Kornimate/medical-research-clean huggingface dataset:
hypersensitivity to pacap-38 in post-traumatic headache

Conditions: Post-Traumatic Headache

Summary: the aim is to investigate whether signaling molecule pacap-38 induces headache with migraine-like features in people with persistent post-traumatic headache (pth) attributed to mild traumatic brain injury (mtbi).


Eligibility criteria:
inclusion criteria: * age 18 to 65 years of age upon entry into screening * history of persistent headache attributed to mild traumatic injury to the head for ≥ 12 months and in accordance with the international classification of headache disorders, 3rd edition (ichd-3) * ≥ 4 monthly headache days on average across the 3 months prior to screening * provision of informed consent prior to initiation of any study-specific activities/procedures. exclusion criteria: * \> 1 mild traumatic injury to the head * history of any primary or secondary headache disorder prior to mild traumatic injury to the head (except for infrequent episodic tension-type headache) * history of moderate or severe injury to the head * history of whiplash injury * history of craniotomy * history or evidence of any other clinically significant disorder, condition or disease (except for those outlined above) than, in the opinion of the site investigator, would pose a risk to subject safety or interfere with study evaluation, procedures or completion * the subject is at risk of self-harm or harm to others as evidenced by past suicidal behavior * female subjects of childbearing potential with a positive pregnancy test during any study visit * cardiovascular disease of any kind, including cerebrovascular diseases * hypertension (systolic blood pressure of ≥150 mmhg and/or diastolic blood pressure of ≥100 mmhg) prior to the start of infusion on the experimental day * hypotension (systolic blood pressure of ≤90 mmhg and/or diastolic blood pressure of ≤50 mmhg) * initiation, discontinuation, or change of dosing of prophylactic medications within 2 months prior to study inclusion * intake of acute medications (e.g. analgesics, triptans) within 48 hours of infusion start * baseline headache intensity of \>3 on an 11-point numeric rating scale (0 being no headache, 10 being the worst imaginable headache) * baseline headache with migraine-like features or self-reported baseline headache that mimics the subjects' usual headache with migraine-like features

Keywords: headache pain
transcranial direct current stimulation associate to constraint induced movement therapy over premotor cortex in severe stroke

Conditions: Stroke; Cerebrovascular Disorders; Cerebral Infarction

Summary: the purpose is to compare the effects of tdcs and constraint induced movement therapy (cimt) in the premotor cortex vs. primary motor cortex in severely subacute stroke survivors.

stroke survivors experience one or more movement-related impairments and activity limitations. in this sense, the premotor cortex (pmc) can be considered as an alternative locus for post-stroke rehabilitation. in relation to physical rehabilitation protocols, associate to neuromodulation, the investigators have chosen a standardized physical therapy protocol for this study, the constraint induced movement therapy (cimt), which presents evidence of good therapeutic results. the investigators hypothesized that applying tdcs and cimt over the pmc promotes motor restoration in stroke patients.

Eligibility criteria:
inclusion criteria: * age between 18 and 65 years * diagnosis of unilateral, non-recurring, subacute stroke * participants also had to be able, by using any method of pinch, to grasp a washcloth from a table top, lift it up a few inches, and release it. exclusion criteria: * patients with difficulty to follow the procedures or understand the instructions; cognitive deficits * tdcs criteria: * use of modulators of the central nervous system drugs * patients with implanted metallic or electronic devices * pacemaker * seizures * pregnancy * any other condition that might limit or interfere in the sensorimotor system
prevention of iron deficiency in breastfed infants

Conditions: Iron Deficiency; Anemia

Summary: with early screening and appropriate iron supplementation, iron deficiency in the first year of life can be prevented in breastfed infants.

infants with low ferritin at 1 month are at high risk of iron deficiency. they will receive iron drops starting at 2 months. all other infants are at low risk of iron deficiency. all infants will receive iron-fortified cereal starting at 4 months of age.

