Kornimate/medical-research-clean huggingface dataset:
intercalated combination of chemotherapy and tyrosine kinase inhibitors as first-line treatment for patients with non-small-cell lung cancer

Conditions: Non-Small-Cell Lung Cancer

Summary: objective: to compare the efficacy and safety of chemotherapy plus intercalated egfr-tyrosine kinase inhibitors (tki) combination therapy with tki alone therapy as first-line treatment for patients with non-small-cell lung cancer (nsclc). methods: patients with untreated, stage iiib/iv, egfr mutation-positive nsclc will be randomly assigned to combination therapy group (receiving four cycles of docetaxel or pemetrexed (on day 1) plus platinum (on day 1) with intercalated tki (gefitinib, erlotinib or icotinib, on day 2-15) every 3 weeks) or tki alone therapy (gefitinib, erlotinib or icotinib, daily). all patients were continued to receive tki until progression or unacceptable to toxicity or death. the primary endpoint was progression-free survivial (pfs). expected results: pfs of combination therapy group will be prolonged to nineteen months while pfs of tki alone therapy group is ten months. overall survival (os) of combination therapy group will be prolonged to 36 months while os of tki alone therapy group is 26 months. hypothesis: platinum-based chemotherapy plus intercalated tki combination therapy as first-line treatment will prolong pfs and os for patients with nsclc.


Eligibility criteria:
inclusion criteria: * adult patients, \>=18 years of age; * advanced (stage iiib/iv) non-small-cell lung cancer; * although stageⅰ-ⅲa, have contraindications to surgery; * egfr mutation-positive (egfr exon-18, exon-19 or exon-21); * measurable disease; * ecog performance status 0 or 1 or 2. exclusion criteria: * wild-type egfr; * prior exposure to agents directed at the her axis; * prior chemotherapy or systemic anti-tumor therapy after advanced disease; * unstable systemic disease; * any other malignancy within last 5 years, except cured basal cell cancer of skin or cured cancer in situ of cervix; * brain metastasis or spinal cord compression.
absorbable versus non-absorbable sutures for wound closure in carpal tunnel release

Conditions: Carpal Tunnel Syndrome; Wound Infection; Suture, Complication

Summary: carpal tunnel syndrome is a prevalent condition, up to 9% in women and 0.6% in men. surgical decompression in the most effective treatment. after surgery, approximately 1,8% of the patients develop a wound infection. possibly, the type of sutures used can influence the prevalence of wound infection. in this rct the incidence of infection is investigated between the use of absorbable versus non-absorbable sutures in carpal tunnel release.

carpal tunnel syndrome is a prevalent condition; up to 9% in women and 0.6% in men. it causes complaints of paresthesia, pain, numbness and loss of strength. surgical decompression is the most effective treatment. after surgery, approximately 1,8% of the patients develop a wound infection. possibly, the type of suture material which is used can influence the prevalence of wound infection. in current clinical practice both absorbable and non absorbable sutures are used. in literature, various hypothesis are described: absorbable sutures could give more reaction of macrophages and therefore a higher chance on infection. this would not be the case for non-absorbable sutures, since they will be removed. however, in literature, there is still not enough evidence for superiority of absorbable or non-absorbable suture. in this rct the incidence of infection is investigated between the use of absorbable versus non-absorbable sutures in carpal tunnel release. the primary outcome is the asepsis wound score. this will be scored by independent investigators. use of antibiotics, handtherapy and extra outpatient visits will be recorded. patients are asked to register their nrs scores the first three weeks after surgery.

