cyrilzakka/clinical-trials huggingface dataset:
Combination Chemotherapy Plus Interferon Alfa or Rituximab in Treating Patients With Stage III or Stage IV Lymphoma

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining interferon alfa or the monoclonal antibody rituximab with chemotherapy may kill more cancer cells.

PURPOSE: Phase II trial to compare the effectiveness of combination chemotherapy plus interferon alfa or rituximab in treating patients who have high risk stage III or stage IV lymphoma.

OBJECTIVES: I. Determine the toxicity of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) with either interferon alfa or rituximab in patients with stage III or IV high risk indolent or intermediate B-cell lymphoma. II. Determine the objective tumor response rate and duration of response for these regimens in these patients. III. Determine the failure free survival and overall survival for these patients on these regimens. IV. Compare the response rate and survival rate of these patients on these regimens to similar patients treated in published studies. V. Compare the toxicities of these regimens in these patients. VI. Determine the quality of life of these patients on these regimens.

OUTLINE: This is a multicenter study. Patients are assigned to one of two treatment arms: Arm I: Patients receive rituximab IV on day 0, and cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1, followed by oral prednisone on days 1-5. Arm II: Patients receive interferon alfa subcutaneously on days 22-26, and cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1, followed by oral prednisone on days 1-5. Treatment repeat every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and prior to chemotherapy for each course. Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually for up to 10 years.

PROJECTED ACCRUAL: A total of 40-80 patients (20-40 per treatment arm) will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed high risk (stage III or IV) indolent or intermediate (stage II to IV) B-cell lymphoma Small cleaved cell lymphoma Waldenstrom's macroglobulinemia Follicular small cleaved cell or mixed cell Follicular large cell Diffuse Immunoblastic High risk is defined as: Increased LDH OR Increased beta-2-microglobulin OR B symptoms OR Bulky disease of greater than 7 cm in diameter OR Extranodal disease other than blood or bone marrow involvement OR Mantle zone histology At least 1 lymph node or visceral lesion at least 2 cm in diameter

PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No active infection or other medical condition this is lifethreatening Not pregnant Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: No prior therapy for lymphoma
Prediction of Delayed Cerebral Ischemia After Subarachnoid Hemorrhage Using Dynamic 18F-FDG PET/CT

A pilot trial for assessing early microvascular alterations after aneurysmal subarachnoid hemorrhage using dynamic 18F-FDG PET/CT. The primary endpoint will be the measure of early changes in cerebral glucose uptake reflecting microperfusion.

We hypothesize that an early irreversible microvascular deterioration following initial bleeding could contribute to DCI occurrence. More precisely, we suspect that DCI areas are somehow overlaps of regions in which microperfusion is precociously altered, shortening circulatory reserves, and territories of secondarily spasmed arteries further lowering blood flow, resulting in ischemia. We aim to explore the potential microvasculature alteration through cerebral glucose perfusion and metabolism assessment using early dynamic 18F-fluorodesoxyglucose Positron Emission Tomography/Computer Tomography (dynamic 18F-FDG PET/CT). If our hypothesis turned out to be valid, we would at the same time be able to determine risk factors for this unpredictable complication and gain remarkable insight into DCI pathophysiology. Thus, the purpose of this trial is to demonstrate, in patients affected by SAH, the correlation between early cerebral glucose uptake defects in 18F-FDG PET/CT and delayed cerebral infarction in magnetic resonance imaging (MRI).

Eligibility Criteria:
Inclusion Criteria:

* written informed consent to participate in the study must be obtained from the subject or proxy/legal representative prior to enrollment.
* males and females aged 18 years and older.
* SAH proven by computed tomography (CT) and that has occurred within the last 72 hours.
* ruptured saccular aneurysm angiographically confirmed by digital subtraction angiogram or CT angiogram, which has been successfully secured by surgical clipping or endovascular coiling.
* high-risk subjects for DCI: "thick clot" on the hospital admission CT (grade 3 or grade 4 on the modified Fisher Scale).
* a woman of childbearing potential is eligible only if the serum pregnancy test performed during the screening period is negative.

