Kornimate/medical-research-clean huggingface dataset:
a open-label study investigating the safety and tolerability of npsp558, a recombinant human parathyroid hormone (rhpth [1-84]), for the treatment of adults with hypoparathyroidism - a clinical extension study (race)

Conditions: Hypoparathyroidism

Summary: this study is a long-term, open-label study using npsp558 for the treatment of adult patients with hypoparathyroidism.

patients with a history of hypoparathyroidism will be enrolled to receive study drug for up to 80 months, which will be injected daily in either thigh. during that time they will be monitored for safety (specifically calcium levels in blood or urine). in addition, the patients' intake of vitamin d and calcium will be measured.

Eligibility criteria:
inclusion criteria: * previously completed the rhpth\[1-84\] relay study (8 weeks of active therapy) and/or previously completed the rhpth\[1-84\] replace study (visit 18). * able to perform daily sc self-injections of study medication (or have a designee perform injection). * women who are (1) postmenopausal; (2) surgically sterilized; or, (3) of childbearing potential with a negative pregnancy test and who consent to use two acceptable methods of contraception for the duration of the study. * males who have female partners of childbearing potential must use two acceptable forms of contraception for the duration of the study. * serum creatinine \<1.5 mg/dl at enrollment. * total serum calcium less than or equal to upper limit of normal (uln) based on local laboratory result prior to enrollment. * serum 25 hydroxy (oh) vitamin d less than or equal to 1.5 times the uln within approximately 16 weeks prior to enrollment. exclusion criteria: * any condition that, in the investigator's opinion after consultation with the sponsor, would preclude the safe use of parathyroid hormone (pth). * pregnant or lactating women. * any disease or condition which has a high probability of precluding the subject from completing the study or where the subject cannot or will not appropriately comply with study requirements.

Keywords: pth 1-84 hypoparathyroidism parathyroid hormone 1-84 npsp558
continuous pre-peritoneal wound infiltration versus epidural analgesia in cancer surgery

Conditions: Abdominal Neoplasms

Summary: the investigators aim is to investigate the effect of continuous preperitoneal bupivacaine wound infiltration versus epidural analgesia on the inflammatory cytokines response following radical cytectomy


Eligibility criteria:
inclusion criteria: * asa i-iii patients * aged 18-60 yr * undergo open abdominal cancer surgery exclusion criteria: * general contraindications for epidural analgesia, * recent history (8 weeks) of, chemotherapy or radiation, * chronic opioid use
effectiveness of levetiracetam in the treatment of body dysmorphic disorder

Conditions: Body Dysmorphic Disorder

Summary: the purpose of this study is to assess the usefulness of a medication (levetiracetam) for people with body dysmorphic disorder.

body dysmorphic disorder (bdd), a perceived defect in appearance (e.g., a "large" nose or facial "scarring"), is a relatively common disorder that causes marked distress and impairment in functioning. recent data suggests that adults with bdd may respond to serotonin reuptake inhibitors (sris); however, response to sris is often only partial. about one third of patients do not respond to an sri. furthermore, patients may stop taking sris because of side effects (e.g., sexual side effects). for these reasons, additional monotherapy and sri augmentation strategies are greatly needed. levetiracetam is primarily used as an antiseizure medication and has a wider safety margin than other antiepileptics. preliminary scientific studies may suggest that it may be helpful for certain psychiatric symptoms and disorders. in the present study we propose to obtain pilot data on 1) levetiracetam monotherapy and 2) levetiracetam augmentation of sris in patients with bdd.

