Kornimate/medical-research-clean huggingface dataset:
single-arm trial to evaluate the role of the immune response to talimogene laherparepvec in unresected melanoma

Conditions: Unresected Stage IIIb to IVM1c Melanoma

Summary: the study is a phase 2, multi centered, single arm study designed to evaluate the correlation between cluster of differentiation 8-positive (cd8+) cell density and objective response rate in adults with unresected stage iiib to ivm1c melanoma. this study will also evaluate the safety and tolerability profile of talimogene laherparepvec.

the study will explore the hypothesis that intratumoral cd8+ cell density at baseline correlates with objective response rate in adults with unresected stage iiib to ivmic melanoma treated with talimogene laherparepvec.

Eligibility criteria:
inclusion criteria: 1. provided informed consent prior to initiation of any study-specific activities/procedures 2. subject with stage iiib to ivm1c melanoma for whom surgery is not recommended 3. candidate for intralesional therapy 4. measurable disease with greatest diameter ≥ 10 mm 5. eastern cooperative oncology group (ecog) performance status of 0 or 1 6. adequate organ function other inclusion criteria may apply exclusion criteria: 1. clinically active cerebral metastases. 2. bone metastases 3. primary ocular or mucosal melanoma 4. active herpetic skin lesions or prior complications of herpes simplex virus type 1 (hsv-1) infection (eg, herpetic keratitis or encephalitis) 5. requires intermittent or chronic systemic (intravenous or oral) treatment with an antiherpetic drug (eg, acyclovir), other than intermittent topical use 6. female subject is pregnant or breast-feeding, or planning to become pregnant during study treatment and through 3 months after the last dose of talimogene laherparepvec 7. female subject of childbearing potential who is unwilling to use acceptable method(s) of effective contraception other exclusion criteria may apply

Keywords: t-vec cd8+ cell density objective response rate unresected melanoma
safety and efficacy of aflibercept in proliferative diabetic retinopathy.

Conditions: Naive Patients With Uncomplicated Proliferative Diabetic Retinopathy

Summary: proliferative diabetic retinopathy is a serious complication of diabetes mellitus, partly consecutive to upregulation of vascular endothelial growth factor (vegf) as a consequence of retinal ischemia leads. aflibercept has been approved by fda and european medicine agency for treatment of exudative age-related macular degeneration, another retinal disease characterized by choroidal new vessels. the aim of this pilot study is to evaluate the efficacy and the safety of aflibercept intravitreal injections compared to panretinal photocoagulation for proliferative diabetic retinopathy.


Eligibility criteria:
inclusion criteria: * patients with diabetes mellitus type 1 or type 2 complicated by pdr * male or female over 18 years * hba1c \<11.6% at study entry * systolic blood pressure \<160 mmhg and diastolic blood pressure \<105 mmhg at study entry * backgrounds clear eye, pupil dilation and patient cooperation sufficient to allow examination or fundus photographs of good quality exclusion criteria: * hypersensitivity to aflibercept or to any of the excipients * history of retinal laser (macular or panretinal photocoagulation), of intravitreal injections, of vitrectomy in the eye studied * pdr associated with tractional retinal detachment in the eye studied * pdr associated with fibrovascular proliferation in the eye studied * florid diabetic retinopathy * eye infection or periocular active or suspected * unbalanced glaucoma in the eye studied * other eye disease in the eye studied * patients with significant medical problems that may interfere with the evaluation of the safety or efficacy of the treatment studied
matched unrelated donor stem cell transplantation (mud-sct) after dose-reduced conditioning for patients with multiple myeloma and relapse after autologous sct

Conditions: Multiple Myeloma

Summary: the purpose of this study is to determine whether a reduced intensity conditioning regimen followed by allogeneic stem cell transplantation from unrelated donors is a feasible and effective treatment for patients with multiple myeloma who failed a previous autologous stem cell transplantation.

the purpose of this study is to determine whether a reduced intensity conditioning regimen followed by allogeneic stem cell transplantation from unrelated donors is a feasible and effective treatment for patients with multiple myeloma who failed a previous autologous stem cell transplantation.

