Kornimate/medical-research-clean huggingface dataset:
effect of sacral nerve stimulation on enteric nervous system

Conditions: Fecal Incontinence

Summary: sacral nerve stimulation (sns) is a new therapeutic option to treat fecal incontinence, although its mecanims of action remains poorly understood. the investigators hypothtized that sns could act on enteric nervous system (ens). to verify this hypothesis, the investigators will collect biopsy samples from patients implanted for sns, and assess whether sns induces changes in ens.

sacral nerve stimulation (sns) is a new therapeutic option to treat fecal incontinence. its efficacy yields 80% approximately, but its mecanims of action remains poorly understood. in particular, sns does not restore anal squeezing contraction nor it increase anal tone. recently, using a porcine model, it was shown that sns changed colonic permeability, suggesting that sns may activate the enteric nervous system (ens). the investigators hypothtized therefore that sns could act on enteric nervous system (ens). to verify this hypothesis, the investigators will collect biopsy samples from patients before and after implantation for sns. the investigators will assess whether sns induces changes in ens, and if this is correlated to sns efficacy.

Eligibility criteria:
inclusion criteria: * fecal incotinence * refractory to medial treatment * eligible to a treatment with sacral nerve stimulation exclusion criteria: * age \< 18 yo * age \< 75 yo * anal defect \> 120° * bilateral interruption of the bulbo-cavernous reflex * patient not able to speack and understand the french language * patient not affilated to the french healthcare system * pregnancy

Keywords: fecal incontinence, sacral nerve stimulation
fosamax for childhood cancer survivors

Conditions: Osteoporosis

Summary: survivors of childhood cancers face a variety of long-term problems. the investigators' recent study found that osteoporosis and osteopenia were common among these patients. the factors leading to, as well as the best treatment option for, this morbidity are unclear. bisphosphonates are currently the standard therapy for osteoporosis in the elderly. however, the efficacy and safety of bisphosphonates for treating osteoporosis in long-term cancer survivors have not been tested. the investigators hypothesize that alendronate, an orally active bisphosphonate, is efficacious and safe in the treatment of osteoporosis in these patients.

the modern treatment for childhood malignancy includes surgery and chemoradiotherapy either individually or in combination. despite the great achievement in improving patient survival, these treatments also greatly enhance the adverse effects on the unfortunate children. our research group has recently conducted a pioneer study on the bone mineralization and bone mineral density (bmd) study in longterm childhood cancer survivors in local patients who have completed anti-cancer treatment for at least five years. this landmark study showed that persistent treatment-related adverse effects on skeletal development are common (up to 50%) in local long-term survivors of childhood cancers. thus, it is important during this critical period of rapid somatic growth in adolescents and young adults that these cancer survivors achieve their peak potential for bone mineralization and strengthening. in this proposed study, we investigate with a randomized and controlled study design on the efficacy of a second-generation oral bisphosphonate, alendronate, to improve bmd over a 36-week period in long-term survivors of childhood cancers in hong kong. in addition to alendronate, all subjects in the active and control groups will receive alfacalcidol (vitamin d) and calcium carbonate throughout the whole study period. the study results will help paediatric oncologists to decide on the optimal remedial treatments against osteoporosis in long-term cancer survivors.

Eligibility criteria:
inclusion criteria: * chinese patients who completed treatments for childhood cancers for at least 5 years * currently followed up in the department of paediatrics of prince of wales hospital * younger than 18 years old at the time of diagnosis of underlying cancers * evidence of osteoporosis (i.e. bmd t- or z-score \< -2.5 at lumbar spine) * older than 15 years of age at the time of recruitment exclusion criteria: * current treatment (i.e. within 6 months) with maintenance systemic or high-dose inhaled corticosteroids * subjects who cannot cooperate for bmd measurements * pregnant female patients * subjects with prior history of allergy to alendronate or in whom alendronate treatment is contraindicated

Keywords: childhood cancer survivors osteoporosis bone mineral density therapy bisphosphonate randomized controlled trial
angiotensinogen gene and hypertension

Conditions: Hypertension

Summary: genetic studies of hypertension, focusing on renin-angiotensin system genes and other interacting genes


Eligibility criteria:
inclusion criteria: * patients with hypertension exclusion criteria: * patients with hypertension and reluctant for the study
harassment of pain clinic staff by patients

Conditions: Patient Violence

Summary: chronic pain is associated with psychological disorders, and many patients have behavioral problems. some patients harass pain services staff. most healthcare staff do not report harassment by patients. quantitative and qualitative analysis of prospective electronic and clinic diary data. evaluation of incidents of clinic staff harassment; caused by patients and patients' family. analysis of causative factors, incident outcome and lessons learned.

chronic pain is associated with psychological and mental health disorders. many patients have personality and behavioral disorders. some patients harass their pain care providers. most healthcare staff do not report harassment by patients. this is a quantitative and qualitative analysis of prospective electronic and clinic diary data. it is an evaluation of incidents of pain clinic staff harassment; caused by patients and patients' family. this is an analysis of incident causative factors, incident outcome and lessons learned. the qualitative information of each incident is presented in a sensitive and careful format.

