Kornimate/medical-research-clean huggingface dataset:
the positive piggy bank - a positive activities intervention for improving functional status in patients with back pain

Conditions: Low Back Pain

Summary: investigators will conduct a randomized controlled trial of a 30-day positive activities intervention, positive piggy bank, compared to a wait-list control group (figure 2). prior to their scheduled appointment to undergo epidural steroid injection, all patients meeting study criteria will be contacted by research staff to be invited to participate in this study. those interested will be asked to arrive 45 minutes before their regularly scheduled appointment. at that time they will learn more about the study and provide informed consent if they choose to participate. participants will then complete the study questionnaires and be randomized 1:1 to the positive piggy bank condition (n=100) or the wait list control group (n = 100). all participants will receive the usual treatment provided at the back \& pain center at the university of michigan, department of anesthesiology (e.g., maintenance of medication regimen, standard office visits). post-intervention (day 30) and 2 months after that (day 90), participants will complete the same questionnaires by mail. the primary outcome will be improved functional status, while secondary outcomes will be symptomatic (i.e., pain, fatigue and sleep) and related to mood and well-being. after the study period, the patients in the wait list control will be offered the positive piggy bank intervention and will be asked to complete one more set of questionnaires at 30 days by mail.


Eligibility criteria:
inclusion criteria: primary diagnosis of back pain and schedule to undergo an epidural steroid injection. : 1. ages 18 to 80; 2. able to read/understand english and give consent; 3. willing and able to comply with all aspects of study procedures; 4. if on antidepressants, medications stable for ≥4 weeks prior to study; 5. no plan to initiate a new non-pharmacological pain intervention during the 30-day study period (e.g., back surgery, physical therapy, cognitive-behavioral therapy); 6. if on pain medications, medications stable for ≥4 weeks prior to study and no plans to switch medications during the 30-day study period. - exclusion criteria: participants may meet all criteria above, but will be excluded under the following additional conditions: 1. having a known psychotic disorder or the presence of another psychiatric condition (e.g., severe depression, suicidal ideation) or cognitive impairment (e.g., severe dyslexia, traumatic brain injury) limiting ability to give consent and/or participate fully in the study; 2. currently undergoing psychotherapeutic care at the back \& pain center; 3. other factors that at the discretion of the investigators would adversely affect study participation. we will not exclude participants who undergo unanticipated changes in treatment, but will handle these data as described later. -
the correlation between uterine endometrial pattern and ectopic pregnancy

Conditions: Ectopic Pregnancy

Summary: a prospective trail. pregnant women in the first trimester with positive bhcg and no visualization of gestational sac will be recruited. the correlation between endometrial pattern and ectopic pregnancy will be assessed.


Eligibility criteria:
inclusion criteria: * first trimester of pregnancy * no visualization of gestational sac exclusion criteria: * hemodynamic instability
treatment of withdrawal symptoms with nada acupuncture in chronic pain patients

Conditions: Chronic Pain; Opiate Withdrawal Syndrome

Summary: this project aims at examining the following hypotheses: * treatment with nada and clonidine reduces intensity of withdrawal symptoms to a greater extent than treatment with clonidine. * opioid withdrawal improves pain, physical and mental functioning and reduces opioid consumption 3 months and 1 year after withdrawal.


Eligibility criteria:
inclusion criteria: * chronic pain patients treated with opioids over 3 months * the patient's doctor or nurse assesses that there is an indication to opioid withdrawal and / or the patient wishes to withdraw. * the patient is motivated for opioid withdrawal * the patient has experienced withdrawal symptoms * the patient must be able to understand, speak and write danish * the patient must be able to transport himself to the pain center exclusion criteria: * children under 18 years old * external ear infection * treatment with benzodiazepines. * active substance abuse and alcohol abuse. * contraindications for treatment with clonidine: * allergy * bradyarrhythmias caused by diseased sinus cube or av block of 2nd or 3rd grade. * lactose intolerance * heart failure * high medullary damage * cardiac conduction disturbances * pregnancy and breastfeeding

