Kornimate/medical-research-clean huggingface dataset:
cd30 car t-cells post autohsct for poor-risk hodgkin lymphoma

Conditions: Classical Hodgkin Lymphoma

Summary: patients with poor risk classical hodgkin lymphoma (chl) will undergo myeloablative chemotherapy (mac) with autologous stem cell transplantation (autohsct) and subsequently receive autologous cd30+ car t-cells.

eligible patients will be screened for study entry and proceed to cell procurement at local sites with collection of peripheral blood mononuclear cells (pbmc) for cd30+ car t-cell manufacturing at unc. patients will then have autologous stem cells collected (pbsc) and stored for future autohsct. after another screening for mac+autohsct, patients who meet criteria will receive beam conditioning followed by autohsct. about 21-42 day after the autologous stem cell infusion, patients will receive their autologous cd30+ car t-cell infusion, if they meet subsequent pre cd30+ car t-cell eligibility criteria.

Eligibility criteria:
inclusion criteria: * age between ≥ 6 and ≤ 29.99 years at the time of consent. * lansky or karnofsky score of ≥ 60% (see appendix vi) * disease status: confirmed diagnosis of cd30+ classical hodgkin lymphoma and meets eligibility to undergo asct. must meet one of the following: induction failure progressive disease disease relapse (1st, 2nd or 3rd) * confirmatory re-biopsy of relapse/refractory/persistent cd30+ chl prior to study entry. * risk factors: patient must meet 2 or more of the established risk factors: performance score (karnofsky/lansky) \ 60ml) by 18f-fluorodeoxyglucose positron emission tomography (pet)/computed tomography (ct) chemo resistant disease (deauville 4-5) after the first re-induction exclusion criteria: * not meeting the inclusion criteria

Keywords: classical hodgkin lymphoma car t-cells
concurrent chemotherapy for recurrent t3/t4 nasopharyngeal carcinoma

Conditions: Nasopharyngeal Carcinoma

Summary: the purpose of this study is to determine whether concurrent chemotherapy and imrt is effective in the treatment of locally stage t3/t4 recurrent nasopharyngeal carcinoma patients compared with imrt alone.

locally t3/t4 recurrent nasopharyngeal carcinoma (npc) may be salvaged by intensity modulated-radiotherapy (imrt), but local control is not good enough and late toxicities is usually severe the aim of this phase iii randomized controlled study is to address the efficacy of concurrent chemotherapy (cisplatin) with imrt to improve local control and lower the occurrence of severe late toxicities compared with imrt alone for locally t3/t4 recurrent npc patients.

Eligibility criteria:
inclusion criteria: * 1.pathologically or clinically confirmed rt3/t4 locally recurrent nasopharyngeal carcinoma; 2.no evidence of distant metastasis 3.more than 1 year from the end of the first course of radiotherapy 4.male, or female not in the phase of lactating or pregnancy 5.ecog 0-2 6.aged 18-70 years old 7.wbc count ≥4×109/l, neutrophile granulocyte count≥1.5×109/l, plt count ≥100×109/l, hb ≥9g/l 8.total bilirubin, ast, alt≤2.0 times of upper normal limits; creatinine ≤1.5 times of upper normal limits 9.written informed consort signed exclusion criteria: 1. only regionally recurrence 2. evidence of distant metastasis 3. prior invasive malignancy; noninvasive cancers (for example, carcinoma in situ of the bladder, oral cavity, or cervix are all permissible) are permitted 4. severe, active co-morbidity 5. prior anti-tumor treatment after diagnosis of local recurrence 6. mri was not performed 3 months after the first course of radiotherapy 7. abnormal function of heart, brain and lungs, etc 8. lactation or pregnancy 9. severe nasopharyngeal mucosal necrosis at the diagnosis of local recurrence

Keywords: concurrent chemotherapy imrt recurrent npc
survival effect of hepato-celiac lymphadenectomy in primary or relapsed ovarian cancer

Conditions: Epithelial Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Carcinoma

Summary: the purpose of this study is to evaluate the safety and the effectiveness of hepato-celiac lymphadenectomy in the treatment of primarily diagnosed advanced epithelial ovarian cancer and platinum-sensitive recurrent ovarian cancer.

this single-arm, single-center, phase ii trial is to evaluate the safety and effectiveness of hepato-celiac lymphadenectomy in the treatment of ovarian cancer with hepato-celiac lymph nodes metastases, in the circumstance of primarily diagnosed advanced epithelial ovarian cancer (primary debulking surgery or interval debulking surgery) and of platinum-sensitive recurrent ovarian cancer (no more than 4 lines of therapy).