Eligibility criteria:
inclusion criteria: * adult chronic pain patients exclusion criteria: * pediatric chronic pain patients

Keywords: harassment by patients
collaborative nurse-pharmacist counseling for self-administered biologics

Conditions: Medication Adherence; Medication Nonadherence; Adverse Drug Event

Summary: the goal of this clinical trial is to learn if nurse-pharmacist counseling can improve patient knowledge and confidence and prevent side effects in patients who start a biologic medication in-office and later continue the medication at home. the main question it aims to answer are: • does nurse-pharmacist counseling improve patient-reported knowledge and confidence in biologic self-treatment when moving from in-office to at-home administration? participants will attend a brief counseling session in office and respond to a pre-counseling and post-counseling survey to look at medication knowledge and confidence. participants will be contacted at three months after the survey to ask if they had any side effects related to their biologic medicine. data will be collected from the participant's medical record at the study institution for up to six months after the study counseling session.


Eligibility criteria:
inclusion criteria: * referred to university of kentucky specialty and infusion services for clinic-administration of a biologic medication * biologic medication is omalizumab, risankizumab-rzaa or ustekinumab * medication administration will be transitioned to self-administration exclusion criteria: * less than 18 years of age * have previously received the qualifying biologic at another institution * non-english speaking subjects * subject will not be performing self-administration at home * does not transition to medication self-administration
treatment of non promyelocytic acute myeloid leukaemia on elderly patients by low dose cytosar plus arsenic trioxide

Conditions: Leukemia, Myeloid, Acute

Summary: our purpose in this study is to explore the feasibility of treatment of non promyelocytic acute myeloid leukaemia on elderly patients. we select ten patients with age further than 60 with comorbidity and treat by low dose cytosar subcutaneous plus arsenic trioxide for ten days in month. we will assess overall response rate and overall survival in end of one year.

acute myeloid leukemia is a disease in which characterised by blast further than 20% in bone marrow plus incomplete differentiation. many of this patients are elderly with age further than 60 years(calgb,ecog,eortc) or 55 years (swog). mortality rate fallowing standard therapy of this patients is high that can reach to 50%. one of methods to apply a remission with least mortality and morbidity and also significant lower cost effects compare to historical and conventional standard regimen is low dose cytosar and arsenic trioxide combination that has been reported complete remission to 34%. we select ten patients with age further than 60 with comorbidity and treat by low dose cytosar subcutaneous plus arsenic trioxide for ten days in month. we will assess overall response rate and overall survival in end of one year.

Eligibility criteria:
inclusion criteria: * elderly patients with non promyelocytic aml * performance status (ecog) 3 or 4 exclusion criteria: * age \<60 years * elevation of ast or alt more than ten times above normal * serum bilirubin above 5 * cr level \> 2

Keywords: aml
comparative study of the inclination angle and complications of eccentric grafts position in acl reconstruction and normal acl: retrospective cohort

Conditions: Anterior Cruciate Ligament Injuries

Summary: the anatomic acl reconstruction aims at functional restoration of the acl to its native dimensions, collagen orientation and insertion sites. even if the anatomic foot prints are correctly chosen for the tibial and femoral tunnels does the position of interference screw in the tibial tunnel alter the acl orientation? the study hypothesized that the position of interference screw in the tibial tunnel would alter the graft orientation in anatomic acl reconstruction. the purpose of this study was to compare graft orientation and inclination angle with posterolateral and anteromedial interference screw position in tibial tunnel in aperture fixation techniques.


Eligibility criteria:
inclusion criteria: * magnetic resonance imaging (mri) of patients with acl reconstruction was compared to mri in which acl was intact. * patients with isolated acl injury who underwent acl reconstruction surgery using quadripled hamstrings graft and operated by a single senior surgeon * both pre-operative and post-operative mri should be available for assessment * no history of trauma in the post-operative or rehabilitation period exclusion criteria: * concomitant bony or other ligament injury to the same knee * history of previous surgery to the same knee * revision acl reconstruction surgery * surgery done at other center or by other doctors at our institute * pre-operative and/or post-operative mri not available

Keywords: acl screw fixation graft inclination reconstruction
pragmatic trial of messaging to providers about treatment of heart failure in the inpatient setting

