cyrilzakka/clinical-trials huggingface dataset:
Risk Adapted Therapy in Diffuse Large B Cell Lymphoma

This randomized phase II trial is studying two different combination chemotherapy regimens to compare how well they work in treating patients with diffuse large B-cell lymphoma.

objectives:

1. To compare the response rates and toxicity of R-CHOP versus DA-EPOCH-R in untreated CD20+ diffuse large B-cell lymphomas.
2. To compare the event-free survival of R-CHOP versus DA-EPOCH-R chemotherapy in untreated CD20+ diffuse large B-cell lymphomas.
3. To develop predictors of outcome of R-CHOP and DA-EPOCH-R chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* 1. Histologically documented de novo CD20+ DLBCL with stage II, III or IV disease.

Stage I primary mediastinal (thymic) DLBCL is also eligible. Diagnosis should be based on an adequate tissue sample, including open biopsy or core needle biopsy.

Needle aspiration for primary diagnosis is unacceptable.

Patients must have one of the following WHO classification subtypes:

Diffuse large B-cell lymphoma (includes morphological variants: centroblastic, immunoblastic, T-cell/histiocyte rich, and anaplastic) Mediastinal (thymic) large B-cell lymphoma Intravascular large B-cell lymphoma Patients without adequate frozen material should have a biopsy performed to obtain material.

2. Patients may be entered if they have received prior limited field radiation therapy or a short course of glucocorticoids (\< 10 days) for an urgent local disease complication at diagnosis (e.g., cord compression, SVC syndrome).

3. Age \>16 years old. 4. ECOG Performance Status 0-2 5. If there is suspicion of cardiac disease, a cardiac ejection fraction must show LVEF \> 45%.

6. Required Initial Laboratory Values (unless non-Hodgkin lymphoma):

* ANC ≥ 1000/μL
* Platelets ≥ 100,000/μL
* Creatinine≤ 1.5 mg/dL or creatinine clearance ≥ 50 cc/min
* Total Bilirubin ≤ 2 mg/dL (unless a history of Gilbert's Disease)

Exclusion Criteria:

* 1- Patients with an underlying low-grade lymphoma, such as a transformed lymphoma or low-grade lymphoma in the bone marrow, are not eligible.

  2- Patients with low international prognostic index are not eligible. 3- Prior cytotoxic chemotherapy or rituximab. Patients who have received chemotherapy for prior malignancies are not eligible.

  4- Active ischemic heart disease or congestive heart failure. 5- Known lymphomatous involvement of the CNS. A lumbar puncture prior to study is not required in the absence of neurological symptoms.

  6- Known HIV disease. Patients with a history of intravenous drug abuse or any other behavior associated with an increased risk of HIV infection should be tested for exposure to the HIV virus. Patients who test positive or who are known to be infected are not eligible.

  7- Pregnant and non-nursing. Treatment would expose an unborn child to significant risks. Women and men of reproductive potential should agree to use an effective form of contraception.

  8- Patients with active medical processes (e.g., uncontrolled bacterial or viral infection, bleeding) not related to their lymphoma should be excluded.
The Impact of Pentoxifylline and Vitamin E on Radiotherapy-induced Toxicity in Head & Neck Cancer Patients

The purpose of this study is to determine whether pentoxifylline and vitamin E are effective in prevention of radiotherapy- induced toxicity in head and neck cancer patients treated with concurrent chemoradiotherapy.

This is a randomized controlled prospective study of pentoxifylline and vitamin E given on daily basis throughout the period of concurrent chemoradiotherapy to patients with carcinoma of the head and neck. All patients will be followed up to 90 days since the first day of treatment. The incidence and severity of adverse events will be assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* Measurable disease
* Patients with squamous cell carcinoma of the head and neck eligible for treatment with concurrent chemo- radiotherapy
* Able to understand and willing to sign a written informed consent document

Exclusion Criteria:

