Kornimate/medical-research-clean huggingface dataset:
new methods of distribution of a self sampler kit for cervical cancer screening

Conditions: Cervical Cancer Cin Grade

Summary: the opportunity of a home, self-collected sample, opens the chance to remove some of the barriers that may discourage women from participating to screening programmes or performing hpv (human papilloma virus)-test. self-sampling is less time consuming and invasive as compared with tests performed at a clinic. it allows for privacy, reduces discomfort and women know nobody would have to handle their body. study hypothesis: the use of a self-sampler may increase the recovery of non-responders women at cervical cancer screening.

in a previous trial (isrctn96071600) the investigators tested on 2400 women, compliance with self sampler device (pantarhei devices, zeist, the netherlands). with this study the investigators analyze the response to two channels of transmission of the device (a model of device easier, and less expensive than the previous), such as screening for colon cancer. the shipment of the device at home and taking on a local pharmacy. involving 15000 women non-responders to previous calls in five different screening programs in italy (rome, bologna, abruzzo region, molise region, veneto region).

Eligibility criteria:
inclusion criteria: all women (aged 35-64 years) non-responding to the screening invitation in the previous year and eligible for recall exclusion criteria: does not meet inclusion criteria

Keywords: cervical cancer prevention screening
pre-operative blood lipid level and post-operative major adverse cardiac event

Conditions: Lipid Metabolism Disorders; Postoperative Complications

Summary: whether the pre-operative blood lipid level and post-operative cardiovascular events is associated is unknown. this study is to find out the main blood lipid and relative protein level change and the post-operative cardiovascular events occurrence.

the participants collected data from their hospital.patients under going non-cardiac surgery were collected. data of triglycerides, cholesterol, low-density lipoprotein and high-density lipoprotein were collected perioperatively. the postoperative major cardiovascular and cerebral events were also identified and collected. other data including perioperative information and surgeries and anesthesia data were gathered. logistic regression models were built and selected. independent risk factors relative to postoperative major cardiovascular and cerebral events were screened and identified. different levels of triglycerides, cholesterol, low-density lipoprotein and high-density lipoprotein were analysed.

Eligibility criteria:
inclusion criteria: * non-cardiac surgery patients with preoperative blood lipid tests exclusion criteria: * electronic records missing or peri-operative data missing
the wild man programme - a nature-based rehabilitation enhancing quality of life for men on long-term sick leave

Conditions: Stress; Anxiety; Depression; Cardiac Disease; Cancer; Diabetes; Copd

Summary: the aim of the present study is to examine whether the nature based 'wild man programme' can help to increase quality of life among men on sick leave compared to treatment as usual. additionally, the study examines which natural environments best work as supportive environments in the rehabilitation.

many men in denmark have poor mental health and need help to recover. however, designing a rehabilitation intervention appealing to men is challenging. the 'wild man programme' is a rehabilitation programme for men on long-term sick leave and with clinical or self-reported stress due to prolonged health problems such as stress, anxiety, depression, cancer, chronic obstructive pulmonary disease (copd), cardiovascular disease or diabetes. the programme is a nature-based rehabilitation (nbr) initiative combining nature experiences, attention training, body awareness training and supporting community spirit. the aim of the present study is to examine whether the 'wild man programme' can help to increase quality of life among men on sick leave compared to treatment as usual. additionally, the study examines which natural environments best work as supportive environments in the rehabilitation. a matched control study comparing an intervention group (n=38) which receives a nine-week nature-based intervention to a control group (n=38) receiving case management as treatment as usual in the municipalities. outcomes are measured at baseline (t1), post treatment (t2), and at follow-up 6 months post intervention (t3). the primary outcome is an improvement in quality of life and the secondary outcome is a decrease in stress level. with the 'wild man programme' we investigate whether it is a model that can be implemented in the health system in denmark to help men with different kinds of health problems improve their quality of life and stress levels. the programme can also deliver valuable information for future nature-based rehabilitation for women (wild woman) and mixed gender groups. the project will also contribute with information on whether the method and the concept can be a valuable tool for health professionals in the health sector.

