Kornimate/medical-research-clean huggingface dataset:
study of htd4010 in healthy volunteers

Conditions: Type 2 Diabetes Mellitus

Summary: to investigate safety and tolerability of htd4010 after single ascending doses (sad) in healthy volunteers

safety, tolerability and pharmacokinetics(pk) assessments are the outcome measure.

Eligibility criteria:
for volunteers in sad: inclusion criteria: 1. body mass index (bmi) ≥18.0 to ≤ 30.0 kg/m2 2. non-diabetic, fasting plasma glucose \< 5.6 mmol/l 3. females must be non-pregnant and non-lactating, and either surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or post-menopausal for ≥12 months. males must be surgically sterile, abstinent or if engaged in sexual relations of child-bearing potential, the participant and his partner must be using an acceptable, highly effective, contraceptive method from screening and for a period of 60 days after the last dose of study drug. 4. ability to provide written informed consent. exclusion criteria: 1. systolic blood pressure \>160 mmhg and/or diastolic blood pressure \>90 mmhg at screening. 2. pregnant or lactating women 3. participation in an investigational study within 30 days prior to dosing or 5 half-lives within the last dose of investigational product whichever is longer. 4. current use of any prescription or over-the-counter (otc) medications, including herbal products and supplements, within 14 days prior to day 1 or 5 half-lives, whichever is longer. use of ≤2g paracetamol per day is allowed prior to and during the study at investigator discretion. 5. any use of non-steroid anti-inflammatory drugs (nsaids) within 7 days prior to dosing. 6. history of any major surgery within 6 months prior to screening 7. history of any serious adverse reaction or hypersensitivity to any of the product components. 8. use of parenterally administered proteins or antibodies within 12 weeks of screening. etc.
investigation of pain incidence after fk506 immunosuppressive therapy in liver transplantation patients

Conditions: Chronic Pain; Liver Transplantation

Summary: fk506 (tacrolimus), a calcineurin inhibitor, is widely used as an immunosuppressant to lower the risk of organ rejection after organ transplantation, and to treat t cell-mediated diseases such as eczema and atopic dermatitis. fk506 treatment often accompanies pain sensation in patients with atopic dermatitis or after organ transplantation. in previous studies, the investigators confirmed that fk506 treatment increased neuronal activity of primary afferent neurons and causes pain behavior in naïve mice. in order to further search for objective clinical evidence, the investigators proposed to investigate pain incidence after fk506 immunosuppressive therapy in liver transplantation patients. the investigators will investigate pain incidence and pain intensity in patients who underwent liver transplant from september of 2011 to may of 2018 in the liver health rehabilitation association. the patients who were divided into two groups based on whether or not fk506 was used in the immunosuppressive therapy. the patients in control group (without fk506 treatment) and fk506-treated group report pain sensation 3 months and 12 months after liver transplant. the investigators will compare the pain incidence between the two groups at both time points. on the other hand, the investigators will further investigate changes in pain sensation after 1st and 2nd reductions of fk506 dose. pain is reported subjectively by the patient using the visual analogue scale (vas) 1 month after dose reduction. in our study, 1st and 2nd reductions of fk506 dose refers to the first two dose-adjustments (approximately 6 months apart) that occurred 3-6 months after the liver transplantation.


Eligibility criteria:
inclusion criteria: 1. had liver transplantation for end-stage liver disease 2. was ≥18 years of age at the time of liver transplantation - exclusion criteria: 1. liver cancer 2. acute (fulminant) liver failure 3. multiorgan transplant 4. chronic postsurgical pain 5. fibromyalgia, osteoarthritis, low back pain and inflammatory pain of any origin 6. peripheral and central neuropathic pain of any origin 7. chronic secondary visceral pain 8. chronic cancer-related pain that is due to cancer or its treatment -

Keywords: chronic pain liver transplantation fk506
maternal scent and preterm infant nutrition

Conditions: Behavior, Infant; Development, Infant; Development, Child

Summary: to study the effect of maternal scent on the oral feeding, behavior and stress level of premature infants hospitalized in the neonatal intensive care unit and to assess its potential effect on their development at 18 to 24 months.

premature infants develop their sense of smell very early in the womb. after birth infants can recognize and distinguish the odor of their mother from their father and others. premature infants are capable of smelling and they experience less pain and agitation when they smell their mother's milk; studies have shown that premature infants have better sucking and feeding, and they may go home earlier when they are exposed to the odor of breast milk. it is not known whether the same will happen if preterm infants are exposed to their mother's smell rather than the smell of the maternal milk.

