Kornimate/medical-research-clean huggingface dataset:
safety, tolerability, and pharmacokinetics of c2n-8e12 in subjects with progressive supranuclear palsy

Conditions: Progressive Supranuclear Palsy

Summary: this study will evaluate the safety and tolerability (maximum tolerated dose (mtd) within the specified dosing range) of single intravenous (iv) infusion of c2n-8e12 in patients with progressive supranuclear palsy (psp).

this study evaluates the safety, tolerability, pharmacokinetics, and maximum tolerated dose (within dosing range) of intravenous (iv) infusion of c2n-8e12 in 32 patients with progressive supranuclear palsy (psp). four sequential cohorts will receive increasing single doses of either c2n-8e12 or placebo. out of every 4 patients enrolled 3 patients will receive drug and 1 will receive placebo. study participants will be followed for a minimum of 2 months post-treatment to monitor for the safety, tolerability, pharmacokinetics, and immunogenicity of c2n-8e12.

Eligibility criteria:
key inclusion criteria: * meets ninds-spsp possible or probable criteria as modified for nnipps and al-108-231 clinical trials * brain mri at screening is consistent with psp; * stable medications for parkinsonism for at least 2 months prior to screening; * agree to use protocol specified methods of contraception. key exclusion criteria: * signs of a progressive neurological disorder that better meets the criteria for types of neurological disorders other than psp; * currently on any other biologic or immunomodulatory therapy; * subjects that reside at a skilled nursing or dementia care facility; * diagnosis of any other significant unrelated neurological or psychiatric disorders that could account for cognitive deficits; * untreated major depression at baseline evaluation, based on clinical judgment and results in geriatric depression scale; * unable to tolerate mri scan at screening or any other contraindication to mri; * any contraindication to or unable to tolerate lumbar puncture at screening, including use of anti-coagulant medications.

Keywords: psp c2n-8e12 tauopathy progressive supranuclear palsy steele richardson olszewski syndrome humanized anti-tau antibody
evaluation and natural history of children with cancer and aids

Conditions: Acquired Immunodeficiency Syndrome; Cancer; HIV Infections; Leukemia; Lymphoma

Summary: patients enrolled in this study will not receive investigational therapy. any treatments rendered will be standard and based on appropriate medical care. should a patient become eligible for an experimental therapy protocol, the normal process of enrollment and informed consent will be followed.

this protocol will enable the pediatric branch to follow selected children with cancer or hiv infection who are not immediately eligible for protocol enrollment but who are likely, within the next year, to become candidates for protocol entry. it will also enable the pediatric branch to follow children who present with either clinical findings that constitute important educational experiences for the nci trainees or who have unique or unusual medical problems that are likely to benefit from the research expertise of the nci.

Eligibility criteria:
children with cancer (or a precancer syndrome) or hiv infection, between the age(s) of 3 months to 30 years, who are evaluated by the pediatric branch and are found to be not immediately eligible for an ongoing protocol but are likely to become a candidate for a future protocol. children with cancer (or a precancer syndrome) or hiv infection, who present with disease manifestations of special interest to pediatric branch investigators, because they are likely to shed light on disease. patients who, when evaluated by the branch, are determined to likely never become eligible for a pediatric branch protocol are not eligible for this protocol. no patients younger than 3 months of age or older than 30 years of age are eligible for this protocol.

Keywords: aids children human immunodeficiency virus
a model-based health education program to improve oral health in school going children

Conditions: Oral Health

Summary: this was a randomized controlled trial to assess how an education program based on health belief model (hbm) may affect oral health status in the elementary school going children. for this, a convenient sample including 112 school going children aged between 6-12 years old were recruited and randomized into intervention or control groups. education program consisted five weekly session each lasted for 1 hour approximately. based on the main constructs of the hbm, each session was organized and a combination of educational methods were used in the intervention group while the control group only received the routine program provided by the dental clinic. measures such as papillary bleeding index; decayed, missing, filled teeth (dmft) and a scale based on the hbm were used for data collection. three months after the intervention the measures were administered again and comparisons between baseline and follow-up were done.

