Kornimate/medical-research-clean huggingface dataset:
evaluating dactinomycin and vincristine in young patients with cancer

Conditions: Childhood Acute Lymphoblastic Leukemia; Childhood Rhabdomyosarcoma; Childhood Soft Tissue Sarcoma; Ewing Sarcoma; Ewing Sarcoma of Bone; Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor (PNET); Unspecified Childhood Solid Tumor, Protocol Specific; Wilms Tumor and Other Childhood Kidney Tumors

Summary: this laboratory study is evaluating how well dactinomycin and vincristine work in treating young patients with cancer. studying samples of blood and urine in the laboratory from patients with cancer may help doctors learn how dactinomycin and vincristine affect the body and how patients will respond to treatment.

primary objectives: i. to characterize the pharmacokinetics (pks) of dactinomycin in infants, children, and adolescents with cancer. ii. to identify demographic or physiological factors that are determinants of dactinomycin disposition. iii. to characterize the pks of vincristine (vcr) in infants, children, and adolescents with cancer. iv. to identify demographic or physiological factors that are determinants of vcr disposition. secondary objectives: i. to examine the correlation of dactinomycin and vcr systemic exposure metrics with toxicity outcomes. ii. to explore the pk, pharmacodynamic, and pharmacogenetic relationships of dactinomycin and vcr in children with cancer. outline: this is a multicenter study. patients undergo blood and urine collection prior to, periodically during, and after treatment with dactinomycin and vincristine for pharmacokinetic, pharmacodynamic, and pharmacogenetic analysis. samples are analyzed using a liquid chromatography-tandem mass spectrometry assay. genomic dna extracted from peripheral blood mononuclear cells is isolated and analyzed by polymerase chain reaction and genotyping assays for genetic variation in genes relevant to the pharmacology of dactinomycin and vincristine. after the final pharmacokinetic sample is collected, patients are followed for up to 6 months.

Eligibility criteria:
inclusion criteria: * diagnosis of cancer, including, but not limited to, any of the following: * acute lymphoblastic leukemia * ewing sarcoma * rhabdomyosarcoma * soft tissue sarcoma * wilms tumor * due to receive or receiving dactinomycin and/or vincristine as a component of cancer treatment on another clinical trial * able to comply with study requirements * other concurrent chemotherapeutic agents allowed
safety and efficacy of state-of-the-art exoskeleton technology to improve mobility in parkinson's disease

Conditions: Parkinson Disease

Summary: the purpose of this study is to test the safety and efficacy of using of a portable exoskeleton for walking training in persons with parkinson's disease that have gait mobility problems and/or postural instability.

this is a feasibility study to examine a novel application of state-of-the-art robotic-assist gait training to improve mobility in people with parkinson's disease (pd). the study will investigate the utility of the keeogo® exoskeleton (a robotic-assist gait training device) for people with pd. the keeogo® offers advantages of being lightweight and portable (for eventual home use) and is relatively quick to attach and remove. the aims here are to establish the safety of the keeogo® for gait training in persons with pd and to preliminarily assess the potential efficacy of the keeogo® for better balance control, gait mobility and fall reduction in persons with pd.

Eligibility criteria:
inclusion criteria: parkinson's participant 1. age 21 years or older, 2. pd confirmed by a movement disorder specialist using uk brain bank criteria, 3. h\&y stage ii, iii, iv, or v. caregiver participant 1. caregiver of pd participant and is willing to complete questionnaire 2. moderate to severe cognitive impairment / dementia (montreal cognitive assessment \< 17/30) except in cases where the clinician and the participants legally authorized representative both determine the participant can safely complete the study exclusion criteria: parkinson's participant 1. neurological, musculoskeletal, or other disorders unrelated to pd contributing to impairment of gait, stance, balance or coordination, 2. history of implantable cardiac device or ablative surgery, 3. moderate to severe cognitive impairment / dementia (montreal cognitive assessment \< 17/30), 4. uncontrolled orthostatic hypotension, 5. feeding tube or associated port placement (peg/j-peg), 6. body height less than 5'1" or greater than 6'3" and 7. body weight greater than 250 pounds. caregiver participant 1) unwilling to complete questionnaire

