Kornimate/medical-research-clean huggingface dataset:
proof of concept of hybrid robotics for gait rehabilitation of persons post-stroke

Conditions: Stroke Sequelae; Gait, Hemiplegic

Summary: persons post-stroke suffer from hemiparesis affecting the functional abilities of the controlesional lower limb. improving walking is therefore a primary rehabilitation goal for such patients. robotic-assisted rehabilitation (rar, e.g. exoskeletons) and functional electrical stimulation (fes) are promising techniques to facilitate the functional recovery after stroke. allowing benefits to be maintained over long term.

exoskeletons were originally developed for subjects with spinal cord injury where they demonstrated a positive impact on rehabilitation and relative costs. the investigators expect the same trend also for stroke. based on prior exploratory activities using an overgorund exoskeleton (twin_acta) in gait rehabilitation post stroke, in this project the aim is to merge the potential of an overground exoskeleton and fes to treat the lower limb motor deficits in persons post-stroke, strengthening their residual abilities. synchronized pairing of the two devices might boost the functional recovery of gait post-stroke by promoting neural reorganization the persons post stroke will undergo 20 gait rehabiliation sessions with the exoskeleton and with fes applied to the lower limb muscles during execution of gait with the aim of improving various gait and quality of life parameters. this experimental intervention will be compared to a control intervention using an exoskeleton alone for gait rehabiltation post stroke.

Eligibility criteria:
inclusion criteria: 18 years or older * diagnosis of first unilateral ischemic or hemorrhagic ictus, at least two weeks from the event, ischemic or hemorrhagic * diagnosis confermed with computer tomography or magnetic resonance imaging * 1 ≤ fac (functional ambulation category) ≤ 3 * 50 kg ≤ weight ≤ 90 kg * 150 cm ≤ height ≤ 192 cm * femor length: 355-475 mm * tibia length: 405-485 mm * pelvic width 690-990 mm * shoe size 36-45 * capable of standing unsupported for at least one minute exclusion criteria: * mini mental state examination score (corrected for age and education) \< 24 * clinical evidence in the medical records of visuospatial and ideomotor apraxia, behavioral disorders, neglect, severe visual and auditory sensory disorders or those which prevent use of the device * patients at risk of fractures or with strategic fractures (unstabilized fractures or spinal instability) * major head trauma * subarachnoid hemorrhage, cerebral thrombosis * cardio-respiratory or internal clinical instability * pregnant or breastfeeding status; * recent malignant neoplasm * chronic inflammatory diseases with joint involvement of the lower limbs; * severe spasticity (ashworth\>3) * significant limitations in passive rom of the hips and knees * problems with the integrity of the skin at the interface surfaces with the device or which would prevent sitting. * implanted electronic devices * epilepsy * severe peripheral neuropathies

Keywords: gait rehabilitation exoskeleton functional electrical stimulation hemiplegia overground
a study of 1592u89 and ethanol when given together to hiv-infected patients

Conditions: HIV Infections

Summary: the purpose of this study is to see how the body processes 1592u89 and ethanol (pure grain alcohol) when they are given together.

patients are randomized to one of the following three regimens: regimen 1: 1592u89 alone. regimen 2: pure grain alcohol diluted in orange juice. regimen 3: 1592u89 plus pure grain alcohol diluted in orange juice. treatment is administered weekly for 3 weeks.