Eligibility criteria:
inclusion criteria: * mother of a baby who was born premature before completing 36 weeks of pregnancy * baby between ages of 5-10 days * medically stable baby * baby already began feeding by mouth or by feeding tube exclusion criteria: * medically unstable baby born after 36 weeks of gestation.

Keywords: maternal scent infant behavior feeding patterns stress levels
total arterial revascularization (tar)

Conditions: Coronary Artery Disease; Coronary Artery Bypass Grafting

Summary: total arterial revascularisation with in-situ confihuration of bita is superior than y-graft in patients underwent cabg.

the main hypothesis of the trial is that in-situ configuration of bilateral internal thoracic arteries is superior than y-graft configuration for macce (mortality, myocardial infarction, repeat revascularization, stroke) during mid-term follow-up in patients with cad who is shedueled for cabg.

Eligibility criteria:
inclusion criteria: * coronary artery disease * stable angina * the need for revascularization of anterior descending and obtuse margin arteries accoring to the 2018 esc/eacts guidelines on myocardial revascularization * informed consent form exclusion criteria: * the diameter of the target arteries is less than 1 mm * stenosis of the subclavian arteries more than 60% * stemi less than 3 month * previous cardiac surgery * bmi \>35 * copd with fev1 \<60% * concomitant pathology that requires simultaneous surgical treatment * cancer with life expectancy less than 5 years

Keywords: total arterial revascularization y-graft in-situ coronary artery bypass grafting
genetic load and phenotype in aggressive amd

Conditions: Age-related Macular Degeneration

Summary: patients with amd will provide cheek cell samples to determine if their is a correlation between genotype (dna markers) and phenotype (the type of amd the patient has).

this study seeks to test individuals who have already progressed to various forms of amd to evaluate correlations between genetic markers and particular features of amd including geographic atrophy and pigment epithelial detachments. we hypothesize that patients with more aggressive forms of amd will have a higher genetic burden contributed by markers in arms 2, complement factor h (cfh), complement component 3 (c3), complement component 2 (c2) , factor b (fb), or other genetic polymorphisms associated with cnv.

Eligibility criteria:
inclusion criteria: * subject is male or female 50 years of age and older * subject provides a signed and dated informed consent * subject agrees to provide two buccal swabs in accordance with this protocol * diagnosis of cnv secondary to amd in at least one eye exclusion criteria: * previous sample donation under this protocol * presence of retinal disease involving the photoreceptors and/or outer retinal layers other than amd loss such as high myopia, retinal dystrophies, central serous retinopathy, vein occlusion, diabetic retinopathy and uveitis or similar outer retinal diseases which have been present prior to the age of 50. * opacities of the ocular media, limitations of pupillary dilation or other problems sufficient to preclude adequate imaging of the posterior segment.

Keywords: age-related macular degeneration amd
wheatgrass juice / lifestyle recommendations / cancer patients' quality of life / chemotherapy treatment

Conditions: Fatigue

Summary: this study is aimed to study the impact of wheatgrass juice and lifestyle recommendations (diet, physical activity and breathing exercises) on the well being, fatigue and hematological parameters of chemotherapy-naive patients with no evidence for symptoms of active oncological disease.the researchers hypothesize that both wheatgrass juice and lifestyle recommendations can improve patient's well-being during chemotherapy.

