Kornimate/medical-research-clean huggingface dataset:
study to evaluate neuromodulation subject experience with contemporary spinal cord stimulation (scs) modalities for chronic pain

Conditions: Pain, Intractable; Pain, Chronic

Summary: medtronic, inc. is sponsoring the sense scs clinical study, a prospective, multi-center, post-market, non-randomized, observational study with a hybrid decentralized model of execution, utilizing a mobile application for the collection of patient reported outcomes (pros). the purpose of the study is to evaluate workflow of a mobile application for collection of pros and to gather data on patient experience with spinal cord stimulation therapy.


Eligibility criteria:
pilot phase inclusion criteria: 1. 18 years of age or older 2. a clinical decision was made for the patient to receive a commercial medtronic scs system (trial and implant) limited to the components for an on-label indication prior to enrollment in the study. note: vectris™ surescan™ mri 1x8 subcompact and specify™surescan™ mri 2x8 leads are not eligible system components 3. able to differentiate between pain associated with the indication for scs implant and other types of pain, as determined by the investigator or designee 4. willing and able to use a personal smart phone for study surveys. note: all subjects participating in the study must be willing to download the insightpro™ clinical trial app and maintain current software updates on their own smart phone. 5. willing and able to provide signed and dated informed consent in english 6. willing and able to comply with all study procedures and visits pilot phase exclusion criteria: 1. any active implantable neuromodulation device or system (e.g., peripheral nerve stimulation, sacral neuromodulation) 2. currently participating, or plans to participate, in another investigational study or has a planned major medical procedure that may interfere with study procedures or confound study results, as determined by the investigator or designee, unless documented pre-approval is provided by the sponsor 3. major untreated or refractory psychiatric comorbidity or other progressive disease (e.g., neurodegenerative disease, heart failure, cancer) that may confound study results, as determined by the investigator or designee 4. serious drug-related behavioral issues (e.g., alcohol dependency, illegal substance abuse), as determined by the investigator or designee 5. pregnant or planning on becoming pregnant 6. involved in an injury claim under current litigation, beneficiary of an injury claim, or receiving worker's compensation 7. patients with buried lead trials/implants will be excluded from this study
pk study of yh22162 fdc compared to combination of twynsta and hygroton

Conditions: Hypertension

Summary: this is a randomized, open-label, single-dose, 2-treatment, 2-period, 2-sequence crossover design.

this is a 2 by 2 cross-over study to evaluate pharmacokinetics of yh22162 fdc compared to reference twynsta and hygroton co-administered in two groups enrolling healthy adult male subjects under fasting conditions. subjects will be admitted to the clinic in the evening before day 1. all subjects will receive a single oral dose of yh22162 fdc or twynsta and hygroton co-administered in the morning on day 1. all the subjects will remain in the clinical unit until completion of all assessments on day 2 including collection post-dose pk sample. subjects will return to the clinic for pharmacokinetic samples at scheduled time. the two treatment periods will be separated by a washout period.

Eligibility criteria:
inclusion criteria: 1. healthy male and female with a body mass index(bmi) between 18.5 and 25 kg/m2 2. who has not suffered from clinically significant disease 3. provision of signed written informed consent exclusion criteria: 1. history of and clinically significant disease 2. a history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs. 3. administration of other investigational products within 3 months prior to the first dosing. 4. volunteers considered not eligible for the clinical trial by the investigator (study doctor) due to reasons including laboratory test results, ecgs, or vital signs. 5. sitting blood pressure meeting the following criteria at screening: 150 ≥ systolic blood pressure ≤100 (mmhg) and 100 ≥ diastolic blood pressure ≤ 60 (mmhg)
fluid coloading and the incidence of hypotension

Conditions: Complications; Cesarean Section; Anesthesia; Adverse Effect, Spinal and Epidural; Other Fluid Overload

Summary: this study was conducted to evaluate the effects of rapid crystalloid (lactated ringer's solution) or colloid (hydroxyethyl starch; hes) cohydration with a second intravenous access line on the incidence of hypotension and ephedrine requirement during spinal anaesthesia for caesarean section.

