Kornimate/medical-research-clean huggingface dataset:
swiss_evidence - compartment compressibility monitoring using cpm#1

Conditions: Compartment Syndromes

Summary: compartment syndrome is a very serious musculoskeletal disorder, which can lead to potentially devastating consequences, such as limb amputation and life-threatening conditions. it is a well described medical condition considered to be an orthopaedic emergency affecting all ages. even though compartment syndrome is a well described medical condition, the appropriate treatment (i.e., fasciotomy to release tissue pressure) is invasive and involves its own risks. furthermore, and of most critical importance is the timing for the intervention of a fasciotomy. the concerned limb may already have had severe, sometimes even irreversible, tissue damage due to high intra-compartmental pressure within 6 to 10 hours. the standard diagnostic method for compartment syndrome is an invasive intra-compartmental pressure measurement via insertion of a pressure monitoring device into the muscle compartment. commercially available intra compartmental pressure monitors have a highly variable intra-observer reproducibility and user errors are common. compared to the invasive modalities, the compremium compartmental compressibility monitoring system (cpm#1) shows promising advantages for the clinical application. not only is the technology used for the cpm#1 device safe and non-invasive for the patient with minimal training required for the healthcare professionals, but it has also demonstrated high intra- and inter-observer reproducibility (as per bench tests and clinical settings with prototypes, to be confirmed in clinical studies like this one). the use of the cpm#1 device therefore facilitates the measurements, as it is based on pre-existing ultrasound methods and avoids any further risks to the patients compared to invasive compartmental pressure diagnosis methods.


Eligibility criteria:
inclusion criteria: * healthy volunteers * male and female * age between 18 and 84 exclusion criteria: * previous surgery to or fracture of the lower leg * peripheral arterial or venous disease * history of compartment syndrome * limb anomalies * general muscle disorder * participants under the influence of excessive alcohol, consumption of narcotics or benzodiazepines prior to procedure * participants under the effect of analgesic (\< 12 hours)
human anti-tnf monoclonal antibody adalimumab in canadian subjects with moderate to severe crohn's disease (access)

Conditions: Crohn's Disease

Summary: to make adalimumab available to subjects suffering from moderately to severely active crohn's disease (cd) and to expand the safety information on adalimumab. the study also assessed changes in patient reported outcome measures from baseline.

this was a phase 3, multicenter, open-label, early access study with an induction regimen of adalimumab 160 mg subcutaneous (sc) at baseline and 80 mg sc at week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at week 4 in subjects with moderately to severely active crohn's disease (cd) who were eligible to receive biologic therapy or who had failed to respond to, lost response to, or were intolerant to infliximab. failure of prior therapy was determined by the investigator. subjects were to have an 8-week wash-out period prior to baseline from the last dose of infliximab.

Eligibility criteria:
inclusion criteria: * males or females 18 years of age and older * females: not of childbearing potential or practicing approved birth control throughout the study and for 150 days after study completion * diagnosis of moderate to severe cd for greater than 16 weeks prior to screening; crohn's disease activity index score \> 220 or harvey bradshaw index equal to or higher than 7, and who are refractory to optimal conventional therapies such as, 5-aminosalicylic acid (5-asa), glucocorticoids, and immunosuppressive therapies (azathioprine, 6-mp and mtx) * subjects who failed prior infliximab therapy (as determined by the primary investigator), including those who never clinically responded ("primary non-responders") exclusion criteria: * history of cancer other than some skin and cervical cancers * history of opportunistic infections, central nervous system (cns) demyelinating disease, chronic viral hepatitis, or untreated tuberculosis * subjects with other, poorly controlled medical conditions * subjects with any prior exposure to tysabri® (natalizumab) * subjects who have received any investigational agent in the past 30 days or 5 half-lives prior to screening (whichever is longer) * female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study
glutamate excitotoxicity in brain metastases from lung, breast and melanoma treated with stereotactic radiosurgery

