Kornimate/medical-research-clean huggingface dataset:
irradiation-based myeloablative conditioning followed by treg/tcon immunotherapy in hsct

Conditions: Acute Myeloid Leukemia; Acute Lymphoid Leukemia; Myeloproliferative Disorders; Lymphoma; Multiple Myeloma; Other Hematologic Malignant Neoplasms

Summary: to evaluate if hyper-fractionated tbi or tmli followed by treg/tcon adoptive immunotherapy improve cgvhd/disease free survival after allogeneic hsct in patients affected by high-risk acute leukemias or other hematologic malignancy where hsct is indicated.

improving cgvhd/disease free survival in patients with high-risk acute leukemias or other hematologic malignancy where hsct is indicated with the use of a regulatory t cell based protocol. hyper-fractionated total body irradiation or total marrow and lymphoid irradiation based conditioning will be followed by the infusion of t regulatory and t conventional cell adoptive immunotherapy and a purified cd34+ hematopoietic stem cell graft. incidence of non relapse mortality, relapse, acute graft versus host disease, chronic graft versus host disease, as well as probability of cgvhd/disease free survival will be assessed in patient subpopulations separated according to hla-matching with the donor (hla-matched hsct and hla-haploidentical hsct) and type of disease (acute myeloid leukemia, acute lymphoid leukemia, lymphoma, multiple myeloma, myeloproliferative disease, and other).

Eligibility criteria:
inclusion criteria: * aml and all in complete remission and with high-risk of relapse * aml and all primarily chemoresistant or relapsed; * chronic myeloid leukemia in accelerated or blastic phase; * patients affected by * multiple myeloma, * non hodgkin lymphoma, * hodgkin lymphoma, * chronic myeloproliferative syndrome, * chronic lymphoid leukemia, * other hematological malignancy at high-risk of relapse or detectable disease and where a hsct is indicated. * age \<75 years * ecog ≤ 2 * acceptable lung, liver, kidney, and heart function and absence of relevant psichiatric diseases * signature of the informed consent exclusion criteria: * age \>75 years * ecog \> 2 * not acceptable lung, liver, kidney, and heart function and presence of relevant psichiatric diseases * pregnancy * no signature of the informed consent
qsm and regional dce mri permeability using gocart technique

Conditions: Intracranial Neoplasm

Summary: this randomized pilot clinical trial studies quantitative susceptibility mapping (qsm) and regional dynamic contrast enhanced (dce) magnetic resonance imaging (mri) permeability using golden-angle cartesian randomized time-resolved (gocart) technique in evaluating regional gadolinium retention in the brain in patients with intracranial neoplasm receiving gadobenate dimeglumine or gadoterate meglumine. mri diagnostic techniques such as, qsm and dce mri, may help to gather information regarding brain changes associated with gadolinium deposits during 8 to 18 months after administration of gadobenate dimeglumine or gadoterate meglumine.

primary objectives: i. to obtain preliminary data (e.g. mean, variance, distribution) in the regional brain parenchymal changes associated with gadolinium (gd) deposition during 8 to 18 months period after administration of gadolinium based contrast agents (gbca) to gd naive intracranial neoplasm patients who will be randomized to gadobenate dimeglumine (multihance) or gadoterate meglumine (dotarem). ii. to explore if areas of increased regional gd deposition at individual level are correlated with baseline regional dce permeability metrics such as volume transfer coefficient reflecting vascular permeability (ktrans), extracellular volume ratio reflecting vascular permeability (ve) and plasma volume (vp) in intracranial neoplasm patients. outline: patients are randomized to 1 of 2 arms. arm i: patients undergo standard of care qsm and t1 weighted imaging (t1wi). patients then receive gadobenate dimeglumine intravenously (iv) and undergo gocart dce mri over 60 minutes. arm ii: patients undergo standard of care qsm and t1wi. patients then receive gadoterate meglumine iv and undergo gocart dce mri over 60 minutes. after completion of study, patients are followed up at 8-18 months.