* Pregnant or lactating women, since imaging cannot be done in this setting.
* Patients treated with vitamin E and/ or pentoxifylline for any other indication
* Patients with recent cerebral and/or retinal hemorrhage
* Patients who have previously exhibited intolerance to pentoxifylline or methylxanthines such as caffeine, theophylline, and theobromine.
* Patients treated with oral anticoagulants.
* Absolute neutrophil count ≤1.5×109/L
* Platelets ≤100×109/L
* AST ≥ 2.5 X institutional upper limit normal (ULN)
* Serum creatinine ≥ 1.5 mg% for males \& 1.4 mg% for females
* Serum bilirubin ≥ 1.5X institutional upper limit normal (ULN)
A Sibling Oocyte Study- Comparison of ZyMotTM Microfluidics Device to Density Gradient for Sperm Selection During ICSI

The primary objective of this study is to evaluate whether the percentage of good quality embryo formation following Intracytoplasmic Sperm Injection (ICSI) is improved with the use of ZyMot method of microfluidic sperm separation compared to density gradient.

During an in vitro fertilization (IVF) cycle, eggs are removed from a woman's ovaries via a minor surgical procedure and are inseminated with sperm in order to create embryos. The insemination process can be via standard IVF or intracytoplasmic sperm injection (ICSI.) Standard IVF is the process of placing thousands of sperm in a culture dish with one or more eggs and allowing them to interact on their own. ICSI is the process by which one sperm is directly injected into each egg.

Prior to using the sperm for insemination, a semen sample is processed and washed in order to obtain the healthiest sperm. A standard sperm preparation procedure is density gradient, in which the sperm is spun via centrifugation and separated from the seminal fluid. An alternate method is via microfluidics, by which the sperm swim up a microfluidic gradient created by a microporous filter between two chambers of a device. Sperm that are capable of navigating through this filter and reaching the end chamber are presumed to be the healthiest sperm. There is some data revealing that ZyMot microfluidics yields healthier sperm compared to the density gradient technique.

The aim of the study is to evaluate whether good quality embryo formation is any different following insemination with sperm separated by microfluidics compared to density gradient.

On the day of oocyte retrieval, the sperm sample will be split between the two different processing methods: density gradient and ZyMot microfluidics. In the event that there are 6 or more mature oocytes and ICSI will be used for insemination, half of the oocytes will be inseminated with sperm processed by density gradient and half with sperm processed by ZyMot microfluidics. The percentage of good quality embryo formation will be compared between the two groups.

Eligibility Criteria:
Inclusion Criteria for Patients:

1. Patient(s) over 18 years of age
2. Patient(s) capable of providing informed consent
3. Use or possible use of ICSI for oocyte insemination
4. At least 6 mature oocytes at time of insemination via ICSI

Exclusion Criteria for Patients:

1. Patient under 18 y/o
2. Patients not capable of providing informed consent
3. Use of IVF for insemination
4. Less than 6 mature oocytes at time of rertrieval
5. Anonymous donor sperm source
6. Surgically retrieved sperm
7. Sperm sample not sufficient for use with ZyMot device

Inclusion Criteria for Donors:

1. Donor(s) over 18 years of age
2. Donor(s) capable of providing informed consent
3. Use of ejaculate sperm, fresh or frozen, for insemination
4. Sufficient sperm for use of ZyMot

Exclusion Criteria for Donors:

1. Anonymous donors
Addition of Paclitaxel to High-Dose Combination Chemotherapy in Treating Patients With High-Risk Breast Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells, allowing higher doses of chemotherapy to be used.

PURPOSE: Phase I/II trial to study the effectiveness of paclitaxel when added to high-dose combination chemotherapy followed by peripheral stem cell transplantation in treating women with breast cancer at high risk of relapse.

OBJECTIVES: I. Estimate the maximum tolerated dose of paclitaxel when given with high-dose carboplatin/cyclophosphamide with autologous peripheral blood stem cell support in women with high-risk stage II/III breast cancer. II. Assess the nonhematologic toxicities associated with this combination. III. Assess the progression-free and overall survival of these patients following this treatment.