Keywords: gait balance freezing
evaluation of cambra versus iccms caries risk assessment models acquisition on treatment plan

Conditions: Dental Caries

Summary: randomized clinical study to evaluate 'caries management by risk assessment' versus 'international caries classification and management system' caries risk assessment models acquisition on treatment plan in young adult population with null hypothesis that international caries classification and management system (iccms™) will have the same clinical performance as caries management by risk assessment (cambra)

. (iccms™) comprehensive patient care pathway considered as significant development from the traditional system of treatment plan. comprehensive patient care should include all recent information related to the biological, social, behavioral, cultural, systemic, and dental/oral risk factors which help development and progression of dental caries. (iccms™) also report all essential decisions that aid to preserve tooth structure; as diagnosis, prevention and restoration only if indicated \[9\]. moreover ( iccms™) deals with caries as a disease and not as a lesion, prevent development of initial caries lesions, and restore moderate or extensive caries lesions with the aim of preserving of tooth structure as much as possible. follow up period is selected to be 12 months, since risk category is changed for better or worse over 1-2 year.

Eligibility criteria:
inclusion criteria: * new patients * able to give informed consent in arabic * unlikely to move from the area within 1y for work educational, or personal reasons (determined by residential history and questioning); * willing to participate regardless of group assignment * willing to comply with all study procedures and protocol * ≥16 permanent teeth exclusion criteria: * patient not willing to have dental radiographs taken * patient with significant past or current medical conditions that might affect oral health or oral flora (i.e., diabetes, human immunodeficiency virus, heart conditions requiring antibiotic prophylaxis) * patient with medication use that might affect the oral flora or salivary flow (e.g., antibiotic use in the past 3 months, drugs associated with dry mouth/xerostomia) * patient with root caries at enrollment * patient with periodontal disease requiring surgery, chemotherapeutic agents, or frequent prophylaxis

Keywords: caries prevention caries management
evaluating rewards-based adherence and electronic medication monitoring in hiv-positive adolescents

Conditions: Human Immunodeficiency Virus (HIV); Acquired Immunodeficiency Syndrome (AIDS)

Summary: the primary objective of this project is to assess the study population's acceptance of two medication adherence support strategies: incentive-based programs and electronic medication monitoring. the study population is adolescents (ages 16 - 24) positive for human immunodeficiency virus (hiv) currently undergoing treatment with antiretrovirals at st. jude's hiv clinic. participation in the study will involve completion of a survey: an audio computer assisted self interview (acasi). the duration of the survey is anticipated to be 10-20 minutes. patient identifiers will not be attached the survey.

whether or not patients take their medications is one of the most noticeable and important predictors of treatment success or failure for hiv infection. ways to improve compliance, specifically rewards-based programs and electronic medication monitoring, have shown some success in limited clinical research studies focused on adult subjects. because the social and developmental factors in adolescents are different from adults, adolescents may not respond to these interventions in the same way as adults. this study will investigate adolescent acceptance and the effectiveness of these programs.

Eligibility criteria:
inclusion criteria: * hiv positive * ages 16-24 years. * participants must understand written or spoken english, because the acasi used in the study can only be administered in english. exclusion criteria: * adolescents with a documented diagnosis of mental retardation or a significant motor or sensory impairment that would preclude participation in the study survey.

