Kornimate/medical-research-clean huggingface dataset:
safety study of recombinant napc2 to prevent tumor progression and metastases in metastatic colon cancer

Conditions: Colon Cancer

Summary: this is a multicenter, two-stage trial with the goal of evaluating up to 100 subjects. this trial will be performed to initiate identification of a safe and effective dose of twice-weekly, subcutaneous rnapc2 for the second-line treatment of metastatic colorectal carcinoma in combination with contemporary 5-fu-based chemotherapy.

cytotoxic chemotherapy combining 5-fluorouracil and leucovorin with irinotecan (folfiri) or oxaliplatin (folfox) or, more recently, treatment with xelox (roche) (capecitabine + oxaliplatin) has been the main approach for the treatment of metastatic colorectal carcinoma (mcrc), but with the advent of targeted therapies, biologic treatments are becoming an area of intense interest. tissue factor (tf) is a transmembrane glycoprotein expressed by upwards of 85% of mcrcs.

Eligibility criteria:
* tissue diagnosis of adenocarcinoma of the colon or rectum * documented metastatic disease with at least one measurable lesion by recist criteria * previously treated with 5-fu-based chemotherapy in the form of folfiri, folfox, or xelox plus bevacizumab as first-line chemotherapy and have recorded progressive disease during treatment or after discontinuation of treatment, when discontinuation of treatment occurred less than 6 months before enrollment (stage i) or randomization (stage ii) * estimated life expectancy of at least 6 months * age 18 to 75 years * last dose of adjuvant or radiosensitizing chemotherapy less than 6 months before enrollment * no other active malignancy for which the subject is currently receiving treatment (other than mcrc) * no ongoing therapy with or need for parenteral and oral antithrombotics including anticoagulants and anti-platelet agents (including aspirin) and thrombolytics * no contraindication to systemic anticoagulation * no contraindication to modified folfox6 or folfiri combination chemotherapy * no receipt of any investigational compound within 28 days of enrollment

Keywords: metastatic colorectal carcinoma (mcrc) colorectal carcinoma (crc) tissue factor factor viia rnapc2 adenocarcinoma targeted therapy coagulation-dependent recist 5-fu-based chemotherapy folfox folfiri leucovorin xelox
evaluate analgesic/sedative efficacy of naproxen sodium and diphenhydramine

Conditions: Sleep

Summary: the objectives of the study are to evaluate the analgesic and hypnotic efficacy of naproxen sodium and diphenhydramine combination when compared to naproxen sodium, diphenhydramine, and an ibuprofen and diphenhydramine combination


Eligibility criteria:
inclusion criteria: * healthy, ambulatory, male and female volunteers between 16-45 years of age; * scheduled to undergo surgical removal of 1 to 3 impacted third molars, one of which must be at least a partial bony mandibular impaction; * have moderate to severe postoperative pain on the categorical pain rating scale and a score of \>/= 50 mm on the 100-mm visual analog pain severity rating scale by 2030 h +/- 15 minutes on the day of surgery; * female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g. oral or patch contraceptives, intrauterine device, depo-provera, or double-barrier and have a negative pregnancy test at screening and prior to surgery. female subjects of nonchildbearing potential must be amenorrheic for at least 2 years or had a hysterectomy and/or bilateral oophorectomy; * provide a personally signed and dated informed consent indicating that the subject has been informed of all pertinent aspects of the trial, (subjects \<18 years of age must sign a written assent and have parental or guardian consent). exclusion criteria: * history of hypersensitivity to naproxen, diphenhydramine, nonsteroidal antiinflammatory drugs (nsaids), tramadol, aspirin or any other antihistamine and similar pharmacological agents or components of the products; * evidence or history of clinically significant (in the judgment of the investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases, or malignancies within the last 5 years; * relevant concomitant disease such as asthma (exercise induced asthma is permitted), chronic sinusitis or nasal structural abnormalities causing greater than 50 percent obstruction (polyposis nasi, marked septal deviation) that can interfere with the conduct of the study in the judgment of the investigator; * current or past history of bleeding disorder(s); * acute illness or local infection prior to surgery that can interfere with the conduct of the study in the judgment of the investigator; * chronic use of antihistamines defined as using 5 or more times a week for 2 or more consecutive weeks during the past 3 months; * positive alcohol breathalyzer test and negative urine drug test prior to surgery; * females who are pregnant or lactating; * chronic or severe sleep problems that do not respond to over the counter (otc) medication and requires a prescription hypnotic or sedative;