Eligibility criteria:
inclusion criteria: * patient with suspected intracranial neoplasm scheduled for routine mri with gbca (gadolinium naive patients) * willingness to comply with the study protocol exclusion criteria: * contraindications for mri or gbca (standard of care) * abnormal renal function with estimated glomerular filtration rate (egfr) less than 30 ml/min/m\^2 based on creatinine obtained within last 30 days * history of previous administration of gbca
hypofractionated radiotherapy as primary therapy for prostate cancer

Conditions: Prostate Cancer

Summary: external beam radiotherapy (rt) is one of the standard curative treatment options for patients with prostate cancer (pc). several randomised trials have shown excellent long-term biochemical outcome with higher radiation doses. nowadays, rt for pc commonly consists of delivering 74-80 gy in 2 gy fractions, resulting in an overall treatment time of 7-8 weeks. the sensitivity of different tissues to fractionation changes can be quantified through the α/β ratio in the linear-quadratic model. dose-response analysis of pc patients treated with both external beam rt and brachytherapy has led to the hypothesis that the α/β ratio of pc is lower than for most other tumors and approaches a value characteristic of late responding tissues. values between 1.2 and 3.9 gy have been calculated. if the α/β ratio of pc is indeed low, then hypofractionating rt treatments can theoretically maintain high bioequivalent tumor doses, shorten overall treatment time and decrease late toxicities.the advantages in terms of patient convenience and treatment cost are obvious. there is level i evidence that shows that hypofractionated radiotherapy schedules have at least equivalent biochemical outcome with only a small increase in acute but not late toxicity when compared to conventional fractionation rt schedules. results on different hypofractionation schedules have been reported, however the optimal hypofractionation is not clear so far. in this randomised trial we would like to compare 2 different radiotherapyschedules: 16 fractions à rato of 4 fractions a week versus 25 fractions à rato of 5 fractions a week. the incidence on acute toxicity and early late toxicity (i.e. within 2 year post radiotherapy) and the impact on quality of life will be registrated and compared. the study will be performed in 2 stages. for stage 1, sample size was calculated to rule out an upper limit of 40% of patients with rtog grade 2 or worse bowel (gi) complications with an expected rate of 25%, based on a one-stage fleming-a'hern design. a power of 83.0% (alpha level 0.038 one-sided) was obtained when including 72 patients per group (144 patients in total). if 22 or more patients out of 72 had grade 2 or worse gi complications, then the study arm was to be rejected. to allow for a dropout of 10%, 160 patients were included in stage 1. sample size for stage 2 was calculated analogously allowing ruling out an upper limit of 35% of patients with rtog grade 2 or worse gi complications with an expected rate of 25%. when including 155 patients per group (310 in total) a power of 85.7% (alpha level 0.049 one-sided) was obtained. if 45 or more patients out of 155 had grade 2 or worse gi complications, then the study arm was to be rejected. the sample size for stage 1 and stage 2 combined was set at 346 (173 per group), with a 10% allowance for dropout.


Eligibility criteria:
inclusion criteria: * patients with t1-4 n0 m0 prostate cancer exclusion criteria: * other no skin cancer diagnosed within 5 years prior to enrolment * no informed consent
next generation to identify genetic causes of disease in patients participating in nichd clinical protocols

Conditions: Genetic Predisposition

Summary: background: - the purpose of this study is to identify changes in genes that cause human diseases. we would like to obtain some of you or your child s dna and test for changes in genes that may contribute to a disease in you or your family. objective: -to allow for exomic or genomic sequencing of nichd patients or family members in order to identify changes in genes that cause or contribute to a specific disease. eligibility: * children who are enrolled in an nichd clinical study where the condition being studied may have a genetic cause. * family members of a child who is eligible for this study. design: * children and family members will supply dna samples. if the samples are already available, no further dna will be needed. * if dna is not available, samples of either blood or skin will be taken. * we will use these samples with new dna sequencing technology that looks at all the human genes we know about. this is known as exome and genome sequencing.

over the last few years advancements in dna sequencing technology have progressed significantly. it now is feasible and economical to sequence the exome (known genes) or the entire genome. this technological advance can be applied to identifying genetic causes of rare diseases where traditional methods such as mapping frequently failed due to insufficient number of cases. these cases often present themselves in the context of other nichd research protocols, such as teaching protocols, where it would not be efficient for the individual investigators to write a new protocol. it will also serve to standardize the consent document across nichd for investigators that do not include exomic/genomic sequencing in their own protocol.

