cyrilzakka/clinical-trials huggingface dataset:
flt3L in Treating Patients With Acute Myeloid Leukemia

RATIONALE: Drugs such as flt3L may stimulate a person's immune system and help kill cancer cells. It is not yet known if flt3L is effective in treating acute myeloid leukemia.

PURPOSE: Randomized phase III trial to determine the effectiveness of flt3L in treating patients who have acute myeloid leukemia that is in remission.

OBJECTIVES:

* Compare the failure-free survival and overall survival in patients with acute myeloid leukemia in complete remission treated with maintenance flt3 ligand vs observation alone.
* Compare the long-term immunologic effects of these regimens in these patients.
* Compare the long-term safety and toxicity of these regimens in these patients.

OUTLINE: This is a randomized study. Patients are stratified according to complete remission (CR) (first vs second vs third or subsequent) and post-remission therapy (yes vs no). Patients are randomized to one of two treatment arms.

* Arm I: Patients receive flt3 ligand subcutaneously daily on days 1-14. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients undergo observation alone. Patients begin treatment or observation within 4 weeks after documentation of CR after induction therapy or within 4 weeks after discharge from hospital after post-remission therapy.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 139 patients will be accrued for this study within approximately 28 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of acute myeloid leukemia in first, second, third, or subsequent complete remission (CR)

  * Must be at least 60 years of age if first CR
  * Must have had histological proof (from bone marrow aspirate, smears, or touch preps of marrow biopsy) of one of the following prior to achieving CR:

    * Acute myeloblastic leukemia (M0, M1, M2)
    * Acute promyelocytic leukemia (M3)
    * Acute myelomonocytic leukemia (M4)
    * Acute monocytic leukemia (M5)
    * Acute erythroleukemia (M6)
    * Acute megakaryocytic leukemia (M7)
    * Refractory anemia with excess blasts in transformation

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* ECOG 0-2

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Bilirubin less than 3 times upper limit of normal (ULN)
* SGOT less than 3 times ULN

Renal:

* Creatinine less than 2 mg/dL

Cardiovascular:

* No clinically significant active cardiac disease

Pulmonary:

* No clinically significant active pulmonary disease

Other:

* Not pregnant or nursing
* Fertile patients must use effective contraception
* No uncontrolled or active autoimmune disease

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Prior autologous bone marrow transplantation (BMT) allowed
* No prior allogeneic BMT
* Other prior immunotherapy allowed if not received during the most recent treatment

Chemotherapy:

* Not specified

Endocrine therapy:

* Not specified

Radiotherapy:

* Not specified

Surgery:

* Not specified
Lenstec Softec HD Posterior Chamber Intraocular Lens Clinical Investigational Protocol

The objectives of this multi-center clinical investigation are to determine the safety and effectiveness of the Lenstec Softec HD Posterior Chamber intraocular lens (IOL) following one year of post-operative assessment.

The Softec HD Posterior Chamber IOL is designed for the treatment of aphakia. The lens is indicated for primary implantation when a cataractous lens has been removed by phacoemulsification with circular tear capsulotomy and the posterior capsule intact. The intended benefit of the Softec HD Posterior Chamber IOL is to provide enhanced vision.

Eligibility Criteria:
Inclusion Criteria:

* Cataract requiring cataract extraction
* Study IOL to only be implanted in 1 eye
* Distance BCVA 20/40 or worse or glare acuity worse than 20/30
* Ability to comply with study follow-up requirements

Exclusion Criteria:

* Patients with serious corneal disease, previous surgery or serious systemic disease
* Ocular condition that could impact vision after cataract surgery
* Pregnant or lactating women
* Use of ocular or systemic medications that could impact vision
Prevalence of Pre-clinical Sjögren Disease and Other Immune Disturbances in Subjects With Autoimmune Thyroiditis Disease

