Kornimate/medical-research-clean huggingface dataset:
effect and safety study of atorvastatin to treat chronic subdural hematoma

Conditions: Chronic Subdural Hematoma

Summary: to evaluate the clinic effects and security of oral administration of atorvastatin on chronic subdural hematoma (csdh).

study design: multi-center, randomized, double-blind, placebo parallel controlled subjects: patients with chronic subdural hematoma (csdh) sample size: 200, including an atorvastatin-treated group of 100 patients and a control group of 100 subjects.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 and \<90 years old, male or female; 2. ct scan reveals supratentorial, unilateral or bilateral chronic subdural hematoma (mri scan is warranted if diagnosis is difficult); 3. markwalder's grading scale and glasgow coma scale (mgs-gcs)\<grade 3; 4. attending physician makes a judgment that cerebral hernia would not occur and surgical operation might not be performed in a short time. conservative treatment is adopted; 5. patients have never undergo surgery on the hematoma 6. patient fully understood the nature of the study, and voluntarily participates and signs informed consent. exclusion criteria: 1. allergic to the statin or its ingredients 2. cerebral herniation might occur at any time; 3. hematoma leads to herniation and warrants surgical operation. 4. hematoma caused by tumors, blood and other known comorbidities; 5. abnormal liver function 6. uncontrolled hepatitis and other liver diseases, as well as suffering from other disease may interfere the study 7. patients have been on oral statin treatment for a long time. 8. patients have been on oral steroids treatment for a long time. 9. participate in clinical trials in the past four weeks; 10. pregnant or breastfeeding 11. failure of completing the trial by poor compliance; 12. for any reason, the researchers believe that the case is not suitable for inclusion.

Keywords: chronic subdural hematoma atorvastatin oral administration therapy
the potential use of bold mri as a noninvasive measure of tumor hypoxia in prostate cancer

Conditions: Prostate Cancer

Summary: hypoxia (low oxygen level) is know to be present in many tumors and may strongly influence the success of treatment and the progression of disease in prostate cancer. the method used to measure tumor oxygen levels in prostate cancer is to place a needle in the prostate itself through the rectum. blood oxygen level dependent imaging (bold mri) is a special mri technique that allows indirect assessment of oxygen levels in blood. this technique is non-invasive, involving no needles. bold has not been applied in humans in prostate cancer. the purpose of this study is to develop a mri-bold technique that allows us to non-invasively measure changes related to tumor hypoxia in prostate cancer. this technique may provide information that will be an independent predictor of patient survival, tumor recurrence and likelihood of treatment response in prostate cancer

hypoxia (low oxygen level) is know to be present in many tumors and may strongly influence the success of treatment and the progression of disease in prostate cancer. the method used to measure tumor oxygen levels in prostate cancer is to place a needle in the prostate itself through the rectum. blood oxygen level dependent imaging (bold mri) is a special mri technique that allows indirect assessment of oxygen levels in blood. this technique is non-invasive, involving no needles. bold has not been applied in humans in prostate cancer. the purpose of this study is to develop a mri-bold technique that allows us to non-invasively measure changes related to tumor hypoxia in prostate cancer. this technique may provide information that will be an independent predictor of patient survival, tumor recurrence and likelihood of treatment response in prostate cancer

Eligibility criteria:
inclusion criteria: * prostate cancer exclusion criteria: * contraindication to mri
real time 3d navigation and traditional us to identify epidural space depth in obese pregnant

Conditions: Pregnancy Related; Obesity

Summary: the aim of this study is to assess the accuracy of the accuro ultrasound device in estimating the epidural space depth compared to the standard ultrasound examination and with the measured needle depth during epidural and spinal insertion in pregnant obese patients

spinenav3dtm technology facilitates image interpretation of individual 2d lumbar spine scans by automating spinal bone landmark detection and depth measurements and providing a real-time assessment of scan plane orientation in 3d. all the subjects will have their lumbar area scanned for the measurements of the depth of the epidural space (recorded in cm) by two blinded anesthesiologists, one using standard ultrasounds and the other the accuro device. all measurements will be performed either in the sitting or in the supine position at l1/l2, l2/l3 and l3/l4 levels. neuraxial anesthesia will be performed by using the previously marked interspace by a blinded anesthesiologist who will measure the epidural space depth during epidural or spinal insertion by marking the needle.

