Kornimate/medical-research-clean huggingface dataset:
evaluation of two glatiramer acetate (ga) formulations in relapsing-remitting multiple sclerosis (rrms) patients

Conditions: Multiple Sclerosis

Summary: this is an open-label, multicenter study conducted at approximately 20 sites. each patient will inject ga daily for 6 weeks utilizing an autoject 2 device to determine overall injection satisfaction.

the study will consist of a 2 week treatment period with participants injecting their current therapy of copaxone 20 mg/1.0 ml glatiramer acetate utilizing an autoject 2. all participants will then roll over to the new formulation of 20 mg/0.5 ml glatiramer acetate with an autoject 2 device for a 4 week treatment period. patient satisfaction will be evaluated using an experience questionnaire throughout the study.

Eligibility criteria:
inclusion criteria: * patients ≥ 18 years of age with a diagnosis of relapse remitting multiple sclerosis (rrms) or clinically isolated syndrome (cis) * currently injecting glatiramer acetate 20 mg/1.0 ml per day subcutaneously (sc) for a minimum of 90 days utilizing the autoject 2 for glass syringe for a minimum of 75% of daily injections * willing and able to complete all procedures and evaluations related to the study * willing to continue to follow usual injection site preparation and routine adjunctive local injection site reactions (lisr) management techniques * willing and able to provide written informed consent exclusion criteria: * currently using or treated with another immunomodulating therapy (imt) in conjunction with ga in the 30 days prior to screening for this study * currently using an investigational drug or using treatment with any other investigational agent in the 30 days prior to screening for this study * pregnant or planning pregnancy or breastfeeding * use of any other parenteral medications (e.g., intramuscular, sc, intravenous, etc.) either currently or in the past 30 days prior to screening for this study * any other medical or psychiatric conditions that would make the patient unsuitable for this research, as determined by the investigator * unwilling to perform all daily injections with an autoject 2 device * previous participation in any study evaluating the new 20 mg/0.5 ml formulation

Keywords: relapsing remitting multiple sclerosis rrms clinically isolated syndrome cis copaxone glatiramer acetate autoject 2
effect of acupuncture on patients with mild hypertension

Conditions: Essential Hypertension

Summary: this is a large scale, open-label, multicenter, randomized controlled clinical trial with four parallel arms. this trial aims to evaluate the effectiveness of affected meridian acupuncture for patients with mild hypertension,with respect to decreasing their blood pressure, safety of acupuncture ,and improving their quality of life as well.

investigators plan to recruit 428 hypertensive patients. eligible patients will be randomized to four different groups.ⅰ. the affected meridian acupuncture group (ama, n=107) will be treated with acupoints on affected meridians.ⅱ.the non-affected meridian acupuncture group (nma, n=107) will be treated with acupoints on non-affected meridians.ⅲ.invasive sham acupuncture group(isa, n=107)will be provided with sham acupoints treatment.ⅳ.waiting-list group(wl, n=107)will not be given any intervention.

Eligibility criteria:
inclusion criteria： 1. patients whose age between 40 and 75 years old, male and female; 2. patients who meet the diagnostic criteria of mild hypertension according to jnc-7 and china's prevention and cure guide of hypertension. mild hypertension (who/ish criteria stage i) systolic blood pressure 159≥(sbp) ≥140 and/or diastolic blood pressure 99≥(dbp) ≥90 . 3. patients who are initially diagnosed as mild hypertension or have been diagnosed as mild hypertension before but have not taken any antihypertensive drugs. 4. patients who are diagnosed as yue-yin style (yin-deficiency accompany with hyperactivity of yang) or yang-ming style (obstruction of phlegm and dampness) according to meridian syndrome differentiation 5. patients who have a good understanding of our study. and willing to comply with our study protocol. 6. informed consent form must be signed by patient or lineal relative. 7. all the tips are matched will be included. exclusion criteria: 1. patients who have been diagnosed as secondary hypertension or malignant hypertension(e.g. cushing's syndrome, coarctation of the aorta，phaeochromocytoma, renal parenchymal disease，primary aldosteronism， renovascular hypertension, obstructive sleep apnoea，drug induced hypertension et al ) 2. patients who accompany with other severe medical conditions (e.g. endocrine disorders, cardiovascular disease. digestive disease. hepatic dysfunction，cerebral vascular disease. renal disease. haematologic disease et al). who may be not safe to join our study. 3. patients with a chronic disease which might not suitable for our study. e.g: epilepsy ,severe depression or anxiety (sas≥70,sds≥70) ,psychosis, allergic constitution, accompany with any infection. 4. pregnant women or women in lactation or women of child bearing potential plan to conceive in the recent six months. 5. patients who currently participate in another clinical trial. 6. patients who had been treated with acupuncture during the previous three months 7. if one of the tips mentioned above is matched will be excluded.