Eligibility criteria:
inclusion criteria: * multiple myeloma stage ii or iii acc. to salmon and durie (chemosensitive or refractory) and relapse or progression after high dose chemotherapy with autologous stem cell support * age 18-60 years * ecog-performance status 0-1 * availability of a hla-compatible unrelated donor (hla-a, -b, -drb1, -dqb1) exclusion criteria: * serious concomitant medical disease that would limit life span or ability to tolerate chemotherapy * severe cardiac failure (ejection fraction \< 40%) * severe impairment of renal function (creatinine clearance \< 50ml/min) * severe impairment of liver function (bilirubine \> 2 fold of upper limits of normal) * pregnant or lactating women * other major organ or system dysfunctions(gi, neurological, psychiatric dysfunctions that would impair tolerance of chemotherapy or prolonged haematological recovery) * positivity for hiv

Keywords: hematopoietic stem cell transplantation multiple myeloma
effect of orange aroma on nausea, vomiting and anxiety during autologous stem cell transplantation

Conditions: Nausea; Vomiting; Anxiety State

Summary: patients undergoing stem cell transplantation for the first time will be entered. participants will be randomized to one of two study arms: arm 1: intervention (routine care+ inhalation aromatherapy); arm 2: control (routine care) hypotheses: (1) patients receiving inhalation aromatherapy will experience less severe nausea and less frequent vomiting episodes than those receiving only routine care; and (2) patients receiving inhalation aromatherapy will demonstrate lower anxiety levels just after ahsct than those receiving only routine care.

earlier research indicates that aromatherapy is promising to relieve in dmso related nausea and anxiety in autologous stem cell transplant patients. the current study seeks to confirm and extend these findings in a 2-arm, open-label randomized, controlled study of 70 cancer patients undergoing autologous stem cell transplantation. all patients will receive a standardized premedication. arm 1: intervention (inhalation aromatherapy with orange essential oil during stem cell infusion); arm 2: control (routine care). the researchers hypothesize that inhalation aromatherapy with orange essential oil will be effective in reducing dmso related nausea and vomiting and demonstrate lower anxiety levels just after autologous stem cell transplantation.

Eligibility criteria:
inclusion criteria: * age \> 18 years, * the absence of any mental conditions including depression, anxiety disorders, psychotic disorders or dementia that may affect the patients' communication abilities exclusion criteria: * patients with chronic obstructive pulmonary disease or asthma, * a history of allergy to orange or orange essential oil, * presence of persistent nausea and vomiting due to conditioning regimens, * receiving antiemetic other than routine premedication, * patients undergoing ahsct for the second or more time were excluded

Keywords: anxiety hematopoietic stem cell transplantation inhalation aromatherapy nausea randomized controlled trial
doxepin solution for alleviation of stubborn breakthrough pain induced by swallowing in patients receiving radiotherapy for nasopharyngeal carcinoma

Conditions: Swallowing-induced Pain

Summary: the goal of this clinical trial is to explore the effectiveness and adverse reactions of doxepin solution spray for alleviation of stubborn breakthrough pain induced by swallowing in patients receiving radiotherapy for nasopharyngeal carcinoma.

patients with nasopharyngeal carcinoma receiving radical radiotherapy or chemoradiotherapy who developed oral mucositis and had a swallowing-induced pain score ≥ 4 were recruited and randomly assigned 1:1 to the experimental group and the control group. patients in the experimental group received a doxepin solution spray to the posterior pharyngeal wall 10 minutes before eating. at least 12 hours later, when the swallowing-induced pain score ≥4, a placebo spray was administered to the posterior pharyngeal wall 10 minutes before eating. patients in the control group received a placebo spray to the posterior pharyngeal wall 10 minutes before eating. at least 12 hours later, when the swallowing-induced pain score ≥4, a doxepin solution spray was administered to the posterior pharyngeal wall 10 minutes before eating. the swallowing-induced pain and incidence of adverse events were assessed at 10 minutes, 20 minutes, 30 minutes, and 1 hour after medication using a patient-reported questionnaire, and safety evaluation was conducted 1 day after treatment.

