Kornimate/medical-research-clean huggingface dataset:
efficacy study of ketamine for postoperative pain in opioid dependent patients

Conditions: Postoperative Pain

Summary: patients who are dependent on opioids often have poor pain relief after major surgery. this study tests the hypothesis that adding intravenous ketamine to a postoperative regimen of intravenous opioids for postoperative pain will improve pain relief in this subset of patients.


Eligibility criteria:
inclusion criteria: * chronic pain \> 6 months * long term use of opioids * major surgery exclusion criteria: * use of regional anesthetic techniques * no need for intravenous (iv) patient controlled analgesia (pca) after surgery

Keywords: ketamine postoperative pain opioid dependent patients acute pain control
a study to evaluate the performance of vibratip® by different clinical users

Conditions: Diabetes

Summary: vibratip® is a pocket-sized, wipe-clean, disposable device that provides a consistent source of gentle vibration. it has been specifically designed to overcome the limitations of tuning forks for testing the integrity of vibration sense in clinic and by the bedside. the product is a hand held device that is used to examine the feet of diabetic patients who are susceptible to peripheral neuropathy that can in turn lead to ulcers. treatment is expensive and can be over a period of time, often not being completely resolved, and can lead to amputation. the product will increase awareness of foot care and achieve a reduction in incidence of foot ulcers. the study aims to evaluate the accuracy of the vibratip device compared to the gold standard, the 10g semmes weinstein monofilament (mf) test, and the accuracy and usability of the vibratip® device, as measured by different community medical practitioners.

primary objective the accuracy of the vibratip® device, as measured by a comparison with the gold standard, the 10g semmes weinstein monofilament (mf) test by a diabetologist. secondary objectives the accuracy and usability of the vibratip® device, as measured by different community medical practitioners compared to expert validation by a diabetologist. prospective, single centre diagnostic evaluation. a single centre in the uk (tameside hospital nhs foundation trust). patients will be recruited while attending tameside hospital nhs foundation trust diabetes clinic for a routine 12 month diabetes check up. subjects will receive a patient letter to invite them to take part in the vibratip study and a patient information leaflet about the study enclosed within their diabetes clinic appointment. the study will aim to invite 180 patients to take part in the study and aims to recruit 100 subjects into the study within 3 months. subjects aged 18 to 75 (inclusive) of either sex with pre-existing diabetes (type 1 and type 2). the study aims to recruit approximately 50 (50%) of patients with diabetic peripheral neuropathy (both painful and painless) and 50 (50%) without diabetic peripheral neuropathy. (we will go for even split if possible)

Eligibility criteria:
inclusion criteria: subjects aged 18 to 75 (inclusive) of either sex subjects from whom consent has been obtained subjects with pre-existing diabetes (type 1 and type 2) exclusion criteria: * subjects unable to give consent * subjects aged less than 18 years or over 75 years * subjects with non-diabetic causes of neuropathy * subjects who have already taken part in the study * subjects who have active foot ulceration on the big toe * subjects who have pad abpi \< 0.7
effects of exercise on energy intake-prescription of resistance exercise

Conditions: Eating Behavior; Food Reward

Summary: healthy young males will complete five trials in a randomized crossover counter-balanced order, including three different inter-set rest of resistance exercise in equal training volume, one repeated until failure and sedentary control. during each trial, blood samples will be collected. the investigators hypothesized that different inter-set rest and training volume would affect subjective appetite and energy intake.


Eligibility criteria:
inclusion criteria: * age: 20-30 * healthy male exclusion criteria: * no acute or chronic musculoskeletal symptoms * smoking * alcohol or drug abuse * failure to conduct resistance exercise
mesa treatment for nk/t cell lymphoma

Conditions: Lymphoma, Extranodal NK-T-Cell

Summary: study on the efficacy and safety of mesa chemotherapy for treating nk/t cell lymphoma

extranodal natural killer (nk)/t-cell lymphoma (enktl), nasal type, is a distinct and heterogeneous histopathologic subtype of non-hodgkin lymphoma (nhl), accounting for 5%\~10%. the frequency of enktl among nhl patients is significantly higher in asia than in western countries. despite radiotherapy and chemotherapy, the prognosis for enktl patients is poor, with 5-year median survival time for primary nasal site was 5 years, for non-nasal extranodal sites 6 months. enktl is so aggressive and has high mortality rate and till now there is no standard therapy. in recent years smile chemotherapy has clinical efficacy and is one of first line therapy for enktl. however it is apparent that this regimen is extremely toxic with grade 4 neutropenia especially for asian patients. on these grounds, new therapy mesa is used for asian patients with enktl in order to achieve good efficacy and safety.

