Kornimate/medical-research-clean huggingface dataset:
histoacryl™ vs. suture for mesh fixation in lichtenstein hernioplasty: a randomized prospective double-blinded study

Conditions: Inguinal Hernia

Summary: this is a prospective, randomized double-blinded study to find out if mesh fixation with n-butyl-2-cyanoacrylate (nbca) are more painless than conventional mesh fixation with sutures in inguinal hernia operation (lichtenstein procedure) in day-case surgery. our hypothesis is that glue fixation is safe, simple and fast method compared to conventional lichtenstein technique.

hypothesis: 1. to use glue (instead of sutures) for mesh fixation during open hernioplasty causes a lower immediate postoperative pain. 2. the use of histoacryl is associated to a lower postoperative complications rate. 3. the use of histoacryl is not associated to a higher hernia recurrence rate. methods: 350 patients with inguinal hernia undergone lichtenstein operation in day-case surgery setting. mesh fixation is performed using 2 methods: cyanoacrylate glue: histoacryl™ (n=175: group h), and non-absorbable sutures: polypropylene 2/0 (n=175: group s). operative time and pain scores, immediate postoperative outcome are followed 1, 7, 30 days and 1 and 5 years postoperatively. surgeon doesn't know previously which fixation method will be used in each patient. this method (glue or sutures) is decided intraoperatively, when mesh is placed, using a blind randomization code (www.randomizer.org) patients are discharged (day-case surgery) if adequate pain control, oral tolerance and spontaneous diuresis is achieved, and after examination by the surgeon in order to discard immediate complications. postoperative oral treatment is prescribed to patients of both groups: dexketoprofen 25 mg/8 h + paracetamol 1 gr/8. follow-up is performed at the medical office by a blind observer (third surgeon) who didn't participate in the surgical procedure, at 1 day, 7 days, 30 days, 1 year and annually thereafter. pain is measured using a vas scale (0-10). operative data (including operating time, complications, hospital stay, etc.), early and late complications, acute and chronic pain and recurrence rate will be recorded.

Eligibility criteria:
inclusion criteria: * unilateral inguinal hernia * primary hernia exclusion criteria: * femoral hernia * recurrent inguinal hernia * immunosuppression (including corticosteroids, radiotherapy, chemotherapy) * chronic renal failure (hemodialysis) * active infection * pregnancy * allergy to polypropylene * patient's refusal

Keywords: inguinal hernia mesh fixation glue cyanoacrylate lichtenstein ambulatory surgery
sleep, mood, and behavior study

Conditions: Sleep Difficulties in Pediatric Anxiety Disorder; Generalized Anxiety Disorder; Separation Anxiety Disorder; Social Phobia

Summary: the purpose of this study is to assess whether improving sleep in children and adolescents with anxiety disorder will further enhance affective, clinical, and social functioning.

this study is one of two interlinking protocols developed to investigate neural, affective, behavioral and social predictors of improvement as a critical next step in advancing the understanding of processes involved in the treatment response of anxiety disorders in youth. this protocol will offer a six to eight session sleep intervention (sleeping tigers)children ages 9-13 who currently have a dsm-iv anxiety disorder and who endorse some level of impairment in their ability to sleep. participants will have completed a 16 session intervention for anxiety (irb submission, child anxiety treatment study cats). we hope to assess whether improving sleep will further enhance affective, clinical, and social functioning.

Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of dsm-iv diagnosis of generalized anxiety disorder (gad), separation anxiety disorder (sad), and social phobia (sp) 2. previous enrollment cognitive behavioral therapy arm in clinicaltrials.gov identifier: nct00774150 study, entitled, " transdisciplinary studies of cbt for anxiety in youth: child anxiety treatment study (cats)" 3. the child/adolescent must have a "sleep problem" defined as: difficulties at least 3 times within a 2-week period in one or more of the following domains: * difficulties going to sleep * difficulties waking during the night * difficulties getting up on time for school because of tiredness/sleepiness * daytime tiredness and/or irritability that the child or parent attributed to insufficient sleep * erratic sleep-wake schedules exclusion criteria: 1. iq below 70 as assessed by the wechsler abbreviated scale of intelligence (wasi). 2. requires current ongoing treatment with psychoactive medications including anxiolytics and antidepressants. 3. acutely suicidal or at risk for harm to self or others. 4. any motor impairments or eye-hand coordination problems 5. sleep disorder or parasomnia. 6. taking any medication that might interfere with sleep. 7. has a medical problem that might interfere with sleep.