background: spinal anaesthesia for caesarean delivery is often associated with hypotension. this study was conducted to evaluate the effects of rapid crystalloid (lactated ringer's solution) or colloid (hydroxyethyl starch; hes) cohydration with a second intravenous access line on the incidence of hypotension and ephedrine requirement during spinal anaesthesia for caesarean section. methods: we studied 90 women with uncomplicated pregnancies undergoing elective caesarean section under spinal anaesthesia. intravenous access was established in all with two peripheral intravenous lines, the first being used for the baseline volume infusion. immediately after induction of spinal anaesthesia, lactated ringer's solution (group l) or hes (group c) infusions were started at the maximal possible rate via the second line in groups l and c respectively. the third group (group e) patients received lactated ringer's solution at a 'keep vein open' rate to maintain the double-blind nature. the incidence of hypotension, ephedrine requirements, total amount of volume and side effects were recorded.

Eligibility criteria:
inclusion criteria: * elective caesarean section under spinal anaesthesia exclusion criteria: * significant coexisting disease such as; pre-eclampsia and hepato-renal disease, * pregnancy preinduced hypertension, * being in active labour or requiring emergency caesarean section, * any contraindication to regional anaesthesia such as local infection or bleeding disorders.

Keywords: anaesthesia spinal ephedrine fluid therapy hypotension
quality register for geriatric psychiatry

Conditions: Geriatric Disorder; Depression

Summary: qualgep (kvalap) is a quality register in viken research network for geriatric psychiatry. the objectives of the register are to enhance our knowledge of old persons with severe psychiatric disorders, and to secure an optimal medical evaluation, treatment and care for these patients. the data in the register will be used for quality assurance and for research. aims: * quality assurance * further development of our diagnostic and screening tools * contributing to improving the treatment, with and without drugs * contributing to improving the dialogue and collaboration between primary healthcare and hospitals

data collected: * demographic data * previous and present disorders and use of drugs * data from relatives regarding: * the patient's cognition * psychiatric health * behaviour * activities of daily living * the stress and care burden of relatives * tests of cognitive functions * methods and duration for treatment * transfer to primary healthcare * possible readmissions

Eligibility criteria:
inclusion criteria: * patients submitted to geriatric psychiatry units and their relatives who sign the consent form exclusion criteria: * patients and relatives who refuse to sign the consent form

Keywords: geriatric psychiatry quality register quality improvement quality control research elderly patients with psychiatric disorders
evaluating the electro magnetic interference of using tablet and smart phone on leadless pacemaker (micra)

Conditions: Bradycardia, Atrial Tachyarrhythmia

Summary: the purpose of this study is to evaluate the effects that electromagnetic field exposure from using a tablet and smart phone have on a leadless pacemaker (micra device).

with advancement in technology, people are exposed to new sources of electromagnetic field like tablets and smart phones. there are magnets in smart phones and tablets that could affect the functions of pacemakers. the main purpose of this study is to evaluate the effects of electromagnetic field exposure from using a tablet and a smart phone with participants that have a leadless pacemaker (micra device) implanted inside them. participants will be asked to report any symptoms that they experience during the testing.

Eligibility criteria:
inclusion criteria: * patients enrolled in micra study and micra ca study at emory university hospital and emory midtown hospital * able to consent exclusion criteria: * patients not enrolled in micra study and micra ca study at emory university hospital and emory midtown hospital * children and vulnerable populations

Keywords: bradycardia atrial tachyarrhythmia smart phone tablet
evaluation on the effect of acupuncture and neuromuscular electrical stimulation on mechanical ventilation patients