Eligibility criteria:
inclusion criteria: * pathological diagnosis is nk/t cell lymphoma； * at least one objective evaluation ( measurable ) lesions * age 15 \~ 60 years old, men and women are not limited * ecog(eastern cooperative oncology group）performance status 0\~3，expected to survive more than 3 months; * heart, kidney function in the normal range * liver function: transminase\< 2 times the normal value * pregnancy tests of women childbearing age must be negative; men and women agree to use effective contraception during the treatment and the following year * before the test sign the written informed consent exclusion criteria: * the early use of methotrexate or/and l-asparaginase; * pregnant or nursing, psychiatric patients complicated with malignant tumor * at the same time the application of other trial drug, drug contraindications exist in research; * serious infection or metabolic diseases * liver dysfunction, serum direct bilirubin, indirect bilirubin, transaminase 2 times higher than normal; serum total protein or albumin below normal; * renal insufficiency, creatinine clearance rate was 2 times higher than normal, especially the creatinine clearance rate is less than 30ml/min; * before entering the group, blood: white blood cell\< 3×10e9/l; absolute neutrophil count\<1.5×10e9/l; platelet\<100×10e9/l ( bone marrow is not violated ); platelet count \<75×10e9/l ( bone marrow invasion ); hemoglobin\<100g/l. * in the 6 months before entering the group, patients with uncontrolled or serious cardiovascular diseases, including myocardial infarction, iii-iv class heart failure, uncontrolled angina or clinically significant pericardial disease, and diabetes and phlebitis; * hiv antibody positive, hbsag positive after antiviral hbv(hepatitis b virus) dna titer in 104copies/ml the following groups. hiv antibody positive, hbsag+ and dna titer in 104copies/ml after antiviral hbv therapy * coagulation abnormalities.

Keywords: mesa, chemotherapy,nk/t cell lymphoma
study of sunitinib administered as 4/2 vs. 2/1 schedule in advanced renal cell carcinoma (rcc)

Conditions: Metastatic Renal Cell Carcinoma

Summary: this study is to evaluate the efficacy, safety, and feasibility of sunitinib in 4/2 and 2/1 regimen in previously untreated metastatic rcc to select the most promising regimen, which should be used in further studies of this patient population.


Eligibility criteria:
inclusion criteria: 1. histologically or cytologically confirmation of renal cell carcinoma with a clear cell histologic component 2. patients must present with stage iv disease not amenable to surgery, radiotherapy, or combined modality therapy with curative intent. 3. measurable disease according to recist criteria are required but patients with evaluable lesions without measurable lesions are allowed to be enrolled to this study 4. ecog performance status 2 or better 5. age 18 years or older 6. adequate bone marrow, hepatic, and renal function 7. life expectancy of \> 3 months 8. singed and dated informed consent of document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment exclusion criteria: 1. known spinal cord compression or carcinomatous meningitis 2. diagnosis of any serious secondary malignancy within the last 2 years, except for adequately treated basal cell or squamous cell carcinoma of skin, or in situ carcinoma of cervix uteri 3. hypertension that cannot be controlled by medications (blood pressure \> 150/90 mmhg despite optimal medical therapy) 4. treatment with anticonvulsant agents and treatment with therapeutic doses of coumadin currently or within 2 weeks prior to first day of sunitinib administration. low dose coumadin for dvt prophylaxis is permitted (up to 2 mg/day). 5. pregnancy or breast feeding. 6. other severe acute or chronic medical or psychiatric condition 7. prior treatment on sunitinib, sorafenib, or bevacizumab.