Keywords: adolescents medication compliance rewards-based incentive programs
multicenter investigation of limitation of infarct size (milis)

Conditions: Cardiovascular Diseases; Coronary Disease; Heart Diseases; Myocardial Infarction; Myocardial Ischemia

Summary: to assess the ability of two separate therapeutic interventions, propranolol and hyaluronidase, to limit the ultimate size of an acute myocardial infarction. a secondary objective was to assess the influence of these therapies upon ventricular function and morbidity following myocardial infarction.

background: the study of methods for minimizing the mass of ischemic infarcted myocardium associated with a myocardial infarction was identified as a topic of research priority in the 1973 report of the panel chairman for the preparation of the national heart, blood vessel, lung, and blood program. in september 1976, the institute convened a workshop involving 32 investigators active in this field, respondents to past solicitations, experts on the topic of collaborative clinical trials, members of previous review committees, and several members of the cardiology advisory committee. the attendees were enthusiastic about the practicality and timeliness of a collaborative clinical trial in this field. the concept of collaborative clinical trials to protect ischemic myocardium was discussed by the cardiology advisory committee in its meeting of september 22, 1976, and was recommended affirmatively and enthusiastically. this trial was part of the institute's initiatives and was reviewed and favorably recommended by the national heart, lung, and blood advisory council at its december 1976 meeting. the trial consisted of five clinical centers, six central laboratories, a clinical coordinating center, and a data coordinating center. design narrative: randomized. group a patients were randomized to propranolol therapy, hyaluronidase therapy, or control therapy; patients assigned to group b (propranolol contraindicated) were assigned to hyaluronidase or control therapy. single-blind for propranolol therapy, double-blind for hyaluronidase or control therapy; fixed sample. detailed follow-up of clinical status and endpoints for a six-month period; annual health status follow-up thereafter. the study completion date listed in this record was obtained from the "end date" entered in the query view report (qvr).

Eligibility criteria:
men and women, under age 75. documented myocardial infarction which could be treated within 18 hours of onset of ischemic symptoms.
a prospective controlled study of serum supar in the csa-treated fsgs patients

Conditions: FSGS

Summary: the purpose of this study is to determine whether the improved responsiveness to treatment achieved by csa in patients with steroid-resistant or steroid-dependent fsgs could be explained by csa's inhibitory action on the circulating supar expression.


Eligibility criteria:
inclusion criteria: * age at entry is between 14 and 70 years * biopsy-proven primary fsgs * proteinuria \>=3 g/day * without corticosteroids or csa treatment before entry exclusion criteria: * chronic inflammatory diseases * malignant tumor * diabetes mellitus * contraindications for the treatment of corticosteroids or csa treatment * untolerate to or unwilling to accept corticosteroids or csa treatment

Keywords: fsgs supar
maxan post market surveillance validation

Conditions: DDD; Deformity; Tumor; Fracture

Summary: this study is being performed to document the outcomes of subjects using our maxan anterior cervical plate and assess them for adjacent level disease. all subjects will be followed for 2 years.

the purpose of this post market surveillance validation is to document the performance and clinical outcomes of the maxan® anterior cervical plate system. dr. park, et.al conducted a retrospective review and found a positive association between adjacent-level ossification following anterior cervical plate procedures and the plate-to-disc distance. 1 they concluded that when the anterior cervical plates were placed at least 5mm away from the adjacent disc spaces, there was a decrease in the likelihood of moderate-to-severe adjacent-level ossification. the design of the maxan anterior cervical plate and accompanying technique allows this type of plate placement; therefore we will be looking at the radiographic outcomes of these subjects and comparing them to the retrospective chart review conducted by dr. park using the maxan technique allows you to achieve plate placement of 5mm from the supraadjacent level which will help minimize the risk of adjacent level ossification.

