Kornimate/medical-research-clean huggingface dataset:
korean post-marketing surveillance for orencia®

Conditions: Rheumatoid Arthritis

Summary: the purpose of this post-marketing surveillance is to investigate and confirm the type and incidence of newly identified adverse events and any other factors affecting safety and efficacy of orencia® so that the regulatory authority can manage the marketing approval properly.

time perspective: prospective / retrospective(on-treatment)

Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * patients must be diagnosed with: adult rheumatoid arthritis (ra): adult patients with moderate-to-severe active ra or * juvenile idiopathic ra: juvenile patients aged 6 years and older with moderate-to-severe active ra exclusion criteria: * children aged \<6 years * pregnant or lactating women * patients who are participating in another study * patients known to be hypersensitive to the active component of the surveillance drug or any other component of the surveillance drug * patients who had a positive tuberculosis screening test but were not treated with standard therapy before participating in the study * patients who have a positive hepatitis virus test * patients who were given a live vaccine concurrently with the surveillance drug or are expected to be given a live vaccine again within 3 months after discontinuation of the surveillance drug
active prevention of msds (musculoskeletal disorders, upper and spine members) in the context of computer screen work

Conditions: Symptomatic Musculoskeletal Diseases; Latent Musculoskeletal Diseases

Summary: evaluate the benefit of an intervention by a computer program comprising active breaks, in the form of a personalized self-program on functional impairment and / or pain, among employees with latent or symptomatic upper extremity msds and spine (+/- eyestrain) in connection with the computer work environment.

the benefit of the intervention will be assessed among four groups of subjects: symptomatic and asymptomatic subjects randomized in control or experimental group. subjects of the experimental group will have to follow an intervention for one month, consisting in active breaks from computer work. control group patients had no intervention. symptoms of msd will be assessed via questionnaire before and after intervention, in all groups.

Eligibility criteria:
inclusion criteria: * - to carry out a professional activity. * to be involved in a computer work for at least 5 hours a day. * to be between 18 and 65 years. exclusion criteria: * - to be in sick leave. * rheumatic and neurological diseases which needed treatment. * workstations which have been recently changed. * a behavioral and/or comprehension trouble

Keywords: musculoskeletal diseases eyestrain occupational diseases computer work muscle stretching exercise computer software application msds
collagenase in the treatment of cellulite

Conditions: Cellulite

Summary: the purpose of this study is to determine if collagenase injection will reduce or eliminate the appearance of cellulite of the thigh.

this is an open label study of collagenase injection therapy for reduction and/or elimination of cellulite of the posterolateral thighs.

Eligibility criteria:
inclusion criteria: * 10 x 10 cm area of cellulite of the posterolateral thigh(s) exclusion criteria: * any chronic, serious or uncontrolled medical condition * inability to conform to study visits (12-15 per year)
letsync: pilot test of mobile health (mhealth) intervention

Conditions: HIV/AIDS

Summary: the pilot test (aka study b) will entail a pilot randomized, controlled trial (rct) of an mhealth behavioral intervention, letsync, with 80 couples (n=160) to assess its acceptability, feasibility, and preliminary impact on retention in care and art adherence as measured by antiretroviral concentrations in hair. participants in the intervention arm will use letsync v1.0 for 6 months and provide acceptability and feasibility data. in the ensuing 2 months, the investigators will make refinements based on participants' data to produce letsync v2.0. then, participants in the waitlist-control arm will receive letsync v2.0, use it for 6 months, and provide acceptability and feasibility data. the intervention arm will continue using letsync v1.0, for a total of 14 months. based on acceptability and feasibility data from waitlist control arm participants between t3 and t4, the investigators will develop letsync v3.0, which will be used for efficacy testing in a full rct trial in the future.


