Kornimate/medical-research-clean huggingface dataset:
treatment of insomnia in migraineurs

Conditions: Insomnia; Migraine

Summary: it is hypothesized that treating insomnia in migraineurs, many of whom also have tension headaches, prolongs total sleep time to the extent that it decreases overall headache frequency. chronic headache sufferers also feel more tired during the day, undoubtedly affecting daytime functioning, which is hypothesized to improve as well with prolonged total sleep time.

the objective of the study is to determine the effect of prolonging total sleep time in migraineurs with insomnia on overall headache frequency, daytime alertness, fatigue, and functioning. the prolongation of total sleep time is accomplished by bedtime administration of 3 mg eszopiclone (lunesta™), compared with placebo through a parallel-group design.

Eligibility criteria:
inclusion criteria: 1. men and women, 18 to 64 years of age (inclusive) with international headache society (ihs)-ii migraine with/without aura and diagnostic and statistical manual (dsm)-iv primary insomnia (sleep onset/sleep maintenance). 2. migraine frequency is 4-12 times per month, with a maximum of 20 days with headache per month, for 1 month or longer prior to screening. 3. a usual, estimated total sleep time of 6½ hours per night or less, for 1 month or longer prior to screening, due to problems falling asleep, waking up during the night, or waking up early. exclusion criteria: 1. abortive migraine treatment with schedule ii-iii opioids. 2. use of caffeine-containing medications, prescription and non-prescription, not exceeding 10 days per month. 3. preventive migraine treatment with tricyclics or anticonvulsants. 4. treatment of insomnia with non-prescription medications, such as diphenhydramine, melatonin, or valerian, and prescription medications, such as hypnotics, barbiturates, benzodiazepines, sedating antihistamines, antidepressants, and antipsychotics.

Keywords: insomnia migraine eszopiclone insomnia in migraineurs
cedar honey in oral lichen planus

Conditions: Erosive and Atrophic Oral Lichen Planus

Summary: the study aimed to evaluate the effect of cedar honey in treatment of erosive and atrophic oral lichen planus ( a common oral problem).


Eligibility criteria:
inclusion criteria: 1. clinically and histopathologically confirmed oral lichen planus without dysplasia in histopathologic evaluation 2. severity of pain≥2 (vas score) 3. severity of lesions≥2 (tong prasom criteria) 4. absence of any treatment in the last month 5. absence of kidney or liver diseases( due to systemic administration of fluconazole to both groups) exclusion criteria: 1. evidence of lichenoid reaction in clinical or histopathologic assessment 2. loss of follow up 3. pregnant patients 4. diabetic patients 5. any other mucosal disease 6. any severe systemic disease 7. patients who refuse doctor's advice 8. any unexpected adverse effect of honey

Keywords: oral lichen planus cedar honey atrophic erosive pain treatment clinical trial
the effect of human amniotic membrane allograft on functional recovery after flexor tendon repair

Conditions: Flexor Tendon Injury

Summary: the objective of this pilot study is to gain observational insight into potential preventive features of amniotic membrane transplantation in the adhesion formation after flexor tendon repair.

the treatment of flexor tendon transection consists of surgical apposition of the lacerated tendon ends using non-absorbable sutures. main complications which result in poor outcome of the tendon repair are the rupture of the tendon apposition or substantial adhesion formation between the two tendons or the tendon and the fibro-osseous canal. adhesion formation is presumed to be a byproduct of the tendon healing. in the course of last 70 decades, the preventive effects of several pharmacological agents and mechanical barriers on adhesion formation have been investigated with some promising findings. one of the mechanical barriers that has been proposed to be suitable for adhesion prevention is human amniotic membrane allograft. however, there are no clinical studies evaluating the use of amniotic membrane in flexor tendon repair. this is a pilot study for the forthcoming randomized controlled study. the objectives of the pilot study are: 1) to test the handleability of the human amniotic membrane allograft in flexor tendon sheath reconstruction in conjunction with flexor tendon repair, 2) to elucidate the possible adverse effects related to the use of amniotic membrane in flexor the sheath, and 3) to gain observational insight into potential preventive features of amniotic membrane transplantation in the adhesion formation. the hypothesis of the pilot study is that the application of the human amniotic membrane allograft in tendon sheath reconstruction in flexor tendon injury patients is technically feasible and results in no adverse effects to the patient. a total of 10 patients with an acute flexor tendon injury will be included in the pilot study. after conventional tendoraphia, the amniotic membrane will be wrapped around the tendons and its borders will be fixed to the remaining tendon sheath. the primary outcome measure is total range of movement after 6 months of the surgery.

