linjc16/ctgov huggingface dataset:
Safety and Efficacy Study of LJP 394 (Abetimus Sodium) to Treat Lupus Kidney Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether LJP 394 (abetimus sodium) is safe and effective in delaying and reducing renal flares in patients with lupus nephritis.

Detailed Description
-----------------
LJP 394 (abetimus sodium) is a unique drug that is specifically designed to lower production of antibodies to double-stranded DNA. These antibodies are believed to contribute to kidney damage in patients with Systemic Lupus Erythematosus (SLE). Rising levels of these antibodies seem to be associated with exacerbations of kidney disease that are known as renal flares. Currently, anti-inflammatory and cytotoxic drugs are used to treat renal flares. Unfortunately, these drugs are often associated with certain unpleasant side effects. The purpose of this trial is to determine whether LJP 394 can delay or reduce the number of renal flares. It is possible that if renal flares can be delayed or reduced, patients may be able to take smaller amounts of anti-inflammatory or cytotoxic drugs and therefore suffer fewer of the side effects associated with these treatments.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Safety and Efficacy Trial of LJP 394 in Systemic Lupus Erythematosus (SLE) Patients With a History of Renal Disease

Conditions
-----------------
Immunologic Diseases, Autoimmune Diseases, Systemic Lupus Erythematosus, Lupus Nephritis, Lupus Glomerulonephritis

Intervention / Treatment
-----------------
* Drug: Abetimus sodium (LJP 394)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Diagnosed with SLE Historical evidence of SLE renal disease Elevated levels of dsDNA antibodies Weight of 40 kg or greater Exclusion Criteria Active SLE renal disease Use of certain anti-inflammatory or cytotoxic therapies or therapeutic interventions during the months immediately before dosing Clinical laboratory test values outside of certain limits Malignant disease or immunodeficiency syndrome Acute or chronic infections History of serious heart disease

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 70 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

| Intervention/Treatment |
| --- |
|Drug: Abetimus sodium (LJP 394)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SLE, Immunologic Diseases, Autoimmune Diseases, Systemic Lupus Erythematosus, Lupus Nephritis, Lupus Glomerulonephritis
Esmolol in Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
This large randomized double-blind clinical trial (esmolol vs placebo) will enroll patients undergoing cardiac surgery to study the additive cardiac protection of this therapeutic strategy.

Official Title
-----------------
Esmolol in Cardiac Surgery. A Randomized Controlled Trial With Clinical

Conditions
-----------------
Cardiac Surgery

Intervention / Treatment
-----------------
* Drug: Esmolol
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: end diastolic diameter >60 mm and/or an ejection fraction <50% written informed consent age >18 years Exclusion Criteria: previous unusual response to esmolol inclusion in other randomized studies esmolol administration in the previous 30 days emergency operation

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: esmolol<br>the study group will receive esmolol (1-3 mg/kg) | Drug: Esmolol<br>* esmolol (1-3 mg/kg) during cardiac surgery<br>* Other names: Beta-blocker; Beta blocker; breviblock;|
| Placebo Comparator: normosaline<br>normosaline (same ml of the study drug) | Drug: Placebo<br>* normosaline (same ml of the study drug)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite endpoint of number of dead patients and/or number of patients requiring prolonged ICU stay. |  | Hospital stay (approximately 2 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with ventricular fibrillation after cardiopulmonary bypass |  | 30 days and 1 year | 
| Number of patients with low cardiac output syndrome |  | 30 days and 1 year | 
| Number of patients requiring post-operative inotropic support |  | 30 days and 1 year | 
| peak postoperative cardiac troponin level |  | 30 days and 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
esmolol, cardiac surgery, cardiac anesthesia, mortality, beta blockers, beta-blockers, cardiac protection
20-year Implant Survival in Periodontally Healthy and Compromised Patients

Study Overview
=================
Brief Summary
-----------------
The aim of this study will be to compare the long-term outcomes of sandblasted and acid-etched (SLA) implants in patients previously treated for periodontitis and in periodontally healthy patients (PHP) after a follow-up of at least 20-years.

Official Title
-----------------
Long-term (20-year) Implant Survival and Success Rates in Patients Healthy and Compromised Patients

Conditions
-----------------
Peri-Implantitis, Dental Implant Failed, Bone Loss

Intervention / Treatment
-----------------
* Other: Oral Rehabilitation with dental implants


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: complete edentulism; presence of an implant-supported overdenture; mucosal diseases; alcohol and drug abuse; pregnancy; uncontrolled metabolic disorders; aggressive periodontitis; no interest in participating in the study Exclusion Criteria: Everything not as Inclusion Criteria

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PHP<br> | Other: Oral Rehabilitation with dental implants<br>* Patients have been treated with oral dental implants supporting fixed dental prostheses<br>|
| Moderate PCP<br> | Other: Oral Rehabilitation with dental implants<br>* Patients have been treated with oral dental implants supporting fixed dental prostheses<br>|
| Severe PCP<br> | Other: Oral Rehabilitation with dental implants<br>* Patients have been treated with oral dental implants supporting fixed dental prostheses<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant survival rate | Change in percentage of dental implants in situ / dental implants placed | Baseline; 10-year at the 20-year follow-up examination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Marginal Bone loss | Changes in mm of the peri-implant marginal bone loss | Baseline; 10-year at the 20-year follow-up examination |
Atypical Hemolytic-Uremic Syndrome (aHUS) Registry

Study Overview
=================
Brief Summary
-----------------
Post-marketing safety data on patients treated and untreated with eculizumab or ravulizumab.

