Kornimate/medical-research-clean huggingface dataset:
risk factors predicting prognosis and outcome of elderly patients with isolated traumatic brain injury

Conditions: Brain Injuries

Summary: although several prognostic models have been developed to predict outcome for patients with severe traumatic brain injury (tbi), currently no study describes the impact of respiratory failure during emergency department treatment on mortality in a population of elderly patients. the purpose of the present study was to evaluate factors predicting poor outcome with special emphasis on the impact of respiratory failure on mortality in elderly patients with isolated severe tbi. all elderly patients (age ≥ 65 years) with isolated severe head injury, admitted to this level i trauma center, during a period of 16 years (from january 1992 to december 2008) were identified from the trauma registry. stepwise logistic regression analysis was used to identify risk factors for a poor prognosis and outcome. the logistic regression found the following variables influencing the mortality: respiratory failure (p\ 15 mm. the present study predicts a strong correlation between respiratory failure, pathological pupillary response, a higher iss and substantial midline shift with poor outcomes in elderly patients sustaining an isolated severe tbi.


Eligibility criteria:
the inclusion criteria for this study were: 1. patients aged 65 years and older and 2. acute severe tbi defined by an abbreviated injury scale (ais-head) score of ≥ 3 for the head region. exclusion criteria for this study were as followed: 1. oral intubation prior to ed-admission; 2. no details of the time of injury (e.g. chronic subdural hematomas) and 3. any concomitant injuries. 4. patients who received oral intubation prior to ed-admission were excluded due to the high variability of indications other than respiratory failure or secondary neurological decline (e.g. intubation required for aspiration protection) that may not be necessarily related to tbi induced secondary respiratory failure.
efficacy of biofeedback pfmt and medication in women with overactive bladder

Conditions: Overactive Bladder

Summary: medical treatment for overactive bladder is acceptable widely. however, the effect of drug treatment is different due to compliance and side effect of the drug. biofeedback-assisted pelvic floor muscle training (pfmt) is the first line recommendation for overactive bladder. the slow effect of biofeedback-assisted pelvic floor muscle training leads to low motivation for continuous treatment and results in compliance difference. this slow effect also changes the degree of improvement in the treatment of overactive bladder. this study is designed to evaluate the efficacy of combination therapy for treatment of female overactive bladder.

participant will be prescribed with oral medication in combination with biofeedback-assisted pelvic floor muscle training (pfmt) for the first month. participant will continue to have biofeedback assisted pfmt for another two months without oral medication. the investigators expected that combination therapy will improve the compliance and severity of symptoms in women with overactive bladder.

Eligibility criteria:
inclusion criteria: 1. overactivity bladder for more than 3 months 2. more then 20 year old,less then 85 year old and acceptable to receive vaginal examination 3. need to match schedule with the investigator's clinic for 5 times,followed by individual therapy, each takes about 30 to 60 minutes, a total of 12 weeks of pelvic floor muscle exercises exclusion criteria: 1. suffering from systemic neuromuscular diseases, such as stroke, spinal cord injury, peripheral neuropathy, etc. 2. glaucoma 3. kidney disease 4. liver disease 5. patients with cardiac rhythm devices. 6. insufficient cognitive function, unable to cooperate with pelvic floor muscle exercises. 7. women during pregnancy. 8. maternity within six weeks after delivery

Keywords: overactive drug only exercise only combination of drug and exercise
intraoperative angioembolization in the management of pelvic fracture-related hemodynamic instability

