Kornimate/medical-research-clean huggingface dataset:
radiation therapy alone compared to radiation therapy plus chemotherapy in treating patients with previously untreated cancer of the nasopharynx

Conditions: Head and Neck Cancer

Summary: rationale: radiation therapy uses high-energy x-rays to damage tumor cells. drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. it is not yet known whether radiation therapy alone is more effective than radiation therapy plus chemotherapy in treating cancer of the nasopharynx. purpose: this randomized phase iii trial is studying how well radiation therapy and chemotherapy works compared to radiation therapy alone in treating patients with previously untreated cancer of the nasopharynx.

objectives: * compare the clinical response, distant metastases, disease-free survival, and overall survival in patients with previously untreated, locally advanced, nonmetastatic nasopharyngeal cancer treated with radiotherapy alone vs concurrent chemoradiotherapy followed by adjuvant chemotherapy. outline: this is a randomized study. patients are randomized to receive radiotherapy alone (arm i) or concurrent chemoradiotherapy followed by adjuvant chemotherapy (arm ii). * arm i: patients receive radiotherapy once daily 5 times a week for 7 weeks. * arm ii: patients receive cisplatin iv over 6-8 hours for 4 consecutive days every 3 weeks for 3 courses. concurrent radiotherapy is given once daily 5 times a week over the 7 week treatment period. this chemoradiotherapy is followed 3 weeks later by adjuvant chemotherapy. patients receive cisplatin iv and fluorouracil iv over 6-8 hours for 4 consecutive days every 4 weeks for 3 courses. patients are followed every 4 months for the first year, every 6 months for the next 2 years, and then annually thereafter until death. projected accrual: a minimum of 200 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed nasopharyngeal cancer that is previously untreated who type iii * stage iii/iv (t3-4 nx m0 or tx n2-3 m0) confirmed by ct pns * no evidence of distant metastases detected on chest x-ray, bone scan, and liver ultrasound patient characteristics: age: * not specified performance status: * ecog 0-1 life expectancy: * not specified hematopoietic: * wbc greater than 3,000/mm\^3 * platelet count greater than 100,000/mm\^3 hepatic: * sap and sgot less than 2 times upper limit of normal * bilirubin less than 1.4 mg/dl renal: * creatinine less than 1.6 mg/dl * creatinine clearance greater than 50 ml/min other: * no other malignant disease prior concurrent therapy: biologic therapy * not specified chemotherapy * not specified endocrine therapy * not specified radiotherapy * not specified surgery * not specified other * see disease characteristics * no concurrent aminoglycoside antibiotics

Keywords: stage iii lymphoepithelioma of the nasopharynx stage iv squamous cell carcinoma of the nasopharynx stage iii squamous cell carcinoma of the nasopharynx stage iv lymphoepithelioma of the nasopharynx
autologous osteoblastic cells implantation to early stage osteonecrosis of the femoral head

Conditions: Avascular Necrosis of Femur Head

Summary: non-traumatic osteonecrosis is a painful disorder of the hip characterized by a necrosis of the osteomedullary tissue, which leads to subchondral bone collapse and joint destruction. core decompression is currently the treatment of choice for early stage osteonecrosis of the femoral head. this method consists in decompressing the rigid intra-osseous chamber to promote revascularization, thus halting progression of the disease and stimulating repair. still this treatment remains highly controversial, since the success rates of the first studies have not been repeated. the exact pathology mechanisms involved in osteonecrosis have not yet be fully elucidated. several hypotheses have been evoked, including fat embolism, trabecular bone microfractures, microvascular tamponade and, more recently, impaired bone and/or mesenchymal cells recruitment. three studies have indicated the potential clinical benefits of cell-based approaches for the treatment of osteonecrosis (hernigou 1997, hernigou \& beaujean 2002, gangji et al. 2004). this is on the basis of these observations that a proprietary population of autologous osteoblastic cells (preob®) has been developed. this phase 2b study aims at demonstrating the efficacy and safety of preob® in the treatment of early stage osteonecrosis of the femoral head. the primary goal of this study was to investigate the safety and efficacy of the implantation of the investigational product preob® (human autologous bone marrow-derived osteoblastic cells) in comparison to bone marrow concentrate (bmc) when implanted at the osteonecrotic lesion of the femoral head, with a follow-up period of up to 5 years.


