Kornimate/medical-research-clean huggingface dataset:
an extension to study ma21573, evaluating tocilizumab in patients with active rheumatoid arthritis and an inadequate response to current non-biological dmards and/or anti-tumor necrosis factor (tnf) therapy

Conditions: Rheumatoid Arthritis

Summary: this study was an extension to study ma21573 \[nct00750880\], which was an open label single arm study to investigate the safety, tolerability and efficacy of tocilizumab monotherapy, or combination therapy with non-biological disease-modifying antirheumatic drugs (dmards), in patients with moderate to severe active rheumatoid arthritis. patients who completed the 24 week core study, and had at least a moderate european league against rheumatism (eular) response, were eligible to enter this long-term extension study, and received tocilizumab 8 mg/kg intravenous (iv) every 4 weeks. the anticipated time on study treatment was 1-2 years, and the target sample size was \> 500 individuals.


Eligibility criteria:
inclusion criteria: - patients who completed the 24-week ma21573 core study, had at least a moderate response based on eular definition criteria and no adverse events (aes), serious adverse events (saes) or conditions that led to unacceptable risk of continued treatment. exclusion criteria: -as for ma21573.
the role of biofeedback in improving continence after anterior resection

Conditions: Rectal Neoplasms; Fecal Incontinence; Aged

Summary: the purpose of this study is to determine whether biofeedback exercises improve anal continence after anterior resection for rectal cancer.

see above

Eligibility criteria:
inclusion criteria: * rectosigmoid or rectal cancer exclusion criteria: * inoperable

Keywords: rectal neoplasms biofeedback (psychology) fecal incontinence aged anterior resection
occupational therapy programme of patients with dementia performing activities of daily living

Conditions: Dementia

Summary: to assess the effectiveness of the stimulation of activities of daily living (sadl) occupational therapy programme on the independence of adl by persons with dementia who are institutionalized. this programme is based on the recovery of the cognitive functions.

this study is a longitudinal and prospective clinical trial approved by the bioethics commission of the university of extremadura. 58 senior citizens institutionalized with dementia in residential homes in extremadura (spain) received a treatment focusing on activities of daily living with the sadl programme and with conventional occupational therapy during 5 weeks. the studied variables were the cognitive level and the independence level performing adl. the variables were measured by an occupational therapist independent to the study at baseline, after 5 weeks of experimental treatment and 6 weeks after the treatment was completed. the standardized tests used were barthel index, lobo's cognoscitive mini test, lawton and brody scale and global deterioration scale (gds).

Eligibility criteria:
inclusion criteria: * institutionalization in residential homes at least 6 months before the commencement of the study. * diagnosis of dementia for at least one year according to the diagnostic and statistical manual of mental disorders (dms iv) criteria. * over 60 years old. * barthel index scores greater than or equal to 40%. * lobo´s cognitive mini test scores greater than or equal to 15 points. * to be included in the badl intervention programme of occupational therapy in the previous 6 months and to have the informed consent signed by the legal tutor. exclusion criteria: * to present psychological or behavior symptoms diagnosed by a doctor. * barthel index scores less than 40% * not being included in the badl intervention programme of occupational therapy in the previous 6 months.

Keywords: activities of daily living, occupational therapy, dementia
effects of dhea/exercise on bone, muscle and balance

Conditions: Osteoporosis; Frailty

Summary: the purpose of this study is to examine whether muscle strength and balance will improve in women with frailty selected for dehydroepiandrosterone sulfate (dheas) levels below 550 ng/dl treated with dheas supplementation and hatha yoga. investigators believe the effects of both treatments will improve outcomes more than either treatment alone and may be additive; in addition, lean body mass, skeletal muscle mass, markers of bone turnover and physical performance will improve following treatment with dhea and/or yoga.

dehydroepiandrosterone (dheas) and yoga may mitigate or reverse the effects of aging and frailty on bone, muscle and balance loss. the mechanism of the effects may be direct - working through androgen or estrogen receptors in bone, muscle or brain. or the effects may be indirect, countering effects of the stress response. the specific aims of this study are: 1. to determine the effects of dehydroepiandrosterone sulfate (dheas) supplementation and/or hatha yoga on muscle strength, balance, body composition and physical performance measures over 6 months in women with osteopenia and some degree of frailty 2. to determine the effect of dehydroepiandrosterone sulfate (dheas) supplementation and/or hatha yoga on function (physical and cognitive), bone metabolism, and cardiovascular risk factors.

