Kornimate/medical-research-clean huggingface dataset:
exercise and motor learning after stroke (study #3)

Conditions: Stroke

Summary: subjects with chronic stroke (\> 6 months post-stroke) will learn a new walking pattern through distorted visual feedback. retention of the pattern will be tested without visual feedback immediately after learning and 24 hours later. subjects will be randomly assigned to the control group or the exercise group. the control group will simply complete the learning task. the exercise group will complete 5 minutes of exercise immediately following the first retention test to test for the effects of exercise on retention 24 hours later.

despite significant time and money spent on post-stroke rehabilitation, stroke survivors are left with reduced walking capacity and significant disability. after stroke, individuals must relearn movements that have been disrupted due to damage to the brain, therefore, enhancing motor learning is critical to improving the rehabilitation of walking after stroke. in this project investigators will examine how individual factors influence motor learning after stroke and use this information to personalize post-stroke rehabilitation.

Eligibility criteria:
inclusion criteria: age 18-85 single, unilateral, chronic stroke (\>6 months post-stroke), confirmed by mri or ct scan score \>1 on question 1b and \>0 on question 1c of the nih stroke scale able to walk at self-selected speed without assistance from another person resting heart rate between 40-100 beats per minute resting blood pressure between 90/60 to 185/100 exclusion criteria: evidence of cerebellar stroke on clinical mri or ct scan, because of role of cerebellum in learning other neurologic conditions in addition to stroke inability to walk outside the home prior to the stroke coronary artery bypass graft or myocardial infarction within past 3 months, musculoskeletal pain that limits walking inability to communicate with investigators visual field cut neglect unexplained dizziness in last 6 months
a study to evaluate the effect of thymoglobulin and reduced doses of steroids to prevent renal transplant rejection

Conditions: Renal Transplantation; Graft Rejection

Summary: this study involves the use of a drug called thymoglobulin, which is approved in the us to treat kidney transplant rejection and in canada to treat and to prevent kidney transplant rejection. this study will evaluate the effect of thymoglobulin and reduced doses of steroids to prevent renal transplant rejection and will provide a basis for future evaluations of thymoglobulin as an immunosuppressive agent to help prevent renal transplant rejection. subjects meeting all inclusion and exclusion criteria are eligible to participate in this study. in addition to standard treatment, study participants will receive either thymoglobulin with rapid discontinuation of steroids or steroids per hospital standards for at least the first 90 days after transplant. the treatment assignment is random and is not chosen by the subject or their physician. subjects will be monitored during treatment with thymoglobulin and during the transplant hospitalization. additional subject monitoring occurs at months 1, 3, 6 and 12 following the transplant. approximately 150 study subjects from 15-20 transplant centers in the united states will be enrolled.


Eligibility criteria:
inclusion criteria: * adult living donor renal transplant recipient * age greater than or equal to 18 * if female and of childbearing potential: a) must not be lactating; b) must have a negative serum b-human chorionic gonadotropin (hcg) test within 24 hours prior to study day 0 (day of transplant) and; c) must agree to practice an acceptable and reliable form of contraception during the study; and * signed informed consent exclusion criteria: * human leukocyte antibody (hla) identical matched living donor transplant recipient * \> 2 previous transplants * current panel reactive antibody (pra) \> 20% * history of a positive cross-match with the donor * active donor or recipient serology positive for human immunodeficiency virus (hiv), hepatitis b virus (hbv) or hepatitis c virus (hcv) * loss of first kidney transplant in \< 1 year * history of noncompliance in clinical trial(s) * history of chronic cs or immunosuppressive use except for inhaled cs to treat asthma * use of any investigational products during the 90 days prior to screening * requirement for multiple organ transplant * patient without a functioning urinary bladder prior to transplant (e.g. patients with self catheterization will be excluded) * known contraindication to administration of rabbit antithymocyte globulin * currently abusing drugs or alcohol * in the opinion of the investigator, at high risk for poor compliance * in the opinion of the investigator, has a significant medical or psychosocial problem or unstable disease state that warrants exclusion from the study. examples of significant problems include, but are not limited to morbid obesity and severe cardiac disease.