Conditions: Pelvic Fractures and Associated Hemodynamic Instability

Summary: mortality associated with pelvic fractures resulting from blunt trauma ranges between 6 and 18%. in cases where hemodynamic instability is also present, the mortality rate is significantly greater, and has been reported as high as 60%. there is no general consensus among traumatologists as to the initial management of this complicated subgroup of patients. it is largely debated whether emergent orthopedic fixation or angiographic embolization should be the first line of treatment for pelvic hemorrhage

pelvic fractures are not usually isolated injuries and it is common that these severely injured patients have concomitant abdominal or thoracic trauma further complicating their management. in situations where multiple sources of hemodynamic instability exist, the need to control hemorrhage quickly becomes imperative. in patients where emergent laparotomy or thoracotomy is indicated, the time until pelvic bleeding sources are addressed is prolonged. some would argue that the best initial management of the pelvic fractures should be surgical stabilization, while others would support immediate angioembolization of actively bleeding pelvic vessels. the main drawback of angiographic embolization is that it occurs in a separate angio suite facility, with concerns being time lost to patient transport and an environment less capable of managing these extremely unstable patients. at hershey medical center, ten patients suffering pelvic fractures with associated hemodynamic instability between 2003 and 2007 were managed with intraoperative angioembolization (in the operating room as opposed to the angio suite). extensive review of published orthopaedic, trauma surgery, and radiology journals yielded no other literature regarding intraoperative angioembolization as a management approach for these patients. whether or not this approach has been carried out at other medical institutions, it is undoubtedly rare and results have yet to be reported in widely available literature. this novel approach has the potential to stop pelvic bleeding sooner and in a more controlled environment, where surgical stabilization can also be accomplished simultaneously. statistical analysis and review of these patients has not been done, but may possibly show improvements in survival, shorter length of hospital stay, less time to embolization, and decreased need for supportive measures such as blood or platelet transfusion.

Eligibility criteria:
inclusion criteria: * patients with pelvic fractures and associated hemodynamic instability * treatment at hershey medical center * patient management involved angioembolization in operating room exclusion criteria: * patients below 18 years of age

Keywords: pelvic fractures angioembolism treatment at hershey medical center angioembolization in operating room
acupuncture in the regulation of dai meridian for polycystic ovarian syndrome patients with abdominal obesity

Conditions: Polycystic Ovarian Syndrome; Obesity, Abdominal

Summary: the purpose of this study is to determine whether the use of electroacupuncture to dredge and regulate dai meridian combined with lifestyle modification are more effective than lifestyle modification only in the treatment of anovulation and hyperandrogenism due to polycystic ovary syndrome (pcos) with abdominal obesity.two thirds of participants will receive electroacupuncture and lifestyle modification in combination, while the other one third will receive lifestyle modification only.

obesity, especially abdominal obesity, is one of most common clinical features of polycystic ovary syndrome, a widely and seriously influenced complex disorder related to reproduction and metabolism. excessive accumulation of adipose tissue in the abdominal organs often leads to insulin resistance, which will increase the harm of hyperandrogenism and exacerbate ovulation disorders and metabolic abnormalities. weight loss, likely beneficial for both reproductive and metabolic dysfunction in this setting , has been generally recommended as a first-line therapy for obese women with pcos and can be accomplished via lifestyle modification and electroacupuncture. what's more, stimulating acupoints of dai meridian can regulate menstrual cycles and treat infertility according to the theory of traditional chinese medicine. however, how much benefits patients will additionally get from the combined therapy is not clear now.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of polycystic ovarian syndrome. * clinical diagnosis of abdominal obesity. * agree to participate in clinical trials. exclusion criteria: * endocrine or neoplastic causes of amenorrhoea, anovulation and hyperandrogenemia, including central nervous system abnormalities, premature ovarian failure, thyroid disease, cushing's syndrome,androgen secreting tumors, congenital adrenal hyperplasia, and hyperprolactinaemia. * patients suffering from other serious diseases(cardiocerebrovascular diseases, damage to the function of liver and kidney, and mental illness). * patients taking hormonal and metabolic drugs within 12 weeks of study entry affecting the judgment of results. * pregnant or breast feeding.