Eligibility criteria:
inclusion criteria: * term infants * gestational age 37-42 weeks * birth weight \> 2500 g * exclusively breastfed at 28 d of age * intend to breast feed until 9 mo of age exclusion criteria: * supplemental formula before 4 mo of age

Keywords: iron deficiency anemia
promoting healthy weight gain during pregnancy

Conditions: Weight Gain

Summary: study goal is to determine whether behavioral lifestyle intervention during pregnancy can reduce the number of women who exceed the institute of medicine recommendations for weight gain during pregnancy. it is hypothesized that the intervention will reduce the number of women who exceed weight gain guidelines relative to standard care. the investigators also expect the intervention to reduce the proportion of women exceeding weight gain guidelines in both normal weight and overweight groups.


Eligibility criteria:
inclusion criteria: * non-smoking, adults, * \< 16 weeks gestation exclusion criteria: * medical comorbidities

Keywords: excessive gestational weight gain
dietary intervention examining tracking with mobile devices

Conditions: Obesity

Summary: the purpose of the study is to test the effectiveness of two different weight loss interventions. both of these interventions will provide weight loss information through twice weekly audio podcasts. in addition to the podcasts, participants will be asked to track their diet using either a wearable device on their wrist or through an app on their smartphone.

this study will last approximately 6 months. participants will attend one 1-hour orientation meeting at the beginning of the study and a 2-hour baseline assessment and training meeting. additional assessments will be conducted at 3 months and 6 months. weekly questionnaires will be administered. everyone in the study will be asked to listen to 2 podcasts per week. each of the podcasts will take about 15 - 20 minutes to listen to and so participants should expect to spend 30 - 40 minutes each week listening to podcasts. participants will also be randomized to either track diet with an app on their smartphone or using a device they wear on their wrist. each week, participants will be sent an email as a reminder on how to use their diet tracking device. they will also be encouraged to monitor their exercise and body weight.

Eligibility criteria:
inclusion criteria: * must be between 18-65 years old * own and use a smartphone and/or a tablet with a data plan * bmi must be between 25-49.9 kg/m2 * must be willing to reduce caloric intake and increase physical activity * not currently participating in a weight loss study in a weight loss study that involved podcasts exclusion criteria: * over the age of 65 years old * currently participating in a weight loss program * has lost more than 10 pounds in the past 6 months * diagnosed with stroke or heart attack * diagnosed with diabetes that is controlled using medication

Keywords: diet weight loss tracking calories
effect of the consumption of fermented dairy drink on common infections in shift-workers

Conditions: Healthy

Summary: this clinical study plans to investigate the effect of the consumption of a fermented dairy drink on the occurrence of common infections. this study will be performed in a healthy adult population of shift workers.


Eligibility criteria:
inclusion criteria: * male/female subjects aged 18 to 65 years (bounds included) * healthy subjects. * subjects working in two- or three-shift work including night work exclusion criteria: * subject with any food allergy * subject in a situation that, in the investigator opinion, could interfere with optimal participation in the present study or could constitute a special risk for the subject.

Keywords: shiftworkers volunteers
adductor canal block with posterior capsular injection for total knee replacement

Conditions: Pain; Osteoarthritis

Summary: to compare early ambulation and ability to participate in rehabilitation in patients undergoing total knee replacement using two different nerve block techniques for pain control. the 2 methods are 1) adductor canal block with posterior capsular injection 2) femoral nerve block with tibial nerve block

early mobilization in the postoperative period is important to the success of surgery following total knee replacement. however, severe post-operative pain is an impediment to early implementation of rehabilitaion program. the use of femoral nerve block combined with tibial nerve block as part of a multimodal analgesic program provides effective pain control but causes weakness of the operative extremity preventing patients from bearing weight, exercising the leg and increasing the risk of falls thereby delaying early participation in rehabilitation. adductor canal block is a new technique that has been described to provide pain control after total knee arthroplasty (1). the advantages of this block is that it could potentially minimize lower extremity weakness because the target nerve (saphenous nerve) blocked in this technique is a purely sensory nerve and does not provide any motor innervation to any muscle groups. adductor canal block lends itself easily to providing prolonged analgesia because a perineural catheter can be inserted and the block maintained by a continuous infusion of dilute local anesthetic solution for days. a disadvantage of this method is that it may not provide adequate analgesia for posterior knee pain in the early postoperative period. by combining adductor canal block with ultrasound guided posterior and antero-medial knee injection, the posterior knee pain can be controlled effectively. posterior and antero-medial knee injection of local anesthetic solution has been used as a method of controlling posterior knee pain after total knee arthroplasty (2).