Keywords: nada
the effect of pemf for patients with knee oa

Conditions: Knee Osteoarthritis; Knee Pain Chronic

Summary: health care costs are increasing alarmingly, which will impose an overwhelming economic burden to an aging society like that of hong kong. for example, degenerative musculoskeletal disorders such as osteoarthritis (oa) present a grand challenge with its high prevalence (\>40% in the elderly suffered from knee oa). oa is a debilitating progressive disease with typical symptoms such as acute pain causing loss of mobility currently there is no cure for oa. pharmacological treatment and new regenerative technologies such as stem cell therapy are actively being developed, but most of these options are very expensive per se, and side effects are not uncommon. costeffectiveness is also a major consideration for devising new therapeutic modalities for oa. there are emerging evidences showing that pulsed electromagnetic field (pemf) can modulae mitochondrial activities for muscle gain. pemf exposure on top of regular exercise training may promote muscle regeneration and tissue healing. this study aims to conduct a double-blinded, randomized controlled trial to investigate the effect of pemf treatment on knee pain in patients with knee oa. we hypothesize that pemf treatment is effective to relief in pain and improve knee function in knee oa subjects. based on the aim of this study, older adult patients (aged 50 or above) with knee oa with kellgren-lawrence grade 2-4 by x-ray, have sedentary lifestyle (tegner activity level less or equal to 3), no acute knee injuries in past 12 months, no muscle strain in past 12 months and not degenerative joint disease in other joints except the involved knee. to estimate the improvement of patients, isometric quadricep muscle strength, posture assessment, serum myokine level, serum vitamin d level and selfreported outcome with questionnaires will be performed.


Eligibility criteria:
inclusion criteria: 1. age 50 or above 2. knee oa with kellgren-lawrence grade 2-4 by x-ray 3. sedentary lifestyle (tegner activity level ≤ 3) 4. no acute knee injuries in past 12 months 5. no muscle strain in past 12 months 6. no degenerative joint diseases in other joints except the involved knee exclusion criteria: 1. age smaller than 50 years old 2. experienced any concomitant bone fracture, acl injury, major meniscus injury 3. any rheumatological diseases 4. metal implants that would cause interference on mri 5. previous contralateral knee injury 6. recent knee injections (prior 3 months) 7. physical inability to undertake testing procedures 8. pregnancy or possibility of pregnancy

Keywords: pulse electromagnetic field pemf knee osteoarthritis knee oa knee pain
spoton trial evaluating the efficacy on balance disorder symptoms (steady)

Conditions: Balance Disorders

Summary: a randomized, double blind, placebo-controlled study to assess the efficacy and safety of spoton specs for the treatment of chronic dizziness \& imbalance.


Eligibility criteria:
inclusion criteria: * age: 18≤ years ≤70 * dhi score of at least 36 (moderate to severe handicap) * one or more symptoms of unsteadiness, dizziness or vertigo are present on most days. symptoms could vary in intensity however lasts for 3 months or more * ability to perform all tests (including computerized test) and interviews * at least three months after the last vestibular balanced rehabilitation therapy - (if applicable) * gave informed consent for participation in the study exclusion criteria: * dizziness disease with fluctuating symptoms * any active or non-controlled disease that might cause dizziness and imbalance, unless well controlled for at least 3 months * moderate-severe depression or anxiety * known related eye disease * pregnant women * currently taken part in a clinical trial or within 30 days prior to screening * concomitant use of any medications that might affect the balance system
modified collaborative assessment vs standard assessment on readiness for psychotherapy among patients with anxiety

Conditions: Psychotherapy; Social Anxiety Disorder; Personality Disorders

Summary: the present study wish to compare the preliminarily effects and feasibility of modified collaborative assessment (mca) - a novel therapeutic approach to diagnostic assessment - with assessment-as-usual among patients with evasiveness as a core psychopathological feature in a randomised controlled study design.

the present study wish to compare the preliminarily effects and feasibility of modified collaborative assessment (mca) - a novel therapeutic approach to diagnostic assessment - with assessment-as-usual (aau) among patients with evasiveness as a core psychopathological feature in a randomised controlled study design. the study will include and randomise 42 patients 1:1 to either mca or aau, which will be administered as a pre-treatment to the standard psychotherapeutic intervention they will receive in the psychotherapeutic clinic. mca will utilize standardised psychological tests administered in collaboration with the patients, in order to thorough diagnose the included patients. the tests available will be the present state examination (pse), the structured clinical interview for dsm-5 personality disorders (scid-5-pd), the screen for cognitive impairment in psychiatry (scip), the autism diagnostic observation schedule (ados-2), the examination of anomalous self-experience (ease), the wechsler adult intelligence scale (wais-iv), the level of personality functioning - brief form 2.0 (lpfs-bf), the personality inventory for dsm-5, 36 item version (pid-36) and the conners´ adult adhd rating scales (caars). data are gathered through a number of questionnaires from patients prior to randomization (t0), at end of mca (t1) and after four weeks of psychotherapy (t2) - absolute time depend on clinical logistics and timing of group therapy onset.

Eligibility criteria:
inclusion criteria: * a tentative icd-10 diagnosis of either sad or epd * going to be offered treatment in the psychiatric community clinics in naestved, maribo or slagelse exclusion criteria: * severe physical health problems. * lack of spoken and written danish corresponding to 9th grade primary school. * eating disorder with bmi \< 18 * psychotic illness * active diagnosis of substance abuse

Keywords: therapeutic assessment psychiatry person-centered mental health service pre-therapy collaborative assessment
effects of acute sci on colonic motility & tone

Conditions: Spinal Cord Injury

Summary: this study will compare individuals with acute sci to control patients in order to: 1. determine if there are changes in colonic tone and sensation after sci by comparing the fasting responses to the postprandial responses; 2. determine if there are changes in colonic phasic motility after sci by comparing the fasting responses to the postprandial responses; 3. determine if colonic motor and sensory function after sci change over time by repeating these studies six month later in sci and control patients.