Eligibility criteria:
inclusion criteria: * arco stage i or ii non-traumatic osteonecrosis of the femoral head, confirmed by conventional x-ray and magnetic resonance imaging (mri) of the hip * aged 18 or higher * ability to provide a written, dated and signed informed consent prior to any study-related procedure to understand and comply with study requirements exclusion criteria: * evidence of malignant disorder in the past five years * positive serology for hepatitis b, hepatitis c, hiv * patient unable to undergo a mri

Keywords: osteonecrosis femoral head hip orthopedics bone musculoskeletal disorders
posoleucel (alvr105, formerly viralym-m) for multi-virus prevention in patients post-allogeneic hematopoietic cell transplant

Conditions: Adenovirus Infection; BK Virus Infection; Cytomegalovirus Infections; Epstein-Barr Virus Infections; Human Herpes Virus-6 Infection; JC Virus Infection

Summary: this is a phase 2 study to evaluate posoleucel (alvr105, formerly viralym-m); an allogeneic, off-the-shelf multi-virus specific t cell therapy that targets six viral pathogens: bk virus, cytomegalovirus, adenovirus, epstein-barr virus, human herpesvirus 6 and jc virus.

this is a phase 2/3, multicenter, randomized, double-blind, placebo controlled trial comparing posoleucel to placebo for the prevention of infection or disease due to adv, bkv, cmv, ebv, hhv-6, or jcv in high-risk adult and pediatric patients after allogeneic hct. there are 2 parts to the study, an open label phase 2 cohort described in this posting, and a randomized, placebo controlled phase 3 cohort described in nct05305040. in the phase 2 part, 25 to 35 eligible allogeneic hct recipients will be enrolled and will receive 7 doses of posoleucel over 12 weeks, followed by a 14 week follow-up period.

Eligibility criteria:
key inclusion criteria * ≥1 year of age at the day of screening visit. * either no evidence of viral infection or viremia, or asymptomatic, viral infection with 3 or fewer viruses of interest at time of screening * within 15 and 42 days of receiving a first allogeneic hct and have demonstrated clinical engraftment * meet one or more of the following criteria at the time of randomization: * related (sibling) donor with at least one mismatch at one of these hla-gene loci: hla-a, -b or -dr * haploidentical donor * unrelated donor with at least one mismatch at one of these hla-gene loci: hla-a, -b, -c, or -dr * use of umbilical cord blood as stem cell source * ex vivo graft manipulation resulting in t cell depletion * lymphocyte count \<180/mm3 and/or cluster of differentiation 4 (cd4) count \<50/mm3 key exclusion criteria: * history of adv, bkv, cmv, ebv, hhv-6, and/or jcv end-organ disease within 6 months prior to randomization * evidence of active grade \>2 acute gvhd * presence of non-minor uncontrolled or progressive bacterial, viral or fungal infections * known history or current (suspected) diagnosis of crs requiring treatment associated with the administration of peptides, proteins, and/or antibodies * ongoing therapy with high-dose systemic corticosteroids (ie, prednisone equivalent dose \>0.5 mg/kg/day) within 24 hours prior to dosing * relapse of primary malignancy other than minimal residual disease note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: allogeneic hematopoietic cell transplant posoleucel alvr105 viralym-m
exercises for urinary incontinence(ui) of women with multiple sclerosis (ms)

Conditions: Urinary Incontinence;; Multiple Sclerosis

Summary: this study will examine whether the paula method is an effective treatment for ui and the correlating lutd symptoms. we assume that the paula method, a simple, non-aerobic exercise method that significantly decreased urinary incontinence in women with mix in two randomized controlled trials, would also be effective in multiple sclerosis (ms) patients with ui. the secondary aim is to evaluate the effectiveness in terms of ms general physical functioning, quality of life and sexual function and to detect adherence and continuity six months post intervention.

the patient will be examined by the neurologist at the ms clinic, at the hadassah university medical center. patients who meet the inclusion criteria will receive an explanation, and will sign informed consent. she will be asked to complete the baseline questionnaires. than the patient will be assigned to an exercise group. after 12 weeks the patient will be asked to complete post intervention questionnaire. apart from the weekly lesson, women will be asked to exercise at home for 15 minutes a day. after six months she will be invited again for a neurological examination and filling an additional questionnaire.