Eligibility criteria:
inclusion criteria: * patients having primary, unilateral total knee arthroplasty * ages 18 - 80 exclusion criteria: * history of neurological disease * neuropathy * diabetes * major systemic illness * pregnancy * chronic narcotic use * allergy to local anesthetic solution or nsaids * inability to give consent or cooperate with the study protocol * bmi\> 40

Keywords: early ambulation knee arthroplasty
national validation and sensitivity to change of the saq

Conditions: Asthma; Severe Asthma

Summary: design a multi-centre mixed methods study of a new asthma specific quality of life questionnaire including limited clinic data. aims to collect further quantitative data to validate a new asthma quality of life scale, the severe asthma questionnaire (saq). to determine the minimum clinically important difference (mcid) of the saq outcome measures questionnaires: 1. the severe asthma questionnaire (saq) 2. the mini asthma quality of life questionnaire (miniaqlq) 3. the eq-5d-5l 4. the asthma control test (act)/ asthma control questionnaire (acq) 5. global rating of change questionnaire (grcq) clinical data comprises: 6. spirometry 7. bmi 8. asthma severity 9. health care utilisation: ed attendance in the last 12 months, hospital admissions in the last 12 months; 10. number of exacerbations in the last 12 months requiring ocs prednisolone dose mg/day (if oral steroid dependent). population all patients aged 16 years or over, who have attended one of three participating uk specialist asthma centres for the validation study and with data also collected from derriford hospital's chest clinic (dhcc) for use in determining minimum clinically important difference. eligibility over 16 years of age diagnosis of severe asthma duration 18 months


Eligibility criteria:
part 1: national validation inclusion criteria: * all patients must have a diagnosis of severe asthma, be taking high dose inhaled corticosteroids (gina step 4 \& 5), and be aged 16 years or over. exclusion criteria: * patients that are unwilling to participate will be excluded from the study. * in the opinion of the physician responsible for the care of the patient, the patient has a condition, other than asthma, which is significantly contributing to their respiratory symptoms, e.g. lung cancer, heart failure or severe chronic obstructive pulmonary disease (copd). * the saq is currently only translated into british english. therefore, if the participant is unable to read in english, they will be unable to participate. part 2: sensitivity to change inclusion criteria * patients commencing a biologic treatment for their severe asthma (gina step 4 \& 5), as per nice guidelines. exclusion criteria * patients will be excluded from the study if they are unwilling to participate * in the opinion of the physician responsible for the care of the patient, the patient has a condition, other than asthma which is significantly contributing to their respiratory symptoms, e.g. lung cancer, heart failure or severe copd.

Keywords: quality of life patient reported outcomes
chronic effects of exercise on motor memory consolidation in elderly people

Conditions: Elderly

Summary: the main purpose of this study was to investigate if a six months period of physical exercise could improve motor memory consolidation in elderly people.

38 subjects of both genders, with a mean age of 71 years old participated in the study. subjects were divided in two groups: a control group and an experimental group. before the intervention of a physical exercise program, subjects performed a finger tapping sequence to measure baseline performance. after the intervention, the assessment of the impact of exercise on motor memory consolidation was held in three stages: training; 1 hour after training and 24 hours after training.

Eligibility criteria:
inclusion criteria: * individuals not engaged in physical activity; * persons aged from 65 years. exclusion criteria: * sensory abnormalities; * mental abnormalities; * motor abnormalities; * other atypical health problems.
effect of surgical site infections on patient reported cosmetic outcomes in dermatologic surgery

Conditions: Surgical Site Infection; Patient Satisfaction

Summary: this study involves surveying two matched groups of patients that underwent dermatologic surgery at our department. one group had a documented surgical site infection and the other didn't. all patients will be asked to complete a questionnaire in which they assess the physical appearance of their scars and its psychosocial impact. results will be compared between the groups.