Eligibility criteria:
* inclusion criteria: 1. proband s that are enrolled in an nichd clinical protocol for which there is a suspicion of an underlying genetic cause for a disease for which they are being evaluated. 2. family members of a proband who is eligible for this protocol. exclusion criteria: 1. normal volunteers unrelated to a proband with the disease of interest.

Keywords: whole exome whole genome rare disorders genetic disorders
a study of pancreatic cancer in xenografts from liver metastases

Conditions: Pancreatic Cancer; Liver Metastases; Tumor Tissue Biopsy; Blood Samples

Summary: this is a feasibility study to perform image-guided liver biopsies in 25 patients who have pancreatic cancer with liver metastasis (cancer in the pancreas that has spread to the liver). this will contribute with samples for the bio-bank (bank of tumors) and develop xenografts (human tumors growing in mice) for further analysis of genes.

this study might bring a better understanding of the metastatic pancreatic cancer and evaluate the differences between the metastatic and the primary pancreatic cancer (the type that does not have metastasis).

Eligibility criteria:
inclusion criteria: * minimum age of 18 years old * pancreatic cancer with liver metastasis * no contraindication to image-guided biopsy of liver metastasis, including uncontrolled bleeding diathesis, uncontrolled malignant pain, inability to lie supine etc) and no significant hepatic dysfunction. * provide written informed consent * ecog 0,1 or 2 exclusion criteria: * inability to lie supine for more than 30 minutes * ecog 3 or more * serious medical risk factors involving any of the major organ systems or including uncontrolled bleeding diathesis, uncontrolled malignant pain, inability to lie supine etc) and no significant hepatic dysfunction.

Keywords: pancreatic cancer liver metastases tumor tissue biopsy blood samples xenografts murine genomic profiling circulating biomarkers
peginterferon α-2b combined co2 laser in condylomata acuminata

Conditions: Condylomata Acuminata

Summary: this is a prospective, randomized, open-label, controlled study, aiming to enroll 30 patients with condylomata acuminata. the study consists of two phases: a treatment phase (weeks w1-w12) and an observation phase (weeks w13-w24). eligible patients will be randomly allocated into three groups at a ratio of 1:1:1: test group 1, test group 2, or the control group. and clinical cure, recurrence rates, adverse events, vital signs, laboratory tests, drug exposure doses, premature withdrawals will be analyzed.


Eligibility criteria:
inclusion criteria: * patients must be between 18 and 65 years old. * patients with positive of human papillomavirus(hpv) nucleic acid test and acetowhite test, were diagnosed as condyloma acuminatum according to clinical manifestations and epidemiological history. * patients' lesions are located on non-cavity areas such as the foreskin, glans penis, labia majora, labia minora, with a number ranging from 1 to 5 individual lesions, and each individual lesion having a diameter less than 1 centimeter. * for female participants with reproductive capability, a negative pregnancy test result is mandatory at the screening stage. * participants must volunteer to enroll in the study and be able to understand and sign a written informed consent form. exclusion criteria: * pregnant women, breastfeeding mothers, or individuals planning to conceive during the study period. * patients who received treatment for genital warts within two weeks prior to screening. * patients with concurrent skin conditions in the affected area that might significantly impact the evaluation of treatment efficacy. * individuals with known severe immunodeficiency or those requiring long-term use of corticosteroids and immunosuppressive agents. * active carriers of hepatitis b virus, hepatitis c virus, human immunodeficiency virus (hiv), or treponema pallidum (syphilis). * patients with a history of severe cardiovascular, hepatic, renal, endocrine, digestive, immune, respiratory, or nervous system diseases. * patients with severe retinal disorders or other serious ophthalmologic conditions. * patients allergic to interferons or excipients in the medication formulation, or those deemed unsuitable for co2 laser treatment. * individuals meeting any contraindications listed in the investigational drug's package insert. * patients who participated in another interventional clinical trial within three months before screening, or those planning to participate in another clinical trial during the study period. * other cases deemed inappropriate for enrollment by the investigator due to various reasons.