Keywords: sleep difficulties in pediatric anxiety disorder neural correlates of pediatric anxiety disorder social correlates of pediatric anxiety disorder generalized anxiety disorder in pediatric populations separation anxiety disorder in pediatric populations social phobia in pediatric populations
stepping training using external feedback in spinal cord injury patients

Conditions: Spinal Cord Injuries

Summary: does a 4-week stepping training program with or without external feedback clinically change functional ability and reduce risk of fall of ambulatory patients with isci? are there significant differences between 4-weeks stepping training with or without external feedback in ambulatory patients with isci?

to compare effects of 4-week stepping training with or without external feedback on functional ability and incidence of falls in ambulatory patients with isci (between-group comparison). to compare the change of functional ability in a group of 4-week stepping training with or without the utility of external feedback (within-group comparison).

Eligibility criteria:
inclusion criteria: * independent ambulatory patients with isci * non-traumatic or traumatic causes * independent walking with or without assistive devices at least 17 meters (functional independence measure locomotor (fim-l) scores 5-7) * age at least 18 years * body mass index (bmi) between 18.5 - 29.9 kg/m2. exclusion criteria: * any conditions or disorders that might affect ability to participate in the study and/or ambulatory ability of the subjects such as * brain function disorders * visual deficits that cannot be corrected using glasses or contact lens * musculoskeletal pain (with an intensity of pain more than 5 out of 10 on a numerical rating pain scale) * deformity of the musculoskeletal system * unable to follow a command of the tests * unstable medical conditions * color blindness

Keywords: rehabilitation neurological condition walking ability feedback external information
the effect of combined decongestive therapy and pneumatic compression pump on body image in patients with lymphedema

Conditions: Lymphedema

Summary: patients with lymphedema may experience pain and body image issues. this study investigates the effect of combined decongestive therapy and pneumatic compression pump on body image in patients with lymphedema secondary to breast cancer treatment.42 women with breast cancer related lymphedema participated. all patients completed the body image and relationships scale. researchers divided the participants randomly into an intervention (n=21) or control group (n=21). in the first phase, cdt was accompanied by use of a compression pump for four weeks, three days per week. in the second phase, combined decongestivetherapy was performed daily without compression pump for four weeks by patients at home. at the end of each phase, both groups completed the questionaire. researchers analyzed the data with spss v.17.

background: lymphedema is a common complication for breast cancer therapy. patients with lymphedema may experience pain and body image issues. this study investigates the effect of combined decongestive therapy and pneumatic compression pump on body image in patients with lymphedema secondary to breast cancer treatment. methods: 42 women with breast cancer related lymphedema participated. all patients completed the body image and relationships scale. researchers divided the participants randomly into an intervention (n=21) or control group (n=21). a certified nurse worked on combined decongestive therapy in the intervention group in two phases. in the first phase, cdt was accompanied by use of a compression pump for four weeks, three days per week. in the second phase, cdt was performed daily without compression pump for four weeks by patients at home. at the end of each phase, both groups completed the questionaire. researchers analyzed the data with spss v.17.

Eligibility criteria:
inclusion criteria: 1. histoty of breast cancer, 2. history of surgery and chemotherapy and as needed hormone therapy and radiotherapy, 3. affected by lymphedema (with degree of mild to severe) based on specialist diagnosis, 4. at least 1 year ago was undergone axillary node dissection, 5. do not have knowledge about combined decongestive therapy, 6. phone accessibility, 7. 35-70 years old. exclusion criteria: 1. psychotic disorder, 2. existence sever pain at axillary area, 3. history of hysterectomy duo to uterus cancer, 4. severe cardiac disease, 5. heart failure, 6. renal failure, 7. severe hypertension, 8. existing other malignancies, 9. recurrent infection in arm, 10. musclo skeletal disease

Keywords: lymphedema secondary to breast cancer breast cancer body image
investigating interventions to reduce residual opioids in the home following legitimate opioid prescribing in children.

