linjc16/ctgov huggingface dataset:
Alemtuzumab in Treating Patients With Advanced Chronic Lymphocytic Leukemia That Did Not Respond to Previous Fludarabine

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Monoclonal antibodies, such as alemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. PURPOSE: This phase II trial is studying how well giving alemtuzumab by injection works in treating patients with advanced chronic lymphocytic leukemia that did not respond to previous fludarabine.

Detailed Description
-----------------
OBJECTIVES: Compare the safety and efficacy of subcutaneous alemtuzumab vs intravenous alemtuzumab in patients with fludarabine-refractory advanced chronic lymphocytic leukemia. Determine the response in patients with high-risk genetic abnormalities (unmutated immunoglobulin variable heavy-chain [IgVH] status, del [17p], del [11q]) treated with subcutaneous alemtuzumab after progression on fludarabine. OUTLINE: This is a multicenter study. Patients receive alemtuzumab IV once, followed 1 week later by alemtuzumab subcutaneously once weekly for up to 12 weeks. PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.

Official Title
-----------------
Subcutaneous Campath-1H in Fludarabine-Refractory CLL

Conditions
-----------------
Leukemia

Intervention / Treatment
-----------------
* Biological: alemtuzumab


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Confirmed diagnosis of previously treated advanced chronic lymphocytic leukemia (CLL) Fludarabine-refractory disease Requires treatment PATIENT CHARACTERISTICS: Life expectancy more than 6 months ECOG 0-2 No severe organ dysfunction No other concomitant or previous neoplasms No autoimmune hemolytic anemia or thrombocytopenia PRIOR CONCURRENT THERAPY: See Disease Characteristics Up to 5 prior chemotherapy regimens allowed

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

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

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

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

Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: alemtuzumab|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and efficacy |  |  | 
| Response |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
refractory chronic lymphocytic leukemia, stage III chronic lymphocytic leukemia, stage IV chronic lymphocytic leukemia
Repair of Ischemic Mitral Regurgitation: Comparison Between Flexible and Rigid Annuloplasty Rings

Study Overview
=================
Brief Summary
-----------------
Mitral valve repair for ischemic mitral regurgitation is performed primarily by annuloplasty. There is some degree of late failure, which may be due in part to the type of ring employed. We want to compare late results with mitral valve annuloplasty using flexible vs rigid annuloplasty rings.

Conditions
-----------------
Mitral Regurgitation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients undergoing CABG with Mitral valve repair for ischemic MR Exclusion Criteria: Other valve procedures
Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------
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
-----------------
Ischemic MR, Annuloplasty
Systemic Inflammatory Response Syndrome (SIRS) in Patients Undergoing Major Procedures in Oral and Maxillofacial Surgery

Study Overview
=================
Brief Summary
-----------------
Patients undergoing major procedures in oral and maxillofacial surgery more often develop a systemic inflammatory response syndrome (SIRS) in the first days of postoperative critical care therapy than patients with a comparable major surgery in other regions. The reasons for this finding are unknown and have not been studied in depth so far. We hypothesize that surgical trauma in this region might activate pro-inflammatory pathways. By examining the proteome of patients at different stages (prior to the surgery, at ICU admission, on the second postoperative day and when SIRS has ended clinically), we aim to identify the involved pro-inflammatory pathways and identify possible target proteins that might be clues to modification of postoperative SIRS in the future.

Official Title
-----------------
Systemic Inflammatory Response Syndrome (SIRS) in Patients Undergoing Major Procedures in Oral and Maxillofacial Surgery

Conditions
-----------------
Systemic Inflammatory Response Syndrome (SIRS)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-99yrs scheduled for elective surgery with risk for development of SIRS written and informed consent Exclusion Criteria: age <18yrs pregnancy emergency surgery failure to obtain patient 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 |
| --- | --- | --- |
| change of concentration of pro-inflammatory cytokines [µg/l] | Change of concentration of pro-inflammatory cytokines from pre-operative sample over icu-admission, 2nd postoperative day and clinical end of SIRS. | up to 10 days post surgery |
Caphosol® Versus State-of-the-art Mouthcare in Patients With Allogeneic Stem Cell Transplantation: a Randomized Controlled Study About the Efficacy of the Mouth Rinse Caphosol®

Study Overview
=================
Brief Summary
-----------------
Randomized controlled study about the efficacy of the mouth rinse Caphosol in patients with allogeneic stem cell transplantation. 85% of the patients receive a severe oral mucositis due to their treatment. 70 patients will be randomized in the intervention (Caphosol) or in the standard (state-of-the-art) group. Primary endpoint is the duration of the mucositis, secondary endpoints are the occurence of oral mucositis measured with the WHO-scale and the occurence of pain measured with the NRS-scale (Numeric Rating Scale). Trial with medical device

