Kornimate/medical-research-clean huggingface dataset:
multimodal analgesia with interfascial continuous wound infiltration: a randomized clinical trial

Conditions: Pain

Summary: objectives: for major laparoscopic surgery, as with open surgery a multimodal analgesia plan can help control postoperative pain. placing a wound catheter intraoperatively following colon surgery could optimize the control of acute pain with less consumption of opioids and few adverse effects. methods: we conducted a prospective, randomized, study of 103 patients scheduled to undergo laparoscopic colon surgery for cancer in galdakao-usansolo hospital. patients were recruited and randomly allocated to wound catheter placement plus standard postoperative analgesia or standard postoperative analgesia alone. a physician from the acute pain management unit monitored all patients for at multiple points over the first 48 hours after surgery. the primary outcome variables were verbal numeric pain scale (nrs) scores and amount of intravenous morphine used via patient controlled infusion.


Eligibility criteria:
inclusion criteria: * patients were eligible for the study if they were aged 18 years or older, with an american society of anesthesiologists (asa) 14 grade of i to iv (anaesthetic risk), were scheduled to undergo laparoscopic colon surgery, and voluntarily agreed to participate by signing an informed consent form. exclusion criteria: * patients were excluded if they were allergic to amides or pyrazolones, were likely to require conversion to open surgery with laparotomy, were long-term users of opioids, required emergency surgery, were unable to participate due to cognitive deterioration, or declined to participate in the study.

Keywords: analgesia post-operative wound catheter infusion laparoscopic colon surgery
incretin effect in pcos women

Conditions: Polycystic Ovary Syndrome

Summary: this study investigates the incretin effect in women with polycystic ovary syndrome (pcos) before and after removal of their insulin resistance by metformin. the investigators' hypothesis is that insulin resistant women with pcos have a reduced incretin effect and elevated glucagon responses as measured by a 75-g oral glucose tolerance test and isoglycemic i.v. glucose infusion. the investigators hypothesise that both can be improved when their insulin resistance is removed.


Eligibility criteria:
inclusion criteria pcos-women: * diagnosed with pcos according to the rotterdam criteria * more than 18 years old * bmi less than 30 kg/m2 * normal glucose tolerance and fasting plasma glucose (assessed by 75-g ogtt) * negative gad65 and islet cell autoantibodies * insulin resistant according to homa-ir * informed consent inclusion criteria healthy women: * more than 18 years old * bmi less than 30 kg/m2 * normal glucose tolerance and fasting plasma glucose (assessed by 75-g ogtt) * negative gad65 and islet cell autoantibodies * informed consent * regular menstrual cycle (28-35 days) * plasma androgen levels within reference levels exclusion criteria pcos and healthy women: * first or second degree relatives with diabetes * pregnancy or breast feeding * treatment with medication which influences the glucose metabolism (incl hormonal contraception) * congenital diseases which cause hyperandrogenism and irregular bleeding * known adrenal hyperplasia * known hyperprolaktinemia * alcohol consumption of more than 20 grams a day * hemoglobin less than 7.8 %

Keywords: incretin effect pcos insulin resistance ogtt iigi
hypoxic-ischemic encephalopathy therapy optimization in neonates for better neuroprotection with inhalative co2

Conditions: Hypoxic-Ischaemic Encephalopathy; Perinatal Asphyxia; Hypocapnia

Summary: this is a phase i, open-label, single center trial to evaluate the feasibility and safety of low concentration co2 gas mixture (5% co2 + 95% air) inhalation in asphyxiated, cooled, mechanically ventilated newborns at risk of hypocapnia with the hypothesis is that hypocapnia, which is driven by hyperventilation in the presence of metabolic acidosis, is deleterious to the injured brain and can be safely avoided with low concentration co2 inhalation.

