Kornimate/medical-research-clean huggingface dataset:
a randomized trial of the effectiveness of aromatherapy on chemotherapy induced nausea and vomiting in children with cancer

Conditions: Brain Tumors; Leukemia; Sarcomas; Neuroblastoma; Lymphoma; Hodgkins Disease

Summary: aromatherapy has anecdotally been reported to decrease nausea and vomiting, decrease anxiety and increase quality of life in cancer patients. therefore, the proposed study aims to assess the effectiveness of aromatherapy versus placebo on nausea, vomiting, anxiety and quality of life among pediatric oncology patients receiving emetogenic chemotherapy.

nausea and vomiting remain two of the most distressing symptoms to children being treated for cancer. nausea and vomiting are directly associated with the administration of chemotherapy, due to effects of the chemotherapy on the gastrointestinal mucosa, and certain chemotherapeutic agents, such as cisplatin, are known to be particularly emetogenic. in addition, anticipatory anxiety has been identified as an important patient factor in the development of post-chemotherapy nausea and vomiting. many drugs have been developed in an effort to diminish nausea and vomiting in children receiving emetogenic chemotherapy and these agents, particularly the 5-hydroxytryptamine receptors, have vastly reduced the amount of nausea and vomiting experienced in this population. however, approximately 50% of children and adolescents still suffer from nausea and/or vomiting even after maximal pharmacological intervention. this suggests that other interventions are needed to further reduce the experienced nausea and vomiting seen in children undergoing chemotherapy. as such, many patients and providers have turned to complementary and alternative medicine (cam) for the relief of nausea and vomiting. aromatherapy is one such modality that has demonstrated some degree of effectiveness in adults suffering from nausea and vomiting due to chemotherapy, motion sickness, or postoperatively. aromatherapy is an inexpensive and easy therapy to administer to children, and many children can self administer aromatherapy depending on their age and the form of aromatherapy. aromatherapy has anecdotally been reported to decrease nausea and vomiting, decrease anxiety and increase quality of life in cancer patients. therefore, the proposed study aims to assess the effectiveness of aromatherapy versus placebo on nausea, vomiting, anxiety and quality of life among pediatric oncology patients receiving emetogenic chemotherapy.

Eligibility criteria:
inclusion criteria: * patients aged 7-21 with a diagnosis of cancer and will be receiving emetogenic chemotherapy. exclusion criteria: * patients allergic to peppermint, ginger or lavender

Keywords: aromatherapy
a safety trial to compare different analgesics in combination with low dose aspirin to study their bleeding properties and their effects on the stomach

Conditions: Analgesics

Summary: the purpose of this study is to compare several analgesics given in approved daily doses in combination with a daily cardioprotective dose of aspirin (81 mg), to study their bleeding properties and their effects on the stomach in healthy volunteers.

the purpose of this randomized, multiple-dose, single-blind, parallel-group study is to examine in healthy volunteers the effects of analgesics given in approved daily doses in addition to daily cardio-protective doses of aspirin (81 mg) on the stomach. all subjects are examined endoscopically before receiving study medication, and at the end of treatment on day 9. each subject takes 81 mg of aspirin daily plus one of the following treatments to be taken daily on days 1 through 8: four doses of acetaminophen 1000 mg, three doses of ibuprofen 400 mg, two doses of naproxen sodium (440 mg in the morning and 220 mg in the evening), four doses of aspirin 650 mg, two doses of celecoxib 200 mg, one dose of rofecoxib 25 mg, or no additional study medication. on day 9, one dose of aspirin 81 mg and only one dose of the assigned treatment drug are taken prior to having an endoscopy. the primary endpoints of the study are the effects of the analgesics on the inhibition of cox-1 activity by aspirin, and any injury to the stomach mucosa, as determined by direct endoscopic observation. safety assessments consist of routine monitoring for adverse events, as well as endoscopic examination of gastric mucosa for erosions and ulcerations occurring during the treatment phase. the study hypothesis is that the effects of acetaminophen on the stomach do not differ from the effects of ibuprofen, naproxen, aspirin, celecoxib, or rofecoxib. 81 mg aspirin and 1of 7 treatments for 8 days: acetaminophen 1000mg 4xday, ibuprofen 400mg 3xday, naproxen 440mg morning and 220mg evening, no additional study medication, aspirin 650mg 4xday, celecoxib 200mg 2xday,rofecoxib 25mg 1xday. on day 9, 1 dose aspirin \& 1 dose study drug before endoscopy.