Conditions: Brain Metastases, Adult

Summary: brain metastases (bm) represents a devastating clinical reality, carrying an estimated survival time of less than one year. number of reasons, including complicated tumor biology and difficulties in modeling metastatic cancer in brain microenvironment, do hinder research on this topic. bm are indeed the most frequent neoplasm in the central nervous system (cns) and is estimated that up to 14% of all newly diagnosed cancers will metastasize to the brain. a number of reasons, including complicated tumor biology and difficulties in modeling metastatic cancer in brain microenvironment, do hinder research on this topic. present knowledge regarding alterations in glutamate (glu) homeostasis and bm is poor. this study aims at investigating glu balance in bm patients and providing supporting evidence to the identification of new putative biomarkers to be used as potential therapeutic targets.

experimental procedure: serum levels of glutamic oxaloacetic transaminase (got1), glutamate pyruvate transaminase (gpt) and lactate dehydrogenase (ldh) levels and serum glutamate, aspartate and lactate levels of a total of 100 patients will be collected and divided in three different groups: * a: bm group (n=50), patients affected by bm from lung, breast and melanoma, candidates to srs * b: control group 1 (n=25), patients with the same primary controlled tumors without nor brain nor extracranial metastases * c: control group 2 (n=25), patients with benign intracranial lesions candidates to srs treatment. in a) and c) serum got1, gpt and ldh levels and serum glutamate, aspartate, lactate levels will be evaluated before and after srs treatment (at 3, 6 and 9 months follow-up). in b) serum biomarkers levels will be only collected at baseline. • oncological and imaging data will be collected during follow-up in patients enrolled in the present studies. mri imaging will be performed at definite timepoints (baseline and 3, 6 and 9 months follow-up). serum levels of markers will be analyzed in each group and results will be compared between them. moreover, mri changes and oncological relevant outcomes will be investigated.

Eligibility criteria:
inclusion criteria (target group) * adult patients carrying melanoma, breast or lung cancer bm of new diagnosis * patients eligible to srs-gk treatment inclusion criteria (control group 1) - adult patients carrying melanoma, breast or lung cancer without bm inclusion criteria (control group 2) * adult patients carrying intracranial extra-axial benign tumor * patients eligible to srs-gk treatment exclusion criteria: * acute or chronic liver disease * severe anemia (hb \<8g/dl) * pregnant or breastfeeding patient * pediatric patients * patients not able to express informed consent

Keywords: brain metastases glutamate stereotactic radiosurgery
biomechanical parameters of gait in patients with parkinson's disease and parkinsonian syndromes

Conditions: Gait Disorders, Neurologic

Summary: gait disorders and falls are frequent in patients with parkinsonian syndromes. in patients with parkinson's disease (pd), these signs occurred later during the course of the disease in comparison to patients with other degenerative parkinsonian disorders. the pathophysiology of these symptoms are still not fully understood. gait initiation challenges the balance control system as the body moves from an upright stable static posture to a continuously unstable gait. the aim of this study is to analyse the gait initiation process in patients with parkinsonian disorders.


Eligibility criteria:
inclusion criteria: * patients able to walk without assistance * patients with parkinson's disease or other degenerative parkinsonian syndromes (progressive supranuclear palsy \[psp\], multiple system atrophy \[msa\], corticobasal degeneration \[cbd\], etc.) exclusion criteria: * other parkinsonian syndromes * dementia * neuroleptic treatment

Keywords: gait disorders postural instability parkinsonian syndrome gait initiation parkinson's disease adults
assessment of burn severity and extent spatial frequency domain imaging

Conditions: Burn; Burn Injury

Summary: the goal of this pilot clinical study is to evaluate the feasibility of collecting spatial frequency domain imaging (sfdi) data in patients with circulatory compromise due to thermal burns using the fda-cleared clarifi imaging system and the next generation handheld m-clarifi. accurate assessment of burn depth and assessment at the point of care is an essential input for clinicians to plan proper treatment and management. sfdi has been shown to be a promising method to evaluate burn depth and extent within 24 hours in pre-clinical studies. the two feasibility goals of this study are as follows: 1) do the values obtained with a commercial sfdi system provide utility in assessing burn depth in a clinical setting? and 2) do clarifi and m-clarifi provide equivalent data when assessing subjects with burn injuries (biomarker imaging values, clinical workflow).