Eligibility criteria:
inclusion criteria: * acute flexor tendon transection in zone 2 in digits 2, 3, 4, or 5 (diagnosed within 1 week after the injury) * age over 18 * patient's willingness to participate in the study exclusion criteria: * tendon transection within 8 mm of its distal insertion (requiring reinsertion) * soft-tissue loss, severe crush, fracture, palmar plate injury, patient requiring revascularization * cognitive impairment or other factors (prisoner, military serviceman) which may affect one's decision making * substance abuse * pregnancy

Keywords: flexor tendon finger amniotic membrane allograft tendon injury
study of arterial recanalization of the central retinal artery occlusions

Conditions: Central Retinal Artery Occlusion

Summary: central retinal artery occlusions (crao) are the equivalent of an ischemic stroke (is) at the retinal level. they share the same risk factors and common pathology. their incidence is lower (8.5 / 100,000) and the functional prognosis is unfavorable in 80% of cases with visual acuity (va) \<1/10. the diagnosis of an crao is clinically based on the sudden occurrence of a decrease in deep visual acuity with fundamentally signs of reactive ischemia. there is no data on early retinal arterial recanalization after crao, nor on the relationship between early recanalization (spontaneous or post-thrombolysis) and visual prognosis.


Eligibility criteria:
inclusion criteria: * central retinal artery occlusion ≤ 24 hours exclusion criteria: * retinal dynamic angiography not performed within 48 hours of onset of symptoms * occlusion of a branch of the central retinal artery

Keywords: thrombolysis recanalization dynamic retinal angiography
effect of corticosteroid treatment on prognosis in ards secondary to covid-19

Conditions: Acute Respiratory Distress Syndrome Secondary to Covid-19

Summary: study conducted on hospitalized patient in critical ill units in nancy and metz to evaluate if early corticosteroid treatment in first seven days after admission improve patients outcome in acute respiratory distress syndrome secondary to covid-19 compared to later corticosteroid therapy or no treatment. also comparison of acquired infection with or without corticosteroid treatment during hospitalisation.


Eligibility criteria:
inclusion criteria: * icu hospitalized with acute respiratory distress syndrome secondary to sars-cov-2 infection diagnosed by pcr test * hospitalized from 01/03/2020 to 30/04/2020 exclusion criteria: * mechanical ventilation more than 48 hours at admission * transfert to another icu during stay for bed management * corticosteroid treatment at admission
study of intensive, home-based family therapy to improve illness management in youth with diabetes

Conditions: Diabetes Mellitus, Insulin Dependent

Summary: the study is a randomized clinical trial testing the effectiveness of multisystemic therapy (mst) for improving the treatment adherence, metabolic control and quality of life of urban adolescents with poorly controlled insulin dependent diabetes.

the deterioration in regimen adherence and metabolic control associated with the adolescent developmental period is well-documented. however, a subset of high-risk adolescents with diabetes demonstrate much more serious adherence problems, as evidenced by chronically poor metabolic control (cpmc) and post-diagnostic admissions for diabetic ketoacidosis (dka). adolescents in cpmc represent a group at high risk for both short and long term diabetes complications and are therefore heavy users of medical resources and health care dollars. minority and low-income children are over-represented among adolescents with cpmc. the design for the proposed study is a randomized, controlled trial with a repeated measures design using a sample of 170 adolescents, 85 of whom will receive mst and 85 of whom will receive a telephone intervention to test the effect of increased attention (control condition). subjects must have a current hemoglobin a1c (hba1c) of \>8% and an average hba1c of \>8% during the past year, must be diagnosed with insulin dependent diabetes for at least one year, be 10-17 years of age and reside in the metro detroit tri-county area. exclusion criteria are severe mental impairment/thought disorder, non-english speaking patient/parent or a co-morbid major medical condition such as cystic fibrosis. families who are randomized to mst receive intensive, home-based family therapy for approximately six months. mst is a community based treatment originally designed for use with adolescents presenting with serious mental health problems, but which is adapted in the present study for use with chronically ill youth and serious adherence difficulties. therapists meet with families two to three times per week at the beginning of treatment with a decreasing number of sessions at the end of treatment.