Eligibility criteria:
inclusion criteria: * subject is scheduled to undergo a one to three-level primary spinal fusion surgery between the levels of c2-t1 (cervical 2 to thoracic 1) using the maxan® anterior cervical plate system. * subject has agreed to participate in this study, sign the informed consent and have agreed to return for the 6, 12 and 24 month follow-up visits. * subjects or their representative must be willing and able to give informed consent. exclusion criteria: * subject has spinal infection or inflammation at any level. * subject is morbidly obese, defined as a bmi greater than 40. * subject has a mental illness, alcoholism or drug abuse. * subject has a metal sensitivity/foreign body sensitivity. * subject has inadequate tissue coverage over the operative site. * subject has an open wound local to the operative area, or rapid joint disease, bone absorption, osteopenia and/or osteoporosis. * female subjects who are pregnant or plan to become pregnant in the next 24 months or who are lactating. * subject who does not meet the specific indications for use of the maxan® anterior cervical plate system. * subjects participating in another clinical research study. * any previous cervical spinal surgery.

Keywords: ddd deformity tumor fracture cervical
early discharge after transradial stenting of coronary arteries in high-risk patients of bleeding

Conditions: Coronary Artery Disease

Summary: rationale: transradial coronary stenting is associated with less risk of access site complications and bleeding compared to femoral approach. major bleeding post-pci is a strong independent predictor of mortality and mace. depending of the antithrombotic regimen and access-site used, bleeding related to access-site represents 50-80% of the cases. whereas transradial approach minimizes the risks of access-site bleeding, it has no impact on non-access site bleeding. peri-procedural anemia is also an independent predictor of mortality and mace. with femoral approach, bivalirudin compared to heparin ± glycoproteins iib-iiia has been associated with a significant reduction in access-site and non-access site related bleeding. in a post-hoc analysis of patients treated by transradial approach in acuity, there was a trend for non-access site bleeding (organ bleeding) with bivalirudin compared to heparin ± glycoproteins iib-iiia. hypotheses: in patients at high-risk of peri-procedural bleeding, bivalirudin ± glycoproteins iib-iiia reduces the risk of bleeding compared to heparin ± glycoproteins iib-iiia. in patients at high-risk of bleeding and undergoing transradial pci, bivalirudin significantly reduces the incidence of non-access site bleeding and peri-procedural anemia.

objectives: the primary objective is to compare the incidence of major bleeding and anemia 24h post-pci in patients at high-risk of bleeding after transradial pci with heparin or bivalirudin.

Eligibility criteria:
inclusion criteria: * at least two of the following additional criteria * at least 70 yrs old * female gender * diabetes * creatinine clearance \<60ml/min * history of gastro-intestinal or other organ bleeding * baseline anemia * current treatment with glycoproteins iib-iiia inhibitors exclusion criteria: * intolerance or allergy to asa, clopidogrel or ticlopidine precluding treatment for 12 months * concurrent participation in other investigational study * femoral sheath (artery)

Keywords: coronary artery stenting, transradial, intracoronary
widening aims and giving patients a voice for expanded structures in breast cancer care jointly developed by patients and physicians

Conditions: Breast Cancer

Summary: the aim of this bzkf project is to record the current care structure for breast cancer patients in order to use this as a basis for developing possible future models for improvement. the active involvement of representatives of regional and national patient organizations in the creation of a patient-based and patient-oriented survey ensures that the needs of patients are the focus. in addition to and in contrast to other projects, relevant questions are explicitly addressed not only to patients but also to physicians in order to identify and specify the interfaces between patient wishes/suggestions and to develop clinical consequences for care. the first objective is to survey the "current situation" by recording the current care structure for breast cancer. the focus is on the survey of both groups on patient-physician communication, time management and coping strategies. by planning the future harmonization of national data structures, the basis is created for the long-term goal of an improved "target", a concept developed jointly by physicians and patients for an improved communication and care structure that focuses on the patient.