oral health problems especially dental carries are common in school children and education programs may help to prevent these conditions. the aim of current study was to investigate how an education program based on health belief model (hbm) may improve oral health status of the elementary school children. one hundred twelve 6-12 year children along with one of their parents assigned into trial and control groups using a randomized controlled trial. for trial group 5 education sessions based on hbm were held, whereas control group only received routine education program delivered by the dental clinic. decayed, missing, filled teeth (dmft) score, papillary bleeding index, and hbm questionnaire for oral were used for evaluation of the program. three month after the intervention reassessment was performed and the changes were measured by student t test as well as analysis of covariance test.

Eligibility criteria:
inclusion criteria: * age between 6-12 years old (elementary school going children) * attendance of at least one parent (either father or mother) when admission and to take part in the intervention * being permanent residents of the enrollment area * having medical record in the dental clinic * ability to speak and understand persian exclusion criteria: * children with advanced oral diseases or other critical conditions or disabilities * those who were using anti-inflammatory agents as a routine * those who had used antibiotics in past two weeks * children with illiterate parents * those on ongoing orthodontic treatments

Keywords: oral health gingival health health education decayed teeth
clinical efficacy of trastuzumab in combination with capecitabine and oxaliplatin for the treatment of her2-positive advanced gastric cancer.

Conditions: Advanced Gastric Carcinoma

Summary: trastuzumab plus chemotherapy prolonged the median overall survival in patients with human epidermal growth factor receptor 2 (her2)-positive advanced gastric cancer (agc). among chemotherapy regimens, oxaliplatin is generally more convenient and tolerable than cisplatin, and becoming an increasingly popular option for the treatment of agc. the aim of the study was to evaluate the efficacy and safety of trastuzumab in combination with capecitabine and oxaliplatin (capox) in her2-positive agc.


Eligibility criteria:
inclusion criteria: * her2-positive agc defined as either her2 immunohistochemistry (ihc) 3+ or ihc 2+ and fluorescence in situ hybridization (fish)+ with no history of previous treatment. exclusion criteria: -
a study of darbepoetin alfa for the treatment of anemia in subjects with a non-myeloid malignancy

Conditions: Anemia

Summary: the purpose of this study is to compare the efficacy of darbepoetin alfa administered using a front-loading approach with subjects receiving standard weekly dosing in the treatment of anemia in subjects with a non-myeloid malignancy and receiving multicycle chemotherapy.


Eligibility criteria:
inclusion criteria: - non-myeloid malignancy - at least 12 additional weeks of cyclic cytotoxic chemotherapy anticipated regardless of schedule - ecog 0-2 - cancer and/or chemotherapy-associated anemia exclusion criteria: - known history of seizure disorder - known primary hematologic disorder, which could cause anemia, other than a non-myeloid malignancy - unstable or uncontrolled disease/condition, related to or affecting cardiac function - clinically significant inflammatory disease - inadequate renal and/or liver function

Keywords: non-myeloid malignancy darbepoetin alfa clinical trial
boo and du and their clinical and urodynamic findings in women with ≥stage ii cystocele

Conditions: Bladder Outlet Obstruction and Detrusor Underactivity in Women With Severe Cystocele

Summary: prevalence rates of bladder outlet obstruction (boo) and detrusor underactivity (du) and their related clinical and urodynamic findings in women with ≥ pelvic organ prolapse quantification stage ii cystocele are important for clinical consultation. thus, the aim of this study was to elucidate the above findings and between-group associations.

between november 2011 and january 2017, medical records of all women with ≥stage ii cystocele who underwent 20 min pad testing and urodynamic studies in a medical center were reviewed. only those with complete data of maximum flow rate (qmax) and detrusor pressure at maximum flow rate (pdetqmax) were enrolled. anova test and post-hoc testing with bonferroni's correction were used for statistical analysis. woman were defined as having du when qmax was \<12 ml/s and pdetqmax was \<10 cmh2o, and were defined as having boo when qmax was \<12 ml/s and pdetqmax was ≥25 cmh2o with sustained detrusor contraction during voiding cystometry.