Conditions: Respiratory Insufficiency Requiring Mechanical Ventilation

Summary: acupuncture is a treatment intervention used globally for a wide variety of disorders. its efficacy has been established over the course of 3000 years, originating in asia and diversifying worldwide.the scientific basis for acupuncture remains unclear. nonetheless, acupuncture releases neurochemical substrates, such as endorphins, serotonin, and norepinephrine.acupuncture is considered to be a safe treatment when applied by a certified acupuncturist.acupuncture has already been deployed in the treatment of sepsis or muscle weakness.studies have revealed that acupuncture significantly improved grip strength and respiratory muscle strength in chronic obstructive pulmonary disease participates.neuromuscular electrical stimulation (nmes) is an alternative to mobilize and exercise because it does not require active patient participation and can be used on bedridden patients.the investigators designed a study to compare the effects of acupuncture, electroacupuncture, and neuromuscular electrical stimulation on mechanical ventilation patients with weaning difficulties


Eligibility criteria:
inclusion criteria: * prolonged mechanical ventilation duration (\>72 h) * stable oxygen saturation, fraction of inspired oxygen≤55%, and positive end expiratory pressure (peep)≤8 cmh2o * dose of dopamine\<10 μg/kg/min and dose of epinephrine\<0.4 μg/kg/min; * mean arterial pressure\>75 mmhg and urine output\>1 ml/kg/h * good healing of the incision after surgery; * normal cognitive function * no history of chronic mental illness or chronic obstructive pulmonary disease exclusion criteria: * inability to perform physical activities * long-term mv prior to admission * neurological comorbidities involving muscles * irreversible disorders with a 6-month mortality rate of\>50% according to acute physiology and chronic health evaluation ii (apacheii) * unsound limbs or unstable fractures * administration of glucocorticoids (prednisone or other corticosteroid dose equivalents\>20 mg/day) for at least 20 days prior to admission * cardiopulmonary resuscitation before admission to the icu * radiotherapy or chemotherapy within the previous 6 months * presence of comorbidities, including acute myocarditis, deep venous thrombosis/embolism, and cerebrovascular accident * patients with implanted pacemakers or defibrillators * pregnancy and lactation patients * patients with active bleeding or bleeding tendency * skin infection or injury at the acupuncture site

Keywords: respiratory failure weaning difficulty
prevalence of heavy menstrual bleeding in female population living in beijing

Conditions: Menorrhagia

Summary: the purpose of the study is to estimate the prevalence of heavy menstrual bleeding (hmb) in females aged between 18 and 50 years old living in bejing.

this study is an observational, cross-sectional study. a representative sample of 2800 eligible women with different occupations such as farmers, service providers, workers, professional specialists, students and civil servants will be recruited. a cluster sampling method with probability proportional to the distribution of occupation in women in beijing will be used. demographic data will be collected by questionnaire. menstrual bleeding will be evaluated by pictorial blood loss assessment chart (pbac). according to the international definition of hmb, a pbac score more than 100 is considered as hmb.

Eligibility criteria:
inclusion criteria: * females aged between 18 and 50 years (inclusive) * stay in beijing for more than 6 months * signed icf was obtained exclusion criteria: * not achieve the menarche * with the last menstruation more than one year ago * experienced amenorrhea, currently take hormone therapy to induce menstruation * had undergone a hysterectomy * currently breastfeeding a baby * being pregnant

Keywords: prevalence menorrhagia
renal sympathetic denervation in moderate to severe chronic kidney disease

Conditions: Hypertension; Chronic Kidney Disease

Summary: a pilot, single-center, prospective, interventional study. the objective is to demonstrate that catheter-based renal denervation using carbon dioxide renal angiography in patients with moderate to severe chronic kidney disease can be performed for treatment of uncontrolled hypertension.

renal sympathetic denervation has been shown to be safe and effective in patients with uncontrolled hypertension and estimated glomerular filtration rate (egfr)\>45 ml/min per 1•73 m². however, the safety and efficacy of this has not been studied in patients with more severe renal impairment. the investigators aim to examine safety and efficacy of renal denervation (rdn) in patients with egfr between 44 and 15 ml/min/1.73 m2 (ckd 3b \& 4) in a pilot study which may be a precursor of a large observational study in the future. moreover, the current imaging protocol and procedure protocol for renal sympathetic denervation requires the use of iodinated contrast, which can have deleterious effects on renal function. the investigators have a proven track record for the use of carbon dioxide angiography in renal artery intervention. the investigators would like to use carbon dioxide angiography in this study to minimize contrast induced deterioration in renal function in this cohort which may again be a precursor of a farther larger study.