Eligibility criteria:
inclusion criteria concurrent medication: allowed: * local treatment for kaposi's sarcoma. * prophylactic treatment for opportunistic infections. patients must have: * hiv-1 infection. * cd4+ lymphocyte count \>= 200 cells/microliter within 14 days prior to study drug administration. * no active diagnosis of aids (other than visceral kaposi's sarcoma) according to the 1993 centers for disease control and prevention (cdc) aids surveillance definition. prior medication: allowed: local treatment for kaposi's sarcoma. exclusion criteria co-existing condition: patients with the following symptoms and conditions are excluded: malabsorption syndrome or other gi dysfunction which may interfere with drug absorption. concurrent medication: excluded: * medications that cannot be withheld for 48 hours (24 hours for antiretrovirals) prior to study drug administration and until 12 hours after study drug administration on each dosing day. * immunomodulators, such as systemic corticosteroids, interleukins and interferons. * cytotoxic chemotherapeutic agents. * acute treatment for opportunistic infections. concurrent treatment: excluded: radiation therapy. patients with the following prior conditions are excluded: * documented history of alcoholism. * history of clinically relevant hepatitis or pancreatitis within 6 months prior to study drug administration. * history of hypersensitivity, anaphylactic, or idiosyncratic reaction to nucleoside analogs. * participation in another research study within the past month. prior medication: excluded: * cytotoxic chemotherapeutic agents within six weeks prior to study drug administration. * immunomodulating agents within six weeks prior to study drug administration. * treatment with the following within 2 weeks prior to study drug administration: * acyclovir, carbamazepine, chloramphenicol, ganciclovir, phenytoin, rifampin, sodium valproate, or valacyclovir. prior treatment: excluded: radiation therapy within 6 weeks prior to study drug administration. 1. regular weekly alcohol intake of more than 21 units (a unit is equal to 1/2 pint beer or 1 glass of wine or 1 oz of liquor). * recent change in normal pattern of alcohol usage (e.g., prolonged use followed by \> one month abstinence). * total abstinence from alcohol use. * positive breath alcohol test upon arrival at the study center prior to any dosing day.

Keywords: drug interactions antiviral agents ethanol abacavir
intraoperative mapping of regional lymphatics draining the primary site of melanoma using isosulfan blue

Conditions: Melanoma

Summary: the purpose of this study is to determine whether we can consistently identify the first lymph node (the "sentinel node") draining your melanoma.

the issue of elective lymph node dissection (lnd) in the management of melanoma patients with clinically negative nodes remains controversial. the concept of elective lnd is attractive because it provides the opportunity to detect and remove occult micrometastases before they become clinically apparent. numerous retrospective analyses have consistently shown a 15-20% long term survival advantage in patients undergoing elective lnd who are found to have positive nodes, compared to those undergoing therapeutic lnd for clinically positive nodes. the majority of patients undergoing elective lnd however, do not have lymph node involvement, and the impact of removal of these negative nodes on the survival of these patients is unknown. the substantial morbidity of these procedures has led to the conduct of a number of important prospective randomized trials designed to define the impact of elective lnd on the survival of patients with clinically node negative melanoma. in 1982, the world health organization reported on the end results of 553 the primary objective of this protocol is to establish the feasibility of lymph node mapping, using preoperative lymphoscintigraphy and intraoperative blue dye injection to detect the sentinel node in patients at risk for regional lymph node metastasis from their primary melanoma.

Eligibility criteria:
inclusion criteria: * primary melanomas clark iii and breslow thickness \> 1 mm, or clark iv-v and any breslow thickness * clinically negative regional nodes exclusion criteria: * previous definitive wide local excision of the primary melanoma with skin graft * an inflammatory lesion in the area of the primary melanoma that is likely to drain to the same nodal basin * pregnancy

Keywords: melanoma negative regional lymph nodes primary melanomas clark iii and breslow thickness > 1 mm, or clark iv-v and any breslow thickness, and clinically negative regional nodes
epidemiological and genetic studies of body mass index

Conditions: Cardiovascular Diseases; Obesity; Heart Diseases

Summary: to identify genes involved in obesity.