chemotherapy-naive patients will be offered to participate in a two arms study. following consent, patients will be randomized to one of two arms. patients in both arms will be provided by booklet and audio-cassette that specify lifestyle recommendations (diet, physical activity and breathing exercises). patients in one of the study arms will be provided in addition with frozen wheatgrass juice (recommended daily dosage of 55-110 cc daily). patients in both arms will be asked to fill in a daily patient's diary monitoring the practice of the lifestyle recommendations. baseline assessment will include the following questionnaires: esas, mycaw, facit- fatigue. evaluation will include weekly esas and facit-fatigue questionnaire and subsequent evaluation (including esas, mycaw, facit- fatigue questionnaires) following 3 and 4 chemotherapy cycles of treatment. follow-up evaluation will be performed at the completion of chemotherapy.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of cancer with no sign of active disease * first-time treatment with chemotherapy exclusion criteria: * treatment with per os administration of chemotherapy

Keywords: fatigue quality of life lifestyle complementary medicine
efficacy and safety of sorafenib as adjuvant and latter radiofrequency ablation for recurrent hepatocellular carcinoma

Conditions: HCC

Summary: radiofrequency ablation is a popular treatment for recurrent hepatocellular carcinoma (hcc),but still has a higher recurrence. sorafenib as neo-adjuvant therapy in combination of rfa was not reported yet. there's a theoretical advantage of this combination. hence in this study the efficacy and safety of pre-administrative sorafenib and latter radiofrequency ablation (rfa) in recurrent hcc will be tested in a multicenter prospective cohort study.

radiofrequency ablation is a popular treatment for recurrent hepatocellular carcinoma (hcc),but still has a higher recurrence. sorafenib as neo-adjuvant therapy in combination of rfa was not reported yet. there's a theoretical advantage of this combination. hence in this study the efficacy and safety of pre-administrative sorafenib and latter radiofrequency ablation (rfa) in recurrent hcc will be tested in a multicenter prospective cohort study. eligible cases will be assigned into the experimental group and the control group. for experiment group, sorafenib tablet will be given for two weeks, and then perform radiofrequency ablation. for the control group, rfa will be performed immediately.

Eligibility criteria:
inclusion criteria: * aged from 18 to 75 years old * without gender restriction * with a favorable liver function of child-pugh a to b * no contraindications to rfa and anesthesia * diagnosed with recurrent hcc * signed informed consent. exclusion criteria: * cancer thrombosis in major vessels/ extrahepatic metastasis * uncontrollable ascites or variceal bleeding * impairment in liver function * severe disorders in vital organ * accompanied with other tumors or infectious disease except hepatitis.
the medacta gmk spherika post-marketing surveillance study

Conditions: Arthropathy; Knee Replacement

Summary: this is a post-marketing surveillance of gmk spherika knee stem prosthesis.

the aim of the current study is to collect clinical and radiological data to monitor the performances of the "gmk® spherika" knee prosthesis implanted via the kinematic alignment technique.

Eligibility criteria:
inclusion criteria: * patients willing to sign the informed consent. * patients able to comply with follow-up requirements, including postoperative weight-bearing restrictions and self-evaluations. * patients 18 - 80 years of age at the time of surgery. * patients requiring a primary total knee replacement (on label use). * patients with intact collateral ligaments. exclusion criteria: * patients with inflammatory arthritis. * morbidly obese patients, with a body mass index (bmi) \> 40. * patients with a history of total or unicompartmental reconstruction of the affected joint. * patients that have had a high tibial osteotomy or femoral osteotomy. * patients with neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device. * patients with a systemic or metabolic disorder leading to progressive bone deterioration. * patients that are immunologically compromised or receiving chronic steroids (\> 30 days). * patients whose bone stock is compromised due to disease or infection, unable to provide adequate support and/or fixation to the prosthesis. * patients with an active or suspected latent infection in or surrounding the knee joint. * pregnant or breastfeeding women.
the effect of ibd flares on serum psa

