linjc16/ctgov huggingface dataset:
European CML Blast Crisis Register

Study Overview
=================
Brief Summary
-----------------
Multicentric prospective and retrospective register collecting patient with CML blast crisis diagnosed in Germany and Europe

Detailed Description
-----------------
Since the advent of treatment with tyrosine kinase inhibitors (TKI), the incidence of blast crises has significantly decreased. Nevertheless, about 5% of patients diagnosed with chronic myeloid leukemia (CML) will evolve into a blast phase at some point during the course of their disease. Furthermore, despite the advances made in CML treatment, outcome of patients with blast crises are still dismal. Due to the rarity of this condition clinical trials are challenging, and collaboration between researchers both at national and international level is needed to collect a meaningful number of data.

Official Title
-----------------
European CML Blast Crisis Register

Conditions
-----------------
Chronic Myeloid Leukemia in Myeloid Blast Crisis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 years Diagnosis of BCR-ABL positive CML blast crisis according to the WHO criteria: Blasts 20% or more of peripheral blood white cells or bone marrow cells or Extramedullary blast proliferation or Large foci or clusters of blasts in bone marrow biopsy Exclusion Criteria: Lack of informed consent

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 |
| --- | --- | --- |
| Overall survival | how many patients survive after a blast crisis event | through study completion in 2024 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of hematologic response to treatment | how many patients have a hematologic response to the local standard Treatment after a blast crisis event | through study completion in 2024 | 
| Rate of molecular response to treatment | how many patients have a molecular response to the local standard Treatment after a blast crisis event | through study completion in 2024 | 
| Rate of blast crises in Europe in the era of TKI treatment | how many patients have blast crisis events compared to all treated CML-patients in the trial centers | through study completion in 2024 |
SAPHNELO Systemic Lupus Erythematosus Japan Post-Marketing Surveillance (PMS)

Study Overview
=================
Brief Summary
-----------------
To collect information on and evaluate the long-term safety and effectiveness of Anifrolumab in patients with systemic lupus erythematosus in the real-world post-marketing setting.

Detailed Description
-----------------
The objective of the Specific Use Result Study is to collect information on and evaluate the long-term safety and effectiveness of Anifrolumab in patients with systemic lupus erythematosus insufficiently responding to currently available treatment in the real-world post-marketing setting. This investigation will be conducted to support the application for re-examination specified in Article 14-4 of the Pharmaceutical Affairs Law.

Official Title
-----------------
Saphnelo for Intravenous Infusion 300 mg Specific Use Result Study All Patient Investigation in Patients With Systemic Lupus Erythematosus

Conditions
-----------------
Lupus Erythematosus, Systemic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with systemic lupus erythematosus insufficiently responding to currently available treatment - Exclusion Criteria: None -
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 |
| --- | --- | --- |
| Incidence of ADRs | Incidence of ADRs related to Anifrolimab. Safety specification: Herpes zoster, serious infections, anaphylaxis, malignancy and reactivation of hepatitis B virus | from the baseline to 52 weeks |
Trial to Compare FFR Measurement With a Non-Side-Hole Guide Catheter Vs. a Side-Hole Guide Catheter

Study Overview
=================
Brief Summary
-----------------
The investigators propose a single center prospective study that will assess two different strategies for measuring Fractional Flow Reserve (FFR) in patients undergoing clinically-indicated coronary angiography in whom FFR measurement is indicated. FFR will be measured with a non-side hole guide catheter (with the guide catheter both engaged and disengaged from the coronary ostium) and with a side-hole guide catheter (with the guide catheter both engaged and disengaged from the coronary ostium) to determine, whether measurements obtained with an engaged side-hole guide catheter are more accurate as compared with those obtained with the engaged non-side hole catheter.

Official Title
-----------------
Trial to Compare FFR Measurement With a Non-Side-Hole Guide Catheter Vs. a Side-Hole Guide Catheter

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Other: FFR Measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undergoing a clinically indicated coronary catheterization Need FFR of a coronary artery lesion Agree to participate and able to provide informed consent Exclusion Criteria: Significant difficulty advancing the pressure measuring guidewire into the coronary artery Severe chronic obstructive pulmonary disease Severe ostial disease (>70% diameter stenosis within 5 mm from the coronary artery ostium)

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: Diagnostic
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Side-Hole Catheter<br>2 FFR measurements from an engaged side-hole guide catheter and a disengaged side-hole guide catheter | Other: FFR Measurement<br> <br> |
| Experimental: Non-Side-Hole Catheter<br>2 FFR measurements from an engaged non-side-hole guide catheter and a disengaged non-side-hole guide catheter | Other: FFR Measurement<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FFR measurement using a guide catheter with and without side holes |  | Less than 1 hour during the coronary angiography |
Study Evaluating Intravenous CMD-193 in Subjects With Advanced Malignant Solid Tumors

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to evaluate the safety, tolerability, and maximum tolerated dose (MTD) of CMD-193 administered intravenously (IV) to subjects with advanced malignant tumors. The secondary purpose is to obtain preliminary information on the pharmacokinetics and antitumor activity of IV CMD-193.

