Kornimate/medical-research-clean huggingface dataset:
korea xeljanz post-marketing surveillance for juvenile idiopathic arthritis

Conditions: Psoriatic Arthritis, Juvenile; Polyarticular Juvenile Idiopathic Arthritis

Summary: this study is to assess the safety and effectiveness of xeljanz in juvenile idiopathic arthritis (jia) patients in routine clinical practice in korea. jia patients experience persistent joint pain, swelling and stiffness. this is a prospective observational study. xeljanz is a jak inhibitor. it was first approved in 2014 for rheumatoid arthritis patients in korea. the ministry of food and drug safety in korea mandates for a drug manufacturer to report the post-marketing surveillance after drug's approval or indication extension. this study is to see the safety and effectiveness of xeljanz in juvenile idiopathic arthritis patients in routine clinical practice in korea. this study is seeking patients who: * are 2 to less than 18 years of age; * are given xeljanz for the treatment of jia. the study sponsor will monitor patients' treatment experience for up to 44 weeks. this will help assess the safety and effects of this study medicine.


Eligibility criteria:
inclusion criteria: subjects must meet all of the following inclusion criteria to be eligible for inclusion in the study: 1. pediatric subjects aged from 2 years to less than 18 years 2. xeljanz administered according to efficacy/effectiveness on the approved labeling 3. patients who will administer xeljanz based on the medical judgement of the investigator 4. evidence of a personally signed and dated informed consent document indicating that the subject (and a legally acceptable representative) has been informed of all pertinent aspects of the study exclusion criteria: subjects meeting any of the following criteria will not be included in the study: 1) subjects who are contraindicated from taking xeljanz according to approved labeling\* \*refer to most recently approved label
effect of autologous fat grafting on acute burn wound healing

Conditions: Burns

Summary: the study evaluates the role of autologous fat grafting and the usage of nanofat in the treatment of the acute burn injuries in different genders and its influences on the healing time and hospital stay, pain control, the need and take of a split thickness skin graft and its size, and the end resulting early scarring, in comparison with control group that were treated with traditional methods, so as to find out new method of treating burn injuries and decreasing its morbidity.

as the patient is admitted, full evaluation locally ( as regard the wound itself and the areas of fat harvesting) and generally (assessment of the general condition) is done, fluid resuscitation is started as the unit protocol hand in hand with the analgesia and other medications prescribed according to the unit protocol. the patient's general condition is optimized for surgery of the fat extraction and grafting which typically should be within the first 6 days of admission. then under anesthesia (any possible type from local and regional up to general anesthesia) liposuction procedure is performed, then fat is processed then grafted at the wound site with other portion prepared as nanofat for topical use and wound coverage, then sterile dressing is applied. typically follow up is held daily with the dressing change day after another with the use of the nanofat only and sterile dressing

Eligibility criteria:
inclusion criteria: * both males and females within the age frame are candidates. * previously healthy individuals with no co-morbid conditions e.g cardiac, hepatic, diabetic, vascular or renal disease. * with tbsa of 10 to 30% affected and of deep dermal to full thickness wound depth, at any part of the body except the genitalia, perineum or the perianal region or those with inhalational injury. exclusion criteria: * other patients aged younger or older than the specified age group. * patients with co-morbid conditions. * patients with smaller or larger bsa than the specified bsa. * burns involving the genitalia, perineum or the perianal region and patients with inhalational injury.
myo-inositol on human semen parameters

Conditions: Asthenozoospermia; Oligospermia

Summary: many clinical evidences suggest that myo-inositol plays a crucial role in human reproduction. also, it was shown that myo-inositol concentration in the seminiferous tubules was higher than in serum, and interestingly it was increasing through the epididymis and the deferent duct mining that sperm cell before ejaculation are stored in a "medium" highly enriched in myo-inositol. starting from this evidences, the investigators hypothesized that myo-inositol may be a possible factor able to improve the semen parameters of samples used in in vitro fertilization cycles.

samples of seminal fluid were obtained from two groups of patients undergoing to an ivf cycle: healthy normospermic subjects and subjects with oligoasthenoteratospermia (oat, \< 15 mil/ml). semen volume, spermatozoa number and motility were evaluated during the initial semen analysis and after density gradient separation method. these parameters were evaluated before and after the administration of 4000mg/die of myo-inositol associated to 400 µg of folic acid (inofolic lolipharma rome) for three months. a third group of healthy normospermic subject were traded with 400 µg of folic acid for three months and was consider a control group.