Eligibility criteria:
inclusion criteria: * age ≥18 years to ≤ 75 years. * pathologic confirmed stage iii or iv epithelial ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma (eoc, ppc, ftc) or platinum sensitive, relapsed eoc, ppc or ftc (no more than 4 lines of therapy) * assessed by the experienced surgeons, complete resection is feasible according to preoperative evaluation * 1 to 3 episodes of neoadjuvant chemotherapy is allowed in primary settings * platinum sensitive relapse is defined as those with platinum-free interval of 6 months or more. * asa score of 1 to 2 * ecog performance status of 0 to 2 * adequate bone marrow, liver and renal function to receive chemotherapy and subsequently to undergo surgery: * white blood cells \>3,000/µl, absolute neutrophil count ≥1,500/µl, platelets ≥100,000/µl, hemoglobin ≥9 g/dl, * serum creatinine \<1.25 x upper normal limit (unl) or creatinine clearance ≥60 ml/min according to cockcroft-gault formula or to local lab measurement * serum bilirubin \<1.25 x unl, ast(sgot) and alt(sgpt) \<2.5 x unl * comply with the study protocol and follow-up. * written informed consent. exclusion criteria: * patients with non-epithelial ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma. * low-grade carcinoma. * mucinous ovarian cancer. * infeasible complete resection according to preoperative evaluation * unresectable pulmonary and hepatic parenchymal metastases, multiple thoracic lymph nodes metastases, brain or bone metastases according to preoperative evaluation. * carcinomatosis on small bowel mesentery or intestinal wall by surgical findings and infeasible optimal surgery by bowel resection or peritonectomy. * progression after neoadjuvant chemotherapy in primary settings. * synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ or breast cancer (without any signs of relapse or activity). * any other concurrent medical conditions contraindicating surgery or chemotherapy that could compromise the adherence to the protocol. * other conditions, such as religious, psychological and other factors, that could interfere with provision of informed consent, compliance to study procedures, or follow-up.

Keywords: ovarian cancer surgery lymph node metastasis hepato-celiac lymphadenectomy
patient perspective on remote monitoring of cardiovascular implantable electronic devices

Conditions: Congestive Heart Failure

Summary: a relatively new and promising development in the area of cardiovascular implantable electronic device therapy is remote patient monitoring (rpm). rpm systems can interrogate the device automatically and send the data from the patients' home to the physician, thereby reducing in-clinic follow-ups. the purpose of this study is to evaluate the effect of rpm + in-clinic follow-up versus in-clinic follow-up only on patient-reported health status and device-acceptance after implantation with an implantable cardioverter defibrillator (icd) or cardiac resynchronization defibrillator (crt-d). secondary objectives are (1) to identify subgroups of patients who prefer rpm over in-clinic visits or vice versa due to specific clinical and psychological factors and (2) to investigate the cost-effectiveness of rpm + in-clinic follow-up compared to in-clinic follow-up only.


Eligibility criteria:
inclusion criteria: * first time icd/crt-d implanted at one of the participating centers * left ventricular ejection fraction \<35% * nyha functional class ii or iii symptoms * icd/crt-d device compatible with the latitude(r) rpm system from boston scientific exclusion criteria: * on the waiting list for heart transplantation * history of psychiatric illness others than affective/anxiety disorders * cognitive impairments * insufficient knowledge of the language to fill in the questionnaires

Keywords: implantable defibrillators remote patient monitoring patient-reported outcomes cost-effectiveness
surgical treatment of lower eyelid involutional entropion and dermatochalasis

Conditions: Eyelid Diseases

Summary: lower eyelid involutional entropion and dermatochalasis are common associated problems. combined approaches give good results.

traditional lower eyelid transcutaneous blepharoplasty ; subciliary incision followed by proper dissection then lower eyelid retractors plication after orbital fat removal . pentagon wedge resection of lateral lower eyelid is done

Eligibility criteria:
inclusion criteria: 1. lower eyelid involutional entropion 2. dermatochalasis exclusion criteria: 1. other eyelid disease, 2. other causes of entropion 3. previous eyelid surgery

Keywords: entropion blepharoplasty
post-marketing safety surveillance of novoseven® in patients with haemophilia and inhibitors by means of the uk haemophilia database

Conditions: Congenital Bleeding Disorder; Haemophilia A; Haemophilia B

Summary: this study is conducted in europe. the purpose of this retrospective study is to collect additional safety information of patients with haemophilia and inhibitors who are treated with rfviia.

non-interventional, retrospective data collection on standard treatments of haemophilia a and b patients with inhibitors in the uk.

Eligibility criteria:
inclusion criteria: * all haemophilia a or b patients with inhibitors treated with novoseven are included exclusion criteria: * no exclusion criteria beyond the contraindications described in the approved product information text
hypophosphatemic rickets in norway

Conditions: Hypophosphatemia, Familial; Rickets; Hyperphosphatemia

Summary: the purpose of the study is to do a follow-up survey of all individuals with hereditary hypophosphatemia in norway, focusing on manifestations in childhood and adolescence. the investigators also want to study phenotype-genotype associations, and look for new genes, in all forms of hereditary hypo and hyperphosphatemia.