Eligibility criteria:
acute sci with impaired colonic tone

Keywords: spinal cord injury, gastrointestinal motility, gastrointestinal transit
effect of enzyme replacement therapy in patients with juvenile-onset pompe disease

Conditions: Pompe's Disease Juvenile Onset

Summary: pompe disease is known as glycogen storage disease type ii, an autosomal recessive disease that results from acid alpha-glucosidase (gaa) deficiency leading to lysosomal glycogen accumulation. patients with classic infantile form have less than 1% of enzyme activity, which explains severe impairment before one year with rapid death without treatment, while later-onset form shows progressive symptoms later in childhood (juvenile form) or adulthood (adult form). enzyme replacement therapy (ert) consists of periodic intravenous infusion of missing gaa produced by the recombinant method. ert improves significantly the cardiac function and the children's survival in classic infantile form. this therapy has been approved for all patients with pompe's disease in the united states and the european union since 2006, but its efficacy was not clear for patients with later-onset form. recent studies show motor improvement in adult patients, but there is little published data for the juvenile form disease. a separate analysis of juvenile form is justified as patients are still in a developmental stage and show clinical symptoms early in life, may have more severe disease and a different response to ert. the recommendation is no treatment in the absence of clinical symptoms, but the consensus does not stratify patients into juvenile- or adult-onset form. ert is an expensive long-term therapy, and its administration every 2 weeks in the hospital is a great limitation for patients. therefore, an evaluation of the treatment effect in patients with the juvenile form is necessary.

this study includes patients from several hospitals in france. the parameters allowing the evaluation of the respiratory and muscular function are collected.

Eligibility criteria:
inclusion criteria: * childhood pompe disease (the first symptoms appear before 18 years old) * follow-up in france exclusion criteria: * infantile pompe disease * cardiomyopathy at diagnosis

Keywords: no cardiomyopathy at diagnosis
replication of the inspire trial in healthcare claims data

Conditions: Chronic Obstructive Pulmonary Disease

Summary: investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. the investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.

this is a non-randomized, non-interventional study that is part of the rct duplicate initiative (www.rctduplicate.org) of the brigham and women's hospital, harvard medical school. it is intended to replicate, as closely as is possible in healthcare insurance claims data, the trial listed below/above. although many features of the trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial. randomization is also not replicable in healthcare claims data but was proxied through a statistical balancing of measured covariates according to standard practice. investigators assume that the rct provides the reference standard treatment effect estimate and that failure to replicate rct findings is indicative of the inadequacy of the healthcare claims data for replication for a range of possible reasons and does not provide information on the validity of the original rct finding.

Eligibility criteria:
inclusion criteria: * age between 40-80 years \[0,0\] days * diagnosis of copd \[all available data, 0\] days * clinical history of at least 1 copd exacerbation \[all available data, -43\] days exclusion criteria: * copd exacerbation \[-42, 0\] days * asthma, eczema, atopic dermatitis, allergic rhinitis \[-180, 0\] days * known respiratory disorder other than copd e.g. pulmonary fibrosis or interstitial lung disease (ild), sarcoidosis, lymphangioleiomyomatosis, primary/pulmonary tuberculosis, cystic fibrosis, pulmonary hypertension/other pulmonary heart disease, lung/pulmonary malignancies, alpha-1 antitrypsin deficiency, pneumoconioses and other lung diseases due to external agents \[all available data, 0\] days * narrow angle glaucoma or prostatic hyperplasia or obstruction of the neck of the bladder \[-180, 0\] days * at least one 30-day supply prescription claims for oral alfuzosin, doxazosin, tamsulosin, silodosin, finasteride 5 mg, dutasteride \[-180,0\] days * lung transplant or lung volume reduction surgery (lvrs) \[all available data, 0\] days * daily long term oxygen therapy (ltot) \[all available data, 0\] days * beta-blockers (except eye drops) \[-180, 0\] days * evidence of alcohol, drug or solvent abuse \[-180, 0\] days * use of salmeterol, tiotropium and fluticasone containing inhaler use \[-180, 0\] days
community services navigation to advance health equity in breast cancer screening

Conditions: Breast Cancer

Summary: the goal of this study is to evaluate if adding community services navigation to the standard referral process for social needs is an effective and scalable strategy for addressing disparities in follow-up to abnormal breast cancer screening results. the investigators will determine the effectiveness of social needs referrals combined with a community services navigation intervention in the screening mammography setting to improving breast screening outcomes in underserved women.