Eligibility criteria:
inclusion criteria: * men and women age 18-65; * current dsm-iv bdd or its delusional variant (delusional disorder, somatic type) for at least 3 months; * a minimum total score of 20 on the yale-brown obsessive compulsive scale modified for bdd (bdd-ybocs) (19); * suitable for treatment in an outpatient setting exclusion criteria: * unstable medical illness, including renal failure or dialysis; * myocardial infarction within 6 months; * current pregnancy or lactation, or inadequate contraception in women of childbearing potential; * a need for prn benzodiazepines, another antiepileptic medication, or an anticipated change in the dose of any concomitant medications while receiving treatment with levetiracetam; * clinically significant suicidality, including a suicide attempt within the past two months; * lifetime history of dsm-iv dementia, schizophrenia, or any other dsm-iv psychotic disorder that is not attributable to bdd; * current or recent (past 3 months) dsm-iv substance abuse or dependence; * initiation of ongoing psychotherapy from a mental health professional within 3 months prior to study baseline; * ongoing cognitive-behavioral therapy from a mental health professional; * previous treatment with levetiracetam; * treatment with investigational medication, depot neuroleptics, or ect within the past 3 months.

Keywords: body dysmorphic disorder levetiracetam
efficacy of surface electrical stimulation for urge urinary incontinence in women

Conditions: Urge Incontinence

Summary: the purpose of this research is to evaluate the effectiveness of the elitone-uui electrical muscle stimulation device on treating urge incontinence. the aim of the device is to stimulate the pelvic floor muscles and surrounding structures to improve urinary incontinence.

the purpose of this research is to evaluate the effectiveness of the elitone-uui electrical muscle stimulation device on treating urge incontinence in women. the aim of the device is to stimulate the pelvic floor muscles and surrounding structures to improve urinary incontinence. this is a randomized prospective controlled study of two active groups with a stimulation frequency difference between the groups.

Eligibility criteria:
inclusion criteria: * predominant urge urinary incontinence as determined by responses to a series of three standard questions from the king's health questionnaire; specifically: * an affirmative response to "is it very difficult to control when you have a strong urge to urinate?", * an affirmative or negative response to "do you lose urine with physical activities such as coughing, sneezing, running?", * and, if an affirmative response to the second question, an affirmative response to "are more of your incontinence episodes due to a strong urge to urinate than to abdominal pressure such as sneezing?" * mild-moderate incontinence symptoms as determined by self-reported typical number of accidents of 1 or more per 24 hours. symptom severity is later verified with data from the daily log (see 5.4) exclusion criteria: * less than 1 incontinence accident (leak) per day\* * severe incontinence as determined by self-reported \>5 accidents per day * currently pregnant, may be pregnant, attempting to become pregnant, or delivery within previous 6 weeks * vaginal or pelvic surgery within previous 6 months * severe obesity as defined by bmi \>= 35 * change in incontinence medication type or dosing within the last 3 months. * history or symptoms of urinary retention, extra-urethral incontinence, overflow incontinence * pelvic pain/painful bladder syndrome * active urinary tract infection (uti) or history of recurrent utis (more than three in a year), or recurrent vaginitis (bacterial/fungal) * tissues protruding outside the vagina at rest * presence of incontinence-associated dermatitis or other perineal skin disorders or lesions, * complete denervation of the pelvic floor * conductive inter-uterine devise (iud/coil) or metal implants in the abdominal or pelvic area, including the hip and lumbar spine, * chronic coughing * previous use of interstim device or botox for ui * implanted cardiac device, untreated cardiac arrhythmia or suffer from other heart problems. * cancer, epilepsy or cognitive dysfunction * underlying neurologic/neuromuscular disorder * impaired decision making, suicidal thoughts, or drug/alcohol dependence * lacks capacity to consent for themselves.

Keywords: incontinence bladder urge urgency stimulation
nihr cv health informatics collaborative

Conditions: Troponin; Age; Mortality; Acute Coronary Syndrome

Summary: the national institute for health research (nihr) cardiovascular health informatics collaborative is an observational, multi-centre and longitudinal study of clinical data from collaborating hospitals. a dataset of the longitudinal record for patients who presented with a suspected acute coronary syndrome, characterised by the request of a troponin test, has been developed (nhic-troponin study).