Eligibility criteria:
inclusion criteria: * all patients in the norwegian population with hereditary hypophosphatemia, with or without rickets * patients in the norwegian population with hereditary hyperphosphatemia exclusion criteria: -
therapeutic effects of plyometric exercises in children with type 1 diabetis

Conditions: Diabetes Mellitus, Type 1

Summary: despite the benefits of physical rehabilitation among adults and children with chronic illness such as diabetes mellitus avoid engaging in different physical activities especially pediatric population. most of the children with type 1 diabetes mellitus receive their medical treatment and follow-up with no change of their functional performance.

we still lack the evidence of plyometric exercises in pediatric population with diabetes mellitus . therefore, the primary aim of this study is to explore the effects of plyometric exercises on blood glucose level, balance and muscle strength in children with 1 diabetes mellitus

Eligibility criteria:
inclusion criteria: * age will range from six to 10 years * both sexes * chronicity of the disease ranges from 3 to \<5 years. * controlled diabetes with insulin dosage described by physician. exclusion criteria: * heriderty sensory or autonomic peripheral neuropathy. * unstable cardio-vascular disorders * history of fractures or surgery in the lower extremities in the past 12 months. * diagnosed with other hormonal diseases. * children who practice regular sports.

Keywords: diabetes mellitus type 1 1 diabetes mellitus plyometric exercises balance muscle strength
short-term presurgical study to assess molecular predictors of lapatinib's effects in primary breast cancer

Conditions: Breast Cancer

Summary: to provide an in vivo measure of the activity of lapatinib. to assess the antiproliferative effects of lapatinib in breast cancer, ie how much lapatinib slows down the growth of cancer cells by measuring k167 (a marker of proliferation) in breast tumours before and after a short treatment with lapatinib.

randomised multi centre double blind pre-surgical study in women with a histological diagnosis of breast cancer by core biopsy.

Eligibility criteria:
inclusion criteria: patients must have a histological or cytologic diagnosis of primary breast cancer with a tumour size adequate for multiple core biopsies informed signed consent scheduled for primary surgery expected to be compliant for duration of study age\ 60%) cardiac ejection fraction within the institutional range of normal as measured by echocardiogram or muga scan eligibility of patients receiving medications known to affect, or with the potential to affect the activity or pharmacokinetics of lapatinib will be determined following review by the trial coordinator the effects if lapatinib on the developing fetus are unknown. for this reason, women of childbearing potential must agree to use adequate non-hormonal contraception for the duration of study participation. able to swallow and retain oral medication. exclusion criteria: patients with prior diagnosis of malignancy except in situ disease or basal cell carcinoma of the skin. patients may be receiving any other investigational agents or receiving concurrent anticancer therapy. in addition, all herbal (alternative) medicines are excluded. evidence of metastatic disease. use of hormonal therapy such as oral contraceptives or hormonal replacement therapy within 4 weeks of study entry. regular use of steroid hormones or other agents that could influence study endpoints history of allergic reactions attributed to compounds of similar chemical or biologic composition to gw572016. uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/ social situations that would limit compliance with study requirements.

Keywords: ki67 molecular antiproliferative
to optimize antenatal management of women with pre term labor using amniocentesis

Conditions: Preterm Birth; Preterm Labor; Intra-amniotic Infection; Amniocentesis Affecting Fetus or Newborn

Summary: implementation of prediction models of risk of spontaneous delivery within 7 days or of intra-amniotic infection in women with preterm labor and intact membranes

to evaluate whether the implementation of prediction models of risk of spontaneous delivery within 7 days or of intra-amniotic infection: 1. optimises antenatal management (regarding steroids, tocolysis, antibiotics, maternal length stay duration) without worsening perinatal outcomes. 2. it is a cost-effective strategy. 3. it improves neonatal outcome (in premature newborns \<30 weeks), and reduces infectious maternal morbility. 4. it improves neurodevelopmental outcome at 1.2 and 5 years.

Eligibility criteria:
inclusion criteria: * pregnant women with singleton pregnancies admitted with a diagnosis of preterm labor between 23.0 and 34.6 weeks, not in labor at randomization and who do not meet exclusion criteria. exclusion criteria: * women who do no accept to be part of the study * maternal age \< 18 years * multiple gestations * clinical chorioamnionitis at randomization (defined by the presence of fever above 38 celsius degrees (ºc), fetal tachycardia (\>160 heart beat per minute \>10 minutes), maternal white blood cells \> 15000/mm3 (not justified by the administration of antenatal steroids). * cervical dilatation \> 3 cm * major structural malformations of fetal complications that are related to neurodevelopmental impairment. * technical problems to perform an amniocentesis (prediction models include information from amniotic fluid: glucose and il-6 concentration).
observational study of norditropin nordiflex® with nordiflex penmate™

Conditions: Growth Hormone Disorder; Growth Hormone Deficiency in Children; Delivery Systems

Summary: this study is conducted in europe. the aim of this study is to evaluate ease of injection of growth hormone in patients using norditropin nordiflex® with nordiflex penmate™. convenience and tolerability of nordiflex penmate™ - an automatic injection and a needle hiding device - is also evaluated.