Keywords: renal cell carcinoma sunitinib phase ii study randomized study
the use of irvingia gabonensis (bush mango)and cissus quadrangularis to reduce weight and blood lipids

Conditions: Obesity; Overweight; Dyslipidemia

Summary: hypothesis: cissus quadrangularis as well as irvingia gabonensis are used in weight management and related conditions. this study set out to investigate if a combination of the two could have additional benefits to overweight and obese people.

to assess and compare the effects of administration of cissus quadrangularis (linn) and a cissus quadrangularis /irvingia gabonensis combination on body weight blood pressure, fasting blood glucose, plasma total and ldl cholesterol in 72 overweight and obese subjects. the study was a 10 week randomized, double-blind, placebo-controlled design, involving 72 obese or overweight participants. participants were randomly divided into three groups (24 participants/ group): group 1 - placebo; group 2 - cissus quadrangularis (cq); group 3 - cissus quadrangularis and irvingia gabonensis (cq-ig). the placebo (250mg) or active formulations ((150 mg cq and 250 mg cq-ig) were administered twice daily before meals. weight as well as fasting blood was taken at baseline, and at 4, 8 and 10 weeks. no major dietary changes or exercises were suggested during the study.

Eligibility criteria:
inclusion criteria: * bmi\>26kg/m2 exclusion criteria: * diabetics * pregnant and lactating * subjects on any other weight loss program * following any specific low calorie diet

Keywords: antiobesity weight loss
comparison of iv topotecan/docetaxel to docetaxel alone in second-line stage iiib/iv non-small cell lung cancer

Conditions: Lung Cancer, Non-Small Cell; Non-Small-Cell Lung Cancer

Summary: the purpose of this study is to compare the efficacy and safety of a weekly regimen of two fda approved drugs in combination versus one fda approved drug in subjects with advanced non-small cell lung cancer who have received one previous chemotherapy excluding taxotere or hycamtin.


Eligibility criteria:
inclusion criteria: * written informed consent * at least 18 years old * confirmed advanced non-small cell lung carcinoma (nsclc) * received one prior chemotherapy for metastatic nsclc excluding taxotere or hycamtin. in addition, subjects are allowed to have previously received a non-cytotoxic therapy, such as an endothelial growth factor receptor (egfr) or angiogenesis inhibitor. * presence of either measurable or non-measurable disease by radiologic study or physical examination. * full recovery and at least 21 days from prior treatment for nsclc; 42 days from treatment with mitomycin or nitrosureas and 30 days from prior non-cytotoxic therapy. * at least 3 weeks since last major surgery (a lesser period is acceptable if deemed in the best interest of the patient). * at least 7 days since prior radiotherapy. * a probable life expectance of at least 3 months. * adequate bone marrow reserve, cbc/platelet, kidney and liver function. exclusion criteria: * concomitant malignancies or other malignancies within the last five years. * symptoms of brain metastases requiring treatment with steroids. * active infection. * severe medical problems other than the diagnosis of nsclc that would limit the ability of the subject to follow study guidelines or expose the subject to extreme risk. * ongoing or planned chemotherapy (other than treatment during this study), immunotherapy, radiotherapy, or investigational therapy for the treatment of nsclc. * use of investigational drug within 30 days or 5 half-lives prior to the first dose of study medication. * women who are pregnant or lactating. * subjects of child-bearing potential refusing to practice adequate contraception. * prior treatment with or history of allergic reaction to either hycamtin or taxotere. * subjects who cannot receive steroid premedication.

Keywords: hycamtin taxotere non-small cell lung cancer nsclc docetaxel topotecan stage iiib/iv advanced
evaluation of treatment with zemplar capsules in the therapy of secondary hyperparathyroidism (shpt)

Conditions: Chronic Kidney Disease; Secondary Hyperparathyroidism

Summary: the aims of this post-marketing observational study (pmos) are to evaluate the time period needed to achieve \> 30% decrease of intact parathyroid hormone (ipth) compared to the initial values and to provide data on the tolerability and compliance of treatment with zemplar (paricalcitol) capsules in the therapy of secondary hyperparathyroidism (shpt) in patients with chronic kidney disease (ckd) stage 3 or 4 in conditions of routine clinical practice.

this is a non-interventional, observational, open-label, multi-country, multicenter post-marketing study in which zemplar (paricalcitol) is prescribed in the usual manner in accordance with the terms of the local marketing authorization. follow up visits will occur 1, 3, 6, 9, and 12 months after screening.