Keywords: naproxen sodium diphenhydramine drugs, investigational
explored about temperature packing care to improve the quality of life for chemotherapy induced peripheral neuropathy (cipn) in colorectal cancer and gastric cancer patient

Conditions: Colorectal Cancer; Gastric Cancer; Chemotherapy-induced Peripheral Neuropathy

Summary: investigate the effectiveness of cold and hot compress interventions in reducing peripheral neuropathy induced by oxaliplatin chemotherapy in colorectal cancer and gastric cancer patients. the primary outcome measures include quality of life, and secondary outcome measures encompass the severity of peripheral neuropathy, manual dexterity assessed through finger strength testing, and the effects on microcirculation blood flow in the hands and feet

chemotherapy-induced peripheral neuropathy (cipn) is a common side effect in cancer patients undergoing chemotherapy, with an overall incidence rate of approximately 70-100% for oxaliplatin. the symptomatology typically manifests as a "glove and stocking" neuropathy, leading to sensory abnormalities that significantly impact patients' activities of daily living and reduce their overall quality of life. furthermore, it may result in dosage reduction, treatment delays, or interruptions. studies indicate that residual symptoms persist in 68.1% of patients one month after the completion of chemotherapy, emphasizing the long-term effects of cipn on post-treatment individuals. consequently, there is a pressing need for evidence-based preventive intervention research.

Eligibility criteria:
inclusion criteria: * individuals aged 20 and above, inclusive, can autonomously decide to participate in this study and complete the participant consent form. * patients diagnosed with colorectal cancer, receiving chemotherapy for the first time, and being prescribed the standard folfox regimen with oxaliplatin as the primary agent are eligible. the dosage is 85mg/m2 administered over a 2-hour injection every 14 days, constituting one treatment cycle. a total of 6 treatment cycles will be conducted. exclusion criteria: * individuals with an undiagnosed medical condition. * individuals with thyroid disorders, diabetes, undergoing dialysis, pregnant, alcohol abusers, and those with immune-related diseases such as lupus erythematosus, scleroderma, dermatomyositis, and rheumatoid arthritis are excluded from the study.. * individuals with defects in hands, feet, or fingers.

Keywords: hot compressing colon cancer colorectal cancer chemotherapy-induced peripheral neuropathy gastric cancer
a novel approach to community-based hiv testing with traditional healers in mwanza, tanzania

Conditions: HIV; Health Behavior

Summary: hiv antiretroviral therapy (art) has the potential to dramatically decrease hiv transmission worldwide. in tanzania, hiv prevalence is \~5%, with 1.6 million people living with hiv/aids; it is the leading cause of hospitalization and death among tanzanian adults. however, less than 50% of hiv-infected tanzanian adults know their status.successful implementation of community-based services requires an understanding of the social and cultural context that influence community engagement with hiv services. specifically, many hiv endemic regions are also medically pluralistic communities, where multiple explanatory frameworks for health and disease co-exist. in these areas, hiv testing and art clinical care do not occur in isolation; traditional healers are commonly utilized instead of or concurrently with biomedical services. therefore, the success of decentralized, community-based hiv services must be founded upon a thorough understanding of medical pluralism, and engagement with traditional healers as stakeholders in community health. this study will investigate the feasibility of involving traditional healers in hiv testing, and pilot an intervention to expand hiv testing within communities that use traditional medicine in mwanza, tanzania.

this study has two specific aims. specific aim 1: tailor a point of care hiv testing intervention for delivery in northwestern tanzania, using data from 1) qualitative interviews and 2) community engagement strategies. interviews with traditional healers, traditional and biomedical clients, and hiv clinic staff will illustrate local variables impacting hiv testing engagement. a community advisory board with stakeholder members will guide program implementation, tailoring protocols to maximize uptake. specific aim 2: conduct a cluster-randomized pilot of the hiv testing intervention. this pilot will offer hiv testing at five traditional healer practice sites, compared with a control group of five healers providing education on community hiv resources..

