and external anal sphincter.<br>|
| Experimental: Cutting seton<br>Cutting seton will be put around the internal and external anal sphincter. | Procedure: Decompression and drainage seton<br>* Incision the internal sphincter over the fistula tract in intersphinteric space to achieve decompression then drainage seton will be put around external sphincter.<br>Procedure: Cutting seton<br>* Cutting seton is introduced from outside openning to internal openning and encircling the internal and external anal sphincter.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence rate | recurrence was defined as the clinical reappearance of the fistula after complete healing. | 12 months after the procedure |
A Retrospective Immunohistochemistry Study of the Expression of Glycine/ Serine Pathway Molecules in Solid Tumors

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the expression of molecules involved in the glycine/serine pathway using immunohistochemistry in solid tumors. Archived paraffin-embedded pathological specimens from the Department of Pathology, NUH will be obtained. Tissue microarray (TMA) is a high-throughput method of analysing large numbers of formalin-fixed, paraffin-embedded tumor at a minimal cost and effort. To analyse the expression of molecules of putative relevance to the glycine/serine pathway, (such as PSPH, PSAT1, SHMT1, and GLDC), TMA technology will be utilised as previously reported (Kristiansen, Zhang, Soong). Tissue arrays will be constructed from solid tumors including cancers of the colon/ rectum, lung, breast, cervix, ovary, endometrium, fallopian tube, prostate, kidney, testis, stomach, liver, brain and lymphoma. One hundred cases of each tumor type (subject to availability) will be stained using immunohistochemistry. Patient Identifiers will not be collected. Societal benefit in terms of knowledge gained to improve understanding of cancer. No direct risk to subjects as this is a retrospective study of archived pathological tumour samples.

Conditions
-----------------
Solid Tumor Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with solid tumor cancer

Ages Eligible for Study
-----------------
Minimum Age: 21 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 the expression of molecules of putative relevance to the glycine/serine pathway | Archived paraffin-embedded pathological specimens from the Department of Pathology, NUH will be obtained. Tissue microarray (TMA) is a high-throughput method of analysing large numbers of formalin-fixed, paraffin-embedded tumor at a minimal cost and effort. To analyse the expression of molecules of putative relevance to the glycine/serine pathway, (such as PSPH, PSAT1, SHMT1, and GLDC), TMA technology will be utilised as previously reported (Kristiansen, Zhang, Soong). Tissue arrays will be constructed from solid tumors including cancers of the colon/ rectum, lung, breast, cervix, ovary, endometrium, fallopian tube, prostate, kidney, testis, stomach, liver, brain and lymphoma. One hundred cases of each tumor type (subject to availability) will be stained using immunohistochemistry. | 5 years |
Molecular and Cellular Mechanisms of the In-stent-thrombosis

Study Overview
=================
Brief Summary
-----------------
In-Stent-Thrombosis is a rare but serious complication after implantation of stents during PTCA.

Detailed Description
-----------------
In this prospective, open, not-randomized, controlled single-center pilot study 80 patients having had an in-stent-thrombosis (40 sub-acute thromboses (SAT), 40 late thromboses (LT)) and a control group of 80 patients having not developed a thrombosis will be compared. The aim of this study is the establishment of diagnostic markers vor prediction of SAT (detection of CD39- and CD73-activity, respectively)and of LT (EPC-number and function, respectively) correspondingly aiming at the early identification of patients with high risk for developing an in-stent-thrombosis.

Official Title
-----------------
Molecular and Cellular Mechanisms of the In-stent-thrombosis. Is it Possible to Predict a In-stent-thrombosis Using Biomarkers?