Keywords: condyloma acuminatum, genital warts, peginterferon α-2b, interferon, co2 laser
study of aripiprazole to treat children and adolescents with autism

Conditions: Autistic Disorder; Asperger Syndrome; Autism Spectrum Disorder

Summary: the purpose of this open label study in children and adolescents is to examine the acute and long-term effects of aripiprazole on problem behaviors associated with autism spectrum disorders and development in areas which appear to be affected by autism spectrum disorders.

the purpose of this open label study in children and adolescents with autism spectrum disorders (asd) is to examine the acute (12 week) and long-term (1 year) effects of aripiprazole on problem behaviors associated with asd and development in three behavioral domains which appear particularly affected by asd. we are also examining the safety and tolerability of aripiprazole in a range of children with autism. 20 children will be enrolled in the treatment part of the study. an additional 10 children, self selected by guardian desire not to pursue pharmacological treatment, will serve as a nonrandomized control group. this group will be provided with support but not any other treatments, come in for fewer visits and will be asked not to seek pharmacologic treatment outside the study. as of january 2010, we have completed enrollment in the treatment arm. currently, we are only looking to enroll individuals in the control arm in which participants would not take any psychiatric medication.

Eligibility criteria:
inclusion criteria: * subjects must be between 30 months and 17 years 11 months, male or female, of any ethnicity and of any cognitive level * meet criteria for diagnosis of autism, asperger's disorder or pervasive developmental order nos (i.e. an autism spectrum disorder) based on clinical evaluation and either the autism diagnostic interview - revised (adi-r) or the autism diagnostic observation scale (ados) * have a guardian who is able and willing to give written informed consent * if competent, subject able and willing to give written assent for their own participation * if on anticonvulsants, subject have been seizure-free and on a stable anticonvulsant regimen for at least 6 months * subjects may receive other nonpharmacologic treatment including dietary treatments exclusion criteria: * diagnosis of rett's syndrome or child disintegrative disorder * taken psychotropic medications other than clonidine or diphenhydramine within 2 weeks * previous trial of aripiprazole * pregnant or nursing * epilepsy or another significant chronic medical illness

Keywords: open label aripiprazole children adolescents autism spectrum disorders
acute-phase response & periodontal treatment in patients with hypertension

Conditions: Periodontitis; Hypertension

Summary: the aim of this study is to compare quadrant scaling and root planing (q-srp) versus full-mouth treatment (fm-srp) in terms of acute-phase responses following non surgical periodontal treatment in patients affected by periodontitis and high blood pressure.

periodontal treatment, consisting in both supra- and sub-gingival mechanical instrumentation of the root surface (scaling and root planing), will be performed by a single periodontist on patients with periodontitis and hypertension. the aim of this study is to compare quadrant scaling and root planing (q-srp) versus full-mouth treatment (fm-srp) in terms of acute-phase responses following non surgical periodontal treatment in patients affected by periodontitis and high blood pressure. treatment will be provided using both hand and ultrasonic instrumentation with ﬁne tips. fm-srp patients will received treatment within 24 h. q-srp patients will received four quadrants sessions of periodontal treatment with an interval of 1 week between sessions. vital, endothelial function and blood inflammatory parameters will be evaluated at baseline, 24 hours after the first treatment and after 3 months. periodontal parameters will be evaluated at baseline and after 3 months.