Eligibility criteria:
the inclusion and exclusion criteria are similar for the two groups. the inclusion criteria are: * male gender * 18 to 68 years of age * clinical or self-reported symptoms of stress, anxiety, depression * clinical diagnosis of cancer, cardiovascular disease, chronic obstructive pulmonary disease (copd), diabetes or other kinds of chronic diseases * ability to walk approximately three kilometers in nature * ability to understand and speak danish the exclusion criteria are: - psychosis or psychotic disorders, brain injuries or physical disabilities that prevent the participant from participating in the physical exercise programme or move about in nature

Keywords: supportive environment theory (set) aesthetic affective theory (aat) attention restoration theory (art) nature-body-mind-community (nbmc)
intraoperative frozen section pathology to guide surgical treatment for lung adenocarcinoma (ectop-1016)

Conditions: Lung Adenocarcinoma; Surgical Procedure, Unspecified; Pathology

Summary: this study is one of eastern cooperative thoracic oncology projects (ectop-1016). the goal of this clinical trial is to confirm the concordance rate between intra-operative frozen section pathological diagnosis and post-operative paraffin embedded pathological diagnosis, and use this result to guide surgical treatment for early stage (ct1n0m0) lung adenocarcinomas.


Eligibility criteria:
inclusion criteria: * patients who sign the informed consent form and are willing to complete the study according to the study protocol; * no previous history of cancer or pulmonary surgery; * solitary lesions or multiple lesions with only one not manifesting as pure ground-glass opacity (ggo) on ct scan; * peripheral clinical t1n0m0 patients that are eligible for surgery; * non-small cell lung cancer is pathologically diagnosed before or at surgery; * no radiation therapy or chemotherapy before surgery. exclusion criteria: * patients with clinical stages other than t1n0m0; * the lesion cannot be completely resected; * previous history of cancer; * patients having received radiation therapy or chemotherapy.

Keywords: intraoperative frozen section pathology surgical treatment lung adenocarcinoma
inverted flap versus internal limiting membrane peeling in small full thickness macular holes

Conditions: Full Thickness Macular Hole

Summary: primary outcome: difference of microperimetry retinal sensitivity after primary vitrectomy for idiopathic full thickness macular holes with inverted flap technique versus internal limiting membrane (ilm) peeling technique secondary outcomes: difference of visual change after primary vitrectomy for idiopathic full thickness macular holes with inverted flap technique versus internal limiting membrane (ilm) peeling technique; difference in closure rate after primary vitrectomy for idiopathic full thickness macular holes with inverted flap technique versus internal limiting membrane (ilm) peeling technique


Eligibility criteria:
inclusion criteria: * \>18 years old * idiopathic full thickness macular hole ≤ 350 micron of diameter * phakic or pseudophakic * absence of systemic adverse conditions exclusion criteria: * concomitant retinal and other ocular disease * previous ocular surgery except cataract surgery * axial length \>26mm

Keywords: full thickness macular hole vitrectomy inverted flap internal limiting membrane peeling
ultrasound guided trigeminal nerve block for typical or atypical facial pain

Conditions: Typical Facial Pain; Atypical Facial Pain

Summary: trigeminal neuralgia is a craniofacial pain syndrome that is typically characterized by unilateral severe, recurrent, electrical pain in one or more distributions of the trigeminal nerve. current treatment strategies include oral medications as first line therapy with surgical interventions reserved for those patients who are refractory to medications or unable to tolerate medication side effects. despite these current treatment options, many patients continue to have symptoms. ultrasound-guided trigeminal nerve block allows for fine adjustment of the needle tip and direct observation of the medicine. local anesthetic and steroids have been successfully used for diagnostic and or therapeutic nerve pain with great success. steroids can be short or long acting in duration with varying side effects. if there exists a difference in duration of action, using the longer acting drug will provide a greater period of symptom relief for the patient and may allow the patient to undergo fewer interventional procedures.