the nhic cardiovascular project in the united kingdom was established to enable the sharing and repurposing of routinely captured clinical data for re-use in research. data sharing for this study has been enabled by establishing a data sharing agreement between each of the collaborating hospitals. the data sharing agreement allows data to be shared between national health service (nhs) hospitals in accordance with an anonymisation and de-identification profile approved by each information governance department, ensuring that patient identities are protected. ethics approval for each dataset has been obtained which detailed the further de-identification steps to ensure that research datasets are fully anonymised. the cardiovascular theme clinical leads developed a standard target data model specification to capture the longitudinal record for patients who presented with a suspected acute coronary syndrome, characterised by the request of a troponin test (nhic-troponin study). the data model was patient centric allowing for minor discrepancies between dataset areas such as missing discharges or test results returning outside of episodes of care. the model included 156 data points, grouped into demographics, cardiovascular risk factors, emergency department attendance and inpatient episodes, biochemistry, revascularisation and mortality. all patients were followed up on the nhs spine application, summary care record until death or censoring on 1st april 2017. this dataset comprised all patients who had a troponin measured at each of the five major academic centres between 2010 (2008 for university college hospital) and 2017. the investigators identified a total of 257948 patient records who underwent troponin testing during the study period. a committee of experts validates the protocol methodology and supervises the data management. a steering committee oversees study proposals including hypotheses, study design and statistical analyses including planned outcome measures.

Eligibility criteria:
inclusion criteria: * all patients presenting to one of the collaborating hospitals. exclusion criteria: * nil
effect of telephone follow-up on repeated suicide attempt in patients

Conditions: Suicide, Attempted

Summary: attempted suicide is a major public health problem, and the efficacies of current postvention protocols vary. the investigators evaluated the effectiveness of telephone follow-up of patients referred to an emergency psychiatric unit for attempted suicide on any further attempt/s over the following year. in a single-center, controlled study with intent to treat, they evaluated the efficacy of a protocol of telephone follow-up of patients at 8, 30, and 60 days after they had been treated for attempted suicide. for comparison, they evaluated as controls patients with similar social and demographic characteristics referred to their emergency psychiatric unit in the year prior to the study who did not receive telephone follow-up after their initial hospitalization. data were analyzed using logistic regression.

the importance of suicide and suicidal attempts recurrence is a major public health problem. indeed, the suicide attempt is one of the most important predictors of suicide, as well as suicidal relapse is considered a suicide risk factor. it is therefore essential to establish the suicidal relapse prevention devices. moreover, the consensus conference on suicidal crisis (6) in particular stresses the importance of organizing continuity of care and foster a therapeutic alliance to avoid a break in continuity of care. this study aims to evaluate the effectiveness of telephone callback patients on suicide rate of recurrence at 6 months of suicidal gesture. a secondary objective is to assess and promote compliance. patients were included after a psychiatric interview following a suicide attempt in the north hospital's emergency unit no emergency hospitalization or indication in the interview before the release of the psychiatric emergency service. the interview provides an assessment of suicide risk and oral information about the protocol. a map showing the coordinates of the psychiatric emergency service and a reminder of the protocol is given. a consent form is signed. this protocol does not replace the usual care.

Eligibility criteria:
inclusion criteria: * patient affiliated or entitled to a social security scheme * patient who have attempted suicide regardless of the medium * patient falling 4 psychiatric sectors covered by the chu of saint-etienne * major and minor patient (with parental permission) * patient for which there is no evidence of psychiatric hospitalization sector or clinic immediately after switching to the suicidal act exclusion criteria: * homeless patient * patients for whom callback is not possible (no phone, incarceration ...) * patient who do not speak french * patient admitted sector or clinic following the psychiatric interview inclusion * patient refusal * medical reason * deleterious character of recontact by a doctor of the psychiatric emergency after passing the act

Keywords: emergency follow-up nurse phone suicide attempts
bi-weekly administration of docetaxel for older men with hormone refractory prostate cancer

Conditions: Prostate Cancer

Summary: this pilot study is designed to determine the feasibility and safety of administering docetaxel at various dosing levels on a bi-weekly schedule in older men with hormone refractory prostate cancer.

the information obtained from this trial will help determine the feasibility and safety of administering docetaxel at various dosing levels on a bi-weekly schedule in this patient population. if the data from this phase i trial are encouraging, a phase ii trial will be conducted to further assess the efficacy of this dosing schedule.