Eligibility criteria:
inclusion criteria: * insulin dependent type 1 or type 2 diabetes * diagnosed with diabetes ≥ 1 year * current hba1c ≥ 8% * average hba1c ≥ 8% over the past year * aged 10 -17 * patient of children's hospital of michigan diabetes clinic * lives within 30 miles of children's hospital of michigan exclusion criteria: * moderate to severe mental retardation (unable to complete study measures) * psychosis or current suicidal intent * any medical diagnosis that alters standard diabetes care

Keywords: diabetes regimen adherence metabolic control adolescents family therapy
trial of pemetrexed versus erlotinib in pretreated patients with non small cell lung cancer (nsclc)

Conditions: Non Small Cell Lung Cancer

Summary: the second-line treatment in advanced nsclc has been currently proved effective in prolonging overall survival and improving quality of life. both pemetrexed and erlotinib have been approved for second-line treatment of nsclc . erlotinib is a valuable option for the treatment of advanced nsclc, especially for elderly patients, due to convenience of administration and safety profile. the role of comprehensive geriatric assessment in treatment efficacy and tolerance is an area of investigation.

this trial will compare the efficacy of pemetrexed versus erlotinib in pretreated patients with advanced nsclc.

Eligibility criteria:
inclusion criteria: * histologically- or cytologically- confirmed non-small-cell lung cancer adenocarcinoma * stage iiib/iv * failure to prior chemotherapy * presence of two-dimensional measurable disease. the measurable disease should not have been irradiated * absence or irradiated and stable central nervous system metastatic disease. * life expectancy of more than 3 months * tissue sample desired for genomic study * age ≥ 18 years * performance status (who) \< 3 * for patients \> 65 years old: "non-frail" according to comprehensive geriatric assessment * adequate bone marrow function (absolute neutrophil count \> 1000/mm\^3, platelet count \> 100000/mm\^3, hemoglobin \> 9gr/mm\^3) * adequate liver (bilirubin \< 1.5 times upper limit of normal and sgot/sgpt \< 2 times upper limit of normal) and renal function (creatinine \< 2mg/dl) * presence of a reliable care giver for patients \> 65 years old * informed consent. exclusion criteria: * psychiatric illness or social situation that would preclude study compliance * other concurrent uncontrolled illness * other invasive malignancy within the past 5 years except nonmelanoma skin cancer

Keywords: cancer non-small-cell lung cancer chemotherapy pemetrexed erlotinib
community awareness, resources and education (care i): project 3

Conditions: Cervical Abnormality

Summary: community awareness, resources and education (care) project - project 3 will determine if appalachian women have unique risk factors for an abnormal pap smear that might contribute to the increased risk of cervical abnormalities, specifically cancer, in their communities.

the aim of care: project 3 is to determine the social, behavioral, and biological variables that might contribute to increased risks of an abnormal pap smear in appalachian women in ohio. to accomplish these aims, a case-control study was proposed. women age 18 and older with an intact cervix, not pregnant, and no current or past history of invasive cervical cancer are recruited at the time of their scheduled pap smear from clinics/physician practices in appalachian region of ohio. women receiving pap tests at participating medical clinics/physician practices are recruited for a case control epidemiologic study assessing hpv prevalence and its impact on cervical intraepithelial neoplasia (cin). cervical mucus will be collected for human papillomavirus (hpv) assays and stored for potential other assays related to hpv. serum will be drawn for hpv serology and stored for future analysis. controls are defined as women with a normal pap smear. cases are defined as women with abnormal pap smear (from atypical squamous cells of uncertain significance (ascus) to cancer.