Eligibility criteria:
inclusion criteria: * 18 years of age or older * not known to be hiv-infected * client of a traditional healer practice * willing to be contacted for monthly follow-up for three months * willing to complete an exit survey at the end of three months * able to provide informed consent inclusion specific to point-of-care hiv testing intervention: * willing to have point of care hiv test * willing to receive results of hiv test exclusion criteria: * less than 18 years of age * known to be hiv-infected * unable to provide informed consent * unwilling to participate in follow-up exclusion specific to point-of-care hiv testing intervention: * unwilling to have point-of-care hiv test * unwilling to receive the results of hiv test
efficacy study comparing 0.9 g and 1.25 g estrogel with placebo for vasomotor symptoms and vulvar and vaginal atrophy

Conditions: Postmenopausal Symptoms

Summary: this study is intended to establish the lowest effective dose of estrogel® for the treatment of vasomotor symptoms associated with menopause.

the primary objective of this study was to establish the lowest effective dose of estrogel® for the treatment of vasomotor symptoms associated with menopause by comparing the efficacy of 0.9 g and 1.25 g estrogel® 0.03% doses with placebo. effects on symptoms of vulvar and vaginal atrophy were assessed as secondary efficacy parameters.

Eligibility criteria:
inclusion criteria: * women 45-65 years * naturally or surgically postmenopausal * experiencing hot flushes exclusion criteria: * hypersensitivity to estrogen replacement therapy * pregnancy or lactating * abnormal pap smear * history/suspected cervical, uterine, adrenal, pituitary, breast or ovarian malignancy

Keywords: post menopausal vasomotor symptoms
effects of probiotics on gut microbiota composition and metabolic outcomes in post- gestational diabetes women

Conditions: Gestational Diabetes

Summary: risk of developing diabetes at a younger age among women with a previous history of gestational diabetes mellitus (post-gdm) has increased by 10-fold compared to the healthy women. however, consistent long-term lifestyle modifications by diet restriction and exercise are challenging. interestingly, probiotics were found to balance gut bacteria and improve host metabolism. thus, the aim of this study is to determine the beneficial roles of probiotics supplementation in post-gdm women.

recent evidence highlighted disturbances in gut microbial compositions were associated with impairment of glucose and inflammation metabolism in women with gdm. probiotics were hypothesized will modulate gut microbial compositions and maintain glucose and inflammation in the post-gdm women. this study aims to elucidate the roles of probiotic supplementation on metabolic and inflammatory outcomes in women with a previous history of gestational diabetes mellitus. this is a 12-week randomized, double-blind, placebo-controlled, parallel-group clinical trial involving participants who had attended postnatal follow-up at universiti kebangsaan malaysia medical centre (ukmmc) with a recent history of gdm and had either postpartum glucose intolerance or overweight (body mass index (bmi) ≥23 kg/m2), or obese (bmi ≥27.5 kg/m2) during eligibility assessment. a total of 166 post-gdm participants with either postpartum glucose intolerance or overweight/obese were randomly assigned to probiotics (n = 83) and placebo (n= 83) groups. eligible participants were given probiotics supplementation consisting of 30 billion colony forming units (cfu) of six viable microorganisms from lactobacillus and bifidobacteria strains, twice daily for 12-week.

Eligibility criteria:
inclusion criteria: * women aged 18-45 years. * attended postnatal follow-up at universiti kebangsaan medical center (four to eight weeks postpartum). * have a recent history of gestational diabetes mellitus. * willing to participate in the study. * had either postpartum glucose intolerance, overweight (bmi ≥23 kg/m2), or obese (bmi ≥27.5 kg/m2) during eligibility assessment. exclusion criteria: * postpartum fasting blood glucose (fbg) level \>8.0 mmol/l, two-hour postprandial (2hpp) glucose level \>12 mmol/l. * symptomatic of hyperglycemia and started on hypoglycemic agent. * have underlying medical illnesses and required regular medications (i.e., pre- pregnancy diabetes, hypertension, congestive heart failure, renal failure, liver cirrhosis, gastrointestinal diseases, autoimmune diseases, and cancer) before and during intervention. * had taken antibiotics / regularly consumed food or supplements rich in prebiotics/probiotics/symbiotics less than 12-week before recruitment or during intervention.