Eligibility criteria:
inclusion criteria: undergoing to ivf cycle oat exclusion criteria: no undergoing to ivf cycle

Keywords: myo-inositol oligoasthenoteratospermia semen parameters ivf
an end-to-end system for assessment and intervention of frailty

Conditions: Frailty

Summary: the study aims to evaluate the feasibility and effectiveness of using saif (an end-to-end system for assessment and intervention of frailty) to reduce the risk and delay the progress of physical frailty.

saif is a personalised, community-based system for both assessment and intervention of frailty. it comprises of 8 modules categorised into 1. interface: virtual nurse and caregiver gateway 2. assessment: computerised screening using fried frailty phenotype (ffp) and frail instruments, gamified walking while talking to assess frailty status and predictive analytics to predict participant's frailty risk 3. intervention: physical exercise kiosks (cycling and taichi) incorporated with games, polypharmacy management and nutrition recommendation a total of 105 eligible community-dwelling older adults were recruited and randomised either to control arm or intervention arm using a single-consent zelen's design. allocation concealment was achieved using permutated block randomisation; both research assistant and participant were blinded to randomisation list during enrolment. all participants completed baseline assessment and subsequent follow-up assessments (2-month, 4-month and 7-month). additionally, participants in the intervention arm began saif interaction for a period of 4 months upon completion of their baseline assessment.

Eligibility criteria:
inclusion criteria: 1. age 60 and above 2. cfs 4 or 5 / cfs 3 with frail score at least 1 / cfs 3 with fpq score at least 1 3. ambulate for at least 10m without walking aid 4. english and/or mandarin speaking exclusion criteria: 1. known diagnosis of dementia or cmmse score \<19 2. parkinson's disease 3. hip surgery within the last 6 months 4. presence of end-stage organ failure, symptomatic heart conditions or copd 5. active arthritis 6. hospitalisation within the last 1 month 7. participants who are unable to provide consent
patient-provider tools to improve the transition to adult care in sickle cell disease

Conditions: Sickle Cell Disease

Summary: the purpose of the study is to develop patient-provider clinical support tools to improve clinical practice, patient self-management, and disease outcomes in sickle cell disease during transition to adult care. the investigators hypothesize that these clinical support tools (patient tool, provider tool, and patient/parent web-based portal) will be feasible, user friendly, and beneficial. the investigators hypothesize that participants will demonstrate better disease self-efficacy at the end of the 6 week intervention and maintain these gains during the follow-up period (up to 1 year post-intervention).

the purpose of the study is to develop patient-provider clinical support tools to improve clinical practice, patient self-management, and disease outcomes in sickle cell disease during transition to adult care.

Eligibility criteria:
inclusion criteria: * have sickle cell disease (scd) * between the ages of 13 and 24 * receive care at cincinnati children's hospital medical center, university hospital, university of cincinnati med peds practice, a practice in the ohio valley scd network, or another local provider * parent/caregiver of a patient with scd age 13-24 years exclusion criteria: * below age 13 * have significant health complication(s) that would interfere with completion of the intervention (by physician report) * have significant cognitive or developmental disabilities (by parent or physician report) due to high demand on participants to understand questions * are not a patient at cincinnati children's hospital medical center, university hospital, university of cincinnati med peds practice, a practice in the ohio valley scd network, or another local provider * are not a parent/caregiver of a patient with scd age 13-24 years

Keywords: anemia, sickle cell transition to adult care self care personal electronic health records adolescent young adult disease management physician-patient relations
cross sectional study to evaluate effects of kinesiotaping on muscle activity during climbing stairs and sport activity

Conditions: Physical Activity

Summary: this study aims to evaluate the effects of iq-tape, kinesiotaping and no taping on muscle activity during daily activity and sport activity.


Eligibility criteria:
inclusion criteria: * healthy * able to perform daily activities and sport performance exclusion criteria: * lower body and pelvic injuries * fractures of the spine oder lower limb * cardiac or neurological diseases
montreal safety and efficacy of the percutaneous transvenous mitral annuloplasty device

Conditions: Heart Failure; Mitral Regurgitation

Summary: reduction in mitral regurgitation due to safe placement of a ptma device in the coronary sinus.


Eligibility criteria:
inclusion criteria: * functional mr 2+ - 4+ with left ventricular enlargement * symptomatic heart failure * 20% - 50% lvef exclusion criteria: * mitral regurgitation of organic origins * recent cardiac interventions * severe comorbidities

Keywords: heart failure mitral regurgitation
impaired toilet training, luts and bowel dysfunction in children with dcd

Conditions: Developmental Coordination Disorder; Lower Urinary Tract Symptoms; Bowel Dysfunction

Summary: this cross-sectional case-control study aimed to determine whether there is a significant difference in the prevalence of impaired toilet training, luts, and functional bowel problems among children diagnosed with dcd and typically developing children (tdc).