Eligibility criteria:
inclusion criteria: * patients affected by periodontal disease * 20% of periodontal pockets of the entire dentition * 20% bleeding on probing of the entire dentition * documented radiographic bone loss * diagnosis of hypertension as measured through international standards exclusion criteria: * age younger than 18 years and older than 80 years * pregnant or lactating females * need of antibiotic coverage for periodontal treatment * treatment with statins and/or acetylsalicylic acid
volumetric bone mineral density and it's relationship with osteoporotic fractures in parkinson's disease

Conditions: Idiopathic Parkinson's Disease

Summary: idiopathic parkinson's disease (ipd) is the second most frequent neurodegenerative disease. its association with osteroporosis and fragility fracture is now clearly demonstrated, but the determinants of this osteoporosis are yet to be explained. our aim was to study factors associated with volumetric bone mineral density (vbmd) and bone microstructure at the tibia and radius in ipd.


Eligibility criteria:
inclusion criteria: * patients with idiopathic parkinson's disease according to the criteria of the ukpdbb. * parkinson's disease of moderate severity (index hoehn and yahr \<5) * patient can respond to questionnaires, with or without help exclusion criteria: * patients with active psychiatric illness preventing the realization of examinations * severe parkinson's disease (index hoehn and yahr ≥5 ) * heavy-morbidity including heart failure nyha\> 3 or chronic respiratory failure, terminal or severe renal impairment known dialyzed * pregnancy

Keywords: osteoporosis parkinson hr-pqct bone microstructure fracture risk
pecs study for cied implantation surgery

Conditions: Pain, Postoperative; Child; Adolescent

Summary: we aim to determine whether pectoral nerve block (pecs) performed after induction of anesthesia but before surgical incision results less opioid use in the post operative period compared with local infiltration alone in children undergoing cardiac implantable electronic device (cied) surgery.

the current anaesthetic management of cied surgery at sickkids is local anaesthetic infiltration by the ep cardiologist or a pectoral nerve block (pecs) on an ad-hoc basis depending on the anaesthesiologist on a case by case basis. it is not known whether one technique provides better post- operative pain control and fewer adverse events than the other. in either case, the patient receives opioids as required during and after the procedure. patients typically go home with a prescription for opioids to be taken for the first few days after surgery. the pecs block is a recognized effective anaesthetic technique used for both intraoperative and postoperative pain control in adult breast surgery, chest wall procedures as well as one case report for cied implantation and a small series in paediatric cardiac surgery. the advantages of the pecs block in these surgical procedures includes improved analgesia and reduced opioid use. the investigators plan to conduct an rct with two groups. group 1 will receive a pecs block (using 0.8 ml/kg of 0.25% bupivacaine with epinephrine 1: 200000 divided in two equal volumes between the two planes) by the anaesthesiologist and local infiltration (up to 0.2 ml/kg of 0.25% bupivacaine with epinephrine 1:200000) by the surgeon. group 2 will receive local infiltration (up to 0.8 ml/kg 0.25 % bupivacaine with epinephrine 1:200000) by the surgeon alone. both groups will be given opioids as rescue analgesics as deemed necessary during their procedure and as rescue analgesia postoperatively, so that no patient will have untreated pain.

Eligibility criteria:
inclusion criteria: • all patients 3-18 years undergoing cied surgery in the chest exclusion criteria: * children \< 3 years of age at time of procedure as bupivacaine is not licensed for this age group. * no parental or patient consent * allergy to bupivacaine * pregnancy or lactation * any condition or diagnosis, that could in the opinion of the principal investigator or delegate interfere with the participant's ability to comply with study instructions, might confound the interpretation of the study results, or put the participant at risk.
a phase ii open-label exploratory study of saquinavir + zidovudine + lamivudine in hiv infected patients

Conditions: HIV Infections

Summary: to explore the antiviral efficacy, tolerability and safety of saquinavir plus zidovudine plus lamivudine.

a total of 30 patients receive the triple drug regimen saquinavir plus zidovudine plus lamivudine until the completion of the analysis after at least 4 weeks of therapy.

Eligibility criteria:
inclusion criteria patients must have: * hiv antibody positive. * cd4 count \>= 150 and \<= 500 cells/mm3. exclusion criteria prior medication: excluded: * prior antiretroviral therapy. * prior protease inhibitor therapy.

Keywords: drug therapy, combination zidovudine hiv protease inhibitors lamivudine saquinavir reverse transcriptase inhibitors anti-hiv agents