background: increased levels of body mass index (bmi) are associated with increased mortality and morbidity from cardiovascular disease, hypertension, diabetes and other disorders. the frequency of obesity and its associated health-related problems is increasing in the american population. design narrative: the study builds upon a two-stage genome scan for bmi performed in the nhlbi family heart study (fhs). in the first, 101 pedigrees were examined with 1027 persons genotyped and a lod of 2.2 was found on chromosome 7. in stage 2, 135 sibships of 380 persons were examined , and a lod of 3.2 was found for the same locus. compelling linkage was found in the combined study (lod = 4.9, chr 7q31.3, 137cm). the lod or logarithm of odds is a statistical estimate of whether two loci (the sites of genes) are likely to lie near each other on a chromosome and are therefore likely to be inherited together as a package. a novel strategy will be used which combines three cutting edge methods: (1) regression tree analyses to identify a homogenous subset of families with evidence for bmi linkage to 7q31.3; (2) dna pooling of samples from linked versus unlinked families; and (3) quantitative pcr of dna pools for very high-density single nucleotide polymorphism (snp) mapping. the combination of these methods will permit a cost effective approach for the identification of genetic polymorphisms in linkage disequilibrium with bmi, and has the potential to become a widely adopted method for gene localization of complex traits. the study was extended through january, 2008 to show compelling evidence for a haplotype in the 5' region of the leptin gene (p\<0.00005) influencing bmi among men in the sample. the study will further demonstrate that the responsible gene in this region is not leptin. snp and haplotype association studies implicate three strong candidate loci and other loci also warrant additional study. the study will confirm snp association in an independent study of 200 families showing linkage to the same position (from dr. r. arlen price's group). those loci with confirmed association will be further characterized by sequencing, genotyping new polymorphisms, and gene expression studies to identify the responsible genes.

Eligibility criteria:
the pi was not involved in the study recruitment or examination of the subjects form which the adipose samples were obtained and all data were de-identified.
digital symptom tracking, patient engagement and quality of life in advanced cancer

Conditions: Quality of Life

Summary: the purpose of this study is to (1) describe patient and clinician engagement in web-based symptom self-monitoring, (2) identify differences in symptom management between intervention and usual care groups, and (3) identify potential outcomes of real-time symptom tracking and management. with the assistance of the study coordinator, participants randomized to the intervention will create an account with noona. patients will be instructed to log symptoms as often as relevant using their own personal devices. patients will also be prompted once per week for 24 weeks to log any recent symptoms. these participants will be sent a symptom questionnaire (sq) via the noona tool that summarizes their symptoms and distress one week prior to each oncology clinic visit. symptoms designated as clinically severe either during regular symptom logging or via the sq will trigger a prompt to contact the clinical team for immediate follow-up.

new patients from three cancer care programs (thoracic oncology, gastrointestinal oncology, and palliative care) at two academic institutions (stanford and ucsf) will be screened for demographic and disease stage data within the patient medical record. eligible patients will be asked by their oncology team whether they would be interested in participating a study of symptom management in oncology care. patients who express interest and ability to participate will be interviewed to determine eligibility.

Eligibility criteria:
inclusion criteria: 1. individuals (men and women) aged 18 years or older 2. biopsy proven (recurrent or metastatic) advanced lung or gastrointestinal cancer 3. no limit on prior lines of therapy in the metastatic setting 4. ecog performance status of 0-2 5. estimated life expectancy of at least 6 months 6. access to smartphone, tablet or computer with capability to utilize symptom tracking application 7. willing and able to provide written, signed informed consent after the nature of the study has been explained, and prior to any research-related procedures 8. willing and able to comply with all study procedures exclusion criteria: 1. concurrent disease or condition that interferes with participation or safety 2. non-english speaking, as the application is developed in the english language 3. non-castrate resistant prostate cancer 4. enrolled in other non-therapeutic or therapeutic clinical trials

Keywords: patient and clinician engagement digital symptom tracking
predictive value of fdg-tep during radiotherapy or chemo-radiotherapy in patients with ncsc on the one-year survival

Conditions: Lung Cancer; NSCLC

Summary: the poor prognosis in the early-stage of lung cancer is due to potential worsening of the disease (local relapse, metastasis), to insufficient efficacy and toxicity of actual treatments. fdg-pet is a medical imaging modality allowing the quantification of the tumour glucose consumption. then, this exam is used for pathology staging, target volume definition for rt, and treatment efficiency few months after rt or crt. our assumption is that an fdg-pet exam during the course of the rt or crt might be predictive of the treatment efficiency few months later. in this study, the investigators propose to perform 4 fdg-pet: first "pet1" before radiotherapy, second "pet2" during the radiotherapy (see rtep1), third and fourth "pet3" "pet4" 3month and 12 month after the therapy. the investigators will investigate the performances of fdg-pet performed during the rt or crt for the prediction of the one-year patient heath outcome. if the predictive value of tep2 is confirmed, the investigators would be able to optimize the planning treatment during the course of the therapy.