Keywords: essential hypertension acupuncture specificity acupoints effect randomized controlled trials
the additional role of supplemental oxygen therapy in accelerated corneal collagen cross-linking in progressive keratoconus. a randomized clinical trial

Conditions: Keratoconus

Summary: it is aimed to investigate the role of supplemental systemic oxygen therapy during accelerated corneal collagen crosslinking (cxl). in this prospective randomized clinical trial, patients with progressive keratoconus who are candidates for receiving cxl will be included. the patients will be randomized and allocated to three different cxl protocol. in the first group (oa-cxl), cxl is performed using an accelerated protocol (9 mw/ cm2 for 10 minutes) in addition to the delivery of systemic oxygen with a rate of 5 liters/min through a nasal mask for 10 minutes during uv-a ablation. patients in the second group (a-cxl) will receive cxl with the same accelerated protocol without additional oxygen therapy. conventional cxl using 30 mw/cm2 uv-a ablation for 30 minutes is perfomed in the patients of the third goup (c-cxl). maximum keratometry in sirius corneal tomography as the primary outcome and uncorrected and corrected distance visual acuity (udva, cdva) and corneal biomechanical properties including corneal resistance factor (crf) and corneal hysteresis (ch) as secondary outcome measures are followed for a six- and 12-months period. a p-value of less than 0.05 is considered as statistically significance level.


Eligibility criteria:
inclusion criteria: * definitive diagnosis of progressive keratoconus for whom cxl is indicated were enrolled in this study * the indication is identified by a cornea specialist and was considered as follows. * patients with the definitive diagnosis of kc who aged 18 or more were considered for the procedure if they had an increase of 1 d in kmax or an increase of 1d in the manifest cylinder over the past 12 months. exclusion criteria: * patients with the previous history of corneal surgery * corneal scar or pathologies like herpetic eye disease or severe dry eye * corneal thickness less than 400 micrometers * pregnant or nursing women * corneal kmax more than 60 * age over 35 years * severe ocular surface disease
surgical approach of hemiarthroplasty after femoral neck fracture: posterolateral or direct lateral

Conditions: Hip Fractures; Surgical Approach; Hemiarthroplasty; Posterolateral; Direct Lateral

Summary: rationale: in the netherlands the two main surgical approaches for hemiarthroplasty are the posterolateral and the direct lateral approach. currently there is no conclusive evidence which of these two approaches results in better patient outcomes. objective: assessing the patient outcome comparing the posterolateral with the direct lateral approach in patients being treated with cemented hemiarthroplasty after femoral neck fractures. study design: a randomised controlled multi-center superiority trial and natural experiment with an economic evaluation alongside. study population: all patients older than 18 years with a femoral neck fracture whereby treatment with cemented hemiarthroplasty is recommended according the national guidelines. intervention: treatment with cemented hemiarthroplasty using the posterolateral approach. standard intervention to be compared to: treatment with cemented hemiarthroplasty using the direct lateral approach. main study parameters/endpoints: the primary outcome is the patient-rated quality of life (eq-5d-5l) at 6 months after surgery. secondary outcomes are: adl functionality (katz), balance test (sppb), tendency to fall (fes-i), pain (nrs), re-interventions, mobility, discharge destination, complications, and cost-effectiveness. nature and extent of the burden and risks associated with participation, benefit and group relatedness: the different approaches in the two treatment arms of the randomised controlled trial are widely used techniques in the netherlands and many of the outcome measures are part of the standard clinical follow-up after hip fracture. therefore, there is no extra risk or burden for participating patients, except for the time to complete some additional follow-up measurements. the primary outcome measurement and secondary outcomes, will be assessed through questionnaires online, by hardcopy or by phone at baseline, 4 weeks, 3 and 6 months postoperatively. the assessment of the short physical performance battery (sppb) balance test, will be performed by one of the study researchers or nurse practitioner to protect continuity and feasibility.