Conditions: Opioid Use, Unspecified

Summary: the overall objective of this study is to evaluate strategies to reduce unused opioids prescribed for pediatric acute post-surgical pain management.

prescription opioids are abused by an estimated 12.5 million americans, and accidental opioid overdose is the leading cause of injury death in the us. many of these drugs originate from leftover prescription opioids related to postoperative overprescribing, lack of proper disposal, and unsafe home storage. governmental guidelines indicate that leftover prescription opioids should be preferentially returned to a drug take back site; however, many people do not utilize these programs due to travel distance, lack of transportation, or other factors. the aims are to quantify the amount of unused opioids in the home following painful pediatric surgical procedures, investigate the impact of formal interventions on disposal of residual opioids in the home following these surgeries, and to identify current behaviors of adolescents and their family members in the handling of unused prescribed opioids.

Eligibility criteria:
inclusion criteria: * male or female children ages 12-17.9 years old * asa physical status 1 and 2 * patients undergoing primary posterior spinal fusion surgery for correction of idiopathic scoliosis. * patients undergoing nuss bar correction of pectus excavatum deformity. exclusion criteria: * oxycodone allergy * severe sleep apnea * developmental delay * neurological disorders * liver disease/impairment * renal disease/decreased renal function * patients on opioid therapy prior to surgery * requires a translator for communication in english

Keywords: opioid stewardship
a pilot test of the relaxation response resiliency program (3rp) in spanish speaking world trade center survivors with post traumatic stress disorder (ptsd)

Conditions: Post Traumatic Stress Disorder (PTSD)

Summary: the objective of this protocol is to test the feasibility and acceptability of the relaxation response resiliency program (3rp), a psychotherapy treatment providing a variety of mind body skills and interventions to decrease medical and mental health symptoms and build resilience, in spanish-speaking world trade center (wtc) survivors, and to examine its clinical effectiveness to reduce post traumatic stress disorder (ptsd), depression, anxiety, and lower respiratory symptoms (lrs) and improve psychosocial functioning.


Eligibility criteria:
inclusion criteria: * score \> or = 44 on the ptsd checklist pcl, considered the broad definition of ptsd syndrome71 * report at least one lrs symptoms (i.e., shortness of breath, wheezing, dyspnea or cough). * spanish speaking exclusion criteria: * regular practice of eliciting relaxation response (i.e., meditation, yoga) in the past 6 months, * serious unmanaged mental illness including bipolar disorder, psychosis, and active substance misuse disorders; * inability to participate in consecutive sessions over 3-month period.
early targeted brain cooling in the cath lab following cardiac arrest

Conditions: Cardiac Arrest

Summary: the objective of the coolcath study is to compare the effect of the rhinochill transnasal cooling system to current standard blanketrol iii cooling blanket in its ability to achieve therapeutic hypothermia (th) induction for patients undergoing th after cardiac arrest. the coolcath study will be a prospective, open-label randomized controlled trial comparing induction of th efficacy and outcomes of patients following cardiac arrest. any patient with return of spontaneous circulation (rosc) following a cardiac arrest within the essex cardiothoracic centre (ctc), or who is brought to the essex ctc and is a candidate for th will be considered for this study.

according to standard practice patients will be fully anaesthetised, intubated and ventilated. patients will have a baseline tympanic temperature measurement taken and then will be randomized to receive induction of th by either rhinochill transnasal cooling system, or standard care using the blanketrol iii cooling blanket. all patients will have tympanic and oesophageal temperature measurement every 10 minutes until they reach th (\ 34 (i.e. have not reached th), these patients will have rhinochill and blanket therapy until they reach \<34 degrees centigrade when the rhinochill will be discontinued.