Eligibility criteria:
inclusion criteria: * female * 18 years or older * able to give informed consent * intact cervix * no prior history of invasive cervical cancer * english speaking * willing to have biological specimens stored for future studies * resident of appalachian ohio exclusion criteria: * pregnant * medical or psychiatric illness that precludes research project requirements, ability to give informed consent, or protocol compliance. * smokers (will be contacted by study team to see if they are eligible/willing to participate in care: project 2

Keywords: appalachian abnormal pap test
a feasibility study of early mobilisation programmes in critical care

Conditions: Critical Illness

Summary: the objective of this study is to determine the feasibility of delivering a very early mobility rehabilitation program in intensive care units (icu), within the context of a randomised controlled trial (rct). this will inform the design of a future rct investigating very early icu rehabilitation in the uk national health service.

early icu-based physical rehabilitation may benefit patients with acute severe respiratory failure by attenuating the development of severe and persistent weakness and impaired physical function seen in these patients. muscle wasting occurs early (within 12 hours) and progresses rapidly after icu admission. patients may suffer from consequent physical impairment for months or years following their discharge. icu based rehabilitation has the potential to improve physical function outcomes, through mitigating muscle wasting. the investigators have successfully introduced a very early icu mobility program in their institution, which results in increased ventilator free days and reduced length of icu stay. the primary aim is to investigate whether this method will work in other icus. empress will test the feasibility of running this intervention as an rct. the results and a concurrent process evaluation will inform the design of a future, multi-centre randomised controlled trial.

Eligibility criteria:
inclusion criteria: * acute/unplanned medical admissions to the icu. * \> 42 years old. * functionally independent prior to icu admission (barthel \>80). * in hospital for \<5 days prior to intubation and ventilation. * intubated and ventilated for \<72 hrs. * expected to remain ventilated for a further 48 hours. exclusion criteria: * in hospital for 5 days or more prior to itu admission. * patients with acute brain or spinal cord injury. * known or suspected neurological / muscular impairment. * condition limiting use of cycle ergometer e.g. lower limb fracture / amputation. * not expected to survive \>48hrs. * persistent therapy exemptions in first 3 days of mechanical ventilation. * body habitus such as unable to use cycle ergometer. * consultant clinician view that patient not suitable or not expected to survive admission.

Keywords: intensive care physiotherapy rehabilitation
incorporating robotic surgery in both mastectomy and diep flap reconstruction

Conditions: Breast Cancer; Breast Reconstruction

Summary: a prospective study will be conducted to assess the outcomes of patients who underwent concurrent robotic-assisted mastectomy and robotic-assisted free diep flap harvest for breast reconstruction between march 2020 and june 25, 2023. demographic data, including age, body mass index (bmi), and medical history, were collected, along with surgical time and perioperative parameters. the incidence of acute and chronic complications was documented.


Eligibility criteria:
inclusion criteria: * patients with unilateral breast cancer received robotic-assisted mastectomy and robotic assisted free diep flap harvest for breast reconstruction exclusion criteria: * none
external pharyngeal exerciser for dysphagia

Conditions: Pharyngeal Dysphagia; Dysphagia; Oral Pharyngeal Dysphagia

Summary: pharyngeal muscle weakness and dysphagia is common in individuals post-stroke or with parkinson's disease and in individuals with head/neck cancer who have undergone surgery and/or radiation therapy. therapeutic options for these patients are limited. this pilot study is intended to assess the feasibility, safety, and efficacy of the external pharyngeal exerciser (epe) on patients with pharyngeal dysphagia receiving swallow therapy. feasibility will be assessed by patient acceptance and practice records. safety will be compared between groups to test whether there is an increased risk of the epe versus standard therapy.

pharyngeal dysphagia is incredibly common in individuals who suffer from neurological disorders such as stroke or parkinson's disease and in individuals with head/neck cancer who have undergone surgery and/or radiation therapy. the pharyngeal muscles in these patients are weak. other than standard patient-driven swallow therapy, the therapeutic options for these patients are limited. response to standard patient-drive therapy is variable and dependent on a variety of factors including the muscles most affected by the underlying disorder and patient motivation. this pilot study is intended to assess the feasibility, safety, and efficacy of the external pharyngeal exerciser (epe) on patients with pharyngeal dysphagia receiving swallow therapy. feasibility will be assessed by patient acceptance and practice records. safety will be compared between groups to test whether there is an increased risk of the epe versus standard therapy.

