Kornimate/medical-research-clean huggingface dataset:
enable i long-term follow-up study

Conditions: Aortic Valve Stenosis; Aortic Valve Insufficiency

Summary: this was a prospective, non-randomized, multi-center, non-interventional post-market study. the study was a post-market long-term follow-up study based on the same cohort of patients (148 patients) enrolled in a previous investigational study from march 2007 to december 2009 (ats 3f enable™ aortic bioprosthesis model 6000, number s2005) involving 10 european sites. patient follow-up took place on a yearly basis up to 10 years after the implant/enrollment. the primary objective of this study was to evaluate the safety and effectiveness of the medtronic ats enable aortic bioprosthesis during long-term follow-up. as this was an observational study, safety and efficacy data were summarized and described. there was no statistically powered study hypothesis.


Eligibility criteria:
inclusion criteria: * patients who were enrolled and implanted for the ats 3f enable™ aortic bioprosthesis model 6000, number s2005 * patient willing to sign the new data release form (drf) or patient informed consent (pic) for the post-market study (what is applicable for the study due to local requirements and regulations) exclusion criteria: * ats 3f enable™ aortic bioprosthesis model 6000 was explanted * patient died * patient lost to follow-up * patient withdrew consent

Keywords: aortic valve replacement aortic valve bioprosthesis
efficacy of mini sling versus transobturator tape in surgical management of women with stress urinary incontinence

Conditions: Stress Urinary Incontinence

Summary: to compare the efficacy of mini sling against transobturator tape for surgical management of women with stress urinary incontinence.

urinary incontinence is defined as involuntary loss of urine and is divided into subtypes according to symptoms. these subtypes include sui, in which urine loss occurs during exertion, physical exercise, coughing or sneezing; urgency urinary incontinence (uui), in which urine loss is associated with urinary urgency; and mixed urinary incontinence (mui), which is characterized by the association of stress loss with urgency. there are non-surgical treatments (e.g., lifestyle modifications, pharmacotherapy, physiotherapy and vaginal pessary) and surgical treatments. as regards sling use, it was found that mid urethral slings techniques achieved high cure rates in women with sui and have become the mainstay for surgical treatment of sui in women over the last 2 decades. one of the modalities of such procedures is the transobturator mid urethral tape (tot). it was introduced to minimize the complications of the previous retropubic tapes, which include injury to the bladder, major vessels, and bowel. in an effort to maintain efficacy while eliminating some of the side effects, a new generation of tapes has been developed, called single incision tapes or mini-slings. they are designed to be shorter in length than standard mid-urethral slings and do not penetrate the tissues as deeply as standard slings.

Eligibility criteria:
inclusion criteria: * women with a medical history of sui * mixed urinary incontinence (mui) in which sui had to be the dominating symptom * confirmed by a positive standardized cough test with 300 cm3 water in the bladder exclusion criteria: * women will be excluded if they are aged \>60 years * had previous incontinence or pelvic organ prolapse surgery * planned or present pregnancy * residual urine volume\>100 ml * previous pelvic irradiation * neurological conditions such as multiple sclerosis * current treatment with corticoids * history of genital or abdominal cancer or a pelvic mass.
study to assess rifaximin soluble solid dispersion (ssd) for the delay of encephalopathy decompensation in cirrhosis

Conditions: Hepatic Encephalopathy

Summary: study rnlc3132 is a phase 3, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of rifaximin ssd-40mg ir for the delay of the first episode of overt hepatic encephalopathy (ohe) decompensation in liver cirrhosis, defined by the presence of medically controlled ascites.


Eligibility criteria:
key inclusion criteria: * diagnosis of liver cirrhosis with medically controlled ascites (\>30 days) not requiring therapeutic paracentesis (could have had paracentesis in the past). * conn (west haven criteria) score of \< 2. * mini-mental state examination (mmse) score \> 24 at screening. * ≥ 18 and ≤ 85 years of age. key exclusion criteria: * active covid-19 that is unresolved * history of sbp * history of evb or aki-hrs within 6 months * history of ohe episode (conn score ≥ 2)
physiotherapy intervention in climacteric women with dyspareunia

Conditions: Dyspareunia

Summary: aim: to evaluate the effectiveness of physical therapy intervention techniques in the improvement of dyspareunia in climacteric women. study design: this is a randomized controlled trial.

search location: menopause and sexuality clinic of the department of obstetrics and gynecology and clinical research center, hospital de clínicas de porto alegre (hcpa). patients or participants: the recruited patients may not be vaginal atrophy (cytology-hormone test) and must provide the diagnosis of dyspareunia for more than six months being confirmed by one of the investigators through the pain score above grade 3 (visual analog pain scale) visual inspection, palpation and a questionnaire about the duration and location of pain. intervention and measures: consist of evaluation of the pelvic floor muscles (oxford scale and perfect), myoelectric assessment (electromyography), quality of life (cervantes scale), sexual function (fsfi), level of depression (beck scale) and pain (visual analog pain scale) before and after physical therapy intervention. expected results: to estimate the effectiveness of pelvic floor training techniques with physical therapy in women with dyspareunia.