Eligibility criteria:
inclusion criteria: * ≥ 18 years at time of trauma * acute hip fracture * hemiarthroplasty as recommended treatment according the national guidelines * dutch or english fluency and literacy * informed consent or by proxy in patients with mental impairment exclusion criteria: * multi-trauma-patient (iss \> 15) * secondary surgery after failed internal fixation * patients with a known metastatic disease and a confirmed pathological fracture of the hip * fracture \> 7 days at time of surgery * high risk of non-compliance/adherence to study procedures (e.g. no dutch residency during follow-up period, or other factors that impair follow-up data collection)
lys228 pk, clinical response, safety and tolerability in patients with complicated urinary tract infection (cuti)

Conditions: Complicated Urinary Tract Infections

Summary: the purpose of the study is to evaluate whether lys228 can be developed for the treatment of complicated urinary tract infections


Eligibility criteria:
inclusion criteria: * male and female patients 18 to 85 years of age with suspected and/or bacteriologically documented complicated uti judges by the investigator to be serious (required patient to be hospitalized for treatment with intravenous antibiotics) exclusion criteria: * urine gram stain that demonstrated that a gram-positive organism was present, or if urine culture results were available, demonstrated gram- positive organisms were present at ≥10e5 cfu/ml * urine culture result available at enrollment and demonstrating more than 2 different species of microorganisms regardless of the colony count * urine culture result available demonstrating fungal uti with colony count \>10e3 cfu/ml * patient had received prior antibiotics within 72 hours before the initiation of study therapy * patients with estimated glomerular filtration rate \< 30ml/min calculated based in study qualified formula

Keywords: urinary tract infection, lys228, beta-lactam antibiotics, creatinine clearance, enterobactericeae
registry of sleep apnea monitoring and atrial fibrillation in pacemaker patients (respire)

Conditions: Bradycardia

Summary: the purpose of the study is to evaluate at 12 months follow-up the association between atrial fibrillation (af) and sleep apnea (sa) severity based on data measured and stored in reply 200 dr pacemaker.

the object of the investigation relates to the function named sleep apnea monitoring or sam function. this function is part of the reply 200 dr pacemakers, whose intended use is cardiac pacing. sleep apnea syndrom (sas) causes serious social and economic problems, not only because of its high prevalence but also because it is associated with increased cardiovascular morbidity and mortality. patients with sleep apnea often have arterial and pulmonary hypertension, a high risk of coronary artery disease, and heart failure, whereas a high percentage of patients show heart rhythm disturbances. in addition, these patients are at increased risk of being involved in traffic accidents, as well as suffering a decline in their family, social, and professional lives. therefore, the prompt diagnosis of these patients could be of great importance. today the gold standard for the diagnosis of sas is overnight polysomnography (psg) in a sleep laboratory. however, the shortage of sleep laboratories and the high cost of psg render this method inadequate for widespread screening. for these reasons, in recent years, there have been attempts to develop alternative diagnostic with a view to simplify the diagnosis. thanks to the feature sam included in the pacemaker, sequences of respiratory cycles are analyzed to detect, to count and to report abnormal breathing events during the night. this analysis is based on the minute ventilation (mv) signal. the mv signal represents the real time expansion/contraction of the thorax of the patient. it is derived of the transthoracic impedance periodic measurements. the device is able to provide the physician with day-by-day respiratory disturbance index (rdi) equal to the sum of events divided by the number of hours per night. physician will also access to the total number of events over the previous night presented per hour.