Conditions
-----------------
Patients With SAT or LT After Stent Implantation (PCI)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients having developed an SAT or LT after stent implantation using PTCA Exclusion Criteria: instabel coronary heart diseases, systemic autoimmune diseases, rheumatic diseases, tumors, impaired kidney or liver function, surgery within the last 3 months, pregnant or lactating 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Patients having developed an in-stent-thrombosis (40 SAT, 40 LT) | |
| 2<br>Patients having not developed an in-stent-thrombosis after stent implantation using PTCA | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The aim of this study is to establish diagnostic markers for prediction of SAT and LT, respectively, by identification of CD39 and CD73-activity and EPC-number and function, respectively. |  | may 08 to may 2010 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
in-stent-thrombosis, CD39, CD73, EPC
Prospective Study of N-acetyltransferase2 (NAT2) and Cytochrome P4502E1 (CYP2E1) Gene as Susceptible Risk Factors for Antituberculosis (ATT) Induced Hepatitis

Study Overview
=================
Brief Summary
-----------------
N-acetyltransferase2 (NAT2) and Cytochrome P4502E1 (CYP2E1) are two drug metabolizing enzymes. Antituberculosis drug isoniazid is acetylated by NAT2 and forms ultimately a nontoxic compound which is metabolized by CYP2E1 to a toxic metabolite. Slow acetylator genotype of NAT2 and wild type genotype of CYP2E1 gene has been attributed to greater toxicity of ATT drug. Therefore this study has been designed to analyze the genetic polymorphism of NAT2 and CYP2E1 genes in tuberculosis patients who developed drug induced hepatitis upon administration of antituberculosis drug.Polymorphism study of NAT2 and CYP2E1 gene may help in predicting the high risk group of ATT induced hepatitis.

Official Title
-----------------
Prospective Study of N-acetyltransferase2 (NAT2) Gene and Rifampicin Induced Cytochrome P-450 as Susceptible Risk Factors for Antituberculosis Drug Induced Hepatitis

Conditions
-----------------
Pulmonary Tuberculosis

Intervention / Treatment
-----------------
* Drug: ATT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with pulmonary tuberculosis Patients receiving conventional antituberculosis drugs Patients who directly presented with antituberculosis drug induced hepatitis Exclusion Criteria: Habitual alcohol drinkers Patients with evidence of viral hepatitis

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 70 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 |
| --- | --- |
| Pulmonary tuberculosis patients<br>Freshly diagnosed pulmonary tuberculosis patients who are started with antituberculosis drugs | Drug: ATT<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Faslodex International Observational Non-Interventional Study in Advanced Breast Cancer (BC)

Study Overview
=================
Brief Summary
-----------------
The purpose is to collect real life data on the use of fulvestrant in normal clinical practice in Austria and document the clinical benefit of fulvestrant treatment.

Official Title
-----------------
Faslodex International Observational Non-Interventional Study in Advanced Breast Cancer

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal women with hormone receptor-positive locally advanced or metastatic breast cancer Ability to read and write and complete questionnaires Provision of written informed consent Patients who already received a prescription for fulvestrant Exclusion Criteria: A subject who does not fulfil all the above mentioned inclusion criteria is not allowed to participate in this NIS
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Patient with advanced BC, already receiving Faslodex therapy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Benefit, defined as the development of at least one of the following stages and holding on for at least 6 month: Complete response, partial response or stable disease |  | Baseline, after 3, 6, 9 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability |  | After 3, 6, 9 month (as per usual clinical practice) | 
| Quality of Life |  | Baseline, after 3, 6, 9 month (as per usual clinical practice) | 
| Performance status (Karnofsky Index) |  | Baseline, after 3, 6, 9 month (as per usual clinical practice) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fiona, Faslodex, Advanced Breast Cancer, Real life data, Collect real life data in clinical practice across Austria
Psychoeducation for the Parents of Attention Deficit Hyperactivity Disorder (ADHD) Children

Study Overview
=================
Brief Summary
-----------------
This study designed and evaluated a psychoeducation program for parents of ADHD children in terms of improving medication adherence and clinical benefits.

Detailed Description
-----------------
ADHD is the most common behavioral disorder with poor outcomes. Medication is the most important treatment for ADHD. The adherence to the medication is extremely low. This study aims to investigate the the effect of a psychoeducation program for parents of ADHD children. The investigators intent to recruit 80 ADHD families. They will be randomized to intervention group and control group using a block randomization design. The intervention group will participate in a psychoeducation program, which includes a presentation from a specialist in ADHD at the baseline, with parent manual provided, posters, and two group sessions at the end of the 2nd and the 4th weeks. The control group only receives general consultation. The knowledge towards ADHD and its treatment, parents' behavior intent, medication adherence, clinical symptoms, and parents' satisfaction will be assessed and compared at the end of the 1st and 3rd months after intervention.