Eligibility criteria:
inclusion criteria: 1. patients 18 years of age or older 2. thermal burns of any depth (superficial, deep partial thickness, or full thickness). exclusion criteria: 1. patients less than 18 years of age 2. pregnant or breastfeeding women

Keywords: sfdi spatial frequency domain imaging burn depth burn injury assessment
cost-effectiveness of adalimumab and surgery vs adalimumab in hs

Conditions: Hidradenitis Suppurativa

Summary: the primary objective of this randomized controlled clinical trial in a real life setting is to evaluate the cost-utility of limumab monotherapy compared with the combination of adalimumab and a maximum of three surgeries after two years of treatment in adult patients with moderate to severe hs.

the primary objective of this randomized controlled clinical trial in a real life setting is to evaluate the cost-utility of limumab monotherapy (group a) with the combination of adalimumab and a maximum of three surgeries (group b) years of treatment in adult patients with moderate to severe hs. patients in group a will be treated with adalimumab monotherapy according to normal clinical practice and will be given the possibility to crossover into group b when they do not achieve the hiscr after 6 months of treatment. additionally patients will be offered treatment with infliximab, according to clinical practice, until the last surgery. patients in group b will receive adalimumab combined with a maximum of three adjuvant excisions of active lesions, both according to routine clinical practice.

Eligibility criteria:
inclusion criteria: * age ≥18 years. * moderate to (very) severe hs defined as a score of ≥3 points on the pga (range 1-5) and with a dlqi of at least 11 (range 0-30). * indication for adalimumab: i.e. uncontrolled disease (hs) under conventional therapy and/or minor surgery. * a diagnosis of hs for more than six months prior to baseline. * clearance of hs can reasonably be achieved with three surgical interventions as based on consensus between two dermatosurgeons. * willing and able to undergo general anaesthesia or procedural sedation and analgesia. * able and willing to give written informed consent and to comply with the study requirements. exclusion criteria: * contraindication for treatment with adalimumab (sepsis or risk of sepsis, active or latent tuberculosis, serious active local and/or chronic infections, heart failure nyha class iii/iv, severe liver disease, pre-existing hiv, active viral hepatitis, demyelinating disease, or allergy to adalimumab or any other ingredients of humira®). * previous or current use of adalimumab or other anti-tnf-α therapy. * current or recurrent clinically significant skin condition in the hs treatment area other than hs. * presence of other uncontrolled clinically significant major disease. * pregnant and lactating women. * malignancy (except basal cell carcinoma), lymphoproliferative disease or a history of malignancy. * current use of oral antibiotics (a washout period of 14 days is required). * current use of oral corticosteroids (a washout period of 30 days is required).

Keywords: acne inversa adalimumab cost-effectiveness
tele-based psychological emotional support for informal caregivers of covid-19 patients in intensive care