Keywords: anti-t cell antibodies living donor renal transplantation acute renal allograft rejection induction therapy with reduction of calcineurin inhibitors
the effect of reco-18 on infertile women undergoing in vitro fertilization-embryo transfer

Conditions: Fertility Disorders; Infertility, Female

Summary: how to improve the fertility of infertile women has become a hot topic in the field of assisted reproduction. animal experiment has shown that reco-18 significantly improved the female fertility in mice, and the specific mechanism was related to reducing follicular atresia, promoting follicle development and improving oocyte quality. therefore the investigators aim to conduct a pilot study to explore the effect of reco-18 in infertile women undergoing assisted reproduction treatment. this study is a prospective, randomized, controlled clinical study. the treatment group takes reco-18 while the control group takes the multi-vitamins. the primary indicator is the ongoing pregnancy rate at 12 weeks' gestation; the secondary indicators are the number of oocytes retrieved, the normal fertilization rate and the rate of high quality embryos, implantation rate, clinical pregnancy rate, and early miscarriage rate.

mitochondrial function is closely related to oocyte quality in female. deficiency of multiple micronutrients is common in infertile women, and supplementation with multiple micronutrients has antioxidant effects to reduce the damage of oxidative stress to fertility, and helps to improve the outcomes of assisted reproductive treatment. reco-18 is a functional food containing a variety of plant extracts and enzymatic soy phospholipids. in in vivo and in vitro senescent models, the investigators found reco-18 to improve oocyte quality mainly by regulating the mitochondrial apoptosis pathway. the investigators also found reco-18 significantly improved the fertility of mice, and the specific mechanism was related to reducing follicular atresia, promoting follicle development and improving oocyte quality. based on the animal experiments, the investigators intend to conduct a clinical trial to explore whether reco-18 plays a role in improving oocyte and embryo quality and pregnancy outcomes in infertile women undergoing in vitro fertilization-embryo transfer.

Eligibility criteria:
inclusion criteria: * female, 20 to 40 years old * the 1st or 2nd cycle of ivf/icsi treatment * bmi≤30kg/m2 * with bilateral ovaries * be eligible for ivf/icsi treatment exclusion criteria: * repeated implantation failures (with previous 3 or more ivf/icsi failures) * moderate to severe endometriosis * untreated hydrosalpinx * untreated endometrial disease * contraindications for assisted reproductive techniques or gestation * a history of ovarian surgery * expected poor ovarian response (por) or previous por * polycystic ovarian syndrome * participants in clinical trials of other drugs within one month prior to enrollment; • hypersensitivity to follicle-stimulating hormone α, fsh, human menopausal gonadotropin, lh or excipients * uncontrolled endocrine diseases (such as hyperthyroidism, hypothyroidism, adrenal gland disease, obesity, etc.) * percutaneous epididymal sperm aspiration or testicular sperm aspiration

Keywords: pregnancy rate in vitro fertilization-embryo transfer
study of c-til052a cell therapy in advanced cervical cancer

Conditions: Cervical Cancer

Summary: a study that aimed to assess the safety and anti-tumor activity of c-til052a cell therapy in subjects with persistent, recurrent and/or metastatic cervical cancer.

for patients with advanced cervical cancer who have failed the standard treatment, no recognized alternative follow-up treatment regimens are available and the prognosis is poor. the study is a single center phase i trial planning to assess the safety, tolerability and the preliminary anti-tumor activity of c-til052a cell therapy in persistent, recurrent and/or metastatic cervical cancer. eligible subjects will receive injection of c-til052a (autologous tumor infiltrating lymphocytes, til) and interleukin 2 (il-2) after lymphodepletion. all subjects will be followed up post treatment for safety and efficacy monitoring and the follow-up period will be 12 months or through study completion.