Eligibility criteria:
inclusion criteria: women ≥18 years old; who have complained of urine leakage in the past four weeks; ms diagnosed with an expanded disability status scale (edss)≤7.5; literate in hebrew and/or english; suffering from ui at least in the 4 last weeks prior to recruitment exclusion criteria: pregnant or breastfeeding women, those within 12 weeks of delivery; 6 weeks of abortion; six months of pelvic surgery; symptomatic urinary tract infection (uti); more than grade 2 genital prolapse, permanent catheterization for urination; women taking medications for ui less then 3 months and women who exercise on regular basis in paula method.

Keywords: multiple sclerosis urinary incontinence
peripheral magnetic stimulation (pms) effects on somatosensory perception in patients with upper limb amputation

Conditions: Phantom Limb Pain

Summary: the study investigates the capabilities of peripheral magnetic stimulation (pms) as a tool for creating somatosensory sensations of various submodalities and analyzing the dynamics of bioelectric signals of the brain (using encephalography (eeg)) in healthy participants and participants with upper limb amputations. during the experiment, the participants' subjective sensations and eeg activity are recorded in response to magnetic pulses of varying intensity. in addition, the continuous pms stimulation protocol and its effect on phantom sensations in participants with amputations will be tested for subsequent implementation in clinical practice.


Eligibility criteria:
for healthy volunteers: inclusion criteria: 1. availability of signed written informed consent. 2. absence of somatic and psychiatric diseases (more details in the exclusion criteria) 3. ability and willingness to comply with the requirements of this protocol. inclusion criteria exclusion criteria: 1. history of epilepsy (participant, participant's close relatives) 2. presence of metal or/and electric stimulators and/or implants in participant's body 3. presence of psychiatric disorders (including a history of), severe depression, suicidal tendencies, or a history of suicide attempts. 4. history of cancer. 5. complicated traumatic brain injury (tbi) or a history of stroke. 6. drug addiction (including a history of). 7. congenital anomaly of upper limb development. 8. anomalies in the development of the central and peripheral nervous systems. 9. pregnancy for stroke patients: 1. history of epilepsy (participant, participant's close relatives) 2. presence of metal or/and electric stimulators and/or implants in participant's body 3. presence of psychiatric disorders (including a history of), severe depression, suicidal tendencies, or a history of suicide attempts. 4. history of cancer. 5. complicated traumatic brain injury (tbi) or a history of stroke. 6. drug addiction (including a history of). 7. congenital anomaly of upper limb development. 8. anomalies in the development of the central and peripheral nervous systems. 9. pregnancy 10. presence of severe somatic pathology 11. presence of severe orthopedic deformity in the limb above the level of amputation. 12. purulent-septic pathology.

Keywords: neuromodulation phantom limb pain neuropathic pain neurostimulation chronic pain peripheral magnetic stimulation pms amputation amputees
fixed lingual mandibular growth modificator

Conditions: Class II Division 1 Malocclusion; Retrognathic Mandible

Summary: the current trial was designed to investigate the possible initial net skeletal and dental effects of treatment with flmgm by a comparative evaluation of treated and untreated cl ii/1 malocclusion subjects. the null hypothesis stated that there were no significant differences in dentofacial changes between flmgm group and control group.

