linjc16/ctgov huggingface dataset:
Observational Study of Disease Severity in Participants Diagnosed With Crohn's Disease and Long Term Impact of Treatment Strategies in Participants With Moderate to Severe Crohn's Disease (Protocol P06484)

Study Overview
=================
Brief Summary
-----------------
This is an observational study to determine the prevalence of moderate to severe Crohn's disease (CD) among patients with active CD and to evaluate existing therapeutic trends in a standard clinical practice.

Official Title
-----------------
Observational Study on Disease Severity, Evaluation Tools and the Long Term Impact of Each Treatment Strategy in the Daily Clinical Practice in Patients With Moderate to Severe Active Crohn's Disease (Protocol P06484)

Conditions
-----------------
Crohn Disease

Intervention / Treatment
-----------------
* Drug: Physician standard-of-care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Must have a diagnosis of active Crohn's Disease irrespective of severity, Must be inadequately controlled with their current therapy and for whom physician decides to switch treatment. Must be between 18 and 65 years of age, of either sex, Must demonstrate willingness to participate in the study by signing the written informed consent. Exclusion Criteria No specific exclusion criteria will be applied to a participant as long as the participant is eligible for the trial

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants<br>All participants enrolled | Drug: Physician standard-of-care<br>* Participants will be treated according to their physician's routine practice and the respective Summary of Product Characteristics (SmPC).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Crohn's disease participants among the study population with a Crohn's Disease Activity Index (CDAI) score of 220-450 at the enrollment to the study. |  | Week 0 | 
| Record of treatment strategy followed |  | Week 0 to 2 years | 
| Change in the CDAI score during the observational period |  | Week 0 to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of surgeries and hospitalizations during the observational period |  | Week 0 to 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Crohn's disease, standard-of-care, Crohn Disease, Active Crohn's Disease
Multicenter Cohort Study of Invasive Fungal Filamentous Fungal Infections in Liver Transplant Patients

Study Overview
=================
Brief Summary
-----------------
Invasive filamentous fungal infections (aspergillosis, scedosporiosis, mucormycosis, fusarium wilt) are frequent and serious in immunocompromised individuals and especially in organ transplant patients. There is little recent data in liver transplantation, especially on the incidence and risk factors of fungal infections

Official Title
-----------------
Multicenter Retrospective Cohort Study of Invasive Fungal Filamentous Fungal Infections in Liver Transplant Patients

Conditions
-----------------
Fungal Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Age ≥18 years old Subject with liver transplantation in one of the centers participating in the study Invasive fungal infection with filamentous fungus between 2007-2021 Proven or probable infection with filamentous fungi according to the EORTC / MSGERC criteria Subject not having expressed, after information, his opposition to the reuse of his data for scientific research purposes. Non-inclusion criteria Subject having expressed opposition to participating in the study Subject not transplanted liver Subject under guardianship, curatorship or safeguard of justice

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 |
| --- | --- | --- |
| Study of the incidence, risk factors and prognostic factors associated with invasive fungal filamentous fungal infections in liver transplant patients. |  | Files analysed retrospectively from January 01, 2007 to December 31, 2021 will be examined] | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fungal Infection, Immunodeficiency, Fungal filamentous, Liver transplant, Organ transplant
Effect of Banana Blossom on Breast Milk Volume in Mothers of Preterm Newborns

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the effect of banana blossom in increasing breast milk volume

Official Title
-----------------
Effect of Banana Blossom on Breast Milk Volume in Mothers of Preterm Newborns, a Randomized, Double Blinded, Placebo-controlled Trial

Conditions
-----------------
Preterm Birth, Postpartum Women

Intervention / Treatment
-----------------
* Drug: Banana Blossom
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postpartum women of preterm newborns Exclusion Criteria: Postpartum women with contraindication for breast feeding such as HIV, herpes zoster at breast, infected wound at breast. Postpartum women with preeclampsia, diabetes mellitus, postpartum hemorrhage. Postpartum women with allergy to banana blossom. Postpartum women with previous breast surgery or nipple surgery. Postpartum women who smoking. Preterm newborns with unstable conditions.