The main study hypothesis is that Sjögren Disease (SD), usually considered a disorder typical of adult females, may occur not exceptionally in adolescence or even in childhood as a subclinical process. There are several pieces of evidence in favor of this hypothesis, from the incidental detection of asymptomatic SD in pediatric age to biobank-based studies showing that biological signs of SD may precede the disease clinical onset by years or decades. The best scenario to verify this hypothesis could be that of autoimmune thyroiditis, for the following three reasons: 1) subjects with Autoimmune thyroiditis (AT) have a high risk of developing SD (7%); 2) in cases with comorbidity of SD and AT the diagnosis of AT had usually been made before; 3) subjects with AT routinely undergo periodic blood examination and neck ultrasonography (US), which may include Salivary Gland Ultrasound (SGUS) providing contributive data to detect an asymptomatic pre-SD. The knowledge of the real association between AT and pre-SD may impact on several aspects of medicine.


Eligibility Criteria:
Inclusion Criteria:

* Subjects between 0-17 years with autoimmune thyroiditis
* Subjects between 0-17 years with previous diagnosis of SD or pre-SD

Exclusion Criteria:

* No informed consent from the patient's guardians
* Active or recent infection within one week
Perfluorocarbon (ABL-101) Oxygenation for Stroke: Trial With GOLD (Glasgow Oxygen Level Dependent Technology) Imaging Theranostic

This study evaluates the safety and tolerability of 3 dose levels of ABL-101 and supplemental oxygen in acute stroke patients.

Only a small proportion of patients are currently suitable for treatment with "clot busting" drugs after a stroke. Being able to visualise potentially rescuable brain tissue on scanning may allow more people to be treated. Currently available methods require extra time to acquire and are not therefore widely used. By carrying significant extra oxygen to the brain, the ABL-101 molecule may not only allow the visualisation of salvageable tissue, but also prevent progression of stroke damage in and have an additional direct benefit on tissue survival. Studies in animal models of stroke show smaller areas of stroke damage after ABL-101. There is therefore a rationale for testing this molecule in stroke patients, both as a diagnostic method, and also as a potential therapeutic agent.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥18 years.
* Males or females not of child-bearing potential defined as being post-menopausal based on cessation of regular menses for a minimum of 12 consecutive months with no alternative cause, permanently sterilised (e.g. hysterectomy, bilateral tubal occlusion, bilateral salpingectomy), or having medically confirmed ovarian failure.
* Ischaemic stroke \<72h after onset.
* Previous functional independence (estimated mRS \<3).
* Capacity to consent.

Exclusion Criteria:

* Women of child bearing potential.
* Contraindications to MRI scanning (eg cardiac pacemaker, ferromagnetic implants, known hypersensitivity to gadolinium containing contrast media).
* Known allergy to ABL-101 or any of its constituents, (including egg phospholipids).
* Clinical need for, or contraindication to, supplemental oxygen.
* Known impaired renal function (eGFR \<30ml/min) precluding radiological contrast.
* Known thrombocytopaenia (platelet count \<150x109) or history of platelet function disorder.
* Known intercurrent infection.
* Known severe COPD or cardiac failure (eg significantly limiting exercise capacity or requiring hospitalisation within the preceding 12 months).
* Known significant liver disease (eg liver failure or cirrhosis, chronic infectious or autoimmune hepatitis, or transaminases \>3 times upper limit of normal).
* Any current medical condition causing impaired immunity (eg HIV infection, hyposplenism) or use of systemic immunosuppressant medication except for inhaled, nasal intra-articular or topical corticosteroids) on an ongoing basis or within the preceding 30 days.
* Any medical condition potentially limiting survival within the study follow-up period.
* Participation in another CTIMP within preceding 90 days.
Treatment of Recurrent Pregnancy Loss Using Mesenchymal Stem Cells

Treatment of Recurrent pregnancy loss using mesenchymal stem cells capable of differentiation in the endometrial-decidual direction.

Treatment of Recurrent pregnancy (characterized by the presense of thin endometrium) loss using mesenchymal stem cells capable of differentiation in the endometrial-decidual direction.

