cyrilzakka/clinical-trials huggingface dataset:
Identification of Occupational Exposures in Acute Hematologic Malignancy

Lymphoid hemopathies are a group of malignant haematological disorders characterized by clonal proliferation of cells of the lymphoid line. Non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL), and multiple myeloma (MM) are the most frequently encountered features of lymphoid hemopathies. Duriong the last 35 years the prevalence of these pathologies has increased in France but also in most industrialized countries. This increased can't be solely explained by demographic changes and improvements in diagnostic techniques. As a result, the involvement of environmental and professional factors is strongly suspected. Studies have shown that these diseases are associated with some professions or type of activity, including agricultural occupations, and other sectors such as agriculture, printing, woodworking. Some organic solvents and pesticides have been suspected of being risk factors of hematologic malignancies. Based on cohort studies and case-control studies, some of them have been identified by the International Cancer Research Center as associated with the occurrence of NHL with a sufficient or limited level of evidence. One of the difficulties encountered in the analysis of the literature has been the permanent evolution of the international classification of lymphoid hemopathies over the past 30 years. The old epidemiological studies are therefore difficult to interpret. Lymphoid hemopathies cover a range of different conditions, thus it is likely that carcinogens involved vary according to the type of hemopathy. Finally, environmental and occupational exposures to various chemicals and biological agents have evolved over time. The aim of this study is firstly to develop and validate a questionnaire to identify and quantify exposures to nuisances (substances and agents) suspected of being associated with the occurrence of NHL, MM and LLC. In a second time, this questionnaire will be used as a support for the realization of a subsequent case-control study to improve epidemiological knowledge on these diseases.

This study is a prospective, multicenter study on patients with a diagnosis of NHL, MM or CLL. All the patients with a diagnosis of NHL, MM or CLL in the participant centers will be purposed to participate. Each patient included will have an interview with a clinical study technician or doctor of occupational medicine. A specific detailed questionnaire has been created for the study. It focuses on specialized professional careers to spread occupational exposures to nuisances (substances and agents) suspected of being associated with NHL, MM or LLC risk. Each questionnaire will be evaluated by a physician expert in occupational disease, to conclude on the parameters exposure to the various suspected carcinogens. The study will cover 300 patients.

Eligibility Criteria:
Inclusion Criteria:

* Incident cases of NHL, MM and CLL diagnosed in hospital hematology departments participating in the study.
* Age between 20 and 80 years

Exclusion Criteria:

* HIV infection
* History of organ or marrow transplant
PST Linkage Based Analysis in the Family of More Than Two Members With Type 1 Diabetes in Taiwan

The purpose of this study is to explore the susceptible genes for Type 1 diabetes in Taiwan through the new genetic study methods.

As an unclear autoimmune disorder, the pathogenesis of type 1 diabetes (T1D) remains elusive. Among all the methods for studying diseases pathophysiology, genetic approach has valuable capability as being both hypothesis-testing and hypothesis-generating. Although geo-epidemiological studies show relatively higher prevalence of T1D in Caucasians than in Asians, whether genetic factors identified in T1D of Caucasians are essential for T1D in Asians is not yet clarified. Although the human leukocyte antigen (HLA) genotype variants have been reported to be associated with T1D, the odds ratio (ORs) is relatively low in Taiwan as comparing with western countries, some families are indeed more than one child with T1D. However, the genetic linkage study in T1D is still limited in Taiwan that hampered the drug development or research in T1D. Therefore, we intend to explore the susceptible genes for T1D of Taiwan in this study, which will provide further researcher directions for this disease.