Eligibility criteria:
inclusion criteria: • indication for carpal tunnel release exclusion criteria: * carpal tunnel syndrome which has yet been operated * injection with corticosteroids

Keywords: carpal tunnel syndrome wound infection absorbable sutures non-absorbable sutures
phase i/ii study of linperlisib plus chidamide for r/r peripheral t-cell lymphoma: a prospective, multi-center study

Conditions: Peripheral T Cell Lymphoma

Summary: hdac inhibitor chidamide and pi3k inhibitor linperlisib has shown clinical activity as mono-therapy in ptcl. the combination of duvelisib and romidepsin is highly active for relapsed and refractory ptcls. the aim of this study is to further explore the efficacy and safety of hdac inhibitor chidamide combined with pi3k inhibitor linperlisib in the treatment of relapsed and refractory ptcls.


Eligibility criteria:
inclusion criteria: * ages 18-75; * pathologically confirmed diagnosis of ptcl, not otherwise specified (ptcl, nos), anaplastic large cell lymphoma (alcl), angioimmunoblastic t-cell lymphoma (aitl), or other ptcl subtypes that the researchers considered to be eligible; * fulfills the criteria for relapsed/refractory lymphoma; * there must be at least one measurable lesion: for measurable lymph node, the longest diameter should be \> 1.5cm, for measurable extranodal lesion, the longest diameter should be \> 1.0cm; * ecog score of 0-2; * adequate bone marrow hematopoietic function: neutrophil count (anc) ≥1.5×109/l, platelet count (plt) ≥80×109/l, hemoglobin (hgb) ≥90g/l; * adequate organ function: nyha grade 1-2, lvef≥50%, alt\ 93%@ra, scr\>60ml/(min·1.73m2); exclusion criteria: * extranodal natural killer/t cell lymphoma; * previously treated with pi3k inhibitors; * acute myocardial infarction or unstable angina, congestive heart failure, symptomatic arrhythmia, and significantly prolonged qt interval (\> 450ms in men and \> 470ms in women) within 6 months; * uncontrolled active infections; * active hepatitis b and c infection (hepatitis b virus dna over 1×103 copies /ml is excluded, hepatitis c virus rna over 1×103 copies /ml is excluded); * pregnant or lactating women;
astragalus membranaceus for brain edema induced by hemorrhagic stroke

Conditions: Stroke; Hemorrhagic Transformation Due to Acute Stroke

Summary: astragalus membranaceus (am) is used to treat stroke for a long period, and a number of studies have known that am can reduce cerebral infarction area and has anti-oxidation. hemorrhagic stroke will induce secondary peri-blood clot edema and that may increase intracranial pressure to exacerbate clinical symptom. therefore, the purpose of the present study was to investigate the effect of am on hemorrhagic stroke edema. the investigators selected 80 hemorrhagic stroke patients , and who the stroke is first attack, they were randomly divided into control and experimental groups, and each group was 40 patients as follows: 1) control group, accepted am placebo 2.8 g three times per day (tid) treatment for continuously 14 days from second day of admission or operation, except standard ordinary treatment; 2) experimental group, accepted am 2.8 g tid treatment for continuously 14 days from second day of admission or operation, except standard ordinary treatment. computer tomography (ct) examination was done at first day, 4th day and 7th day of admission, respectively. the ratio of brain edema was calculated by ct image, and inflammatory index including the levels of c-reactive protein (crp), erythrocyte sedimentation rate (esr)，creatine kinase bb isoenzyme (cmbb). d-dimer from venous blood also were measured. in addition, the score including glasgow outcome scale (gos), modified rankin scale (mrs), function independence measure (fim), barthel index (bi) was recorded one week, four weeks and 12 weeks after admission or surgical operation, as an index for clinical symptoms. the index for the therapeutic effect of am was according to above-mentioned the ratio of brain edema, inflammatory index and clinical symptoms. the investigators expected the results of the present study may provide a scientific evidence for the hemorrhagic stroke edema treatment of am, thus, the present study may contribute to use the method of integrated chinese and western medicine for the treatment of stroke, and to the research of chinese medicine.