Official Title
-----------------
Evaluation of a Psychoeducation Program for the Parents of Attention Deficit Hyperactivity Disorder

Conditions
-----------------
ADHD

Intervention / Treatment
-----------------
* Behavioral: psychoeducation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: parents of ADHD children diagnosed with ADHD 6 - 16 years old; first referral to the hospital; candidate for medication according to both the doctor and the family Exclusion Criteria: inappropriate for medication; being illiterate of the parent or the primary caregiver; unable to be followed-up.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 16 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention group<br>A psychoeducation program was delivered to the parents/caregivers | Behavioral: psychoeducation<br>* The intervention included a presentation by a psychiatrist, with parent manual provided, and then two group sessions at the 2nd and 4th weeks to address further concerns of the parents<br>|
| No Intervention: control group<br>This group waited for 3 months, only receiving general consultation. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication adherence rate |  | 3 months |
Patient-derived Organoids Predicts the Clinical Efficiency of Colorectal Liver Metastasis

Study Overview
=================
Brief Summary
-----------------
Accumulating evidence indicates that patient- derived organoids (PDOs) can predict drug responses in the clinic. Metastasis is the main cause of death in colorectal cancer patients, and the treatment of patients with liver metastasis remains poor. Tumor heterogeneity is the cause of treatment failure. In this study, we aim the investigate the consistency of drug sensitivity for the matched primary and metastatic tumor in patients with liver metastasis.

Official Title
-----------------
The Exploratory Study of Patient-derived Organoids for the Prediction and Evaluation of Clinical Efficiency Effect of Colorectal Cancer Liver Metastasis

Conditions
-----------------
Explore the Consistency of Drug Sensitivity Between Primary Colorectal Cancer and Liver Metastases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically proven colorectal cancer with liver metastasis Aged between 18 and 70 years Written informed and signed consent Accessible to surgery sample of metastasis and primary tumor Exclusion Criteria: Less than 18 years and older than 70 years Not able to give informed consent Not accessible to surgery sample

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- | --- |
| The consistency of drug sensitivity | To test the consistency of drug sensitivity of primary tumor and its matched liver metastasis | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The establishment of PDO | To test the rate of PDO derived from primary and matched metastatic colorectal cancer . | 3 years |
Effect of Local Anesthetic EMLA (Lidocaine 2.5% and Prilocaine 2.5%) Cream and Reduction in Dose, Pain and Intravenous Analgesic During Permanent Pacemaker Implantation

Study Overview
=================
Brief Summary
-----------------
The investigators believe that the local anesthetic EMLA (Lidocaine 2.5% and Prilocaine 2.5%) cream will lessen pain and reduce the need for anesthesia and analgesia, when implanting a permanent pacemaker.

Conditions
-----------------
Pacemaker Implantation, Pain

Intervention / Treatment
-----------------
* Drug: EMLA Analgesic Cream
* Drug: Dormicum 2.5 mg and Pethidine 25 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients undergoing pacemaker implantation Exclusion Criteria: Dementia Patients Psychiatric Patients Unconscious Patients Patients with sensitivity to EMLA

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EMLA analgesic cream<br>Patients who have had EMLA analgesic cream applied to area before pacemaker implantation | Drug: EMLA Analgesic Cream<br> <br> |
| Active Comparator: Routine treatment<br>Patients who have received routine treatment (Dormicum 2.5 mg and Pethidine 25 mg) before and during pacemaker implantation | Drug: Dormicum 2.5 mg and Pethidine 25 mg<br>* Routine anesthesia and analgesia ( Dormicum 2.5 mg and Pethidine 25 mg )normally given to patients before and during pacemaker implantation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain reduction | EMLA anesthetic cream will be applied to area where pacemaker is to be implanted. Pain reduction will be measured using the visual analog scale (VAS) at three intervals. | One hour |