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

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Banana blossom<br>Participants received banana blossom 225 mg tablet orally four time per day for 14 days. | Drug: Banana Blossom<br>* Banana Blossom 225 mg tablet orally four times per day for 14 days<br>|
| Placebo Comparator: Placebo<br>Participants received placebo tablet orally four time per day for 14 days. | Drug: Placebo<br>* Placebo tablet orally four times per day for 14 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breast milk volume per day at day 14 | Breast milk volume measurement in milliliters | at day 14 | 
| Breast milk volume per day at day 3 | Breast milk volume measurement in milliliters | at day 3 | 
| Breast milk volume per day at day 7 | Breast milk volume measurement in milliliters | at day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of good satisfaction | satisfaction evaluated by 5 Likert scales | at 14 days | 
| percentage of side effects during intervention | percentage of participants with side effects such as headache, nausea/vomiting assessing by asking | day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 | 
| percentage of drug compliance | percentage of complete drug use assessing by remained drug counting | at 14 days | 
| factors associated with increasing breast milk volume | factors associated with increasing breast milk volume assessing by univariate and multivariate analysis | at 14 days |
A Phase II Study of Carboplatin Plus Irinotecan Versus Irinotecan in Children With Refractory Solid Tumors

Study Overview
=================
Brief Summary
-----------------
This clinical research study is being conducted to investigate the effectiveness of combining carboplatin and irinotecan, versus irinotecan alone, in treating children who have refractory solid tumors.

Conditions
-----------------
Neoplasms

Intervention / Treatment
-----------------
* Drug: carboplatin + irinotecan
* Drug: irinotecan


Participation Criteria
=================
Eligibility Criteria
-----------------
children 1-21 years of age confirmed diagnosis of measurable solid tumor, including brain tumor, which has progressed on or after standard therapy, or for which no effective standard therapy is known at least 4 weeks since last dose of immunotherapy, radiotherapy, or chemotherapy no more than 3 prior chemotherapies no symptomatic brain metastases

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 21 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br> | Drug: carboplatin + irinotecan<br>* Solution, IV, Carbopaltin AUC 4 mg/ml.min every 21 days; irinotecan 12 mg/m2/day x 10 days , Minimum of two cycles of chemotherapy projected to be up to 6.<br>* Other names: Paraplatin;|
| Active Comparator: Arm B<br> | Drug: irinotecan<br>* Solution, IV, irinotecan 12 mg/m2/day x 10 days, minimum of two cycles of chemotherapy projected to be up to 6.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| estimate response rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluate safety |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
unspecified childhood solid tumor, protocol specific
Efficacy and Safety of Levetiracetam in Routine Clinical Practice in Czech and Slovak Republics, Hungary, and Romania.

Study Overview
=================
Brief Summary
-----------------
To evaluate, over 1 year period, the efficacy and safety of newly prescribed levetiracetam as add-on treatment (POS, myoclonoc seizures in JME and PGTCS in IGE) or primary monotherapy (partial onset seizures) in adult and paediatric patients within the approved age limits in routine clinical practice in Czech and Slovak Republics, Hungary, and Romania. Non-interventional study.