Eligibility criteria:
inclusion criteria: * age ≥ 65 years; * histologically confirmed adenocarcinoma of the prostate; * metastatic disease; * unresponsive or refractory to hormonal therapy, as defined by at least 1 of the following criteria: progression of bidimensionally measurable disease; progression of evaluable but not measurable disease (bone scan); at least 2 consecutive rises in psa at least 1 week apart; * patients must have serum testosterone levels \< 50 ng/ml at time of study entry. for patients who are medically castrated, lutenizing hormone releasing hormone analog must continue to maintain testicular suppression; * prior nonsteroidal antiandrogens (flutamide, ketoconazole, bicalutamide, or nilutamide) allowed if disease progression occurred. no evidence of response after antiandrogen withdrawal within 4 weeks for patients treated with flutamide, ketoconazole, nilutamide and 6 weeks for patients treated with bicalutamide; * chemotherapy naïve; * full recovery from the effects of any prior surgery or radiation therapy. at least 4 weeks since any radiation therapy; * ecog performance status 0-2; * adequate kidney, liver, and bone marrow functions; * signed study-specific informed consent form. exclusion criteria: * concurrent chemotherapy or immunotherapy; * patients who have received an investigational drug within 4 weeks of registration; * prior or concurrent malignancies (other than surgically treated carcinoma in situ of the cervix and squamous or basal cell carcinoma of the skin) within the preceding five years; * serious medical or psychiatric illness which would prevent informed consent; * life expectancy \< 3 months; * active uncontrolled bacterial, viral, or fungal infection until these conditions are corrected or controlled; * known hypersensitivity to study drug or to other drugs formulated with polysorbate 80.

Keywords: elderly
pain control of thoracoscopic major pulmonary resection

Conditions: Postoperative Pain

Summary: the purpose of this study is to evaluate whether pre-emptive local bupivacaine injection is a better alternative pain control modality than the conventional intravenous patient controlled analgesia.

despite less postoperative pain from video assisted thoracic surgery (vats) than thoracotomy, pain is still an important issue in its recovery period. after vats procedure, intravenous patient controlled analgesia (iv pca) is being used for pain control. however, the side effects of iv pca are nausea, vomiting, sleepiness, and urination difficulty which interrupt the early recovery. it is established that pre-emptive local bupivacaine injection is more economical, has almost no side effects, and finally, it is effective for the postoperative 24 hours. the purpose of this study is to evaluate whether pre-emptive local bupivacaine injection is a better alternative pain control modality than the conventional intravenous patient controlled analgesia.

Eligibility criteria:
inclusion criteria: * patients that are expected to receive vats segmenectomy or lobectomy regardless of disease entity exclusion criteria: * not done by vats anatomical resection * patient does not agree to the study * postoperative hospital stay exceeds 7 days due to postoperative complications * existence of preoperative renal insufficiency (cr \> 1.5) * ot/pt \> 120 * history of lidocaine hypersensitivity

Keywords: video assisted thoracic surgery postoperative pain intravenous patient controlled analgesia bupivacaine major pulmonary resection post pulmonary resection
mean platelet volume and stemi clinical risk scores in prediction of impaired myocardial perfusion in acute stemi patients undergoing primary percutaneous coronary intervention.