Eligibility criteria:
inclusion criteria: * all patients presenting to the northwestern pain center who are eligible and scheduled to receive a ultrasound-guided trigeminal nerve block. exclusion criteria: * exclusion is the same for patients who are not eligible for ultrasound guided nerve blocks.
determining the extent of diffusion tensor abnormalities in focal cortical dysplasia

Conditions: Focal Cortical Dysplasia; Epilepsy

Summary: focal cortical dysplasia (fcd) is a common finding in epilepsy surgery in pediatric patients. children with intractable epilepsy would have extensive tests to identify the cause of epilepsy; this includes mr brain, video eeg and magnetoencephalography (meg). the white matter next to fcd is frequently found to be abnormal on pathology. diffusion tensor imaging (dti) can be used to study the abnormal white matter and the area that often extends beyond the area that is visible.

focal cortical dysplasia (fcd) is a highly epileptogenic form of malformation of cortical development that may require surgical resection for epilepsy control. with abnormal development and organization of neurons within the cortex, the white matter projecting from the abnormal cortex is likely to be abnormal as well. the abnormality in the white matter involves not only the subcortical white matter, but also the long tracts in the deep white matter associated with the dysplastic cortex. histologically, the subcortical white matter adjacent to the dysplastic cortex has been found to be abnormal. studies using diffusion tensor imaging (dti) to investigate the white matter adjacent to the mr visible abnormality have demonstrated reduced fractional anisotropy. however, electrographic abnormality in fcd often extends beyond the visible mr abnormality and surgical outcome of epilepsy surgery in fcd is dependent on excising the mr visible abnormality as well as electrographically abnormal area beyond the mr visible abnormality. the cortical and white matter abnormalities are therefore assumed to extend beyond the mr visible lesion. the short-term goal of this study is to determine whether quantitative measures of the abnormal white matter using dti are able to provide surrogate markers for the extent of fcd. whilst surgical outcome data is not available for the purpose of this study, these children will be followed up and in the longer term, the extent of fcd as determined by dti will be compared with clinical outcome post surgery. this study will help determine the potential value of this technique in identifying areas of fcd that appear normal on structural mr. in the long term, this technique can be extended to study children with intractable epilepsy with (i) mr occult lesion and (ii) developmental tumor with mr occult fcd adjacent to the tumor.

Eligibility criteria:
inclusion criteria: * children with intractable epilepsy with suspected fcd for mri \& meg exclusion criteria: * children with contraindications to mri such as those with pacemaker

Keywords: epilepsy magnetic resonance imaging magnetoencephalography
fetal heart interventricular septum in fetuses of diabetic mothers

Conditions: Pregnancy; Diabetes Mellitus

Summary: the investigators asume that the measurement of the fetal heart interventricular septum can serve as a good tool to predict glucose control in pregnant patients with diabetes mellitus. the investigators will measure the septum width in patients with diabetes and will correlate to standard measurements of the glucuse levels.

in this study the investigators will follow patients with diabetes mellitus - mainly gestational. the investigators will measure the width of the interventricular septum and correlate with conventional measures of blood glucose measurements in this population. the investigators will try to assess whether measurement of the septum can be an earlier and better predictor of glucose control in this population.

Eligibility criteria:
inclusion criteria: * all consequtive pregnant women * with diabetes mellitus - gestational and non gestational exclusion criteria: .no willing to participate. * suspected heart anomaly

Keywords: pregnancy diabetes mellitus
dfd06 cream vs clobetasol propionate cream, 0.05% hypothalamic- pituitary-adrenal (hpa) axis suppression study in patients with moderate to severe plaque psoriasis

Conditions: Psoriasis

Summary: the purpose of this study is to evaluate the potential of dfd06 cream to suppress the hpa (hypothalamic-pituitary-adrenal) axis as compared to clobetasol propionate cream, 0.05% cream when applied twice daily for 15 days.

this was a 15-day, randomized, multicenter, comparator-controlled, open-label study. approximately 50 subjects with moderate to severe plaque psoriasis were to be randomized to treatment with dfd-06 cream or clobetasol propionate cream in a 1:1 ratio. study products were applied twice daily for 15 days to all affected areas on the body excluding face, scalp, groin, axillae, and other intertriginous areas. subject visits were scheduled at screening, baseline (day 1), day 8, day 15, and day 43 (if needed to confirm recovery). clinical determinations of disease severity were conducted using the investigator's global assessment (iga) for overall severity at each visit.