Eligibility criteria:
inclusion criteria: 1. ≥ 18 years old 2. post cardiac arrest with return of spontaneous circulation 3. receiving therapeutic hypothermia as part of post-cardiac arrest care exclusion criteria: 1. cardiac arrest caused by trauma, head injury, massive haemorrhage, drug overdose, cerebrovascular accident, drowning, electric shock or hanging 2. already hypothermic 3. nasal obstruction preventing the insertion of a nasal catheter 4. do not attempt to resuscitate (dnar) orders 5. known terminal illness (eg. malignancy in the end stages) 6. known or obvious pregnancy 7. known coagulation disorder (except those induced by medication eg. thrombolytics) 8. known o2- dependency

Keywords: therapeutic hypothermia cardiac arrest randomised controlled trial pilot study
comparison to early detect of the sepsis

Conditions: Sepsis Scores

Summary: the aim of the study was to identify co-variates associated with 30-day mortality in septic patients admitted to the emergency department in order to improve morbidity \& mortality as a sequence of sepsis in assiut \& suez canal universities by comparing both scores by utilizing parameters that are readily available .

there are a relatively large number of conditions where urgent intervention is required in order to secure the best outcome for the patient. examples include sepsis, myocardial infarction (mi). clinical diagnosis of some of these conditions is not always straightforward, but a common theme is that many present with deranged physiology and vital signs. implementation of an early warning score on arrival at hospital has helped to identify seriously ill patients . there is a high mortality rate associated with severe infection at all ages sepsis occurs when life-threatening organ dysfunction is associated with infection. what is a national early warning score (news)? the following six simple physiological parameters are included in the scoring system: respiratory rate, oxygen saturation, temperature; the normal human body temperature range is typically stated as 36.5-37 °c( ), systolic blood pressure, pulse rate \& level of consciousness. what is a sepsis patient evaluation in the emergency department (speed)? the following simple clinical, physiological and laboratory parameters are included in the scoring system : hypotension (systolic pressure \ 2.4 mmol/l \& source of infection as pneumonia.

Eligibility criteria:
inclusion criteria: * age of 18 - 80 years. * patients of both genders. exclusion criteria: * patient refusal . * accepts healthy volunteers . * aged below 18 years
cerebrolysin in cadasil

Conditions: Cadasil

Summary: the objective of this trial is the global risk-benefit assessment of cerebrolysin as compared to placebo in patients with genetically proven cadasil. in addition, a traditional approach will be taken based on an evaluation of the separate risk and benefit domains in comparison with placebo.

safety data area collected throughout the study (adverse events, vital signs and laboratory tests) and thereafter in case of ongoing serious adverse events (saes) at study endpoint. optional secondary parameters include analyses of biomarkers (samples of blood, hair, urine, and saliva).

Eligibility criteria:
inclusion criteria: 1. patients of ≥18 years of age, all genders 2. diagnosis of cadasil based on clinical symptoms, mri, and genetic analysis 3. moca \>11 4. adequate visual, auditory, and language skills (no language interpreter required) to follow study procedures 5. patient is not of childbearing potential (i.e. women are post-menopausal for two years, surgically sterile, or using adequate method of contraception) 6. patient participates voluntarily and gave written informed consent exclusion criteria: 1. any significant neurological disease/conditions other than cadasil 2. focal lesions that may be responsible for the cognitive status of the patient (e.g. infectious disease, space-occupying lesion, normal pressure hydrocephalus) 3. any other diseases/conditions that may affect compliance with the protocol, such as: 1. severe psychiatric disorders within the last three months 2. delusional symptoms 3. history of schizophrenia, schizoaffective disorder, bipolar affective disorder 4. major depressive disorder newly identified within eight weeks before screening 5. history of alcohol or substance abuse or dependence within the past two years 4. any circumstances that -in the investigator's opinion- may result in the patient's non-compliance with study procedures, e.g. fragile or thin veins that prevent many i.v. infusions 5. any other disease/conditions that may affect the safety assessment, such as: 1. history of systemic cancer within the past two years 2. history of myocardial infarction in the past year or unstable or severe cardiovascular disease (including uncontrolled hypertension and/or history of unstable hypertension not compensated by antihypertensive therapy) 3. any clinically significant laboratory abnormalities at screening 4. uncontrolled insulin-requiring diabetes or non-insulin dependent diabetes mellitus (hba1c \>87 mmol/mol) 6. use of concomitant medication with neuroprotective/neurotrophic/nootropic effects (e.g. ginkgo biloba, erythropoietin, citicoline, amantadine, piracetam) 7. any condition that would represent a contraindication for cerebrolysin administration: 1. hypersensitivity to one of the components of the drug 2. epilepsy 3. severe renal impairment (estimated glomerular filtration rate \[egfr\] \<30 ml/min/1.73 m2 as assessed at local laboratory within one month before screening)
effects of upper extremity rehabilitation robot and transcranial direct current stimulation among patients with stroke