Eligibility criteria:
inclusion criteria: 1. female or male; 2. aged between 30 and 75 years; 3. randomized allocation to a study group within 24 hours of hemorrhagic stroke onset; 4. this was the patient's first hemorrhagic stroke, and the location of hemorrhage was the putamen; 5. treatment may or may not have been included surgery; and 6. the subject or their legal representative gave written informed consent to participate. exclusion criteria: 1. recent thrombolysis treatment; 2. history of previous stroke; 3. full-dose or long-term anti-coagulation therapy; 4. hemorrhagic stroke but the location was not putamen; 5. coexisting systemic diseases such as terminal cancer, renal failure, liver cirrhosis, severe dementia, or psychosis; 6. participation in another clinical trial within the last three months; and 7. pregnancy or lactation.

Keywords: complementary therapies acute hemorrhagic stroke
effectiveness and safety of lenvatinib combined with chinese herbal medicine for patients with unresectable hepatocellular carcinoma: a real-world study in china

Conditions: Unresectable Hepatocellular Carcinoma

Summary: this study aims to assess the effectiveness and safety of lenvatinib plus chinese herbal medicine (chm) for patients with uhcc in china.

liver resection is one of the most important treatments for hepatocellular carcinoma (hcc). however, only a minority of patients have the opportunity to undergo surgery. the development of systemic therapy has dramatically changed the management of unresectable hcc (uhcc). and lenvatinib garners a recommendation as the primary treatment for uhcc. many patients with uhcc in asian countries seek complementary and alternative therapies with traditional chinese medicine (tcm). however, the impact of lenvatinib combined with chm on uhcc patients remains unclear. in this study, we conducted a retrospective cohort study to assess the effectiveness and safety of lenvatinib plus chm for patients with uhcc in china.

Eligibility criteria:
inclusion criteria: * at least 18 years old * histologically confirmed hcc unsuitable for resection * lenvatinib as first- or second-line therapy exclusion criteria: * patients with other primary tumors * patients who had only one visit record and were lost to follow-up or refused follow-up * patients with any other factors affecting study data collection
prevalence and risk factors for postoperative delirium 48 hours after surgery

Conditions: Postoperative Delirium

Summary: to determine the overall prevalence of postoperative delirium (poi) and its association with different risk factors in order to establish prevention plans to reduce its incidence and/or duration in spanish hospitals. to this end, patients over 18 years of age who underwent urgent and scheduled surgery requiring hospital admission under any type of anaesthesia during two specific days will be recruited and pre-, intra- and postoperative data will be collected.


Eligibility criteria:
inclusion criteria: * patients over 18 years of age undergoing urgent and scheduled surgery requiring hospital admission, under any type of anaesthesia. exclusion criteria: * presence of pre-surgical delirium. * outpatient surgery.
a trial evaluating efficacy and safety of oxaliplatin with 5-fluorouracil in patients with recurrent ovarian carcinoma

Conditions: Ovarian Carcinoma; Relapse

Summary: this is a phase ii study for recurrent ovarian carcinoma platinum-sensitive and resistant tumors folfox regimen.

evaluation of the safety and the efficacy of a combination of oxaliplatin and 5fu (folfox) in patients with ovarian carcinoma relapsing either after platinum-combined regimen. the folfox regimen is administered every 14 days. evaluation of the toxicity is performed at each cycle and evaluation of the efficacy every 4 cycles of chemotherapy.

Eligibility criteria:
inclusion criteria: * ovarian carcinoma relapse exclusion criteria: * neurotoxicity grade iii renal clearance \< 60 ml/min

Keywords: ovarian carcinoma bordet relapse
quell opioid reduction and pain relief in patients with cancer

Conditions: Pain; Metastatic Breast Cancer; Prostate Cancer; Colorectal Cancer

Summary: to study effects the quell device has on opioid consumption and pain relief in patients with cancer.