Eligibility criteria:
inclusion criteria: individuals are eligible if they: * self-identify as racial/ethnic minority * self-identify as a cisgender man * are hiv-positive themselves, or are the partner of someone who is living with hiv * are age 18 or older * have a primary relationship partner, defined as someone to whom the participant is committed above anyone else for three or more months * uses and owns a personal smartphone * willing and able to provide informed consent partners are eligible if they: * self-identify as a cisgender man * are age 18 or older * have a primary relationship partner that is the referring participant * uses and owns a personal smartphone * willing and able to provide informed consent exclusion criteria: those who: * report fear of intimate partner violence (ipv) resulting from participation * are unwilling or unable to disclose hiv status to primary partner * present evidence of severe cognitive impairment that would prevent comprehension of study procedures assessed during informed consent

Keywords: hiv/aids mhealth intervention african american men
effect of reflexology massage on pain and anxiety.

Conditions: Pain; Anxiety

Summary: aim: the aim of this study is to examine the effects of reflexology hand massage group and placebo group on pain and anxiety in patients undergoing coronary artery bypass graft surgery. method: individuals who have undergone coronary artery bypass graft surgery in accordance with the sampling inclusion criteria will be allocated to the reflexology and placebo groups by block randomization using the randomization method. after the groups are determined, the patients in the reflexology hand massage group and placebo group will be asked to fill in the socio-demographic information form, the state anxiety scale and the visual analog scale will be taken. in addition to the standard nursing care of the hospital, individuals in the reflexology group and placebo group will be massaged for 10 minutes, a total of 20 minutes, after the extubation procedure. individuals in the reflexology group and placebo group will be followed up before the massage (0. minute) and after the massage at the 5th, 30th and 60th minutes, and the data will be recorded.

pain and anxiety are common postoperative problems that impair recovery and quality of life in patients undergoing coronary artery bypass graft (cabg) surgery. these problems cause changes in physiological parameters, prolonged recovery, sleep problems and a decrease in quality of life in patients. hand reflexology, which is among the non-pharmacological methods, is an effective intervention that nurses can apply independently in the management of pain and anxiety.therefore, this study aimed to examine the effect of reflexology on pain and anxiety.

Eligibility criteria:
inclusion criteria: * to be over 18 years of age, * to know turkish and to agree to participate in the research * no previous open heart surgery * non-urgent planned bypass surgery * without any intra-aortic balloon pump or pacemaker * not taking inotropic drugs * patients who have no problem to apply massage; those who do not have any skin lesions, burns * extubated * not taking analgesics exclusion criteria: * mitral valve repair or replacement during cabg surgery * those who have any skin lesions, burns, open wounds, muscle and bone-related pathological disease, phlebitis * not disconnected from mechanical ventilation * having a risk factor for complications (e.g: ejection fraction \< 35%)

Keywords: hand reflexology nursing care pain management
sidlenafil in combination with oral anticoagulants in patients with intermediate-high risk of pulmonary embolism

Conditions: Pulmonary Embolism; Intermediate-high Risk; Combination of Oral Anticoagulation Therapy and Sildenafil

Summary: pilot randomized study of the sidlenafil efficacy in combination with oral anticoagulants in the treatment of patients with intermediate-high risk of pulmonary embolism


Eligibility criteria:
inclusion criteria: * pulmonary embolism confirmed by ct scan with contrast, with localization of thrombusa in at least one main or proximal lobar pulmonary artery. * right-left ventricular ratio (rv / lv) ≥1 derived from the apical four-chamber view * who gave written informed consent to participate in research exclusion criteria: * age \ 80 years * symptoms of pulmonary embolism\> 14 days * inadequate echocardiographic image quality in the apical four-chamber projection, which limits the measurement of rv / lv ratio * a significant risk of bleeding * the administration of thrombolytic drugs within the previous 4 days * active bleeding * known coagulopathy * thrombocytopenia \<100,10\^9 / l * previous use of vitamin k antagonists with an inr\> 2.5 at admission * history of any intracranial or spinal surgery or trauma or intracranial / spinal bleeding * intracranial neoplasm * arteriovenous malformations or aneurysms * gih \<3 months * cataract surgery * obstetrical manipulation * cardiopulmonary resuscitation needed. * other invasive procedures \<10 days * allergy, hypersensitivity, thrombocytopenia to heparin or tissue plasminogen activator * allergy to iodine contrast * a well-known right-left cardiac shunt, for example, a large patent foramen ovale, or atrial septal defect; large (\> 10 mm), or a blood clot in right atrium/right ventricle * systolic blood pressure \ 90 mm hg * severe hypertension (systolic\> 180 mm hg or diastolic\> 105 mm hg.). * pregnancy, lactation, delivery\<30 days * participation in any other study (drug or device) * life expectancy \<90 days * refusal to participate in the study