Eligibility Criteria:
Inclusion Criteria:

1. Type 1 diabetes on the criteria of the American Diabetes Association with a very low C-peptide level (\<0.35 ng/mL) with or without the experience of diabetic ketoacidosis.
2. The subjects whose four grandparents are of Chinese Han origin

Exclusion Criteria:

1. Patients with ages of onset more than 35 years are excluded.
2. The families having any member with known possible type 2 diabetes
Study to Evaluate the Effectiveness of Cardiac Rehabilitation (Rehab) for Acute Decompensated Heart Failure Patients on 6 Minute Walk Test and Quality of Life

The aim of the investigators' project is to determine if patients admitted with a primary diagnosis of heart failure to Sanford Health facilities in regional southeastern South Dakota demonstrate benefits in improvement in functional capacity, quality of life, and a reduction in hospital readmission rates from a cardiac rehab program immediately following a discharge for an acute decompensated heart failure diagnosis related inpatient hospitalization encounter. The investigators hypothesize that those that receive cardiac rehab will have improved quality of life and reduced readmission rates at 30 and 90 days.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Admitted with acute, decompensated heart failure
* Signed informed consent

Exclusion Criteria:

* Approved by Center for Medicare and Medicaid Services (CMS) to enroll in cardiac rehab
* Have an elective procedure that would interrupt their exercise program
* Unable to partake in an exercise program due to physical incapacities
* Pregnancy
* Unable to read and understand the consent form
Preserving Autonomy Through Foot Health: a Study on the Acceptability of a Program Including Various Workshops for the Elderly

Every year in France, 2 million falls by people over 65 are responsible for 10,000 deaths, the leading cause of accidental death, and more than 130,000 hospitalizations.

The investigators will combine minimalist footwear, plantar massage, and workshops to re-learn walking and posture. The main objective of this study is to verify the acceptability and feasibility of this program among the elderly.

Study participants will benefit from a plantar massage session (5-10 min massage performed by a podiatrist) and one posture and walking workshop per week, also supervised by the podiatrist. Minimalist shoes have been purchased by the centers and used during the workshops. They will also be available to participants outside the workshops for the duration of the study.

Eligibility Criteria:
Inclusion Criteria:

* People over 65 years of age
* Able to walk independently with or without a walking aid (cane, walker, etc.)
* Persons affiliated with a social security system or assimilated
* Persons (participants, guardians, or curators where applicable) who have been informed and have given their written consent to participate in the study.

Exclusion Criteria:

* People with a contraindication to wearing minimalist shoes
* Persons unable to participate in the various workshops
* Refusal to participate in research
* Persons under court protection
* Persons unable to walk
* Persons with any other contraindication at the investigator's discretion
Prospective Randomized Study of Accelerated Radiation Therapy (PRART)

Patients with Stage 0 ductal carcinoma in situ (Tis (DCIS), Stage T1-T2, lymph node negative(N0) breast cancers will be randomized to receive whole breast radiotherapy with a concomitant boost to the tumor bed over 15 fractions (Arm 1, standard) versus 10 fractions (Arm 2, experimental).


Eligibility Criteria:
Inclusion Criteria:

* Women status post segmental mastectomy
* If unilateral, pT1-2 breast cancer excised with negative margins
* If bilateral, pT1-2 breast cancer excised with negative margins AND/OR pTis excised with negative margins.
* Clinically N0 or pN0 or sentinel node negative
* Ductal carcinoma in situ DCIS with negative margins (no DCIS on inked margins).

Exclusion Criteria:

* Previous radiation therapy to the ipsilateral breast.
* 90 days from last surgery, unless s/p adjuvant chemotherapy
* 60 days from last chemotherapy
* Male breast cancer
Adoptive T-cell Therapy for Resistant Viral Infections After Allogeneic HSCT

The aim of the study is to evaluate the adverse events and the efficacy of virus specific T lymphocytes selected in vitro from a family donor to treat some refractory viral infections as Adenovirus (ADV), Ebstein Barr virus (EBV), Cytomegalovirus (CMV) that developed in young patients (age between 0 and 21 years) after allogeneic hematopoietic cell transplantation (allo-HSCT) performed at the Transplant Clinical Unit of the IRCCS G. Gaslini Institute (IGG).

The rationale for the study is based on the evidence that, despite the progress obtained in the management and prevention of viral infections in the patients who received allo-HSCT, some viral infections continue to be severe complications that may occurred before the immune recovery. Some of these viral reactivations are not responsive to the first or second line treatment and their treatment may be represent an important issue. The adoptive cellular immunotherapy based on the infusion of virus-specific T lymphocytes represent a valid therapeutic option and the quick access to this cellular therapy is crucial to prevent severe organ complications related to viral infection. In this study, the use of virus-specific T lymphocytes obtained from a seropositive family donor, briefly activated in vitro and immunomagnetically captured by their capacity to secrete IFN-gamma allows to obtain a rapidly usable T-lymphocyte population (both CD4+ and CD8+) potentially able to expand into the patient. The effectiveness, safety (peptides used are synthetic, no animal components, closed system production), good tolerance and speed of modality (less than 36 hours for production) is reported by many clinical studies.

