Kornimate/medical-research-clean huggingface dataset:
physical activity, disability and quality of life before and after lumbar spine surgery

Conditions: Lumbar Spine Degeneration; Physical Activity; Quality of Life; Disability Physical; Pain

Summary: to date it is unknown how physical activity levels in adults is limited before and after lumbar spine surgery and if physical activity level is associated with disability and limitations of quality of life. the main objective is to compare physical activity preoperatively and 6 and 12 weeks postoperatively in patients undergoing lumbar spine surgery with norm data. in addition, the investigators will study the association of changes in physical activity, disability and quality of live.

patients scheduled for planned lumbar spine surgery will be contacted to participate in this study. all outcomes will be assessed within 1 week preoperatively and at 6 and 12 weeks postoperatively. changes in outcome scores will be detected using analysis of variance. association of changes in physical activity and changes in secondary outcomes will be detected using stepwise linear regression models.

Eligibility criteria:
inclusion criteria: * primary lumbar spine surgery * single or multi level surgery on segments l2 to s1 (e.g. discectomy, decompression, laminectomy, foraminotomy) * german speaking exclusion criteria: * stabilisation or fusion surgery or surgery above l2 * previous lumbar spine surgery * indication: scoliosis, fracture, trauma, infection, tumor * limited walking ability due to other conditions * psychiatric conditions or dementia

Keywords: activity monitor questionnaire oswestry disability index
feeling of being in control of one's own action

Conditions: Schizophrenia; Bipolar Disorders

Summary: the investigators aim is to understand the cognitive mechanisms that contribute to the emergence of delusions of control (the belief that one's own actions or thoughts are controlled by an external force). these symptoms are mainly encountered in patients with schizophrenia, and the investigators will distinguish patients with schizophrenia with or without this symptom together with patients with bipolar disorder. based on the investigators previous studies, this project will help to determine the role of two elementary mechanisms in the ability to feel in control of voluntary actions: (1) the processing of the sensory consequences of action, and (2) the ability to build mental representations for sequenced actions.


Eligibility criteria:
inclusion criteria: * patients with schizophrenia or bipolar disorders (criteria dsm iv) or healthy controls matched with patients on age, sex and education level * 18-55 years old exclusion criteria: * past history affecting cns * invalidating sensory disorders * intake of psychotropic drugs, except for patients * intake of benzodiazepines
rhythm and multisensoriality's effects on the motor development in children with cerebral palsy

Conditions: Cerebral Palsy

Summary: cerebral palsy (cp) affects the motor function but also the cognitive function of the child. physical activity brings motor and cognitive benefits and appears as an important aspect of the therapy that is offered to them. the child is seating in front of a computer, seating comfortably on a chair during 1 hour. the experimental task consists in learning a sequence of taps on "serial reaction time task" type buzzers (srtt) in which the child must press a buzzer corresponding to one of the 4 squares that on the screen. the sequence corresponds to 10 steps in a particular order.

cerebral palsy (cp) affects the motor function but also the cognitive function of the child. physical activity brings motor and cognitive benefits and appears as an important aspect of the therapy that is offered to them. in particular, the learning of movements in the presence of multisensory rhythmic information seems to have beneficial effects at the cognitive and motor level. the present study aims to test the respective effects of rhythm and multisensoriality on motor learning in children with cerebral palsy. the motor learning task is known as the "serial reaction time task" (srtt). it consists in repeating a sequence of movements of the upper limbs using visual-spatial information alone (v). it will test the addition of synchronous auditory stimulation to visual information or rhythmic auditory stimulation(var), to contrast with a control condition with non-rhythmic auditory stimulation (vanr). the performance of the children will be measured by the reaction time (rt), its stability and the number of errors made throughout the motor learning. the child is placed in front of a screen on which 4 luminous stimuli are presented on a horizontal plane. four buzzers are placed in front of him, each buzzer corresponds to the position of a stimulus. the stimuli light up in a predetermined sequence (10 positions) and the child must press the buzzer corresponding to the position of the stimulus that comes on. four blocks of 5 sequences are repeated to test the general learning (b1 to b4) and then a block of random stimuli is presented to test the specific learning of the sequence (b5).