Eligibility criteria:
inclusion criteria: * english and spanish speakers * received an abnormal result of a screening mammogram * self-reports at least one social need on the b-sincere screener exclusion criteria: -prior diagnosis of breast cancer
web-based international multi-center clinical study for parkinson's disease

Conditions: Parkinson Disease

Summary: the objectives of this study are (1) to compare the clinical outcome in correlation with the electrode positions estimated by web-based image fusion of the preoperative mri and the postoperative brain ct taken at a stable period after surgery using mutual information technique in the patients with advanced parkinson's disease (pd) after bilateral stn dbs and (2) to examine whether the documentation of the electrode position by using mutual information technique at a stable period after unilateral or bilateral stn stimulation provides useful information for the postoperative programming.


Eligibility criteria:
inclusion criteria: * advanced parkinson disease patients exclusion criteria: * the patients who have experienced any perioperative or postoperative complications * the patients with severe cognitive impairment, ongoing psychiatric problems, an unsatisfactory general condition for evaluation, or an inability

Keywords: electrodeposition subthalamic nucleus deep brain stimulation parkinson disease
necrotizing enterocolitis (nec) and b. lactis in premature babies

Conditions: Necrotizing Enterocolitis

Summary: the purpose of the trial is to demonstrate the effect of b. lactis in reducing the incidence of necrotizing enterocolitis (nec) compared to placebo in preterm infants.


Eligibility criteria:
inclusion criteria: * weight between 800 - 1500g * tolerating enteral feeding within 48 hours * having obtained his/her parents or legal representative informed consent exclusion criteria: * chromosomal abnormality * hydrops featalis * congenital malformation of the gastrointestinal tract * congenital heart defects or other major congenital abnormalities likely to affect feeding and/or feeding tolerance * currently participating in another clinical trial

Keywords: b. lactis preterm necrotizing enterocolitis (nec)
left ventricular hypertrophy and spironolactone in end stage renal disease

Conditions: Kidney Failure, Chronic

Summary: the hypothesis of this trial is to assess the effect of spironolactone on heart size and mass

dialysis patients have significant morbidity and mortality associated with left ventricular hypertrophy and cardiac failure. aldosterone may have an important role in the development of myocardial hypertrophy and remodeling. animal studies have demonstrated beneficial effects of aldosterone antagonists on myocardial hypertrophy, and human studies have shown significant survival benefit in a non-dialysis population with congestive heart failure. this study evaluates the effect of spironolactone (an aldosterone receptor antagonist) on cardiac hypertrophy in the end-stage renal disease population.

Eligibility criteria:
inclusion criteria: * hemodialysis patients exclusion criteria: * non compliance * hyperkalemia * pregnancy * expected survival less than 9 months

Keywords: kidney failure, chronic hemodialysis spironolactone
turning pattern of different body segments during turns and turning performance

Conditions: Parkinson's Disease

Summary: this is a cross-sectional exploratory study. a total of 25 people with pd, 25 young healthy adults, and 25 middle to older adults will be recruited. axial segment turning pattern and turning performance will be evaluated in two visits using the vicon 3d motion analysis system, gaitup, and 3d motion camera. the independent variables are the initiation timing of the head, upper trunk, pelvis, ankle, and foot when turning and the initiation sequence of turning (% turn). the dependent variables are turning performance, including turning velocity, turning steps, turning step length, turning step width), and stance phase (%).

the first aim of the present study is to explore the correlation between axial segment turning pattern and turning performance in people with pd and healthy adults. the second aim is to verify the validity and reliability of 3d motion camera in turning evaluation. a total of 25 people with pd, 25 young healthy adults, and 25 middle to older adults will be recruited. axial segment turning pattern and turning performance will be evaluated in two visits using the vicon 3d motion analysis system, gaitup, and 3d motion camera. the independent variables are the initiation timing of the head, upper trunk, pelvis, ankle, and foot when turning and the initiation sequence of turning (% turn). the dependent variables are turning performance, including turning velocity, turning steps, turning step length, turning step width), and stance phase (%). for the data analysis, the shapiro-wilk test will be used to check for normal distribution. pearson's correlation coefficient or spearman's rank correlation coefficient will be used to examine the correlations between axial segment initiation timing and turning performance. to verify the validity and reliability, pearson's correlation coefficient will be used for concurrent criterion validity. intraclass correlation one-way random model will be used for test-retest reliability, showed with intraclass correlation coefficient and 95% confidence interval. a p-value of less than 0.05 is considered statistically significant.

Eligibility criteria:
inclusion criteria: * able to walk 5 meters without assistance device * able to turn independently exclusion criteria: * with neurological disorders * mmse\< 24 * any systemic and musculoskeletal disturbances or other causes of walking inability

Keywords: parkinson's disease turning inter-segmental coordination en bloc turning turning performance