65 patients with a documented surgical site infection will be compared to 65 patients with normal wound healing in terms of patient reported outcome regarding scar physical appearance and psychosocial impact using scar-q questionnaire.

Eligibility criteria:
inclusion criteria: * patient above 18 years of age that underwent a dermatosurgical procedure at our department between march 2017 and march 2020. exclusion criteria: * patients assessed as not suitable for telephone survey due to hearing disabilities or cognitive impairment
ultrasonic aspiration versus co2 laser ablation for the treatment of vulvar intraepithelial neoplasia

Conditions: Vulvar Intraepithelial Neoplasia (VIN)

Summary: the primary objective of this study is to evaluate the incidence of vulva dysplasia recurrence within 12 months of treatment with carbon dioxide (co2) laser ablation or ultrasonic aspiration.

incidence of vulvar intraepithelial neoplasia (vin) is increasing among women and there still lacks a standard of care for optimal treatment. current treatment options aim to treat the symptoms associated with vin and result in a high recurrence rate. due to the high reoccurrence rate and the nature of the current treatments, a more effective treatment option is warranted. an effective treatment that targets only the diseased areas could potentially decrease recurrence rates. additionally, a more conservative treatment modality could contribute to reduced risks of scarring, discomfort, and psychosocial and sexual distraught. the researchers hypothesize that treatment for vin with ultrasonic aspiration will have a 60% reduction in recurrence rates over 12 months as compared to co2 laser aspiration. this study will employ a randomized controlled trial (rct) design. this is a phase iii study to determine the effectiveness of a more targeted treatment therapy for vin (comparing ultrasonic aspiration versus co2 laser ablation). potential participants will be identified through the gynecological clinical practices following diagnosis of high grade vin and will be randomized (1:1) to one of the treatment therapies. randomization will be stratified for multi-focal disease and human papillomavirus (hpv) status. both the sonopet ultrasonic aspirator and the co2 laser ablation devices are fda approved devices for the treatment of vulvar dysplasia.

Eligibility criteria:
inclusion criteria: * women 18-89 years old * women diagnosed with high-grade vin (diagnosed by pathology) * women referred for vulva sparing treatment for dysplasia * women available for follow-up of treatment for 12 months exclusion criteria: * women who are pregnant * women with low-grade vin dysplasia (diagnosed by pathology) * women with vaginal intraepithelial neoplasia(vain) * women requiring vulvectomy for treatment * women unable to provide informed consent
beta-lactam antibiotics initial exposure optimised in critically ill patients with sepsis

Conditions: Sepsis - to Reduce Mortality in the Intensive Care Unit; Sepsis; Septic Shock

Summary: the aim of this study is to investigate if an initial short double dose of beta-lactam antibiotics will reduce mortality in critically ill patients with sepsis.

objective to determine if using higher dosages of beta-lactam antibiotics in the initial phase of sepsis improves clinical outcome of critically ill patients. main trial endpoints the main trial endpoint is all cause 28-day mortality. secondary trial endpoints secondary trial endpoints include: hospital length of stay, icu length of stay, microbiological eradication, time to shock reversal, clinical cure, δ lactate, δ pct, δ sofa, 90- day mortality, 365-day mortality, pharmacodynamic target, post study calculation of the costs in both study, groups, eq5d questionnaire 3 and 12 months after admission, imta productivity questionnaire 3 and 12 months after admission, imta medical consumption questionnaire 3 and 12 months after admission and the number of adverse events. trial design this is an open label, randomized controlled trial. trial population the trial population will consist of adult patients admitted to the intensive care department with sepsis who will be treated according to protocol with beta-lactam antibiotics. interventions during the trial participants in the intervention group will receive a double dose of antibiotics for the first 48 hours in comparison to the standard dose in the control group.