Eligibility criteria:
inclusion criteria: * dyspareunia complaint for at least six months * visual analog scale of pain above 3 * trophic vagina exclusion criteria: * vaginal atrophy * neurological disorders * lack of cognition and understanding * urinary tract infection and / or genital infections * prolapse grade 2 and 3 * severe systemic disease * performing physical therapy

Keywords: dyspareunia pelvic floor muscles women
medico-economic evaluation of preoperative cerebral oximetry monitoring during carotid endarterectomy

Conditions: Internal Carotid Stenosis

Summary: in france, in 2007, 17 000 patients underwent carotid endarterectomy. the risk of having an ipsilateral postoperative stroke after carotid endarterectomy remains at 1-1.5%. there is no consensus concerning the best cerebral monitoring and hemodynamic optimisation during carotid cross-clamping. the objective of this prospective, multicentric, double-blinded and randomized study is to evaluate the interest of continuous cerebral oximetry monitoring by invos™ cerebral oximeter to direct the hemodynamic optimisation during carotid endarterectomy and reduce the new-onset of postoperative radiological (mri) ischemic lesions. a cost/effectiveness analysis will be conducted to estimate the impact of this monitoring versus standard care on direct and indirect postoperative costs during 120 days. a substudy will evaluate the effect of this monitoring on neurocognitive outcome and on a serum marker of brain injury, protein s-100b

after consent, patients will be randomized in two groups: one group with continuous per operative cerebral oximetry monitoring associated with hemodynamic optimisation algorithm (excluding norepinephrine) if cerebral oximetry decrease more than 15% under the preoperative baseline; the second group is continuously monitored with cerebral oximeter but this latter is blinded to the medical team, the alarm switch off , and patients are managed with the standard care of the centre. all patients have a preoperative and a postoperative diffusion cerebral mri to detect new onset of cerebral ischemic lesion. the amount and the volume of cerebral ischemic lesions will be scored to compare groups. quality of life as well as direct (medical and nonmedical) and indirect costs were collected using questionnaires during the 120 postoperative days. a substudy including 200 patients will be conducted to compare the two groups concerning postoperative protein s-100b level and a composite score of neurocognitive tests (measured pre- and postoperatively) the trial will be conducted according to gcp

Eligibility criteria:
inclusion criteria: * patients (male-female) over 18 y.o. * presenting an internal carotid stenosis requiring surgery * mini mental state examination \>24 during preoperative examination * informed written consentexclusion criteria: exclusion criteria: * severe renal failure or requiring dialysis * liver failure or cirrhosis (child class ≥ b) or prothrombin activity\<50% * heart failure (nyha ≥ iii), left ventricular ejection fraction \< 40%, acute coronary syndrome, * associated surgery * pregnancy * contraindication to mri * history of allergy to modified gelatine or starch * history of allergy to adhesive part of electrode

Keywords: with surgical indication cerebral oximetry carotid endarterectomy mri ischemic lesion cost/effectiveness analysis neurocognitive outcome protein s-100b
a high resolution pharmacokinetic/pharmacodynamic model of propofol in morbidly obese subjects

Conditions: Morbid Obesity

Summary: this study will determine how morbid obesity affects the distribution and metabolism of the drug propofol. the investigators hypothesize that propofol will be distributed and metabolized differently in morbidly obese subjects as compared to normal weight subjects.


Eligibility criteria:
inclusion criteria: * adult age (ages 18-70) * body mass index greater than 40 or between 20-25 * american society of anesthesiologists class i, ii, or iii * undergoing elective surgical procedure requiring general anesthesia exclusion criteria: * evidence of cardiovascular or pulmonary disease * kidney or liver dysfunction * drug allergy to propofol * history of difficult airway * on prescribed or over the counter anxiolytics, antipsychotics, or sleeping aids * unable to speak or understand english

Keywords: pharmacokinetics pharmacodynamics
comparison of peng block and ficb in hip fracture patients

Conditions: Hip Fractures; Regional Anesthesia

Summary: fascia iliaca compartment block (ficb) has been considered the block of choice for patients with hip fracture. however, pericapsular nerve group (peng) block, one of the relatively newly-developed blocks, could be also used for analgesia in patients with hip fracture. since peng block could block the accessory obturator nerve, peng block might have greater analgesic effects compared to ficb theoretically. however, the comparison of these two blocks in patients with hip fracture has not performed in clinical setting. thus, we aimed to compare the analgesic effect of peng block and ficb.