Eligibility criteria:
inclusion criteria: 1. provide informed written consent. 2. age ≥ 18 years. 3. histologically confirmed as nasopharyngeal carcinoma, and currently undergoing radical radiotherapy or chemoradiotherapy. 4. physical examination demonstrating the presence of radiation-induced mucositis in the oral cavity and/or oropharynx. 5. at least 4 (out of 10) patient-reported swallowing-induced pain as measured by the numeric rating scale of pain. 6. being able to complete the questionnaires independently or with assistance. 7. ecog performance status 0, 1 or 2. exclusion criteria: 1. known allergy to doxepin, tricyclic antidepressants, or any known component of the drug formulation. 2. use of a tricyclic antidepressant or monoamine oxidase inhibitor within 14 days prior to registration. 3. current untreated or unhealed oral candidiasis or oral herpes simplex virus infection. 4. untreated narrow angle glaucoma within 6 weeks prior to registration. 5. untreated urinary retention within 6 weeks prior to registration. 6. administration of cryotherapy to prevent oral mucositis within 6 weeks prior to registration. 7. current serious heart disease or a recent history of myocardial infarction. 8. current untreated or unresolved conditions like epilepsy, hyperthyroidism, hepatic dysfunction, delirium, and neutropenia. 9. pregnant or lactating women.

Keywords: nasopharyngeal carcinoma oral mucositis radiotherapy swallowing-induced pain doxepin
bicarbonate v saline to prevent contrast nephropathy

Conditions: Kidney Failure, Acute; Contrast Media

Summary: slowing of kidney function occurs in a minority of people given dye during angiography. the purpose of this study is to compare two different types of fluid given into a vein to reduce the risk of kidney injury: salt in water or baking soda in water.

a decline in kidney function after contrast is associated with prolonged hospital stay, adverse cardiac events, and higher mortality both in hospital and in the long term. deliberate administration of fluids is recommended to reduce the risk of contrast nephropathy. however, data to support specific recommendations are lacking and the optimal fluid regimen remains unclear. it has been hypothesized that alkalinization of tubular fluid might be beneficial by reducing ph dependent free radical levels. a recent trial found a lower frequency of creatinine rise \> 25% within two days of contrast with a 7 hour infusion of isotonic sodium bicarbonate than with saline infusion (merten gj, jama 2004). however, it remains to be proven that bicarbonate is superior as this trial has a number of methodological flaws. comparison: iv 1/6 m sodium bicarbonate or iv 0.9% saline, each isotonic fluid given at the same rate of sodium administration (3.25 ml/kg over 1 hour pre-contrast, followed by 1.1 ml/kg/hr for 6 hours for bicarbonate; 3.5 ml/kg over 1 hour pre-contrast, followed by 1.2 ml/kg/hr for 6 hours for saline). total infusion time 7 hours (for both). maximum rate of fluid permitted is that for a body weight of 110 kg. intra-vascular iso- or low-osmolality contrast in the minimal dose needed to complete the required imaging.

Eligibility criteria:
inclusion criteria: * booked for cardiac or other non-renal arteriography * pre-existing reduced kidney function: serum creatinine \>= 1.3 \& \ = 1.5 \& \<= 5 mg/dl (male gender) * age \> 18 years exclusion criteria: * gfr mdrd estimate \< 15 ml/min/m2 * end-stage renal disease already on dialysis * known current acute kidney failure with serum creatinine rise of \> 0.5 mg/dl within 24 hours * pulmonary edema - current or within 48 hours * clinically relevant ascites, edema or other fluid overload * uncontrolled hypertension (\> 165 mmhg systolic, or \> 105 mmhg diastolic) * hemodynamically unstable patient requiring iv nitroglycerine, or iv fluid or inotropes for blood pressure support * emergency (unplanned) angiography * iv contrast procedure * exposure to iodinated radiocontrast within 3 days prior to study * prior anaphylactoid reaction to contrast * planned administration of n-acetylcysteine * planned administration of dopamine, fenoldopam or mannitol * current pregnancy

Keywords: contrast induced nephropathy chronic kidney disease acute renal failure end-stage renal disease cardiovascular diseases coronary catheterization percutaneous coronary intervention intra-arterial angiography bicarbonate saline
aggressive hydration in patients with st -elevation myocardial infarction undergoing primary percutaneous coronary intervention to prevent contrast-induced nephropathy