Eligibility criteria:
inclusion criteria: 1. age \> 20y/o 2. cystocele \> stage ii 3. complete pad test and urodynamic study exclusion criteria: 1. pregnancy 2. urinary tract infection 3. had received pelvic reconstruction surgery

Keywords: cystocele bladder outlet obstruction detrusor underactivity urodynamic study
qtx3544 in patients with advanced solid tumors with kras g12v mutations

Conditions: Advanced Solid Tumors

Summary: phase 1 study to determine the safety, tolerability, and anti-tumor activity of qtx3544 as a single agent or in combination with cetuximab.


Eligibility criteria:
inclusion criteria: * pathologically documented, locally advanced or metastatic malignancy with kras g12v mutations identified through molecular testing (ngs- or pcr-based) with a clinical laboratory improvement amendments-certified (or equivalent) diagnostic. * part 1: advanced solid tumors with at least one prior systemic therapy. * evaluable and measurable disease per recist v1.1. * part 2 and 3: measurable disease per recist v1.1. exclusion criteria: * active brain metastasis or carcinomatous meningitis * significant cardiovascular disease * active infection requiring intravenous (iv) antibiotics * prior treatment with a kras inhibitor other protocol-defined inclusion/exclusion criteria may apply
validation study of linear quantification of cd3+ cells in localized colorectal carcinomas

Conditions: Metastatic Colorectal Cancer

Summary: the purpose of this study is to confirm that linear quantification of cd3+ cells is a prognostic biomarker in localized colorectal carcinomas.

adult patients of both gender who have underwent surgical resection of stage iii colorectal carcinoma and randomised to receive a chemotherapy folfox or folfox + cetuximab in the petacc8 trial.

Eligibility criteria:
inclusion criteria: * patient included in petacc08 study * signed informed consent for translational study * ffpe tumor sample available for cd3 staining exclusion criteria: - patient who have withdrawn their consent for petacc08 and/or for petacc08 translational study

Keywords: colon and rectum carcinoma immune response biomarker prognosis
interest of photographs by smartphone in dermatology

Conditions: Dermatitis

Summary: to study the diagnostic performance of the images on the smartphone compare the result of the clinical examination, all the dermatoses combined and by family of pathology (inflammatory, wound, oncology, infectious, allergology), during urgent request requests in dermatology

the study is conducted in the dermatology department, for a maximum duration of 6 months. we include patients who require dermatological advice and for whom their doctor sends us photographs. doctors contact us by telephone, describe the symptoms and send photographs according to the secure procedure. patients are admitted for consultation and the diagnosis by photography is compared with the clinical diagnosis

Eligibility criteria:
inclusion criteria: * for which our fellow doctors ask a dermatological opinion for diagnostic purposes, after clinical examination of the patient, in an emergency * after obtaining the oral consent by the requesting doctor then informing and signing a non-opposition form during the consultation at the university hospital of nancy * affiliation to a social protection * doctors must have signed and sent back an ethical charter, where they undertake to send the image via mssante, then to erase the image of the smartphone exclusion criteria: * patients under the protection of justice, tutorship or curatorship * doctors : lack of smartphone powerful enough to offer a quality image
decision to limit or withdraw specific therapies for advanced cancer and hematological malignancies.