Keywords: electroacupuncture lifestyle modification diet exercise dai meridian
manual therapy in tension-type headache

Conditions: Tension-Type Headache

Summary: tension-type headache (tth) causes a significant negative impact on working and daily life due to the reduction in work productivity and family and social activities causes. there is evidence that manual therapy and exercise reduce nociceptive input from the cervical spine and surrounding muscles, the use of manual therapy in tth management

increased cranio-cervical muscle sensitivity is the most prominent finding in tth. also, neck pain is markedly more common in individuals with tth compared with the control population (88.4%, and 56.7%, respectively). therefore, current research on the pathogenesis of tth focuses on the role of musculoskeletal disorders in the cervical spine and the facilitation of nociceptive pain processing. it has been suggested that peripheral sensitivity of nociceptors in cranio-cervical muscles and other cervical structures, as well as sensitivity of nociceptive pain pathways in the central nervous system (cns) due to long-term nociceptive stimuli may play a role in development and chronification of tth

Eligibility criteria:
inclusion criteria: * diagnosis of tth was made based on the international classification of headache disorders criteria, third edition (ichd-3 beta) * (bilateral localization, pressing and tightening pain, mild-moderate intensity \[≤7.0 on a visual analog scale (vas)\] * no increase in pain during physical activity * patients did not report any photophobia, phonophobia, vomiting or nausea, as requested by the ichd-iii diagnostic criteria * had symptoms for more than 3 months * the patients had to have had at least one segmental dysfunction of the upper cervical spine in all groups (by functional and pain-provocation tests). exclusion criteria: * any other primary or secondary headache according to the ichd-iii criteria * a history of neck or head trauma (e.g., whiplash) * any red flags (vertebral tumor, fracture, dislocation and infection, metabolic diseases, rheumatic and connective tissue diseases, systemic neuromuscular diseases, prolonged history of steroid use) * diagnosis of any structural spinal disorders (osteoporosis, disc herniation, myelopathy, spinal stenosis, spondylolisthesis) * prior surgery to the cervical spine * application of other treatment methods such as physical therapy or anesthetic block to the head and neck area within the last 3 months * initiation of pharmacologic prophylaxis within two months prior to randomization * pregnancy
evaluating the effect of a decision aid on shared decision making for prostate cancer screening

Conditions: Prostate Cancer

Summary: decision-aids are tools to educate patients on a given topic so that they may better participate in shared-decision making in their health care. given the complexities associated with psa testing, many professional organizations have advocated for shared-decision making for psa testing. however, no consensus exists as to how best educate and involve patients in the shared-decision making process. the goal of this study is to evaluate a pilot program utilizing a simple psa screening decision-aid presented in two different fashions in a primary care clinic with a large fraction of african-american patients. the investigators will evaluate the effectiveness of this program to educate patients on the risks and benefits of prostate specific antigen (psa) testing, on their subsequent level of comfort with their decision about whether to receive psa testing, and on the comfort level of physicians on their patient's decisions regarding psa testing, and importantly, how well these strategies can be implemented into the daily work-flow of a clinic. if successful, this program may serve as a model for the broader implementation of such strategies across minnesota and the country.

this pilot project will evaluate two approaches to implementing the use of a simple printed psa screening decision-aid (da) administered in an urban primary care clinic populated with a significant number of african-americans. all subjects will complete a survey assessing their knowledge and attitudes about psa screening and shared decision making (sdm), and physicians will also be briefly queried about their perceptions of the sdm process. after the first three month implementation period we will conduct focus groups with clinic staff to guide changes and refinements to the use of da in the clinical setting. another three month implementation period will follow using the same methods to assess outcomes. finally we will conduct another round of focus groups to assess the overall impact of the interventions.

Eligibility criteria:
inclusion criteria: * males ages 50-75 * able to read and speak english * provide written informed consent exclusion criteria: * diagnosis of prostate cancer * psa testing within last 12 months * previous prostate biopsy * voiding problems as reason for clinic visit * visit scheduled same day or 'walk-in' patient

Keywords: psa screening decision aids
pharmacologically triggered migraine without aura and neuroimaging

Conditions: Migraine With Aura

Summary: migraine is a highly disabling disorder affecting 14% of the general population worldwide and ranked as the 6th most debilitating disease worldwide by the who. one of the most fundamental questions of migraine, which remains to be elucidated, is the mechanism behind the generation of migraine attacks. the investigators will use calcitonin gene-related peptide (cgrp) and sildenafil as pharmacological triggers of migraine, combined with advanced neuroimaging techniques, to investigate the attack initiating pathophysiology. both substances have previously been administered to healthy participants and migraine without aura patients, inducing headache and migraine-like-attacks. the investigators hope to contribute with novelty to the current understanding of the migraine pathophysiology and development of more efficient treatment of migraine.


