linjc16/ctgov huggingface dataset:
A Multicenter Breast Cancer Biospecimen Registry

Study Overview
=================
Brief Summary
-----------------
This study is being performed to collect blood for the development of noninvasive tests that can screen for or diagnose cancer. Blood samples will be collected from women who are scheduled to have breast biopsies.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Females of all racial and ethnic groups who are 40 years or older. Women must: have suspected neoplasm of the breast (BIRADS 4 or 5) based on the results of any breast screening or diagnostic imaging, such as mammogram, and be selected or scheduled for a breast biopsy which has not yet been conducted at the time of enrollment. Exclusion Criteria: Inability to sign informed consent. More than one radiological finding. Any current or prior cancer (with the exception of non-melanoma skin cancer or a suspected breast malignancy targeted for biopsy). Any known or suspected acute illness or condition - including acute infections - at the time of enrollment or within the previous 30 days. Any surgery, hospitalization, or institutionalization (such as in a nursing home) during the previous 3 months. Received any experimental therapeutic treatment during the previous 3 months. Received any blood product transfusion within the previous 3 months. Use of illegal drugs during the previous 3 months. Pregnant or nursing at the time of enrollment or in the preceding 12 months.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

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

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 patients with untreated newly diagnosed breast cancer. |  | 1 Year |
Allergy Testing of Patients Labeled as Penicillin Allergic

Study Overview
=================
Brief Summary
-----------------
Patients labeled as penicillin allergic, rarely have this confirmed and being labeled as penicillin allergic is associated with increased health care costs, adverse effects and antibiotic resistance. The investigators will recruit participants from primary care practices labeled as penicillin allergic and offer allergy testing. The aim of this study is to develop a community, outpatient program for evaluation of penicillin allergy.

Official Title
-----------------
Allergy Testing of Primary Care Patients Labeled as Penicillin Allergic

Conditions
-----------------
Drug Hypersensitivity

Intervention / Treatment
-----------------
* Other: Penicillin allergy testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Labeled as having penicillin or amoxicillin allergy Family history of penicillin allergy Exclusion Criteria: History of beta-lactam associated toxic epidermal necrolysis/Stevens Johnson syndrome to penicillin or amoxicillin History of Drug induced Eosinophilia with Systemic Symptoms (DRESS) History of drug induced: autoimmune hepatitis/interstitial nephritis, or hemolytic anemia Poorly controlled asthma or heart disease Currently pregnant Unable to discontinue certain medications that may interfere with testing including (antihistamines, steroids, beta-blockers, tricyclic antidepressants, omalizumab)

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

| Intervention/Treatment |
| --- |
|Other: Penicillin allergy testing|The standard protocol for testing for penicillin hypersensitivity, including initial skin testing with prick and intradermal evaluation followed by oral challenge if skin testing is negative.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Allergy testing for penicillin allergy results |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant satisfaction after allergy testing with follow-up questionnaire | A questionnaire will be provided to participants to review their experience with penicillin allergy testing, whether they will take penicillin in the future and if it is valuable information to be tested. Answers will be yes and no. This information will tell us | Within 6 months following testing | 
| Development of new drug allergies following negative testing questionnaire | Follow-up questionnaire will be sent to participants to evaluate whether they have needed any antibiotics and if so, whether they've had any reactions. This will be two yes/no questions to assess the incidence of development of new allergic reaction following negative testing. | 6 months-2 years |
Booster Effect of mRNA Vaccine on Antibody Response for SARS-CoV-2 After Complete Vaccination With Sinos

Study Overview
=================
Brief Summary
-----------------
In most parts of the world, mRNA vaccines were used to provide protection to population against COVID 19. However, in some countries, including Pakistan, traditional viral vaccines named as Sinovac and Sinopharm were used for mass level immunization. Though these vaccines were approved by WHO, their efficacy had been questioned. Now after recommendation of booster doses, we aim to see the effect of mRNA vaccine as a booster dose after Sinovac and Sinopharm in terms of antibody response. (IgG RBD SARS CoV2)