specific aims: 1. to test the feasibility of low concentration inhalative co2 gas mixture (5% co2 + 95% air) administration to achieve a desired range of pco2 of 40-60 mmhg in asphyxiated, cooled, mechanically ventilated newborns at risk of hypocapnia with moderate to severe hypoxic-ischemic encephalopathy. 2. to test the safety of co2 gas mixture (5% co2 + 95% air) inhalation in asphyxiated, cooled, mechanically ventilated newborns at risk of hypocapnia with moderate to severe hypoxic-ischemic encephalopathy. term infants (≥ 36 weeks of gestation) will have to be at risk of hypocapnia to be eligible, as defined by a temperature corrected pco2 ≤ 40 mmhg in blood gas analysis, at any time within six hours of life. the gas mixture will be administered through patient circuits in conventional ventilators. administered co2 level will be closely monitored at the inhalation circuit (constant 5% = 36 mmhg). blood gas samples will be taken hourly to ensure targeted and tolerable pco2 levels.

Eligibility criteria:
inclusion criteria: * at any time within six hours of life the temperature corrected pco2 is less than or equal to 40 mmhg after the parameters of mechanical ventilation is set according to standard protocol (simv+vg 5ml/kg, fr 20/min, peep 5 h20cm, ti 0,35-0,45 sec). * moderate hypoxic- ischaemic encephalopathy, fulfilling toby criteria (a, b, c). * ≥ 36. gest. week * \< 6th hours of life * hypothermia treatment * parental consent form * spontaneous breathing * endotracheal intubation * auc, vuc in place exclusion criteria: * major birth defect * meconium aspiration syndrome * need for combined catecholamine therapy * fio2 \> 40% * htc \< 35% * acid-base status: ph \ 15mm * excessive bicarbonate administration during initial stabilization (\> 1mmol/kg)

Keywords: hypothermia treatment hypocapnia inhaled co2 neuroprotection
eortc quality of life measurement strategies in progressive cancer

Conditions: Cancer

Summary: rationale: health-related quality of life (hrqol) in people diagnosed with cancer is of increasing interest as an endpoint in clinical care and research. it helps keep track of patients' functioning and wellbeing, and informs the net clinical benefit of treatment. however, gathering hrqol information becomes increasingly harder when patients experience disease progression. therefore we need to develop measurement strategies of hrqol within the progressive disease setting. objective: the overall aim of the project is to develop recommendations to optimise the measurement and analysis of hrqol outcomes of cancer patients within the progressive disease setting. the aim of this sub-study is to identify the preferences of patients, their carers as proxies, and health-care professionals (hcps) about the research objectives, how often and how we should assess hrqol, and how we might limit dropout over time. sub-study design: an international, multi-centre study using semi-structured interviews. procedures: across europe, we aim to interview adult people diagnosed with cancer who experience progressive disease (n=30), their carers as proxies (n=30), and hcps involved in cancer care and/or research (n=15). the uk site will aim to recruit a maximum of 10 patients and 10 proxies. patients and carers will be interviewed twice to evaluate whether preferences change over time. study outcomes: findings can help in optimising the measurement and analysis of hrqol outcomes of cancer patients in the progressive disease setting. this will help to better inform both clinical decision-making and regulatory processes.


Eligibility criteria:
inclusion criteria: patient- adult (\> 18 years of age) * histologically proven or radiologically diagnosed cancer * clinical and/or radiological progressive disease according to recist criteria * poor prognosis, i.e. expected survival time \ 18 years of age) * partner, relative or close friend of a patient who is eligible according to the criteria specified above exclusion criteria: * participants without understanding of the official language of the country in which they live * participants with any psychiatric condition or cognitive impairment, as determined by the treating physician, that would hamper providing informed consent for research participation
enlightn german observational study of renal denervation for uncontrolled hypertension

Conditions: Uncontrolled Hypertension

Summary: the purpose of this observational study is to further evaluate the safety and performance of the enlightn™ renal denervation system in the treatment of patients with uncontrolled hypertension in clinical routine practice.

this is a post market, multi-center, open label, observational study. approximately 500 subjects with uncontrolled hypertension will undergo renal artery ablation at approximately 40 investigational sites located in germany and will be followed for 1 year post procedure.the expected duration of the investigation will be approximately 4 years.