Eligibility Criteria:
Inclusion Criteria:

* female patients of reproductive age 18-49 years;
* recurrent pregnancy loss without current pregnancy with thin endometrium;
* unsuccessful IVF cycles due to thin endometrium;
* endometrial thickness is ≤6 mm in the first and second phases of the menstrual cycle;
* uterine infertility associated with endometrial hypoplasia;
* the absence of genetic diseases that prevent pregnancy;
* absence of taking hormonal drugs for 3 months prior to enrollment in the study.

Exclusion Criteria:

* patients with congenital malformations of the genital organs: agenesis and aplasia of the uterus, bicornuate uterus, unicornuate uterus, congenital fistula between the uterus and the digestive and urinary tracts, other congenital anomalies of the body and cervix. congenital anomaly of the body and cervix, unspecified, other specified developmental anomalies;
* acute inflammatory processes in the uterus;
* acute or chronic infectious and non-infectious diseases in the acute stage, including HIV, hepatitis B and C, syphilis, tuberculosis, chlamydia, myco-, ureaplasmosis, herpes, toxoplasmosis, rubella, cytomegalovirus, gonorrhea, trichomoniasis, etc.;
* autoimmune diseases;
* patients with malignant tumor including a history;
* patients with benign tumors of the uterus and appendages;
* miscarriage not associated with a thin endometrium, including immunological origin;
* hyper- or hypogonadotropic insufficiency of ovarian function, hyperandrogenemia of any origin;
* allergic reactions in the acute stage, established hypersensitivity to any component of the biomedical cell product;
* permanent therapy with cytostatics, hormones;
* mental and behavioral disorders that make it impossible for patients to participate in the study, drug and/or alcohol addiction.
Identification of Risk Patients in Emergency Medical Services

Background: Inadequate nutrition has been associated with growing risk of falling and impaired ability in elderly patients. Falling is a significant threat to the health of the elderly. It is estimated that one third of people over the age of 65 experience at least one falling each year. Over 60% of the falls cause serious injury or disability. Adequate nutrition increases the muscle strength of the elderly. Therefore, determining and managing the nutrition level is important for preventing falling. As far as we know emergency medical services has never before reported being a part of prevention by performing risk identification.

Aim: The purpose of the study is to assess whether it is possible to use a simple screening tool to find out the risk of falling, the nutritional status and the level of cognitive functioning activity when the EMS faces the elderly over the age of 70 years. In addition, the flow of information between primary care and emergency services and nutritionists is examined.

Material and method: Identification of poor nutrition is carried out in the Helsinki University hospital area. All people over the age of 70 requiring ambulance transport will be included in the study for 4 months during 2018. A structured electronic form is used to identify the malnutrition, the level of cognitive functioning activity and the risk of falling. The assessment is performed during the transport. The data is analyzed by the SPSS statistical program both by descriptive and statistical significance by looking at the methods suitable for the data.

Conclusion: The information produced by the research aims to develop (a) Identifying in the ambulance those patients who are at risk; and (b) activating nursing staff and nutritionists and, by means of these measures, increase the number of patients receiving effective nutrition therapy.

Eligibility Criteria:
Inclusion Criteria:

* All people over the age of 70 requiring ambulance transport will be included in the study for 4 months during 2018.

Exclusion Criteria:

-
Intraperitoneal Chemotherapy in Recurrent Ovarian Cancer

This study aims to compare intravenous chemotherapy versus intraperitoneal chemotherapy in patients with recurrent ovarian cancer.