Detailed Description
-----------------
In most parts of the world, mRNA vaccines were used to provide protection to population against COVID 19. However, in some countries, including Pakistan, traditional viral vaccines named as Sinovac and Sinopharm were used for mass level immunization. Though these vaccines were approved by WHO, their efficacy had been questioned. Now after recommendation of booster doses, we aim to see the effect of mRNA vaccine (BNT162b2, pfizer) as a booster dose after Sinovac and Sinopharm in terms of antibody response. (IgG RBD SARS CoV2). The antobody IgG RBD levels will be checked before the booster dose and then after 3 weeks of the booster.

Official Title
-----------------
Booster Effect of mRNA Vaccine After Complete Vaccination With Sinos: an Observational Study

Conditions
-----------------
Vaccine Reaction

Intervention / Treatment
-----------------
* Biological: booster vaccine for COVID 19


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: people who have received two doses of sinopharm or sinovac and six months have passed after the second dose Exclusion Criteria: people getting one shot of sinopharm or sinovac or got vaccine other than sinopharm and sinovac.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: booster vaccine for COVID 19|The effect of Booster vaccine will be seen in participants in terms of antibody response IgG|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IgG RBD levels | to see the effect of booster vaccine after 3 weeks in terms of IgG RBD | after 3 weeks of booster vaccine dose |
A Prospective Observational Study of Clinical Outcomes for the NanoString® Technologies Prosigna™ Gene Signature Assay

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to assess the extent to which the Prosigna™ Breast Cancer Prognostic Gene Signature Assay affects the medical oncologist's treatment recommendations regarding adjuvant chemotherapy and actual treatments received for patients with early-stage breast cancer.

Detailed Description
-----------------
Changes in treatment recommendations will include (1) hormonal therapy alone, (2) hormonal therapy plus chemotherapy, and (3) changes in types of chemotherapy if chemotherapy was recommended before and after the test.

Official Title
-----------------
A Prospective Observational Study of Clinical Outcomes for the NanoString® Technologies, Inc. Breast Cancer Intrinsic Subtype Test

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Resected node-negative, estrogen-receptor-positive, HER2-negative early- stage invasive breast cancer (T1-T2, N0, pN0 (i+), pN0 (mol+), M0) Estrogen receptor status will be evaluated by Immunohistochemistry (IHC) and more than 1% of stained tumor cells will be considered positive. HER2 status will be evaluated by IHC (0 or 1+, or 2+ will be considered negative) and by in-situ fluorescence hybridization. Postmenopausal women defined as: Natural Amenorrhea > 12 months, regardless of age Bilateral oophorectomy, regardless of age (the oophorectomy must have been carried out at least 4 weeks before entering the study) Radiological castration with amenorrhea > 3 months, regardless of age Hysterectomy and postmenopausal blood levels Able to give consent Eligible for treatment of breast cancer with adjuvant chemotherapy ECOG performance status of 0 or 1 Exclusion Criteria: Tumor size T3-T4 Non-invasive breast cancer (e.g., Paget's disease, DCIS) Tumors with nodes that are not N0, pN0 (i+), or pN0 (mol+) Tumors that are estrogen-receptor negative or HER2 positive Have metastatic disease Unable to give informed consent Unable to complete patient reported outcome surveys Have contraindications for adjuvant chemotherapy Age, performance status, significant comorbidities ECOG performance status > 1
Sexes Eligible for Study
-----------------
Female

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 proportion of patients whose choice of treatment is changed as a result of receiving the Prosigna test result. |  | 6 months |
Co-infections in Children Hospitalised for Bronchiolitis

Study Overview
=================
Brief Summary
-----------------
Observational cohort study in children hospitalized for acute bronchiolitis. Patients are nursed in cohort isolation. Aim is to investigate the incidence and clinical impact of co-infections in this group.