Eligibility criteria:
inclusion criteria: * ≥18 years of age * receiving intravenous antibiotic therapy of the target drugs (including continuous infusion of beta-lactam antibiotics) * primary infection * admitted to the icu * meeting the sepsis-3 criteria for septic shock: sepsis in addition to shock requiring the start of vasopressors to maintain a mean arterial pressure 65 mmhg or greater, and a serum lac tate level greater than 2.0 mmol/l following "adequate fluid resuscitation". exclusion criteria: * patient or legal representative not available to give informed consent within 72 hours after admittance * pregnancy * admittance for burn wounds * patients receiving target antibiotics only as prophylaxis within the context of selective diges tive tract decontamination (sdd) * enrolment in another interventional trial * patient received the study antibiotic for more than 24 hours before inclusion * patient receiving extracorporeal membrane oxygenation (ecmo) * patient is already treated with a double dose of antibiotics based on suspected infection

Keywords: sepsis intensive care critically ill antibiotic septic shock
biomarker development for response prediction by dna mutational analysis

Conditions: Neoplasm Metastasis

Summary: the purpose of this study is to determine whether it is possible to predict response to chemotherapy in patients with metastatic cancer who are treated with irinotecan by determining the mutational profile of the tumor.


Eligibility criteria:
inclusion criteria: 1. patients with a metastatic solid tumor who have failed at least one line of palliative chemotherapy and are irinotecan naïve. 2. patients who are, as per local protocol, eligible for palliative treatment with (standard of care) irinotecan. 3. measurable metastatic lesion(s), according to recist 1.1 criteria. 4. radiological measurable metastatic lesion(s) of which a histological biopsy can safely be obtained: 1. patients with safely accessible metastases. 2. patients not known with bleeding disorders (such as hemophilia) or bleeding complications from biopsies, dental procedures or surgeries. 3. patients not using any anti-coagulant medication at the time of biopsy: all aspirin derivatives, nsaid's, coumarines, platelet function inhibitors, heparins (including lmwhs) and oral factor xa inhibitors are not allowed, unless medication can either be safely stopped or counteracted. 4. adequate coagulation status on the day of biopsy as measured by: * ptt \< 1.5 x uln * aptt \< 1.5 x uln * platelet count 100 x 10\*9 / l or higher * pt-inr \< 1.6 * hb \> 6 5. biopsies should be performed at least four weeks after last bevacizumab administration. 5. patients age 18 years or up, willing and able to comply with the protocol as judged by the investigator with a signed informed consent. exclusion criteria: patients not meeting all of the above inclusion criteria.

Keywords: feasibility studies sequence analysis, dna biological markers solid tumors neoplasm metastasis irinotecan pharmacokinetics sn-38 carboxylesterase activity within metastasis
high-field mri characterization of wrist and hand cartilage abnormalities in inflammatory and chronic rheumatisms

Conditions: Abnormality; Inflammation; Rheumatism

Summary: the present project aims at evaluating the diagnostic potential of high-field mri (3 teslas) for joint disease. at this field, given that isotropic image resolution of 400 microns can be obtained, one could expect an early detection of joint abnormalities. the additional aim of this project will be to develop a quantitative analyse of the corresponding high-resolution images.


Eligibility criteria:
inclusion criteria: * gp suspects or affected by rheumatoid polyarthritis 1. morning articular stiffness of at least 15 minutes. 2. arthalgias or arthritises of at least three joints(articulations), among which those of the hand. 3. possible rheumatoid presence of a factor(mailman) and\\or antibody anti peptides positive citrullinés. 4. typical possible radiological hurts on the standard clichés(pictures) of the reached(affected) joints(articulations). * gp affected by stiffening spondylitis with axial and peripheral infringement : . lumbago and steepness lumbar vertebra inflammatory. 2. arthralgias and\\or peripheral arthritises 3. possible presence of an allèle hla 4. possible presence of a sacro-illite 5. absence of the other rheumatic markers * gp affected by connectivity with anti-nuclear antibody positive and / or specific antibodies, suffering of polyarthralgias with or without arthritis * gp healthy control * gp presenting a degenerative osteoarthritis of the wrist traumatic comment, noticed radiologically, which will serve as not inflammatory control. exclusion criteria: * claustrophobia, * metallic foreign bodies, * pacemakers the pregnant women, * parturients or who breast-feed are excluded from the study

Keywords: wrist and hand cartilage abnormalities in inflammatory and chronic rheumatisms