Eligibility criteria:
inclusion criteria: * asa status \>iii * obese bmi\>30 * term gestatio \> 37 weeks * singleton pregnancy * undergoing elective cesarean section with spinal anesthesia * requesting epidural labor analgesia exclusion criteria: * contraindications to neuraxial block * severe scoliosis * previous spine surgery
comparison of robot-assisted gait training and conventional therapy in multiple sclerosis patients

Conditions: Multiple Sclerosis

Summary: the aim of this study is to compare conventional neurorehabilitation with robot-assisted gait training program in terms of fatigue, anxiety, depression and quality of life.

gait disturbances are common in multiple sclerosis (ms) patients. nowadays, gait training with robot assisted technology is used for rehabilitation. in several studies conventional rehabilitation was compared with robot assisted rehabilitation program, and they found no superior effects of robot assisted walking program. in this study we aimed to compare these modalities in terms of fatigue, anxiety and quality of life.

Eligibility criteria:
inclusion criteria: * 18-70 years old multiple sclerosis patients * edss score: 5.5-7.5 * being oriented and cooperated * mini-mental score ≥24/30 exclusion criteria: * modified ashworth \>3 in lower extremity muscles * cognitive impairment * botox injection within last 6-months * having another neurological disease * pregnancy or breast-feeding

Keywords: rehabilitation robot assisted gait training
efficacy of sorafenib added to standard primary therapy in elderly patients with newly diagnosed aml

Conditions: Acute Myeloid Leukemia

Summary: the primary purpose of the study is to determine, whether the addition of sorafenib to standard chemotherapy in elderly patients with newly diagnosed aml improves treatment results (event free survival).


Eligibility criteria:
inclusion criteria: * patients with newly diagnosed aml (except apl) according to the fab and who classification, including aml evolving from mds or other hematologic diseases and aml after previous cytotoxic therapy or radiation (secondary aml) * bone marrow aspirate or biopsy must contain \>= 20% blasts of all nucleated cells, with the exception of aml fab m6, where \>= 30% of non-erythroid cells must be leukemic blasts * age \>= 61 years * informed consent, personally signed and dated to participate in the study * male patients enrolled in this trial must use adequate barrier birth control measures during the course of the sorafenib treatment and for at least 3 months after the last administration of sorafenib exclusion criteria: * central nervous system manifestation of aml * cardiac disease: heart failure nyha iii° or iv°; active coronary artery disease (mi more than 6 months prior to study entry is permitted); serious cardiac ventricular arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted) * chronically impaired renal function (creatinin clearance \< 30 ml/min) * chronic pulmonary disease with relevant hypoxia * inadequate liver function (alt and ast \>= 2.5 x uln) * total bilirubin \>= 1.5 x uln * resting blood pressure (bp) consistently higher than systolic 160 mmhg and/or diastolic 95 mmhg * any severe concomitant condition which makes it undesirable for the patient to participate in the study or which could jeopardise compliance with the protocol * uncontrolled active infection * concurrent malignancies other than aml * previous treatment of aml except hydroxyurea and up to 2 days \<= 100 mg/m²/d cytarabine * known hiv and/or hepatitis c infection * evidence or history of cns disease, including primary or metastatic brain tumors, seizure disorders * thrombotic or embolic events such as cerebrovascular accident or pulmonary embolism within 1 year of study entry * evidence or history of severe non-leukemia associated bleeding diathesis or coagulopathy * history of organ allograft * concomitant treatment with kinase inhibitors, angiogenesis inhibitors and myelotarg * patients with major surgery, open biopsy or significant traumatic injury within 4 weeks of start or first dose * serious, non-healing wound, ulcer or bone fracture * allergy to study medication or excipients in study medication * investigational drug therapy outside of this trial during or within 4 weeks of study entry * patients who are not eligible for standard chemotherapy

Keywords: sorafenib acute myeloid leukemia flt3 aml kinase inhibitor
a study exploring the safety, tolerability, and efficacy of a 28 day course followed by an additional 56 day course of itacitinib in subjects with active rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this is a study evaluating a 28-day course followed by a 56-day course of itacitinib in patients with active rheumatoid arthritis (ra). the study will evaluate safety and efficacy parameters of itacitinib.