Detailed Description
-----------------
Observational cohort study in children hospitalized for acute bronchiolitis. Patients are nursed in cohort isolation, meaning that all patients admitted for bronchiolitis are cohorted together, irrespective of viral diagnosis. Aim is to investigate the incidence and clinical impact of co-infections in this group.

Official Title
-----------------
Co-infections in Children Hospitalised for Bronchiolitis: Incidence, Clinical Symptoms and Influence of Cohort Isolation

Conditions
-----------------
Bronchiolitis

Intervention / Treatment
-----------------
* Other: cohort isolation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: younger than 2 years admitted for bronchiolitis Exclusion Criteria: chronic lung disease congenital heart defect down syndrome

Ages Eligible for Study
-----------------
Maximum Age: 24 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 |
| --- | --- |
| cohort isolation<br>patients with bronchiolitis are cohorted together irrespective of viral agent diagnosed, thus respiratory syncytial virus (RSV)-positive patient stay in the same room as RSV-negative patients | Other: cohort isolation<br>* all patients hospitalised for bronchiolitis are nursed in one room together, separated from patients without bronchiolitis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| co-infection | co-infection acquired during hospitalisation, patient will be followed during hospitalisation and until 1 week after discharge from the hospital, since average duration of hospitalisation in infants with bronchiolitis is 3 days, the time frame will be approximately 2 weeks | approximately 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical severity | clinical severity defined as, days of oxygen supplementation, tube feeding, dyspnea score, length of hospitalisation | approximately 2 weeks |
Reliability of Ultrasound Examination of the Inferior Caval Vein

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare validity of examination and measurement of inferior caval vein from different views in critically ill patients on mechanical ventilation.

Detailed Description
-----------------
A maximal and minimal diameter of inferior caval vein will be measured by transthoracic echocardiography in critically ill patients on mechanical ventilation hospitalised in the intensive care unit from four different views: Subcostal view on the inferior caval vein in the long axis, subcostal view on the inferior caval vein in the short axis, right lateral view on the inferior caval vein in the long axis, right lateral view on the inferior caval vein in the short axis. Comparison between the results of measurements in the subcostal view in the long axis and other views will be performed.

Official Title
-----------------
Reliability of Ultrasound Examination of the Inferior Caval Vein From Different Views in Critically Ill Patients on Artificial Lung Ventilation

Conditions
-----------------
Transthoracic Echocardiography

Intervention / Treatment
-----------------
* Diagnostic Test: Conventional transthoracic echocardiographic examination at the intensive care unit.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inpatients Patients on mechanical ventilation indicated for transthoracic echocardiographic examination Exclusion Criteria: Age <18 years Insufficient imaging quality Refusal of echocardiographic examination by patient

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Critically ill patients<br>Critically ill patients hospitalised in the intensive care unit indicated to echocardiographic examination. | Diagnostic Test: Conventional transthoracic echocardiographic examination at the intensive care unit.<br>* Conventional transthoracic echocardiographic examination at the intensive care unit targeted to inferior caval vein examination from different views.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between maximal and minimal diameter of the inferior caval vein from subcostal and right lateral view | Inferior caval vein measurements are key parameters for assessment of preload and fluid responsiveness | During the intervention |
Efficacy and Safety of Metformin Plus Biphasic Insulin Aspart 30 in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in South America. The aim of this trial is to evaluate the efficacy of metformin plus biphasic insulin aspart or insulin NPH on blood glucose control in subjects with type 2 diabetes.