Detailed Description
-----------------
The study will capture post-marketing safety data on patients treated with eculizumab or ravulizumab. Additionally, the study will collect information on the progression of disease in all patients.

Official Title
-----------------
An Observational, Non-Interventional, Multi-Center, Multi-National Study of Patients With Atypical Hemolytic-Uremic Syndrome (aHUS Registry)

Conditions
-----------------
Atypical Hemolytic-Uremic Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients of any age, including minors, who have been diagnosed with aHUS Patients with or without an identified complement pathogenic variant or anti-complement factor antibody Able to give written informed consent. Patient or patient's parent/legal guardian must be willing and able to given written informed consent and the patient (if minor) must be willing to give written informed assent [if applicable as determined by the central Institutional Review Boards/Independent Ethics Committees (IRB/IEC)]. ADAMTS13 > 5%, if performed. Exclusion Criteria: Hemolytic Uremic Syndrome (HUS) only due to Shiga Toxin producing Escherichia coli (STEC). Unable to give written informed consent. Patient or patient's parent/legal guardian unable to give written informed consent. Patient (if minor) unable to give written informed assent (if applicable as determined by the central Institutional Review Boards/Independent Ethics Committees [IRB/IEC]).
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 |
| --- | --- | --- |
| Proportion of patients who experience specified events | To collect and evaluate safety and effectiveness data specific to the use of eculizumab or ravulizumab in aHUS patients. | 10 years | 
| Time to first and subsequent occurrence of specified events. | To assess the long term manifestations of thrombotic microangiopathy (TMA) complications of aHUS as well as other clinical outcomes, including morbidity and mortality in aHUS patients, receiving eculizumab or ravulizumab treatment or other disease management approaches | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atypical Hemolytic-Uremic Syndrome, aHUS, Thrombotic Microangiopathy, TMA
Impact of MultiPoint Pacing Technology in CRT Patients With Reduced RV-to-LV Delay

Study Overview
=================
Brief Summary
-----------------
Observational, retrospective and perspective study with acute and chronic endpoints

Detailed Description
-----------------
Study to assess the benefit from Multipoint Pacing (MPP) in presence of RV-to-LV delay<80ms in terms of rate of CRT responder patients at 6 Months from CRT-D system implantation

Official Title
-----------------
Impact of MultiPoint Pacing Technology in CRT Patients With Reduced RV-to-LV Delay

Conditions
-----------------
Cardiac Resynchronization Therapy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Indication to CRT-D system implantation according to current guidelines or CRT-D system already implanted in patient scheduled to CRT-D system implantation according to current guidelines Exclusion Criteria: Right Bundle Branch Block Severe Irreversible Renal Failure (eGFR<30) NYHA IV Atrio-Ventricular Block above the 1st grade Prosthetic Valves Atrial Fibrillation at implantation

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group1-CRT<br>Patients with RV-to-LV delay≥80ms, CRT standard programming (single-point) | |
| Group2-MPP<br>Patients with RV-to-LV delay<80ms, CRT programming with MPP (multi-point) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of CRT responder patients | A patient is considered responder if Left Ventricular End-Systolic Volume at 6 Months from CRT-D system implantation is reduced at least of 15% towards the baseline value | 6 Months |
Analgetics vs Analgetics and Antibiotics for Pediatric Clinical and Sonographic Orchitis or Epididymitis

Study Overview
=================
Brief Summary
-----------------
Some children are admitted to pediatric emergency department due to epididymitis or orchitis. Some of them are treated by analgetics only whie some are treated by analgetics with antibiotics. The study will compare clinical presentation between groups and will compare pediatric urologic outpatient clinic follow up findings.

Detailed Description
-----------------
Some children are admitted to pediatric emergency department due to epididymitis or orchitis. Some of them are treated by analgetics only whie some are treated by analgetics with antibiotics. The study will compare clinical presentation between groups and will compare pediatric urologic outpatient clinic follow up findings.