the study was prospective controlled clinical trial conducted at the department of orthodontics, between may/2009 and june/2011. the protocol of study was approved by the council of scientific research and postgraduate studies. the original study sample included 43 patients (25 treated, 18 untreated). of the 43 patients initially enrolled, 38 completed this trial and comprised the final sample, and 5 (4 treated, 1 untreated) were excluded . all patients and parents gave prior informed consent to their inclusion in the investigation. patients of both groups were followed on a parallel basis during a period of 8 months and included in the trial regardless of achievement of a class i incisor relationship. all patient of treatment group (n=21) were treated with flmgm, and treatment was continued beyond this time point if the class ii malocclusion was not fully corrected and clinical objectives were not achieved. on the other hand, no orthodontic treatment was performed during that duration for the subjects of control group (n=17), and most of control subjects were offered suitable treatment at a later date. for each patient, a direct digital lateral cephalogram was taken pre- and post- treatment/observation using pax 400 (vatech co., korea) with the same settings. cephalograms were digitized on screen and analyzed in a blind manner by the same orthodontist using a cephalometric software (viewbox, 3.1.1.13, kifissia). . all linear measurements were reduced to life size (enlargement: 7.54%). pretreatment equivalence, changes occurring during the examination period in each group and comparison of changes observed in both groups were tested for significance with t-tests using spss . p values of less than 0.05 were considered statistically significant. to assess the method error, twenty cephalograms were randomly picked from both groups and redigitized and analyzed by the same orthodontist after 1 month, and the method error was calculated by dahlberg's formula.

Eligibility criteria:
inclusion criteria: before treatment, each patient fulfilled the following criteria: 1. cl ii/1 malocclusion with an overjet greater than 4 mm. 2. mild to moderate class ii skeletal pattern (a-n-b \> 4°) with retrognathic mandible (s-n-b \< 76°). 3. growth potential. fishman skeletal maturation indicator (smi) method28 was used to assess the hand-wrist radiographs, and only patients in the peak of the pubertal growth spurt, which occurs on average between smis 4 to 7,29 at the beginning of the treatment/observation period were invited. exclusion criteria: -

Keywords: class ii division 1 malocclusion dentofacial orthopedics fixed lingual mandibular growth modificator (flmgm)
phase 2 clinical trial to investigate the safety, tolerability and efficacy of yh1885l in patients with non-erosive reflux disease(nerd)

Conditions: Non-erosive Reflux Disease

Summary: randomized, double-blind, active-controlled, multi-center phase 2 clinical trial to investigate the safety, tolerability and efficacy of yh1885l in patients with non-erosive reflux disease(nerd)


Eligibility criteria:
inclusion criteria: * subjects who signed written informed consent form * more than 20 yr subject * subjects who agree the use of medically accepted birth control during trial * grade n, m by egd test * subject who experience 2 day out of 1 week during recent 1 month * subject who experience 2 day out of 1 week during run-in period exclusion criteria: * subjects who can write the diary by himself, herself * pregnant woman, breastfeeding woman * allgeric or intolerabiliy to revaprazan or esomeprazole * feeling of heavy stomach, distention * surgery history in stomach or esophagus * active medical history of stomach, esophagus area * other system disorder which can disturb this trial * hep b, c virus, hiv carrier or patients * past history of malignant tumor * any psychiatric past or current history * abnormal lab test * abnormal ecg test * zollinger-ellison disease * current or past history of substance, drug abuse * subject who should regulary takes medication which can disturb this trial

Keywords: nerd
effect of listed music with motivational video and nutrition on non-stress test and anxiety level of mother

Conditions: Pregnancy Related

Summary: objective: the research was conducted to determine the effect of music and nutrition played together with motivational video on non-stress test (nst) result and mother's anxiety level. method: the study was conducted as a randomized controlled clinical trial. the sample of the study consisted of 360 pregnant women, two experimental and one control group (120 pregnant women in each). in the study, pregnant women in the first experimental group were provided to consume cake and fruit juice 30 minutes before the nst procedure. the second experimental group was provided to eat fruit juice and cake before nst, and the video created with a similar content was given about the developments and changes occurring in the mother and fetus during pregnancy, and was watched for about 15-20 minutes during the nst procedure accompanied by music that provided relaxation. the data of the study were collected by using the participant presentation form, nst evaluation form and state anxiety inventory.

non stress test (nst) has been used frequently in fetal health assessment in recent years due to its easy application, cheapness, reliability and rapid assessment. false negativity rates of nst also cause an increase in cesarean rates. studies in recent years show that there are methods and factors that increase fetal movements and shorten nst application time. it was observed that nutrient intake, music playing, fetal acoustic vibration application and halogen light applications before nst increased fetal movements and shortened nst time.