Eligibility criteria:
inclusion criteria: * in general good health with normal hemostatic (blood coagulation) parameters * able to swallow study medication * non-smoker * negative for h. pylori infection * if female, must not be pregnant or breast feeding exclusion criteria: * have taken anti-inflammatory drugs within one week of study entry, any analgesic within 24 hours before baseline endoscopy, or systemic steroids within 6 weeks of study entry * unable to tolerate oral drugs or have had gastrointestinal disease or prior gastrointestinal surgery that could interfere with the study medication * unable to understand or follow instructions * have a medical condition or clinically significant abnormal laboratory results that may be relevant to participation in the study

Keywords: aspirin analgesics cyclooxygenase activity non-steroidal antiinflammatory drugs
investigating relearn neurofeedback as treatment for chronic musculoskeletal pain

Conditions: Chronic Knee Pain; Chronic Pain; Osteoarthritis

Summary: this clinical investigation will be carried out as a randomized controlled trial conducted at the northern regional hospital, hjørring. this investigation will enrol 36 patients suffering from severe knee osteoarthritis pain, primarily from the orthopaedic ward at hjørring hospital, where potential participants will be identified during routine consultations. the relearn intervention consists of encephalography (eeg) neurofeedback of cerebral movement evoked signatures of pain, where the participants will be instructed in attempting to manipulate these signatures to reduce pain perception. this investigation is carried out to analyse the clinical performance and safety of the relearn neurofeedback software.

the participants will be randomized into treatment group a and control group b, 1:1 and be stratified based on age, sex, and ethnicity. group a participants will be asked to attend eight sessions of relearn neurofeedback with an approximate duration of 45 minutes per session, and group b participants will be asked to attend eight sessions with no intervention and serve as no-treatment controls with an approximate duration of 5 minutes per session. both groups (a and b) will undergo three follow-up sessions: one month, three months, and five months post intervention.

Eligibility criteria:
inclusion criteria: 1. age 18-65 years old 2. knee arthrosis (kellgren-lawrence score of ≥ 2) 3. 24h vas ≥ 4 4. ongoing pain, lasting more than three months exclusion criteria: participants who meet any of the below criteria will be excluded from the investigation: 5. pregnant or lactating woman 6. use of opioids or cannabis 7. active drug addiction defined as the use of cannabis, opioids, or other drugs 8. previous or current neurologic, systemic, or mental illness, including any liver, kidney or metabolic disease. 9. rheumatoid arthritis 10. evidence of other pain types such as visceral, neuropathic, or malignant pain. 11. evidence of other sources of ongoing pain such as root affect, traumas, or congenital malformation 12. severe inflammation in the area of interest 13. blindness or deafness 14. consumption of alcohol, caffeine, nicotine on test day 15. recent history of fractures or surgery in the area of interest 16. participation in other clinical trials throughout the study period and one month prior to participation 17. history of epilepsy 18. obesity class iii and above. i.e. bmi \> 39,9

Keywords: chronic pain chronic knee pain osteoarthritis neurofeedback eeg emg movement evoked potentials neuroplasticity pain perception
evaluation of comfort in a spinal collar

Conditions: Neck Injuries

Summary: this is an observational study which aims to assess the comfort of a spinal collar in patients who have them fitted as part of their clinical care due to neck injury.

the study follows the patient journey including long term follow up (up to 120 days following admission). the information gathered will be from the standard clinical care delivered and include demographics, baseline function, the injuries sustained following trauma and prescribed analgesia with records of the most recent time and dose administered. any scans done of the neck for clinical purposes will be anonymised and analysed for measurements of angulation. in addition to this there will be a survey on the comfort of the collar and of their functional ability at the current time at various points during their inpatient admission.

Eligibility criteria:
inclusion criteria: 1. all patients aged 18yrs and over with a c-spine injury immobilised in a spinal collar 2. patients must be nursed on major trauma ward 3. ability to give informed consent to participate in the study. exclusion criteria: 1. patients under 18yrs age 2. patients who lack capacity to consent for entry into the study 3. patients who are receiving level 2( high dependency unit) or level 3 (intensive care unit) clinical care 4. patients who are unable to complete the visual analogue score or questionnaire due to having co-existent severe hearing and visual impairment. severe hearing impairment will be defined as unable to hear the researcher with hearing aids if required. severe visual impairment will be defined as being unable to read the patient information sheet even with visual aids. 5. patients unable to understand the patient leaflet in english.

Keywords: neck injuries
expanded access program for avapritinib

Conditions: Solid Tumors

Summary: this record comprises the currently available expanded access programs (eap) for avapritinib (blu-285): 1) a post trial access (pta) program to provide continued access to treatment with avapritinib to blu-285-1107 participants with solid tumors who are unable to access commercially available avapritinib after trial blu-285-1107 (nct04908176) has ended.