Eligibility criteria:
inclusion criteria: * patients 18 years of age or older * patients with chronic kidney disease (ckd) stage 3 and 4 and secondary hyperparathyroidism (shpt) * patients with intact parathyroid hormone (ipth) \> 70 pg/ml and with chronic kidney disease (ckd) stage 3 or with intact parathyroid hormone (ipth) \> 110 pg/ml and with chronic kidney disease (ckd) stage 4 * patients clinically indicated for treatment with zemplar capsules * patient must provide the authorization to use his/her data for statistical evaluation before entering to the post marketing observational study (pmos). local law requirements are to be followed exclusion criteria: * patients with clinically important hypercalcemia = calcium \> 2.6 mmol/l (10.5 mg/dl) * patients suffering from proved intoxication of vitamin d or patient with known hypersensitivity to paricalcitol or any other part of the product

Keywords: zemplar capsules chronic kidney disease (ckd) stage 3 or 4 secondary hyperparathyroidism (shpt) postmarketing observational study (pmos)
urological injuries during obstetric and gynecological operations

Conditions: Urologic Injuries

Summary: iatrogenic urinary tract injuries are more common during obstetric and gynaecological procedures averaging 2.6 per 1000 surgeries . the objective of the study is to estimate the incidence of iatrogenic urinary tract injuries and risk factors during obstetric and gynaecological operations. embryologically, the urinary system and genital system have a common origin, so anatomically they are so close that predisposes to iatrogenic trauma to it during obstetric and gynaecological operations. the bladder and distal ureters are the most commonly involved organs. the bladder is a retroperitoneal structure, its trigone rests over the anterior vaginal fornix and the base rests on lower uterine segment and cervix.

risk factors may contribute to intra-operative bladder injury - include : 1. prolonged labour with distended bladder. 2. obstructed labour. 3. previous cesarean section. 4. previous myomectomy. 5. previous laparotomy. 6. cases with possibility of altered anatomy, fibrosis or direct extension of disease process as in cases of chronic pelvic inflammatory disease, endometriosis, and large fibroids especially in the broad ligament, previous pelvic surgery, malignancy, previous irradiation and congenital abnormalities of urogenital system. 7. past history of uterine perforation, septic abortion. 8. in presence of labour, station of the presenting fetal part deeper than or equal to +1, and a large baby were independent risks for a bladder injury during caesarean section. 9. well effacement and dilatation of cervix (uterine incision may fall over vagina and dissection of bladder from vagina is difficult in compare to lower uterine segment). 10. preterm cesarean section where lower segment is not well formed. 11. during cesarean hysterectomy. 12. rupture uterus may also be combined with bladder injuries. 13. placenta percreta may penetrate the bladder and cause injury. urinary tract injury can be diagnosed intraoperative : 1. presence of urine in the operative field. 2. hematuria 3. methylene blue test

Eligibility criteria:
inclusion criteria: * women that undergo obstetric or gynecological surgery complicated by urinary tract injury * aged 15 years or older * elective surgeries * good performance status exclusion criteria: * not meeting all of the inclusion criteria
a phase i/ii study of s-1 and weekly docetaxel for metastatic gastric carcinoma

Conditions: Stomach Neoplasms

Summary: this study is an open-label, single center, nonrandomized study, consisting of a dose-escalating phase i study in advanced solid cancer and a subsequent phase ii study in metastatic gastric cancer. in phase i study, we aim to determine the mtd and the recommended dose of s-1 combined with docetaxel given every 3 weeks. dose level and escalating schedule are followings * s-1(level 0, 1/2, 3/4, 5: 60, 70, 80, 90 mg/m2/day) q 12 hours po days 1-14) * docetaxel (level 0/1,2/3, 4/5: 25, 30, 35 mg/m2) mixed in d5w 200 ml iv over 60 min: days 1, 8with dexamethasone 8 mg po q 12hr for 3 days (total 6 doses: d0-2)and parenteral pheniramine maleate 1 ample (45.5mg) before docetaxel