Conditions: Advanced Cancer; Ethics

Summary: the decision to limit or withdraw specific therapies (dlwt) in patients with advanced cancer is a complex process that is always painful for patients, relatives and professionals. for more than 10 years, shared decision making has been more and more emphasized. however, few data in the literature rely on clinical research. in order to understand their difficulties and issues, this study explores the determinants and modalities of dlwt and analyses the feasibility of different methods for investigating this decision making process.

this study explores the decision-making process for patients with advanced cancer when the question to imit or withdraw specific therapies (dlwt) is raised, with a cross-analysis of physicians and pts points of view. this study took place in 5 oncology and hematology units : 2 university hospitals, 1 general hospital, 1 cancer center and 1 private hospital. the study included two different approaches: an epidemiological section to identify the prevalence of these situations in different institutions and a qualitative study section exploring factors influencing the decision process. the epidemiological analysis included all hospitalized patients identified with advanced cancer for whom the question of dlwt was raised in a given week or during the two weeks preceding the investigation. the qualitative analysis was based on interviews with the referent oncologist (or hematologist) and his patient (conducted by a physician and a psychologist respectively) as well as interviews with other partners involved in the situation (care staff and relatives) depending on the center. researchers also participated in multidisciplinary meetings and monitored changes in the decision over a three month period.

Eligibility criteria:
inclusion criteria: * patients with advanced cancer * existence of a questioning about dlwt * absence of guide lines exclusion criteria: * incapacity of the patient to participate to an interview * absence of informed consent

Keywords: decision making
influenza vaccination in bone marrow transplantation

Conditions: Influenza

Summary: the purpose of this study is to determine whether influenza vaccination protects patients who receive a certain type of bone marrow transplantation.

patients who receive bone marrow transplantation are at high risk for complications from influenza infection. it is not whether influenza vaccination protects patients who undergo a type of bone marrow transplantation called "nonmyeloablative", or "reduced intensity" bone marrow transplantation. this study compares the response to influenza vaccination in a group of these patients to that in healthy people.

Eligibility criteria:
inclusion criteria: * patients were included if they had received ric allo hsct 3 months or more prior to enrollment, and were between the age of 18 and 65 years. * controls were health care providers at our institution, between the ages of 18 and 65 years, who were in good health, and who are routinely offered influenza vaccination. exclusion criteria: * patients were excluded if they failed to engraft, or had relapse of the underlying disease requiring chemotherapy or immunotherapy. * patients and controls were also excluded if they had history of egg allergy, acute febrile illness at the time of vaccination, or influenza-like illness within 4 weeks prior to vaccination.

Keywords: peripheral blood stem cell transplantation non-myeloabalative influenza vaccination humoral immune response immunogenicity
minimally-invasive stabilization of pelvic metastases with photodynamic nails: a multi-center prospective study of functional outcome

Conditions: Pelvic Metastasis

Summary: determine whether patients exhibit early functional improvement after minimally-invasive placement of illuminoss photodynamic nails for peri-acetabular pelvic metastasis at 3 months following procedure

primary objectives 1. evaluate whether patients exhibit early functional improvement after minimally-invasive placement of illuminoss photodynamic nails for peri-acetabular pelvic metastasis at 3 months following procedure secondary objectives 1. evaluate whether the procedure relieves pain 2. evaluate radiographic stability of the implant 3. evaluate functional outcome at earlier time points (2 weeks or 6 weeks) and at 6 months and possibly later time points 4. evaluate reoperation rate and complications

Eligibility criteria:
inclusion criteria: * patients must have a histologically confirmed malignancy from prior biopsy of the primary tumor or a metastatic site. patients with carcinoma, myeloma, and lymphoma may be included in the study. patients should have metastatic involvement of the periacetabular region that is visible radiographically. biopsy of acetabular disease is not required for this study. * age ≥18 years (illuminoss is approved only for skeletally mature patients) * suitable candidate for general anesthesia * ability to understand and the willingness to sign a written informed consent document. * able and willing to fill out pre-operative and post-operative functional outcome surveys * absolute neutrophil count ≥ 1,500/mcl * platelets ≥ 50,000/mcl exclusion criteria: * patients with uncontrolled intercurrent illness (e.g., recent pneumonia or myocardial infarction that would significantly increase risk of general anesthesia) * human immunodeficiency virus (hiv)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. * patients with psychiatric illness/social situations that would limit compliance with study requirements. * pregnant women are excluded from this study because of the risk of general anesthesia and radiation exposure (fluoroscopy) to the fetus * history of allergic reactions attributed to compounds of similar chemical or biologic composition to dental resins or pet.
sand play - the effect of biodiversity exposure on atopic dermatitis