Exclusion Criteria:

* PET/CT contradications
* MRI contradications
* gadolinium or meglumine hypersensitivity
* glomerular filtration rate \<30mL/min
* SAH due to other causes than ruptured saccular aneurysm.
* post-HSA cardiac arrest.
* high sustained ICP ( \>20mmHg lasting \>20min) despite optimal treatment.
* significant and concomitant organ failure amongst the following: hypotension with systolic blood pressure \<90mmHg refractory to treatment; unresolved pulmonary edema or pneumonia with severe hypoxia defined as PaO2/FiO2 \<150; severe cardiac failure requiring inotropic support.
* patients with "do-not-resuscitate" orders, withdrawal of care situation, dying patient.
* vulnerable patient populations (minor, legal vulnerability, prisoner)
* pregnant and nursing mothers.
Effect of Sitagliptin on Endothelial Progenitor Cells

Endothelial progenitor cells (EPCs) are involved in cardiovascular homeostasis, through angiogenesis and endothelial healing. Diabetic patients have a high risk of cardiovascular events and low levels of circulating EPCs.

Sitagliptin is an oral DPP-IV antagonist, approved for the treatment of type 2 diabetes. It increases the bioavailability of endogenous incretins, thus improving insulin and glucagon secretion. SDF-1, one of the major EPC regulators, is also a substrate of DPP-IV. This study tests the hypothesis that sitagliptin increases the levels of circulating EPCs in type 2 diabetic patients.

Diabetic patients suffer an elevated wirk of cardiovascular events, which strongly impact on morbidity and mortality. The mechanisms that lead to cardiovascular disease in diabetes include alterations in the endothelial layer, due to hyperglycemia, oxidative stress and other associated abnormalities. Endothelial progenitor cells (EPCs) are bone marrow-derived cells involved in endothelial repair after injury, and they have been found to be reduced in diabetic patients. Thus, reduced EPCs in diabetes may be another mechanism of vascular disease induction. Reduction of EPCs in diabetes is attributable at least in part to the impairment of bone marrow mobilization, which is regulated by the chemokine SDF-1alpha, among others.

The oral hypoglycemia agent sitagliptin is a dipeptidyl dipeptidase-IV inhibitor, which prevents degradation of endogenous incretins (GIP and GLP-1), thus re-equilibrating insulin and glucagon secretion. Sitagliptin may also increase the concentrations of SDF-1alpha, which is another substrate of DPP-IV. The hypothesis is that sitagliptin may increase circulating EPC levels, through SDF-alpha.

This is going to be a pilot, non-randomized controlled 4-week trial of 100 mg oral sitagliptin therapy added to metformin/sulphonylureas in poorly controlled type 2 diabetic patients. At baseline and 4 weeks after the initiation of therapy blood samples will be drawn for the determination of circulating EPC levels, and concentrations of SDF-1alpha. EPCs will be defined as CD34+KDR+ cells and measured by flow cytometry as previously described in detail. SDF-1alpha will be measured using ELISA kits according to the manufacturer's instructions.

Changes between baseline and 4 weeks will be evaluated using two-tailed paired Student's t test and statistical significance accepted at p\<0.05.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes;
* Both genders
* Age 40-80
* fasting c-peptide \>=1.0 ng/L
* Therapy with metformin or sulphonylureas
* HbA1c \>7.0%
* No contraindications to sitagliptin use

Exclusion Criteria:

* Type 1 diabetes
* Age \<40 or \>80
* fasting c-peptide \<1.0 ng/L
* Therapy with TZD
* HbA1c \<=7.0%
* Acute concomitant diseases
* Immunological disorders
* Recent (within 3 months) cardiovascular events or surgery
* Pregnancy and lactation
* Inability to provide informed consent
The Effect of a Contingency Management Intervention on Substance Use

Contingency management interventions involve providing a tangible reward for progress toward treatment goals. The purpose of this study is to determine whether a contingency management intervention added to usual care leads to improved attendance and decreased substance use in patients attending outpatient substance use disorders treatment.