Eligibility Criteria:
Inclusion Criteria:

* women who had recurrent ovarian cancer and was treated with either intravenous or intraperitoneal platinum based chemotherapy

Exclusion Criteria:

* women who did not complete the designated treatment course (exception to those who had to quit due to progressive disease or death of any cause)
Determinants of Quality of Life Related to Health in Alzheimer Disease

Study the factors that explain Health-Related Quality of Life (HRQL) in patients with Alzheimer disease including:

* The influence of the environment (physical and human) on Health-Related Quality of Life (HRQL),
* The influence of non-drug and drug treatments on Health-Related Quality of Life (HRQL),
* The influence of formal and informal help mobilized,
* The influence of interactions "patient - caregiver" on Health-Related Quality of Life (HRQL),
* The influence of the ratio necessary cost on available resources on Health-Related Quality of Life (HRQL)


Eligibility Criteria:
Inclusion Criteria:

* Patients with Alzheimer disease (DSM IV and NINCDS-ADRDA)
* Patients with MMSE (Mini Mental State Examination) \> or = 10
* Out patients

Exclusion Criteria:

* Severe sensory disturbances,
* Non French speaking
ADA Gene Transfer Into Hematopoietic Stem/Progenitor Cells for the Treatment of ADA-SCID

This is a phase I/II protocol to evaluate the safety and efficacy of ADA gene transfer into hematopoietic stem/progenitor cells for the treatment of adenosine deaminase (ADA)-deficiency. This condition is an autosomal recessive form of Severe Combined Immunodeficiency (SCID) characterized by impaired immune responses, recurrent infections, failure to thrive and systemic toxicity due to accumulation of purine metabolites. Transplants from an human leukocyte-antigen (HLA)-identical sibling donor is the treatment of choice, but available for a minority of patients. The use of alternative bone marrow donors or enzyme replacement therapy is associated with important drawbacks. The drug product studied in this protocol consists of autologous cluster of differentiation (CD)34+ hematopoietic stem/progenitor cells engineered ex vivo with a retroviral vector encoding the therapeutic gene ADA. The engineered CD34+ cells are infused following a nonmyeloablative conditioning with busulfan to make space in the bone marrow. The study objectives are: a) to evaluate the safety and the clinical efficacy of gene therapy, in the absence of enzyme replacement therapy; b) to evaluate the biological activity (engraftment, ADA expression) of ADA transduced CD34+ cells and their hematopoietic progeny. c) to evaluate the immunological reconstitution and purine metabolism after gene therapy.

The safety of the study will be evaluated by description of all adverse events and adverse drug reactions.

The study is aimed at reaching the minimum sample size of ten patients.

Eligibility Criteria:
Inclusion Criteria:

* ADA-SCID with no HLA-identical sibling donor available
* pediatric age and at least one of the following criteria:
* inadequate immune response after PEG-ADA for \> 6 months
* patients who discontinued PEG-ADA due to intolerance, allergy or auto-immunity
* patients for whom enzyme replacement therapy is not a life long therapeutic option

Exclusion Criteria:

* HIV infection
* history or current malignancy
* Patients who received a previous gene therapy treatment in the 12 months prior to receiving Strimvelis
* any other conditions dangerous for the patients according to the investigator
Efficacy and Safety of C2L-OCT-01 PR in Acromegalic Patients

The purpose of this study is to assess the biological safety and efficacy of using the drug, C2L-OCT-01 PR, 30 mg to treat acromegalic patients.


Eligibility Criteria:
Inclusion Criteria:

* Subject must be diagnosed with active acromegaly.
* If subject is treated with a long acting somatostatin analogue, the treatment must have been unchanged for a period of at least 12 weeks prior to entry.
* If subject is treated with a 30 mg dose of a depot formulation of a somatostatin analogue, the IGF-1 levels must be normal at entry.
* If subject is treated with a 20 mg dose of a depot formulation of a somatostatin analogue, any value of IGF-1 is acceptable.
* If the subject is receiving an immediate release formulation of a somatostatin analogue or a dopamine agonist, the IGF-1 values must be above 10% of the reference range based on gender and age.
* If the subject is receiving a dopamine agonist, it must be stopped 14 days prior to receiving the study medication.
* The subject should be able to understand the instructions, provide a written consent and abide by the study restrictions.

