Kornimate/medical-research-clean huggingface dataset:
esm-derived personalised feedback for women at risk of common mental disorder

Conditions: Women at Risk of Common Mental Disorders

Summary: this study aims to examine the effectiveness of experience sampling method (esm) derived personalised feedback for women at risk of common mental disorder in hong kong, in reducing individuals depressive and anxiety symptoms.

women who are at-risk for common mental disorders and have completed the online screening for jockey club mental wellness project for women (jcwow) will be recruited. this study aims to test the effectiveness of esm-derived personalized feedback in reducing symptoms of depression and anxiety using a randomised controlled trial. after given written consent, the participants will be required to undergo a 5 days baseline esm data collection (week 0). upon completion of baseline data collection, they will be randomly assigned to the intervention (esm-f), active reference (esm) or control (con) group. the participants in the intervention group will participate in an esm procedure (three days per week over a 6-week period) using through sms system (week 1 - 6). this group will receive weekly standardised feedback on personalised patterns of positive affect. the active reference group will also participate in the same esm procedure without a weekly feedback. the control group will not be required to undergo this 6-week data collection procedure. at week 7, all three groups will undergo another 5 days of post-intervention esm data collection in order to examine the naturalistic and interventional changes on the depressive symptoms. from week 8 onwards, the participants will be contacted 5 times (week 8, 12, 16, 20 and 32) via telephone to follow-up their condition. after 32 weeks, both active reference and control group will receive the report.

Eligibility criteria:
inclusion criteria: * women within the age range of 18-64 * identified as at-risk for depressive disorders (idd) using the depression subscale (scored 10 or above) in dass-21 * willing to provide written informed consent * understand cantonese and can read or write chinese * use a smartphone exclusion criteria: * those mental conditions that require other treatment priorities (e.g., major depression, suicidal risk, substance abuse, current or past episodes of psychotic disorder, personality disorders). * those medical conditions that severely limit participation, comprehension, or adherence to treatment (e.g., epilepsy, dementia, terminal medical illness). * those who are receiving structured psychotherapy or counselling.

Keywords: experience sampling method at risk depression women randomized controlled trials feedback anxiety
assessment of pelvic floor function in elderly

Conditions: Urinary Incontinence

Summary: the purpose of this study is to demonstrate the importance of functional assessment of the pelvic floor (afa) in older women, as prognostic factor for urinary incontinence (ui).

incontinence elderly assessment

Eligibility criteria:
inclusion criteria: * elderly women * urinary incontinence exclusion criteria: * cesarean surgery

Keywords: urinary incontinence pelvic floor functional evaluation
qualitative assessment of the impact of ttns on qol and participation

Conditions: Neurogenic Bladder; Urinary Retention; Urinary Tract Infections; Spinal Cord Injuries

Summary: this study through the use of semi-structured interviews or focus groups will explore the lived experience with transcutaneous tibial nerve stimulation (ttns) with neurogenic lower urinary tract dysfunction to generate user-defined themes regarding bladder function and catheter-related barriers and the daily impacts on one's life.

identify nlutd user-defined themes regarding bladder function and and the daily impacts on one's life specific aim: using iterative, semi-structured interviews or focus groups to explore the lived experience using ttns neuromodulation to generate user-defined themes regarding bladder function and the daily impacts on one's life.

Eligibility criteria:
inclusion: participated in ttns study for 1 year.

Keywords: quality of life participation barrier
comparison of intraocular pressure measurement with the novel tonovera device with other commonly used devices

Conditions: Glaucoma

Summary: we are testing the accuracy of reichert's tono-vera tonometer by comparing measurements of iop with this device and measurements with other commonly-used tonometers, including goldmann applanation and icare.

this is a comparative study between the tonovera, the gold standard goldmann applanation tonometry (gat) and an established rebound tonometry device, icare. iop measurements will be obtained using the following devices: reichert's prototype tono-vera rebound tonometer (a rebound tonometer in development), icare's ic100 rebound tonometer (a device commonly used in clinical practice), gat (a device commonly used in clinical practice). reichert's ipac handheld pachymeter (a device commonly used in clinical practice) will be used to measure the test subject's central corneal thickness (cct), measured in µm if cct is not already on file. an autorefractor keratometer (ark) (a device commonly used in clinical practice) will be used to measure necessary vision correction and corneal curvature. the ocular response analyzer (a device commonly used in clinical practice) will be used to measure corneal hysteresis. multiple iop measurements will be taken with each device on each eye for all subjects: 3 along the central cornea, 3 along the peripheral cornea, and 3 along the sclera.