Eligibility criteria:
inclusion criteria: for all children: * age between 6 and 14 years * obtaining the informed consent of the person possessing parental authority for all children for children with cerebral palsy: * diagnosis of spastic cerebral palsy of levels gmfcs i to iv * ability to press buzzers with the palm of the hand, manual ability classification system (masc) i to iv * ability to understand instructions ("tap a buzzer along with a picture or sound") (investigator's appreciation) for control children: no pathology diagnosed exclusion criteria: for all children: * children with a characteristic psychiatric pathology. * disorders of the understanding * hearing deficiency * uncorrected visual impairment

Keywords: rhythm serial reaction time task
african american cancer clinical trial decisions: testing tailored messages

Conditions: Myeloma; Lymphoma; Leukemia

Summary: the purpose of this study is to determine if the use of tailored health messages and/or involving physicians are effective in increasing african american (aa) patient activation in a clinical trial consultation. the proposal will use a composite score for patient activation derived from the street patient activation coding system. this will help to determine the effectiveness of our intervention on patient activation and patient centered clinical trial decision.

a randomized clinical trial (using a 2x2 factorial design) to inform our knowledge of the efficacy of a tailored health message intervention, using different depths of tailoring and involving physicians, on aa cancer patients' active communication in ct consultations as measured by the street patient activation measure. in this study 357 aa cancer patients will be randomized into one of four experimental groups group 1 - messages tailored on electronic medical record (emr) data. group 2 - messages tailored on emr + physician involvement. group 3 - messages tailored on emr + survey. group 4 - messages tailored on emr + survey + physician involvement. we will also measure patient: a) trust in their physician, b) trust in medical research, c) preferences that include information and decision involvement, d) communication self-efficacy, e) patient-family member communication congruence, f) consultation satisfaction and g) decision outcomes that include decisional conflict, decision satisfaction and decision regret.

Eligibility criteria:
inclusion criteria: * 21 years of age or older * have a cancer diagnosis * self identify as african american * therapeutic phase i, ii or iii clinical trial at massey cancer center (regardless of whether or not they join the therapeutic trial) * be able to provide informed consent * we will also recruit one family member/caregiver (n = 357) of each participating patient * consented patients will not be excluded from this study if their family member declines to participate by completing the cancer communication assessment tool for families (ccat-f). exclusions criteria: -none
project andale--increasing exercise in hispanic women

Conditions: Cardiovascular Diseases; Heart Diseases

Summary: to determine the differential effectiveness of a culturally tailored program to shape and maintain moderate intensity physical activity and to improve cardiorespiratory fitness among low ses sedentary latino women.

background: latino women are at high risk for cardiovascular (cvd) and other chronic diseases, in part, due to sedentary lifestyle, obesity, and poor fitness. few studies assess long-term physical activity, fewer observe maintenance and none have demonstrated effective procedures for sustaining exercise. only one study has demonstrated increased moderate exercise and none has demonstrated maintenance of physical activity among latino women. theoretically-based procedures (shaping, contingency management, relapse prevention, and social reinforcement) hypothesized as necessary to maintain physical activity had not yet been tested experimentally. design narrative: the 210 latinas were assigned at random to one of three groups: one six month physical activity intervention, one physical activity plus maintenance intervention, and one safety education control. exercise training emphasized walking. bilingual exercise leaders, aided by peer models from the community, used shaping procedures to establish daily walking in participants. in the maintenance program, family incentives reinforced transfer to community exercise and were used to establish positive feedback loops to promote activity within the family. peer led community exercise sessions, and community activism were also used to establish social networks which reinforced sustained physical activity. program support was faded out as naturally occurring social support for community exercise was established. four (baseline, post-intervention, post-maintenance, follow-up), repeated measures over 24 months assessed fitness (vo2max), physical activity (par), and cvd risk factors. theoretically important mediating variables, such as self-efficacy, social support, stage of change for exercise, decisional balance, and home exercise environment were explored. repeated measures analyses were used to determine significant differences among groups, time and group by time main effects. this study was the first to attempt to engineer maintenance of physical activity among minority women. results will provide a model to be used to sustain physical activity and reduce the risk of cardiovascular and other diseases. if effective, this analysis will also serve as a model for designing programs to sustain physical activity in the increasingly sedentary general population. the study was renewed in january 2000 to continue through december 2001.