Eligibility Criteria:
Inclusion criteria:

* Allogeneic transplant with any cells source and conditioning regimen
* Age between 0-21 years
* Viral infection/reactivation (CMV, EBV, ADV)
* Resistance of viral infections to treatments
* Absence of concomitant severe uncontrolled infections
* Life expectancy exceeding 30 days
* Absence of acute or chronic uncontrolled Graft versus Host Disease (GvHD)
* Absence of acute kidney damage (creatinine value\> 3 times the value normal with respect to age) not related to viral infection;
* Absence of severe acute liver injury (direct bilirubin\> 3mg / dl or glutamic-oxaloacetic transaminase -SGOT\> 500 UI/L) not related to viral infection;
* Presence of informed consent to the treatment of the patient / parent /legal guardian.

Exclusion Criteria:

* Absence of a suitable donor (seronegativity for the virus in question and / or failure to respond to the secretion test)
* Patient with severe renal and/or hepatic impairment as specified above
* Primary or secondary graft failure
* Relapse of malignant underlying disease
Leukapheresis to Obtain Lymphocytes for Studies on Antiretroviral Naive HIV-infected Patients

To further investigate differences in the immunologic function of various lymphocyte subsets in HIV-infected patients who are treated early in their infection and during the chronic phase of the infection. Studies will also be done to further delineate the various antigen-specific and innate immune responses including characterization of soluble factors associated with primary HIV infection.

Primary HIV-1 infected and chronically infected individuals will be recruited and leukapheresis will be performed. This one year study requires that patients be apheresed once before initiating therapy and on two other occasions (at month 6 and month 12) after suppression of plasma viremia. Peripheral blood mononuclear cells will be isolated by sodium diatrizoate density centrifugation and subjected to immunologic and virologic studies.

Eligibility Criteria:
Inclusion Criteria:

* Adult HIV-1 infected patient
* For primary infected patients anyone with an exposure to a known source of HIV infected material or individual, with symptoms and signs if present consistent with primary HIV infection, a negative ELISA, indeterminate Western blot for HIV and a positive HIV plasma RNA levels \> 10,000 copies/mL by either RT-PCR or bDNA
* Chronic HIV-infected patients should have a positive ELISA and a confirmatory western blot and willingness to give informed consent for the storage of blood.
* Willingness to be able to make follow-up visits for apheresis at 6 and 12 months for those who undergo antiretroviral therapy

Exclusion Criteria:

* Pregnant women
Phase I Pilot Study of CD34 Enriched, Fanconi's Anemia Complementation Group C Gene Transduced Autologous Peripheral Blood Stem Cell Transplantation in Patients With Fanconi's Anemia

OBJECTIVES: I. Determine the safety of transferring the Fanconi anemia complementation group C (FACC) gene to hematopoietic progenitors by retroviral mediated gene transfer in patients with Fanconi's anemia, complementation group C.

II. Determine the extent of engraftment following this treatment regimen without prior ablation of recipient marrow in these patients.

III. Determine the ability of this treatment regimen to correct the cell phenotype and improve hematopoietic function in these patients.

PROTOCOL OUTLINE: Patients receive filgrastim (G-CSF) subcutaneously daily on days 0-6 followed by apheresis to collect peripheral blood stem cells (PBSC) on days 5-7. PBSCs are processed in vitro for enrichment of CD34 cells and transduced with a Fanconi's anemia complementation C (FACC) retroviral vector on days 5-10. Patients receive transduced PBSCs IV over no more than 2 hours on days 8-10. PBSC infusions may be repeated no more than every 2 months for up to 4 courses total.