OUTLINE: This is a dose-finding study. All patients undergo collection of peripheral blood stem cells (PBSC) with granulocyte colony-stimulating factor (G-CSF) mobilization prior to high-dose chemotherapy. Cohorts of 3-5 patients are treated at successively higher dose levels of paclitaxel until a maximum tolerated dose (MTD) is found. Paclitaxel is given as a single 6-hour infusion, followed by fixed doses of high-dose cyclophosphamide for 2 days, then carboplatin for 3 days. Four days later, patients receive PBSC and G-CSF for hematopoietic reconstitution. Additional patients are entered at the MTD. Patients are followed every 3 months for 1 year, every 4 months for 1 year, then every 4-6 months thereafter.

PROJECTED ACCRUAL: It is expected that 24-30 patients will be accrued; a study duration of 1-1.5 years is anticipated.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically diagnosed adenocarcinoma of the breast of the following stages: Stage II/IIIA disease with 4 or more involved axillary lymph nodes Stage IIIB Inflammatory No bone marrow involvement documented on bone marrow aspiration and biopsy Prior breast cancer allowed Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: 18 to 65 Sex: Women only Menopausal status: Not specified Performance status: Karnofsky 70%-100% Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2.0 mg/dL Renal: Creatinine clearance at least 60 mL/min Cardiovascular: Left ventricular ejection fraction at least 50% by MUGA No abnormal cardiac conduction documented as second- or third-degree heart block or bundle branch block Pulmonary: DLCO at least 60% of predicted Other: Not HIV positive No history of second malignancy within 5 years except: Nonmelanomatous skin cancer In situ carcinoma of the cervix No pregnant women

PRIOR CONCURRENT THERAPY: At least 3 courses of induction therapy required, with regimen at the discretion of the investigator No disease progression during induction
A Safety Study of Lintuzumab in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome

Phase 1a is an open-label, multi-dose, single-arm, dose-escalation study to define the toxicity profile, pharmacokinetics, and antitumor activity of SGN-33 in patients with myelodysplastic syndrome (MDS), acute myelogenous leukemia(AML), and CD33+ myeloproliferative diseases. Phase 1b includes patients with AML or MDS treated at the highest tolerated dose from phase 1a.


Eligibility Criteria:
Inclusion Criteria:

1. Patients must have a diagnosis of MDS or AML.
2. Patients must have an ECOG performance status ≤ 2 and a life expectancy \> 3 months.

Exclusion Criteria:

1. Patients who have received prior therapy with gemtuzumab ozogamicin (Mylotarg®) or other anti-CD33 monoclonal antibody treatment.
2. Patients with a prior allogeneic transplant.
3. Patients with known leptomeningeal or CNS involvement of leukemia. Patients with onset of CNS symptoms within the past 12 months will also be excluded.
4. Patients receiving chemotherapy within the last four weeks.
Samarium Sm 153 Lexidronam Pentasodium and High-Dose Melphalan in Treating Patients With Multiple Myeloma Undergoing Stem Cell Transplant

RATIONALE: Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing. Samarium Sm 153 lexidronam pentasodium contains a radioactive substance that kill cancer cells. Peripheral blood stem cell transplant using stem cells from the patient may be able to replace immune cells that were destroyed by chemotherapy and radioactive drugs used to kill cancer cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of samarium Sm 153 lexidronam pentasodium when given together with high-dose melphalan in treating patients with multiple myeloma undergoing stem cell transplant.

OBJECTIVES:

* To find the maximum tolerated dose of samarium Sm 153 lexidronam pentasodium when given with fixed high-dose melphalan as a conditioning regimen for autologous peripheral blood stem cell transplantation in patients with multiple myeloma. (Phase I)
* To assess the response rates of this regimen in these patients. (Phase II)

OUTLINE: This is a phase I, dose-escalation study of samarium Sm 153 lexidronam pentasodium followed by a phase II study.

* Phase I: Patients receive samarium Sm 153 lexidronam pentasodium IV once between days -14 and -10. Patients also receive melphalan IV on day -1. Patients undergo peripheral blood stem cell transplantation on day 0. Patients receive sargramostim (GM-CSF) subcutaneously once daily beginning on day 6 and continuing until blood counts recover.
* Phase II: Patients receive samarium Sm 153 lexidronam pentasodium at the MTD determined in phase I .