Eligibility criteria:
inclusion criteria: * ability to provide signed and dated informed consent form. patients willing to comply with all study procedures and be available for the duration of the study. male or female patients aged 18 to 99 patients in good general health as evidenced by ability to come to their appointment on day of study. exclusion criteria: * patients age less than 18 years patients unable or unwilling to provide informed consent to participate in the study patients for which an accurate tonometry reading cannot be performed. this may include those with blepharospasm (lid squeezers), nystagmus, extensive corneal pathology, or contact lens wearers who cannot remove their contact lens.patients with significant scleral thinning patients with a known allergy to proparacaine or fluorescein as these are used to anesthetize and allow measurement respectively of the eye when used with the goldmann tonometer.
3rd-year post-surgical evaluation of adjacent segment disc degeneration onset in lumbar spine (spinal fusion vs. lumbar arthroplasty with disc replacement)

Conditions: Spine Surgery

Summary: the main objective of the study is to compare the onset of adjacent segment disk degeneration in two groups of patients (one "spinal fusion group" and one "lumbar arthroplasty with disc replacement" group) with each patient acting as their own control for either group under study and more than three years of follow-up.

this is a non-randomized prospective monocentric open cohort study. patients whose surgical intervention goes back to more than 3 years will be preselected from the keops database and contacted by phone. information on the study and its restrictions is delivered to the patient. the investigator organizes the inclusion visit. the patient is seen for consultation by the orthopedic surgeon (inclusion visit /end of research) ; the information notice is given to the patient who is free to ask questions about the study. the patient's consent is collected. the investigator proceeds with a clinical examination (the lasègue manoeuver), evaluates pain (evn, dn4) and administers four different questionnaires . the patient is then oriented towards the imaging department where he/she will have the benefit of and magnetic resonance imaging and also a spinal x-ray(front and profile ; roussouly classification). the patient's participation in the study ends once the examination is over. the consultation in the orthopedic department and the imaging session will be planned in such a way that they can be performed all on the same day. the study program provides for 12 months of inclusion and 4 months of data management, statistical analysis and writing up the report on the study.

Eligibility criteria:
inclusion criteria: * all patients who have given written, informed consent. * all patients covered by a health insurance scheme. * all patients aged over 18. * all patients operated with a lumbar spine disk prosthesis or vertebral arthrodesis with an anterior approach at the orthopedic, traumatology and spine surgery department of nimes university hospital, france, at least 3 years previously. * all patients who have undergone initial mri before surgery. exclusion criteria: * any patient taking part in a category 1 interventional study and in an exclusion period determined by a previous study. * any patient under legal protection, guardianship or tutorship. * any patient who refuses to sign the consent form. * any patient for whom it is impossible to give clear information. * any patient with contra-indications for magnetic resonance imaging such as an incompatible pacemaker, claustrophobia, metal apparatus or prosthetic hip. * any patient with a septic complication. * any patient with instrumentation or posterior arthrodesis.

Keywords: arthroplasty arthrodesis disc degeneration lumbar spine spinal fusion
the effect of dns therapy on asymmetry in children after surgery of congenital heart disease

Conditions: Congenital Heart Disease in Children

Summary: this thesis will examine the consequences of congenital heart disease (chd) surgery in children. the main goal of this work is to point out the possible development of late consequences after cardiac surgery in childhood (e.g. asymmetry, scoliosis, hypomobility of the spine) and to assess the effect of dns therapy on the resolution of the consequences. for patients, after an intensive three-week rehabilitation intervention, an improvement in the monitored initial parameters is expected, which would lead to an improvement in the quality of life.

as part of the diploma thesis, a study will be conducted in patients after cardiac surgery performed at the motol hospital within the children's cardiology center. the intervention will be performed in rehabilitation clinic teplice nad bečvou. the study group will include children aged 6-18 years after vsv surgery without other serious health complications. the subjects will undergo therapy according to dns for 3 weeks. therapy according to dns will take place twice a day (1x individual physiotherapy 40 minutes, 1x group 40 minutes) and will be supplemented with conventional therapy (e.g. scar care). the initial examination will be performed by a doctor and a trained physiotherapist in a blinded mode (information about which patients are undergoing the intervention will not be known). the initial examination will include imaging of the spine, ideally eos (low radiation exposure). during the initial and final examination, a trunk stabilization examination will be performed according to the dns protocol with photo documentation, the values of mip and mep oral pressures (cm h₂o) will be measured, the symmetry index will be measured using the scodiac software, the mobility of the spine will be examined (schober distance, stibor distance, otto inclination distance, thomayer distance, in cm) and the respiratory amplitudes on the chest will be measured (mesosternal and xiphosternal, in cm). the subjects will complete the sf-36 quality of life questionnaire before the start of therapy and after its completion. the parameters will be compared during the initial and final examination.