Official Title
-----------------
Analgetics vs Analgetics and Antibiotics for Pediatric Clinical and Sonographic Orchitis or Epididymitis

Conditions
-----------------
Epididymitis Orchitis

Intervention / Treatment
-----------------
* Other: Antibiotics


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All children admitted to pediatric emergency department due to epididymitis or orchitis Exclusion Criteria: No sonographic or laboratory exam Antibiotic treatment before diagnosis No outpatient follow-up Known urologic congenital malformations Admission to inpatient department or emergency surgery

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

Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Analgetics only<br>Children with epididymitis / orchitis treated by analgetics only. | Other: Antibiotics<br>* Children with epididymitis / orchitis who were treated by antibiotics in addition to analgetics.<br>|
| Analgetics and antibiotics<br>Children with epididymitis / orchitis treated by analgetics and antibiotics. | Other: Antibiotics<br>* Children with epididymitis / orchitis who were treated by antibiotics in addition to analgetics.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healing | No symptoms any more | 1 month |
Analysis of the Glutathione Cycle in Children With Rett Syndrome

Study Overview
=================
Brief Summary
-----------------
Analyis of the Glutathione Cycle in Children with Rett Syndrome

Detailed Description
-----------------
To analyze the levels of glutathione and relevant glutathione metabolites in children with Rett syndrome in an effort to better understand disease pathology and biochemistry.

Official Title
-----------------
EPITRA-14-001: Analysis of the Glutathione Cycle in Children With Rett Syndrome

Conditions
-----------------
Rett Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 2 and 10, inclusive Genetically-confirmed diagnosis of Rett syndrome with MeCP2 mutation No change in dietary supplements in three months prior to the initial blood draw No participation in interventional pharmaceutical clinical trials in prior 12 months Exclusion Criteria: None other than meeting Inclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 10 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 |
| --- | --- | --- |
| Analysis of changes in levels of glutathione and relevant glutathione metabolites in children with Rett syndrome from baseline to the end of month 6 |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rett, MeCP2, Glutathione, Cysteine, ROS
This is an Early Study to Investigate the Effect of Gimatecan® in Adults With Malignant Glioma.

Study Overview
=================
Brief Summary
-----------------
Gimatecan® is Sigma-Tau Research's new, potent, oral Topoisomerase I inhibitor. Drugs in this class play a crucial role in destroying DNA replication in tumors. We are conducting this study to determine the Maximum Tolerated Dose of our compound. In addition, we plan to assess the drug's ability to affect the evolution of malignant gliomas, when given as a capsule, rather than by intravenous injection.

Official Title
-----------------
Oral ST1481 in Adults With Malignant Glioma: a Phase I-II Clinical Trial

Conditions
-----------------
Malignant Glioma

Intervention / Treatment
-----------------
* Drug: Gimatecan® (ST 1481)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Histologically confirmed diagnosis of a recurrent primary malignant glioma Life expectancy of at least 3 months with normal hematological, liver and renal function Exclusion criteria: Pregnant and lactating patients Participation in any investigating drug study within 4 weeks preceding treatment start or concurrent treatment with any other anti-cancer therapy Gastrointestinal dysfunction that could alter absorption or motility

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Gimatecan® (ST 1481)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Malignant Glioma, Camptothecin, Pharmacokinetics
The Pandemic's Effect on Diagnosis and Treatment of Rectal Cancer

Study Overview
=================
Brief Summary
-----------------
Colorectal cancer is common with an annual prevalence of 6000. The majority can be cured and the five year survival rate is over 60%. In december 2019 reports came in about SARS-Cov-2, which later was named Covid-19. The World Health Organization classified it as a pandemic in March 2020. In Sweden the number of patients with Covid-19 increased mainly in the urban areas in March 2020. Care for patients with other diseases were affected and local changes from guidelines were adopted. In some regions and countries the indications for adjuvant and neoadjuvant treatment for colorectal cancer were somewhat changed. The number of patients diagnosed with colorectal cancer also decreased, as well as other types of cancer. The true effect on outcome with a delayed diagnosis remains unknown. The aim of this study is to evaluate the effects of the Covid-19 pandemic on the diagnosis, treatment and survival of patients with colorectal cancer.

Official Title
-----------------
An Analysis of Covid-19 Effect on Patients With Colorectal Cancer - Follow-up Regarding Tumour Stage, Neoadjuvant Treatment, Delay and Long-term Survival

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

Intervention / Treatment
-----------------
* Other: Diagnosed during or not during the pandemic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Rectal cancer diagnosis 2019-2022 Exclusion Criteria: No rectal cancer diagnosis 2019-2022

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 |
| --- | --- |
| Patients diagnosed before, during or after the pandemic<br>Patients with rectal cancer | Other: Diagnosed during or not during the pandemic<br>* We will create a group of patients that are diagnosed before and after the pandemic and one group diagnosed during the pandemic<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Yearly incidence of rectal cancer | The number of patients diagnosed yearly 2019, 2020, 2021 and 2022 | 2019-2022 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms at diagnosis | Symptoms at diagnosis as reported by patients | 6 months prior diagnosis | 
| Patient's delay | Delay from symptoms until doctors appointment | 12 months prior diagnosis | 
| Doctor's delay | Delay from doctor's appointment until diagnosis | 12 months prior diagnosis | 
| Treatment changes | Any changes from the treatment plan due to covid-19 | Diagnosis and 12 months following |