Design: This will be a randomized, controlled trial. 360 veterans presenting for specialty substance use disorders treatment at the Minneapolis VAMC and the VA Puget Sound Health Care System will be randomly assigned to 8 weeks of Usual Care or Usual Care plus Contingency Management. Minimal exclusion criteria include primary cannabis dependence, primary opioid dependence, screening positive for pathological gambling, serious psychiatric symptoms or suicide risk. Randomization will be stratified by site and primary substance use disorder (alcohol or stimulant). All participants will meet with a research assistant twice per week to submit urine drug and breath alcohol samples. Participants randomized to the contingency management interventions will have the opportunity to draw tokens (with replacement) from a bowl each time they submit negative urine drug and breath alcohol screens. The number of drawings allowed escalates with continuous weeks of negative screens or returns to baseline if screens are positive or missed. Half of the 500 tokens will result in social reinforcement ("Good Job!"). The remainder will earn a VA canteen voucher worth monetary value. Follow-up assessments occur 2, 6, and 12 months after enrollment into the study. Primary outcomes measures include number of days with negative urine drug and breath alcohol screens during the intervention phase, days of treatment attendance during the intervention phase, and percent days abstinent on the Timeline Follow-Back interview at follow-up assessments. Secondary outcomes include a brief assessment of employment, housing, legal, and psychiatric status, and administrative data on VA service utilization. A process evaluation and an economic analysis are included.

Eligibility Criteria:
Inclusion Criteria:

* veterans presenting for outpatient substance use disorders treatment with a diagnosis of alcohol, cocaine, amphetamine, or methamphetamine dependence

Exclusion Criteria:

* primary cannabis dependence
* primary opioid dependence
* severe psychiatric symptoms
* suicide risk
* positive history or screen for pathological gambling
* lacking transportation or living too far away to attend twice per week research appointments
Chemotherapy Monitoring With Breast Computed Tomography (CT)

The purpose of this study is to determine if dedicated breast computed tomography can be used successfully to monitor tumor response in breast cancer patients undergoing neoadjuvant chemotherapy.

Before undergoing surgery to remove the tumor, it is common for breast cancer patients to first undergo chemotherapy or hormonal therapy. The main goal of the therapy is to reduce the size of the tumor before it is removed. Unfortunately, therapy response varies a lot between patients. The development of an effective therapy response monitoring method could reduce the time that a patient undergoes ineffectual therapy or unnecessary therapy after complete response.

Dedicated breast computed tomography (or breast CT), a new way of imaging the breast, has been introduced in the last few years. Breast CT is an x-ray exam that uses 3D imaging to show the breast in its real three dimensional shape. Combined with the use of special chemicals called iodine contrast enhancement, breast CT can provide images of both the anatomy and the blood flow in the breast. We propose to use breast CT to carefully monitor the response to therapy of breast cancer patients undergoing therapy before surgery.

Eligibility Criteria:
3.1 Eligibility Criteria

* All subjects will be women at least 18 years of age that will undergo standard or research pre-operative hormonal therapy for breast cancer before lumpectomy or mastectomy.
* Women who have undergone pre treatment breast MR imaging to verify that no additional findings are present.

3.2 Ineligibility Criteria

* Subject does not meet any of the inclusion criteria
* Women with suspected or confirmed pregnancy
* Women who have had bilateral mastectomy
* Women who are unable to remain in a prone position on the BCT system for the required amount of time
* Women who cannot give informed consent
* Women with metastasis
* Male subjects
* Women with implants
* Women with breast augmentation, except for unilateral augmentation done for prior mastectomy
* Women who are allergic to iodine
* Women with physical limitations such as, but not limited to: frozen shoulder, recent heart surgery, pace maker, neck problems or any other condition that would prohibit them from lying face down
* Women who have had problems or reactions to contrast, such as nausea/vomiting, itching, hives, B/P changes, respirator distress, cardiac arrest.
* Women with history of Diabetes, kidney disease, kidney surgery, dialysis, heart disease-such as Congestive Heart Failure, Multiple Myeloma, Sickle Cell Anemia, Lupus, Rheumatoid Arthritis or other Autoimmune disease, recent surgery, chemotherapy, dehydration, high use of NSAIDs such as Ibuprofen
A Companion Study for Studies THAL-MM-003, CC-5013-MM-009, and CC-5013-MM-010 for Subjects With Multiple Myeloma

The study evaluated the safety of Lenalidomide monotherapy in participants with advanced multiple myeloma who had discontinued treatment with combination thalidomide plus high-dose dexamethasone or high-dose dexamethasone alone in studies Thal-MM-003, CC-5013-MM-009 and CC-5013-MM-010 due to the development of documented disease progression or the inability to tolerate the lowest dosing regimen per previous protocol of thalidomide and/or high-dose dexamethasone without grade 3 or 4 toxicity.