Eligibility criteria:
inclusion criteria: * being 18 or over * being pregnant more than 32 weeks gestation, * having at least one live birth, * having had nst before, exclusion criteria: * having any risk factor (preeclampsia, iugg, early membrane rupture, getational diabetes etc.) during pregnancy * urinary contraction after nst, * it is a cardiovascular disease diagnosed in the fetus.

Keywords: non stress test motivational video music nutrition state anxiety
18f-facbc pet/ct and the psa kinetics for pca patients with biochemical recurrence.

Conditions: Biochemical Relapse Fo Malignant Neoplasm of Prostate

Summary: prostate cancer (pca) is the fifth-most common cancer for male with a seventh highest cancer-related death in taiwan. currently, the incidence and mortality rate are still increasing rapidly. the treatment decision planning is made up by clinical charts like gleason score (gs), tnm stage and serum prostate-specific antigen (psa) level. however, after definitive therapy for pca with either external beam radiotherapy (ebrt) or radical prostatectomy (rp), up to half patients experience biochemical recurrence (bcr). although not all patients with bcr proceed to develop disease progression, it is important to identify early lesion to initiate salvage treatment. anti-1-amino-3-\[18f\]fluorocyclobutane-1-carboxylic acid (18f-facbc) positron emission tomography (pet) is a imaging marker for l-amino acid transport evaluation. many cancers including pca have up-regulated amino acid transport tied to their proliferative potential. recently, 18f-facbc was included in the national comprehensive cancer network (nccn) guidelines for the management of recurrent pca patients. as we know, psa level and psa kinetics are valuable for the prediction of recurrence. the objective of this study is to investigate the correlation between the detection rate of 18f-facbc pet/ct and the psa kinetics for pca patients with bcr.


Eligibility criteria:
inclusion criteria: * pca patients with bcr * serum psa data and pathologic report * agreement consent exclusion criteria: * claustrophobia and unstable vital signs * disagreement

Keywords: prostate cancer 18f-facbc biochemical recurrence
nccn renal cell registry

Conditions: Renal Cell Carcinoma

Summary: this study will consist of three parts: 1) a retrospective chart review of patients treated for mrcc from july 2013 until the start of the educational intervention; 2) an educational program for dcn community oncology providers and dcn community patients with mrcc, lasting 8 - 10 months, and 3) a second retrospective chart review of patients treated for mrcc starting at the time of the educational intervention until the intervention is completed.

the initial retrospective cohort will serve as the pre-education control, and the second cohort will be the experimental group to assess the efficacy of the educational intervention to change care of patients with mrcc. chart reviews. this study will begin with a multi-site chart review conducted at the duke cancer network affiliated sites. the chart review will begin in late fall, 2015. the duke cancer network team will perform chart abstraction for this study, with a goal of reviewing at least 60 charts of patients treated between july 2013 and october 2015. the second data collection period will collect data on patients with mrcc seen at dcn sites after the date in fall 2015 when the educational intervention is rolled out. the target will again be at least 60 charts of patients treated during the time the educational intervention is actively available.

Eligibility criteria:
inclusion criteria: * oncology providers (physicians, nurse practitioners, physicians' assistants) at dcn affiliated sites will be invited to use the performance support system and participate in the online virtual tumor boards for cme credit. exclusion criteria: * non dcn affiliated sites providers
a study with health educational material on health promotion in cancer survivors

Conditions: Stomach Cancer; Colon Cancer; Thyroid Cancer; Breast Cancer

Summary: the purpose of this study is to provide educational material to promote screening for second primary cancer for the intervention group, or educational material to instruct appropriate use of dietary supplement for the control group.


Eligibility criteria:
inclusion criteria: * age \>=18, \<80 * cancer survivors (pathologically confirmed) * finished primary treatment (surgery, radiotherapy, chemotherapy) * \>= 1 year from cancer diagnosis * no evidence of recurrence, metastasis, and second primary cancer * no evidence of hereditary cancer * ecog 0,1,2 * ability in reading korean educational material exclusion criteria: * ecog 3,4 * disagree with the investigators study purpose