Keywords: pulmonary embolism sildenafil oral anticoagulation therapy
creating and assessing a voice dataset for automated classification of chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this work aims to evaluate whether voice recordings collected from patients diagnosed with copd and healthy control groups can be used to detect the disease using machine learning techniques.

voice data and sociodemographic data on gender and age will be collected through the "voicediganostic" application from the company voice diagnostic, which allows one to participate without location dependency. participants with a diagnosis will be marked as the copd group, and others will be marked as the healthy control group. private information such as known comorbidities, personal security numbers, health parameters and communication information will be separately noticed in a participation table for each group. the collected data will be transformed into mathematical vocal measures called voice features. a dataset consisting of voice features in conjunction with demographics and health data will be constructed for further usage as an input to ml techniques. descriptive statistical analysis will be held on attributes containing information on input data and gained outcomes from ml algorithms. the achieved results will be presented in the form of summary tables and graphs.

Eligibility criteria:
inclusion criteria: * being 18 years old and older. exclusion criteria: * being under 18 years old.

Keywords: automatic classification copd machine learning mobile phone
an open label extension trial of eculizumab in relapsing nmo patients

Conditions: Neuromyelitis Optica; Neuromyelitis Optica Spectrum Disorder

Summary: the purpose of this study is to determine whether eculizumab long-term use is safe and effective in patients with relapsing nmo.

this study is an open label extension study to confirm the long term safety and efficacy of eculizumab in subjects with relapsing nmo who have completed the initial double-blind, randomized, placebo-controlled trial ecu-nmo-301.

Eligibility criteria:
key inclusion criteria: 1. patient completed the ecu-nmo-301 trial 2. patient has given written informed consent key exclusion criteria: 1. patients who have withdrawn from the ecu-nmo-301 trial as a result of an ae related to trial drug 2. female patients who are pregnant, breastfeeding, or intend to conceive during the course of the trial

Keywords: long-term safety study extension trial eculizumab neuromyelitis optica spectrum disorder devic's disease transverse myelitis optic neuritis relapse nmo-igg cns autoimmune disorders demyelinating disorders
masitinib in combination with folfiri for second-line treatment of patients with metastatic colorectal cancer

Conditions: Metastatic Colorectal Cancer

Summary: the objective is to compare the efficacy and safety of masitinib in combination with folfiri ( irinotecan, 5-fluorouracil and folinic acid) to placebo in combination with folfiri in second line treatment of patients.


Eligibility criteria:
inclusion criteria: * patient with non-resectable metastatic colorectal cancer * metastatic disease not amenable to surgical resection * patient in second line treatment after progression according to recist criteria * patient with measurable lesions according to recist criteria (version 1.1) * patient eligible for a standard second line treatment with folfiri * patient with ecog ≤ 2 * patient with adequate organ function * patient with life expectancy \> 3 months * female or male patient ≥ 18 * patient weight \> 40 kg and bmi \> 18 exclusion criteria: * patient who cannot receive folfiri * more than 1 prior chemotherapy regimens for metastatic colorectal cancer * pregnant, intent to be pregnant, or nursing female patient * patient with any chronic inflammatory bowel disease * patient treated for a cancer other than colorectal cancer within five years before enrollment * patient with an hepatic involvement \> 50% * patient with active central nervous system (cns) metastasis or history of cns metastases * patient with an active infection * patient presenting with cardiac disorders * any previous treatment with an investigational agent or chemotherapy or biological agent within four weeks prior to baseline.
sleeve gastrectomy for morbid-obesity sequelae after transplantation