Eligibility criteria:
no eligibility criteria
sram study_postate cancer

Conditions: Advanced Prostate Cancer

Summary: this is a phase 2 randomized study for high risk localized prostate cancer (t3 to t4 disease and/or psa \> 20 and/or gleason score ≥ 8) without evidence of distant and nodal metastasis. patient will be randomized to:arm 1 * conventional imrt rapidarc imrt to prostate and pelvic nodes. 76gy to prostate, 70gy to proximal 2/3 of seminal vesicles, and 50gy to pelvic nodes (up to bifurcation of common iliac nodes). * 38 fractions of daily treatment, monday to friday or arm 2 sbrt * rapidarc imrt to prostate and pelvic nodes. 40gy to prostate, 36.25gy to proximal 2/3 of seminal vesicles, and 25gy to pelvic nodes (up to bifurcation of common iliac nodes) * 5 fractions of weekly treatment. once fraction per week. all patients will be given neoadjuvant and adjuvant androgen deprivation therapy (detail as below)


Eligibility criteria:
inclusion criteria: * histological confirmation of prostate adenocarcinoma * high risk prostate cancer patients (i.e. t3 to t4 disease and/or psa \> 20 and/or gleason score ≥ 8) * ecog performance score 0-1 * age ≥ 18 * history/physical examination within 2 weeks prior to registration * able to sign informed-consent exclusion criteria: * patients with active cancer other than prostate cancer and non-melanoma skin cancer. * evidence of distant metastases * regional lymph node involvement * previous radical surgery (prostatectomy), cryosurgery, or hifu for prostate cancer * previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy * previous hormonal therapy, such as lhrh agonists (e.g., goserelin, leuprolide) or lhrh antagonists (e.g., degarelix), anti-androgens (e.g., flutamide, bicalutamide), estrogens (e.g. des), or surgical castration (orchiectomy) * unstable angina and/or congestive heart failure requiring hospitalization, transmural myocardial infarction within the last 6 months, acute bacterial or fungal infection requiring intravenous antibiotics, chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration * patients who have received prior chemotherapy.
food protein-induced enterocolitis syndrome (fpies) in 14 children

Conditions: Allergy; Pediatric Disorder

Summary: food protein-induced enterocolitis syndrome (fpiees) is a particular non-immunoglobulin e-mediated food allergy. a retrospective descriptive single-center study was conducted. subjects included were children with acute fpies who consulted the allergy department of the nancy regional university hospital between november 2013 and june 2016.

as it is a descriptive study, the primary outcome is not a measure. therefore it is not possible to include the name of the measurement or measurement tool used to assess the measure in the primary outcome measure title.

Eligibility criteria:
inclusion criteria: * child from 0 to 17 years with acute fpies exclusion criteria: -
a non-interventional study with aromasin® as adjuvant treatment of invasive early breast cancer

Conditions: Invasive Early Breast Cancer

Summary: the ies study (a5991012) investigated 4742 patients treated for 2 to 3 years with tamoxifen, who either continued the same treatment or switched to aromasin® for a total treatment period of 5 years. only 65 romanian patients were enrolled in the ies study. it would therefore appear to be essential to evaluate and confirm the tolerability of aromasin® and the ways in which it is used on a broader sample of patients and under the standard conditions of use as stipulated in the ma. this non-interventional study was designed to address these issues.