Eligibility criteria:
inclusion criteria: * pharyngeal dysphagia diagnosed with validated questionnaire and modified barium swallow. participants must be at least 18 years of age or older. * pharyngeal dysphagia secondary to central neurological disorder such as parkinson's disease or stroke * pharyngeal dysphagia head/neck cancer secondary to surgery/radiation * pharyngeal dysphagia secondary to elderly age \> 65 exclusion criteria: * carotid artery bruit or carotid vascular disorders * muscle diseases like muscular dystrophies, myopathies * neuro-muscular junction disorders myasthenia gravis, eaton-lambert disorders * current esophageal symptoms like heartburn, dysphagia, chest pain or regurgitation * autonomic dysfunction * pregnancy or lactation * advanced uncontrolled medical disorders (copd, congestive heart failure, cirrhosis, cancer, chronic renal failure, etc) * medically unstable
globus reflect tether - hud

Conditions: Scoliosis Idiopathic

Summary: the purpose of this device is to treat children and adolescents with scoliosis who have growth remaining. in patients with a curvature about the spine, reflect holds the convexity of the curve in place so that the concavity can grow, thereby harnessing the power of normal spine growth to correct the deformity.

the globus reflect scoliosis correction system aims to provide curve correction for scoliosis patients who are still actively growing. surgical correction is accomplished without spinal fusion, instead utilizing anterior vertebral body tethering. this device received an hde exemption from the fda and requires musc irb approval to be used.

Eligibility criteria:
inclusion criteria: * skeletally immature patients that require surgical treatment to obtain and maintain correction of progressive idiopathic scoliosis, with a major cobb angle of 35 to 60 degrees whose osseous structure is dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging. * patients should have failed bracing and/or be intolerant to brace wear. exclusion criteria: * pregnancy (current) * prior spinal or chest surgery * mri abnormalities (including syrinx greater than 4mm, chiari malformation, or tethered cord) * neuromuscular, thoracogenic, cardiogenic scoliosis, or any other non-idiopathic scoliosis * associated syndrome, including marfan disease or neurofibromatosis * sanders stage greater than 4 * thoracic curve less than 35 or greater than 60 * lumbar curve greater than or equal to 35 * unable or unwilling to firmly commit to returning for required follow-up visits * investigator judgement that the subject/family may not be a candidate for the intervention
pmcf study on craniofix®2 system used for the fixation of craniotomized bone flaps and fractures

Conditions: Skull Fractures

Summary: the craniofix®2 pmcf study has been set up as an action within the framework of a proactive post-market surveillance system of the manufacturer. the aim of this observational study is to collect systematically and proactively data regarding the performance of craniofix®2, like adverse events (aes), handling and cosmetic outcome, under daily clinical practice when used as intended by the manufacturer.


Eligibility criteria:
inclusion criteria: * written informed consent * age ≥ 18 years * use of craniofix®2 system according to ifu * planned postoperative mri within clinical routine exclusion criteria: * pregnancy * patients with hypersensitivity to metals or allergies to the implant materials * inflammations in the region of the implant site * bone conditions that rule out the application of craniofix®2 titanium clamps * use with artificial cranial bone flaps * bone tumors in the area supporting the implant * degenerative bone diseases * missing dura mater * application in the facial skull (viscerocranium) and in the orbital or skull-base region * combination of implant components from different manufacturers, i.e. additional use of plates and screws on the same bone fragment

Keywords: bone flap fixation fractures to the neurocranium craniotomized bone flaps