Conditions: Inflammatory Bowel Diseases; Prostate Cancer

Summary: this study will measure prostate specific antigen (psa) values in men with inflammatory bowel disease (ibd) before, during, and following a flare. in addition, the effect of any psa increase will be analyzed and correlated to the location of disease (rectal vs. other). study findings may help men with ibd by identifying pitfalls in prostate cancer screening for this population and help to stratify and understand the effect ibd has on the prostatic milieu. by optimizing how men with ibd are screened for prostate cancer, future unnecessary healthcare encounters and expenditures may be reduced for this patient group.

over one million adults in the u.s. are estimated to suffer from inflammatory bowel disease (ibd), accounting for more than 2 million ambulatory and emergency room visits annually. this healthcare utilization may lead to an average increase of $5,000-$8,000 in annual medical expenditure per patient. reducing unnecessary medical interactions and expenditures in this patient group is paramount and requires individualized disease monitoring and healthcare screening one screening test that may lead to additional exams and costs is the prostate specific antigen (psa) test used to screen for prostate cancer. while psa screening can reduce prostate cancer mortality, false-positive elevations are common, especially in the setting of non-malignant prostate inflammation. this research group recently reported in a large retrospective case-control series that after age 65, men with ibd who underwent prostate cancer screening at northwestern memorial hospital (nmh) had higher serum psa values than non-ibd controls. in addition, men with ibd had a significantly higher risk of clinically significant prostate cancer even when controlling for differences in psa and other relevant covariates. however, whether the elevation in psa is related to inflammation in these men with ibd versus a true reflection of an increased risk of prostate cancer is unclear. furthermore, the interplay of ibd status and screening psa values is currently unknown. this study will measure psa values in men with ibd before, during, and following a flare. in addition, the effect of any psa increase will be analyzed and correlated to the location of disease (rectal vs. other). study findings may help men with ibd by identifying pitfalls in prostate cancer screening for this population and help to stratify and understand the effect ibd has on the prostatic milieu. by optimizing how men with ibd are screened for prostate cancer, future unnecessary healthcare encounters and expenditures may be reduced for this patient group.

Eligibility criteria:
inclusion criteria: * men, ages 40-69 years old * confirmed diagnosis of ibd presenting to the northwestern memorial hospital gastroenterology clinic exclusion criteria: * history of prostate cancer or prior prostate procedures (biopsies or transurethral resection)

Keywords: prostate specific antigen ibd psa
an observational study of mabthera/rituxan (rituximab) and alternative tnf-inhibitors in patients with rheumatoid arthritis and an inadequate response to a single previous tnf-inhibitor

Conditions: Rheumatoid Arthritis

Summary: this multicenter, prospective, observational study will assess the efficacy of mabthera/rituxan (rituximab) and alternative tnf-inhibitors in patients with rheumatoid arthritis who are non-responders or intolerant to a single previous tnf-inhibitor. data will be collected from each patient from the time of change in biologic therapy for 12 months.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * patients with rheumatoid arthritis (ra) who have not responded or have been intolerant to a single tnf-inhibitor therapy * initiated on treatment with mabthera/rituxan or an alternative tnf-inhibitor therapy, in accordance with the relevant summary of product characteristics exclusion criteria: * patients whose second biologic therapy is given as part of a clinical trial studying ra treatment
heart rate variability (hrv) in pituitary adenoma

Conditions: Pituitary Adenoma

Summary: several studies have been reported that heart rate is known to be associated with prognosis in chronic diseases and acute diseases. for example, a decrease in heart rate following myocardial infarction may lead to a higher mortality rate. it is also known to predict heart failure, diabetic neuropathy, and even depression. the combined pituitary function test artificially induces hypoglycemia to observe the secretion of pituitary hormone. the degree of change in heart rate during hypoglycemia can predict the adequacy of the test, and heart rate can be changed according to the characteristic of the tumor. also, the prognosis can be predicted based on this. in our study, we used a licensed device approved by kfda (korea food and drug administration) to measure heart rate variability in patients with pituitary adenoma.