Conditions: Posttraumatic Stress Disorder; Prolonged Grief Disorder; COVID

Summary: the experience of a loved one's stay in a covid-19 intensive care unit (icu), either intubated or on respiratory support, forces family caregivers (hereafter 'caregivers') to face core existential fears, such as uncertainty and death. it also poses a serious threat to basic human needs for autonomy, competence, and relatedness, as family caregivers have no control over the illness, and limited prior competence in dealing with critical illness. covid-19 likely aggravates this experience, as social distancing cuts caregivers off from visiting patients in the icu, from using their usual social supportive network and the threat of infection extends to caregivers themselves, their children and family. combined, these extreme circumstances put caregivers in emotional turmoil and in need of psychological support and assistance in managing difficult emotions. icu caregivers are at risk of developing clinically relevant symptoms of anxiety or posttraumatic stress. during the patient's icu stay, caregivers experience peri-traumatic distress, such as helplessness, grief, frustration and anger, that may predict later posttraumatic stress disorder (ptsd). symptoms of anxiety and ptsd may last for months to years after the patient's discharge. further, caregivers of patients who die in an icu may be at greater risk of prolonged grief disorder. supportive interventions may reduce psychological late effects in icu caregivers, but the primary focus of the majority of interventions has been on communication or surrogate decision making. the co-cares study aims to develop and test the feasibility of a tele-delivered psychological intervention to enable caregivers of icu patients with covid-19 to better endure the overwhelming uncertainty and emotional strain and reduce the risk of posttraumatic stress and prolonged grief. the study hypothesizes that providing psychological intervention during and after the patients' hospitalization, can decrease peri-traumatic distress during icu hospitalization and decrease risk of post-traumatic stress, anxiety, depression and perceived stress following discharge, as well as prolonged grief in bereavement. a secondary hypothesis is that changes in emotion regulation mediate effects of the intervention on long-term psychological outcomes.


Eligibility criteria:
inclusion criteria: * close relatives or friends of a patient hospitalized in an intensive care or intermediary care wards with covid-19 * capable of completing online questionnaires * speak danish sufficiently for a therapeutic dialogue * provide informed consent exclusion criteria: * suffering from a severe psychiatric disorder (such as schizophrenia) or in ongoing psychotherapeutic treatment for a psychiatric disorder (such as major depression generalized anxiety disorder or others), that cannot be paused * unable to complete verbal phone- or videoconferencing calls * unable to complete electronic questionnaires

Keywords: informal caregiver covid-19
effects of exercise on patients with hemiparetic stroke

Conditions: Stroke; Hemiplegia; Cardiovascular Disease

Summary: this randomized trial investigates the hypothesis that regular aerobic exercise training using a task specific gait training modality will improve cardiovascular fitness, functional mobility, and reduce risk factors for recurrent cardiovascular events in chronic hemiparetic stroke patients, when compared to matched controls performing just stretching.

the aims are to determine whether 6 months progressive graded treadmill training: 1) improves cardiovascular fitness levels and reduces the excessive energy demands of hemiparetic gait, as defined by oxygen consumption levels based on open circuit spirometry during peak and submaximal exercise ambulation tasks; 2) increases free living physical activity measured by portable kinematic recording devices and quantitative in vivo determination of energy expenditure using stable isotopes; and, 3) improves the cardiovascular-metabolic risk factor profile including measures of key endogenous fibrinolysis regulatory enzymes \[plasma tissue plasminogen activator (t-pa) and its main circulating inhibitor (pai-1)\], fasting lipoprotein lipid profiles, blood pressure, and oral glucose tolerance and insulin responses. measurements of body composition at baseline and after training will further determine the effects of aerobic exercise training on muscle mass and central obesity.

Eligibility criteria:
males or females ages 40 yrs to 80 yrs who are chronic hemiparetic stroke patients.

Keywords: cerebrovascular disorders exercise rehabilitation
validity and reliability of outcome measures in patients with cancer of the head and neck

Conditions: Head and Neck Cancer

Summary: the purpose of this study is to establish the six-minute walk test, 10-meter walk test, 30 second chair stand, linear analog scale of function, and the modifed brief fatigue inventory as reliable and valid outcome measurements for patients with head and neck cancer.

this study will be looking at the test-retest reliability and validity of various outcome measures in patients with cancer of the head and neck. testing will occur in 2 visits within one week.