Eligibility criteria:
inclusion criteria: 1. in phase i:histologically or cytologically confirmed advanced solid cancer in phase ii:histologically or cytologically confirmed metastatic gastric adenocarcinoma 2. age: over 18 years 3. no prior chemotherapy or radiotherapy (including any adjuvant hemotherapy) in phase ii portion previous chemotherapy up to two regimens (including adjuvant chemotherapy) is allowed in phase i portion; patients are required to have discontinued chemotherapy, immunotherapy, and radiotherapy for at least 4 weeks before entry into phase i portion 4. disease status must be that of measurable disease defined as: lesions that can be accurately measured in at least one dimension \>10 mm with spiral ctscan and palpable ln (including supraclavicular ln) in physical examination. 5. performance status: ecog 0-2 6. adequate major organ function including the following hematopoietic function: wbc\>4,000/mm3 or anc\> 2,000/mm3, platelet count ³ 100,000/mm3hepatic function: bilirubin unl (upper normal limit), ast/alt levels 2.5x unl renal function: creatinine unl 7. patients should sign an informed consent exclusion criteria: 1. inadequate cardiovascular function: new york heart association class iii or iv heart disease active angina or myocardial infarction within the past 6 monthshistory of significant ventricular arrhythmia requiring medication with antiarrhythmics or significantconduction system abnormality 2. other malignancy within the past 3 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix 3. pregnant or nursing women 4. serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy 5. psychiatric disorder that would preclude compliance 6. patients receiving a concomitant treatment with drugs interacting with s-1 or docetaxel: flucytosine, phenitoin, warfarin et al.

Keywords: stomach neoplasms phase i/ii combination chemotherapy s-1 docetaxel
project women's insomnia sleep health equity study (wishes)

Conditions: Insomnia; Sleep Health; Cardiometabolic Health

Summary: the purpose of this study is to achieve health and healthcare equity by implementing an equity-focused, mindfulness-based sleep intervention to reduce stress and sleep deficiency-related cardiometabolic disease burden in black women.

in phases 1 and 2, the investigator will identify multi-level barriers and facilitators to implementing the online mindfulness-based therapy for insomnia (mbti) through an equity lens using community-engaged research with key stakeholders. the investigators will then develop and refine equity-focused implementation strategies with the community advisory board, comprised of community-based organization members, african methodist episcopal zion church networks, clinicians, and community health workers (chws). in phase 3, the investigators will use a hybrid type 1 effectiveness/implementation design with a pragmatic randomized controlled trial with mbti and a waitlist control in black women with insomnia. specialists will assess and address social needs of black women, and registered nurses will deliver the online mbti intervention in the community settings. the focus of this registration is phase 3. the study will contribute to equity-focused implementation science and policy decisions by providing multi-level implementation determinants, equity-relevant metrics, and contextual factors through community-engaged research and evaluation of the outcomes.

Eligibility criteria:
inclusion criteria: * self-identified black women * english speaking * meet icsd3 diagnostic criteria for insomnia disorders, defined as difficulty initiating or maintaining sleep that occurs despite adequate opportunity to sleep with at least one associated daytime impairment symptom (isi \> 7) * additional quantitative insomnia criteria based on research recommendations and the new icsd3: (a) severity of sleep onset latency or wake time after sleep onset of ≥31 min, (b) occurring ≥3 nights a week, and (c) for ≥ 3 months. exclusion criteria: * psychosis or unstable/significant depression, anxiety, or substance abuse under active care (more than 1 monthly mental healthcare visit or requiring more than 1 psychotropic medicine daily) * significant current practice of any form of meditation (\>15min per day) * obstructive sleep apnea (osa), restless legs syndrome (rls), or circadian rhythm related condition (shift worker, use of medication that influence circadian rhythm, e.g., parkinson's disease) * active or terminal cancer.
special survey for paediatric subjects

Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: this study is conducted in japan. the aim of this study is to collect safety and efficacy data when using novorapid® (insulin aspart) in children with type 1 and type 2 diabetes under normal clinical practice conditions.


Eligibility criteria:
inclusion criteria: * requiring insulin therapy * no treatment history of novorapid® (insulin aspart)