Eligibility criteria:
inclusion criteria: * subject is planned to undergo a renal denervation procedure for the treatment of hypertension * subject is ≥18 years of age at time of consent * subject must be able and willing to provide written informed consent * subject must be able and willing to comply with the required follow-up schedule * subject has office systolic blood pressure (sbp) ≥ 140 mmhg * subject has established hypertension (diagnosed ≥12 months prior to baseline) and is on a guideline based drug regimen at a stable (≥ 14 days) and a fully tolerated dose consisting of ≥3 anti-hypertensive medications (including 1 diuretic), or subject has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ace-i/ angiotensin receptor blocker (arb), calcium channel blockers, beta blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs exclusion criteria: * subject has known significant renovascular abnormalities such as renal artery stenosis \> 30% * subject has undergone prior renal angioplasty, renal denervation, indwelling renal stents, and/or abdominal aortic stent grafts * subject has a history of hemodynamically significant valvular heart disease * subject has blood clotting abnormalities * subject life expectancy is \< 12 months, as determined by the study investigator * subject is participating in another clinical study which has the potential

Keywords: uncontrolled hypertension renal denervation
quadriceps strengthening with patellar taping in patellofemoral pain syndrome among young adult male athletes

Conditions: Patellofemoral Disorder; Anterior Knee Pain

Summary: this study aims to investigate the effects of electromyography biofeedback (emg-bf) guided isometric quadriceps strengthening with patellar taping and isometric exercise alone in young adult male athletes with patellofemoral pain syndrome (pfps).

a total of 60 adult male athletes aged 18 to 45 years will be recruited from two cities (majmaah and riyadh) of saudi arabia. subjects will be included with the history of knee pain during activities such as descending and ascending stairs, squatting, and running, had positive j sign (lateral tilt of patella), and a sign of patellar malalignment on the radiograph. individuals with the history of fracture around knee, patella dislocation, knee deformity (e.g., genu varum), flexion contracture, ligaments/meniscal injuries, and osteoarthritis of knee will be excluded from the study. the protocol was submitted to and approved by the ethical sub-committee of college of applied medical science, majmaah, saudi arabia (ethics number: murec-nov./com-2o20/11-2). participants will be requested to sign a written informed consent form approved by the institution ethics committee. participants will be randomly assigned to group a (experimental group): electromyography biofeedback (emg-bf) guided maximum voluntary isometric contraction exercise with patellar taping; group b (control group): sham emg-bf guided maximum voluntary isometric contraction without patellar taping. the outcome measure for this study will be the mean changes in maximum voluntary isometric contraction (mvic) of the quadriceps muscle, pain intensity, and functional status up to 6 weeks.

Eligibility criteria:
inclusion criteria: 1. knee pain during activities such as descending and ascending stairs, squatting, and running, 2. positive j sign (lateral tilt of patella), 3. sign of patellar malalignment on radiograph. exclusion criteria: 1. fracture around knee, 2. patella dislocation, 3. knee deformity (e.g., genu varum), 4. knee flexion contracture, 5. ligaments/meniscal injuries, and 6. osteoarthritis of knee.

Keywords: pain; strength; function; pfps; athletes; young adults
a pharmacokinetics (pk) study in lice infested children 6 months to 3 years of age

Conditions: Head Lice

Summary: the purpose of this study is to determine the bioavailability of 0.5% ivermectin cream in a pediatric population aged 6 months to 3 years.