Eligibility Criteria:
Inclusion Criteria:

* Understand and voluntarily sign an informed consent form.
* Age ≥ 18 years at time of signing the informed consent form.
* Able to adhere to the study visit schedule and other protocol requirements
* Participants with multiple myeloma and were enrolled in either THAL-MM-003, CC-5013-MM-009, or CC-5013-MM-010 and discontinued study therapy with thalidomide and high-dose dexamethasone or high-dose dexamethasone alone due to:

documented disease progression OR inability to tolerate the lowest dosing regimen allowed on previous protocol without a grade 3 or 4 toxicity.

* Eastern Cooperative Oncology Group (ECOG) performance status score 0,1,2
* Recovery from thalidomide or dexamethasone-related toxicity to ≤ grade 2 (NCI CTC)
* Females of child-bearing potential (FCBP) must agree to using two methods of contraception

Exclusion Criteria:

* Prior development of a ≥ grade 2 allergic reaction/hypersensitivity or prior development of a grade ≥ 3 rash or desquamation while taking thalidomide National Cancer Institute Common toxicity Criteria (NCI CTC)
* Use of any standard/experimental anti-myeloma therapy within 28 days of randomization or use of any experimental non-drug therapy within 56 days of initiation of drug treatment
* Any serious medical condition, laboratory abnormality, or psychiatric illness that will prevent the participant from signing the informed consent form or that will place the participant at an unacceptable risk for toxicity if he/she participates in the study.
* Pregnant or lactating females.
* Prior therapy with CC-5013; prior history of malignancies, other than multiple myeloma (except basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast), unless subject has been free of disease for ≥ 5 years
* More than 4 months has elapsed since the last dose of study drug was administered on study Tal MM-003, CC-5013-MM-009, CC-5013-MM-010
* Absolute neutrophil count (ANC) \<1,000cells/mm\^3 (1.0 X 10\^9/L)
* Platelet count \<75,000/mm\^3 (30 X 10\^9/L) for those with \<50% if the bone marrow nucleated cells re plasma cells; Platelet count \<30,000/mm\^3 (30 X 10\^9/L) for those with \<50% if the bone marrow nucleated cells re plasma cells
* Serum creatinine \>2.5mg/dL; serum SGOT/AST or SGPT/ALT x upper limits of normal (ULN)
* Serum total bilirubin \>2.0mg/d/L
Study of NMS-1116354 in Solid Tumors

The purpose of this study is to evaluate the safety profile of NMS-1116354, a CDC7 kinase inhibitor, in adult patients with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Advanced/metastatic solid tumors, for which no alternative effective standard therapy is available
2. Maximum of 4 regimens of prior cancer therapy allowed
3. Prior radiotherapy allowed if no more than 25% of BM reserve irradiated
4. Resolution of all acute toxic effects (excluding alopecia) of any prior anticancer therapy
5. ECOG performance status (PS) 0 or 1
6. Adult (age \>/= 18 and \</= 80 years) patients
7. Adequate renal, liver and BM reserve
8. Capability to swallow capsules intact

Exclusion Criteria:

1. Current enrollment in another therapeutic clinical trial
2. Known brain metastases
3. Currently active second malignancy
4. Major surgery within 4 weeks prior to treatment
5. Any of the following in the past 6 months: myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis
6. Pregnancy or breast-feeding women
7. Known active infections
8. Gastrointestinal disease or other malabsorption syndromes that would impact on drug absorption
9. Adrenal insufficiency
10. Other severe acute or chronic medical or psychiatric condition that could compromise protocol objectives
OptiMized REsistaNt Starch in Inflammatory Bowel Disease: the MEND Trial

The purpose of the study is to determine if a plant-based resistant starch that is optimized for the individual will target the underlying cause of inflammatory bowel disease and restore a "healthier" gut microbiome in pediatric participants with inflammatory bowel disease.