Eligibility criteria:
inclusion criteria: 1. aged 18 to 70 years at screening 2. voluntary participation and able to sign the informed consent form 3. patients with histologically confirmed persistent, recurrent and/or metastatic cervical cancer who failed the standard treatment. 4. has access to tumor tissue and can isolate ≥1.0g of tumor tissue mass for the preparation of autologous tumor infiltrating lymphocytes 5. at least one measurable target lesion (per recist v1.1) 6. ecog performance status score: 0\~1 7. expected survival ≥ 3 months 8. negative serum or urine pregnancy test results for females of child-bearing age at screening exclusion criteria: 1. uncontrolled cns disease, severe cerebrovascular disease or obvious neurological symptoms (including mental disease) 2. symptomic chronic obstructive pulmonary disease or persistent asthma 3. uncontrolled cardiovascular diseases 4. history of primary immune deficiency, autoimmune disease or chronic inflammatory disease 5. high-risk subjects with rapid tumor progression as judged by the investigator(s) 6. complicated with infectious diseases, such as hepatitis b/c, syphilis, aids 7. history of organ transplantation or allogeneic cell therapy 8. any situation judged by the investigator(s) that will have safety concern or interfere with the study results

Keywords: gynecological tumor tumor infiltrating lymphocytes
fluid overload in peritoneal dialysis

Conditions: End Stage Renal Disease

Summary: the objective of this study is to determine the effectiveness of treating peritoneal dialysis (pd) patients with fluid overload by a structured nurse-lead intervention protocol. we plan to recruit 100 pd patients with fluid overload. these patients will be assessed and managed by a renal nurse specialist in the ambulatory renal center according to a standardized protocol. the improvement in the degree of overhydration will be determined by bioimpedance spectroscopy 4 and 12 weeks after treatment.

fluid overload is a common problem in peritoneal dialysis (pd) patients and it is associated with left ventricular hypertrophy and other adverse cardiac consequences. fluid management is therefore an important aspect in the management of dialysis patient. in hong kong, pd patients with common medical problems related to dialysis are assessed and managed in the renal nurse clinic by pre-approved intervention protocols. although it is the general impression that management of pd patients with fluid overload by a nurse-lead intervention protocol is robust and could reduce the work load of medical staff, the efficacy of this approach remains undetermined. the objective of this study is to determine the effectiveness of treating pd patients with fluid overload by a structured nurse-lead intervention protocol. we plan to recruit 100 pd patients with fluid overload, which is defined as overhydration (oh) ≥ 2 litres as measured by bioimpedance spectroscopy. these patients will be assessed and managed by a renal nurse specialist in the ambulatory renal center according to a standardized protocol previously approved by the hospital authority. the improvement in the degree of overhydration will be determined by bioimpedance spectroscopy 4 and 12 weeks after treatment. change in body weight, blood pressure, degree of oedema, as well as the knowledge on salt and fluid restriction will also be assessed.

Eligibility criteria:
inclusion criteria: * pd patients with overhydration (oh) ≥ 2 litres as measured by bioimpedance spectroscopy exclusion criteria: * overt pulmonary edema and required urgent medical care * cognitive impairment or problem of communication * unlikely to survive for more than three months * mechanical problems of the dialysis catheter * active peritonitis or peritoneal failure
perioperative opioid-induced hyperalgesia and its prevention with ketamine and methadone

Conditions: Post Operative Pain; Hyperalgesia

Summary: background: in perioperative period inhibition of n-methyl-d-aspartate receptor prevents opioid-induced hyperalgesia and reduce postoperative opioid requirement after abdominal surgery. methadone is both a µ-opioid receptor agonist like morphine and a n-methyl-d-aspartate antagonist. study aim. to evaluate the efficacy of intraoperative ketamine and postoperative methadone analgesia in preventing opioid-induced hyperalgesia after abdominal surgery.

not desired

Eligibility criteria:
inclusion criteria: * patients undergoing open colo-rectal surgery exclusion criteria: * asa status more than ii, history of chronic pain, ischemic heart disease or chronic pulmonary disease, allergy to any drugs used in the protocol. body max index more than 35.