Eligibility criteria:
inclusion criteria: * subject must be 6 months to 3 years of age, inclusive, when informed consent is signed. * subject must be infested with head lice as demonstrated by the presence of at least 1 live louse prior to treatment. * subject is in general good health. * subject's parent/guardian (caregiver) must be willing and able to bring subject to all study visits as scheduled. * subject's caregiver must have provided written informed consent (assent is not required due to the young age of the subjects). * subject's caregiver must agree to comply with the following study restrictions: * will not use any other form of lice treatment (eg, commercial, community/anecdotal, or mechanical/manual) on the subject for the duration of the study, unless directed to do so by study personnel. * will not shampoo, wash, or rinse the subject's hair or scalp until the day 2 treatment evaluation has been completed. * will not cut or chemically treat subject's hair in the period between screening and follow-up on day 15. * will use only study-provided shampoo on the subject for the duration of the study. * will follow all study instructions. exclusion criteria: * subjects who have received any otc or prescription treatment for head lice in the last 2 weeks. * subjects or subjects' caregivers who are unable to comply with the study obligations and all study visits. * subjects whose caregivers do not understand the requirements for participation and/or may be likely to exhibit poor compliance, in the opinion of the investigator. * subjects with eczema, atopic dermatitis, or other chronic conditions of the scalp and skin. * subjects with visible skin/scalp condition(s) that are not attributable to head lice infestation, such as an erythema score that is \> 2, blisters, or any other condition that, in the opinion of the investigative personnel or sponsor, would interfere with the pk, safety and/or efficacy evaluations. * subjects with a history of allergy to ivermectin or any ingredients commonly included in hair products such as shampoos, hair conditioners, or styling aids. * subjects with other diagnoses that, in the opinion of the investigator, would interfere with the pk, safety, and/or efficacy assessments or would preclude study participation. * subjects who have been treated with a systemic antibiotic within 2 weeks before screening. * subject currently taking warfarin sodium (coumadin®) or has taken within 2 weeks before screening. * subjects who have been enrolled in any clinical study within the past 30 days; subjects may not participate in another study while participating in this study.

Keywords: head lice pediculus
develop and implement asthma controlling strategies (2)

Conditions: Asthma; Lung Diseases

Summary: to develop and implement asthma controlling strategies for inner city and high risk populations.

background: asthma is a serious chronic disease affecting about 12 million americans; about 3 million are children. the study was part of an initiative, "developing and implementing at the state and local level educational strategies and interventions for controlling asthma in inner city and high risk populations", released in february 1993 by the national asthma education program of the office of prevention, education and control.

Eligibility criteria:
no eligibility criteria
explaining the invisible using the pearl system

Conditions: Prostate Cancer

Summary: radiotherapy uses high doses of x-rays directed at tumours to kill them, an unfortunate side effect is healthy surrounding tissue will receive some of the x-ray dose and is damaged. approximately 22% of radiotherapy patients receive treatment to cure prostate cancer. the technique used requires patients to maintain full bladder and empty bowel because they are next to the prostate, the aim of radiotherapy planning is to minimise the radiation dose received to healthy organs and tissues as this will reduce side effects. pearl is commercial interactive pc software that shows realistic and functional 3d models of linac's (machines that deliver radiotherapy treatment). using pearl it's possible to display realistic patient treatments including how an individual would be laid on a treatment couch and how the machine will move and sound during treatment. additionally pearl provides the opportunity to look inside the body to view internal anatomy and show where the radiotherapy treatment is directed. information prior to treatment in radiotherapy is normally given verbally one to one. the investigators believe this information can be more easily understood if pearl is used in conjunction with this verbal exchange. pearl gives visual and audio representation of the treatment experience, and demonstrates the reasons behind required preparations. research aim is to demonstrate patients who receive information using pearl have greater understanding, reduced anxiety and reduced radiation dose. this will be tested using two groups of patients receiving radiotherapy to the prostate. group a - verbal information, group b - verbal information and pearl demonstration. data collection is via patient questionnaires and review of cone beam computer tomography (cbct) images that are taken prior to each radiotherapy treatment as standard practice. cbct's are used to locate the treatment area and assess bladder and bowel status and ensure all of these are suitable to deliver treatment accurately.


Eligibility criteria:
inclusion criteria: * patients diagnosed with cancer of the prostate of the following staging: t1-3b, n0-1, m0. * clinical intention to treat using external radiotherapy based on three local departmental protocols: tp-cp-97, tp-cp-98 and tp-cp-99. these protocols dictate that the patients receive vmat planned treatment, require a full bladder and empty rectum and require daily localisation using kv cone beam ct (cbct). * patients consented to the study. exclusion criteria: * patients who do not fulfil the inclusion criteria. * patients diagnosed with depression. * blind patients or patients with severe visual impairment. * patients with reduced understanding due to mental impairment. * patients not willing to consent to the study. * prisoners and young offenders. * patients who are unable to understand verbal explanations given in english.