Blood samples are collected periodically to determine clearance of samarium Sm 153 lexidronam pentasodium and bone marrow dosimetry.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of multiple myeloma requiring treatment
* Must have at least 2 x 10\^6 CD34+ cells collected for peripheral blood stem cell transplantation

PATIENT CHARACTERISTICS:

Inclusion criteria:

* ECOG performance status (PS) 0-2 (ECOG PS \> 2 allowed if secondary to neuropathy or acute bone event)
* Direct bilirubin ≤ 2.0 mg/dL
* Alkaline phosphatase ≤ 750 μ/L
* Creatinine ≤ 3.0 mg/dL
* Ejection fraction ≥ 45%
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception for 6 months after the completion of study therapy

Exclusion criteria:

* DLCO \< 50%
* FVC \< 50%
* FEV_1 \< 50%
* Active malignancy with the exception of nonmelanoma skin cancer
* Uncontrolled infection
* NYHA class III-IV cardiac disease

PRIOR CONCURRENT THERAPY:

* May or may not have received prior chemotherapy
* At least 3 weeks since prior chemotherapy

  * Cyclophosphamide pulsing for stem cell collection allowed
* At least 4 weeks since prior biologic therapy
* At least 2 weeks since prior bisphosphonates and bisphosphonates maybe resumed 1 month post-study treatment
The Effects of Dexmedetomidine on Inflammatory Mediators After One Lung Ventilation During Video-assisted Thoracoscopic Surgery

During lung surgery, mechanical one-lung ventilation is usually mandatory to provide appropriate surgical condition. However, not only mechanical ventilation is associated with inflammatory response, but also one lung ventilation will result in detrimental effects such as ischemia and reperfusion injury, and systemic inflammatory responses.

Dexmedetomidine is an alpha-2 selective agonist. It was reported that dexmedetomidine decreased reperfusion injury, reduce the release of proinflammatory mediator and protected lungs from reperfusion injury in esophageal cancer patients who undergoing one lung ventilation from reducing oxidative stress metabolites. However, other details of protective effects is still unknown.

High mobility group box 1 (HMGB1) is an important proinflammatory factor. It was found to be related to ventilator induced lung injury in several condition. Animal studies also showed that dexmedetomidine reduces the expression of messenger ribonucleic acid in lipopolysaccharide-activated macrophage so that decrease the amount of HMGB1 release. However, clinical trials about these are still lacking.

In this study, we will investigate the protective effects of dexmedetomidine to patients undergoing video-assisted thoracoscopic surgery, especially on the specific inflammatory markers- plasma HMGB1 and other inflammatory cytokines (eg. interleukin-1. interleukin-6). This will let us to know the role of HMGB1 during one-lung ventilation injury and the effect of dexmedetomidine in regulating the release of HMGB1. This study will become a basis of further medical therapy in treating inflammation.


Eligibility Criteria:
Inclusion Criteria:

1. American Society of Anesthesiologists physical classification I-II patients who receive VATS lobectomy
2. Patients with the following will be excluded:

   * suspect of infection, eg. white blood cell count\> 10000 ; fever\> 38.3℃
   * preoperative cardiac or renal dysfunction, eg. New York Heart Association \>= II, estimated glomerular filtration rate\< 60
   * predisposing liver dysfunction, eg. aspartate aminotransferase or alanine aminotransferase \>100; total bilirubin\> 2mg/dl; \>= Child B liver cirrhosis
Assessment of Strategies for the Management of Flu-like Symptoms in MS Patients Commencing Treatment With Betaferon (INFLUENCE)

This will be prospective, multicentre, observational study. Patients who will initiate treatment with IFNβ-1b (Betaferon) will be followed up to 6 months. Baseline visit (visit 0) i.e. treatment initiation plus four follow-up visits (visits 1-4). For each patient demographics, medical history data, safety parameters, presence of flu-like symptoms and measures to prevent or treat these symptoms will be collected.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of relapsing-remitting multiple sclerosis (RRMS) according to McDonald (2005) criteria
* Age \>/= 18 years old
* Treatment MS patients in whom the attending physician has decided to initiate therapy with interferon beta-1b; Betaferon
* Minimum 6 months wash-out period from previous IFNβ
* Written Informed Consent signed