Patients are followed monthly for 3 months, every 3 months for 9 months, every 6 months for the next year, and then yearly thereafter.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Fanconi's anemia, complementation group C (FACC) Confirmed by diepoxybutane or mitomycin testing AND DNA analysis indicating FACC mutations
* Patients at least 25 kg weight
* No acute leukemia OR Bone marrow aspirate with greater than 10% blasts
* No patients who elect bone marrow transplantation

--Prior/Concurrent Therapy--

* At least 14 days since prior therapy for any acute viral, bacterial, or fungal infection

--Patient Characteristics--

* Performance status: Karnofsky 40-100%
* Hepatic: SGOT, SGPT, and alkaline phosphatase no greater than 5 times upper limit of normal (ULN) PT/PTT no greater than 1.5 times ULN Serum amylase no greater than 1.5 times ULN Bilirubin no greater than 2.5 mg/dL Triglyceride less than 400 mg/dL
* Renal: Creatinine clearance greater than 50 mL/min
* Cardiovascular: Normal cardiac function No ischemic heart disease that may be considered an anesthetic or operative risk
* Pulmonary: No lung disease that may be considered an anesthetic or operative risk Resting transcutaneous oxygen saturation greater than 90% on room air
* Other: HIV negative Hepatitis B surface antigen negative No underlying condition that may preclude study therapy (e.g., allergies to study reagents)
* No acute viral, bacterial, or fungal infection Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
Clinical and Social Trajectory of Children and Adolescents With Disruptive Behavior

Conduct disorders are defined as "repetitive and persistent pattern of behavior in which the basic rights of others or major age-appropriate norms are violated". So defined, these disorders are at the crossroads of psychiatry, social field and justice. Conduct disorder management is a public health issue and a societal question. Conduct disorders affect 5 to 9% of 15-year old boys.

Care management of children and adolescents admitted for disruptive behaviors in emergency rooms is an issue. No consensus or official recommendation exists. However, use of emergency care in this context is increasing in most western countries and it exposes to several risks (inappropriate use of hospitalizations, social rupture, ignorance of comorbidities and suicide risk). The Trajectories project is designed to describe children and adolescents with disruptive behaviors, their care management and to follow their life trajectory and psychiatric evolution after admission to emergency rooms. Better understanding this population will improve their medical and social care management, thereby giving professionals the right tools.

The main objective of this project is to implement a multidisciplinary and integrative research combining clinical considerations and social sciences to determine the "trajectory" of this population.


Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents admitted to emergency rooms for aggressiveness, violence, fugue or theft

Exclusion Criteria:

* Children and adolescents admitted to emergency rooms for a reason not directly link with aggressiveness, violence, fugue or theft
* Opposition to the subject or the family to participate to this research
Neoadjuvant Dose-dense Chemotherapy for HR+/HER2- Breast Cancer Patients With High Proliferation Index

Studies have shown that dose-dense chemotherapy reduces the risk of recurrence and death of breast cancer patients comparing with standard-schedule chemotherapy. But some research data indicate that HR+/HER2- breast cancer patients benefit from dose-dense chemotherapy while some have negative results. How to identify HR+/HER2 breast cancer patients who are more likely to benefit from dose-dense chemotherapy is strongly necessary. Ki67 is a marker reflecting the proliferation of tumor cells. Breast cancer patients with high Ki67 are more likely to benefit from dose-dense chemotherapy. The purpose of this project is to investigate the efficacy and safety of neoadjuvant dose-dense chemotherapy for HR+/HER2- breast cancer patients with high proliferation index. At the same time, we will explore biomarkers, such as MammaPrint and BluePrint, to further identify patients who benefit more from neoadjuvant dose-dense chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Females with age of 18 to 70 years old.
* Newly diagnosed breast cancer patients.
* Planned neoadjuvant chemotherapy.
* Hormone receptor status: Estrogen receptor (ER)-positive or Progesterone Receptor (PR)- positive.
* HER2/neu-negative.
* Ki67≥30%.
* Clinical stage IIB-IIIC.
* Informed consent form understood and signed.
* Patient agrees to all follow-up visits.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
* Women of childbearing potential must have a negative serum pregnancy test.