Keywords: pearl
hd-tdcs over the dacc in high trait impulsivity

Conditions: Impulsive Behavior

Summary: psychological disorders characterized by impulsivity often show alterations in dorsal anterior cingulate cortex (dacc) activity. recent research has therefore focused on non-invasive neurostimulation therapies for the modulation of functional activity in the dacc. to date there has only been one proof-of-concept study providing evidence for modulating dacc activity with non-invasive electrical neurostimulation (e.g. transcranial electrical stimulation). since transcranial direct current stimulation (tdcs) is relatively safe, tolerable, and mobile as compared to other neurostimulation techniques, it is worthwhile looking further into the effects of tdcs on functional dacc activity. the aim of the present research is to explore whether hd-tdcs can induce changes in the dacc in individuals with high trait impulsivity (n=20) in a double-blind cross-over study. functional changes in dacc activity will be measured by the error related negativity (ern), which is an event related potential generated by the dacc. the ern is less pronounced in people that score high on impulsivity. it is therefore expect enhanced ern amplitudes after hd-tdcs over the dacc. in addition, performance on the multisource interference task will be used as measure of dacc activity. it is hypothesize that increased dacc activity will be related to decreased impulsivity in high impulsive individuals as shown by improved inhibitory control on the go/nogo task. the results of the study may have implications for patient populations that are characterized by impulsivity.


Eligibility criteria:
inclusion criteria: * right-handed * score \> 46 on supps-p exclusion criteria: * score low on trait impulsivity as determined by a score of \< 47 on the supps-p short form * history of dsm-5 defined neurological illness, mental illness or traumatic brain injury, * currently taking any psychoactive medications, * have metal anywhere in the head, except the mouth. this includes metallic objects such as screws, plates and clips from surgical procedures. * currently pregnant or lactating, * being left-handed

Keywords: impulsivity hd-tdcs dacc ern go/nogo msit
intervention effect of transcranial alternating current stimulation (tacs) on disorder of consciousness (doc)

Conditions: Disorders of Consciousness

Summary: to investigate the effect of high definition-transcranial alternating current stimulation(hd-tacs) on consciousness promotion in patients with chronic consciousness disorders and the underlying neural mechanism by eeg.

forty patients with chronic consciousness disorder who met the inclusion criteria were recruited with the informed consent of the family. all the participants were randomized to receive "active" or "sham" treatment protocol. stimulation was performed using a alternating stimulator linked to one anodal electrode and four cathodal electrodes. the anodal electrode was placed over the left dorsolateral prefrontal cortex (dlpfc; f3 in the 10-20 international system of eeg placement), and the four cathodal electrodes (afz, fcz, f7, and c5 in the 10-20 international system eeg placement) were placed around the anodal electrode to form a current loop. twenty 2 milliampere (ma) sessions (ramp-up and ramp-down periods of 30 and 30 seconds, respectively) were applied for 20 minutes per session, twice daily over 10 consecutive days, and the stimulus frequency was set as 6 hertz (hz). sham tacs was delivered using the same protocol and current intensity, but the period of active stimulation was only during the ramp-up and ramp-down periods of 30 and 30 seconds. before and after the tacs treatment, the state of consciousness was assessed according to coma recovery scale-revised(crs-r), and19-channel eeg data were collected.

Eligibility criteria:
inclusion criteria: 1. patients diagnosed as chronic disorders of consciousness based on crs-r assessment by at least two professional neurologists; 2. the age requirement is between 18 and 75; 3. vital signs need to be stable; 4. no neuromuscular blockers and sedatives have been used within 24 hours before the study and the entire protocol; 5. no improvement in the state of consciousness was observed within one week before the start of the study. exclusion criteria: 1. previous or current diagnosis of severe neurocognitive degenerative diseases; 2. metal implantation in the head; 3. previous surgical procedures resulted in skull defect; 4. previous history of epilepsy.

Keywords: doc tacs