Eligibility criteria:
inclusion criteria: * age between 18 and 50 years * weight: 50-100 kg * diagnosis of migraine without aura (patient group only) * attacks of migraine without aura at least once every second month (patient group only) exclusion criteria: * inconsistent laterality of headache * history or family history of migraine (healthy subject group only) * tension-type headache more than one day per month on average (healthy subject group only) * tension-type headache to such a degree that the episodic migraine diagnosis is no longer fulfilled * any other primary headache disorder * daily intake of medication (apart from oral contraceptives) * intake of any medication less than 4 half-lives before study start * daily smoking * pregnant or breastfeeding women * headache 48 h prior to study day * hypertension on the study day (systolic bp\>150 mmhg or diastolic bp\> 100 mmhg) * hypotension on the study day (systolic bp\<90 mmhg or diastolic bp\<50 mmhg) * history of any cardiovascular disease including cerebrovascular disease * any disorder, that is deemed ineligible for participation by the study physicians * contraindications of mri * no use of safe contraception (women of fertile age only)
a prospective, phase iv, surveillance registry study to evaluate the safety of definity® in clinical practice

Conditions: Cardiovascular Disease

Summary: the purpose of this registry study is to gather safety information on the current clinical use of and the safety of definity®


Eligibility criteria:
inclusion criteria * patients who, in the investigator's opinion, require definity® echocardiography due to suboptimal, unenhanced images. exclusion criteria * known hypersensitivity to perflutren, definity®, or other echo contrast agent. * prior sae associated with perflutren, definity®, or administration of other echo contrast agent.

Keywords: definity safety survelliance
phase 1 single dose study of alxn1101 in healthy volunteers

Conditions: Molybdenum Cofactor Deficiency (MoCD); Rare Autosomal Recessive Disorder; Deficiency of Activity of Molybdenum-dependent Enzymes (Sulfite Oxidase [SOX], Xanthine Dehydrogenase, and Aldehyde Oxidase)

Summary: phase 1 single dose study of alxn1101 in healthy volunteers.

this is a first-in-human (fih), randomized, blinded, placebo-controlled, single-dose, sequential-cohort, dose-escalation study to evaluate the safety, tolerability, and pharmacokinetics (pk) of a single dose of alxn1101 in healthy adult subjects.

Eligibility criteria:
key inclusion criteria: 1. male or female subjects ≥ 18 and ≤ 60 years of age and weight ≥ 55 kg and ≤ 100 kg 2. willing and able to give written informed consent 3. female subjects of child bearing potential must have a negative serum pregnancy test or must be practicing an approved contraceptive regimen for the duration of the study 4. male subjects must be practicing an acceptable barrier method of contraception key exclusion criteria: 1. pregnant or nursing female subjects 2. qtcf \> 450 msec for males and \> 470 msec for females, or a family history of long qt syndrome. 3. crcl \< 80 ml/min 4. cbc in acceptable range; sgot or sgpt above the uln 5. hiv, hepatitis b or hepatitis c virus infection 6. other active systemic infection or malignancy 7. investigational drug study within 60 days 8. major surgery within the prior 90 days 9. history of illicit drug use or chronic alcohol dependence within 2 years prior to this study 10. positive urine drug toxicology screen or serum alcohol test 11. alcohol consumption within 48 hours prior to study drug administration 12. recently donated or lost ≥ 499 ml of blood 13. recent hormone replacement therapy or use of prescription medications

Keywords: molybdenum cofactor deficiency (mocd) deficiency of activity of molybdenum-dependent enzymes
testing the feasibility and preliminary effect of summer camp