Eligibility criteria:
inclusion criteria: * subjects with active ra aged 18 to 75 years of age and meet tender and swollen joint assessment expectations defined in the study protocol. * c-reactive protein (crp) or erythrocyte sedimentation rate (esr) laboratory values meet minimal study protocol expectations. exclusion criteria: * females who are pregnant or breastfeeding. * men and women who cannot comply with requirements to avoid fathering a child or becoming pregnant, respectively. * subjects treated with a biologic agent within 12 weeks prior to first dose of study drug. (12 months in the case of rituximab.) * subjects with a history or currently suspected inflammatory disease other than ra. * subjects with a history of hematological disorders.

Keywords: rheumatoid arthritis ra active
efficacy of subantimicrobial dose doxycycline for moderate to severe and active graves' orbitopathy

Conditions: Graves Ophthalmopathy; Graves Disease; Eye Diseases; Thyroid Diseases; Endocrine System Diseases; Eye Diseases, Hereditary; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Summary: the aim of this study is to evaluate the effects of subantimicrobial dose doxycycline (50 mg/d), administered for 12 wk, for patients with active moderate-severe graves' orbitopathy (go).

graves'orbitopathy is an autoimmune disease characterised by an inflammatory phase followed by fibrosis. surgery to correct eyelid swelling, proptosis, and diplopia is effective, but can not be done until the inflammatory phase has passed. to arrest the inflammatory phase, several types of immunosuppressive treatments have been investigated. corticosteroids are the first-choice immunosuppressive treatment, but they often cause severe side-effects. subantimicrobial dose doxycycline posses known anti-inflammatory effects that are separate from their antibacterial mode of action. this mode of action has lead to the routine use of subantimicrobial dose doxycycline for rosacea, periodontitis and multiple sclerosis. we propose to test the effect of subantimicrobial dose doxycycline for non-sight threatening, moderate-severe, inflammatory go.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of graves' orbitopathy * moderate-severe go according to eugogo statements, patients with moderate-severe go usually have any one or more of the following：moderate or severe soft tissue involvement, exophthalmos≥3mm above normal for race and gender, inconstant, or constant diplopia. * clinical activity score ≥ 3 * being euthyroid for at least 1 month before the date of inclusion * must be able to swallow tablets * written informed consent is obtained exclusion criteria: * mild graves' orbitopathy * sight-threatening graves' orbitopathy * clinical activity score \< 3 * previous treatment for go oral steroids, intravenous steroids, radiotherapy * pregnant females as determined by positive (serum or urine) human chorionic gonadotropin (hcg) test at screening or prior to dosing, or lactating females * uncontrolled diabetes or hypertension * history of mental / psychiatric disorder * hepatic dysfunction (albumin (alb),aspartate transaminase (ast), alanine aminotransferase (alt) and alkaline phosphates levels must be within normal range for eligibility) * renal impairment (urea and creatinine levels must be within normal range) * doxycycline allergy or intolerance

Keywords: graves' orbitopathy graves´ ophthalmopathy thyroid eye disease thyroid-associated ophthalmopathy doxycycline eugogo cas
treatment of moderate to severe facial acne vulgaris

Conditions: Acne Vulgaris

Summary: randomized, multi-center, double-blind, placebo-controlled 12-week study to assess the safety and efficacy of 3 doses of an oral formulation of doxycycline oral tablets using the investigator's global assessment (iga) score and the absolute change from baseline in inflammatory lesion count in patients with moderate to severe facial acne vulgaris. additionally, the absolute change from baseline in non-inflammatory and total lesions of the active study medication to placebo will be evaluated.