Keywords: hyperalgesia patient controlled analgesia morphine methadone ketamine
pharmacokinetic drug-drug interaction study of dovitinib (tki258) in patients with advanced solid tumors

Conditions: Advanced Solid Tumors, Excluding Breast Cancer

Summary: this is a multi-center, open-label, phase i study to assess the effects of dovitinib (tki258) on the pharmacokinetics of a cocktail of caffeine, diclofenac, omeprazole and midazolam in patients with advanced solid tumors, excluding breast cancer. the aim of this study is to evaluate the potential effect of dovitinib (tki258) on the metabolism of the probe drugs caffeine, diclofenac, omeprazole and midazolam, which are metabolized by cyp1a2, cyp2c9, cyp2c19 and cyp3a4 respectively (cytochrome p450 isoenzyme), comparing the single-dose pharmacokinetics (auctlast, aucinf and cmax parameters) of each of the individual probe drug co-administered with and without multiple dose of dovitinib (tki258) 500 mg under a 5 days on / 2 days off dose schedule. the study foresees two treatment phases: ddi (drug-drug interaction) followed by post-ddi. during the ddi phase patients receive treatment with the probe drug cocktail and dovitinib (tki258). during the post-ddi phase patients may continue to receive treatment with dovitinib (tki258) until disease progression (assessed by recist 1.1), unacceptable toxicity, death or discontinuation from the study treatment for any other reason.


Eligibility criteria:
inclusion criteria: * patients with a cytopathologically or histopathologically confirmed diagnosis of an advanced solid tumor, excluding breast cancer which has progressed despite standard therapy or for which no standard therapy exists * ecog performance status 0 or 1 and anticipated life expectancy ≥ 3 months * patient must meet protocol-specific laboratory values exclusion criteria: * patients with brain metastases * patients who have received or who are expected to receive any prohibited medications and therapies * patients who have received cyp1a2 inducer, cyp2c9/2c19 inducer or cyp3a4 inducer medications within 30 days prior to start study treatment or are expected to receive during the first 14 days after starting the study treatment * patients with a known hypersensitivity to benzodiazepines * patients who have not recovered from previous anti-cancer therapies * patient with impairment of gastrointestinal (gi) function or gi disease that may significantly alter the absorption of tki258 * patients who have concurrent severe and/or uncontrolled concomitant medical conditions that could compromise participation in the study * female patients who are pregnant or breast-feeding * fertile males or women not willing to use highly effective methods of contraception * other protocol-defined inclusion/exclusion criteria will apply

Keywords: cancer, tumors, phase i, drug-drug interaction, pharmacokinetic, probe drug, caffeine, diclofenac, omeprazole, midazolam, cyp1a2, cyp2c9, cyp2c19, cyp3a4
exercise intervention for pts with metastatic castration-resistant prostate cancer receiving abiraterone or enzalutamide

Conditions: Metastatic Castration Resistant Prostate Cancer (mCRPC)

Summary: this randomized pilot study will be conducted in men with metastatic castration resistant prostate cancer (mcrpc) within 3 months of initiating abiraterone or enzalutamide. the purpose of this pilot study is to evaluate the effects of a 12 week exercise intervention in mcrpc patients who have recently started on additional androgen suppression therapy.

this randomized pilot study will be conducted in men with metastatic castration resistant prostate cancer (mcrpc) within 3 months of initiating abiraterone or enzalutamide. the purpose of this pilot study is to evaluate the effects of a 12 week exercise intervention in mcrpc patients who have recently started on additional androgen suppression therapy. the investigators will also explore the effects of the exercise training on biomarkers of inflammation-hormonal status and their potential association with changes in lean mass and function.

Eligibility criteria:
inclusion criteria: 1. ≥18 years of age 2. metastatic disease that has progressed despite castrate levels of testosterone (surgically or medically castrated, with testosterone levels of \< 50 ng/dl) 3. no prior chemotherapy 4. initiated therapy with either abiraterone plus a glucocorticoid or enzalutamide within the 3 months prior to randomization 5. ability to engage safely in moderate exercise as determined by their treating physician 6. not previously engaged in regular exercise training (\>1-2 d/wk for \> 30 min/d) in the past 6 months 7. be able to speak and read english exclusion criteria: 1. any condition that causes severe pain with exertion 2. history of bone fractures 3. active cardiovascular disease including any of the following: * new york heart association (nyha) grade ii or greater congestive heart failure * history of myocardial infarction or unstable angina within 6 months prior to day 1 * history of stroke or transient ischemic attack within 6 months prior to day 1 4. acute or chronic respiratory disease 5. acute or chronic bone/joint/muscular abnormalities compromising their ability to exercise 6. neurological conditions that affect balance and, or muscle strength 7. dementia, altered mental status or any psychiatric condition prohibiting the understanding or rendering of informed consent

Keywords: metastatic castration resistant prostate cancer prostate cancer mcrpc pilot study unc lineberger exercise
ultrasound-guided genicular nerve block for total knee arthroplasty.