Official Title
-----------------
Evaluation of Efficacy and Safety of Metformin Plus Biphasic Insulin Aspart or Insulin NPH in Subjects With Type 2 Diabetes

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: metformin
* Drug: biphasic insulin aspart


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes Currently treated with insulin NPH or are insulin-naive Body mass index (BMI) below 35.0 kg/m2 HbA1c between 7.5-11.0% Exclusion Criteria: Participation in any other clinical trial involving investigational products within the last 3 months History of drug or alcohol dependence Known impaired hepatic function Known or suspected allergy to human insulin NPH, insulin aspart or any component of the composition

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

| Intervention/Treatment |
| --- |
|Drug: metformin|nan|
|Drug: biphasic insulin aspart|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | after 12 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PPBG values |  |  | 
| Glucose profiles |  |  | 
| Hypoglycemia |  |  | 
| Adverse events |  |  |
Open Label Trial to Study the Long-term Safety and Efficacy of Seletracetam for the Treatment of Epilepsy

Study Overview
=================
Brief Summary
-----------------
This is a safety and efficacy study of add-on therapy with seletracetam in epilepsy patients who have participated in a previous seletracetam study

Official Title
-----------------
An Open-label, Multicenter, Follow-up Trial to Evaluate the Long-term Safety and Efficacy of Seletracetam Used as Adjunctive Treatment Using a Flexible Dosing Scheme of 4 to 80 mg b.i.d. in Subjects Aged 16 Years or Older Suffering From Epilepsy

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Drug: Seletracetam (ucb 44212)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A signed and dated IRB/IEC approved written informed consent form Male/female age 18 years (16 years where permitted) to 65 years Minimum body weight of 40 kg Patients having participated in a previous seletracetam study Female patients without childbearing potential or using a medically accepted non-hormonal contraceptive method are eligible. Exclusion Criteria: Ongoing psychiatric disease other than mild controlled disorders Subject with clinically significant abnormalities in laboratory tests or ECG Poor compliance with visit schedule or medication intake in a previous seletracetam study Subject taking part in another clinical/pharmacological study, with the exception of seletracetam studies, in the 30 days preceding enrollment

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Seletracetam (ucb 44212)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety profile of seletracetam |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in seizure frequency |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Partial onset, primary generalized seizures, seletracetam
Study Comparing Graft Function in Renal Allograft Recepients Receiving Reduced or Standard Dose CsA With Sirolimus

Study Overview
=================
Brief Summary
-----------------
This study evaluated renal graft function (based on calcuated creatinine clearance) 12 months after transplantation in patients receiving either a regimen of reduced dose or standard dose cyclosporine in combination with sirolimus and corticosteroids. The incidence of acute graft rejection at 6 and 12 months following transplantation and patient and graft survival at 12 months were evaluated also.

Detailed Description
-----------------
This study evaluated renal graft function (based on calcuated creatinine clearance) 12 months after kidney transplantation in patients receiving either a regimen of reduced dose or standard dose cyclosporine (CsA) in combination with sirolimus and corticosteroids. The incidence of acute graft rejection at 6 and 12 months following transplantation and patient and graft survival at 12 months after transplantation were evaluated also.

Official Title
-----------------
A Comparative, Open-label Study to Evaluate Graft Function in de Novo Renal Allograft Recipients Treated With Either a 'Reduced Dose' or a 'Standard Dose' of Cyclosporine in Combination With Sirolimus and Corticosteroids

Conditions
-----------------
Kidney Transplantation

Intervention / Treatment
-----------------
* Drug: Rapamune® (Sirolimus)
* Drug: Neoral® (Cyclosporine)
* Drug: Corticosteroids


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults more than 18 years of age End-stage renal disease, with patients receiving a primary or secondary renal allograft from a cadaveric, living-unrelated or living-related mismatched donor Patients with a secondary transplant must have maintained their primary graft for at least 6 months Exclusion Criteria: Planned antibody induction therapy Multiple organ transplants Patients at a high risk of acute rejection

Ages Eligible for Study
-----------------
Minimum Age: 18 Months

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

| Intervention/Treatment |
| --- |
|Drug: Rapamune® (Sirolimus)|nan|
|Drug: Neoral® (Cyclosporine)|nan|
|Drug: Corticosteroids|Left up to local practice but steroids are typically used perioperatively|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calculated creatinine clearance to evaluate renal function at 12 months post transplantation |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of acute graft rejection at 6 and 12 months post transplantation and patient and graft survival at 12 months post transplantation |  | 12 months |