Eligibility criteria:
inclusion criteria: * children 6-18 years, surgery of congenital heart disease exclusion criteria: * any other disease

Keywords: congenital heart disease rehabilitation complication of surgical treatment postural asymmetry maximal expiratory pressure minimal expiratory pressure
st monitoring to detect acute coronary syndrome events in implantable cardioverter defibrillator patients

Conditions: Coronary Artery Disease

Summary: this is a prospective, non-randomized, multicenter, pivotal investigational device exemption (ide) study. the intent of this study is to demonstrate the safety and effectiveness of the st monitoring feature in st jude medical icd systems.

this is a prospective, non-randomized, multicenter, pivotal ide study. the intent of this study is to demonstrate the safety and effectiveness of the st monitoring feature in the fortify® st, fortify assura® st, and ellipse® st family of devices, as well as any future st jude medical devices with the same st monitoring feature capabilities. effectiveness of the device will be evaluated by analyzing the sensitivity of the st monitoring feature to detect clinical events. in addition, safety of the st monitoring feature will be evaluated by demonstrating a low percentage of patients with false positive events.

Eligibility criteria:
inclusion criteria: * eligible patients will meet all of the following: 1. have an indication for an icd implantation or pulse generator change 2. have documented coronary artery disease. documented coronary artery disease is defined as having at least one of the following present a) evidence of a prior mi on ecg and/or cardiac enzymes, b) prior revascularization (by coronary artery bypass grafting or percutaneous coronary intervention) c) angina and/or st-t wave abnormalities indicative of ischemia on exercise stress test, nuclear stress test, or echo stress test, or d) coronary artery disease diagnosed by coronary angiography. 3. willing and able to comply with protocol requirements, including keeping all required visits 4. willing to participate in the study and able to sign an irb approved informed consent form 5. be at least 18 years of age when enrolled in the study exclusion criteria: * patients will be excluded if they meet any of the following: 1. are pacemaker dependent (defined as a need for ventricular pacing ≥ 20% of the time) 2. have nyha class iv heart failure 3. have persistent or permanent atrial fibrillation 4. have a known history of intermittent bundle branch block 5. pregnant or planning a pregnancy during the study participation 6. have a life expectancy of \< 1 year due to any condition 7. are currently participating in a clinical investigation that includes an active treatment arm.

Keywords: icd indicated patients documented cad
exploratory study assessing synchronisation of egg sacs with degarelix

Conditions: Infertility, Female

Summary: the main purpose of this clinical research study is to investigate if degarelix can synchronise the growth of the egg sacs in the ovaries and if degarelix has any effect on the lining of the womb.

for the primary end-point (data collected on stimulation day 1), the study will compare degarelix 2.5 mg administered in the mid-luteal phase to placebo administered in the mid-luteal phase. after stimulation day 1 the placebo group will be split into two groups: a degarelix 2.5 mg follicular group and a ganirelix 0.25 mg group.

Eligibility criteria:
inclusion criteria * signed informed consent form, prior to screening evaluations * in good physical and mental health * pre-menopausal females between the ages of 18-35 years (both inclusive) at the time of randomisation * regular menstrual cycles of 26-35 days duration (both inclusive), presumed to be ovulatory * body mass index (bmi) between 18 and 29 kg/m2 (both inclusive) * willing to donate the retrieved oocytes * willing to use an adequate barrier method of contraception from informed consent to day hcg injection +7 and to use an adequate barrier or hormonal method of contraception from day hcg injection +7 to the end-of-study visit exclusion criteria * abnormal karyotype * any known clinically significant systemic disease (e.g., insulin dependent diabetes) * any known endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney) which can compromise participation in the study * diagnosed with polycystic ovarian syndrome or endometriosis stage iii/iv * diagnosed as "poor responder" * history of recurrent miscarriage (defined as three consecutive spontaneous losses before weeks 24 of pregnancy) * pregnancy or lactation * use of any investigational drug during 3 months prior to start of the current coh cycle * previous participation in the study * hypersensitivity to any trial product

Keywords: assisted reproductive technology (art) oocyte donors undergoing controlled ovarian hyperstimulation for assisted reproductive technologies
acl versus all + acl study

Conditions: Anterior Cruciate Ligament Injury; Ligament Rupture

Summary: the aim of the study is to show a reduction of a re-rupture rate with an acl (antero crusader ligament) + all (anterolateral ligament) combined technique compared to a classical kenneth-jones acl (antero crusader ligament) reconstruction technique.

the aim is to evaluate the rate of re-rupture and to analyze knee function through scores analysis as international knee documentation committee subjective knee (ikdc), knee injury and osteoarthritis outcome score (koos), lysholm-tegner, and by objective measurements of laximetry and rotation. this study should include 2 groups of 296 patients with isolated acl (antero crusader ligament) with clinical rotation : * operated by a conventional patellar tendon technique (first group) * operated by a technique combining a all (anterolateral ligament) and acl plasty for the second group