this is a prospective, non-comparative, non interventional study (nis) in four hundred (400) postmenopausal women hormone-receptor positive invasive with early breast cancer, following 2-3 years of initial adjuvant tamoxifen therapy conducted in 60 sites from romania according to protocol a5991091.the selection of patients based on diagnosis, the attribution of medicinal products and the follow-up of the subjects fall within the current medical practice. a non-interventional study is primarily observational in nature. the present non-interventional study is performed by medical oncologist and medical oncologist /radiation oncologist who agree to take part in this project. n/a the study was prematurely terminated on august 31th 2012 due to unexpected high rate of patient withdrawal caused by aromasin reimbursement policy change in romania; there were no safety issues related to study termination.

Eligibility criteria:
inclusion criteria: * postmenopausal females, defined as one from the next : 1. natural menopause \>/=1 year, 2. surgical ovariectomy, 3. chemotherapy-induced amenorrhoea \>/=2 years. * patients who have had surgical treatment for histological confirmed breast cancer that was non-metastatic at the time of the initial diagnosis. * patients who are disease-free after 2 or 3 years of adjuvant tamoxifen treatment. * patients whose tumour was estrogen receptor positive (er+). * evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study. exclusion criteria: * patients for whom aromasin® treatment is contraindicated (see smpc). * presence of metastasis or a contra lateral tumour. * other adjuvant endocrine therapy. * another concomitant antineoplastic treatment * participation in a clinical trial with an investigational drug during the 30 days prior to enrolment in the study. * the patients are not supposed to participate to any other trial during all the study period.

Keywords: prospective non-comparative nis 600 postmenopausal hormone-receptor positive ebc tamoxifen current medical practice.
efficacy and safety of daratumumab in combination with bortezomib, thalidomide, and dexamethasone regimens in newly diagnosed multiple myeloma

Conditions: Newly Diagnosed Multiple Myeloma

Summary: this is an observational, multi-center, non-interventional study, which is designed to evaluate the safety and efficacy of daratumumab in combination with bortezomib, thalidomide, and dexamethasone (d-vtd) regimens in ndmm patients with renal dysfunction in real-world clinical practice. the data collected in this trial are for subjects with ndmm and renal dysfunction treated with d-vtd regimen and consist of 2 treatment phases, efficacy and safety data from induction phase and consolidation phase.


Eligibility criteria:
inclusion criteria: 1. newly diagnosed multiple myeloma; 2. age over 18 years, male or female; 3. glomerular filtration rate (egfr) \< 40 ml/min 4. patients must have the ability to understand and voluntarily sign the informed consent form, which must be signed before any trial process; 5. patients who completed at least one course of treatment were included in the safety observation; 6. patients who completed at least 2 courses of treatment were included in the efficacy observation; exclusion criteria: 1. acute and chronic renal insufficiency not caused by myeloma; 2. are receiving any other investigational drug or investigational medical device; 3. patients with other cancers confirmed before mm diagnosis, except cervical carcinoma in situ or scaly cell carcinoma of the skin and basal cell carcinoma that are considered cured for more than 3 years before enrollment; 4. patients who do not complete a course of dvtd treatment for any reason, unless permanent discontinuation or death due to the drug;
safety, tolerability, and pharmacokinetics of uhe-103 cream in subjects with tinea cruris and/or tinea pedis

Conditions: Tinea Cruris; Tinea Pedis

Summary: this phase 1 study has been designed to determine the safety, tolerability and pharmacokinetics (pk) of uhe 103 cream compared to naftin cream, 2% under maximal use conditions for 2 weeks treatment in subjects with tinea cruris and/or tinea pedis