Eligibility criteria:
inclusion criteria: * women over age 65 years * bone mineral density t-score less than -1 * at least one of the five components of the frailty phenotype (low hand grip strength, low walking speed, low physical activity, weight loss or sense of exhaustion) * dheas levels less than 550 ng/dl * able to come or be brought to the university of connecticut health center (uchc) for outpatient visits * mammogram within the preceding 12 months exclusion criteria: * disease or medication known to affect bone or muscle metabolism (i.e., paget's disease, osteomalacia or 25ohd level less than 10 ng/dl, hyperparathyroidism: current use of corticosteroids, calcitonin, heparin, phenytoin, phenobarbital, methotrexate, bisphosphonates, calcitonin, selective estrogen receptor modulator or pth) * use of androgen or estrogen in the preceding year * use of psychiatric medications including antipsychotic medications and ssri * metastatic or advanced cancer (other than skin cancer) * history of breast cancer * active cardiac ischemia by history of angina or myocardial infarction in the preceding 6 months

Keywords: bone mineral density bone turnover markers strength balance
non surgical treatment of periimplantitis

Conditions: Peri-Implantitis and Peri-implant Mucositis

Summary: 20 consecutive adult implant patients, presenting the signs of peri-implant mucositis (probing depth ≥4 mm combined with bleeding and/or pus on probing) or initial peri-implantitis (probing depth ≥4 mm, bleeding and suppuration plus radiographic loss of supporting bone ≤30% compared with the situation after implant placement) will be included. sites will be treated by ultrasonic debridement of the pocket, performed using a piezoceramic ultrasonic device. for the purpose, a tip will be connected to the handpiece led (5 minutes/pocket) . then, it will be followed by the subgingival use of erythritol powder applied by the use of handpiece connected to an airflow unit 2x5 seconds/pocket. at this time the subgingival delivery of metronidazole gel will be provided. after instrumentation, patients will rinse with chlorhexidine 0.20% 3 times/day for 2 weeks. at baseline, 1 month, 3 months and 6 months the following parameters will be evaluated: probing pocket depth (ppd), bleeding on probing (bop), clinical attachment level (cal).


Eligibility criteria:
inclusion criteria: * adult patients suffering from peri-implant mucositis or peri-implantitis exclusion criteria: * heavy smokers current pregnant history of malignancy long-term steroidal or antibiotic therapy
oral lat8881 in neuropathic pain

Conditions: Neuropathic Pain; Diabetic Peripheral Neuropathy (DPN); Post Herpetic Neuralgia (PHN)

Summary: this is a randomised, placebo-controlled, double-blind, crossover, phase iia study to investigate the efficacy and safety of oral lat8881 in neuropathic pain.

this is a randomised, placebo-controlled, double-blind, crossover, phase iia study to investigate the efficacy and safety of oral lat8881 in neuropathic pain. after a one week baseline period, subjects entered into the study will be randomised to receive investigational medicinal product (imp) (lat8881 or placebo) twice daily for four weeks. the first treatment period will be followed by a washout period of two weeks and then a second baseline period of one week. subjects will not take any imp over these three weeks. after the second baseline period, subjects will cross over to receive the second treatment (either lat8881 or placebo, whichever treatment was not received in the first treatment period) twice daily for four weeks. the pharmacokinetics (pk) of lat8881 will be investigated in 15 subjects (pk subjects) at selected australian sites.

Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of post herpetic neuralgia, with pain persisting for at least 3 months after the onset of herpes zoster rash or 2. clinical diagnosis of distal painful polyneuropathy due to type i or type ii diabetes mellitus with: 1. symmetrical, bilateral pain in the lower extremities for at least 3 months and 2. diabetes under control for at least 3 months prior to randomisation, as indicated by a glycated haemoglobin level (hba1c) of ≤ 11% (97 mmol/mol) and on a stable dose of insulin or oral diabetic medication for 3 months prior to screening, and 3. no change in diabetic medication planned for the duration of the study 3. positive sensory symptoms (mechanical or thermal) associated with neuropathic pain, confirmed by: 1. paindetect questionnaire (pd-q) and 2. clinical assessment, showing signs of neuropathic pain in either a dermatomal (phn) or distal symmetrical distribution (dpn) 8. an average daily pain score on the numeric pain rating scale (nprs) of at least 4 and no more than 8 in the last five diary entries before randomisation exclusion criteria: 1. presence of moderate to severe pain from other causes that may confound assessment or self-evaluation of np. 2. subjects with both dpn and phn
novel approach of hayman uterine compression sutures for management of severe atonic postpartum hemorrhage: three vertical sutures

Conditions: Uterine Atony

Summary: maternal deaths due to uterine atony bleeding are the leading causes of maternal death in our country and all over the world. in this respect, our clinic is among the clinics with the highest number of experience in our country and aims to reduce maternal deaths and mothers who will need intensive care due to bleeding with a hemorrhage stopping technique that will have a serious contribution to both our country and the world literature. our primary goal, thanks to the bleeding-stopping technique, to reduce their deaths. our secondary aim is, thanks to the bleeding-stopping technique we offer, to prevent and reduce the complications seen in mothers during the operative period.

our research was carried out to our obstetrics clinic between 01 agustus 2015 - 01 december 2020. patients transplanted due to postpartum bleeding and patients requiring surgery due to abnormal postpartum bleeding in our clinic will be included. patients with a previously known bleeding disorder will not be included in the study. in our study, the parameters of the patients who had bleeding due to postpartum uterine atony and who needed uterine surgery previously underwent triple hayman compression suture to stop bleeding will be included in the study. patients with a triple hayman suture covering the upper 2/3 of the uterus to stop uterine bleeding will be evaluated in the study.

Eligibility criteria:
inclusion criteria: * postpartum bleeding after birth * patients referred to our clinic from an external center due to postpartum bleeding * patients who have given birth due to pregnancy older than 24 weeks and have atony bleeding exclusion criteria: -
attention bias modification treatment (abmt) and cognitive-behavioral group therapy (cbgt) in social anxiety disorder

Conditions: Social Anxiety Disorder

Summary: this rct examines the effectiveness of attention bias modification treatment (abmt) as an augment to cognitive-behavioral group treatment (cbgt) for social anxiety disorder (sad) in adults. it is expected that abmt vs. control training condition would achieve better therapeutic outcomes as indicated reduction in symptoms. participants from three groups (estimated 40 patients) will be offered to participate in the study

outpatients seeking treatment for social anxiety disorder (sad) at geha anxiety-disorders clinic will be randomized into two groups (abmt+cbgt; placebo control+cbgt). one group will undergo an attention bias modification treatment (abmt) aimed at diverting attention away from socially-threatening stimuli. the second group will receive a placebo-control not designed to affect attention. both groups will also undergo a standard cognitive-behavioral group treatment (cbgt) comprising 18 weekly sessions of 1.5-hr duration (along the lines of heimberg, juster, hope \& mattia 1995 and clark \& wells 1995). symptoms and attention bias measures will be taken at three time points: pre-treatment, post-treatment,and at 3-month follow-up. the study includes the following steps: a) initial assessment of participants' psychopathology and symptom levels; b) attention bias measurement; c) 8 sessions of abmt/placebo control delivered as part of the cbgt sessions; d) two booster abmt/placebo treatments will be delivered at sessions 13 and 16 of the cbgt protocol. e) post-treatment assessment will include symptom and attention bias assessments. finally, f) a three-month follow up assessment. the goal of the study is to to test the effectiveness of abmt as an add-on to established cbgt protocol for social anxiety disorder.