Eligibility criteria:
inclusion criteria: * must be between 12 and 45 years of age. * has a diagnosis of moderate to severe facial acne vulgaris with no more than two nodules on the face exclusion criteria: * is allergic to tetracycline-class antibiotics or to any ingredient in the study medication. * has a history of pseudomembranous colitis or antibiotic-associated colitis. * has a history of hepatitis or liver damage or renal impairment.
getting under the skin of the menopausal hot flush

Conditions: Menopause

Summary: the aim of this research is to 1) test how the skin blood vessels and sweat glands function in women who experience hot flushes by using skin microdialysis to deliver small amounts of substances to the skin that cause increased skin blood flow and sweating, and 2) examine the structure of the skin blood vessels and sweat glands in the skin of women who experience hot flushes by taking a very small skin biopsy. any changes in the function or structure of the skin blood vessels or sweat glands in women with hot flushes would increase our understanding of what causes hot flushes and help to design effective treatments.

in a cross-sectional design, participants will attend the laboratory on two separate occasions. at visit 1, anthropometric measurements will be recorded and a venous blood sample will be collected to determine hormone status (e.g. oestradiol level) and pro-inflammatory markers (e.g. il-8, prostaglandin 2e). participants will then undergo assessment of post-ganglionic skin blood vessel and sweat gland responsiveness (transdermal/cutaneous microdialysis). at visit 2 (\~7 days later), participants will undergo a skin punch biopsy.

Eligibility criteria:
inclusion criteria: * aged \>45 years for the postmenopausal cohort and aged 18-30 years for the premenopausal cohort * female * amenorrhoeic for \>6 months (postmenopausal criteria) * \>4 hot flushes per day (symptomatic postmenopausal criteria) * eumenorrhoeic with regular menstrual cycles (premenopausal criteria) * healthy * non-smoker * bmi 18-30 kg/m2 * no history of cardiovascular or respiratory disease * no history of metabolic disease e.g. type ii diabetes * drink \<14 units of alcohol per week * not taking any medication or treatments to alleviate hot flushes exclusion criteria: * aged \< 18 years or 31-44 years * male * smokers * medical history of cardiovascular/respiratory disease * medical history of metabolic disease e.g. type ii diabetes * drink \>15 units of alcohol per week * on medication or treatments to alleviate hot flushes or have taken such medication/treatment within the previous 6 months * bmi of \ 30 kg/m2 * vaccination (\<1 week) due to induced systemic inflammatory reaction * local forearm infection * allergy to local anaesthetic/marcain/amide-group anaesthetics * pregnant

Keywords: hot flush skin blood flow sweating structure function
metoclopramide versus ketorolac for tension-type headache

Conditions: Headache

Summary: occasionally, episodic tension-type headache may be severe enough to require an emergency department (ed) visit. the purpose of this study is to compare two commonly used medications to see which is better for tension type headache. patients who present to the ed with an acute tension-type headache requiring treatment with injectable medication will be randomized to metoclopramide or ketorolac.


Eligibility criteria:
inclusion criteria: * acute tension type headache exclusion criteria: * contraindications to investigational medications * secondary cause of headache

Keywords: headache tension-type headache
anti-diabetic medications to fight pd and lbd

Conditions: Lewy Body Dementia; Parkinson Disease

Summary: the purpose of this study is to test the hypothesis that dpp4 inhibitors and sglt2 inhibitors are well tolerated and have beneficial neurological effects, specifically for parkinson's disease and lewy body dementia.


Eligibility criteria:
inclusion criteria: * parkinson's disease or lewy body dementia (diagnosis confirmed by neurologist at mayo clinic) with stable neurological treatment in the past approximately three months. * glucose intolerance or mild diabetes: the american diabetes association criteria for pre-diabetes/ glucose intolerance includes fasting glucose 100-125, random glucose 140-199, or hemoglobin a1c 5.7-6.4% and diabetes is \> 125 mg/dl, \> 200 mg/dl, and 6.5% or greater, respectively (40). it has been previously reported that 50-80% of individuals with parkinson's disease have abnormal glucose tolerance (17), so this should not limit recruitment. exclusion criteria: * use of insulin or other anti-diabetes medications other than metformin. * contraindication to taking a dpp4 inhibitor or sglt2 inhibitor including: allergy, history of angioedema, pancreatitis, active gallbladder disease, renal impairment with egfr \< 45). * bleeding disorder, use of anticoagulants, thrombocytopenia, or severe anemia. * use of high dose steroids. * current systemic chemotherapy. * pregnancy or breastfeeding. * recent (within 30 days) or recurrent (defined as more than one in the past 12 months) urinary tract infection or yeast infection. * other contraindication that would make study participation unsafe or make study related data unable to be interpreted.
accelerated partial breast irradiation versus standard or hypofractionated whole-breast irradiation, in early breast cancer, after breast-conserving surgery