Eligibility criteria:
inclusion criteria: * patient eligible for implantation of a dual-chamber pacemaker according to current available guidelines * patient with reply 200 dr implantation performed * patient who provides signed and dated informed consent (according to the laws and regulations of the country in which the observational study is conducted) exclusion criteria: * inability to understand the purpose of the study or refusal to co-operate * unavailability for routine follow-ups at the implanting centre * already included in another clinical study that could affect the results of this study * inability or refusal to provide informed consent * patient is minor (less than 18-years old) * patient is pregnant * patient is forfeiture of freedom or under guardianship
effect of self-foot massage on diabetic individuals

Conditions: Diabetes Mellitus

Summary: the aim of this study is to evaluate the effect of self-foot massage on peripheral neuropathic pain, peripheral skin temperature and patient comfort in individuals with diabetes.

diabetes mellitus (dm) is the most important metabolic disease that can affect almost every organ system in the body. although diabetes causes many macrovascular and microvascular complications, one of the rare microvascular complications is peripheral neuropathy. one of the common complementary and integrative applications in the management of diabetic peripheral neuropathy is foot massage. the aim of this study is to evaluate the effect of self-foot massage on peripheral neuropathic pain, peripheral skin temperature and patient comfort in individuals with diabetes. individuals participating in the study will be divided into intervention and control groups. the individuals in the foot massage group will be given foot massage training by the researcher. later, people with diabetes will be enabled to continue self-massage at home. to encourage the continuation of the intervention, the researcher will be called once a week by phone and her questions will be answered. there will be no additional application other than routine to the control group, data collection forms will be applied and recorded at the beginning of the study and at the end of four weeks. in the collection of data, "individual description form, visuel analog scale- (vas), dn4 pain questionnaire and general comfort questionnaire- short form" will be used. in addition, peripheral skin temperature will be measured with a skin thermometer.

Eligibility criteria:
inclusion criteria: * 18 years of age or above, * having been diagnosed with type 2 diabetes at least 6 months ago, * hba1c level\> 6.5%, * being able to do personal care for personal hygiene management, * no peripheral circulation problems, * do not have any problems such as speech or hearing that prevent communication, * physical and cognitive health levels are suitable for answering the data collection form, * agreeing to participate in the research, * it is planned to include patients who can speak and understand turkish. exclusion criteria: * individuals with other health problems that may cause peripheral neuropathy (chemotherapy, neurological, etc.), * patients with organ damage (gangrene or foot / finger amputation) due to diabetes mellitus or any other reason, malignancy, tuberculosis, asthma, or any contagious disease, * individuals with a history of disease that may cause changes in peripheral skin temperature (raynaud's disease, etc.) * who do not agree to participate in the research, * speaking and hearing impairments that interfere with the collection

Keywords: type 2 diabetes foot massage neuropathic pain skin temperature comfort
the comparison of diagnostic tese and tesa in non-obstructive azoospermic

Conditions: Infertility

Summary: azoospermia , as the name suggests , refers to the condition in which there are no sperm in the semen. this diagnosis can come as a rude shock, because most men with a zero sperm count have normal libido; normal sexual function; and their semen looks completely normal too. the diagnosis can only be made by examining the semen under a microscope in the laboratory.men with non-obstructive azoospermia have a normal passageway, but abnormal testicular function, and their testes do not produce sperm normally. some of these men may have small testes on clinical examination. the testicular failure may be partial, which means that only a few areas of the testes produce sperm, but this sperm production is not enough for it to be ejaculated. other men may have complete testicular failure, which means there is no sperm production at all in the entire testes. the only way to differentiate between complete and partial testicular failure is by doing multiple testicular micro-biopsies to sample different areas of the testes and send them for pathological examination. this technique is called tesa, or testicular sperm aspiration ( also known as tese, or testicular sperm extraction) or mtese ( micro-testicular sperm extraction).

this study was performed on 180 men with non-obstructive azoospermia (noa), referring to royan infertility center, according to inclusion and exclusion criteria. testis selection (right and left) and techniques (tese or tesa) were performed randomly in patients. for every patient based on random order, tesa or tese was performed as the following procedures. the testis was aspirated at three separated sites (upper, middle and lower pole), using 20 ml syringe and 18-gauge needle or testicular biopsy (tese) was taken from the same 3 sites.