Conditions
-----------------
Allogeneic Stem Cell Transplantation

Intervention / Treatment
-----------------
* Device: Caphosol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Allogeneic stem cell transplantation Male and female patients age 18-80 Signed informed consent after information Exclusion criteria: Contra-indications due to ethical reasons Unable to read or write Unable to speak or understand the german language Low-salt diet

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: State-of-the-art mouth care<br> | |
| Active Comparator: Mouth rinse Caphosol<br>Mouth rinse,aqueous solution. Caphosol is a preparation comprising two separately packaged aqueous solutions, a phosphate solution and a calcium solution, which, when both solutions are combined in equal volumes, forms a solution supersaturated with respect to both calcium and phosphate ions. | Device: Caphosol<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of oral mucositis |  | 20-30 days |
Axillary Lymphadenectomy. A Randomized Trial Comparing Bipolar Vessel Sealing To Conventional Technique

Study Overview
=================
Brief Summary
-----------------
lymphorrehea remains the most frequent complication after axillary lymphadenectomy. we hyphothesize that the use of a bipolar vessel sealing may reduce the rate of lymph collection compared to the traditional surgical technique

Official Title
-----------------
Axillary Lymphadenectomy. A Randomized Trial Comparing Bipolar Vessel Sealing To Conventional Technique

Conditions
-----------------
Axilla Node Dissection

Intervention / Treatment
-----------------
* Procedure: bipolar vessel sealing
* Procedure: control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with documented breast cancer (by histology or cytology) and candidate to elective axillary lymphadenectomy Exclusion Criteria: Age less than 18 years Denied written informed content Previous axillary operations (except for sentinel node biopsy) Preoperative radio-chemotherapy Scheduled reconstructive breast operation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vessel sealing<br>axilla dissection using this device | Procedure: bipolar vessel sealing<br> <br> |
| Active Comparator: control<br>standard surgical technique | Procedure: control<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction of lymphorrhea rate |  | forth postoperative day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction of lymph output from the axillary drain |  | forth postoperative days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
axilla, surgery, technique, bipolar vessel sealing
Optical Coherence Tomography in the Diagnosis of Scleritis and Episcleritis

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to describe the optical coherence tomography (OCT) findings in eyes with scleral inflammation and to differentiate cases with anterior scleritis from those with episcleritis and normal controls.

Detailed Description
-----------------
A total of 40 eyes will be included. 20 eyes with scleral inflammation and 20 eyes from healthy subjects as controls. Each patient will undergo complete ophthalmic and medical examination. Laboratory studies will performed whenever indicated. Optical coherence tomography B-scans of the sclera in the perilimbal area will done for all cases.

Official Title
-----------------
Optical Coherence Tomography in the Diagnosis of Scleritis and Episcleritis

Conditions
-----------------
Scleritis and Episcleritis

Intervention / Treatment
-----------------
* Other: Optical Coherence Tomography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over the age of 18 years any gender Patients with clinical signs of scleritis or episcleritis Signed informed consent Exclusion Criteria: Infectious keratitis or conjunctivitis Patients 18 years or younger Inability to open the eye

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with clinical signs of scleritis or episcleritis<br>Optical Coherence Tomography for patients with scleral inflammation | Other: Optical Coherence Tomography<br> <br> |
| Experimental: Normal subjects with normal sclera<br>Optical Coherence Tomography on eyes with normal scleral | Other: Optical Coherence Tomography<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe the optical coherence tomography (OCT) findings in eyes with scleral inflammation | To differentiate cases with anterior scleritis from those with episcleritis and normal controls | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Scleritis, Episcleritis, Optical coherence Tomography
A Post-marketing Study on the Safety of Abatacept Treatment in Denmark Using the Danish Database

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to expand on the ongoing post-marketing monitoring of abatacept to include all participants with rheumatoid arthritis (RA) and psoriatic arthritis (PsA) treated with abatacept captured in Danish Database for Biologic Therapies (DANBIO).