Conditions: Atopic Dermatitis; Nature, Human; Microbial Colonization; Immune System and Related Disorders

Summary: the prevalence of atopic dermatitis has increased along with urbanization and biodiversity loss. according to biodiversity hypothesis, the main reason is urban lifestyle and reduced contact to microbial diversity. previous studies indicate association between atopic dermatitis and exposure to natural microbes in childhood. sand play - the effect of biodiversity exposure on atopic dermatitis will investigate whether the exposure to microbial diversity in sandbox reduces the symptoms of atopic dermatitis, alters commensal microbiota and modifies immune regulation in children.

our specific aims are: to assess if exposure to microbial diversity reduces eczema area and severity index (easi) and patient-oriented eczema measure (poem). assess whether the sand play alters plasma cytokine profiles, white blood cell distributions, allergy specific ige, and commensal microbial communities on skin, in saliva and gut. the investigators will recruit approximately 80 (40 study subjects per treatment) subjects with atopic dermatitis and aged between 2-5.

Eligibility criteria:
inclusion criteria: * eczema area and severity index ≥ 2 exclusion criteria: * eczema area and severity index \< 2 * immune deficiencies, i.e., antibody deficiency * immunosuppressive systematic medications * a disease affecting immune response (e.g., colitis ulcerosa, rheumatoid arthritis, crohn's disease, diabetes) * cancer diagnosis * topical medication for the treatment of atopic dermatitis during the trial * disability affecting the immune response (e.g. down's syndrome) * non-participation in the national vaccine program * participation in another intervention or follow-up study

Keywords: atopy biodiversity commensal microbiota microbial exposure
the parkcycle study: aerobic exercise in pd

Conditions: Parkinson's Disease

Summary: the primary goal of this study is to determine the neuroprotective qualities of long-term, in home, exercise therapy program in human pd patients. it is hypothesized that an exercise intervention might delay the onset of levo-dopa therapy (i.e. evidence for neuroprotection). the first part involves a pilot-study in which the feasibility of the intervention and outcome measures will be tested.

neuroprotective therapy (i.e. therapy that slows the disease process) is an unmet medical need in parkinson's disease (pd). animal studies have shown that 'intensive' exercise improves motor function and may have neuroprotective properties. the promising animal results have not been translated to patients with pd so far. this is a two-cluster randomised control trial in which twenty patients (10 at each site) will undergo a 6-month exercise intervention on a stationary virtual reality bike and twenty patients (10 at each site)will serve as controls.

Eligibility criteria:
inclusion criteria: * diagnosis of idiopathic parkinson's disease according to the uk queen square brain bank criteria * hoehn \& yahr disease stages i-ii * age between 30 and 75 years * having insufficient physical activity according to the acsm guideline for adults, 50-64 years old with a chronic condition * untreated with anti-parkinsonian medication or receiving medication, for less than two years, medication-responsive without fluctuations. exclusion criteria: * unclear diagnosis with red flags * advanced problems in cognitive functioning: mini mental state examination (mmse)19 score \< 24 * serious co-morbidity: neurological or orthopedic disorder that severely affects movement; known by specialist or medical practitioner * pulmonary diseases; known by specialist or medical practitioner * stroke * high risk of cardiovascular complications: * hypertension (systole \>150 and diastole \> 100) * diabetes mellitus; known by specialist or medical practitioner * cardiac valve defect (especially aortic valve stenosis); known by specialist or medical practitioner * cardiac rhythm disorder; known by specialist or medical practitioner * heart failure; known by specialist or medical practitioner * use of ß-blockers * not able to complete american (for cleveland site) or dutch questionnaires (for the nijmegen site) * daily institutionalized care * contra-indications for fmri: * pregnancy * metallic implants or electronic devices * previous seizure * claustrophobia * not able to keep the head still for longer period, i.e. due to severe head tremor

Keywords: parkinson's disease neuroprotective intensive exercise