Eligibility criteria:
inclusion criteria: * a signed consent form * men and women between the ages of 18 and 60. * meeting a current diagnosis of social anxiety disorder (sp) according to the dsm-iv * a minimum of a 1-year duration of sp * sp as the primary diagnosis: in cases of co-morbidity, sp will be deemed as the most distressing and clinically significant condition among the co-morbid disorders * stable pharmacotherapy: participants receiving a pharmacological treatment who are taking a stable medication for at least 3 months before the beginning of cbgt. exclusion criteria: * psychotic episode in the past or the present time. * co-morbidity with any neurological disorder (i.e., epilepsy, brain injury). * another psychotherapeutic treatment during the study. * usage of neuroleptic medication. * change in medication status during the study. * substantial usage of drugs or alcohol in the present time. * poor judgment capacity (i.e., children under 18 and special populations).

Keywords: social anxiety attention modification dot-probe gcbt
study of the enterprise self-expanding stent system with endovascular coil embolization of wide- neck saccular intracranial artery aneurysms

Conditions: Intracranial, Wide-Neck, Saccular Aneurysms

Summary: cordis self expanding stent for use with embolic coils for the treatment of wide-neck, intracranial, saccular aneurysms arising from a parent vessel


Eligibility criteria:
inclusion criteria: * pts with intracranial, wide-neck, saccular aneurysms exclusion criteria: * subject with hunt and hess grade iv or v subarachnoid hemorrhage.

Keywords: intracranial wide-neck saccular aneurysms
a phase 2, multicenter, open-label study of medi-551 in adults with relapsed or refractory chronic lymphocytic leukemia (cll)

Conditions: Chronic Lymphocytic Leukemia (CLL)

Summary: the overall purpose of the study was to determine if medi-551, when used in combination with salvage chemotherapy (bendamustine) in participants with relapsed or refractory cll who are not eligible for autologous stem cell transplant (asct), had superior efficacy compared to rituximab in the same population.


Eligibility criteria:
inclusion criteria: * histologically confirmed b-cell chronic lymphocytic leukemia (cll) according to the national cancer institute criteria; eastern cooperative oncology group (ecog) performance status of 0, 1, or 2; adequate hematological function exclusion criteria: * any chemotherapy, radiotherapy, immunotherapy, biologic, investigational, or hormonal therapy for treatment of lymphoma within 28 days prior to treatment; * exposure to bendamustine within the 180 days before study enrollment * prior autologous or allogeneic stem cell transplantation (sct); * clinically significant abnormality on electrocardiogram (ecg) as determined by the treating physician or medical monitor; * history of other invasive malignancy within 5 years except for localized/in situ carcinomas; * evidence of active infection, confirmed current central nervous system involvement by leukemia or lymphoma;

Keywords: chronic lymphocytic leukemia; leukemia; b-cell malignancy; anti-cd19; monoclonal antibody; cll; refractory; relapse; non-hodgkin's lymphoma
research on outpatient adolescent treatment for comorbid substance use and internalizing disorders

Conditions: Substance-Related Disorders; Depressive Disorder; Anxiety Disorder

Summary: adolescent substance abuse results in significant negative outcomes and extraordinary costs for youths, their families, communities, and society. moreover, rates of psychiatric comorbidity among substance abusing youth range from 25% up to 82%, and youths with a dual diagnosis are more than twice as costly to treat compared to those with no comorbidity. the applicant principal investigator recently completed a pilot project funded by the national institute on drug abuse focused on developing and piloting a psychosocial treatment specifically for youth presenting for outpatient treatment with co-occurring substance use and internalizing (i.e., mood and/or anxiety) problems. results were promising with the experimental group exhibiting significantly less substance use and more rapid reductions in anxiety and depressive symptoms compared to the control group. the proposed research is a randomized clinical trial (rct) to compare the experimental treatment (outpatient treatment for adolescents; opt-a) to an "active placebo" on key clinical indices from pre-treatment through 18 months. the proposed rct (n = 160) employs the treatment manual, quality assurance protocol, and therapist training protocol developed and successfully tested in the pilot study, to evaluate the efficacy of opt-a for youth referred to outpatient treatment of co-occurring substance use and internalizing problems. the following outcomes will be evaluated: drug use; mental health; behavioral, school, peer, and family functioning; and consumer satisfaction. the intervention addresses one of the more prevalent and most challenging, costly, and understudied presenting problems among adolescent outpatients. if successful, this research could provide a considerable contribution in the treatment field for youth with co-occurring substance use and internalizing disorders.