Eligibility criteria:
inclusion criteria: * histologically confirmed non-small cell lung cancer * fertile patients must use effective contraception * who performance status \<2 * measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (≥ 10 mm with spiral ct scan) exclusion criteria: * pregnant or lactating females * baseline fludeoxyglucose f 18 (fdg)-positron emission tomography (pet) scan without any target lesion * unable to under pet ct evaluation * other concurrent investigational agents * no planning to undergo curative intent radiotherapy * familial, social, geographic, or psychological conditions that would preclude study participation * prior malignancy progressive disease

Keywords: positron-emission tomography pet scan non-small-cell lung carcinoma radiation oncology suv
pradaxa (dabigatran etexilate) vte prevention after elective total hip or knee replacement surgery

Conditions: Venous Thromboembolism; Arthroplasty, Replacement

Summary: an open, prospective, observational study to collect data on safety (major bleeding events) and efficacy (symptomatic venous thromboembolism(vte)) of a switch from enoxaparin to dabigatran etexilate in patients with total knee replacement (tkr) and total hip replacement (thr)


Eligibility criteria:
inclusion criteria: patients age 18 years or above undergoing elective total hip or knee replacement surgery exclusion criteria: according to the label recommendation for pradaxa 220 mg qd
the effect of cooling with a bed topper and linen on itch in clinical routine

Conditions: Itch

Summary: this single-blinded (only patients blinded) study is to assess the effect of cooling beddings on itch. the primary objective is to test whether or not the use of the cooling beddings during 3 days can add at least 20% improvement in (nocturnal) itch as measured by the 0-10 nrs in comparison to a control group that does not use the cooling beddings.

itch is the most common skin-related symptom. staying/sleeping in a bed with a cooling properties could have a positive effect on (nocturnal) itch intensity, sleep quality and daytime performance in consequence. a mattress topper and bed linen with cooling effects that are commercially available (https://www.oba.ch/cool_gel_topper) by the oba ag (basel), which is the supplier of beds and bedding items of the university hospital basel, has been used in clinical routine. this single-blinded (only patients blinded) study is to assess the effect of cooling beddings on itch and to better rationalize the beddings 'use. no comparative data is available and the design is purely exploratory. the primary objective of this study is to test whether or not the use of the cooling beddings during 3 days can add at least 20% improvement in (nocturnal) itch as measured by the 0-10 nrs in comparison to a control group that does not use the cooling beddings.

Eligibility criteria:
inclusion criteria: * mean itch intensity nrs \> 5 in the past 3 days * literacy and ability to read * inpatient stay required for \> 3 nights exclusion criteria: * age \< 18 years * illiteracy * cognitive impairment (exclusion in case of mild cognitive impairment according to the montreal-cognitive assessment (moca)) * the duration of the hospitalisation is foreseen to be shorter than 3 days * para- and tetraplegia * hemisensory syndrome * core body temperature \>38°c * use of other bedding \> 8 hours or 2nd time request * use of an occlusive therapy

Keywords: cooling beddings sleep quality scratching itch reduction itch; nocturnal
efficacy and safety of inotuzumab ozogamicin in treating adult patients with ph negative all with minimal residual disease positive after induction chemotherapy

Conditions: Acute Lymphocytic Leukemia

Summary: a single-center, single-arm, open-label, interventional, phase ii clinical trial to evaluate the efficacy and safety of ino in b-all achieved cr/cri after 1l induction chemotherapy with positive minimal residual disease.