Eligibility criteria:
inclusion criteria: * diagnosed with dcd by a multidisciplinary team (dcd case group) * children with a typical development, grade and gender matched with the dcd case group (tdc control group). exclusion criteria: * a dcd-q score indicative for dcd (tdc control group) * presence of other developmental disorders, such as ass, adhd or intellectual disability (tdc control group)
a study to assess the impact of sarcopenia on the outcomes of colorectal cancer patients treated with chemotherapy combined with bevacizumab

Conditions: Metastatic Colorectal Cancer

Summary: the purpose of this study is to explore the relationship between sarcopenia, as defined by computed tomography, treatment related outcomes and other body composition related parameters in a patient population receiving bevacizumab beyond progression.


Eligibility criteria:
inclusion criteria: * patients treated in first line with bevacizumab for whom it is decided, and who are clinically considered eligible, to continue the treatment with bevacizumab beyond pd1. * women of childbearing potential have to use effective contraception during (and up to 6 months after) treatment. * availability of specific retrospective data at diagnosis and during 1st line treatment exclusion criteria: * patients who are participating or participated in first line in any other interventional clinical trial involving non-standard of care procedures impacting the body composition * dementia or another mental condition making it impossible to fill out questionnaires
improving patient education for lymphoma and leukemia inpatients

Conditions: Leukemia; Lymphoma

Summary: the purpose of this study is to evaluate the impact of a structured, dvd educational intervention about what to expect during inpatient treatment of a newly diagnosed cancer. the focus of the study will be newly diagnosed lymphoma and acute leukemia patients and their family members. outcome variables will be the patient and family member's satisfaction with inpatient teaching and anxiety about inpatient treatment.

the purpose of this study is to evaluate the impact of a structured, dvd educational intervention about what to expect during inpatient treatment of a newly diagnosed cancer. the focus of the study will be newly diagnosed lymphoma and acute leukemia patients and their family members. outcome variables will be the patient and family member's satisfaction with inpatient teaching and anxiety about inpatient treatment. the experimental group will watch a dvd educational presentation of information about unit routines and activities; leukemia/lymphoma; treatment modalities and procedures; treatment of side effects; and patient and family members activities of importance to prevent infection and promote well-being during cancer treatment. participants in the control group will receive usual educational teaching by their assigned nursing staff.

Eligibility criteria:
inclusion criteria: for participants admitted for suspect diagnosis of leukemia or lymphoma: * admission to the hematology/leukemia unit (6e) at emory university hospital with a suspected or actual new diagnosis of leukemia or lymphoma within the past 24 hours * english-speaking * completed education to at least the 6th grade level * no significant auditory or visual deficits with corrective devices * no central nervous system involvement of disease * physiologically stable * not at end of life * no alterations in mental status * agrees to family member (family member; significant other; friend) participation in study and to selecting the individual who could participate for family members: * willing to view dvd and read education booklet * selected by patient to participate * english speaking * no significant auditory or visual deficits with corrective devices * no alterations in mental status * completed education to at least the 6th grade level exclusion criteria: * at end of life * altered mental status * significant auditory or visual deficits with corrective devices
mobilization of stem cells with amd3100 (plerixafor) in non-hodgkin's lymphoma patients

Conditions: Lymphoma, Non-Hodgkin

Summary: the purpose of this study is to determine whether the combination of amd3100 (plerixafor) and granulocyte colony-stimulating factor (g-csf or generic name filgrastim) is better than g-csf alone to mobilize and collect the optimal number of stem cells in non-hodgkin's lymphoma patients for autologous transplantation.

a peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. currently filgrastim (g-csf), a colony stimulating factor, is used to cause the growth and mobilization of stem cells from bone marrow to peripheral blood, which can then be collected from the peripheral blood by a process called apheresis. plerixafor aids in the release of the stem cells from the bone marrow into the peripheral blood, possibly allowing for a more rapid collection of a larger number of stem cells from the peripheral blood. larger stem cell doses for transplantation correlate to faster recovery times after high dose chemotherapy followed with stem cell transplantation. this study is intended to determine whether the combination of plerixafor with filgrastim is better than filgrastim alone in helping non-hodgkin's lymphoma patients collect at least 5 million stem cells in four or less apheresis sessions. this study was previously posted by anormed, inc. in november 2006, anormed, inc. was acquired by genzyme corporation. genzyme corporation is the sponsor of the trial.

Eligibility criteria:
inclusion criteria (abbreviated list): * non-hodgkin's lymphoma in first or second complete or partial remission * eastern cooperative oncology group (ecog) performance status of 0 or 1 * white blood cell count (wbc) \> 2.5\*10\^9/l * platelet (plt) \> 100\*10\^9/l exclusion criteria (abbreviated list): * failed previous stem cell collection * prior autologous or allogeneic transplant * brain metastases or bone marrow involvement \> 20% * radiation to pelvis * abnormal electrocardiogram (ecg) with rhythm disturbance (ventricular arrhythmias) or other conduction abnormality

Keywords: non-hodgkin's lymphoma stem cell mobilization
effect of supplemental vitamin d on skeletal muscle function in chronic obstructive pulmonary disease (copd) patients

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: the purpose of this study is to determine whether or not vitamin d supplementation can improve physical performance in persons with severe chronic obstructive pulmonary disease (copd).