Eligibility criteria:
inclusion criteria (patients): * breast cancer or dcis * women and men aged 18 years and older exclusion criteria (patients): * women and men \< 18 years * no histologically confirmed breast cancer or dcis diagnosis inclusion criteria (physicians): - treatment of breast cancer patients

Keywords: communication patient-physician-relationship questionnaire
genomic testing and resulting medical decisions

Conditions: Cancer of Unknown Origin; Cancer Refractory; Cancer of Stomach; Cancer Head Neck; Cancer of Skin; Cancer, Lung; Cancer Colorectal; Cancer of Esophagus; Cancer, Bladder; Cancer, Uterus; Cancer Cervix; Cancer Liver; Cancer, Kidney; Cancer, Breast; Hematologic Neoplasms

Summary: there is no evidence available about which molecular profiling methods are currently used for cancer patients in austrian clinical practice. the construction of the registry proposed as a completely independent research endeavor, will be helpful for scientific evaluation and the establishment of highly credible data.

in the situation of enormous possible beneficial options for patients, health care systems, researchers and companies and the simultaneously present high number of uncertainties, the establishment of an independent registry for patients undergoing any type of comprehensive genomic profiling offers many advantages. in particular, an overview of the speed of development, the "market penetration", the use of the technology in specific indications (tumor types, stages and in specific situations of unresponsiveness to certain drugs), the frequency by which treatment decisions will definitely follow the result of comprehensive genomic profiling and the reasons for this, the treatment outcome of such patients, the platform technologies applied (in-house (which types), vs. commercial) and the development of these parameters over time and in relation to the development of novel drugs will be analyzed. the registry proposes to cover the time period from the years 2016 to 2019, which will allow for assessment of both the current and emerging landscape of genomic/molecular testing practice in austria and effect of molecular profiling on patient care and outcome.

Eligibility criteria:
inclusion criteria: this registry will include cancer patients for which broad genomic profiling is indicated as assessed by the medical need and as deemed appropriate by the physician, for example * cancer with high mutational load and suspicion of regular or frequent formation of neoantigens * skin, lung, stomach, esophagus, colorectum, bladder, uterus, cervix, liver, head and neck, kidney, breast * lymphoma b-cell * any other neoplastic disease where molecular targeting is performed but treatment fails * cancer of unknown primary origin (cup) * planned or already carried out comprehensive genomic testing as of jan 1, 2016 note: this registry will not initially register patients who are tested for only 1-5 mutations by conventional means, but patients undergoing genomic profiling based on ngs) * a patient´s signed informed consent * patients ≥ 18 years of age exclusion criteria: * due to the non-interventional design of the registry there are no specific exclusion criteria.
poc hiv testing and early dtg use for infants

Conditions: HIV

Summary: this study is being conducted to explore the feasibility of implementing targeted birth hiv testing of high-risk neonates using facility-based point-of-care (poc) hiv diagnostics, and to improve the ability to implement the best standard-of-care treatment possible. infants found to be hiv infected will be immediately offered enrollment into a dolutegravir (dtg) antiretroviral treatment study cohort (if maternal consent is granted) or referred for treatment at a government facility. infants who enter the study treatment cohort will be prospectively followed through 96 weeks of age. art will follow botswana guidelines.


Eligibility criteria:
inclusion criteria for point-of-care infant hiv testing: 1. mother 18 years of age or older 2. mother willing and able to provide verbal consent for infant testing 3. infant birth weight ≥1.5kg 4. presence of any of the following risk factors: \ 24 weeks gestation in pregnancy; cd4 cell count known to be \<350 cells/mm3 within the past year; self-described poor adherence in pregnancy (1 or more complete days of missed art) exclusion criteria for point-of-care infant hiv testing: 1) medical condition making it unlikely that the infant will survive to 24 months inclusion criteria for infant longitudinal treatment cohort: 1. mother 18 years of age or older 2. mother willing and able to provide written informed consent for study participation for herself and her infant 3. positive point-of-care hiv screening for infant (hiv dna pcr pending or completed) 4. infant eligible for art treatment in accordance with the botswana government program 5. infant birth weight ≥1.5 kg exclusion criteria for infant longitudinal treatment cohort: 1. medical condition making it unlikely that the infant will survive to 24 months 2. infant unable to start treatment-dose art \< 168 hours of age 3. infant unable to attend follow-up visits at a bhp study clinic in gaborone or francistown