Conditions: ST Elevation Myocardial Infarction

Summary: to compare the efficacy of 2 different hydration strategies, hydration according to clinical guideline and adequate hydration, on contrast-induced nephropathy in patients with stemi undergoing primary pci to investigate the possible beneficial role of periprocedural adequate hydration.

all consecutive patients with stemi，age at least 18 years, who were candidates for primary pci at our institution were considered for enrollment in the present study. initial exclusion criteria were contrast medium administration within the previous 14 days, end-stage renal failure requiring dialysis, and refusal to give informed consent. eligible patients were randomly assigned in a 1:1 ratio to receive preprocedure and postprocedure hydration (adequate hydration group), hydration according to clinical guideline (guideline hydration group，control group )

Eligibility criteria:
inclusion criteria: * all consecutive patients with stemi, age at least 18 years, who were candidates for primary pci were considered for enrollment. exclusion criteria: * contrast medium administration within the previous 14 days or follow 72 hours, * end-stage renal failure or renal transplantation, and refuse pci or dead during the procedure, * heart failure of cardiac shock or new york heart association class iv, * recent acute kidney injury defined as an absolute increase of 0.5 mg/dl in serum creatinine over baseline in the past 24h * ,the presence of lactation, pregnancy, * malignant tumour or life expectancy less than 1 year, * allergy to contrast, peri-procedural receipt of metformin non-steroidalanti-inflammatory drugs in the past 48h and during the study period, * planned renal catheterization or heart valvular surgery。

Keywords: acute myocardial infarction,contrast,coronary intervention
effectiveness of a nurse-led integrative health and wellness programme among newly diagnosed type 2 diabetes patients

Conditions: Diabetes Mellitus, Type 2

Summary: this randomized controlled trial aims to investigate the effectiveness of an integrative medicine (traditional chinese medicine and western medicine) based structured education programme for newly diagnosed type 2 diabetes patients. the theoretical frame of this study is based on the health belief model and self efficacy theory. the hypotheses of this study are: 1) participants in the intervention group will have higher level of self-management behaviour after intervention compared to participants in the control group; 2) participants in the intervention group will have better diabetes knowledge after intervention compared to participants in the control group; 3) participants in the intervention group will have higher level of self-efficacy after intervention compared to participants in the control group; 4) participants in the intervention group will be less depressed after intervention compared to participants in the control group; 5) participants in the intervention group will have better qol after intervention compared to participants in the control group; 6) participants in the intervention group will gain greater reduction in hba1c after intervention compared to participants in the control group; 7) participants in the intervention group will gain greater reduction in fasting blood glucose after intervention compared to participants in the control group; 8) participants in the intervention group will gain greater reduction in bp after intervention compared to participants in the control group; 9) participants in the intervention group will gain greater reduction in bmi after intervention compared to participants in the control group.


Eligibility criteria:
inclusion criteria: * individuals diagnosed with type 2 diabetes in the preceding six months * individuals aged ≥ 18 years * individuals who were permanent residents of xi'an city, china * individuals without mental disorders * individuals who were voluntary to participate in the study exclusion criteria: * individuals with a terminal illness * individuals who were physically disabled * individuals who were taking part in other studies * individuals with aural or visual problems
perma-based intervention on negative emotions, adherence, and complications in postoperative glioma patients

Conditions: Glioma

Summary: the goal of this clinical trial is to evaluate whether a perma-based integrated psychological intervention can reduce negative emotions, enhance treatment adherence, and decrease the risk of complications in postoperative glioma patients. the main questions it aims to answer are: can the perma-based psychological intervention significantly improve anxiety and depression scores in postoperative glioma patients? does the intervention improve treatment adherence, reduce complications, and enhance quality of life compared to standard care? researchers will compare an observation group receiving the perma-based psychological intervention to a control group receiving standard postoperative care to see if the intervention improves patient outcomes. participants will: receive either standard postoperative care (control group) or perma-based psychological intervention for one month (observation group). be assessed on: self-rating depression scale (sds) and self-rating anxiety scale (sas). treatment adherence scale and complication record form. quality of life scale. be followed for complications using kaplan-meier survival analysis.