Eligibility criteria:
inclusion criteria: * 10 to 17 years of age * residing with at least one adult caregiver who serves as a parent figure * in need of treatment for a substance abuse or dependence disorder * in need of treatment for an axis i mood disorder and/or anxiety disorder exclusion criteria: * pervasive developmental disorder * active psychotic disorder * severe or profound mental retardation
skin cancer and hyperthermia and radiotherapy

Conditions: Basal Cell Carcinoma; Squamous Cell Carcinoma Skin; Non-melanoma Skin Cancer

Summary: the sahara trial assesses wether combining ultrahypofractionated accelerated radiotherapy (rt) with hyperthermia is as effective as standard hypofractionated high-dose radiation in treating non-melanoma skin cancer (nmsc).

the sahara trial is investigating if adding hyperthermia to radiotherapy (rt) can enhance treatment outcomes by making cancer cells more sensitive to radiation, thus requiring lower doses and potentially reducing side effects. the trial compares high-dose rt alone with de-escalated rt plus hyperthermia. the aim is to demonstrate that the combination is non-inferior to standard rt in treating non-melanoma skin cancer (nmsc). the trial is designed for elderly people of 65 years or older.

Eligibility criteria:
inclusion criteria: * personally signed and dated written informed consent * histologically confirmed invasive non-melanoma skin cancer (nmsc), including basal cell carcinoma (bcc) and squamous cell carcinoma (scc) of any differentiation * ≥ t2 (tnm classification 8th edition) * tumor thickness up to 2cm (maximum depth invasion and/or exophytic growth, measured on pathology report or imaging) * local recurrence allowed, if primary treatment longer ago than 6 months (after primary treatment other than radiotherapy (rt)) * age ≥ 65 years * eastern cooperative oncology group (ecog) performance status 0-2, with a life expectancy of more than 6 months * presentation at the swiss hyperthermia network (shn) tumor conference mandatory exclusion criteria: * other histology than bcc or scc * t1 tumor and/or n+ (according to tnm classification 8th edition) * tumors after resection (r1 or r2 as well as adjuvant indication) * tumor invasion into critical areas * several lesions exceeding the capacity of one treatment/radiation field (multiple lesions within one treatment field are acceptable) * previous (one month) or concurrent chemo- or immunotherapy * patients with connective tissue disorders (e.g. sclerodermia, lupus erythematodes) * lesions inside or in proximity (within 3cm) previously irradiated area * medical immunosuppression * wira-specific exclusion criteria * tattoos in irradiated area * increased photosensitivity (either due to simultaneous treatment with photosensitivity-enhancing medications or conditions such as porphyria)

Keywords: bcc scc skin w-ira hyperthermia radiotherapy for non-melanoma skin cancer non-melanoma skin cancer w-ira combined with rt hyperthermia
effect of glycerol hyperhydration on running economy of long-distance runners

Conditions: Running; Physical Conditioning, Human

Summary: the aim of this study was to evaluate the effects of hyperhydration with glycerol on running economy (re) in trained runners. the main questions sought to be answered are: 1. does hyperhydration with glycerol improve running economy? 2. are there beneficial effects on physical performance? the researchers will conduct a clinical trial with 30 runners (15 men, 15 women) in three sessions. in the first session, vo2peak was determined and running speeds were established for sessions 2 and 3. in the second session, participants performed a stress test. in the second session, participants performed a running test in the euhydrated state under fluid restriction, and in the third session, with glycerol supplementation (22 ml/kg sports drink + 1.2 g/kg glycerol). variables such as caloric cost unit (ccu), oxygen cost unit (ocu), heart rate (hr), body temperature (bt) and perceived exertion (rpe) were evaluated.


Eligibility criteria:
inclusion criteria: 1. competitive runners with a minimum record of 4.2 min/km. 2. age between 18 and 35 years old 3. apparently healthy athletes 4. signature of informed consent form exclusion criteria: 1. presence of comorbidities that could alter the study variables (such as arterial hypertension, hyperthyroidism or heart disease). 2. consumption of medications or stimulants (such as caffeine or diuretics) 48 hours before the tests. 3. pregnancy. -

Keywords: glycerol athletic performance sports nutritional sciences thermoregulation running