Eligibility criteria:
inclusion criteria: subjects must present with a clinical diagnosis of stable (at least 3 months) plaque psoriasis. subjects with psoriasis involving 20 to 50% body surface area (bsa), not including the face, scalp, groin, axillae and other intertriginous areas. subjects must have an iga grade of at least 3 (moderate) at the baseline visit subjects whose results from the screening adrenocorticotropic hormone (acth) stimulation test are considered normal (cortisol level \>18 ug/dl at 30 minutes post stimulation) and show no other signs of abnormal hpa function or adrenal response exclusion criteria: current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis. history of organ transplant requiring immunosuppression, hiv, or other immunocompromised state. have received treatment for any type of cancer within 5 years of the baseline visit except skin cancer and cervical cancer (in situ) are allowed if at least 1 year before the baseline visit. use within 60 days prior to the baseline visit of: 1) immunosuppressive drugs (e.g., tacrolimus, pimecrolimus), or 2) systemic antipsoriatic treatment (e.g., methotrexate, cyclosporine, hydroxyurea) use within 30 days prior to the baseline visit of: 1) topical antipsoriatic drugs (salicylic acid, anthralin, coal tar, calcipotriene), 2) psoralen and ultraviolet a (puva) therapy, 3) systemic anti-inflammatory agents (e.g., mycophenolate mofetil, sulfasalazine, 6-thioguanine), or 4) ultraviolet b (uvb) therapy. use within 30 days prior to the screening visit of any product containing corticosteroids. inhaled, intraocular, intranasal, etc. steroids are not allowed. subjects who have an abnormal sleep schedule or work at night. subjects with a known history of acute adrenal crisis, addison's disease or decreased adrenal output, low pituitary function or pituitary tumors. subjects who have a history of an adverse reaction to cosyntropin injection or similar test reagents. -

Keywords: psoriasis
annatto-derived gg for statin-associated myopathy

Conditions: Myopathy; Primary

Summary: to evaluate the effects of 3-months annatto-derived geranylgeraniol (gg) supplementation on statin-associated skeletal muscle health.

statins are widely prescribed cholesterol-lowering oral drugs. the majority of reported adverse effects due to statin include muscle pain, weakness, cramp, and tiredness. coq10 supplementation has been widely used to reduce statin-related muscle complaints. several human studies have been reported with inconsistent effects of coq10 on statin-related symptoms. this study is to investigate the role of 3-month annatto-derived geranylgeraniol (gg) in statin-related muscle outcomes in humans. qualified subjects will be matched by age, gender, and body weight, and then randomly assigned to a no gg group, a low gg dose group, or a high gg dose group. the outcome measures will be assessed at baseline and after 3 months. muscle-associated measurements will be recorded using subject questionnaires (also follow-up after 3 and 6 months), muscle performance results, and blood samples. we will monitor the safety of subjects after 3 months. food intake, physical activity, and medication changes will be recorded at baseline and after 3 months. all data will be analyzed statistically.

Eligibility criteria:
inclusion criteria: * age ≥40 of either sex * statin-treated patients with muscle pain alone or accompanied by other symptoms. * patients currently receiving a statin who developed new-onset myalgias in within 90 day of initiation or a dosage increase exclusion criteria: * malignancy or significant neurological or psychiatric disturbances, including alcohol or drug abuse. * woman who is pregnant, breastfeeding, or of childbearing potential and not taking adequate contraceptive precautions. * had coq10 supplement one month before starting the study. * genetic musculoskeletal and neurologic disorder known to affect skeletal muscle metabolism * had steroid medication one month before starting the study.
generation of thrombin and prediction of deep vein thrombosis post prosthetic orthopedic surgery of the lower limbs

Conditions: Deep Vein Thrombosis; Total Hip Prosthesis; Knee Prosthesis

Summary: the numerical ratio between the value of the thrombin generation test performed without soluble thrombomodulin and the value of the thrombin generation test performed in the presence of soluble thrombomodulin, performed pre-surgically, could predict the risk of early venous thromboembolism after placement of total hip or knee prosthesis.