Conditions: No-Reflow Phenomenon

Summary: predicting no reflow in ppci of stemi patients using mean platelet volume together with stemi clinical risk scores


Eligibility criteria:
inclusion criteria: * patients presenting with acute stemi, within 24 hours of symptoms, fulfilling criteria for ppci protocol in our facility exclusion criteria: * patients presenting more than 24 hours of symptoms onset * patients not eligible for ppci program in our facility
tranexamic acid for preventing progressive intracranial haemorrhage in traumatic brain injury

Conditions: Brain Injuries

Summary: the study's objective is to evaluate the effectiveness and safety of tranexamic acid for adult patients with moderate to severe tbi.with the research question as "does txa reduce the incidence of progressive intracranial haemorrhage by 50% compared to placebo in moderate to severe adult tbi patients at khon kaen hospital?"

traumatic brain injury (tbi) is a major public health problem with poor outcome especially with progressive intracranial haemorrhage (pih) in severe patients. there are links between coagulopathic change after brain injury and delayed traumatic haemorrhage revealed by ct brain. antifibrinolytic treatment can reduce blood loss after surgery and perhaps in moderate to severe tbi by similar haemostatic responses. it is justified to determine benefit for reversing hyperfibrinolysis after tbi. tranexamic acid (txa) has been shown to have significant clinical benefit in effectively reducing surgical bleeding in systematic reviews. it has been shown to have no effect on coagulation parameters and no demonstrated harmful effect in systematic reviews. this study is designed to determine the effectiveness of txa in preventing pih in patients with moderate to severe tbi. the treatment regimen if effective can be applied in general trauma practice worldwide.

Eligibility criteria:
inclusion criteria: * moderate to severe injuries(post-resuscitation scores gcs 4-12) * age \>= 16 year * non-penetrating tbi in 8 hours onset * first ct brain in 8 hours onset * non neurosurgical or in 8 hours onset exclusion criteria: * patients with coagulopathy * serum creatinine over than 2 mg% * with associated major organ injury requiring surgery within 8 hours of injury * pregnancy * receiving any medication which affects haemostasis

Keywords: traumatic brain injury (tbi) adults moderately severe tbi delayed traumatic intracranial haemorrhage expanding traumatic intracranial haemorrhage progressive intracranial haemorrhage (pih) antifibrinolytic agent tranexamic acid (txa) randomised, placebo-controlled trial human
education against tobacco randomized trial

Conditions: Tobacco; Prevention; Adolescents; Schools

Summary: a two armed randomized trial is evaluating the effect of the medical-student-delivered school-based intervention education against tobacco on the smoking behavior of adolescents in 7th grade of secondary school. the primary endpoint is the change in smoking prevalence between the two groups.


Eligibility criteria:
inclusion criteria: * pupils of 7th grade of regular secondary schools in germany exclusion criteria: * not fulfilling the inclusion criteria
outcomes after chiropractic spinal manipulative therapy with lumbar disc herniation and radiculopathy

Conditions: Lumbar Disc Herniation

Summary: in a study that was approved nine years ago (ek-22/2009) we could show (i) that spinal manipulative therapy (smt) is a very effective and safe treatment for acute and chronic lumbar disc herniation (ldh); (ii) that smt is as effective and less expensive than lumbar nerve root injections and (iii) that the recurrence rate up to one year was very low in acute and in chronic ldh patients. however, the long-term outcome of this conservatively treated ldh patients is unknown. thus, the objective of this amendment is to investigate the proportion of long-term recurrences in these patients who were treated with smt for their ldh and to compare these results with already existing data from other treatments, e.g. surgery. this is important information to know whether this conservative method is a sustainable approach for treating ldh.

all 148 patients with magnetic resonance imaging-confirmed disc herniation who were recruited for the study ek 22-2009 will be re-contacted to assess the course of their back problem during the past approx. nine years using a questionnaire.

Eligibility criteria:
inclusion criteria: -the same patients who were recruited for the study ek-22/2009 exclusion criteria: * the same as for study ek-22/2009: patients with specific pathologies of the lumbar spine that are contraindications to chiropractic manipulative treatment, such as tumors, infections, inflammatory spondylarthropathies, acute fractures, paget's disease and severe osteoporosis, will be excluded. also excluded will be patients with previous spinal surgery, signs of cauda equina syndrome (ces), sequestration of disc material, body mass index \>30, spondylolisthesis, neurogenic claudication and pregnancy.

Keywords: long-term outcome