Eligibility criteria:
inclusion criteria: * patients with total isolated antero crusader ligament (acl) rupture who are candidates for surgical reconstruction * patients between 18 and 35 years old * patients with weekly sporting activities * patients with chronic rotatory instability with a positive pivot shift * patients who have been informed and do not object the research exclusion criteria: * patients with multi-ligament knee involvement * patients under 18 years old or over 35 years old * patients with a bmi of under 18.5 or over 30 * patients with any contraindication to general anaesthesia * professional sportsmen/women * patients with congenital malformation or a rheumatic disease * patients with repeated antero crusader ligament (acl) rupture * patients with serious ligament disease in the contralateral knee * patients who refuse to take part in the study
homeless youth study - stepping stone 2.0

Conditions: Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse)

Summary: housing instability is both a cause and consequence of mental health problems. as such youth experiencing housing instability (e.g., homeless or marginally housed) have higher rates of mental health problems.because of their circumstances, these youth also face significant barriers to mental health care and are therefore less likely to receive the treatment that they need. mobile technology may offer a novel platform for increasing access to mental health care in this population. the primary goals of this pilot study are to (1) establish the feasibility and acceptability of delivering automated mental health interventions via smartphone technology, (2) examine the extent to which automated mental health interventions delivered via mobile technology improve mental health in homeless, marginally-housed, and exiting foster youth.


Eligibility criteria:
inclusion criteria: * 16-25 years * english-speaking * youth must meet one of the following risk criteria * experiencing housing instability as defined by: * lacking a fixed, regular, and adequate nighttime residence or whose primary nighttime residence is a shelter, institution, or a "public or private place not designed for, or ordinarily used as, a regular sleeping accommodation for human beings" * sharing the housing of other persons due to loss of housing \[or\] economic hardship. * frequent moves, poor housing quality (e.g., living in severely overcrowded housing). * imminently leaving the foster care system * willingness and ability to comply with requirements of the study protocol exclusion criteria: \* inability to understand study procedures and participate in the informed consent process.
enhanced problem-solving therapy and hiv engagement support to improve perinatal mental health & hiv outcomes in malawi

Conditions: HIV; Depression; Depression, Postpartum

Summary: the main objective of the proposed study is to evaluate the effectiveness of the enhanced friendship bench intervention to improve perinatal depression, hiv care engagement, and infant health outcomes among pregnant women with hiv and depression in malawi.

in our r34 pilot trial, the enhanced friendship bench intervention showed strong feasibility, acceptability, fidelity, and preliminary effectiveness to improve perinatal depression and engagement in hiv care. the goal of this proposal is to evaluate the effectiveness of the enhanced friendship bench in a fully powered randomized control trial to improve perinatal depression, hiv care engagement, and infant health outcomes, examine mediators and moderators that help elucidate mechanisms of action, and collect key implementation measures to accelerate the translation of findings into practice.

Eligibility criteria:
inclusion criteria: * presenting for antenatal care at one of our 5 recruitment sites * ≥ 18 years of age * ≤ 34 weeks gestation * hiv-positive, based on medical records * initiating, re-initiating, or on established art during index pregnancy * elevated depressive symptoms as indicated by a epds score ≥10. the epds is widely used to assess perinatal mood disorders that has been validated in perinatal populations in malawi with this cut point to identify probable perinatal depression exclusion criteria: * suicidal ideation evaluated as acute risk. * other health concerns requiring emergent response.
effects of vildagliptine and glimepiride on glucose variability

Conditions: Diabetes Mellitus, Non-Insulin-Dependent

Summary: the purpose of this study is to analyze the differences of blood sugar level and glycemic variability between sulfonylurea and dpp-4 inhibitor groups applying cgms for a chosen number of type 2 dm patients. the investigators also reveal influences of each drugs on cardiovascular risk factors by measuring related biomarkers.

we enroll patients with type 2 dm with uncontrolled glucose level on metformin monotherapy over 1000mg /day (hba1c over 7%). before drug administration, we conduct basal lab study including cgms. after 3 month of random administration of vildagliptin or glimepiride, we check cgms, glucose levels, cv biomarkers, and estimate hypoglycemic index. we replace with the other drug for 3 months, and then conduct the same measurements. no wash-out period is necessary since result variables are measured after the 3 months of administration for a different drug.

Eligibility criteria:
inclusion criteria: * with type 2 dm * with uncontrolled glucose level on metformin monotherapy over 1000mg /day (hba1c over 7%). provided that the tolerance for metformin is poor, enrollment of patients with lower dose of metfomrin is open. * who have never been prescribed with test drugs, sulfonylurea or dpp-4 inhibitor/glp-1 analogue in 3 months * who can be applied with cgms exclusion criteria: * who has liver function abnormality or renal function abnormality * who has any kind of diseases, operations, medical treatments that can affect glucose levels