Eligibility criteria:
inclusion criteria: 1. new diagnosed b-all in hematologic complete remission (cr) after 1l induction chemotherapy with mrd positive. molecular disease or mrd is defined by a value of at least of 10-4 (0.01%) by multicolor flow cytometry. 2. age ≥18 years 3. ecog ps score: 0 to 2 4. functions of the main organs are normal, if the following criteria are met: 1. total bilirubin (bil) ≤ 1.5 × upper limit of normal (uln) 2. aspartate aminotransferase (ast) or alanine aminotransferase (alt) ≤ 2.5 × uln 3. serum creatinine ≤ 1.5 × uln 4. creatinine clearance ≥ 30 ml/min 5. no active or co-existing malignancy with a life expectancy of less than 12 months 6. patients are voluntarily enrolled into the study and have good compliance, and the informed consent form (icf) needs to be signed. exclusion criteria: 1. mixed lineage leukemia 2. clinically significant liver disease such as history of veno-occlusive disease (vod)/ sinusoidal obstruction syndrome (sos) 3. patients with severe and / or uncontrolled diseases, such as: 1. unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months before randomization, severe uncontrolled arrhythmias; uncontrolled blood pressure (systolic blood pressure \> 140 mmhg, diastolic blood pressure \> 90 mmhg) 2. liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis 3. known to be human immunodeficiency virus positive (hiv+) 4. active and uncontrolled disease/infection as judged by the treating physician 5. active central nervous system (cns) or extramedullary disease 6. patients who have other malignant tumors at the same time; patients who are evaluated by the investigator to have concomitant diseases that seriously endanger the safety of the patients or affect the patients to complete the study 4. pregnant or nursing women 5. unable or unwilling to sign the consent form 6. monoclonal antibodies therapy within 2 weeks before study entry 7. radiotherapy or cancer chemotherapy (except for induction chemo) or any investigational drug within 2 weeks before study entry 8. patients who have severe allergies (≥ grade 3) to active ingredients and any excipients of ino 9. patients in other situations who are evaluated by the investigator to be ineligible
increasing activity in liver transplant patients

Conditions: Liver Transplant

Summary: will adult liver transplant patients who are provided with physical activity (walking) instructions increase their physical activity and perceive an improved quality of life?


Eligibility criteria:
inclusion criteria: * adult patients 18-65 years of age who receive a liver transplant at mayo clinic jacksonville. * adult patients who are 5-21 days post liver transplant. * must be followed by mayo clinic jacksonville at 4 months postoperatively. * approved by a hepatologist and/or transplant surgeon to participate. exclusion criteria: * patients with active infections * patients with encephalopathy or cognitive dysfunction * patients who receive a combined liver-kidney transplant * patients with severe debility * patients who require assistance to ambulate.

Keywords: liver transplant physical activity quality of life
insulin glulisine in type 2 diabetic patients

Conditions: Diabetes Mellitus, Type 2

Summary: to evaluate the efficacy of a single injection of glulisine before the main meal added to insulin glargine plus oral antidiabetic drugs (oads) compared to insulin glargine plus oads in type 2 diabetic patients poorly controlled with basal insulin plus oads.


Eligibility criteria:
inclusion criteria: * diabetes mellitus, type 2 * 25 \< bmi \< 45 kg/m² * 7,5% \< hba1c \< 9% * treated with a basal insulin (nph, insulin zinc, insulin glargine or insulin detemir), and at least 1g metformin daily, for more than 3 months exclusion criteria: * type 1 diabetes mellitus * treatment with oads only * treatment with thiazolidinediones, with exenatide or with pramlintide * treatment with an insulin other than basal insulin (premix, rapid insulin, fast-acting insulin analogue) * active proliferative diabetic retinopathy, * pregnancy (women of childbearing potential must have a negative pregnancy test at study entry and effective contraception) * breast-feeding * history of hypersensitivity to the study drugs or to drugs with a similar chemical structure. * treatment with systemic corticosteroids in the 3 months prior to study entry * treatment with any investigational product in the 2 months prior to study entry * previous treatment with insulin glulisine * likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol * clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major disease making implementation of the protocol or interpretation of the study results difficult * impaired hepatic function * impaired renal function * history of drug or alcohol abuse the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.