Eligibility criteria:
inclusion criteria: -participant has received treatment with avapritinib in blu-285-1107 clinical trial and continues to receive clinical benefit from avapritinib treatment, as assessed by the investigator. exclusion criteria: * participant requires ongoing treatment or has received treatment within 28 days before the start of avapritinib administration with drugs or foods that are strong cyp3a inhibitors or inducers. * female participants of childbearing potential who are unwilling, if not postmenopausal or surgically sterile, to abstain from sexual intercourse or employ highly effective contraception from the time of informed consent and for at least 6 weeks after the last dose of study treatment. * male participants who are unwilling, if not surgically sterile, to abstain from sexual intercourse or employ highly effective contraception from the time of informed consent and for at least 6 weeks after the last dose of study treatment. * participant is pregnant, as documented by a serum β-hcg pregnancy test. participants with β- hcg values that are within the range for pregnancy but are not pregnant (false-positives) may be enrolled with written consent of the sponsor after pregnancy has been ruled out. * female participants of nonchildbearing potential (premenarchal, bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) do not require a serum β-hcg test. * participant is breastfeeding. * participants who require anticoagulants, with the exception of stable doses of prophylactic reversible anticoagulants. * participants who are unable to swallow tablets.

Keywords: avapritinib blu-285 solid tumors gastrointestinal stromal tumors (gist) gliomas
effect of arterial cannulation on the continuous and non-invasive hemoglobin monitoring

Conditions: Gastric Cancer

Summary: the primary purpose of this study is to investigate the effect of arterial cannulation on the continuous and non-invasive hemoglobin monitoring during laparoscopic gastrectomy


Eligibility criteria:
inclusion criteria: * laparoscopic gastrectomy under general anesthesia exclusion criteria: * atypical hemoglobin disease, infective state, cardiovascular disease, peripheral vascular disease
using mindfulness in an enhanced recovery after surgery protocol to support recovery after colorectal surgery

Conditions: Pain After Surgery; Anxiety After Surgery

Summary: this study teaches participants who are having colorectal surgery how to use mindfulness to feel calmer and manage pain better. participants will be randomized (like a flip of a coin) into one of two groups: mindfulness intervention or standard treatment. those in the mindfulness group will have a 30-minute zoom session before surgery to learn simple mindfulness exercises like deep breathing, using senses, and staying focused on the present. on the day after surgery, participants will watch a short video review of the mindfulness exercises. regardless of the group assigned, participants may be asked to complete questionnaires, and some participants will be asked to complete a semi-structured interview via zoom, about 2 weeks to 1 month after surgery. additionally, access to the mindfulness curriculum will be provided to those not randomized to that group. investigators will collect information such as age, surgery details, pain levels, and pain medication usage. participants will also fill out surveys before and after surgery to assess physical and mental well-being. all personal information will be kept safe, and interviews or zoom sessions will be deleted after notes are taken without names attached. participants will be in this study for about 4 weeks.


Eligibility criteria:
inclusion criteria: * patients scheduled for a bowel resection and enrolled in the uh institutional eras pathway * patients will be admitted to the inpatient hospital for at least one day postoperatively * aged 18 or older * receiving surgery at designated university hospitals locations (cleveland medical center, ahuja, st. john's medical center) * english-speaking * access to the internet via phone, laptop, or ipad exclusion criteria: * surgery for palliative purposes only * surgery for ostomy take-down only * discharged on day of surgery * history of substance use disorder * allergy or intolerance to all opioids * insufficient english proficiency * no access to the internet outside clinical settings * significant visual, hearing or cognitive impairment

Keywords: colorectal surgery patients mindfulness enhanced recovery after surgery
score! active trial

Conditions: Chronic Disease; Childhood Obesity

Summary: hamilton is a city with a growing newcomer population. families who are new to canada do not always have the same resources to access healthy active living (hal) activities as compared to canadian-born families. the score! active trial will recruit newcomer families with young children in hamilton and help provide them with access to hal activities. through this, the investigators want to see if newcomer children's perspectives of physical activity will change over time. they will also see if increasing newcomer children's access to these resources will promote an increase in hal behaviours.

the investigators will conduct a pragmatic, stepped-wedge cluster randomized trial in 14 neighbourhoods to determine the impact of score! active trial on the primary outcome of pa self-efficacy among 5-11-year-old children. the sw-crt involves the sequential transition of clusters, in this case neighbourhoods, from control to intervention conditions in a randomized order. in this case, the method is pragmatic because recruitment and initial baseline measures in each community will occur just before the initiation of the intervention. there have been methodological challenges noted with sw-crt including identification and recruitment bias, within cluster bias, and secular trends. however, this design is ideal for the implementation of the score! active trial because for practical reasons, it is not possible to deliver the intervention to many clusters at the same time. the trial will be reported using consort guidelines and extension of sw-crt.