Keywords: gestational diabetes probiotics gut microbiota glycemic control
rehabilitation of post-stroke aphasia by targeting phonological, and lexico-semantic deficits with speech output tasks

Conditions: Aphasia, Acquired; Stroke; Anomia

Summary: aphasia in brain-damaged adult patients refers "to the more or less complete loss of the ability to use language" resulting from acquired brain damage, typically of the left hemisphere. the defective spoken output of persons with aphasia (pwa) has anomia as a main clinical manifestation. improving anomia is a main goal of any language treatment. the present randomized controlled study assessed the effectiveness of a novel, two-week, rehabilitation protocol (pholexsem), focused on phonological, semantic, and lexical deficits, aiming at improving lexical retrieval, and, generally, spoken output. the effects of the pholexsem treatment were compared to those of a control treatment, i.e., a promoting aphasics communicative effectiveness (pace) protocol. finally, we studied the effects of age, education, disease duration, brain lesion volume, and functional independence (functional idependence measure, fim) on the treatment-induced linguistic improvements.


Eligibility criteria:
inclusion criteria: * acquired brain-damage * presence of aphasia exclusion criteria: * global aphasia * undergoing another treatment for aphasia
efficacy of gabapentin in prevention of tourniquet pain and hypertension

Conditions: Tourniquet-induced Pain; Tourniquet-induced Hypertension

Summary: the purpose of the study is to find out if taking a dose of gabapentin 600 mg by mouth (po) before surgery will help prevent the development of tourniquet pain and hypertension while the tourniquet is inflated during orif of tibia fracture.


Eligibility criteria:
inclusion criteria: * patient ages 18-64 * asa physical status 1-3 * schedule for orif tibia fracture with use of pneumatic tourniquet exclusion criteria: * allergy to study medications * polytrauma * lower extremity crush injury * chronic opioid use * sickle cell disease or trait * peripheral vascular disease * poorly controlled hypertension * history of dvt/pe * morbid obesity (bmi \> 35) * patient or surgeon refusal * patient inability to properly describe postoperative pain to investigators

Keywords: narcotic use other acute pain
personalized versus standard hydration for prevention of ci-aki: a randomized trial with bioimpedance analysis

Conditions: Acute Kidney Injury

Summary: the aim of this study was to evaluate, in patients with "lower fluid status" defined by bioimpedance analysis, whether two different protocol of iv isotonic saline infusion are associated with different volume expansion and differing risks for ci-aki in patients undergoing coronary angiographic procedures.

iodinated contrast media are a well-recognized cause of iatrogenic acute kidney injury in patients undergoing imaging diagnostic or therapeutic procedures (contrast-induced acute kidney injury, ci-aki). several protocols have been tested for the prevention of ci-aki, including periprocedural hydration with isotonic saline or sodium bicarbonate, antioxidant compounds, use of low- or iso-osmolar contrast agents, and hemofiltration or dialysis. the results of these interventions and strategies have been often disappointing or inconclusive and intravenous volume expansion remains the only therapy of undisputed efficacy. bioimpedance analysis is an inexpensive, rapid, and accurate tool for evaluating a patient's hydration status, and can be performed at the bedside within minutes \[maioli, jacc 1014;63:1387-94\]. in this study we defined patients with "lower fluid status" with high risk of ci-aki (male with resistance/height ratio \> 315 ohm/meter and female \> 380 ohm/meter). biva may represent the optimal tool to monitor the adequacy of volume expansion and protective strategy delivery. however, most hydration protocols rely on a "one size fits all" approach with a fixed volume and time of infusion without an assessment of whether adequate hydration was achieved. this practice risks either under-hydration without true amelioration of ci-aki risk or over-hydration with risk of adverse outcomes. thus, on the basis of results of biva testing a randomized fluid infusion plan is prescribed.