Official Title
-----------------
Long-term Evaluation of the Efficacy and Safety of Levetiracetam in Routine Clinical Practice in the Czech and Slovak Republics, Hungary, and Romania - Non-interventional Study

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnoses of partial onset seizures (POS) with or without secondary generalisation or Juvenile Myoclonic Epilepsy (JME) or another IGE with PGTCS newly prescribed levetiracetam as add-on treatment (POS, myoclonic seizures in JME and PGTCS in IGE) or monotherapy (partial onset seizures only) in newly diagnosed patients. Newly prescribed means inclusion of the patients in whom a decision has been made to prescribe LEV and the first dose is just to be prescribed. age 4 years or above for partial onset seizures, 12 years or above for MS in JME or PGTCS in IGE, 16 years or above for monotherapy patient written informed consent Exclusion Criteria: indications other than those defined in inclusion criteria history of allergic or anaphylactic reactions to levetiracetam or other pyrrolidone derivatives and excipients included

Ages Eligible for Study
-----------------
Minimum Age: 4 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 |
| --- | --- |
| Levetiracetam<br>Patients treated with Levetiracetam | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention rate after 6 and 12 months |  | 6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seizure freedom for the last 6 and 12 months |  | 6 and 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Levetiracetam, Keppra, Epilepsy, Efficacy, Safety
Long Term Outcomes After Laparoscopic Intersphincteric Resection With Total Mesorectal Excision for Low Rectal Cancer.

Study Overview
=================
Brief Summary
-----------------
Through a double blinded study, patients with low rectal cancer will be randomized into two equal groups to compare between the 5 year disease free survival as a primary outcome measure.

Official Title
-----------------
Long Term Outcomes After Laparoscopic Intersphincteric Resection With Total Mesorectal Excision for Low Rectal Cancer: a Double Blind Randomized Clinical Trial

Conditions
-----------------
Low Rectal Cancer

Intervention / Treatment
-----------------
* Procedure: laparoscopic intersphincteric resection
* Procedure: open intersphincteric resection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Low rectal cancer below 5 cm from the anal verge Fit for laparoscopic total mesorectal excsion T2, T3 rectal cancer No distant metstasis Exclusion Criteria: T1, AND T4 Distant metastasis Tumor infiltrating the dentate line unwilling to participate

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Laparoscopic group<br> | Procedure: laparoscopic intersphincteric resection<br>* laparoscopic intersphincteric resection for low rectal cancer<br>|
| Active Comparator: Open group<br> | Procedure: open intersphincteric resection<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Free survival |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local recurrence |  | 5 years | 
| Distant metstasis |  | 5 years | 
| 5 year survival |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intersphincteric resection, laparoscopic rectal rescetion, total mesorectal excsison
ABCSG 8 - Adjuvant Treatment in Patients With Hormone Receptor-positive Breast Cancer With Good to Moderate Differentiation.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the difference in event-free survival between postmenopausal women with hormone receptor-positive early breast cancer who switched from tamoxifen to anastrozole and those who continued to receive tamoxifen.

Official Title
-----------------
Adjuvant Endocrine Therapy in Postmenopausal Patients With HR +ve BC With Good to Moderate Differentiation - ARNO (Arimidex + Nolvadex). Primary Treatment for 2 Years With Tamoxifen Thereafter Randomisation to: Tamoxifen 3 Years or Anastrozole 3 Years.

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

Intervention / Treatment
-----------------
* Drug: Tamoxifen
* Drug: Anastrozole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Invasive mammary carcinoma after radical treatment, without prior chemo/hormone/radiation therapy. At least 6 lymph nodes examined. Good or intermediate tumour differentiation. <6 weeks before start of adjuvant therapy. Oestrogen or Progesterone positive Exclusion Criteria: Premenopausal. Preoperative hormonal/antihormonal/radiation/cytoxic chemo. Second malignant tumour/status post second malignant tumour. In-situ/T4 carcinoma. Age >80 years. World Health Organisation performance index >3. Serious accompanying diseases

Ages Eligible for Study
-----------------
Maximum Age: 80 Years

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

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: Tamoxifen|nan|
|Drug: Anastrozole|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the difference in event free survival and overall survival (subject to stand-alone or combined/meta-analysis) between postmenopausal women with HR +ve early BC who switched from tamoxifen to anastrozole and those who continued on tamoxifen. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the difference in event free survival & overall survival (subject to stand-alone or combined/meta-analysis) plus side effects between postmenopausal women with HR+ve early BC who switched from tam to anastrozole and those who continued on tam. |  |  |
Comparison of Dexamethasone Oral Preparations to Assess Taste and Acceptance in Children With Asthma and Croup