Eligibility Criteria:
Inclusion Criteria:

* Capable of giving informed consent, or if appropriate, have an acceptable representative capable of giving consent on the participant's behalf.
* Enrolled in the main parent study.
* Existing Crohn's disease or ulcerative colitis diagnosis.
* In clinical remission or with mild disease (wPCDAI of 0-39.5 for CD; PUCAI of 0-30 for UC) with no changes in standard of care treatment for the previous month and without anticipated changes for the next month.
* Ability and willingness to comply with study procedures (e.g. stool collections) for the entire length of the study.
* Willing to provide consent/assent for the collection of stool samples.

Exclusion Criteria:

* Allergy to resistant starch or excipients.
* Co-existing diagnosis with diabetes mellitus.
* Treatment with another investigational drug or intervention throughout the study.
* Current drug or alcohol dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
* Inability or unwillingness of an individual or legal guardian to give written informed consent.
* Concomitant chronic disease requiring medications.
* Requirement for antibiotic therapy \>2 weeks duration.
* Participant's microbiota does not respond to any of the resistant starch from the assembled panel as measured through the RapidAIM evaluation following the initial stool sample collection.
* Patients with previous intestinal surgery.
Comparison of Diabetes Patients - Care Trajectory Versus Convention

In Belgium, various structures and reimbursement programs are in place for managing Type 2 Diabetes Mellitus (T2DM). The Diabetes Care Trajectory is primarily utilized for patients who require a maximum of two insulin injections per day. In contrast, patients needing multiple daily insulin injections are managed under a diabetes convention program.

The Diabetes Care Trajectory has been operational since 2009. However, unlike patients in the diabetes convention program, where the profile and quality of care are regularly audited, there is limited information available regarding the profile and outcomes of patients within the Care Trajectory. This retrospective study aims to compare the profiles, including complications and quality of care, of T2DM patients across both groups.

This retrospective study will collect data from T2DM patients enrolled in either the Diabetes Care Trajectory or the diabetes convention program. The data gathered will encompass quality of care, clinical status, complications, and metabolic state.

The profiles of these patient populations will be compared cross-sectionally for each year within the study period (2009-2024). Additionally, a longitudinal analysis will be conducted to examine the evolution of these profiles over the entire study period. Data will be extracted from electronic case records maintained at participating sites across Belgium.

Eligibility Criteria:
Inclusion Criteria:

* Followed in one of the NexusHealth hospitals in Belgium: https://www.nexuzhealth.com/en/why-nexuzhealth/patients/affiliated-healthcare-institutions
* Having being diagnosed with type 2 diabetes mellitus
* Followed in the Diabetes Care Trajectory or in the Diabetes Convention (group B) in Belgium Exclusion Criteria: no specific exclusion criteria
The Use of Airtraq Laryngoscope Versus Macintosh Laryngoscope and Fiberoptic Bronchoscope by Experienced Anesthesiologists

The investigators hypothesize that when used by experienced anesthesiologists, Airtraq laryngoscope will increase the first-attempt success rate with shorter intubation times and more stable hemodynamic parameters.

The special design of the Airtraq allows the direct exposure of the glottic opening without the necessity of optimal alignment of the oral, pharyngeal and laryngeal axes. The results of the meta-analysis comparing the Airtraq with the conventional Macintosh laryngoscope concluded that the use of Airtraq results in a rapid and accurate intubation. The main advantages of the fiberoptic bronchoscope are minimal airway trauma and minimal deterioration of the hemodynamic parameters.

The purpose of this study is to compare the hemodynamic parameters, intubation times, complications during and after intubation and postoperative sore throat scores of the patients having normal airway anatomy, intubated with Airtraq, Macintosh laryngoscope or fiberoptic bronchoscope, by experienced anesthesiologists.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status classification of 1 or 2, undergoing elective surgery under general anesthesia and requiring endotracheal intubation

Exclusion Criteria:

* Patients with ASA 3 or 4, Mallampati score of 3 or 4, history of difficult intubation, thyromental distance less than 6.5 cm, sternomental distance less than 12.5 cm, body mass index higher than 35 kg/m2 and limited neck mobility