Conditions: Childhood Obesity Prevention

Summary: this pilot randomized controlled trial was designed to assess the feasibility and preliminary efficacy of randomizing children, ages 6-12 years from two low-income communities in rhode island, to attend a summer day camp (camp) or to experience summer as usual (sau). children randomized to camp attended a boys and girls club summer day camp for 8-weeks in summer 2017 or 2018. as part of the consent process, children randomized to sau agreed to experience an unstructured summer (i.e. not enroll in more than one week of summer camp, summer school or other structured summer programming). primary feasibility outcomes included retention, engagement and completion of midsummer measures. secondary outcomes, change in bmiz (a proxy for excess summer weight gain), physical activity engagement, sedentary behavior, and diet (energy intake and diet quality), were collected by blinded research staff at the end of the school year, midsummer and the end of the summer.


Eligibility criteria:
inclusion criteria: * qualify for free or reduced-price meals at school * speak english (for purposes of camp participation) * agree, along with their parent(s), to randomization. exclusion criteria: * a medical condition that interferes with participation in physical activity * enrollment in summer programming (camp, summer school, etc) for more than one week

Keywords: summer camp child overweight / obesity diet physical activity
maintenance therapy using lenalidomide in myeloma

Conditions: Myeloma

Summary: maintenance treatment of myeloma.


Eligibility criteria:
inclusion criteria: * no signs of progression after transplant * effective contraception if necessary (oral contraception for females and barrier methods of contraception for sexually active males) * no active severe infection * satisfactory restoration of the haematological parameters defined by: pn \>1,000/mm3 and platelets \> 75,000/mm3 * bilirubin \< 35 umol/l and got/gpt/pal\<3n * creatinine \< 160 umol/l.

Keywords: myeloma revlimid maintenance therapy autologous stem cell transplantation
nearwave optical molecular monitoring

Conditions: Breast Cancer; HER2-positive Breast Cancer; TNBC - Triple-Negative Breast Cancer; HER2-negative Breast Cancer; Invasive Breast Carcinoma

Summary: the purpose of this study is to assess the feasibility of the nearwave optical molecular monitoring system for monitoring therapy progression and predicting pathologic complete response (pcr) of breast cancer patients undergoing neoadjuvant chemotherapy (nac).

this is a prospective, observational, pilot study. due to the investigational nature of the nearwave device, imaging data collected will not be used to inform patient treatment. since this is our first experience with the nearwave device and there does not exist any preliminary data with this device, we are performing this pilot study to establish whether data collected is of high enough quality to warrant further study. primary objective: the primary objective of this study is to assess the feasibility of using the nearwave optical molecular monitoring system during therapy to predict pcr in breast cancer patients undergoing nac, measured by the data quality captured with the device.

Eligibility criteria:
inclusion criteria: 1. women ≥ 18 years old at the time of informed consent 2. ability to provide written informed consent and hipaa authorization 3. patients who: 1. have been diagnosed with invasive breast cancer by tissue biopsy and have not yet started any therapy for the disease; a) subtype her2 positive (ihc 3+ or if ihc 2+, then positive by fish), with any er status, or b) subtype tnbc, defined by: her2 negative and er/pr negative or low (er and pr ≤ 9%, weak staining) 2. with ≥2 cm tumor size in the largest dimension as measured by ultrasound, mri, or mammography. if multifocal disease, at least one tumor must measure ≥2 cm 3. are planned to receive neoadjuvant chemotherapy followed by surgery 4. will be at least two weeks out from biopsy of the primary lesion at the time of baseline visit 5. have a palpable breast mass as determined by a treating physician exclusion criteria: 1. patients with significant bruising or hematoma from diagnostic breast biopsy, as determined by clinical judgement (mild ecchymosis okay) 2. inflammatory breast cancer 3. prior breast cancer requiring surgery or radiation in either breast 4. pregnant or nursing due to changes in breast architecture 5. patients with a bmi of ≥ 40, unless the lesion is near the surface (\<3 cm from the skin surface), based on diagnostic scan measurements 6. patients with any tattoos on their breasts

Keywords: neoadjuvant chemotherapy breast cancer imaging nearwave invasive breast cancer