Study Overview
=================
Brief Summary
-----------------
Study of the palatability and acceptability of dexamethasone oral tablets crushed and placed in apple sauce or pudding in comparison with the IV solution mixed with sugar syrup and given orally. It is hypothesized that dexamethasone tablets crushed and administered in apple sauce or pudding will be more palatable and acceptable for pediatric patients receiving dexamethasone for an acute asthma exacerbation or croup.

Official Title
-----------------
Comparison of Dexamethasone Oral Preparations to Assess Palatability and Adverse Effects in Children With Asthma and Croup

Conditions
-----------------
Asthma, Croup

Intervention / Treatment
-----------------
* Drug: Dexamethasone IV for PO
* Drug: Dexamethasone crushed tablets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of acute asthma exacerbation or croup (laryngotracheitis) in the Vanderbilt Children's Hospital Emergency Department Age 1 to 7 years Dexamethasone treatment indicated No other acute or chronic process accounting for signs and symptoms (e.g., foreign body aspiration, pneumonia, cystic fibrosis) Have not received systemic corticosteroid for current episode prior to enrollment Exclusion Criteria: Allergy to dexamethasone or apple sauce and pudding Unable to take medication orally

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 7 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexamethasone IV for PO<br>Dexamethasone IV for PO solution mixed with sugar syrup to be given orally | Drug: Dexamethasone IV for PO<br>* Common pediatric emergency department practice<br>* Other names: Dexamethasone injection;|
| Active Comparator: Dexamethasone crushed tablets<br>Dexamethasone tablet crushed and placed in apple sauce or pudding to be given orally | Drug: Dexamethasone crushed tablets<br>* Alternative route of administration for patients unable to swallow tablet whole<br>* Other names: Dexamethasone oral tablet;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Nausea | Presence of nausea after medication administration (yes/no) measured by participant self-report | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Requiring Second Dose of Dexamethasone | Reason for patient needing a second dose of dexamethasone; such as spit dose up or vomiting dose | 1 hour |
Efficacy and Safety of Tazarotene Gel in Nail Psoriasis

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine the efficacy and safety of topical application of the gel compared to placebo in nail psoriasis.

Official Title
-----------------
A Phase II Trial to Evaluate the Anti-psoriatic Efficacy and Tolerability of Tazarotene in a Gel Formulation in Patients With Mild to Moderate Nail Psoriasis - Parallel Group Comparison

Conditions
-----------------
Nail Psoriasis

Intervention / Treatment
-----------------
* Drug: Experimental Tazarotene Gel
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Key inclusion criteria: Mild to moderate nail psoriasis on at least one fingernail Exclusion Criteria: Key exclusion criteria: any other skin condition, with a potential to affect the nails or to interfere with evaluation of the disease; history of hypersensitivity to retinoids or to other components of the trial medication topical treatment of nails with antipsoriatics in the 4 weeks preceding the treatment phase; systemic treatment of psoriasis within the three months before the treatment phase of the trial or during the trial intralesional steroid injection before the treatment phase of the trial phototherapy before the treatment phase of the trial; any chronic infection or condition capable of interfering with the conduct of the trial; evidence of drug or alcohol abuse; symptoms of a clinically significant illness that may influence the outcome of the trial in the four weeks preceding the treatment phase of the trial; participation in another clinical trial within the last 4 weeks prior to first treatment in this clinical trial; pregnancy or nursing;

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tazarotene Gel<br>once daily | Drug: Experimental Tazarotene Gel<br> <br> |
| Placebo Comparator: Placebo Gel<br>once daily | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % reduction in the Nail Psoriasis Severity Index ( NAPSI ) |  | Day85 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability |  | Day 85 |