Conditions: Liver Transplantation; Obesity

Summary: complications associated with excess weight (hypertension, coronary artery disease and diabetes) have become major causes of morbidity and mortality after liver transplantation (lt). to ensure excellent long-term outcomes with lt it is critically important to understand the best strategies to minimize obesity and its associated complications in our patients. weight loss can be achieved through dieting and exercise, but most patients are unable to maintain the weight loss. in the general population, bariatric surgery is much more effective than medical treatment for permanent weight loss and prevention or reduction of obesity-associated complications. the purpose of this study is to determine the safety and effectiveness of performing sleeve gastrectomy (sg) procedure in the early post-lt period in obese patients. the patient population for this study will be anyone listed for liver transplantation at toronto general hospital (university health network, toronto, on, canada) and meeting the current standard criteria for bariatric surgery (bmi\>40, or bmi\>35 with at least 1 obesity-related complication).this study will randomly assign eligible participants to one of two groups (1:1). patients in group 1 will receive standard lifestyle/diet counselling while patients in group 2 will undergo sg-specific counselling prior to transplant and the sg procedure within 2 weeks of lt (if safe to do so). all participants will be followed for 12 months.


Eligibility criteria:
inclusion criteria: * actively listed for liver transplantation at university health network * bmi at screening of a) \>40; or b) bmi \>35 and 1 obesity-related complication \[diabetes (defined as hyperglycemia requiring medication(s) for control), hypertension (defined as a persistently elevated systolic pressure greater than 140 mmhg and/or requiring medication(s) for control), hypercholesterolemia (defined as elevated lipids requiring medication for control)\] or a diagnosis of non alcoholic fatty liver disease (defined as the presence of a fatty liver on imaging without a secondary cause such as alcohol abuse) or non alcoholic steatohepatitis * upper endoscopy showing no contraindications to a sleeve gastrectomy procedure exclusion criteria: * • listed for re-transplantation, or transplantation of another organ (eg. kidney). * previous bariatric surgery. * contraindication to undergoing sleeve gastrectomy such as severe gastroesophageal reflux disease or barrett's esophagus * meld (model end-stage liver disease) score \> 35 at the time of transplantation * presence of any condition that in the opinion of the investigator(s) could compromise the patient's ability to comply with study procedures * patients with a bmi \<32 at transplant or having weight loss of 20% or more (pre-transplant estimated dry body weight compared to estimated dry body weight at screening) * presence of any other condition that, in the opinion of the investigator(s), could compromise the patient's ability to safely undergo, or benefit from, the sg procedure (eg. significant sarcopenia)
a study to evaluate the effects of asoprisnil(j867) in women with uterine fibroids who are scheduled for a hysterectomy

Conditions: Uterine Fibroids; Leiomyoma

Summary: the objective of this study is to evaluate the effects of 10 mg and 25 mg doses of asoprisnil, compared to placebo, taken daily for 12 weeks, on uterine blood flow and the morphology of the endometrium and uterine fibroids.

no medical therapy is currently available for the long-term treatment of uterine fibroids. the objective of this study is to determine the effects of asoprisnil in uterine fibroid growth suppression. full thickness biopsies obtained from surgical procedures will allow the assessment of asoprisnil's effects on the basalis, the myometrium, and on endometrial angiogenesis. various other exploratory immunohistological and biochemical specimens will be collected to evaluate the mechanisms of action of asoprisnil in the endometrium, the myometrium, and in uterine fibroids.