Eligibility criteria:
inclusion criteria: * age 18-85 * within 3 months of surgery, or are currently undergoing radiation and/or chemotherapy for a diagnosis of head and neck cancer * community dwelling * able to provide informed consent, answer relevant questionnaires,follow instructions provided during testing exclusion criteria: * vulnerable populations (minors, prisoners) * medical comorbidities which limit the safe completion of the 6mwt, gait speed, and strength testing * inability to return for a second day of testing within one week

Keywords: head and neck cancer physical function cancer related fatigue gait speed 6mwt 10-meter walk test 30-second chair stand linear analog scale of function modified brief fatigue inventory
imsi in couples with previous implantation failures

Conditions: Male Infertility; Female Infertility

Summary: there is a lack of clarity regarding the justification to instruct the couple to shift from intracytoplasmic sperm injection (icsi) to intracytoplasmic morphologically selected sperm injection (imsi). in this study, we aim at evaluating the efficacy of imsi in couples with previous implantation failure with icsi.


Eligibility criteria:
inclusion criteria: * patients with icsi indication, who have previously underwent \>= 1 icsi attempt in which at least 2 blastocysts were transferred, with no implantation. * regular menstrual cycles every 25-35 days. * body mass index less than 35 as calculated according to the following formula: body weight (kg) / height x height (m2) * presence of both ovaries. * no pelvic and / or clinically significant uterine anomalies. * normal cervical cytology. * serum follicle stimulating hormone (fsh) within normal limits. exclusion criteria: * clinically significant systemic disease. * infection by the human immunodeficiency virus (hiv). * infection by the by the hepatitis c virus * positive test for surface antigens of hepatitis b. * endometriosis stages iii - iv (classification of the american society for reproductive medicine). * hydrosalpinx, unilateral or bilateral. * abnormal gynecological bleeding, undiagnosed. * allergy or hypersensitivity to human gonadotropin preparations or any other related to the study medication. -simultaneous participation in another clinical trial. -

Keywords: sperm morphology icsi imsi implantation pregnancy
assessing the effects of three oral care regimens

Conditions: Dental Plaque; Gingivitis

Summary: assessing the effects of three oral care regimen on plaque, gingivitis, and tooth whitening: a randomized, person-centric, comparative effectiveness clinical research study by the practitioners engaged in applied research and learning (pearl) network.

six month, five visit study of plaque, gingivitis, and tooth whitening with three randomized intervention groups using fda marketed and approved products and devices. one hundred fifty (150) subjects from the patient base of 10 pearl network associated dental offices on the east coast of the united states will be entered into the clinical research study. this is a post-marketing comparative effectiveness research study. having a total of 5 visits over a six month period. adverse events and side effects for the products used are being assessed.

Eligibility criteria:
inclusion criteria 1. subject males or females 18 to 70 years old (inclusive). 2. availability for the 6 months duration of the clinical research study 3. good general health 4. subject able and willing to follow study procedures and instructions 5. subject read, understood and signed an informed consent form 6. subject present with at least 20 natural teeth in the functional dentition (excluding third molars), including the following natural (uncrowned) teeth for shading: #6, #7, #8, #9, #10, #11 exclusion criteria potential subjects must not have any of the following conditions: 1. presence of orthodontic bands 2. presence of partial removable dentures 3. tumor(s) of the soft or hard tissues of the oral cavity 4. restorations or crowns that would interfere with color measurements on the following teeth: #6, #7, #8 , #9, #10 \& #11 (upper six front teeth) 5. advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone) 6. five or more carious lesions requiring immediate restorative treatment 7. antibiotic use any time during the one month prior to entry into the study 8. participation in any other clinical study or test panel within the one month prior to entry into the study 9. history of allergies to oral care/personal care consumer products or their ingredients. 10. on any prescription medicines that might interfere with the study outcome 11. an existing medical condition which prohibits eating or drinking for periods up to 4 hours 12. history of alcohol or drug abuse 13. pregnant or lactating

Keywords: tooth whitening