Conditions: Stroke

Summary: effects of upper extremity rehabilitation robot and transcranial direct current stimulation on upper extremity function among subjects with tremor after stroke


Eligibility criteria:
inclusion criteria: * stroke with cerebellar hemorrhage or infarction * ataxia or tremor on upper extremities secondary to stroke * cognitively intact enough to understand and follow the instructions from the investigator exclusion criteria: * history of surgery of affected upper limb * fracture of affected upper limb

Keywords: cerebellar stroke upper extremity rehabilitation robot transcranial direct current stimulation stroke rehabilitation
a multipart, open-label study to evaluate the safety and efficacy of abt-450/r/abt-267 with and without abt-333 coadministered with and without ribavirin in adult with genotype 1 or 4 hepatitis c virus (hcv) infection and human immunodeficiency virus, type 1 coinfection

Conditions: Hepatitis C Virus Infection; Human Immunodeficiency Virus Infection; Chronic Hepatitis C; Compensated Cirrhosis and Non-cirrhotics

Summary: the primary objectives of this study are to assess the safety of abt-450/r/abt-267 with and without abt-333 coadministered with and without ribavirin (rbv) for 12 and 24 weeks in hcv gt1- or 4-infected participants with hiv-1 coinfection and to evaluate the percentage of subjects achieving hcv ribonucleic acid (rna) \< lower limit of quantification (lloq) 12 weeks following treatment.


Eligibility criteria:
inclusion criteria: * chronic hcv infection at screening defined as: positive anti-hcv antibodies (ab) at screening and hcv rna \> 1,000 iu/ml at screening. * plasma hiv-1 rna \< 40 copies/ml during screening using abbott realtime hiv-1 assay. * on a stable qualifying hiv-1 antiretroviral therapy regimen. exclusion criteria: * positive test result at screening for hepatitis b surface antigen. * evidence of hcv genotype other than genotype 1 or genotype 4 during screening. * receipt of any other investigational or commercially available anti-hcv agents (for example, telaprevir, boceprevir, simeprevir, daclatasvir and ledipasvir) with the exception of interferon (including pegylated-interferon alfa-2a or alfa-2b), sofosbuvir and ribavirin. * consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive abt-450, abt-267, abt-333, ritonavir or ribavirin. * chronic human immunodeficiency virus, type 2 (hiv-2) infection.

Keywords: hcv genotype 4 interferon-free hepatitis c genotype 1 compensated cirrhosis hepatitis c genotype 4 hcv / hiv coinfection cirrhotic hepatitis c hiv-1 hcv genotype 1
epidemiology and long term outcome of critically ill patients requiring renal replacement therapy in southeast asia and india (insea-rrt registry)

Conditions: Acute Kidney Injury

Summary: acute kidney injury is associated with increased short-term and long-term morbidity and mortality. long-term data is lacking in low to middle-income countries. our study aims to follow the acute kidney injury patients stage 3 in intensive care units for 2 years to observe mortality and associated factors.


Eligibility criteria:
inclusion criteria: * aki stage 3 * at least 18 years old exclusion criteria: * esrd patients (egfr \< 15 ml/min/1.73 m2)

Keywords: acute kidney injury renal replacement therapy intensive care unit