Conditions: Heart Failure

Summary: a randomized single-blind interventional trial to test the effectiveness of an electronic medical record-based best practice alert recommending evidence-based medical therapies versus usual care in inpatient adult patients presenting with heart failure with reduced ejection fraction.

heart failure (hf) is the major cause of healthcare expenditure, morbidity, and mortality in the united states. hf is the primary diagnosis for hospital discharge in \~1 million and a secondary diagnosis in \~2 million hospitalizations annually in the us. in fact, inpatient admissions account for more than half of hf healthcare expenditure. however, data from several registries over the last three decades has failed to see use of these evidence- based therapies at levels noted in clinical trials, despite aggressive guideline recommendations and promotion by thought leaders in the field. it remains unclear as to why many patients with hf reduced ejection fraction (hfref) are not on evidence-based therapies especially post hospital discharge and why the percentages are consistent across national registries over time. whether the gap between clinical trial use and real-world practice is due to a lack of knowledge or providers making individualized decisions about their patients is unclear. a simple way to test this hypothesis is to examine whether electronic health record (ehr) based "best practice advisories" (bpas) can increase use of evidence based therapies. if found to be effective, these low cost interventions can be rapidly applied across large healthcare systems. the goal of this trial is to determine the effectiveness of a bpa alert system that informs providers about evidence-based medical therapy for the treatment of hfref versus usual care (no alert) in the inpatient setting.

Eligibility criteria:
inclusion criteria: * adults ≥18 years admitted to a hospital within the yale new haven hospital system (either yale new haven hospital, st. raphael's campus, greenwich hospital, or bridgeport hospital). * have hfref defined as: 1. nt-pro-bnp \>500 pg/ml within 24 hours of admission 2. on iv loop diuretic within 24 hours of admission 3. left ventricular ejection fraction ≤40% (most recent) exclusion criteria: * patients within 48 hours of admission * patients in the intensive care unit * patients on hospice service * patients receiving intravenous milrinone * patient on npo (nothing by mouth) order * patients on all evidence based medical therapy for hfref (on all 4 classes of evidence based medical therapy: beta-blockers, acei/arb/arni, mra, sglt2i) * opted out of medical record research
clinical utility and safety of pramlintide in subjects with type 1 and type 2 diabetes mellitus

Conditions: Type 1 Diabetes Mellitus; Type 2 Diabetes Mellitus

Summary: this open-label, multicenter study is designed to investigate the clinical utility and safety of pramlintide treatment in subjects with type 1 and type 2 diabetes who are failing to achieve the desired level of glycemic control using insulin therapy.


Eligibility criteria:
inclusion criteria: * the subject has a clinical diagnosis of type 1 diabetes mellitus requiring treatment with insulin for a minimum of 6 months at screening; -or- the subject has a clinical diagnosis of type 2 diabetes requiring treatment with insulin with or without oral antidiabetic agents for a minimum of 6 months at screening. * the subject has a hba1c of 7.0% to 11.0% at screening.

Keywords: diabetes amylin symlin pramlintide acetate
intra-ocular pressure and ventilation

Conditions: Pneumoperitoneum

Summary: background: positive pressure pneumoperitoneum (pp) may involve adverse pathophysiological changes, including increased intra-thoracic and ocular pressure, when combined with standard ventilation. high frequency jet ventilation (hfjv) was reported to reduce the adverse cardiovascular effects during laparoscopic cholecystectomy. aim: to study the effects of hfjv on intra-ocular pressure changes (reflecting intra-cranial pressure) during laparoscopic surgery under pp.

patients and methods: the investigators studied 2 groups of patients electively scheduled for laparoscopic cholecystectomy. the study group included 10 patients that were ventilated by high frequency jet ventilation (hfjv). in the control group (16 patients) the investigators used the standard intermittent positive pressure ventilation (ippv). both groups were matched according to clinical and hemodynamic parameters. intra-ocular pressure was measured by a senior ophthalmologist that was blinded to the ventilation technique. laparoscopic surgery was done as usual, and the intra-peritoneal pressure was automatically set on 14 mmhg. statistical significance was considered whenever p value was less than 0.05. the investigators anticipate that the use of hfjv during laparoscopic operations under pp may prevent increased intra-ocular pressure that accompanies increased intra-abdominal pressure under conventional ventilation (ippv).