Exclusion Criteria:

* Women of childbearing potential who are not taking adequate contraception or who are pregnant or lactating.
* Subjects previously treated with a growth hormone receptor antagonist (Pegvisomant) within 12 weeks of study entry.
* Subjects who have undergone pituitary surgery within 6 months or radiotherapy within 2 years prior to admission into the study
* Subjects who present some form of intolerance or allergy to the test article or one of its non-active ingredients
* Subject who have any other condition that alters the growth hormone or IGF-1 levels.
* Subjects with signs or symptoms related to a tumor compression of the optical chiasm.
A Study of Pemetrexed in Children With Recurrent Cancer

To determine the response rate of pemetrexed given every 21 days for the treatment of children with relapsed or refractory osteosarcoma, Ewing's sarcoma/peripheral primitive neuroectodermal tumors (PNET), rhabdomyosarcoma, neuroblastoma, ependymoma, medulloblastoma/supratentorial PNET or non-brain stem high-grade glioma.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have osteosarcoma, Ewing's sarcoma, medulloblastoma, neuroblastoma, rhabdomyosarcoma, ependymoma or high-grade non-brainstem glioma
* Measurable disease
* Eastern Cooperative Oncology Group (ECOG) performance 0,1,2
* Adequate renal, liver and bone marrow function
* Patient's current disease state must be one with no known curative therapy or therapy proven to prolong survival with an acceptable quality of life

Exclusion Criteria:

* Growth factors that support platelet or white cell number or function must not have been administered within the last 7 days prior to enrollment (14 days if Neulasta)
* Patients with central nervous system (CNS) tumors who have not been on a stable or decreasing dose of dexamethasone or other corticosteroid for 7 days prior to enrollment
* Patients with uncontrolled infection
* Patients who have received pemetrexed previously
* Patients with pleural effusions or ascites
Online Motor Control in People With Parkinson's Disease

This study aims to better understand how people with Parkinson's control reaching movements. Specifically, we are asking how these individuals respond to different environmental perturbations. Testing includes reaching movements made within a virtual reality set-up.

Parkinson's disease (PD) is the second most common neurodegenerative disease, affecting approximately up to 10 million people worldwide and with 60,000 new cases diagnosed annually in the U.S. alone. Some of the most common signs and symptoms in individuals with PD are slowed and small movements and difficulty in movement initiation. The ability to correct movements online in response to environmental changes is an important part of daily living. Online movement corrections in reaching refer to the ability to smoothly change how and where you reach in response to a change in the environment. For example, one can adjust the position of the hand and arm when trying to catch a butterfly flying in the air. Generally speaking, online movement corrections can happen in response to visual perturbations (e.g., trying to catch a butterfly) or to force perturbations (e.g., someone knocks your hand while you're holding a coffee mug). Since individuals with PD have trouble with movements, it stands to reason that they may have problems with online movement corrections. Surprisingly, very little is known about online movement corrections in individuals with PD. The current evidence suggests that individuals with PD can make online movement corrections to small visual perturbations, but whether they can successfully respond to large visual perturbations is debatable. Furthermore, whether individuals with PD can make online movement corrections to force perturbations has not been studied. The aim of this project is to investigate if individuals with PD can make online movement corrections during reaching to visual and/or force perturbations. We will test both individuals with PD and age-matched healthy controls. They will perform reaching movements while visual or force perturbations are applied. We will use various perturbation strengths in order to test for potential differences in responses to small and large perturbations. Results from this study will provide new information on how individuals with PD make online movement corrections, and possibly provide insight to improving rehabilitation for PD.

Eligibility Criteria:
Inclusion criteria (all participants):

* Age 18-85 years
* Able to perform reaching movements of \~20 cm (8 inches)
* MMSE score ≥ 26/30
* Willing and able to attend all testing sessions

Inclusion criteria (PD group only):

* Diagnosis of idiopathic Parkinson's disease per self report
* Currently taking dopaminergic/dopamine agonist medication

Exclusion criteria (all participants):

* Any chronic or recent upper extremity musculoskeletal conditions that affects reaching
* Any neurological disorders other than Parkinson's disease (e.g., seizure disorders, closed head injuries with loss of consciousness greater than 15 minutes, CNS neoplasm, history of stroke)