Eligibility criteria:
inclusion criteria: * non obstructive azoospermia * no previous biopsy exclusion criteria: * atrophic testis * fsh levels more than 4 times normal range

Keywords: tese tesa non obstructive azoospermi
neuromodulation with transcranial direct current stimulation (tdcs) to control excess weight

Conditions: Overweight and Obesity

Summary: the purpose of this study is to examine the effects of noninvasive neuromodulation with transcranial direct current stimulation (tdcs) aimed at enhancing the excitability of the left prefrontal cortex in middle-aged women with excess body weight. this is a randomized, parallel, double-blind study with a duration of 4 weeks. outcome measures will include changes in performance in a computerized task assessing executive functions, subjective measures of food craving and appetite and changes in body weight.

a total of 40 subjects with overweight or class i obesity will be enrolled and randomized into either group 1) active tdcs or group 2) sham (control) tdcs. the duration of the study will be 4 weeks. during the first two weeks participants will receive eight sessions of tdcs. at week 2 they will also start a hypocaloric diet. the stimulation sessions (duration: 20 minutes, intensity: 2 ma) will be applied once daily (5 days in a row) during the first week and 3 alternate days (monday, wednesday and friday) during the second week. at week 2 and until the end of the study subjects will also start a hypocaloric diet. the study aims are: 1. to examine whether anodal tdcs applied over the left prefrontal cortex can improve executive functions/inhibitory control and reduce subjective ratings of food craving and appetite. 2. to study whether anodal tdcs applied over the left prefrontal cortex, in combination with a hypocaloric diet, can facilitate weight reduction and maintenance over time.

Eligibility criteria:
inclusion criteria: * body mass index (bmi) between 25 and 35 kg/m2 exclusion criteria: * endocrinology disorder, such as diabetes mellitus or thyroid disease * addiction * neurological, psychiatric or any other major medical condition * hormonal therapy * contraindications to receive tdcs (past history of seizures or epilepsy, metallic implants on the head, skin disease or lesions in the area to be stimulated).

Keywords: obesity overweight neuromodulation transcranial direct current stimulation (tdcs)
a study of bevacizumab (avastin®) in combination with temozolomide and radiotherapy in participants with newly diagnosed glioblastoma

Conditions: Glioblastoma

Summary: this 2 arm study investigated the efficacy and safety of the addition of bevacizumab to the current standard of care (multimodality therapy of concurrent radiotherapy plus temozolomide followed by adjuvant temozolomide) as compared to the current standard of care alone. participants were randomly assigned to either the bevacizumab (10 milligrams per kilogram (mg/kg) intravenously \[iv\] once every 2 week \[q2w\]) or the placebo arm, in combination with radiation therapy (total dose 60 gray \[gy\], administered as 2 gy fractions, 5 days/week) plus temozolomide (75 milligrams per meter squared \[mg/m\^2\] oral administration \[po\] daily) for 6 weeks. after a 4 week treatment break, participants continued to receive bevacizumab (10 mg/kg iv q2w) or placebo, plus temozolomide (150-200 mg/m\^2 po daily on days 1-5 of each 4 week cycle) for 6 cycles of maintenance treatment or until disease progression or unacceptable toxicity, whichever occured first. following the maintenance phase, bevacizumab (15 mg/kg iv every 3 weeks \[q3w\]) or placebo monotherapy continued. the time on study treatment was until disease progression.


Eligibility criteria:
key inclusion criteria: * newly diagnosed glioblastoma * world health organization (who) performance status less than or equal to (\<=2) * stable or decreasing corticosteroid dose within 5 days prior to randomization key exclusion criteria: * evidence of recent hemorrhage on postoperative magnetic resonance imaging (mri) of brain * any prior chemotherapy or immunotherapy for glioblastomas and low grade astrocytomas * any prior radiotherapy to brain * clinically significant cardiovascular disease * history of greater than or equal to (\>=) grade 2 hemoptysis within 1 month prior to randomization * previous centralized screening for methylguanine-dna methyltransferase (mgmt) status for enrollment into a clinical trial