Exclusion Criteria:

* Patients previously treated with any of the disease modifying drugs (DMDs), with the exception of IFNβ therapy which ended at least 6 months earlier
* Patients receiving treatment with IFN beta other than Betaferon (Bayer)
Position Change and Back Massage Versus Early Ambulation on Post Transfemoral Coronary Angiography Complications

The study aimed to assess the effect of position change and back massage versus early ambulation on post transfemoral coronary angiography complications.

Post transfemoral coronary angiography (TFCA) may be associated with complications such as oozing, bleeding, ecchymosis, hematoma, and back pain. As a result, nursing practice must be geared toward enhancing patient safety post-transfemoral coronary angiography procedure. This study aimed to assess the effect of position change and back massage versus early ambulation on post transfemoral coronary angiography complications. A quasi-experimental research design was used to conduct this study at the Coronary Care Unit of the selected university hospital in Egypt. A convenience sample of 185 patients undergoing transfemoral coronary angiography was included in the study during the first 6 hours post-transfemoral coronary angiography and randomly assigned to two groups: 92 patients received position change and back massage (PCBM group), and 93 patients underwent early ambulation after the first 3 hours post-transfemoral coronary angiography (EA group). The used tool was "Post Transfemoral Coronary Angiography Complication Assessment".

Eligibility Criteria:
Inclusion Criteria:

* Mean arterial blood pressure ≥70 mmHg.
* Heart rate ≥ 60 b/m.
* Manual compression closure technique on the access site
* Partial thromboplastin time \< 90 seconds.
* Prothrombin time \<16 seconds).
* No anticoagulant therapy within 24 hours before the cardiac catheterization procedure.

Exclusion Criteria:

* Patients who had a history of previous coronary stents.
* chronic pain,
* chronic obstructive pulmonary disease.
* Renal failure,
* Hypercoagulable conditions such as protein C.
* Cardiopulmonary resuscitation during angiography.
* Femoral artery ruptures during angiography.
* Chest pain with new electrocardiograph change.
Tai Chi in Spondyloarthritis

Our hypothesis is that tai chi sessions would increase physical activity of patients with Spondyloarthitis. The main objective is to study the effect of tai chi sessions (16 vs.0) on global physical activity of Spondyloarthitis patients, compared to a control group without tai chi.

Selection and inclusion of patients will be done by principal investigator of Rheumatology Department. After verification of inclusion and non-inclusion criteria by principal investigator and signature of consent, patients will be randomized by 1: 1 randomization (centralized randomization by statistician into 2 groups at M0). They will participate in sessions in a deferred manner due to two per week for each group:

* Interventional "A" group: 32 sessions (on average 2/week) performed from M0 to M4 in 15 patients.
* Control "B" group: 16 sessions (on average 2/week) performed from M2 to M4 in 15 patients.

Patients of "B" group will be not performing sessions with "A" group patients. Sessions lasting about 45 minutes will be proposed from Monday to Friday in a room planned from this activity within the CHU. Exercises will be adapted and personalized according to each one. Evaluations will be carried out at M0, M2 and at the end of the protocol at M4.

Assessment of pain and stress will be done before and after each session. Final assessment will be done at 4 months after randomization. Fitness assessment and tai chi sessions will be conducted by APA student.

Eligibility Criteria:
Inclusion Criteria:

* Patient age \> 18 years old with Spondyloarthitis (ASAS criteria), with activity deemed stable by rheumatologist.
* Patient able to walk without help
* Patient able to complete a questionnaire
* Patient giving informed consent.
* Patient covered by social security

Exclusion Criteria:

* Patient with disorder of higher mental function or psychiatric disorders.
* Patient who has previously contribute to a tai chi program.
* Patient with an absolute contraindication to physical activity.
* Protected populations: pregnant women, breastfeeding women, tutorship, trusteeship, deprived of liberty, safeguard of justice