Conditions: Malignant Neoplasm of Breast

Summary: radiotherapy has been confirmed as an important treatment breast-conserving surgery reducing the risk of any recurrence of breast cancer and breast cancer-related mortality in patients with early breast cancer. there are no comparative data on the ideal radiotherapy treatment regimen for patients with early stage breast cancer who underwent conservative surgery in the brazilian population.

the investigators propose a prospective, randomized, pilot study, with active control, to evaluate the viability and safety of accelerated partial breast irradiation, in 5 fractions, comparing with the radiotherapy regimens of the whole breast in 15 and 5 fractions, in patients with breast cancer, in initial stage, who underwent conservative surgery.

Eligibility criteria:
inclusion criteria: * information to the patient and signed informed consent; * women aged ≥50 years * breast conserving surgery * pathologic tumor size \< 3 cm (maximum microscopic diameter of the invasive component) * invasive adenocarcinoma (except classic invasive lobular carcinoma) * unifocal disease * histopathologic grades i or ii * eastern cooperative oncology group (ecog) 0-1 * lymphovascular invasion absent * negative axillary lymph nodes * minimum microscopic margins of non-cancerous tissue of 2mm (excluding deep margin when in deep fascia) * no prior breast or mediastinal radiotherapy * no hematogenous metastases exclusion criteria: * previous malignancy (except non-melanomatous skin cancer) * mastectomy * classical-type invasive lobular carcinoma * neoadjuvant chemotherapy * human epidermal growth factor receptor-type 2 positive (her2+) * triple-negative breast cancers * intravascular lymphoma present * contraindications to radiotherapy. * no geographical, social or psychologic reasons that would prevent study follow

Keywords: breast cancer radiotherapy hypofractionated breast-conserving surgery
trigger point electroacupuncture treatment in patients with chronic low back pain

Conditions: Chronic Low Back Pain (CLBP); Trigger Points

Summary: electroacupuncture is an application of acupuncture combined with electrical stimulation of acupuncture points through acupuncture needles to achieve faster pain relief than acupuncture. recently, research has shown that trigger point acupuncture has a significant effect in reducing pain better than acupuncture on acupoints in patients with chronic low back pain. however, no research has compared the pain relief effect between trigger point electroacupuncture and electroacupuncture on acupoints in patients with chronic low back pain. this study was conducted to address this question.

participants and methods: a blinded randomized controlled clinical trial was conducted involving 60 chronic low back pain participants, randomly divided into two groups (a and b): 30 receiving electroacupuncture at the trigger point (group a) and 30 receiving electroacupuncture on the meridian (group b) for 10 sessions. the primary outcomes were visual analogue scale (vas), bpi index, and trigger point count.

Eligibility criteria:
inclusion criteria: * patients aged 20 or older who consented to participate in the study; * individuals experiencing lbp persisting for more than 3 months with an average vas score of 5 cm or over; * patients displaying trigger points in back exclusion criteria: * major trauma or systemic disease such as rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, scheuermann disease; * systemic symptoms such as weight loss, fever of unknown origin, anorexia, personal history of malignancy, diffuse pain and joint stiffness; * symptoms of infection such as fever, meningeal irritation signs, photophobia; * symptoms of central motor neuron damage such as hoffmann sign, babinski sign, hyperreflexia, spasticity, incontinence, sexual dysfunction; * symptoms of serious acute diseases such as myocardial infarction (chest pain, sweating, shortness of breath), arterial dissections (tearing sensation, headache, blurred vision); * conditions unsuitable for acupuncture such as inflammation of skin in need of acupuncture, weak or exhausted patients, severe comorbidities; * being treated with other methods. elimination criteria: patients experiencing adverse events from the intervention leading to their discomfort and withdrawal from the study

Keywords: electro-acupuncture trigger points low back pain