Eligibility criteria:
inclusion criteria: * the patient must have his consent and signed the consent form. * the patient must affiliated or a beneficiary of a health insurance plan. * the patient is at least 18 years old * patient with an indication of total hip prosthesis or total knee replacement surgery set unilateral exclusion criteria: * the patient is participating in another interventional study. * the patient is in an exclusion period determined by a previous study. * minor patients, people in emergency situations. * the patient is under the protection of justice, guardianship or curatorship. * the patient refuses to sign the consent. * it is not possible to inform the patient. * the patient is pregnant, parturient, or breastfeeding. * the patient has a contraindication (or incompatible drug combination) to drug thromboprophylaxis applied according to good clinical practice and recommendations of learned societies * long-term anticoagulant therapy for personal thrombotic history. * known hemorrhagic disease. * haemorrhagic risk perceived during the consultation of preoperative anesthesia, leading to modify / develop the usual thromboprophylaxis. * chronic liver disease. * chronic renal failure with calculated clearance \<30 ml / min. * extreme body mass index: \ 40 kg.m-2 * total hip prosthesis or total knee prosthesis in the immediate aftermath of a bone fracture. * total hip prosthesis resumption. * installation of more than one joint prosthesis. * surgery in the previous 3 months. * infective push in the previous 3 months. * indication of haemostatic treatment for abnormal haemorrhagic risk. * severe impairment of renal function with a calculated clearance \<30 ml / min. * contraindication (allergic, metabolic, other ...) to usual drug thromboprophylaxis. * condition requiring dosage adjustment of drug thromboprophylaxis. * indication to put in place intermittent pneumatic compression for perioperative thromboprophylaxis.
relationship between level of hemoglobin a1c and platelet function in patients undergoing cardiac surgery

Conditions: Diabetes Mellitus; Complication of Coronary Artery Bypass Graft; Blood Platelet Disorders

Summary: the aim of this study is to evaluate whether increased level of hemoglobin a1c (hba1c) correlates to higher level of platelet reactivity assessed by impedance aggregometry in patients with diabetes mellitus undergoing elective coronary artery bypass grafting (cabg).

this study will be conducted at cardiac surgery department, university hospital center zagreb. it will be conducted in prospective observational fashion. diabetic patients undergoing isolated, primary on-pump cabg will be consecutively recruited. patients requiring urgent procedure will be excluded. blood samples, both for conventional lab. findings (including hba1c) and impedance aggregometry will be drawn prior to surgery and postoperatively on daily basis. cohort sample will be divided into two subgroups according to hba1c level (group 1 with hba1c \< 7% and group 2 with hba1c ≥ 7%, respectively). respective subgroups will be compared for basic demographic data, laboratory findings including those obtained using platelet function testing, and for clinical outcomes, respectively. multiple-electrode aggregometry: whole blood aggregation will be determined using a new-generation impedance aggregometer (multiplate analyzer; roche diagnostics). in brief, when platelets expose receptors on their surface they get activated and stick on the multiplate sensor wires enhancing the electrical resistance between them. an increase in impedance is expressed in arbitrary area under the curve (auc) units. platelet aggregation is determined in response to stimulation with arachidonic acid (aspi (aspirin-sensitive patients identification) test designed to evaluate the effect to acetylsalicylic acid (asa)) and adenosine diphosphate (adp) (adp test designed to evaluate the effect of thienopyridines, such as clopidogrel).

Eligibility criteria:
inclusion criteria: * patients undergoing isolated primary on-pump cabg * elective surgery * diabetic patients including insulin-dependent diabetes mellitus (iddm) and non-insulin-dependent diabetes mellitus niddm * patients on antiplatelet therapy (aspirin and/or clopidogrel) pre- and postoperatively exclusion criteria: * missing consent * patients with cardiac surgical procedures other than isolated cabg * patients on antiplatelet therapy other than aspirin or clopidogrel * urgent surgery * off-pump cabg * redo cabg

Keywords: hemoglobin a1c coronary artery bypass grafting impedance aggregometry platelet reactivity clinical outcomes