Eligibility criteria:
inclusion criteria: * patients aged 18-75 years with a clinic systolic blood pressure of 140 mm hg or more despite compliance with three or more antihypertensive drugs, * egfr\ 15 ml/min per 1.73 m². exclusion criteria: * egfr \<15 ml/min per 1.73 m², * type 1 diabetes, * substantial stenotic valvular heart disease, * pregnancy or planned pregnancy during the study, * a history of myocardial infarction, unstable angina, or cerebrovascular accident in the previous 6 months.

Keywords: carbon dioxide angiography renal sympathetic denervation uncontrolled hypertension chronic kidney disease
autologous mesenchymal stromal cell therapy in heart failure

Conditions: Congestive Heart Failure

Summary: it is a single centre, randomised controlled study of the effect of noga-guided direct intramyocardial injection of mesenchymal stromal cells on the development of new myocardium and blood vessels in patients with heart failure. stem cells will be obtained from the bone marrow and culture expanded for 6 - 8 weeks before injected into the myocardium. the patients will be followed with safety, clinical, mri and ct endpoints for 1 year.

the primary objective is to investigate the regenerative capacity of direct intra-myocardial injection of mesenchymal stromal cells in patients with reduced left ventricular ef (≤45%) and heart failure nyha 2-3. a total of 60 patients with will be enrolled in the study and randomised 2: 1 to cells or placebo (saline). the patients will be followed for 12 months. the primary endpoint is changes in left ventricle end-systolic volume (lvesv) at 6 months follow-up. the secondary endpoints are changes in left ventricular ejection fraction (lvef), end-diastolic volume and end-systolic mass at 6 months follow-up. other secondary endpoints are nyha, ccs, kansas city cardiomyopathy questionnaire (kccq), 6 min walking test, and major adverse events endpoints: all-causes death, cardiovascular death, and hospitalization for worsening heart failure and mi at 12 months follow-up.

Eligibility criteria:
inclusion criteria: * ef \< 45 % * nyha 2 - 3 exclusion criteria: * acute coronary syndrome within last 6 weeks. * pregnancy * fev1 \<1.0 * cancer * any severe disease which could interfere with the treatment or the outcome

Keywords: heart failure stem cell mesenchymal stromal cell mesenchymal stem cell
a study of egb 761® (tanakan®) in dementia of alzheimer type onset in patients suffering from memory complaints

Conditions: Memory Disorders, Age-Related; Retention Disorders, Cognitive

Summary: the purpose of this study is to determine whether tanakan® is effective at slowing the progression from memory complaint to dementia of alzheimer's type.


Eligibility criteria:
inclusion criteria: * spontaneously reporting a memory complaint * short anxiety battery test \< 6, (only if patient screened at gp site) * geriatric depression scale \< 15 * mini-mental state (mms) \> 25 in gp's office (in hospital site mms is done as complementary scale) exclusion criteria: * objective memory impairment * clinician rated dementia staging system \> 0.5 * mini-mental state \< 25 * dementia, past history of seizures, parkinson disease
agouti-related peptide (agrp) in healthy mothers and mothers with preeclampsia and their offspring

Conditions: Preeclampsia

Summary: the study is focused on the investigation of possible associations between plasma/serum levels of agouti related peptide (agrp) and its genetic background in healthy women with physiological pregnancy (non-preeclamptic) and women with preeclampsia, in the postpartum period, and in their offspring.

the study is focused on investigation of possible genotype-phenotype interactions of agouti-related peptide (agrp) in postpartum non-preeclamptic women and preeclamptic women and in their offspring.