Official Title
-----------------
Phase 1 Dose-Escalation Study of Intravenous CMD-193 in Subjects With Advanced Malignant Solid Tumors

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

Intervention / Treatment
-----------------
* Drug: CMD-193


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Malignant solid tumor progressed, or no standard treatment available Tumor expression of Lewis Y antigen Exclusion Criteria: Cancer therapy within 28 days before enrollment Pregnant or breastfeeding women Unstable or serious concurrent medical conditions

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 74 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: CMD-193|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose Limiting Toxicity, Adverse Event |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics parameters, Tumor assessment |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tumor
Colorectal Cancer in Crohn's Disease

Study Overview
=================
Brief Summary
-----------------
Retrospective multicentre study. All patients with a diagnosis of Crohn's disease (CD) and operated for colorectal cancer (CRC) between 01/01/2010 and 01/01/2020 will be included in the dataset. Data will include preoperative, intraoperative and postoperative variables, with long term follow up when feasible. The study will focus on a comparison between patients treated with total proctocolectomy (TPC) and patients treated with subtotal colectomy (STC) or segmental resection (SR). Primary endpoints will be oncologic outcomes, postoperative morbidity and mortality. Secondary endpoints include quality of life (QoL).

Official Title
-----------------
Colorectal Cancer in Crohn's Disease: Long Term Outcomes of Different Surgical Procedures

Conditions
-----------------
Crohn Disease, Colorectal Cancer, Inflammatory Bowel Diseases

Intervention / Treatment
-----------------
* Procedure: Total proctocolectomy
* Procedure: Total colectomy
* Procedure: Segmental colectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with a diagnosis of Crohn's disease and concomitant primary colorectal cancer who underwent surgery in an expert centre between 01/01/2010 and 01/01/2020 Exclusion Criteria: Patients who underwent non-oncologic segmental resection will be excluded from outcome analysis. Patients with known genetic colorectal cancer syndromes (eg. Familial Adenomatous Polyposis, Hereditary Non-Polyposis ColoRectal Cancer Syndrome)

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 |
| --- | --- |
| Chron's disease patients with colorectal cancer<br>This group of patients with Chron's disease have been diagnosed with colorectal cancer and treated surgically | Procedure: Total proctocolectomy<br>* excision of the whole large bowel including colon and rectum and end ileostomy fashioning<br>Procedure: Total colectomy<br>* excision of the colon with preservation of the rectum<br>Procedure: Segmental colectomy<br>* excision of a segment of colon<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | percentage of patients alive | 5 years | 
| disease free survival | percentage of patients disease free | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colorectal surgery
Tigecycline for Treatment of Rapidly Growing Mycobacteria

Study Overview
=================
Brief Summary
-----------------
To determine the safety, tolerance, and efficacy of Tigecycline when given daily to patients with rapidly growing mycobacterial disease (especially M.abscessus).

Detailed Description
-----------------
To assess the safety and efficacy of tigecycline in the treatment of drug resistant rapidly growing mycobacterial disease especially M. abscessus

Official Title
-----------------
Use of Tigecycline for Treatment of Serious Infection Due to Rapidly Growing Mycobacteria (Especially M.Abscessus)

Conditions
-----------------
Mycobacterium Abscessus Lung Disease, Rapidly Growing Mycobacterial Lung Disease

Intervention / Treatment
-----------------
* Drug: Tigecycline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Positive cultures for rapidly growing mycobacteria Patients who have drug resistant isolates or are intolerant of macrolides or have serious infections unresponsive to currently available drugs Adults and children 10 years of age and older Pretreatment isolate of M. avium complex available for MIC determination Available for followup appointments Exclusion Criteria: History of tetracycline allergy If a menstruating female, not pregnant and on adequate birth control

Ages Eligible for Study
-----------------
Minimum Age: 10 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tigecycline<br>tigecycline titrated dose according to patient age and clinical status | Drug: Tigecycline<br>* Tigecycline dosage based on age and clinical status of patient.<br>* Other names: tygacil;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical and microbiological outcomes such as clinical symptoms and laboratory cultures | culture neg X3 ( sputum conversion) | 6 mos | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical and Microbiological outcomes | clinical and radiographic improvements | 6 mos |
Clinical Monitoring, MRI and Neuro-Ophthalmology of a Cohort of Patients With a Clinically Isolated Syndrome (CIS)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to develop tools to detect, measure, monitor and predict axonal damage in the course of CIS and during Multiple sclerosis (MS), in order to be able to consider as early as possible an adaptation of the background treatment in patients with MS. patients with radiological criteria of poor long-term clinical course.