Eligibility criteria:
inclusion criteria: * ①meeting the relevant diagnostic criteria from the 5th edition of the world health organization classification of central nervous system (cns) tumors, and confirmed through postoperative pathological examination; * ②underwent surgical treatment; * ③clear consciousness, with good communication ability, and capable of cooperating with healthcare personnel to complete the study; * ④complete clinical data. exclusion criteria: * ①concurrent diagnosis of other malignant tumors; * ②coexisting cognitive impairment or other psychiatric disorders; * ③combined liver or kidney dysfunction, immune system disorders, or other severe diseases; * ④presence of infectious diseases; * ⑤pregnant or breastfeeding women.

Keywords: perma glioma integrated psychological intervention sas sds complication
investigating the effect of obesity on eosinophil recruitment in human adipose tissue

Conditions: Obese; Healthy

Summary: researchers are trying to better understand the relationship between inflammation in adipose tissue (at) and insulin resistance.


Eligibility criteria:
inclusion criteria: * adults ages 30-50 years * non-smokers * lean subjects with a bmi of 25 or less, gender specific normal body fat, * obese, non-diabetic subjects with a bmi between 30 and 50 and taking no medications affecting glucose metabolism or lipid metabolism * subjects scheduled for an elective laparoscopic or laparotomy abdominal surgery exclusion criteria: * receiving corticosteroid therapy or have a history of asthma, copd or atopic syndrome * taking any biologic treatment for any autoimmune disorder * taking any leukotriene receptor antagonist acting medications (ex. montelukast) * smoking
microperimetric evaluation after half-dose photodynamic therapy for chronic central serous chorioretinopathy

Conditions: Chronic Central Serous Chorioretinopathy

Summary: a half-dose photodynamic therapy, a relative new treatment, has been widely performed to treat central serous chorioretinopathy. the researchers aimed to investigate whether the therapy improved the patient's visual acuity as well as the retinal sensitivity. the researchers also investigate which clinical factors, if any, were associated with the results; visual acuity or retinal sensitivity after the treatment.

the best-corrected visual acuity (bcva), macular sensitivity, and fixation stability were evaluated at the baseline and at 1, 3, 6, and 12 months after the half-dose photodynamic therapy. the macular sensitivity and fixation stability were determined by mp-1 microperimetry (nidek, vigonza, italy). the researchers analysed whether the bcva and retinal sensitivity significantly improved or not. and if yes, the researchers were interested at which period after treatment the significant improvement was found. also, the researchers investigated which improved first, bcva or retinal sensitivity.

Eligibility criteria:
inclusion criteria: * the presence of subretinal fluid involving the fovea in the optical coherence tomographic (oct) images * a serous retinal detachment of at least 6 months duration. exclusion criteria: * evidence of a choroidal neovascularization (cnv), polypoidal choroidal vasculopathy, or other maculopathy documented by fluorescein angiography or indocyanine green angiography

Keywords: microperimetry fixation point retinal sensitivity photodynamic therapy chronic central serous chorioretinopathy
therapeutic effect of self-administered auricular acupressure on insomnia induced by anxiety

Conditions: Insomnia Due to Anxiety and Fear

Summary: this is a sham-controlled randomized trial to identify the effectiveness of treating insomnia induced by anxiety with self-administered auricular acupressure in malaysia.

112 subjects with insomnia and anxiety who fit to the inclusion and exclusion criteria will be recruited into the trial. after initial screening, subjects will be randomly allocated to vaccaria seed tapes (experimental arm) or non-varracia seed plain tapes (sham comparator arm). on the sixth day for the trial (after 5 days of daily auricular acupressure), the isi and ham-a score of subjects will be reassessed again. the subjects have to stop applying auricular acupressure for the next five days and reassess their isi and ham-a score again on the eleventh day.

Eligibility criteria:
inclusion criteria: * all malaysian aged above 18 years old who are suffering from chronic insomnia based on international classification of sleep disorders 3(icsd-3) and with insomnia severity index (isi) of 18 and above and more than 3 months. * willing to comply with the recommended periodic acupressure stimulation every day during the 1 week period. exclusion criteria: * subject with insomnia score below 18 based on insomnia severity index (isi). * subject with stress and anxiety level below 18 in the hamilton anxiety rating scale (ham-a). * subject with the history of skin sensitivity. * subject who just started on new medication to treat insomnia.

Keywords: auricular acupressure insomnia anxiety randomized sham controlled trial