Eligibility criteria:
inclusion criteria: * over 19 year old * those with normal blood pressure range: 90mmhg \<systolic \<140mmhg, 60mmhg \<diastolic \<100mmhg * voluntary participants who visited seoul st. mary's hospital exclusion criteria: * those who have been diagnosed with sleep disorders, diabetes, arrhythmia, psychiatric disorder, physical or mental breakdown, drug addicts * diabetes, hypertension, cardiovascular disease diagnosed by taking a drug related to the disease * pregnant or lactating women * those who drank within 12 hours before participating in the trial * those who are deemed inappropriate by clinical trial researchers
effects of aerobic cycling training in patients with gynecologic cancer-related lower extremity lymphedema

Conditions: Lymphedema; Lymphedema, Lower Limb; Gynecologic Cancer

Summary: comparison of complete decongestive treatment and complete decongestive treatment + cycling ergometry treatment in patients with gynecologic cancer-related lower extremity lymphedema in terms of quality of life, lower extremity functionality and lower extremity volume measurement

after being informed about study and potential risks, all patients giving written informed consent will undergo screening period determine eligibility for study entry. the patients who met the eligibility recruitments will get into the assessment. the study will include 63 participants (31 controls and 32 interventions). simple randomization will be preferred in this study. the coin toss method will be used for simple randomization. researcher will record demographic and clinical data of the patients and will evaluate the patients' pre-treatment volumes by circumference measurement method. researcher will evaluate quality of life by lymphedema quality of life questionnaire (lymqol) and lower extremity functionality by lower extremity functional scale (lefs). while the patients in non-cycling group will get only complete decongestive treatment (cdt) for 3 weeks, the patients in cycling group will get cdt+cycling ergometry treatment for 3 weeks.cycling ergometry treatment will be performed with voit at-200 black collection horizontal bike for 20 minutes. exercise intensity will be adjusted to %40-59 of heart rate reserve (hrr). at the end of treatment; researcher will evaluate volume, functionality and quality of life of the patients again and will compare the two groups in terms of volume measurement, functionality and quality of life.

Eligibility criteria:
inclusion criteria: * being cognitively competent * chemotherapy radiotherapy etc. treatment has been completed and there is no oncological risk * signing written informed consent to participate in the study exclusion criteria: * cardiac failure * uncontrolled hypertension * having kidney failure * having a systemic infection * local infection such as erysipelas and cellulitis in the lower extremities * venous insufficiency (dvt etc.) * presence of any neuromuscular disease affecting the lower extremities * having lipolymphedema * fracture in the lower extremity * having active metastasis * having a language problem * being pregnant * being unable to continue treatment

Keywords: aerobic training cycling ergometry gynecological cancer lymphedema
study of trm-1 (trail-r1 monoclonal antibody) in subjects with relapsed or refractory non-hodgkin's lymphoma (nhl)

Conditions: Lymphoma, Non-Hodgkin

Summary: the purpose of this study is to evaluate the safety, efficacy and exposure to trm-1 in subjects with relapsed or refractory non-hodgkin's lymphoma (nhl).


Eligibility criteria:
primary inclusion criteria: * relapsed or refractory histologically confirmed non-hodgkin's lymphoma * previously treated with at least 1 therapeutic regimen and relapsed or progressed or failed to achieve a response after the last regimen * 18 years of age or older primary exclusion criteria: * received a non-fda approved investigational agent within the last 4 weeks * received cancer therapies (chemotherapy, biological therapy \[including hormonotherapy\], radiation therapy or immunosuppressants within the last 3 weeks, 8 weeks for monoclonal antibodies, radioimmunotherapy or nitrosourea * eligible for a hematopoietic stem cell transplant (hsct) or have had an autologous hsct within the last 16 weeks * prior history of an allogeneic hsct * hiv, aids-related lymphoma, central nervous system (cns) lymphoma, hepatitis-b or hepatitis-c * infection requiring antibiotics within the last 4 weeks * major surgery within the last 4 weeks * pregnant or breast-feeding women * history of other cancers within the past 5 years