Eligibility criteria:
inclusion criteria: * for preeclampsia: * development of hypertension after the 20th week of pregnancy (systolic blood pressure, ≥140 mmhg; and/or diastolic blood pressure, ≥90 mmhg; measured at rest on two consecutive occasions at least 24 h apart) in previously normotensive women, and the onset of proteinuria (\>300 mg of urinary protein/l over 24 h) * single-fetus pregnancy * age range 18-35 y * no preconceptional history of hypertension * for mother with physiological pregnancies: * uncomplicated * spontaneous conception * single-fetus pregnancy * age range 18-35 y * spontaneous uncomplicated delivery * no history of preconceptional hypertension exclusion criteria: * for preeclampsia: * multiple pregnancy * preeclampsia superimposed to chronic hypertension preceding pregnancy * kidney disease * fetal malformations * for mothers with physiological pregnancies: * in vitro fertilization * fetal malformations * multiple pregnancy * events of bleeding

Keywords: preeclampsia agouti-related peptide intrauterine growth birth weight intrauterine growth restriction due to preeclampsia
effects of complex decongestive therapy on proprioception, balance and tactile sense

Conditions: Lymphedema of Leg; Sensitisation; Balanced; Therapy-Associated Cancer

Summary: the aim of this study is to investigate the effects of complex decongestive physiotherapy (cdp) on propriseception, balance and sensation in patients with secondary lymphedema that develops in the lower extremities after cancer surgery.


Eligibility criteria:
inclusion criteria: * being between the ages of 18-65 * having unilateral lymphedema in the lower extremity secondary to cancer surgery exclusion criteria: * having bilateral lower extremity lymphedema * having an active infection * having a mental cognitive disorder * being at a level where communication and cooperation cannot be established * situations where manual lymphatic drainage is contraindicated (such as severe heart failure and/or uncontrolled rhythm disorder, uncontrolled hypertension, pregnancy, presence of thrombus, active infection) * presence of metastasis
physical activity and smell trainings to help individuals with coronavirus disease (covid-19) recover from persistent smell and taste impairments - a pilot study

Conditions: Covid19

Summary: the primary objective of this study is to identify efficient treatments to help those with chemosensory losses due to coronavirus disease (covid-19). to do so, 75 participants, men and women, aged 18 years old and above living in canada will be recruited. participants will be randomly assigned to one of the following three groups (25 in each group): physical activity, smell training, and control. here is a quick summary of what participants in each group will have to do remotely during 12 weeks: * physical activity group: engage in physical activity for 12 weeks and wear a smart watch daily. attend a 15-minute virtual meeting with a research professional every two weeks, that is six times during the 12 weeks. * smell training group: smell four odors twice a day for 12 weeks and evaluate their sensory perceptions via an online survey sent for each session specifically. attend a 15-minute virtual meeting with a research professional every two weeks, that is six times during the 12 weeks. * control group: not change their usual routine for 12 weeks. complete an online 15-minute follow-up questionnaire every two weeks, that is six times over the 12 weeks. in addition, within each group, 10 individuals from montreal, quebec will be randomly selected to complete additional assessments in the laboratory. to distinguish this subgroup, it is called the "in-person subgroup." participants will be assessed at the beginning of the intervention period, immediately after the intervention period, and 12 weeks after the end of the intervention period. the assessments include various questionnaires on sociodemographic data, physical and mental health, lifestyle habits, sensory dysfunction, nutritional preferences, as well as self-administered smell and taste tests sent by mail. the in-person subgroup only will have to do the following additional assessments: smell and taste tests using special equipment (olfactometer, gustometer, electroencephalogram) and online questionnaires on food intake for the day.


Eligibility criteria:
inclusion criteria: * be 18 years old and above * have had covid-19 diagnosed by laboratory tests * have recovered from covid-19 * have persistent problems with your sense of smell and/or taste due to covid-19 in the past 3 months or more (priority to participants with only this complication) * have access to a computer and internet connection and be able to download the zoom application * have access to a smart phone ("texting" and bluetooth) * live in canada exclusion criteria: * do 150 minutes or more of physical activity that makes you out of breath every week * have limitations related to a training aiming at improving the sense of smell * have physical limitations that may limit physical activity * be part of another study that may influence the current study

Keywords: olfactory training physical activity chemosensory impairments persistent smell impairment