Eligibility criteria:
inclusion criteria: * newcomer families (those who have been in canada for 10 years or less) with at least 1 child aged 5 up to 11 (11.99 years) living in a hamilton, ontario. * at least one parent/guardian born outside of canada and residing in canada ≤ 10 years. * families must be living in one of the designated neighbourhood clusters exclusion criteria: * children participating in organized physical activity programs for 3 or more times per week * families with involvement with child protection services and/or foster care
interleukin 12 (il-12) for the treatment of cryptosporidiosis in aids patients

Conditions: HIV Infections; Cryptosporidiosis

Summary: there is no proven effective treatment for chronic diarrhea caused by the parasite cryptosporidium in advanced aids. this trial will test the safety of interleukin-12 (il-12) as part of a combination therapy for this parasite.

cryptosporidium parvum can cause chronic diarrhea and biliary disease in people with aids, resulting in significant morbidity and mortality. highly effective antiparasitic treatment for this infection is not currently available. paromomycin and azithromycin have some efficacy and have been used in combination in a small number of patients. however, in clinical trials of this drug combination, patients remained infected with the parasite despite improvement of their symptoms. improving the immune system with highly active antiretroviral therapy (haart) has been the most effective therapy described for cryptosporidiosis (chronic infection with cryptosporidium parvum), with over 80% of patients showing improvement. however, immune reconstitution is not possible in all patients. interferon gamma expression is strongly associated with control of cryptosporidiosis. il-12 stimulates interferon gamma, and il-12 treatment has been shown to prevent cryptosporidiosis in mice. this study will evaluate il-12 in combination with standard therapy for cryptosporidiosis in patients with aids. this is a dose-escalation study. all patients will be treated with paromomycin and azithromycin. the initial group will be treated with either 110 ng/kg il-12 (6 patients) or placebo injections (2 patients) twice a week for 4 weeks. if the initial dose is ineffective and the combination of drugs is tolerated, a second group of patients will be randomized to either 300 ng/kg il-12 (6 patients) or placebo injections (2 patients) twice a week for 4 weeks. patients will be evaluated for eradication of the parasite (as measured by immunofluorescence and intestinal biopsy), decreases in stool frequency, decreases in 24 hour stool volume, stimulation of intestinal th1 cytokine production, increases in body weight, improvements in karnofsky score, and improvements in serum alkaline phosphatase levels and transaminases (if elevated at baseline).

Eligibility criteria:
inclusion criteria: * hiv infection * cd4 cell count \< 150 cells/µl * stable antiretroviral regime that includes at least two nucleotide analogues for at least 4 weeks * viral load \< 10,000 copies/ml * chronic diarrhea, defined as three loose or watery bowel movements a day for 5 days per week over 3 weeks * stool positive for cryptosporidium and no other enteric pathogen (bacterial culture, c. difficile toxin assay, afb stain, ova and parasite examination, and stain for microsporidia) * karnofsky score \>= 70 * acceptable methods of contraception exclusion criteria: * pregnant * active opportunistic infection * history of hypersensitivity or significant intolerance to aminoglycosides, macrolide antibiotics, or colony stimulating factors * requires intravenous fluids

Keywords: chronic diarrhea interleukin 12
predictive model for ponv for patient received gynecological laparoscopic surgery

Conditions: Postoperative Nausea and Vomiting

Summary: this is a prospective study to dynamically predict the risk of ponv in patients undergoing gynecologic laparoscopic surgery.


Eligibility criteria:
inclusion criteria: -all female patients receiving gynecological laparoscopic surgery. exclusion criteria: -patients requiring intraoperative open-surgery, requiring other procedures in addition to gynecological laparoscopy, with severe organ dysfunction, unstable postoperative vital signs or requiring transfer to icu.
characterization of cardiac hemodynamics during multisite pacing

Conditions: Heart Failure

Summary: the purpose of this study is to evaluate the effects of multipoint pacing (mpp) on cardiac hemodynamics assessed by pressure-volume loop during mpp at implant. nyha functional class assessment and echocardiographic measurements are performed at 3 months and 12 months post-implant to characterize long-term effect of mpp.


Eligibility criteria:
inclusion criteria: * be scheduled to undergo implant of a st jude medical crt-d system with approved standard indication by esc/ehra guidelines * be in sinus rhythm at the time of enrollment * have the ability to provide informed consent for study participation and be willing and able to comply with the clinical investigation plan (cip) described evaluations and follow-up schedule exclusion criteria: * exhibit cheyne-stokes respiration * have persistent or permanent atrial fibrillation * have complete heart block * be in nyha iv functional class * have a recent myocardial infarction within 40 days prior to enrollment * have undergone cardiac surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures in the following 7 months * have had a recent cva or tia within 3 months prior to enrollment * have had intravenous inotropic support in the last 30 days * be less than 18 years of age * be pregnant