Eligibility criteria:
inclusion criteria: * patients undergoing elective laparoscopic cholecystectomy exclusion criteria: * ophthalmologic and severe cardiopulmonary diseases
aiming towards evidence based interpretation of cardiac biomarkers in patients presenting with chest pain using point of care assays

Conditions: Acute Coronary Syndrome

Summary: the aim of the current study is to perform a rct comparing safety and efficiency of a standard care (in-line with current esc recommendations) to an algorithm that utilize a poc troponin tests for bedside measurement, the instruments could be located in the ed and return results in few minutes.

ischemic coronary artery disease is an important health challenge and a common cause of death worldwide. patients with symptoms suggestive of acute coronary syndrome are frequently referred to the emergency department (ed) and impose a high work-load on hospitals. since 2009, high-sensitivity cardiac troponin (hs-ctn) assays have become a crucial ed tool for differentiating between patients with and without non-st-elevation myocardial infarction (nstemi). accordingly, the european society of cardiology (esc) recommends 0-1 hour algorithms that use hs-ctn for rule-out and rule-in of nstemi. additionally, the clinical suspicion of acute coronary syndrome (acs) or other life-threating conditions must be low. unfortunately, these algorithms have been difficult to implement into routine and clinical practice, and are only used by a limited number of hospitals due to lack of randomized clinical trials and practical obstacles, including turnaround time for troponins. the aim of the current study is to perform a rct comparing safety and efficiency of a standard care (in-line with current esc recommendations) to an algorithm that utilize a poc troponin tests for bedside measurement, the instruments could be located in the ed and return results in few minutes.

Eligibility criteria:
inclusion criteria: patients \> 17 years who are referred to the emergency department of haukeland university hospital with chest pain suspect of acs exclusion criteria: 1. stemi (ecg criteria) 2. patients without stemi who are immediately transferred to cardiac catheterisation lab (due to heart failure, arrhythmia etc.) without possibility for blood sampling 3. patients admitted from nursing homes 4. patients transferred from other hospitals (e.g. for pci treatment) 5. less than 2 months life expectancy from comorbid clinical conditions 6. not possible to provide informed consent due to cognitive impairment, language problems or other reasons
acute effects of dairy and meat proteins on bone metabolism and metabolic profile

Conditions: Obesity; Bone Metabolism

Summary: the purpose of this randomized, controlled, cross over single meal study is to investigate the metabolic effects of a breakfast rich in dairy proteins and to determine biomarkers for their intake. the results from this project will increase our knowledge about nutritional value of dairy proteins, which is necessary to decide whether dairy products can be recommended for prevention of weight related bone loss.


Eligibility criteria:
inclusion criteria: * healthy males and females between 18 and 50 years * bmi 25-40 exclusion criteria: * physical activity more than 10 hours weekly * smoking * diagnosed osteoporosis in at least one parent * dietary supplements and vitamin pills (during the study and 2 months before the start) * vegetarians and vegans * lactose intolerant * women who are pregnant, breastfeeding or post-menstrual * regular intake of medication * chronic diseases (including osteoporosis, cancer, diabetes, cardiovascular disease and mental disorders) * participation in other clinical trials that could affect the test results * donation of blod within 3 months before intervention start * hypersensitivity to paraaminobenzoic acid (paba) * not able to comply with the procedures established by the protocol

Keywords: obesity adults bone metabolism metabolic profile dairy protein meat protein
restore calcium alginate dressing, silver vs aquacel ag in the treatment of critically colonized venous leg ulcers

Conditions: Venous Ulcer; Infection

Summary: calcium alginate dressings with silver have been found to be safe and effective for use for leg ulcers. the primary objective is to compare restore calcium alginate dressing, silver to aqualcel ag dressing on the following parameters: no further progression toward infection (bioburden), ease of application and removal, and percent progression to closure. the secondary objective is to obtain photographic documentation of the leg ulcers during the course of the study.


Eligibility criteria:
inclusion criteria: 1. is 18 years or older; male or female. 2. previous diagnosis of venous insufficiency proven by a positive venous duplex with reflux. 3. has a venous ulcer with a wound area between 5 cm2 - 40 cm2. 4. has an ankle brachial index (abi) \>0.8. 5. has a venous ulcer with duration less than 24 months. 6. has a venous ulcer which is critically colonized (not infected) based on the lazareth study model. ulcers are considered to be critically colonized if at least three of the five following signs are present: severe spontaneous pain between two dressing changes,perilesional erythema,local edema,malodour,heavy exudation 7. is currently using profore as their standard of care. 8. has not received antibiotics for 6 weeks prior to enrollment. exclusion criteria 1. has an allergy to one of the components of the dressings (calcium alginate, hydrocolloid \[carboxymethylceullose\], silver). 2. is currently on antibiotics. 3. has a negative venous duplex. 4. is unable to tolerate 4 layer compression. 5. is unable to continue contact with the investigator for a period of at least two weeks. 6. is unwilling or unable to comply with the study protocol.

Keywords: leg ulcer infection closure wound dressings