Eligibility criteria:
inclusion criteria: * after the physician decision has been made to use norditropin nordiflex® growth hormone therapy in accordance with the locally approved labelling, any subject is eligible for the study, including newly diagnosed subjects who have never received growth hormone therapy before and subjects who were treated with the other growth hormone products (with exclusion of patients who received previously norditropin nordiflex®) and need to be switched to a new product. the selection of the subjects will be at the discretion of the individual physician exclusion criteria: * contraindications to norditropin® growth hormone therapy * subjects who have received norditropin nordiflex® prior to this study
clinical evaluation of acupuncture treatment on alzheimer's disease in apoe e4 carriers and non-carriers

Conditions: Alzheimer Disease; Cognitive Impairment

Summary: the goal of this clinical trial is to learn if acupuncture works to treat mild-to-moderate alzheimer's disease, as well as the difference of its effect in apoe e4 carriers and non-carriers. it will also learn about the safety of acupuncture. researchers will compare acupuncture to a placebo (sham acupuncture) to see if acupuncture works to relieve the cognitive impairment and improve the ability of daily living and the quality of life. in addition, the plasma and neuroimaging biomarkers will be included as objective indexes. participants will: experience acupuncture or sham acupuncture 3 times per week for 12 weeks, and receive a 52-week follow-up. visit the clinic at week 12, week 38 and week 64 for checkups and tests.

this is a two-centre randomized controlled trial. a total of 176 participants with mild-to-moderate alzheimer's disease, 88 apoe e4 carriers and 88 non-carriers, will be randomly assigned to either an acupuncture combined with donepezil group or a sham acupuncture combined with donepezil group with a ratio of 1:1. the main acupoints are du 24, ex-hn 3, du 20, ex-hn 1, gb 12, ht 7, ki 6, gb39. there will be 12 weeks of 3-session treatment for each participant, and a 52-week follow-up in total. the primary outcome is the change and effective rate from baseline in the adas-cog score measured at week 12.

Eligibility criteria:
inclusion criteria: * aged between 50-85 years * diagnosed by the criteria of neurological communicative disorders and stroke and the alzheimer disease and related disorders association (nincds-adrda) * cognitive impairment based on the scores of the chinese version of the mini mental state examination (mmse) (patients with mild to moderate alzheimers disease, 11≤primary school degree≤22, 11≤junior high school degree or above≤26 * magnetic resonance imaging (mri) confirmation of atrophy of the hippocampus or the medial temporal lobe volume, mri manifestation of high possibility of alzheimer disease * the medial temporal lobe atrophy rating scale (mta-scale) score (≥2 for those under 75 years, and ≥3 for those over 75 years) * voluntarily joining this study with informed consents exclusion criteria: * cognitive impairment caused by other factors (e.g. vascular dementia, dementia with lewy bodies, frontotemporal dementia, hormone or metabolic abnormalities, hypothyroidism, folic acid or vitamin b12 deficiency, delirium or other mental and emotional disorders (such as schizophrenia and depression)) * a serious heart condition, hepatic disease, renal system disease, hematopoietic system disease, or whole-body malnutrition * aphasia, disturbance of consciousness, or failure to cooperate with the related examinations due to physical disability * contraindications to undergoing an mri scan such as claustrophobia or pacemaker implantation. * anticoagulant treatments such as warfarin or heparin * use of pacemakers or receiving acupuncture in the past 2 weeks
evaluation of prognostic monitoring for young breast cancer patients

Conditions: Breast Cancer Female

Summary: the relationship between immune inflammation-related protein complexes in blood and recurrence or metastasis of breast cancer with completed standard treatment for young ladies will be studied.

200 patients younger than 35 with breast cancer will be followed up. peripheral venous blood was collected every 3 to 6 months. change regularity of breast cancer-specific immune inflammation-related protein complexes in blood at different follow-up time points will be studied. the relationship between disease specific protein complexes and pathological state of patients will be analyzed.

Eligibility criteria:
inclusion criteria: * female * invasive breast cancer patients confirmed by postoperative pathology after surgery for breast lump * breast cancer-related chemotherapy and radiotherapy completed * young ladies with ages equal 35 or below exclusion criteria: * male * aged above 35 * breast carcinoma in situ * women in pregnancy or breastfeeding * suffering from other malignant tumors * non-compliant patient