Eligibility criteria:
inclusion criteria: * copd * forced expiratory volume in one second (fev1) \< or = 50% of predicted * smoking history of at least 10 pack-years * able to ambulate independently or with the use of an ambulatory assist device (such as a cane or walker) exclusion criteria: * currently taking \> 500 i.u. per day of vitamin d supplements * primary diagnosis of asthma * uncompensated heart failure * heart attack in the previous 6 months * kidney disease (glomerular filtration rate \< 45 ml/min/1.73m2)

Keywords: chronic obstructive pulmonary disease vitamin d cholecalciferol skeletal muscle
axillary radiotherapy for early stage breast cancer with limited positive sentinel lymph nodes

Conditions: Breast Cancer

Summary: this study is designed to evaluate the feasibility and safety of axillary radiotherapy for early stage breast cancer with limited positive sentinel lymph nodes.

randomized clinical trials have demonstrated that complete axillary lymph node dissection is not necessary in patients with 1-2 positive sentinel lymph nodes who undergo breast conserving surgery, whole breast irradiation, and systemic therapy. however, whether or not the regional lymph node should be irradiated and if radiation given, whether or not all levels of axillary lymph node and internal mammary and supraclavicular lymph node should be irradiated is unknown. the purpose of this study is to evaluate the feasibility and safety of axillary level i-ii areas radiotherapy for early stage breast cancer with 1-2 positive sentinel lymph nodes and no further axillary lymph node dissection.

Eligibility criteria:
inclusion criteria: * female * 18\~70 years old * pathologically confirmed invasive breast cancer * a clinical t1-2n0m0 tumor * treated with breast conserving surgery and sentinel lymph node biopsy * 1\~2 positive sentinel lymph nodes, including micro-metastases or macro-metastases. * ecog score 1\~2 * written informed consent exclusion criteria: * patients underwent complete axillary lymph node dissection * patients underwent mastectomy * patients underwent neoadjuvant therapy * clinically node positive pre-operative * sentinel lymph nodes only containing isolated tumour cells (\<0.2 mm) * prior history of invasive breast cancer or previous or concurrent other malignancies within the past 5 years * previous radiation therapy of breast or thorax * medical contraindication for radiotherapy * prior axillary surgery or radiotherapy * unable or unwilling to receive breast conserving surgery or sentinel lymph node biopsy * pregnant or nursing

Keywords: breast cancer positive sentinel lymph nodes axillary radiotherapy
implementation of minimally invasive surgery for grade iii hemorrhoids

Conditions: Hemorrhoidectomy; Minimal Invasive Surgery

Summary: hemorrhoids are vascular-elastic structures of the anal canal that contribute to continence. their enlargement and descent lead to symptoms such as rectal bleeding and the sensation of anal swelling, known as hemorrhoidal syndrome. in advanced cases (goligher grade iii-iv), surgery is the only effective treatment. open excisional hemorrhoidectomy (oeh), based on the milligan-morgan technique, is the standard procedure. although effective in the long term, it causes severe postoperative pain. minimally invasive surgery (mis) employs enhanced visualization devices to improve surgical precision and reduce tissue damage. while widely used in specialties with small surgical fields, it has not yet been explored in anal surgery. its advantages include reduced tissue injury and improved healing, although it presents a learning curve and an initially longer surgical time. the ideal framework evaluates surgical innovations in five stages: idea, development, exploration, evaluation, and long-term study. in stage 1, the first application in humans is documented, analyzing outcomes and feasibility. since no previous studies on the application of mis in oeh have been found, the investigators propose a study within stage 1 of the ideal model to assess the feasibility of this technique. the investigators believe its incorporation into open excisional hemorrhoidectomy could result in less postoperative pain and faster patient recovery.


Eligibility criteria:
inclusion criteria * age over 18 years * grade iii hemorrhoids * bmi below 30 * indication for oeh surgery * signed written informed consent exclusion criteria * acute hemorrhoidal disease (thrombosis) * previous hemorrhoid surgery * coexistence of anal fissure * coexistence of perianal fistula * coexistence of rectal or anal prolapse * active inflammatory bowel disease * active anal or colorectal cancer * language barrier or difficulty in oral and/or written comprehension

Keywords: hemorrhoids grade iii-iv hemorrhoidectomy minimal invasive surgery ideal stage 1