single site, double blinded, placebo controlled randomized clinical trial. 40 subjects will be selected based on the inclusion criteria and then randomized to either the intervention group or the placebo control group. prior to the start of this study, a controlled substance utilization review and evaluation (cures) reports will be acquired to establish baseline number of opioid prescriptions for each subject. subjects will track how consistently they are using pain medications, both opioids and non-opioids, during the two weeks prior to the start of the study. they will also provide twice daily recordings of their pain intensity via a mobile application. at the end of this two-week period, each subject will be fitted with a quell device or a sham device, including initial calibration to the subject's comfort level as described in the background section.once the study subjects have started using the device, we will also be able to monitor and track their sleep wirelessly via the mobile application as long as they are wearing the device. subjects will receive weekly check in's to monitor the functionality of the device and to help troubleshoot any issues with the device for the duration of subject participation in the study. these check-ins will take place in person, by phone, and or per subject's usual outpatient oncology visits. each subject will use their device for 8 weeks, during which they will continue to track their pain, sleep and frequency of pain medication use as stated above. study investigators will receive automated alerts via email to ensure that study are participants using their devices and that the devices are powered on at regular intervals for the duration of the study.total duration of subject participation will be 10 weeks.

Eligibility criteria:
inclusion criteria: 1. male or female greater than or equal to 18 year of age at visit one. 2. documented diagnosis of metastatic breast, prostate or colorectal cancer with a prognosis of 6 month or greater as determined by the primary oncologist. 3. visual evidence that subject owns a smart phone and is able to use basic mobile applications such as downloading an app, opening the app, and performing one simple task within the app. 4. subject speaks and reads english fluently. 5. subject able to understand and grant informed consent. 6. live in an area with cellular data connectivity available as provided by the subject. 7. documented adherence with clinic follow up visits per medical records. 8. subject using at least one opioid medication on a daily basis. exclusion criteria: 1. subject has a cardiac pacemaker, implanted defibrillator or other implanted electronic device. 2. inability to complete subjective data as required; e.g. on mobile application and questionnaires. 3. does not live in an area with suitable cellular data connectivity. 4. has infrequent scheduled clinic visits.
comparison of tai chi and frenkel's exercises in patients with stroke

Conditions: Stroke

Summary: the main objective of this study is to compare the effectiveness of tai chi and frenkel's exercises to improve balance, fall risk and activities of daily living in patients with stroke.

a total of 44 patients will be recruited after inclusion and exclusion criteria. patients will be recruited through nonprobability convenience sampling technique and will be randomized through lottery method into either a group a or a group b, and for each group, the number of patients will be identical. group a will receive tai chi exercises for 1-hour class, 3 times per week for 12 weeks along with routine physical therapy. routine treatment includes range of motion (rom) exercise, stretching \& strengthening exercises, passive movements \& gait training. group a will receive the tai chi exercise with conventional treatment and group b will receive frenkel's exercise with conventional treatment. treatment dosage will be 1 session per day of 1 hour class, 2 sets per session, and 5 repetitions per set, 3 times per week and for 12 weeks. patients will be assessed at baseline and after the treatment using a variety of measurement scales. after the completion of this time period, the assessment of balance, activities of daily living and fall risk will be performed again and will be compared to baseline assessment to check the comparison between 2 interventions. the risk fall will be measured by stratify risk assessment tool, activities of daily will be measured by the barthel index (bi) , while balance will be assessed by using berg balance scale (bbc). data will be analyzed by using spss (statistical package for social sciences) 23 version.

Eligibility criteria:
inclusion criteria: * community-dwelling survivors of stroke who were aged ≥50 years * both genders can participate in the study * ≥3 months poststroke * the vital signs were stable * survivors of both hemorrhagic and ischemic stroke * modified rankin scale 14 score of three or less * short physical performance battery 15 score of 3 to 9 * mini-mental state exam 16,17 score of 18 or greater. exclusion criteria: * the subject is unable to perform exercises. * subjects with diagnosed vestibular disease. * the subjects included in the experiment were normal elderly without stroke diseases. * the subjects had dyskinesias and could not complete tai chi exercises. * serious medical condition (e.g. active cancer treatment. * stroke survivors whom had no disability that would interfere with study participation. * subject taking medications that increases the incidence of fall. * subjects who undergoes strength and balance training in the past 3 months.