Exclusion Criteria:

* Metastatic disease
* Pregnancy.
* Nursing mothers.
* Active or uncontrolled infection.
* Presence of another malignancies.
* Granulocyte count \< 1.5\*10\^9/L.
* Platelet count \< 100\*10\^9/L.
* Hemoglobin \< 90g/L.
* Serum Creatinine more than 1.5 upper limit.
* AST and ALT more than 2.5 upper limit.
* LVEF\< 50%.
A Study of ILB2109 in Patients With Advanced Solid Malignancies

This is a multicenter, open-label, phase Ia study to evaluate the safety, tolerability and preliminary efficacy of ILB2109, a A2a receptor antagonist, in patients with locally advanced or metastatic solid malignancies.

This is a two-part study consists of dose escalation and dose expansion. The dose escalation part adopts a 3+3 protocol design and consists of 5 cohorts. Based on the data obtained from the escalation study, selected cohorts will be expanded to further investigate the safety and efficacy of the study drug. The escalation part consists of a single-dose cycle (Cycle 0) followed by multiple-dose cycles (Cycle 1 and above). Subjects will be assessed for safety and efficacy outcomes at pre-specified time points.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytological confirmed, solid, malignant tumor that is refractory to standard therapy or for which no standard of care regimen currently exists;
* At least one assessable tumor lesion according to RECIST v1.1 in dose escalation part of the study ; At least one measurable tumor lesion according to RECIST v1.1 in dose expansion part of the study;
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
* Major organ functions are normal, meets pre-specified lab requirements;
* Females of reproductive age must have a negative serological hCG test during the screening period;
* Subjects of reproductive age (both male and female) must agree to use contraceptive methods from signing Informed Consent to 90 days post the last dose;

Exclusion Criteria:

* Has received any investigational medicinal product or other systemic anticancer treatment within 4 weeks prior to the first dose of study treatment;
* Unable to take medication orally, or has impaired GI function;
* Has received systemic glucocorticoids (prednisone\>10 mg/ day or an equivalent dose of another drug of the same class) or other immunosuppressants within 14 days prior to the first dose of study treatment;
* Has received live, attenuated vaccines within 4 weeks prior to the first dose of study treatment;
* Has active infection that requires intravenous anti-infective therapy;
* History of HIV infection, or other acquired, congenital immunodeficiency disease, or a history of organ transplantation;
* History of serious cardiovascular and cerebrovascular diseases;
* History of adverse effect from previous antineoplastic therapy that has not returned to CTCAE grade 5.0 ≤1;
* Cerebral parenchymal or meningeal metastasis;
* History of ≥ Grade 3 irAE or ≥ Grade 2 myocarditis from previous immune therapy;
Pomegranate Extract Supplementation in Colorectal Cancer Patients

The most relevant pomegranate phenolics (ellagitannins and ellagic acid) are extensively metabolized by the human gut microbiota to yield a number of metabolites called urolithins (mainly Uro-A). Urolithins have been reported to regulate in vivo the expression of genes involved in inflammation and cancer. Our hypothesis is that urolithins can be detected in the human colon mucosa where these metabolites can exert anti-inflammatory and anti-cancer activities. After colonoscopy and diagnosis, colorectal cancer patients will consume capsules containing three different pomegranate extract formulations until surgery. The aims of this trial are:

* To evaluate the disposition of pomegranate phenolics and urolithins in tumoral and normal colon tissues.
* To evaluate gene expression profiling and protein markers in tumoral and normal colon tissues from these patients.
* To compare different pomegranate extract formulations on the above.


Eligibility Criteria:
Inclusion Criteria:

* Colorectal cancer diagnosis.
* Surgery required.
* WHO status: between 0 and 2.
* Hemoglobin \>10 g/dL
* ALT \>2.5-fold above the normal value.
* Serum Bilirubin \>1.5-fold above the normal value.
* Creatinine \<140 micromol/L

Exclusion Criteria:

* Patients who do not satisfy inclusion criteria and,
* Active pectic ulcer.
* Pregnancy or breastfeeding.
* Alcoholism.
* Chemotherapy or radiotherapy a month prior to recruitment.
* Treatment with steroids or other anti-inflammatory drugs a week prior to recruitment.