Conditions: Pain

Summary: the hypothesis is to demonstrate the analgesic non-inferiority of the ultrasound-guided geniculate nerve block when compared to the local infiltration analgesia (lia). it is expected to maintain the quality of analgesia with a selective blockade of the nerves responsible for the sensitive innervation of the knee, reducing the total dose of local anesthetic and adrenaline very markedly.

the main objective is to demonstrate that the ultrasound-guided geniculate nerve block provides not-inferior analgesia to lia in patients undergoing primary total knee arthroplasty (tka) in the first 24 hours postoperatively, and during the first mobilization using the numerical evaluation of the pain (nrs). the secondary objectives are to demonstrate that the consumption of opioids and the range of joint mobility are not inferior in those patients who receive geniculate nerve blocks compared to those who receive lia.

Eligibility criteria:
inclusion criteria: * subjects scheduled for primary elective total knee arthroplasty * american society of anesthesiologists physical status i-iii * bmi 18-40 kg/m2 exclusion criteria: * inability to cooperate with protocol * allergy to any medication of protocol * contraindication to peripheral nerve block (e.g. local or systemic infection, neurologic deficit or disorder, previous trauma or surgery to ipsilateral knee, etc.) * revision or prothesis replacement knee surgery * chronic opioid consumption (daily morphine equivalent of \>30 mg for at least four weeks prior to surgery) * bleeding diathesis or non-pharmacological coagulopathy

Keywords: pain analgesia lia ultrasound genicular nerve block
azithromycin reduction to reach elimination of trachoma b

Conditions: Trachoma

Summary: the investigators propose a randomized controlled trial of discontinuation versus continuation of annual mass azithromycin distribution in hypoendemic communities of maniema, drc. the investigators will randomize communities with up to 20% trachomatous inflammation - follicular (tf) prevalence following at least 5 years of mass azithromycin distribution to discontinuation or continuation of 3 additional years of annual mass azithromycin distribution.


Eligibility criteria:
inclusion criteria: * provision of appropriate informed consent * stated willingness to comply with all study procedures * live in one of the 80 communities with up to 20% prevalence of tf selected for the trial exclusion criteria: * does not consent to participation * unwilling to comply with all study procedures * does not live in one of the 80 communities with up to 20% prevalence of tf selected for the trial
seoul national university hospital systemic sclerosis cohort

Conditions: Systemic Sclerosis

Summary: to establish a new prospective cohort of korean patients with systemic sclerosis and track the natural history of the disease over time. to generate new hypotheses for further investigation.

systemic sclerosis (ssc) is a multisystem and heterogeneous disease characterized by an unpredictable course and high morbidity and mortality. the complexity of ssc requires interdisciplinary diagnostic and therapeutic management and result in a growing burden for all health-care systems. for this reasons, researchers are seeking new diagnostic and therapeutic strategies to improve management of these patients. in order to improve clinical care and to develop recommendations for the diagnosis and treatment of ssc, disease registries are used to capture and track key patient information. therefore, ssc research associations and consortiums play a pivotal role to perform ongoing research and data collection to understanding the disease and support research projects. currently, several national ssc registries in the uk, germany, usa, canada, brazil, australia and international registry, eustar (european league against rheumatism scleroderma trial and research), have been established. however, the natural history of asian populations are fully evaluated. therefore, investigators decided to establish ssc cohort in korean patients.

Eligibility criteria:
inclusion criteria: * ssc diagnosis according to 1980 or 2013 acr classification criteria or 2001 criteria for the classification of early systemic sclerosis exclusion criteria: * when patients refuse to take part in the study

Keywords: systemic sclerosis cohort korean