Keywords: tai chi exercise frenkel's exercise stroke adl fall risk balance
a study to investigate the response of participants with type 2 diabetes mellitus on once-weekly retatrutide to hypoglycemia

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to measure the effect of retatrutide versus placebo, administered every week, on time to recovery from hypoglycemia during hypoglycemic clamp in participants with type 2 diabetes mellitus (t2dm) following 16 weeks of treatment.


Eligibility criteria:
inclusion criteria: * have been diagnosed with t2dm for at least 6 months prior to screening. * treated with diet and exercise and stable treatment with metformin with or without allowed oral antihyperglycemic medications (oams), 3 months prior to screening. * treatment with metformin will be considered stable if all prescribed total daily doses for this period were ±850 mg from the original prescription for the same participant. * allowed oams include dipeptidyl peptidase-4 (dpp-iv) inhibitors, sodium-glucose co-transporter-2 (sglt2) inhibitors, glinides, or sulfonylureas. * have a hemoglobin a1c value at screening of * ≥6.5% and ≤9.5% if on metformin only or * ≥6.0% and ≤8.5% if on metformin in combination with allowed oams. * have a bmi within the range 25.0 kg/m2 and 45.0 kg/m2 kg/m2 (both inclusive). * have had a stable body weight that is less than 5% change in body weight for more than 3 months prior to screening. exclusion criteria: * have type 1 diabetes mellitus. * have had more than 1 episode of severe hypoglycemia, as defined by the american diabetes association criteria, within 6 months before screening or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms. * have had 1 or more episodes of ketoacidosis or hyperosmolar state/coma requiring hospitalization within the 6 months prior to screening. * have impaired renal estimated glomerular filtration rate \<60 ml/min/1.73 m2 calculated by chronic kidney disease-epidemiology. * have acute or chronic pancreatitis or a history of acute idiopathic pancreatitis. * have elevations in * serum aspartate aminotransferase (ast) \>2.5× upper limit normal (uln) * serum alanine aminotransferase (alt) \>2.5×uln * total bilirubin level (tbl) \>1.5×uln, or * alkaline phosphatase (alp) level ≥1.5× uln. * have a known clinically significant gastric emptying abnormality.
the effect of toremifene treatment to the magnetic resonance imaging (mri) findings in premenstrual mastalgia

Conditions: Breast Pain

Summary: the purpose of this study is to determine the effect of toremifene treatment to the mri findings of the breast in women suffering from premenstrual mastalgia.

benign breast pain is a common complaint of women in western countries. as many as 41-69% of women reported having mastalgia sufficient to interfere with their daily routines. approximately 8-10% of premenopausal women suffer monthly from moderate to severe breast pain.tamoxifen has previously been found to be effective in reducing premenstrual mastalgia. we showed that another triphenylethylene derivative, toremifene, significantly alleviated cyclical breast pain as compared to placebo. in this study women suffering from cyclical breast pain are randomly allocated to receive toremifene (20mg) or placebo during the luteal phase for three consecutive cycles. the patients are then crossed over after a wash-out period to placebo or toremifene, respectively. the mri investigations are made at two occasions during the premenstrual period after three cycles of toremifene and after three cycles of placebo.

Eligibility criteria:
inclusion criteria: * premenstrual mastalgia * age 20-45 years * reliable non-hormonal contraception exclusion criteria: * pregnancy * breast cancer or uterine corpus cancer * unexplained menstrual disorders * serious health problems * hormonal contraception, including hormonal iud trade name mirena * oestrogen and/or progestin treatment * hysterectomy and/or oophorectomy or radiation therapy * artificial cardiac pacemaker/metallic prostheses

Keywords: premenstrual syndrome mastalgia toremifene selective estrogen receptor modulators