Eligibility criteria:
inclusion criteria: * asa ps 1-4 * age: ≥19 * baseline pain score (associated with hip fracture): ≥4 exclusion criteria: * patients who do not agree to participate in this study * patients with uncontrolled hypertension, hyperthyroidism, severe dementia * allergic to ropivacaine * contraindicated to spinal anesthesia due to coagulopathy, severe aortic stenosis/mitral stenosis, or active infection on lumbar region * patients who are considered ineligible with any other reason by investigators

Keywords: pericapsular nerve group block fascia iliaca compartment block hip fracture regional anesthesia dynamic pain
fecal microbiota transfer in liver cancer to overcome resistance to atezolizumab/bevacizumab (flora)

Conditions: Immunotherapy

Summary: the interventional, randomized, placebo-controlled, single blind phase ii-trial flora will assess safety and immunogenicity of fecal microbiota transfer in combination with standard of care immunotherapy in advanced hepatocellular carcinoma (hcc) in a parallel group design. subjects will be randomized 2:1 into either the fmt or placebo group.

eligible hcc patients visiting the outpatient clinics of lcch at the study sites at nct heidelberg and university medical center mannheim will be enrolled into the study after informed consent. patients undergo 2:1 randomization into either the fmt or placebo group. study lead in with a first sonographically guided tumor biopsy, if not already performed for diagnostic purposes, and a sigmoidoscopy will be scheduled within 10 days after study enrollment in an outpatient setting. start of active pharmacotherapy with a/b will begin within five working days after sigmoidoscopy. a/b administration will be administered as standard of care every 21 days. at day -3 to 0 oral vancomycin will be given 4x 250mg to the verum group. at day 0 and 21, concurrent to the first and second cycle of a/b, encapsulated fmt will be administered on the same day. at day 40-42, before the third cycle of a/b, a second biopsy of the liver lesion and a sigmoidoscopy will be performed. clinical efficacy and safety will be assessed as indicated per protocol analysis.

Eligibility criteria:
inclusion criteria: 1. age 18 years or older 2. confirmed imaging or histological diagnosis of unresectable hcc, bclc stadium c 3. ecog performance status of 0-1 exclusion criteria: 1. advanced liver cirrhosis (child-pugh score c) 2. diagnosis of immunodeficiency (e.g. hiv, immunosuppressants) 3. usage of antibiotics within 2 weeks prior enrollment

Keywords: immunotherapy fecal microbiota transfer hcc gut microbiota tumor microenvironment
healthy together program evaluation (phase 3)

Conditions: Health Knowledge, Attitudes, Practice; Overweight and Obesity

Summary: healthy together is a program that promotes the achievement and maintenance of healthy weights in children and their families.

the purpose of the phase 3 scale up project is to expand the reach and impact of healthy together (ht), by supporting the integration of the ht program into core services of organizations serving children (up to 18 years) and families, particularly those from under-served populations across diverse communities and settings in canada. the ht program offers a flexible, effective, integrated approach, relevant to multiple contexts, creating potential to become a sustainable approach to promoting healthier weights in canadian children. the objectives of the evaluation for phase 3 are to: 1. describe the effectiveness of the ht program in relation to knowledge, attitude and behavior change at the individual, family, and community level. 2. monitor quality and sustainability of ht, when offered as part of core service by organizations to meet diverse community needs and cultural contexts. 3. create an effective knowledge mobilization framework to increase practice and policy influence of ht, in collaboration with regional, provincial and national networks.

Eligibility criteria:
community partner organizations with capacity and infrastructure to implement the ht program are eligible to be implementation sites. priority is given to community organizations serving indigenous, immigrants/refugees, low income/low literacy groups, and families residing in rural communities. all sites will be required to integrate ht into their existing services. inclusion criteria for each participant group are as follows: families: ht is designed for children (up to 18 years of age) and families. children and families participating in programs offered by the partner organizations are eligible to attend ht. all interested families will be able to access the program regardless of their previous knowledge or skill level. participants do not have to be overweight/obese to participate in sessions. ht facilitators: staff members who are identified by the partner organizations, trained to implement the ht program and directly involved in ht program delivery will be eligible to participate in the evaluation. directors of partner organizations: partner organizations will be asked to identify a director (supervisor) that has administrative responsibility for overseeing the delivery of services for children/families that includes the ht program. national advisory committee (nac): members of the national advisory committee established by the bridge youth and family service society for phase 3 of this project. exclusion criteria: family members who have not participated in any of the ht sessions offered as part of on-going services provided by the partner organization.