Eligibility criteria:
inclusion criteria: * premenopausal women, at least 18 years of age * diagnosis of uterine fibroid(s), confirmed by ultrasound * history of menstrual cycles between 17 and 42 days * otherwise in good health * scheduled for a hysterectomy at the end of the treatment period * negative pregnancy test * agrees to double barrier method of contraception * pap test with no evidence of malignancy or pre-malignant changes * endometrial biopsy with no significant histological disorder exclusion criteria: * less than 3 months after having a baby or breast-feeding * any abnormal lab or procedure result the study-doctor considers important * severe reaction(s) to or are currently using any hormone therapy * history of cancer or alcohol or drug abuse * diagnosis of polycystic ovary syndrome * history of prolactinoma * current use of intrauterine device * significant gynecological disorder * uterine size \> 32 weeks gestation * current diagnosis of endometriosis * uterine artery embolization within 6 months

Keywords: fibroid uterus leiomyoma uterine fibroids hysterectomy asoprisnil
daa treatment in donor hcv-positive to recipient hcv-negative heart transplant

Conditions: End Stage Heart Disease; Hepatitis C

Summary: this is a proof of concept, single center study for the donation of hcv-positive hearts to hcv negative recipient patients, with preemptive, interventional treatment with 12 weeks of commercially available daa therapy to prevent hcv transmission upon transplantation.

the goal of this study is to determine if preoperative dosing and sustained administration of pan-genotypic daa therapy after cardiac transplantation prevents the transmission of hepatitis c virus (hcv) infection from an hcv-positive donor heart to an hcv naïve recipient.

Eligibility criteria:
inclusion criteria: * recipient is age ≥ 18 years * serum alt within normal limits with no history of liver disease * lack of sensitization (i.e. pra \< 20%) that would be expected to result in a high likelihood of needing aggressive immunosuppression to treat rejection exclusion criteria: * sensitization (i.e. pra \>20%) * any liver disease in recipient * albumin \< 3g/dl or platelet count \< 75 x 103/ml * need for dual organ transplant

Keywords: heart disease heart transplant hcv hepatitis c
improving work outcome for people with severe mental illness

Conditions: Schizophrenia, Schizotypal and Delusional Disorders; Bipolar Affective Disorder; Recurrent Depressive Disorder

Summary: the purpose of this study is to investigate the efficacy of ips in denmark and compare effects of 1. individual placement and support (ips) vs. 2. ips + cognitive remediation and work-related social skills training vs. 3. standard intervention, among individuals with severe mental illness.

individual placement and support (ips) is established as the most effective vocational intervention available for persons with severe mental illness,and the intervention is widely recognized as an evidence-based practice. despite evidence, long-term job retention and economic self-sufficiency have not been clearly demonstrated. research has suggested that integrating methods such as cognitive remediation and social skills training could reduce such limitations. further, there has not been conducted any randomized controled trials with ips in scandinavian countries with highly developed and generous social security and welfare systems, and with high thresholds to the open labour market. the aim of this study is to investigate the effectiveness of ips in denmark and compare effects of 1. ips vs. 2. ips + cognitive remediation and work-related social skills training vs. 3. standard intervention. the intervention is based on the 7 principles of ips supported employment, and ips enhanced with cognitive remediation and work-related social skills training, consists of 24 sessions of computer based cognitive training and 24 group based sessions of cognitive coping strategies and work-related social skills training.

Eligibility criteria:
inclusion criteria: psychosis within the schizophrenic spectrum (f 2, international classification of diseases (icd 10)). severe depression (f33, icd-10) or bipolar disorder (f31, icd-10) and minimum 3 years psychiatric treatment. motivated for employment or education. 18 to 65 years old. participants must speak and understand danish. exclusion criteria: lack of informed consent above 64 years and receiving state pension match group 1 (no problems besides unemployment)

Keywords: severe mental illness vocational rehabilitation supported employment individual placement and support cognitive remediation social skill training