Eligibility criteria:
inclusion criteria: * consecutive patients admitted in cardiology unit for coronary or peripheral angiography with "lower fluid status" defined on the basis bio-impedance analysis (male with resistance/height ratio \> 315 ohm/meter and female \> 380 ohm/meter). exclusion criteria: * contrast medium administration within the 10 days * end stage renal failure requiring dialysis * refused to give informed consent

Keywords: contrast-induced nephropathy contrast-induced acute kidney injury contrast media angiography coronary percutaneous intervention
treating depression and anxiety in the cardiac rehabilitation pathway

Conditions: Depression; Anxiety; Cardiac Rehabilitation

Summary: cardiac rehabilitation (cr) services aim to improve heart disease patients' health and quality of life, and reduce the risk of further cardiac events. depression and anxiety (distress) are common among cr patients: 37% of patents have significant anxiety and/or depressive symptoms. distressed patients are at greater risk of death, further cardiac events and poorer quality of life than those without distress and they use more healthcare. available drug and psychological treatments have only small effects on distress and quality of life, and no effects on physical health. therefore, it is essential that more effective treatments for depression and anxiety are integrated into cr services. extensive evidence shows that a particular style of thinking dominated by rumination (dwelling on the past) and worry maintains emotional distress. a psychological intervention (metacognitive therapy) that reduces this style of thinking alleviates depression and anxiety in mental health settings. the investigators aim to conduct a pilot trial of the group intervention and in work stream 2 the investigators will undertake a full-scale trial to evaluate whether adding the group intervention to standard cr is more effective at alleviating anxiety and depression than standard cr alone.


Eligibility criteria:
inclusion criteria: * heart disease patients referred to cr with: acute coronary syndrome * following revascularisation; stable heart failure * stable angina, implanted cardioverter defibrillators * heart valve repair/replacement * heart transplantation and ventricular assist devices * adult congenital heart disease * must have a score of 8 or more on either the depression or anxiety subscale of the hads * competent level of english language skills exclusion criteria: * cognitive impairment which precludes informed consent/ability to participate * acute suicidality * active psychotic disorders * current drug/alcohol abuse * concurrent psychological intervention for emotional distress * antidepressant or anxiolytic medication initiated in previous 8 weeks * life expectancy of less than 12 months
a novel optical spectral imaging system for imaging breast tumor margins

Conditions: Breast Cancer

Summary: the goal of this research is to further develop novel optical assay systems for intra operative assessment of tumor margins in partial mastectomy or mastectomy specimens.

the goal of this research is to further develop novel optical assay systems for intra operative assessment of tumor margins in partial mastectomy or mastectomy specimens. we are seeking to establish the accuracy of first and second-generation prototypes of technologies utilizing optical spectroscopy for intra operative margin assessment in partial mastectomy or mastectomy specimens. the aims associated with this research are as follows, (1) to evaluate the device-tissue interface on reduction mammoplasty specimens from a total of 20 patients, (2) to assess random and systematic errors of the new miniature system on mastectomy specimens from a total of 40 patients (3) to test the sensitivity, and specificity of the miniature spectral imaging system for margin assessment on excised partial mastectomy or mastectomy specimens from a total of 150 patients undergoing breast conserving surgery. last patient's surgery took place in 2017 and recruitment remained open. later the team encountered staffing issues; therefore the study status was updated to suspended. we recently made the decision to no longer attempt to enroll the remaining 2 subjects and focus on the data analysis only.

Eligibility criteria:
inclusion criteria: * patients undergoing a reduction mammoplasty or * patients undergoing a lumpectomy mastectomy for the treatment of an invasive or non-invasive breast malignancy * age \> 18 * clinically detectable disease either by physical examination or radiographic studies * patients of all ethnic and gender groups will be included. protocol accrual will be reviewed annually to include a determination of minority and gender representation. if accrual demonstrates under-representation of any group with comparison to disease incidence in that group, appropriate measures will be undertaken to increase participation of patients of that minority or gender group * ability to understand and the willingness to sign a written informed consent document. exclusion criteria: * patients considered in "vulnerable" populations.

Keywords: reduction mammoplasty mastectomy partial mastectomy lumpectomy breast conserving surgery breast cancer