Official Title
-----------------
A Nationwide Post-marketing Study on the Safety of Abatacept Treatment in Denmark Using the DANBIO Register

Conditions
-----------------
Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of rheumatoid arthritis (RA) or psoriatic arthritis (PsA) Receiving treatment with abatacept Receiving treatment with non-targeted DMARD Receiving treatment with targeted DMARD Exclusion Criteria: -Not applicable

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 |
| --- | --- |
| Abatacept Group<br>Participants with established rheumatoid arthritis (RA) or psoriatic arthritis (PsA) and receiving abatacept | |
| Non-targeted Disease Modifying Anti-rheumatic Drug (DMARD) Group<br>Participants with established RA or PsA and not previously treated with any targeted disease modifying anti-rheumatic drugs (DMARDs) and who start treatment with a non-targeted DMARD | |
| Targeted DMARD Group<br>Participants with established RA or PsA and previously treated without abatacept who start treatment with targeted DMARDs | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence Rates of Overall Malignancies |  | Up to 5 years | 
| Incidence Rates of Melanoma |  | Up to 5 years | 
| Incidence Rates of Non-melanoma Skin Cancer |  | Up to 5 years | 
| Incidence Rates of Basal Cell Carcinoma |  | Up to 5 years | 
| Incidence Rates of Squamous Cell Carcinoma |  | Up to 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Abatacept, Orencia, Malignancies, Long-term safety follow-up
Mid-term Effect Observation of Biodegradable Conduit Small Gap Tublization Repairing Peripheral Nerve Injury

Study Overview
=================
Brief Summary
-----------------
To observe the Mid-term clinical effect of biodegradable conduit small gap tublization to repair peripheral nerve injury in multi-center．

Detailed Description
-----------------
In the study，150 cases of fresh peripheral nerve injury in the upper extremities are recruited in multi-center． After formally informed and obtaining the consent，the biodegradable conduit small gap tublization are used to repair the nerve．Their nerve functional recovery conditions are clinically observed according to the standard score methods provided by SHEN Ning-jiang and British Medical Research Council at 3 years after surgery．The excellent and good rates of the overall nerve functional recovery are calculated．

Official Title
-----------------
A Multi-center Study on Mid-term Effect Observation of Biodegradable Conduit Small Gap Tublization Repairing Peripheral Nerve Injury

Conditions
-----------------
Peripheral Nerve Injuries

Intervention / Treatment
-----------------
* Other: Degradable Conduit Small Gap Tublization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: fresh peripheral nerve injury in the upper extremities Exclusion Criteria: acute myocardial infarction history within 6 months, old and pathological peripheral nerve injury, acute and chronic infection, various consumptive diseases unable to tolerate surgery

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 |
| --- | --- |
| Degradable conduit small gap tublization<br>patients with fresh peripheral nerve injury in the upper extremities,repaired with degradable conduit small gap tublization | Other: Degradable Conduit Small Gap Tublization<br>* Degradable Conduit Small Gap Tublization Repairing Peripheral Nerve Injury<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nerve function 1 | standard score methods provided by British Medical Research Council | 3 years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nerve function 2 | standard score methods provided by Shen Ningjiang Using MSA system | 3 years after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Peripheral nervous system diseases, Wounds and injuries, Nerve regeneration, Biocompatible materials, Surgical procedures
Cognitive Effects of Interferon in Patients With Melanoma

Study Overview
=================
Brief Summary
-----------------
Interferon alpha is the only approved adjuvant biologic therapy for individuals diagnosed with high risk malignant melanoma (stage 2 or 3). There is evidence that interferon has some adverse cognitive effects on patients, but there are limited data. The investigators hypothesis is that compared to patients with melanoma who do not receive interferon, patients who have melanoma and are treated with interferon will show an objective decrease in performance on neurocognitive assessment. This study will enroll patients with melanoma who qualify for interferon, and either decide to undergo interferon treatment or choose watchful waiting instead. All patients will be assessed with a cognitive testing battery twice. Observation patients will undergo testing at their first appointment in which they consent to the study, as well as at their next physician visit, approximately 3 months from the first visit. Interferon patients will be tested immediately prior to starting interferon, as well as immediately after completing high dose interferon.

Official Title
-----------------
A Pilot Study of Neurocognitive Function in Patients Treated With Adjuvant Interferon Alpha-2b for High-Risk Melanoma

Conditions
-----------------
Melanoma

Intervention / Treatment
-----------------
* Biological: Interferon alpha


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with high risk malignant melanoma (defined as American Joint Committee on Cancer Stage IIb or greater) electing to undergo treatment with either adjuvant interferon alpha-2b, or observation only. Age 18 years or older. Karnofsky performance status greater than 60. Fluent English speaker. Exclusion Criteria: History of neurologic or psychiatric disease that will affect patient's ability to complete protocol tests. Clinical or radiological evidence of brain metastasis. Any condition, which in the opinion of the investigator makes the subject unsuitable for study participation.

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 |
| --- | --- |
| Observation<br>Patients with melanoma who qualify for interferon treatment, but choose not to receive it. | |
| Interferon alpha<br>Patients who receive high dose interferon alpha for 4 weeks | Biological: Interferon alpha<br> <br> * Other names: Intron-A;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cognitive function | Cognitive function as assessed by a brief neurocognitive testing battery | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Melanoma, Interferon, Cognition