Official Title
-----------------
Clinical Monitoring, MRI and Neuro-Ophthalmology of a Cohort of Patients With a Clinically Isolated Syndrome

Conditions
-----------------
Clinically Isolated Syndrome, Multiple Sclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient who has had a CIS of less than 4 months (+/- 15 days), with at least 1 inflammatory lesion on his initial brain MRI or with normal brain MRI associated with the presence of oligoclonal bands in the CSF, Exclusion Criteria: Atypical CIS for a first relapse of multiple sclerosis (extensive myelitis, bilateral retrobulbar optic neuritis immediately) CIS dating more than 4 months (+/- 15 days) Corticotherapy in the last 4 weeks

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- | --- |
| severity of the disease defined by Expanded Disability Status Scale (EDSS) ≥ 2.0 |  | At 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of a second push |  | At 5 years | 
| Occurrence of progression of the EDSS (Expanded Disability Status Scale) score | The scale evaluated the pyramidal, cerebellar, sensory, visual and mental functions . These make it possible to obtain a quotation between 0 and 10. The walk is called normal from 0 to 3.5. The walk is hampered from 4 and impossible from 7.5. The coast of 10 corresponds to the death of the patient. This measure differentiates two groups: severe EDSS and non-severe EDSS group, | At 5 years | 
| Occurrence of a handicap objectified by the Multiple Sclerosis Functional Composite(MSFC) |  | At 5 years | 
| variation of parameters measuring axonal pain / degeneration in MRI |  | At 5 years | 
| variation of parameters measuring axonal pain / degeneration in OCT |  | At 5 years |
Opioid Induced Bowel Dysfunction in Patients Undergoing Cesarean Section

Study Overview
=================
Brief Summary
-----------------
Constipation is common in pregnant women. Surgery, anaesthesia and opioid analgesics may further impair bowel function. The aim of the present study was to evaluate if oxycodone-naloxone combination compared to oxycodone reduced bowel dysfunction in patients undergoing caesarean section.

Official Title
-----------------
Opioid Induced Bowel Dysfunction in Patients Undergoing Cesarean Section

Conditions
-----------------
Constipation, Pain, Postoperative

Intervention / Treatment
-----------------
* Procedure: Caesarean section
* Drug: Oxycodone
* Drug: oxycodone-naloxone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • elective caesarean section in spinal anaesthesia normal full term single pregnancy age 18 years or more BMI 20 - 35 kg/m2 written informed consent obtained Exclusion Criteria: • not normal or full term pregnancy age less than 18 years allergy to study drugs substance misuse other contraindication to used study drugs no informed consent

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oxycodone<br>Oxycodone 10 mg prolonged release tablet twice a day after caesarean section | Procedure: Caesarean section<br>* After caesarean section oxycodone or oxycodone-naloxone prolonged release tablet twice a day is started for pain medication<br>Drug: Oxycodone<br> <br> |
| Experimental: Oxycodone-naloxone<br>Oxycodone-naloxone 10/5 mg prolonged release tablet twice a day after caesarean section | Procedure: Caesarean section<br>* After caesarean section oxycodone or oxycodone-naloxone prolonged release tablet twice a day is started for pain medication<br>Drug: oxycodone-naloxone<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with opioid induced bowel dysfunction assessed with bowel function index |  | time from the first drug intake up to three weeks postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxycodone concentrations in maternal plasma |  | time before the first drug intake to the day when patient leaves the hospital up to maximum of seven days postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
constipation, oxycodone, caesarean section
Follow-up Study of Safety of Enteric-coated Mycophenolate Sodium in Patients Who Successfully Completed Study CERL080A302

Study Overview
=================
Brief Summary
-----------------
Aim of study is to collect long term safety data on enteric-coated mycophenolate sodium 720 mg bid in combination with cyclosporine with/without steroids in regard to adverse events, serious adverse events, and patient and graft survival. After successful completion of the study CERL080A302, patients who previously were receiving enteric-coated mycophenolate sodium or MMF were given opportunity to remain on enteric-coated mycophenolate sodium or convert MMF to enteric-coated mycophenolate sodium.

Official Title
-----------------
Multicenter, Open-label Follow-up Study on the Safety of Enteric-coated Mycophenolate Sodium in Maintenance Renal Transplant Patients

Conditions
-----------------
Renal Transplant

Intervention / Treatment
-----------------
* Drug: Mycophenolate sodium (enteric coated)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -First cadaveric, living unrelated or living related donor kidney transplant recipients who completed study CERL080A302 Exclusion Criteria: Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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: Mycophenolate sodium (enteric coated)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the incidence and severity of GI adverse events (AEs) and neutropenia in the first 3 months of treatment in maintenance renal transplant patients. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety/efficacy based on adverse event (AE) reporting. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Renal Transplant, adults, immunosuppressant