Keywords: healthy weights health promotion scale-up family health prevention childhood obesity physical activity cooking activity family education model
the brain symphony for post-stroke rehabilitation

Conditions: Stroke

Summary: music listening intervention has made great strides in improving the condition of stroke survivors. thus, this research explores the effects of music listening intervention on post-stroke survivors during rehabilitation by using p. ramlee songs.

objective: music listening intervention has made great strides in improving the condition of stroke survivors. thus, this research explores the effects of music listening intervention on post-stroke survivors during rehabilitation by using p. ramlee songs. materials \& methods: in the first phase, surveys were conducted to determine the selection of songs to be used in the second phase. the second phase is applying music listening intervention on a small sample of 20 subjects, aged 55 years old and above. the participants were categorized into two groups: stroke survivors and healthy individuals and randomized into control group (without music) and experimental group (with music). the second phase consists of three stages. stage one is to pre-screen and select potential subjects before the experiment. the second stage aims to determine the effect of p. ramlee music on stroke survivors during their rehabilitation through augmenting their brain neuroplasticity with measurement of the mep using tms. the final stage compares the effects of mep between lesion and non-lesion areas.

Eligibility criteria:
inclusion criteria: * healthy * no history of seizures or epilepsy * able to hear well * able to attend experiment sessions without scheduling conflicts * no contraindications to undergoing tms exclusion criteria: • none

Keywords: music listening stroke rehabilitation transcranial magnetic stimulation (tms) neuroplasticity p. ramlee music
quality of life of patients over 75 yars undergoing palliative chemotherapy

Conditions: Colorectal Cancer; Pancreatic Cancer; Biliary Cancer; Hepatic Cancer; Oesophageal Cancer; Gastric Cancer

Summary: the aim of this research is to evaluate the quality of life of patients over 75 years of age undergoing palliative chemotherapy for digestive cancer. it is a non-interventional study that evaluates the quality of life before and after a cycle of chemotherapy with a composite criterion including: a standardized questionnaire "cancer specific quality of life questionnaire" (qlqc30), an assessment of autonomy by "activity of daily living" questionnaire (adl), and the number of days of hospitalization.

the number of patients undergoing chemotherapy continues to increase as well as the age of cancer patients, it is estimated that in 2050 one cancer out of two will be discovered in a person over 75 years of age. digestive cancers account for the majority of these patients, the goals of these palliative chemotherapies are to improve survival and maintain or improve quality of life. since the 2009 cancer plan, a specific geriatric onco-geriatrics organization has been set up with the creation of geriatric onco-coordination units. one of the objectives of this plan is to achieve a 5% inclusion rate of patients over 75 years of age in clinical trials. however, there are relatively few studies in patients over 75 years of age concerning quality of life, as they are often excluded from trials and survival is preferred as the primary outcome. this observational study evaluates the quality of life of patients at the time of the first chemotherapy treatment and then at the end of the first cycle of chemotherapy at 3 months by a standardized questionnaire, an evaluation of autonomy and the number of days of hospitalization.

Eligibility criteria:
inclusion criteria: * age over 75 years old * suffering from digestive cancer : colorectal, pancreatic, biliary, oesophageal, gastric * palliative cancer : not resectable, multimetastatic * decision in multi-disciplinary liaising meeting (cpr) to perform a first course of palliative chemotherapy * having received an informed consent form * understanding french language exclusion criteria: * cognitive disorders * patient benefiting from a legal protection measure * life expectancy below 1 year * not understanding french language

Keywords: digestive cancer, age other 75 years old, palliative therapy, quality of life
change of lifestyle by persons in risk of type 2 diabetes

Conditions: Type 2 Diabetes

Summary: we know that changing lifestyle can prevent type 2 diabetes. the challenge is how to help people changing their lifestyle. we have people in 2 groups: half of them is meeting in grops of 10 persons (interventiongroup), the other ones are just visiting their doctor (controlgroup).

the intervention group are meeting different healt proffesionals (nurse, doctor, eksperts on nutrition,experts on activity and experts on how to change. they have 7 meetings in groups of 10 persons over 3 months. the controlgroup are just meeting their own doctor or the doctor in the hospital 2 times a year. we tell all that small changes are making big differenses (in weight and the chanse of getting ill). everyone is told that lack of aktivity is the main reason to obesity. lack of activity also influense in whar you eat. herefore is activity in the "center".

Eligibility criteria:
inclusion criteria: diabetes risk score above 9 points. exclusion criteria: persons with diabetes, serious heart disease, cancer or psychiatric disorder. they have to speak and understand norwegian language.

Keywords: metabolic syndrome lifestyle obesity