Eligibility criteria:
inclusion criteria: 1. subject is a male or non-pregnant female 18 years of age or older. 2. subject has provided written informed consent. 3. subject has a clinical diagnosis of moccasin-type tinea pedis with at least moderate scaling on at least 1 foot at visit 1/screening; 4. subject has a clinical diagnosis of interdigital tinea pedis with at least moderate scaling on at least 1 foot (without moccasin-type tinea pedis) and tinea cruris at visit 1/screening. 5. subject is willing and able to apply the test article(s) as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study. exclusion criteria: 1. subject is pregnant, lactating, or is planning to become pregnant during the study. 2. subject has any skin pathology or condition that could interfere with the evaluation of the test article or requires use of interfering topical, systemic, or surgical therapy. 3. subject has any clinically significant medical abnormality or history of chronic disease (cardiovascular, gastrointestinal, neurological, hematopoietic, immunosuppression \[hiv\], hepatic \[hepatitis b or c\], psychological, renal systems, or respiratory), including conditions (e.g., gastrointestinal surgery) that may interfere with the absorption, metabolism, or excretion of investigational product. 4. subject has used any of the following topical products on the feet or groin within 4 weeks of visit 2/enrollment: antifungals, antibacterials, or corticosteroid therapy. 5. subject has applied any topical naftifine products to any part of their body within 4 weeks of visit 2/enrollment. 6. subject has used topical keratolytics (e.g., urea, ammonium lactate, salicylic acid) on the feet or groin within 1 week of visit 2/enrollment. 7. subject has used any other topical products on the feet or groin within 24 hours of visit 2/enrollment including, but not limited to non-medicated moisturizers, antipruritics, analgesics, anesthetics, etc. 8. subject has received systemic antifungal therapy within 8 weeks or 5 half lives of the antifungal (whichever is longer) of visit 2/enrollment. 9. subject is currently enrolled in an investigational drug, biologic, or device study. 10. subject has previously been enrolled in a study for uhe-103. 11. subject has used an investigational drug, investigational biologic, or investigational device treatment within 30 days prior to visit 2/enrollment. 12. subject has a history of sensitivity to any of the ingredients in the test articles.
radial artery patency and bleeding, efficacy, adverse event trial

Conditions: Percutaneous Coronary Intervention

Summary: the objectives of this study are to demonstrate the safety and efficacy of the new 6fr sheath (glidesheath slender; terumo, tokyo,japan ; gss) compared with the contemporary 5fr sheath (hydrophilic coating sheath from terumo; tokyo, japan (standard of care ; soc).


Eligibility criteria:
inclusion criteria: * patient is able to verbally acknowledge an understanding of the associated risks, benefits and treatment alternatives and he or his legally authorized representative provides written informed consent prior to the randomization, as approved by the appropriate irb. * patient who is expected to diagnose by coronary artery angiography or followed by pci. * patient must agree to undergo all protocol-required follow-up examinations. * patient who can accept radial access. exclusion criteria: * patient has other medical illness (e.g., cancer or congestive heart failure) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year). * hemodialysis patient * stemi

Keywords: transradial intervention radial artery
tango for alzheimer's disease patients' caregivers

Conditions: Alzheimer's Disease

Summary: the goal of the project is to determine the extent to which indices of inflammatory biomarkers, cognition and mood, are influenced by a partnered, dance-based intervention vs control condition in african american (aa) female family caregivers, at high risk for alzheimer's disease (ad).

the importance of informal family caregiving in alzheimer's disease (ad) is well-established. african-american caregivers are most often middle aged adult children of ad patients (vs. spouses), women, and are at higher risk for chronic health problems. ad lifestyle interventions offer an alternative to medication, and are generally affordable, accessible, and adaptable to the lives of caregivers. to date, most non-pharmaceutical interventions have focused on exercise and nutrition, both of which have proven to be highly successful in conferring ad related benefits and decreasing ad risk. the goal of the project is to determine the extent to which indices of inflammatory biomarkers, cognition and mood, are influenced by a partnered, dance-based intervention vs control condition in african american (aa) female family caregivers, at high risk for alzheimer's disease.

Eligibility criteria:
inclusion criteria: * women family caregivers from the emory adrc and dr. wharton's studies of alzheimer's disease (ad) caregivers * parental diagnosis 'probable ad' * african-american * 45-65 years of age

Keywords: alzheimer's disease african-american women caregivers tango dance-based intervention